SPERMCHECK FERTILITY by PRINCETON BIOMEDITECH CORP.

SpermCheck® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/mL. The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over the counter home use.

Device Description

SpermCheck® Fertility is an immunochromatographic test for the rapid, qualitative detection of sperm concentration.

AI/ML Overview

The provided text describes the 510(k) summary for the SpermCheck® Fertility device. Here's a breakdown of the requested information based on the text:

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

The document does not explicitly state "acceptance criteria" with specific numerical thresholds that the device had to meet and then report its performance against them. Instead, it focuses on substantial equivalence to existing devices. The key performance characteristic mentioned is its ability to detect sperm concentration at or above 20,000,000 sperm/mL.

Performance Metric	Reported Device Performance
Qualitative detection of sperm concentration	Detects sperm concentration at or above 20,000,000 sperm/mL.
Equivalence to microscopic analysis	Substantially equivalent to standard microscopic analysis (counting by Hemacytometer) based on WHO guidelines.
Equivalence to other rapid tests	Substantially equivalent to K073039, SpermCheck® Vasectomy Test; K041039, Fertell Male Fertility Test; and K011679, FertilMARQ™ Home Diagnostic Screening Test.

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

The document does not provide details on the sample size used for the test set or the data provenance (country of origin, retrospective/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)

The document does not provide details on the number of experts or their qualifications used to establish ground truth for a test set. It mentions "standard microscopic analysis (counting by Hemacytometer) based on WHO guidelines" as a comparator, which implies expert analysis, but specifics are missing.

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

The document does not provide details on any adjudication method used for a test set.

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 section is not applicable as the device described is a qualitative home-use immunochromatographic test, not an AI-based system assisting human readers. It's a standalone diagnostic.

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

Yes, a standalone performance was done. The SpermCheck® Fertility is an "immunochromatographic test for the rapid, qualitative detection of sperm concentration" intended for "over the counter home use." This inherently means it operates as a standalone device without a human-in-the-loop performance aspect beyond the user interpreting the visual result of the test. The primary comparative study mentioned is against "standard microscopic analysis (counting by Hemacytometer)."

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

The ground truth for comparison appears to be the "standard microscopic analysis (counting by Hemacytometer) based on WHO guidelines." This implicitly relies on expert interpretation and established laboratory procedures, which can be considered a form of "expert consensus" or established "diagnostic standard."

8. The sample size for the training set

The document does not provide details on the sample size for a training set. As an immunochromatographic test, it's unlikely to have a "training set" in the machine learning sense. The development would involve analytical validation and clinical testing, but not a separate training phase for an algorithm.

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

The document does not provide details on a training set or how its ground truth was established, as it's not an AI/machine learning device.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.

The assigned 510(k) number is: K10034 |

Date of Summary: January 29, 2010

MAY - 4 2010

1. Submitted by: Princeton BioMeditech Corporation 4242 U.S. Route 1, Monmouth Jct., NJ 08852 Phone: 732-274-1000 Fax: 732-274-1010
1. Device Name: Trade Names: SpermCheck® Fertility Common or Usual Name: Semen analysis test device Classification Name: Obstetrics/gynecology
1. Identification of legally marketed devices to which claims of equivalence are made:

Hemacytometer

K073039. SpermCheck® Vasectomy Test by Princeton BioMeditech Corp.

K041039, Fertell Male Fertility Test by Genosis Ltd.

K011679. FertilMARO™ Home Diagnostic Screening Test for Male Infertility. by Embryotech Laboratories, Inc.
1. Device Description: SpermCheck® Fertility is an immunochromatographic test for the rapid, qualitative detection of sperm concentration.

6. Intended Use:

Sperm Check® Fertility is a qualitative test that detects sperm concentration at or above 20,000,000 sperm/mL. The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over the counter home use.

1. Substantial Equivalence:
  SpermCheck® Fertility is substantially equivalent to the standard microscopic analysis (counting by Hemacytometer) based on WHO guidelines in its performance. The principles of action for the assay are substantially equivalent to K073039, SpermCheck® Vasectorny Test by Princeton BioMeditech Corp. and K041039, Fertell Male Fertility Test by Genosis Ltd. All three tests are Chromatographic Immunoassays to detect sperm concentration qualitatively. SpermCheck Fertility is also substantially equivalent to FertilMARQ™ Home Diagnostic Screening Test for Male Infertility by Embryotech Laboratories, Inc., K011679, in detecting sperm by a colorimetric assay to determine subfertile sperm concentrations qualitatively.

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Conclusion: SpermCheck® Fertility is substantially equivalent in determining sperm concentrations qualitatively to: standard microscopic analysis (counting by Hemacytometer); K073039, SpermCheck® Vasectorny Test by Princeton BioMeditech Corp.; K041039, Fertell Male Fertility Test by Genosis Ltd.; and K011679, FertilMARQ™ Home Diagnostic Screening Test for Male Infertility by Embryotech Laboratories, Inc.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Princeton BioMeditech Corporation c/o Dr. Kyung-ah Kim Director 4242 US Route 1 Monmouth Junction, NJ 08852

JUN 1 5 2012

Re: K100341

Trade/Device Name: SpermCheck® Fertility Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Date: February 3, 2010 Received: February 5, 2010

Dear Dr. Kim:

This letter corrects our substantially equivalent letter of May 4, 2010.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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Page 2 – Dr. Kyung-ah Kim

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

im chan

Maria M. Chan. Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: SpermCheck® Fertility

Indications For Use:

Prescription Use _ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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ﻝ

Ronnie Philip

Division

Office of In Vitro Dlagno Device Evaluation and

510K k10034/

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”