The Sagami Polyurethane Semen Collection Device is intended to be used as an accessory to the Oves Cervical Cap to collect semen for transfer to the cap prior to insertion in artificial insemination procedures.

Device Description

The subject device is a polyurethane condom.

AI/ML Overview

Here's the analysis of the provided text regarding the acceptance criteria and study for the Conceivex Latex-free Semen Collector:

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria in a table format, nor does it provide numerical performance results. Instead, it relies on a qualitative assessment of "no deleterious effects" compared to predicate devices.

Acceptance Criteria (Inferred)	Reported Device Performance
No deleterious effects on human semen.	"Human Sperm Survival Assay... demonstrated that the condom material has no deleterious effects on human semen."
No deleterious effects on embryo development.	"Mouse Embryo Assay performed on the Sagami non-latex condom demonstrated that the condom material has no deleterious effects on... embryo development."
Equivalence in safety and effectiveness to predicate devices.	"The results of this testing demonstrate that the new devices is as safe and effective as the predicates."

Study Details

Sample size used for the test set and the data provenance:
- Human Sperm Survival Assay: Not specified.
- Mouse Embryo Assay: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here refers to the biological assays (sperm survival, embryo development) which are scientific measurements rather than expert interpretations.
Adjudication method for the test set: Not applicable. This concept typically applies to studies where human reviewers assess data against a standard, not to laboratory assays.
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: Not applicable. This study focuses on the biological safety of a device material, not on AI-assisted diagnostic effectiveness.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical semen collector, not an algorithm.
The type of ground truth used:
- Human Sperm Survival Assay: Biological assay measuring sperm viability/function.
- Mouse Embryo Assay: Biological assay measuring embryo development.
The sample size for the training set: Not applicable. This is not a machine learning or AI-driven device, so there is no training set in the conventional sense.
How the ground truth for the training set was established: Not applicable, as there is no training set. The "ground truth" for the testing (assays) was established through scientific measurement in laboratory conditions.

Summary

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K080752

SECTION 5 - 510(K) SUMMARY

Submitter:	Conceivex, Inc.5 East Main StreetSaranac, MI 48881616-642-0257
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Contact: Michael LaVean

Date of Summary: March 14, 2008

Common Name: Polyurethane Condom Trade Name: Conceivex Latex-free Semen Collector Classification Name: Condom, Synthetic

A. Predicate Devices

The predicate devices are the Trojan Supra Polyurethane Condom, cleared under K050828, and the Conceivex Semen Collector cleared under K063227.

B. Device Description

The subject device is a polyurethane condom.

C. Intended Use

The Semen Collection Device is intended to be used as an accessory to the Oves Cervical Cap to collect semen for transfer to the cap prior to insertion in artificial insemination procedures.

D. Substantial Equivalence Summary

The Sagami Semen Collector is equivalent to the Sagami condom as it is the same condom made by the same manufacturer. The Sagami Semen Collector is also equivalent to the Avanti Semen Collection devices have the same intended use and indications for use, they are both made of polyurethane, and both have the same performance characteristics. Testing performed on the Sagami Condom demonstrates that with the new Indication for Use, it is as safe and as effective as the predicate device and thus, is substantially equivalent to it.

E. Technological Characteristics

The technological characteristics of the new device and the predicate device are identical.

F. Testing

MAY 1 4 2008

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A Human Sperm Survival Assay and a Mouse Embryo Assay performed on the Sagami non-latex condom demonstrated that the condom material has no deleterious effects on human semen or embryo development. The results of this testing demonstrate that the new devices is as safe and effective as the predicates.

G. Conclusion

This pre-market submission has demonstrated Substantial Equivalence as defined and understood in: Section 513(i) of the FD&C Act, as Amended; 21 CFR Section 807, and; guidance documents issued by the Center for Devices and Radiological Health.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the top half of the circle. The bottom half of the circle contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". In the center of the seal is an abstract symbol that resembles an eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 1 4 2008

Conveivex, Inc. % Mr. Blix Winston, MPA, MS Submission Correspondent ACMD Consulting, LLC 2600 Mullinix Mill Road MT. AIRY MD 21771

Re: K080752

Trade/Device Name: Conceivex Latex-free Semen Collector Regulation Number: 21 CFR 884.5250 Regulation Name: Cervical cap Regulatory Class: II Product Code: OBB Dated: March 14, 2008 Received: April 22, 2008

Dear Mr. Winston:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bookers ined the device is substantially equivalent (for the indications for referenced in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in all onelouders to regard that of the Medical Device Amendments, or to devices that provision in that 20, 1970, and encolances 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 therefore, mainter 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 (Premarket IT your de rio is olabellion (boo ao re) intilional controls. Existing major regulations affecting your Apployall, It the 70 sable of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a circular seal with the text "1906-2006" at the top. The letters "FDA" are in the center of the seal, with the word "Centennial" underneath. There are three stars below the word "Centennial". The seal is surrounded by a border of stars and text.

Protecting and Promoting Public Health

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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.

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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours.

Nancy 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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Indication for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Conceivex Latex-free Semen Collector

Indications for Use:

Prescription Use(Part 21 CFR 801 Subpart D)	✓
AND/OR
Over-The-Counter Use(21 CFR 801 Subpart C)

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

510(k) Number	K080752
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4.1

Regulation Number and Section

§ 884.5250 Cervical cap.

(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).