G-SPERM, MODEL 10032 by VITROLIFE SWEDEN AB

The provided document is a 510(k) premarket notification summary for the G-SPERM™ Assisted Reproduction Media, submitted by Vitrolife Sweden AB. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the typical format of a device performance study as might be expected for an imaging or diagnostic device.

The main purpose of a 510(k) summary like this is to establish that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics as the predicate, or, if there are differences, those differences do not raise new questions of safety or effectiveness.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not applicable to this type of regulatory submission and are not found in the provided text.

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance:

This information is not present in the provided 510(k) summary. The document states that "The technological characteristics of G-SPERMTM are essentially similar to those of the predicate device. The G-SPERM is a modification of the predicate device and is intended to be supplemented with albumin prior to use. Other formulation changes were made to improve the performance of the G-SPERM device. None of these differences raise new questions of safety or effectiveness." This statement implies that the performance is considered acceptable because it's equivalent to the predicate, but no specific performance metrics or acceptance criteria are listed.

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

This information is not present in the provided 510(k) summary. The document does not describe a clinical study or a test set as part of its substantial equivalence claim.

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):

This information is not applicable and not present in the provided 510(k) summary. "Ground truth" in the context of device performance studies (especially for AI or diagnostic tools) is not relevant for this type of submission which relies on demonstrating equivalence to a predicate device for an assisted reproduction medium.

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

This information is not applicable and not present in the provided 510(k) summary as there is no described test set or study requiring adjudication.

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:

This information is not applicable and not present in the provided 510(k) summary. This type of study is relevant for diagnostic devices (especially those utilizing AI to assist human readers), which is not the nature of the G-SPERM™ Assisted Reproduction Media.

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

This information is not applicable and not present in the provided 510(k) summary. The G-SPERM™ is a culture medium, not an algorithm or a device that functions in a "standalone" algorithmic capacity.

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

This information is not applicable and not present in the provided 510(k) summary. As explained in point 3, the concept of "ground truth" for this type of product and submission is not relevant.

8. The sample size for the training set:

This information is not applicable and not present in the provided 510(k) summary. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable and not present in the provided 510(k) summary.

In summary, the provided document is a regulatory submission for premarket notification (510(k)) that focuses on demonstrating "substantial equivalence" to a predicate device. It does not contain the detailed performance study information with acceptance criteria, sample sizes, and ground truth establishment that would be present for a novel device or an AI-enabled diagnostic tool.

Summary

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SEP 6 2002

PREMARKET NOTIFICATION SUMMARY IX.

KO22247

Submitted by: Vitrolife Sweden AB Mölndalsvägen 30 SE-412 63 Gothenburg SWEDEN Contact Person: Mr. Eiler Anderson Vitrolife Sweden AB Mölndalsvägen 30

Date Prepared:

Trade Name:

Common Name:

Classification Name:

Predicate Device:

Description of the Device:

Bicarbonate buffered medium containing Hyaluronan. For use after the addition of G-MMTM or HSAsolution™ and pre-equilibration at +37°C and 6 % CO2.

Intended Use: Medium for In Vitro Fertilization Procedures

Technological Characteristics: The technological characteristics of G-SPERMTM are essentially similar to those of the predicate device. The G-SPERM is a modification of the predicate device and is intended to be supplemented with albumin prior to use. Other formulation changes were made to improve the performance of the G-SPERM device. None of these differences raise new questions of safety or effectiveness.

SE-412 63 Gothenburg

Assisted Reproduction Media

(21 C.F.R. § 884.6180)

Reproductive Media and Supplements

SWEDEN

July 10, 2002

G-SPERM™

SpermRinse™

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its head and wings. The eagle is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 6 2002

Vitrolife Sweden AB % Mr. Gary L. Yingling Kirkpatrick & Lockhart 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K022247

Trade/Device Name: G-SPERM™ Assisted Reproduction Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II

Product Code: 85 MQL Dated: July 10, 2002 Received: July 12, 2002

Dear Mr. Yingling:

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. Snogdon

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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X: ~ INDICATIONS FOR USE STATEMENT

510(k) Number:

KO22247

Device Name:

G-SPERM™ Assisted Reproduction Media

Indications For Use:

Medium for sperm preparation.

R-A. Phillips NCS

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

(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 C.F.R. § 801.109)

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( )ver-the Counter 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.