The product is intended to be used cryopreservative for protecting human sperm during cryopreservation, an adjunct to one of the techniques for ART (assisted reproductive technology).

Device Description

Sperm CryoProtec™ is a buffered salt solution containing human serum albumin and glycerol (10%), has a stable shelf-life of at least 12 months in the unopened bottle at ambient temperature. The product has extremely low endotoxin levels, protects sperm during cryopreservation, and is produced according to cGMP (pharmaceutical device registration). No material of animal origin is included in the product and no antibiotics are present, since antibiotics can have a detrimental effect on sperm. Glycerol, which is also toxic to sperm, is present at the lowest concentration found to be compatible with a cryoprotectant effect.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Sperm CryoProtec™ device:

The provided documents are a 510(k) summary and the FDA's clearance letter. These documents describe the device and its intended use, and state that the device is substantially equivalent to a predicate device based on clinical trials and comparative testing. However, they do not provide detailed acceptance criteria or the specific methodologies of the clinical trials or comparative testing. The information is high-level and focuses on regulatory equivalence rather than detailed performance metrics.

Therefore, many of the requested items cannot be definitively answered from the provided text.

Acceptance Criteria and Device Performance

The provided text states: "The results of clinical trials and comparative testing against predicate product indicates that the new device is as safe and effective as the predicate device." This is the core acceptance criterion presented – substantial equivalence in safety and effectiveness to the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion	Reported Device Performance	Comments from Document
Safety	As safe as predicate device	"The results of clinical trials and comparative testing against predicate product indicates that the new device is as safe and effective as the predicate device."
Effectiveness	As effective as predicate device	"The results of clinical trials and comparative testing against predicate product indicates that the new device is as safe and effective as the predicate device."
Intended Use	Same as predicate device	"The intended use of the product is the same."
Composition	Similar to predicate device	"Based on the similarity of composition, product testing results, and intended use, Sperm CryoProtec™ is substantially equivalent to the predicate device named above."
Product Testing	Supports equivalence	"Based on the similarity of composition, product testing results, and intended use, Sperm CryoProtec™ is substantially equivalent to the predicate device named above."

Study Details (Based on available information in the document)

Given the limited information, assumptions are made where necessary or the item is marked as "Not specified."

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "clinical trials and comparative testing."
- Data Provenance: Not specified. It does not mention country of origin or whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. The document does not detail how individual data points were evaluated or by whom.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
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:
- MRMC Study: Not applicable. This device is a cryopreservative, not an AI or imaging diagnostic device that would involve "human readers."
- Effect Size: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable as this is a medical chemical/biological product, not an algorithm. The "performance" refers to the product's ability to protect sperm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the effectiveness of a cryopreservative would typically involve objective laboratory parameters following cryopreservation and thawing, such as sperm motility, viability, and perhaps success rates in assisted reproductive technologies (ART) if clinical outcomes were part of the trials. The document broadly states "clinical trials and comparative testing," implying that relevant metrics were measured and compared to the predicate device.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "training" here would be product development and formulation.
How the ground truth for the training set was established: Not applicable. (See #7).

Summary

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023206

EXHIBIT 2 NidaCon International AB Mölndalsvägen 22 S-412 63, Göteborg, Sweden Tel +46-31-405440 Fax +46 31-405415

Contact: Paul V. Holmes MSc, PhD, DrMedSc., General Manager September 23, 2002 510(k) Summary of Safety and Effectiveness

1. Identification of the Device: Proprietary-Trade Name: Sperm CryoProtecTM Classification Name/Product Code: Reproductive Media and Supplements (21 CFR 884.6180) Procode: 85 MQL Common/Usual Name: Assisted Reproduction Media
1. Equivalent legally marketed devices: Medi-Cult Sperm Freeze Medium Cat. No. 1067, K991333
1. Indications for Use (intended use) The product is intended to be used cryopreservative for protecting human sperm during cryopreservation, an adjunct to one of the techniques for ART (assisted reproductive technology).
1. Description of the Device: Sperm CryoProtec™ is a buffered salt solution containing human serum albumin and glycerol (10%), has a stable shelf-life of at least 12 months in the unopened bottle at ambient temperature. The product has extremely low endotoxin levels, protects sperm during cryopreservation, and is produced according to cGMP (pharmaceutical device registration). No material of animal origin is included in the product and no antibiotics are present, since antibiotics can have a detrimental effect on sperm. Glycerol, which is also toxic to sperm, is present at the lowest concentration found to be compatible with a cryoprotectant effect.
1. Safety and Effectiveness, comparison to predicate devices. The results of clinical trials and comparative testing against predicate product indicates that the new device is as safe and effective as the predicate device. The intended use of the product is the same.
1. Conclusion: Based on the similarity of composition, product testing results, and intended use, Sperm CryoProtec™ is substantially equivalent to the predicate device named above

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight.

Public Health Service

8 2002

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NidaCon International AB % Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

Re: K023206

Trade/Device Name: Sperm CryoProtecTM Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements

Regulatory Class: II Product Code: 85 MOL

Dated: September 23, 2002 Received: September 25, 2002

Dear Mr. Kamm:

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. Iisting 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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Page 2

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) 594-459
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-461
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-461
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-465
Other	(301) 594-469

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,

Henry C. Snodgin

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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j) Indications for Use

510(k) Number__

Device Name: Sperm CryoProtec™

KO232060

Indications for Use: The product is intended to be used cryopreservative for protecting human sperm during cryopreservation, an adjunct to one of the techniques for ART (assisted reproductive technology).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use \checkmark OR Over the Counter Use __
(Per 21 CFR 801.109)

David C. Wegman

(Division Sign-Off) Division of Reproductive, Ab 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.