(326 days)
The Richter Male Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
This condom is made of a natural rubber latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is colorless, non flavored, non scented; straight walled with a reservoir tip. The nominal length is 185 mm, nominal width, 54 mm and nominal thickness 0.07mm. It is lubricated with silicone (viscosity 250 cps), and cornstarch is used as a dressing material. This condom conforms to current established national and international voluntary standards including ASTM D3492 and ISO 4074.
The provided document is a 510(k) premarket notification for a male latex condom. It describes the device, its intended use, and its conformance to established standards. However, it does not include a study that proves the device meets specific acceptance criteria with detailed performance metrics, sample sizes, ground truth establishment, or comparative effectiveness studies.
Instead, the document states: "This condom conforms to current established national and international voluntary standards including ASTM D3492 and ISO 4074." It also mentions: "This condom has the same technological characteristics as the predicate condoms identified above. It is made from natural rubber latex and the design is in conformance with ASTM D3492 and ISO 4074 Male Latex Condom Standards."
Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria with reported device performance or answer most of the specific questions about a study, as the detailed study data is not present in this document.
However, I can infer the acceptance criteria based on the referenced standards. For the purpose of answering your request, I will interpret the conformance to ASTM D3492 and ISO 4074 as the acceptance criteria, and the statement of conformance as the "reported device performance."
Here's the closest possible answer based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from ASTM D3492 & ISO 4074)* | Reported Device Performance |
|---|---|
| Physical Dimensions: | Conforms to ASTM D3492 & ISO 4074 |
| - Nominal Width | |
| - Nominal Length | |
| - Thickness | |
| Burst Properties (Volume and Pressure): | Conforms to ASTM D3492 & ISO 4074 |
| - Before aging | |
| - After accelerated aging | |
| Freedom from Holes (Water Leak Test): | Conforms to ASTM D3492 & ISO 4074 |
| Tensile Properties: | Conforms to ASTM D3492 & ISO 4074 |
| - Tensile Strength | |
| - Elongation at Break | |
| Package Integrity: | Conforms to ASTM D3492 & ISO 4074 |
| Labeling Requirements: | Conforms to ASTM D3492 & ISO 4074 |
Note: The specific numerical values for each criterion are detailed within ASTM D3492 and ISO 4074, which are not included in this document. The document only states conformance to these standards, implying that the device meets all their stipulated requirements.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided document. Testing under ASTM D3492 and ISO 4074 would involve specific sampling plans, but these details are absent.
- Data Provenance: Not specified. The manufacturer is Richter Rubber Technology SBN BHD, Malaysia. It is plausible that testing took place in Malaysia or a contracted lab. The document does not state if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. For condom testing as per ASTM/ISO standards, ground truth is established by objective physical and mechanical measurements according to specified test methods, not by expert consensus (e.g., radiologists).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/None. Performance is determined by objective measurements against predefined thresholds in the standards directly, not through adjudication of expert opinions.
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 device is a physical product (male latex condom), not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth is established by objective, standardized physical and mechanical test methods and measurements as defined in ASTM D3492 and ISO 4074. For example, for "burst volume," the ground truth is the measured volume of air the condom can contain before bursting under specific conditions.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
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JAN 1 4 2008
Kd7 4511
Abbreviated 510 (k) Notification for a Male Latex Condom
Page 5 of 13
I. 510(k) SUMMARY
| Submitted By: | Richter Rubber Technology SBN BHDPlot 33, Kuala Ketil Industrial Estate09300 Kuala Ketil, KedahMalaysia |
|---|---|
| Contact Person: | Eli J. Carter, ConsultantPO Box 12139Durham, NC 27709Tel: 919 544 4098; Fax: 919 544 5849Email: carterej@aol.com |
| Date Prepared: | December 26, 2007 |
| Proprietary Name: | None |
| Common Name: | Male Latex Condom: 54 mm (nominal width), 185 mm (nominallength), straight-wall with reservoir tip, silicone lubricated, colorless,flavorless, unscented |
| Classification Name: | Male Latex Condom |
| Predicate Devices: | UNIDUS Male Latex Condom - K023059 |
| Description of Device: | This condom is made of a natural rubber latex sheath, whichcompletely covers the erect penis with a closely fitted membrane. Thiscondom is colorless, non flavored, non scented; straight walled with areservoir tip. The nominal length is 185 mm, nominal width, 54 mmand nominal thickness 0.07mm. It is lubricated with silicone (viscosity250 cps), and cornstarch is used as a dressing material. This condomconforms to current established national and international voluntarystandards including ASTM D3492 and 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 tohelp prevent pregnancy and the transmission of sexually transmitteddiseases, including HIV. |
User Instructions and Precautions are provided to insure proper
use and disposal of the product after use. See Package Labeling
and Insert - (Attachment 2).
| Technological Characteristics: | This condom has the same technological characteristics as the predicatecondoms identified above. It is made from natural rubber latex and |
|---|---|
| -------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------- |
the design is in conformance with ASTM D3492 and ISO 4074 Male
Latex Condom Standards.
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JAN 1 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richter Rubber Technology SBN BHD % Eli J. Carter, Ph.D. Consultant Family Health International P.O. Box 12139 DURHAM NC 27709
Re: K070511
Trade/Device Name: Richter Male Latex Condom: 54 mm (nominal width), 185 mm (nominal length), straight-wall with reservoir tip, silicone lubricated, colorless, flavorless, unscented
Regulation Number: 21 CFR 884.5300
Regulation Name: Condom
Regulatory Class: II Product Code: HIS
Product Code. 115
Dated: December 26, 2007 Received: December 31, 2007
Dear Dr. Carter:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{2}------------------------------------------------
Page 2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Information for a Male Latex Condom 510(k) Submission
Page 11 of 13
II. INDICATIONS FOR USE STATEMENT
:
| 510(k) Number: | K070511 |
|---|---|
| Device Name: | Richter Male Latex Condom54mm (nominal width), 185 mm (nominal length), straight-wallwith reservoir tip, silicone lubricated, colorless, flavorless,unscented |
| Indications for Use: | The Richter Male Latex Condom is used for contraception and forprophylactic purposes (to help prevent pregnancy and the transmissionof sexually transmitted diseases) |
.
の 2007年 10月 2007 10:00 PM 100 100 100 100 100 100
(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 | ||
| (Division Sign-Off) |
§ 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.