Embryo Biopsy Medium is intended for use in assisted reproductive technology procedures that involve the manipulation of embryos. Specifically, Embryo Biopsy Medium is intended for use as a temporary culture medium during embryo biopsy blastomere removal procedures.

Device Description

Embryo Biopsy Medium is a defined media intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in human fallopian tubes. Embryo Biopsy Medium uses a combination of HEPES/sodium bicarbonate buffering system and is appropriate for those procedures that do not require the use of a carbon dioxide incubator.

AI/ML Overview

The provided text describes the 510(k) summary for "Embryo Biopsy Medium" and its predicate device. This document is a regulatory submission for a medical device and not a study report detailing acceptance criteria for an AI/ML powered device.

Therefore, most of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for AI models, training set details) is not applicable to this document as it pertains to a traditional medical device (a culture medium) and not an AI-powered diagnostic or predictive tool.

However, I can extract the acceptance criteria and the "performance data" as described for this non-AI device.

Acceptance Criteria and Device Performance for Embryo Biopsy Medium

The provided document describes a traditional medical device (a culture medium), not an AI-powered device. Therefore, the typical acceptance criteria and study methodologies for AI/ML devices (e.g., sensitivity, specificity, MRMC studies, training/test sets, expert ground truth) are not applicable.

Instead, the acceptance criteria for this medical device are based on its biological function and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Safety: Does not adversely impact embryonic growth and is free from toxic components.	Measured by Mouse Embryo Assay (MEA): "Embryo Biopsy Medium is assayed by mouse embryo assay prior to its release to market. This assay assures that the product will not adversely impact embryonic growth and that no toxic components are present."
Functional Efficacy (Intended Use): Suitable for its intended use, which is to prevent compaction of cleavage-stage embryos and allow for easier separation and removal of 1-2 blastomeres during embryo biopsy procedures, while maintaining physiological pH in an ambient atmosphere.	Historical Clinical Use: "The equivalent of Embryo Biopsy Medium has been used in a variety of clinical settings for the same intended use for a number of years and has become the standard medium used for the fertilization and growth of human gametes and embryos." pH Maintenance: Contains a combined sodium bicarbonate/HEPES Buffer system to maintain physiological pH in ambient atmosphere (does not require CO2 incubator).
Quality Control: Meets quality control standards for endotoxin and sterility.	Assay for Release: "endotoxin and sterility testing will be performed as a condition of release for this product."
Regulatory Compliance: Meets criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.	The submission's conclusion states: "The conclusion from performance testing as well as a review of the historical information contained in professional literature shows that Embryo Biopsy Medium is suitable for the intended use and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335."

The following sections are Not Applicable (N/A) as this document describes a traditional medical device, not an AI/ML powered device.

2. Sample size used for the test set and the data provenance

N/A. The performance data relies on Mouse Embryo Assays and historical clinical use, not a distinct "test set" in the context of an AI/ML study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. Ground truth as understood for AI/ML models is not directly applicable here. The "ground truth" for this device's performance is its biological effect (non-toxicity, pH maintenance, support of embryonic growth/manipulation) demonstrated through laboratory assays and established clinical practice.

4. Adjudication method for the test set

N/A. No adjudication method described as it's not a diagnostic reading task.

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

N/A. This is not an AI-powered device.

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

N/A. This is not an AI-powered device.

7. The type of ground truth used

For the Mouse Embryo Assay (MEA), the ground truth is the observable outcome of embryonic development (e.g., toxicity, normal growth).
For the pH maintenance, the ground truth is the measured pH value.
For endotoxin and sterility, the ground truth is the absence or presence of contamination as determined by standard laboratory tests.
For the intended use claims, the ground truth is established through "historical information contained in professional literature" and "clinical settings for the same intended use."

8. The sample size for the training set

N/A. This is not an AI-powered device, so there is no training set.

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

N/A. This is not an AI-powered device, so there is no training set.

Summary

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5 2002 ர்பட

April 15, 200

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: Wendell Lee, Pharm, D.

Date Submitted: April 15, 2002

Device Identification:

Trade Name:	Embryo Biopsy Medium
Common Name:	Embryo Biopsy Medium
Classification Name:	Reproductive Media (21 CFR, 884.6180)

Predicate Device:

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

Description:

Intended Use:

Embryo Biopsy Medium is intended for use during embryo biopsy procedures of human embryos.

Embryo Biopsy Medium

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K021358
April 15, 2002 Page 2 of 2

Technological Characteristics:

Embryo Biopsy Medium prevents compaction of cleavage-stage embryos and allows for easier separation and removal of 1-2 blastomers during embryo biopsy procedures. Embryo Biopsy Medium contains a combined sodium bicarbonate/HEPES Buffer system to maintain physiological pH in ambient atmosphere (does not require CO2 incubator).

Performance Data:

Embryo Biopsy Medium is assayed by mouse embryo assay prior to its release to market. This assay assures that the product will not adversely impact embryonic growth and that no toxic components are present. The equivalent of Embryo Biopsy Medium has been used in a variety of clinical settings for the same intended use for a number of years and has become the standard medium used for the fertilization and growth of human gametes and embryos.

Additional Information:

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

Conclusion:

The conclusion from performance testing as well as a review of the historical information contained in professional literature shows that Embryo Biopsy Medium is suitable for the intended use and meets 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

ப்பட 5 2002

Wendell Lee, Ph.D. Quality Systems and Regulatory Affairs IRVINE Scientific Sales Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588

Re: K021358

Trade/Device Name: Embryo Biopsy Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II

Product Code: 85 MQL Dated: April 15, 2002 Received: April 29, 2002

Dear Dr. Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy C. Brogdon

Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:_Embryo Biopsy Media

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use . (Per 21 CFR 801.109)

Nancy C. Hogdon

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

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.