(72 days)
The HAVE IT condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Not Found
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics for the SAFE™ Male Latex Condom in the way a modern AI device submission would. Instead, it focuses on the device being "substantially equivalent" to legally marketed predicate devices and complying with existing regulations for latex condoms.
However, based on the context of condom regulation, general implied performance criteria would be:
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Material & Design | Substantially equivalent to predicate devices for contraception and STD prevention. | Determined to be substantially equivalent. |
| Shelf Life/Stability | Complies with 21 CFR 801.435 regarding expiration dating and shelf life. | Must comply retrospectively, data not provided in 510(k). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not detail a specific "test set" or sample size in the context of a study for this device. The approval is based on "substantial equivalence" to predicate devices and adherence to established regulations. Therefore, there's no explicitly mentioned test set for evaluating the device's performance that would typically be described for a software or AI device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is not a study requiring expert-established ground truth in the way a diagnostic AI device would. The ground truth for condom effectiveness is based on historical performance of predicate devices and regulatory standards built on extensive public health data.
4. Adjudication Method for the Test Set:
Not applicable. There was no specific "test set" and thus no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. This is a pre-market notification for a physical medical device (latex condom), not an AI algorithm. Therefore, an MRMC study is not relevant and was not conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
Not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used:
The ground truth for the SAFE™ Male Latex Condom is based on:
- Established performance of predicate devices: The FDA determined that this condom is "substantially equivalent" to other legally marketed condoms, which have a track record of effectiveness for contraception and STD prevention.
- Regulatory standards and scientific understanding: The regulations like 21 CFR 884.5300 and 801.435 are built upon decades of scientific evidence and public health data regarding the efficacy and safety of latex condoms.
8. The Sample Size for the Training Set:
Not applicable. This is a physical device, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As this is not an AI algorithm, there is no training set or associated ground truth establishment process.
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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 features a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2002
Mr. Ang Teck Leong Managing Director SSN Medical Products SDN BHD No. 1 Jalan 203 Off Jalan Tandang 46050 Petaling Jaya Selangor Darul Ehsan MALAYSIA
Re: K013773
Trade Name/Device: SAFE™ Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name:Condom Regulatory Class: II Product Code: 85 HIS Dated: December 29, 2001 Received: January 11, 2002
Dear Mr. Leong:
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 (QS) 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.
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Page 2 - Mr. Leong
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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 §884.5300 and §884.5310) 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(j) 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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification''(21 CFR §807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Navicj C. Bogdan
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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SECTION VII
INDICATIONS FOR USE STATEMENT
| 510(k) Number | : K013773 |
|---|---|
| Device Name | : HAVE ITTM Male Natural Rubber Latex Condom |
| Indications For Use | : The HAVE IT condom is used for contraception and forprophylactic purposes (to help prevent pregnancy and thetransmission of sexually transmitted diseases). |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDITHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | ✓ |
|---|---|
| ---------------------- | --- |
Nancy C. Pierson
(Division Sign-Off) Division of Reproductive, and Radiological I 510(k) Number
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§ 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.