Embryo Freeze Media Kit is intended for use in the assisted reproductive procedure, of embryo cryopreservation. The two media kit is designed to protect human cleavage-stage embryos during rapid freezing procedures and during frozen storage.

Embryo Thaw Media Kit is intended for use in the assisted reproductive procedure of thawing frozen cleavage-stage embryos. The three media kit is designed to protect human cleavage-stage embryos during warming and thawing after cryopreservation.

Device Description

The five media that comprise the two kits, Embryo Freeze Media Kit and Embryo Thaw Media Kit are all based upon the formulation of modified human tubal fluid (K983586). The two media in the Embryo Freeze Media kit are intended to be used sequentially, for the preparation for, and cryopreservation of, human blastocysts. The first medium to be used, F1, which is used in preparation for freezing, contains 1.5M PROH. The second medium, F2, to be used during cryostorage, containing 1.5M PROH and 0.1M sucrose. Both F1 and F2 are also supplemented with human serum albumin (HSA).

The three media in the Embryo Thaw Media kit are also intended for sequential use in the thawing and recovery of cryopreserved human embryo. The first medium used in the thawing process, T1, contains 1.0M PROH and 0.2M sucrose. The second medium, T2 contains 0.5M PROH and 0.2M sucrose. T3 contains 0.2M sucrose. Each T1, T2 and T3 contain HSA. All five media contain gentamicin sulfate.

The media in the Embryo Freeze Media Kit, F1 and F2 are designed to be used sequentially for the preparation of embryos for cryopreservation, and as the protective media during cryostorage. The media in the Embryo Thaw Kit, T1, T2 and T3 are also designed for sequential use, in the thawing and recovery of cryopreserved human embryos. None of the media are intended to contact the patient.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Irvine Scientific Embryo Freeze Media Kit and Embryo Thaw Media Kit:

Given the nature of the product (embryo cryopreservation and thawing media) and the provided text, the "acceptance criteria" discussed are primarily related to general performance and suitability for the intended use, rather than specific numerical performance metrics typical of AI medical devices. The "study" refers to performance evaluations conducted by independent laboratories.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria/Requirement	Reported Device Performance
Suitability for intended use (cryopreservation of human cleavage-stage embryos)	"Performed at least as well as the control freeze/thaw media in use in the laboratories."
Suitability for intended use (thawing and recovery of cryopreserved human embryos)	"Performed at least as well as the control freeze/thaw media in use in the laboratories."
Compliance with general requirements outlined in 63 FR 48428, Docket number 97N-0335 (Notice of Final Rule for reproductive media)	"Suitable for their intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428. Docket number 97N-0335."
Endotoxin levels	To be performed as a condition of release; results reported on lot-specific CofA. (No specific performance metric mentioned for the study, but a quality control measure.)
Mouse embryo freezing and recovery assay performance	To be performed as a condition of release; results reported on lot-specific CofA. (No specific performance metric mentioned for the study, but a quality control measure.)
Sterility	To be performed as a condition of release; results reported on lot-specific CofA. (No specific performance metric mentioned for the study, but a quality control measure.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document explicitly states that the studies were performed using "mouse embryos". No specific number of mouse embryos is provided.
Data Provenance: The studies were conducted by "five independent field laboratories." The country of origin is not specified, but the submission is to the US FDA, implying that some or all of these labs could be in the US. The studies were retrospective in the sense that they were conducted to support the 510(k) submission, but the specific nature of the data collection (e.g., from existing cryopreservation programs or newly designed experiments) is not detailed. Given they use mouse embryos, it's highly likely they were specifically designed experimental studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The studies were conducted by "five independent field laboratories," but it's not stated how many experts within these labs assessed the outcomes or their specific qualifications. The "ground truth" here would likely be the assessment of embryo viability, cryosurvival, and developmental potential post-thaw, as determined by standard laboratory protocols and expert observation.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the product, adjudication might involve comparing the performance of the test media to existing control media, potentially through observational assessment by lab personnel.

