(141 days)
Not Found
No
The device description and performance studies focus on physical components and user instructions, with no mention of AI or ML technologies.
Yes
The device is indicated for assisted insemination in situations like low sperm count, sperm immobility, or hostile vaginal environment, directly addressing a health condition to aid conception.
No.
The device facilitates conception through assisted insemination and provides tools for tracking fertility and confirming pregnancy, but it does not diagnose medical conditions. The kit's use is indicated for situations where specific conditions "have been diagnosed," implying the diagnosis occurs prior to using the device.
No
The device description clearly lists multiple physical components including a cervical cap, semen collection condom, ovulation predictors, and a pregnancy test. It also includes literature and a journal, but the core function relies on these physical items.
Based on the provided information, the Conceivex Conception Kit is partially an IVD (In Vitro Diagnostic).
Here's why:
-
The kit contains components that are clearly IVDs:
- Ovulation Predictors: These devices test urine to detect the surge in luteinizing hormone (LH), which indicates ovulation. This is a classic example of an in vitro diagnostic test.
- Pregnancy Test: This device tests urine to detect the presence of human chorionic gonadotropin (hCG), which indicates pregnancy. This is also a classic example of an in vitro diagnostic test.
-
The kit also contains components that are NOT IVDs:
- Oves Cervical Cap: This is a medical device used to physically hold semen near the cervix. It does not perform a diagnostic test.
- Avanti Semen Collection Condom: This is a medical device used for semen collection. It does not perform a diagnostic test.
- 'Pre Vaginal Lubricant: This is a medical device used for lubrication. It does not perform a diagnostic test.
- Literature (Instructions for Use, Conception Wheel, Conception Journal, Medical Provider Note): These are informational materials, not diagnostic devices.
In summary: The Conceivex Conception Kit is a kit that includes IVD components (ovulation predictors and pregnancy test) along with other medical devices and informational materials. Therefore, while the entire kit is not solely an IVD, it does contain devices that fall under the definition of an IVD.
N/A
Intended Use / Indications for Use
The Conceivex Conception Kit is indicated for assisted insemination in situations in which low sperm count, sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician instruction. The Cap should not be left in place for longer than 6 hours.
Product codes
OBB
Device Description
The Conceivex Conception Kit includes the following literature: Instructions for Use, a "Conception Wheel" to help plan in timing a pregnancy, a "Conception Journal" booklet to assist in charting the fertility cycle and keep track of medical information, and a Medical Provider Note to alert the woman's health care provider that she is trying to become pregnant.
The kit contains three identical boxes, each of which contain: one Oves Cervical Cap, one cervical cap for practice, one Avanti Semen Collection Condom, eight Ovulation Predictors, a Pregnancy Test, and a sample of 'Pre Vaginal Lubricant. The three boxes enable the woman to try to conceive by using the Kit through three ovulation cycles.
Once the couple has visited with a physician and decides they would like to become pregnant, they begin recording details of their cycle in the Conception Journal. Next, using the ovulation predictor, they identify their most fertile day in a given month. During sex they use the semen collector and afterwards transfer the specimen into the Conception Cap. The Conception Cap is then placed over the cervix for 4-6 hours. At the end of the woman's cycle, she uses the Conceivex pregnancy test kit to determine if conception has been achieved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix, vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home Use following physician instruction
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
A Human Sperm Survival Assay and a Mouse Embryo Test performed on the non-latex condom demonstrated that the condom material has no deleterious effects on human semen or embryo development. Clinical testing carried out with the Cap demonstrated that the lay person can understand the revised Instructions for Use and manipulate and insert the cap correctly without direct supervision.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of this testing demonstrate that the devices with the new Indications for Use are as safe and effective as their predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K063227
SECTION 5 - 510(K) SUMMARY
| Submitter: | Conceivex, Inc.
