(58 days)
Not Found
No
The device description and performance studies focus on the material properties and biological compatibility of a polyurethane condom, with no mention of AI or ML.
No.
The device is described as a "Semen Collection Device" intended as an "accessory" to another device (Oves Cervical Cap) for collecting semen for transfer. Its purpose is collection, not treatment or diagnosis of a medical condition.
No
The device is described as a semen collection device intended for artificial insemination procedures, and performance studies focus on its safety for semen and embryo development, not on diagnosing any medical condition.
No
The device description explicitly states it is a "polyurethane condom," which is a physical hardware device, not software.
Based on the provided information, the Sagami Polyurethane Semen Collection Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to collect semen for transfer to a cervical cap for artificial insemination. This is a procedure performed on the human body, not a test performed in vitro (outside the body) on a sample to diagnose a condition.
- Device Description: It is described as a polyurethane condom, which is a physical collection device.
- Lack of IVD Characteristics: The description does not mention any analysis of the semen sample itself, any diagnostic purpose, or any components typically associated with IVDs (reagents, test strips, analyzers, etc.).
- Performance Studies: The performance studies focus on the safety of the material for semen and embryo development, not on the diagnostic accuracy of analyzing the semen.
Therefore, this device is a medical device used in a procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OBB
Device Description
The subject device is a polyurethane condom.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
SECTION 5 - 510(K) SUMMARY
| Submitter: | Conceivex, Inc.
5 East Main Street
Saranac, MI 48881
616-642-0257 |
| ------------ | ---------------------------------------------------------------------------- |
|---|
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
1
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.
2
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
3
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
4
Indication for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Conceivex Latex-free Semen Collector
·
Indications for Use:
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.
| 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 |
|---|---|
| --------------- | --------- |
4.1