Write a Biological Evaluation Report (BER) for your start-up medical device company? Review the testing, please provide test results spelled out in submission?

Device Information You company is developing and will be manufacturing a new device, called CuPid. CuPid is a non-hormonal based, copper intrauterine device that prevents pregnancy, typically also referred to as an IUD. CuPid is being submitted under a 510(k) using the ParaGard T 380A Intrauterine Copper Contraceptive as the predicated device. The device is intended to be used as a contraceptive device that, once placed by an appropriate professional, will be in place for up to 5 years. The device can be removed and replaced as necessary by an appropriate professional.

The testing that was performed on CuPid includes the following:

1. Test Description: Chemical Characterization Analysis

Gas Chromatography Mass Spectroscopy Compounds Detected

Solvent Extractables Molecular CAS SMILES Confidence Total Name Formula Level Amount (ug/test article) Water No Compounds Detected above AET IPA C18H38 593- CCCCCCCCCCCCCCCCCC Confident 231 Octadecane 45-3 Hexane C18H38 593- CCCCCCCCCCCCCCCCCC Confident 183 Octadecane 45-3 Hexane C15H32 629- CCCCCCCCCCCCCCC Confident 28,000 N-Pentadecane 62-9Solvent Extractables Molecular CAS SMILES Confidence Total Name Formula Level Amount (ug/test article) Water No Compounds Detected above AET PA C42H6303 31570-04-4 CC(C)(C)C Confident 453 P 1=CC(=C(C= C1)OP(OC2= C(C=C(C=CZ) c(c)(qq)c(c )(C)C)OC3=C (C=C(C=C3)C (C)(qq)c(C) (C)C)c(C)(Q) Irgafos 168 C PA Methyl 3- C18H2803 6386-38-5 0=C(OC)C Tentative 205 (3,5-di-tert- CC1=CC(C(C butyl-4- )(CC)=C(0) hydroxyphe C(C(C)(C)C)= nyl propion C1 ate IPA C39H6008 36913-60-7 OCC(COC(C Confident 736 CC1=CC(C(C )(CC)=C(0) c(c(C) (C)q)= (1)=0)(CO) COC(CCC2= Irganox cc(c(C) (C)C) 1010 =c(0)c(c(C) degradant (C)C)=C2)=0 Hexane No Compounds Detected above AETSolvent Extractables Name CAS Total Amount (ug/test article) Water Chromium 7440-47-3 0.2 Copper 7440-50-8 250 Sodium 7440-23-5 1,000Material Name Additional Material Information (i.e. colorants) Color Constituent: Titanium Dioxide (White) Resin, Compounded DSM Thermoplastic Copolyester Elastomer (34 Shore) Amitel UV Stabilizer (Tinuvin 622) Stabilizer (Irgafos 168) Color Constituent: Titanium Dioxide (White) Color Constituent: MPC Black 110-007-065 Resin, Compounded DSM Amitel Thermoplastic Copolyester Elastomer (53 Shore) UV Stabilizer (Tinuvin 622) Stabilizer (Irgafos 168) Copper Wire Elemental Copper 316L Stainless Steel N/AObservations Particulates Fragments Extract Transparency Extract Color Pre Extraction None None Clear Normal Post Extraction None None Clear NormalErythema Edema 0 = No erythema 0 = No edema 1 = Very slight erythema (barely perceptible) 1 = Very slight edema (barely perceptible) 2 = Well defined erythema 2 = Well defined edema (edges of area well- defined by definite raising) 3 = Moderate erythema 3 = Moderate edema (raised ~1 mm) 4 = Severe erythema (beet redness) to eschar formation 4 = Severe edema (raised 1 mm and extending preventing grading of erythema beyond exposure area)Patch test Reaction* Grading scale No visible change - No erythema and edema O Discrete or patchy erythema Moderate and confluent erythema 2 Intense erythema and/or swelling 3 * Dermal Observation Scoring (as per Magnusson and Kligman scale)Test Article and Controls Cytotoxicity Score* 24 Hours 48 Hours 72 Hours Test Article 0/0/0 1/1/1 3/3/3 Positive Control 4/4/4 4/4/4 4/4/4 Negative Control 0/0/0 0/0/0 0/0/0 Cell Control 0/0/0 0/0/0 0/0/0 *Testing was completed in triplicate