5 East Main Street
Saranac, MI 48881
616-642-0257 |
|------------|----------------------------------------------------------------------------|
| Contact: | Michael LaVean |
MAR 1 4 2007
Date of Summary: October 15, 2006 Common Name: Convenience Kit for Assisted Reproduction Trade Name: Conceivex Conception Kit Classification Name: Unclassified
A. Predicate Devices
Two of the 510(k)-cleared devices in the Conceivex Conception Kit are being submitted in this Premarket Notification, each with a new Indication for Use. The first predicate is the Oves Cervical Cap, K993953. The second is the Durex Avanti Polyurethane Condom, K902936.
B. Device Description
The Conceivex Conception Kit includes the following literature: Instructions for Use, a "Conception Wheel" to help plan in timing a pregnancy, a "Conception Journal" booklet to assist in charting the fertility cycle and keep track of medical information, and a Medical Provider Note to alert the woman's health care provider that she is trying to become pregnant.
The kit contains three identical boxes, each of which contain: one Oves Cervical Cap, one cervical cap for practice, one Avanti Semen Collection Condom, eight Ovulation Predictors, a Pregnancy Test, and a sample of 'Pre Vaginal Lubricant. The three boxes enable the woman to try to conceive by using the Kit through three ovulation cycles.
Once the couple has visited with a physician and decides they would like to become pregnant, they begin recording details of their cycle in the Conception Journal. Next, using the ovulation predictor, they identify their most fertile day in a given month. During sex they use the semen collector and afterwards transfer the specimen into the Conception Cap. The Conception Cap is then placed over the cervix for 4-6 hours. At the end of the woman's cycle, she uses the Conceivex pregnancy test kit to determine if conception has been achieved.
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1
C. Intended Use
The Conceivex Conception Kit is indicated for assisted insemination in situations in which low sperm count, sperm immobility, or a hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician instruction. The cap should not be left in place longer than 6 hours.
D. Substantial Equivalence Summary
The devices in the Kit are identical in all respects to the predicate devices. The Conceivex Conception Kit adds the following new indications for use to two of the components of the kit: Home Use to the Cervical Cap, and the Semen Collector to the Condom. Testing performed on both devices demonstrated that with the new Indications for Use, the devices are as safe and effective as the predicate devices and thus, are substantially equivalent to them.
The differences between the new indications for the devices that are the subject of this Premarket Notification, and the predicate devices, have been evaluated through testing to show that they are not critical to the intended theapeutic effect of the predicates, nor do they affect the safety or effectiveness of the devices when used as labeled.
E. Technological Characteristics
Because the two devices that are covered in this application are identical to the predicate devices, the technological characteristics of the new devices and the predicate devices are identical.
F. Testing
A Human Sperm Survival Assay and a Mouse Embryo Test performed on the non-latex condom demonstrated that the condom material has no deleterious effects on human semen or embryo development. Clinical testing carried out with the Cap demonstrated that the lay person can understand the revised Instructions for Use and manipulate and insert the cap correctly without direct supervision. The results of this testing demonstrate that the devices with the new Indications for Use are as safe and effective as their 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
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAR 1 4 2007
Conceivex, Inc. c/o Blix Winston, M.P.A., M.S. Submission Correspondent AC Consulting 2600 Mullinix Mill Road MT AIRY MD 21771
Re: K063227
Trade/Device Name: Conceivex Conception Kit Regulation Number: 21 CFR §884.5250 Regulation Name: Cervical cap Regulatory Class: II Product Code: OBB Dated: February 22, 2007 Received; February 22, 2007
Dear Mr. Winston:
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 (Premarket, Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" in a cursive font in the middle. The letters "FDA" are prominently displayed in a bold font in the center of the logo. There are three stars at the bottom of the logo. The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.
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 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" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K063227
Device Name: Conceivex Conception Kit
Indications for Use:
The Conceivex Conception Kit is indicated for assisted insemination in situations in which low sperm count, sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician instruction. The Cap should not be left in place for longer than 6 hours.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 4.2 RR
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063227