(85 days)
The UNIDUS condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, nominal thickness 0.06mm and colored pink, yellow, green or black. It is lubricated with silicone and cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
The provided text describes a 510(k) Notification for a Male Latex Condom and does not contain information about a medical device that utilizes AI, nor does it detail a study with the specific criteria requested (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance).
The information in the document pertains to the regulatory submission for a physical medical device (a latex condom) and focuses on its substantial equivalence to a predicate device based on manufacturing standards and material properties, rather than performance metrics from a clinical study as would be relevant for an AI-powered device.
Therefore, I cannot fulfill the request to provide acceptance criteria and study details for an AI-powered device from the given text.
However, based on the information provided, I can construct a table of acceptance criteria and reported device performance related to the physical specifications and regulatory compliance of the latex condom as described in the 510(k) summary.
Acceptance Criteria and Reported Device Performance (Based on Latex Condom Specifications)
| Acceptance Criteria (from ASTM D3492/ISO 4074 compliance) | Reported Device Performance (from K023129 submission) |
|---|---|
| Nominal length | 180-mm |
| Nominal width | 52-mm |
| Nominal thickness | 0.06mm |
| Material | Natural latex sheath |
| Wall type | Straight-walled |
| Tip type | Reservoir tip |
| Lubrication | Silicone |
| Dressing material | Cornstarch |
| Color options | Pink, yellow, green or black |
| Compliance with ASTM D3492 | Conforms to standard |
| Compliance with ISO 4074 | Conforms to standard |
Regarding the specific questions about an AI device study:
- A table of acceptance criteria and the reported device performance: See the table above for the physical device specifications. There is no information for an AI device.
- Sample size used for the test set and the data provenance: Not applicable. This is not an AI device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI device.
- Adjudication method for the test set: Not applicable. This is not an AI device.
- 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: Not applicable. This is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used: For a physical condom, "ground truth" would be the measured physical properties and adherence to manufacturing standards (e.g., length, width, thickness, burst strength, freedom from holes, packaging integrity). The document states conformance to ASTM D3492 and ISO 4074.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable. This is not an AI device.
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DEC 1 3 2002
Abbreviated 510 (k) Notification for a Male Latex Condom
Page 5 of 13
II. 510(k) SUMMARY
| Submitted By: | UNIDUS CorporationSeokyung Bldg., 51 Bang-1 DongSongpa-KuSeoul, Republic of Korea | |
|---|---|---|
| Contact Persons: | Eli J. CarterConsultant to UNIDUS Corporation1219 Little Creek RoadDurham, NC 27713 | H.S. LeeManaging DirectorUNIDUS CorporationSeokyung Building 51,Bangi-Dong, Songpa-K-Seoul, Korea |
| Date Prepared: | September 11, 2002 |
|---|---|
| Proprietary Name: | N/A |
| Common Name: | Male Latex Condom |
| Classification Name: | Male Latex Condom |
| Predicate Device: | Sime Health Ltd. Latex Condom; K932983 |
| Description of Device: | This condom is made of a natural latex sheath, which completelycovers the erect penis with a closely fitted membrane. This condom isstraight-walled with a reservoir tip; nominal length 180-mm, nominalwidth 52-mm, nominal thickness 0.06mm and colored pink, yellow,green or black. It is lubricated with silicone and cornstarch is used as adressing material. This condom is designed to conform to establishednational and international voluntary standards including ASTM D3492and ISO 4074. |
| 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 purposes to |
help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV.
Technological Characteristics:
This condom has the same technological characteristics as the predicate The design is in conformance with ASTM condom identified above. Latex Condom Standard D3492 and that the condom is made of natural rubber latex.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the top half of the circle. The logo is black and white and appears to be slightly distressed.
Public Health Service
DEC 13 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Unidus Cororation % Mr. Eli J. Carter Consultant 1219 Little Creek Road DURHAM NC 27713
Re: K023129
Trade Name/Device: Male Natural Rubber Latex Condom with Color Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: September 11. 2002 Received: September 19, 2002
Dear Mr. Carter:
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 OS 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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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 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. 8801.435(c) 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.
Kamil Stoch
$\pi$
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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| Information for a Male Latex Condom 510(k) Submission | Page 11 of 13 | |
|---|---|---|
| ------------------------------------------------------- | -- | --------------- |
VII. INDICATIONS FOR USE STATEMENT
| 510(k) Number | K023129 |
|---|---|
| Device Name | Male Natural Rubber Latex Condom with Color |
| Indications for Use: | The UNIDUS condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEED Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | OR Over-the-Counter Use X |
|---|---|
| ------------------------------------------ | ----------------------------------------- |
·
§ 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.