(245 days)
The Invigra Condom is used for contraception and for prophylactic purposes. Invigra Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.
Invigara Male Latex Condom, Lubricated and Black Colored
This document is a 510(k) clearance letter from the FDA for a medical device: "Invigra Male Latex Condom, Lubricated and Black Colored." As such, it does not describe a study involving an algorithm or AI. The document primarily confirms substantial equivalence to a predicate device and outlines regulatory requirements for condom labeling and manufacturing.
Therefore, many of the requested details about acceptance criteria, device performance, study design, expert involvement, and ground truth are not applicable to this type of regulatory document.
However, I can extract the following relevant information:
- Device Name: Invigra Male Natural Rubber Latex Condom
- Indications for Use: Contraception and prophylactic purposes (reducing the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis).
- Regulatory Class: Class II
- Product Code: 85 HIS
- Regulation Number: 21 CFR 884.5300 (Condom)
Regarding "Acceptance Criteria" and "Reported Device Performance":
For a condom, "acceptance criteria" and "device performance" are typically defined by performance standards that relate to physical properties like burst volume, burst pressure, tensile strength, and freedom from holes, rather than AI performance metrics like sensitivity or specificity. While these criteria are crucial for device approval, they are not detailed in this FDA clearance letter. The letter assumes compliance with these standards (e.g., through good manufacturing practices and required testing for expiration dating) but doesn't explicitly list them or report specific performance values.
Therefore, many parts of your request are not directly addressed by the provided document.
Here's how I would answer based on the provided text, indicating what is not applicable (N/A) or not provided (NP):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Typical for Condoms) | Reported Device Performance (as per this document) |
|---|---|
| Burst Volume/Pressure | NP (Assumed to meet standards for 510(k) approval) |
| Freedom from Holes | NP (Assumed to meet standards for 510(k) approval) |
| Tensile Strength | NP (Assumed to meet standards for 510(k) approval) |
| Expiration Date/Shelf Life | Must comply with 21 CFR 801.435. Supported by test data. Max 5 years. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This document refers to the regulatory clearance of a physical medical device (condom), not an AI/algorithm-based device. No specific "test set" for an algorithm is mentioned or required for this type of submission. Data provenance for performance testing (e.g., burst testing) would be part of the manufacturer's quality system but is not detailed in this 510(k) letter.
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)
- N/A. As above, this is for a physical device, not an AI. "Ground truth" for condom performance would be established through laboratory testing against recognized standards, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable for a physical device 510(k) submission.
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
- N/A. No AI or human reader component for this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. Not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth (for condom performance): Based on established international and national standards (e.g., ISO, ASTM, FDA guidance) for physical properties like burst volume, burst pressure, and freedom from holes. The document also specifically mentions "test data developed under the conditions specified in §801.435(d)" for expiration dating.
- Ground Truth (for substantial equivalence): The "ground truth" for regulatory clearance is the performance and safety profile of the legally marketed predicate device. The applicant (Indus Medicare Limited) demonstrated that their Invigra condom is "substantially equivalent" to this predicate.
8. The sample size for the training set
- N/A. No AI training set.
9. How the ground truth for the training set was established
- N/A. No AI training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 8 2003
Mr. P. Janardhan Reddy Director Indus Medicare Limited 1-10-60/3, "Suryodaya", Begumpet, Hyderabad, 500 016, INDIA
Re: K022614
Trade Name/Device: Invigara Male Latex Condom, Lubricated and Black Colored Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: 85 HIS Dated: January 9, 2003 Received: January 17, 2003
Dear Mr. Reddy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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Page 2 - Mr. Reddy
predicate device results in a classification for your device and thus, permits your device to proceed to the market.
Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR 8884.5300 and 8884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in §801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the earlier of the two expiration dates. Although supporting data is not to be provided in your 510(k) submission, §801.435(i) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, &801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in §801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4616. 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/dsma/dsmamain.html".
Sincerely vours.
David A. Hyman
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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VII. INDICATIONS FOR USE STATEMENT
Applied For KOZZ 614 510(K) Number:
Invigra – Male Natural Rubber Latex Condom Device Name:
The Invigra Condom is used for contraception and for Indications for use: prophylactic purposes. Invigra Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.
(Please do not write below this line)
Concurrence of CDRH, Office of Device Evoluation (ODB)
David A. Segen
(Division Sign-Of Division of Reproduc and Radiologica: 510(k) Number
INDUS MEDICARE LIMITED
Page 18
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.