Bovine Serum Albumin ((BSA) is intended for those assisted reproductive procedures that require the use of a protein supplement. In particular, BSA is intended for use during in vitro fertilization, during in vitro embryo culture to the desired stage of embryo development, and for the cryopreservation of human embryos.

Device Description

Bovine Serum Albumin, Fraction V 10% solution consists of Bovine Serum Albumin from United States source animals (10mg/mL) in a sterile saline solution. Bovine Serum Albumin, Fraction V Powder consists of BSA from United States source animals.

AI/ML Overview

The provided text describes a medical device, Bovine Serum Albumin (BSA), not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set size, and how ground truth was established for training data) are not applicable.

However, I can extract information regarding the acceptance criteria and the study that proves this particular device meets those criteria:

Device: Bovine Serum Albumin (BSA)
Intended Use: For use in assisted reproductive procedures (in vitro fertilization, embryo culture, and cryopreservation of human embryos) that require protein supplementation.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (implicitly derived from "Notice of Final Rule, 63 FR 48428, Docket number 97N-0335")	Reported Device Performance (from "Performance Data" and "Additional Information" sections)
Functionality for intended use: Support embryonic growth	Assured by Mouse Embryo Assay prior to release to market. The product has been used in clinical settings for years and is a standard protein supplement.
Absence of toxic components: Non-toxic for embryonic growth	Assured by Mouse Embryo Assay prior to release to market.
Sterility	Tested as a condition of release.
Endotoxin levels	Tested as a condition of release.
Suitability for intended use, meeting criteria of Notice of Final Rule.	Performance testing and review of historical professional literature concluded suitability.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in terms of number of embryo cultures. The "Mouse embryo assay" ("MEA") is a biological test, and typically involves a certain number of embryos, but the specific quantity is not mentioned.
Data Provenance: Not explicitly detailed. The BSA itself is stated to be from "United States source animals." The clinical use mentioned is broad ("in a variety of clinical settings"), without specific countries or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a biological product, and its performance is evaluated by a standardized biological assay (Mouse Embryo Assay) rather than expert interpretation of a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a biological product, and its performance is evaluated by a standardized biological assay.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI/ML device. The "standalone" performance here would refer to the product's direct effect on embryos, which is tested via the Mouse Embryo Assay.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this product's performance is established through functional biological assay (Mouse Embryo Assay) and analytical testing (endotoxin, sterility). The Mouse Embryo Assay measures the ability of the product to support embryo development and ensures the absence of toxicity.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device, so there is no "training set."

Summary

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Irvine Scientific

JE 491338 14 1939

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IRVINE SCIENTIFIC

510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)

Submitted by:

Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705-5588

Telephone: (800) 437-5706 Facsimile: (949) 261-6522

Contact: Roberta L. Johnson

Date Submitted: April 16, 1999

Device Identification:

Trade Name:	Bovine Serum Albumin (BSA)
Common Name:	Protein supplement for in vitro embryo culture
Classification Name:	Reproductive Media (21 CFR, 886.6180)

Predicate Device:

Notice of Final Rule, 63 FR 48428, Docket number 97N-0335

Description:

Bovine Serum Albumin (BSA)

2511 Daimler Street · Santa Ana, CA · 927055588 · 949-261-7800 · 800-437-5706 · FAX: 949-261-6522 · http://www.ci.com

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Intended Use:

Bovine Serum Albumin is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth.

Technological Characteristics:

Depending upon the procedure used, an appropriate amount of pre-warmed, equilibrated BSA is withdrawn, and added to the culture dish and support medium. After the desired stage of embryo development is achieved, the embryo is removed from the culture dish, placed into a HEPES-buffered transfer medium, and implanted into the patient. BSA is not intended to contact the patient.

Performance Data:

BSA is assayed by mouse embryo assay prior to release to market. This assay assures that the product is both functional for its intended use, the support of embryonic growth, and that no toxic components are present in the formulation. Bovine Serum Albumin has been used in a variety of clinical settings, for their intended use, for a number of years. In that time, the product has become one of the standard protein supplements used for the in vitro fertilization and growth of human gametes and embryos.

Additional Information:

Mouse embryo testing will be performed as a condition of release for this product, as well as endotoxin and sterility testing. Results of all release assays performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling.

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Conclusion:

The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that Bovine Serum Albumin is suitable for its intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 1999

Ms. Roberta L. Johnson Manager, Regulatory Affairs Irvine Scientific. Inc. 2511 Daimler Road Santa Ana, CA 92705-5588 Re: K991338 Bovine Serum Albumin (BSA) Dated: April 16, 1999 Received: April 19, 1999 Requlatory Class: II 21 CFR §884.6180/Procode: 85 MQL

Dear Ms. Johnson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director. Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Irvine Scientific

INDICATIONS FOR USE STATEMENT (page 1 of 1)

510(K) Number: K99 1338

Device Name: Bovine Serum Albumin (BSA)

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rate Peller

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number

Prescription Use __
(Per 21 CFR 801.109)

Regulation Number and Section

§ 884.6180 Reproductive media and supplements.

(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.