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

No, an MRMC study was not done. This type of study (MRMC) and the concept of "human readers improving with AI assistance" are relevant for AI/radiology devices. This product is a cryopreservation media kit, not an AI diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not applicable. This product is a biological medium, not an algorithm. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" was established by the performance of mouse embryos in terms of freezing, thawing, and recovery using the media kits. This would involve observable outcomes like:

Survival rate post-thaw.
Morphology and developmental progression (e.g., re-expansion, hatching potential) of the thawed embryos.
Comparison of these metrics against a "control freeze/thaw media."

This can be considered laboratory-based observational and biological outcomes data, assessed by the staff of the independent laboratories.

8. The Sample Size for the Training Set

This information is not applicable/provided. The product is a chemical media kit, not an AI model. Therefore, there is no "training set" in the machine learning sense. The formulation would have been developed through R&D and optimization, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the reasons stated in point 8.

Summary

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Irvine Scientific

JAN 1 8 2002

K013518

October 18, 2001

Page 1 of 3

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, PhD.

Date Submitted: January 27, 2000

Device Identification:

Trade Name:	Embryo Freeze Media KitEmbryo Thaw Media Kit
Common Name:	Embryo cryopreservation mediaEmbryo thawing and recovery media
Classification Name:	Reproductive Media (21 CFR, 888.6180)

Predicate Device:

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

Description:

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October 18, 2001 Y

are intended to be used sequentially, for the preparation for, and cryopreservation of, human blastocysts. The first medium to be used, F1, which is used in preparation for freezing, contains 1.5M PROH. The second medium, F2, to be used during cryostorage, containing 1.5M PROH and 0.1M sucrose. Both F1 and F2 are also supplemented with human serum albumin (HSA).

Intended Use:

The Embryo Freeze Media Kit is intended for use in the preparation for, and cryopreservation of, human Cleavage Stage (C-S) embryos. The Embryo Thaw Media Kit is intended for use in the thawing and recovery of cryopreserved human embryos.

Technological Characteristics:

Embryos are routinely stored for use in future assisted reproductive procedures. In some instances, excess eggs will be retrieved from the patient, and fertilized. If development of these fertilized eggs indicates a potential for viability during implantation, they may be frozen for future use. In the event that the current transfer is unsuccessful, and does not result in a clinical pregnancy, the patient has embryos in reserve that may be used for implantation in future procedures. Embryos are also routinely frozen when patients have a history of unsuccessful implantation procedures, and also for those patients who desire multiple children. Media to protect the embryos during the preparation for cryopreservation, during

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K013518
October 18, 2001 Page 3 of 3

Performance Data:

The Embryo Freeze Media Kit and the Embryo Thaw Media kit have been studied by five independent field laboratories, using mouse embryos and the protocol for embryo freezing, thawing and recovery presented in the product inserts for these kits. The conclusion from all laboratories that evaluated the kits was that the Embryo Freeze Media kit and Embryo Thaw Media kit performed at least as well as the control freeze/thaw media in use in the laboratories.

Additional Information:

Endotoxin, mouse embryo freezing and recovery assay performance and sterility tests will be performed as a condition of release for these products. Results of all release assays performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling.

Conclusion:

The results from the field testing of these products demonstrates that Embryo Freeze Media Kit and Embryo Thaw Media kit are suitable for their intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428. Docket number 97N-0335.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2002

Wendell Lee, Pharm.D. Vice President Ouality Systems and Regulatory Affairs Irvine Scientific Sales Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588

Re: K013518

Trade/Device Name: Embryo Freeze Media Kit and Embryo Thaw Media Kit Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MOL Dated: October 18, 2001 Received: October 23, 2001

Dear Mr. 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

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INDICATIONS FOR USE STATEMENT (page 1 of 2)

510(K) Number: KO13518

Device Name: Embryo Freeze Media Kit; Embryo Thaw Media Kit

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

Diwalon
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number.

K013518

Prescription Use

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.