(137 days)
Mighty Man (Dynamic Linkers) condom, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness.
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has the specification as enclosed in Annexure I & IV.
The provided text is a 510(k) summary for a latex condom, and it does not contain any information about acceptance criteria, device performance studies (beyond conformance to ASTM D 3492), or details about ground truth, sample sizes, or expert adjudication specific to an AI/ML device.
Therefore, I cannot fulfill your request for the specific information regarding an AI/ML device's acceptance criteria and studies from this document. This document is related to a traditional medical device (condom) and its premarket notification to the FDA to demonstrate substantial equivalence to a predicate device.
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MAR 2 0 2000
II. 510(k) SUMMARY
Submitted by Medtech Products Limited S - 59, 20th Street, Anna Nagar West, Chennai 600 040 India 91 44 628 7857 / 628 8829 Tel : Fax : 91 44 628 3660 Email : medtech@vsnl.com
Contact Person Dr A.V.K.Reddy
Date Prepared
Oct 20, 1999
Proprietary Name
Mighty Man (Dynamic Linkers)
Common Name Latex Condom
Classification Name Condom (21 CFR 884.5300)
Predicate Name
Pleasure Plus Lifestyle Xtra Pleasure
Description of Device : This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has the specification as enclosed in Annexure I & IV .
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Intended use of the Device : This latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purpose (to help prevent pregnancy and the transmission of sexually transmitted diseases)
Characteristics : This condom has the same Technological technological characteristics as the the predicate condom identified above. This condom design is in conformance with ASTM Latex Condom Standard D 3492 and that the condom is made of natural rubber latex. This condom is a patented design under US Patent No : 5,836,308 with a special design to enhance acceptability. How the condom works and its intended benefits are detailed in Annexure II.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of a bird, possibly an eagle, with three wing-like shapes above its body. The bird is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2000
A.V.K. Reddy, M.D. Chairman & Managing Director Medtech Products, Ltd. S-59, 20th Street Anna Nagar West Chennai 600 040 INDIA
Re: K993737
Natural Rubber Latex Condoms - Mighty Man (Dynamic Linkers) Dated: January 31, 2000 Received: February 7, 2000 Regulatory Class: II 21 CFR §884.5300/Procode: 85 HIS
Dear Dr. 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 (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.
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.
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Page 2 - A.V.K. Reddy, M.D.
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(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 products 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 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.
Climati C. Alpom
Daniel G. Schultz, M.D. Captain, USPHS Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT VII.
| 510(k) number : | K993737 |
|---|---|
| Device Name : | Mighty Man (Dynamic Linkers) |
| Indications for use : | Mighty Man (Dynamic Linkers) condom,when properly used, are highly effective againstpregnancy although no contraceptive canguarantee 100% effectiveness. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ---------------------------------------
Toril A. Skarsem
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number.
§ 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.