(46 days)
The Thai Nippon condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and 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, and nominal thickness 0.06mm. The condom is offered in natural latex color, red, blue, green, and yellow.
The provided text is a 510(k) Summary for a Male Latex Condom and a subsequent FDA clearance letter. It is not a study report for a device using AI, statistical analysis, or comparison metrics like sensitivity, specificity, or AUC, which are typically found in studies with acceptance criteria, sample sizes, and expert ground truth.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, experts, and adjudication methods is not available in the provided document.
Here's what can be extracted based on the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document states that the device's design is in conformance with ASTM Latex Condom Standard D3492. This standard sets the acceptance criteria for these types of devices. The reported device performance is presented as a direct comparison of technological characteristics to a predicate device, implying that the new device meets or is equivalent to the predicate's performance, which is presumably compliant with the ASTM standard.
| Acceptance Criteria (Implied by conformance to ASTM D3492) | Reported Device Performance (Table comparing to Predicate) |
|---|---|
| Length (mm): (Defined by ASTM D3492) | Length (mm): 180 (matches predicate) |
| Width (mm): (Defined by ASTM D3492) | Width (mm): 52 (matches predicate) |
| Thickness (mm): Min. (Defined by ASTM D3492) | Thickness (mm): 0.03 min. (matches predicate) |
| Lubricant System: (Defined by ASTM D3492, if applicable) | Lubricant System: Silicone (matches predicate) |
| Reservoir Tip: (Defined by ASTM D3492, if applicable) | Reservoir Tip: Yes (matches predicate) |
Note: The specific numerical acceptance criteria (e.g., minimum burst pressure, maximum pinhole rate) detailed in ASTM D3492 are not explicitly listed in this document but are the underlying performance requirements the device is claiming to meet.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified in the provided documents. The document describes the device and its intended use, along with a comparison to a predicate device, but does not include details of testing methodologies or sample sizes for performance evaluation.
- Data provenance: Not applicable in the context of this 510(k) summary, as it's not a clinical study report with patient data. The device itself is manufactured by Thai Nippon Rubber Industry, Ltd. in Thailand.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a submission for a medical device (condom) and does not involve expert interpretation or ground truth establishment in the way an AI diagnostic device would. Compliance with standards and physical properties are the primary evaluation methods.
4. Adjudication method for the test set
- Not applicable. No expert adjudication method is described.
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
- Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used
- The "ground truth" for this device's performance is its physical properties (length, width, thickness, presence of lubricant, reservoir tip) and its ability to conform to established industry standards like ASTM D3492, which includes performance requirements such as burst volume/pressure and freedom from holes. These are typically verified through laboratory testing and quality control processes.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" like an AI model.
9. How the ground truth for the training set was established
- Not applicable.
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994095
Abbreviated 510 (k) for Male Latex Condoms
Page 5 of 13
| II. | 510(k) SUMMARY | JAN 1 8 2000 | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Submitted By: | Thai Nippon Rubber Industry, Ltd.49-49/1, EPZ-1Laemchabang Industrial EstateThungsukhla, Sriracha, ChonburiThailandTelephone: 66-38-490258-9Fax: 66-38-490414 | |||||||||||||||||||
| Contact Persons: | Eli J. CarterConsultant to Thai Nippon1219 Little Creek RoadDurham, NC 27713Sandeep ParabManager QC/QAThai Nippon Rubber Industry Co. | |||||||||||||||||||
| Date Prepared: | December 1, 1999 | |||||||||||||||||||
| Proprietary Name: | No Specific Brand Name | |||||||||||||||||||
| Common Name: | Latex Male Condom | |||||||||||||||||||
| Classification: | Condom (21 CFR 884.5300) | |||||||||||||||||||
| Predicate Device: | Suretex Latex Male Condom (K941258) | |||||||||||||||||||
| 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, and nominal thickness 0.06mm. The condom is offeredin natural latex color, red, blue, green, and yellow. | |||||||||||||||||||
| 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 tohelp prevent pregnancy and the transmission of sexually transmitteddiseases. | |||||||||||||||||||
| Technological Characteristics: | This condom has the same technological characteristics as the predicatecondom identified above. The design is in conformance with ASTMLatex Condom Standard D3492 and that the condom is made of naturalrubber latex. The follows provides a direct comparison to the predicatedevice: | |||||||||||||||||||
| Feature One Touch Predicate Device Length (mm) 180 180 Width (mm) 52 52 Thickness (mm) 0.03 min. 0.03 min. Lubricant System Silicone Silicone Reservoir Tip Yes Yes |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2000
Thai Nippon Rubber Industry Co., Ltd. c/o Mr. Eli J. Carter Consultant to Thai Nippon Rubber 1219 Little Creek Road Durham, N.C. 27713
Re: K994095
One Touch™ Latex Condoms Dated: January 3, 2000 Received: January 10, 2000 Requiatory Class: II 21 CFR §884.5300/Procode: 85 HIS
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 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.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, 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: | K994095 |
|---|---|
| Device Name: | Male Natural Rubber Latex Condom |
| Indications for Use: | The Thai Nippon condom is used for contraception and forprophylactic purposes (to help prevent pregnancy and transmissionof sexually transmitted diseases). |
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | OR | Over - The - Counter - USE (Optional Format 1 - 2 - ✓ ) |
|---|---|---|
| --------------------------------------- | ---- | --------------------------------------------------------------------------------------------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K994095 |
|---|---|
| --------------- | --------- |
§ 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.