(253 days)
The Medical Latex (DUA) condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
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Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the CARE Condom (K120555):
Based on the provided FDA 510(k) approval letter and indications for use, this document does not contain the detailed acceptance criteria or a study description in the format requested for a medical device that uses algorithms or AI for diagnostic/prognostic purposes.
The document is a traditional 510(k) approval letter for a condom, which is a physical medical device. The "acceptance criteria" and "study" described in your prompt (e.g., sample size for test set, experts for ground truth, MRMC study, AI effectiveness) are relevant for devices like AI-powered diagnostic software, imaging analysis tools, or similar computational devices.
For a physical device like a condom, the "acceptance criteria" generally refer to quality control standards (e.g., burst pressure, freedom from holes, dimensions, lubricity), and the "study" would be performance testing against international standards (e.g., ISO 4074 for natural rubber latex condoms) and clinical studies for characteristics like breakage rate, slippage rate, and pregnancy prevention rate. This information is typically found in the 510(k) submission summary/report, not in the FDA's approval letter or the indications for use statement.
Therefore, many of the requested fields cannot be populated from the given text. I will fill in what can be inferred and explicitly state where information is missing due to the nature of the device and the provided document.
Acceptance Criteria and Device Performance for CARE Condom (K120555)
The provided document is an FDA 510(k) clearance letter for a condom. Such letters confirm substantial equivalence to a predicate device but typically do not detail the specific performance acceptance criteria or the full study reports. These details are usually found within the 510(k) summary submitted by the manufacturer. The "acceptance criteria" for condoms generally relate to physical performance tests rather than algorithmic performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Pinhole/Hole Formation | (Not specified in provided text) | (Not specified in provided text) |
| Burst Volume & Pressure | (Not specified in provided text) | (Not specified in provided text) |
| Dimensions (Length, Width) | (Not specified in provided text) | (Not specified in provided text) |
| Lubricity | (Not specified in provided text) | (Not specified in provided text) |
| Biocompatibility | (Not specified in provided text) | (Not specified in provided text) |
| Shelf Life/Stability | (Not specified in provided text) | (Not specified in provided text) |
| Clinical Effectiveness (Pregnancy Prevention Rate) | (Not specified in provided text) | (Not specified in provided text) |
| Clinical Effectiveness (STI Prevention Rate) | (Not specified in provided text) | (Not specified in provided text) |
Note: The actual specifications for these criteria would be based on international standards for condoms (e.g., ISO 4074 for natural rubber latex condoms) which are used for 510(k) substantial equivalence. The provided document does not contain these specific values.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in the provided document. Condom testing involves batches of product for physical tests and potentially cohorts for clinical studies.
- Data Provenance: Not specified, but generally, testing for condoms would be performed by the manufacturer, often at their facilities or certified labs. Clinical studies, if performed, could be multi-site or single-site.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable in the context of this device. For physical performance testing (burst, pinholes), the "ground truth" is determined by standardized test methods and calibrated equipment, not by expert consensus. For clinical outcomes (pregnancy, STI), the ground truth is statistical incidence within a study population.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Performance criteria for condoms are typically objective measurements against a standard, not subjective interpretations requiring adjudication. Clinical study outcomes are statistically analyzed.
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
- This question is not applicable to the CARE Condom as it is not an AI-powered diagnostic or interpretive device. MRMC studies are used to evaluate diagnostic accuracy of human readers, sometimes with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable to the CARE Condom as it is not an algorithm or AI device.
7. The type of ground truth used
- For physical performance: Objective measurements against established international standards (e.g., ISO 4074).
- For clinical efficacy (e.g., pregnancy prevention, STI prevention): Clinical outcomes data from well-designed studies (e.g., incidence of pregnancy or STIs in study participants using the device).
- The provided document does not explicitly state which specific type was used or the results.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable in the context of a physical medical device. "Training set" refers to data used to develop and refine algorithms, which is not relevant for a condom. The manufacturing process does involve quality control and process validation, which might involve data, but it's not a "training set" in the AI sense.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Date: November 2, 2012.
Medical-Latex (DUA) SDN. BHD % Ms. Uma Devi Assistant Manager - QA/ RA Plo 8 Senai Industrial Estate SENAI JOHOR MALAYSIA 81400
Re: K120555
Trade/Device Name: CARE Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: October 17, 2012 Received: October 22, 2012
Dear Ms. Devi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Uma Devi
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i lease of advisou that I be intent that your device complies with other requirements of the Act that I Dr Hab Intact and regulations administered by other Federal agencies. You must or any I catal statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K Fart 607), aboning (21 CFR 803); good manufacturing practice requirements as set de rice-related daverse oreals) (1) OFF Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific and to boutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Ocher for Doviets and And Andrew by reference to premarket notification" (21CFR Part now the regulation online of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the I va may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Beiersdorf
OUAL SON BHD Reg. No. 163948
Plo 8 Senai Industrial Esta 81400 Senai Johor Malaysia (+6) 07-597 8100 Tel +6) 07-599 1316 Fax E-mail Medical-Latexto Be
Indications for Use
510(k) Number (K120555):
Device Name: CARE Condom
- Smooth Surface
- Superthin condom
- Regular condom
- Retarding condom
- Superthin condom
-
- Textured surface
- a. Stimulating(ribbed) condom
- G-Pleasure(ribbed ,dotted and flared) condom
Indications For Use: The Medical Latex (DUA) condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
AND/OR Over-The Counter Use 日 Prescription Use Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
Benjamin R. Fisher -S 2012.11.02 14:34:20 -04'00'
Division Sign-Off) ion of Reproductive, Gastro-Renal, and Urological Devices
§ 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.