(54 days)
Nonlubricated rubber male condom for use as a contraceptive and prophylactic.
Condom, smooth surface, reservoir end, approximately 180 mm in length and 52 mm in width (Type 1, Style 2, Class A) colored rubber contraceptive device, nonlubricated or lubricated with silicone.
This 510(k) summary is for a condom, a mechanical contraceptive device. The provided text is a 510(k) notification letter, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study report with specific acceptance criteria and performance data for the device itself.
Therefore, many of the requested elements for a scientific study of an AI/algorithm-based device are not directly applicable or available in this document. The information primarily pertains to regulatory approval based on demonstrating equivalence to already approved condoms.
Here's a breakdown of the available information and why other points are not applicable:
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided in a format typical for an AI/algorithm study. The acceptance criteria for condoms relate to physical properties and manufacturing standards, not algorithmic performance. The document states the device is "substantially equivalent" to predicate devices, implying it meets the same established performance criteria for condoms.
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Sample sized used for the test set and the data provenance: Not applicable. There isn't a "test set" in the context of an AI/algorithm. The regulatory approval is based on manufacturing standards and performance tests for condoms, which are not detailed here beyond the general statement of substantial equivalence.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the context of expert consensus isn't relevant for a physical condom. The "ground truth" for a condom is its physical properties and effectiveness as a contraceptive, established through well-defined laboratory tests (e.g., burst strength, leakage) and clinical trials (for effectiveness), which are not detailed in this 510(k) summary.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device like a condom.
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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, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for a condom's efficacy and safety is established through a combination of:
- Laboratory Testing: Physical properties like burst strength, volume, and absence of holes, as per international and national standards (e.g., ISO, ASTM). These tests are typically conducted by manufacturers according to their quality control processes.
- Clinical Studies (for initial condom approval): Efficacy and safety are established through large-scale clinical trials comparing use of condoms to other or no contraceptive methods. The 510(k) process for this specific device relies on the fact that the predicate devices have already demonstrated this.
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The sample size for the training set: Not applicable for this type of device.
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How the ground truth for the training set was established: Not applicable for this type of device.
Summary of relevant information from the provided document:
- Device Name: Condom, smooth surface, reservoir end, approximately 180 mm in length and 52 mm in width (Type 1, Style 2, Class A) colored rubber contraceptive device, nonlubricated or lubricated with silicone.
- Intended Use: Nonlubricated rubber male condom for use as a contraceptive and prophylactic.
- Regulatory Class: Class II, Condom (rubber) Contraceptive - 85HIS.
- Predicate Devices: K963319 (nonlubricated), K963321 (lubricated), and Ansell Inc. Condom (K901112) listed under the trade name Lifestyle®.
- Demonstration of Acceptance Criteria: The filing states the device is "substantially equivalent" to the predicate devices. This implies that the device meets the same established performance standards (e.g., physical integrity, burst volume, hole detection) that allowed the predicate devices to be marketed. The specific numerical acceptance criteria and performance data are not detailed in this 510(k) summary but would be part of the underlying design control and testing documentation held by the manufacturer. The "study" proving this is implicitly the battery of tests conducted by the manufacturer to demonstrate compliance with relevant standards and equivalence to the predicate devices, though these specific tests are not reported in this summary. The primary "proof" is the FDA's concurrence that it is substantially equivalent.
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| 510(k) Summary Notification | |
|---|---|
| Submitter: | Custom Services International, Inc.3111 Post Rd.Las Vegas, NV 89118 |
| AUG 20 1997 | |
| Telephone Number: | (702) 897-1789 |
| Contact: | Lillie C. Thomas, M.S.Director of Quality Assurance |
| Registration Number: | 2951584 |
| Date Submitted: | June 26, 1997 |
| Name of the Device: | Condom, smooth surface, reservoir end, approximately 180 mm inlength and 52 mm in width (Type 1, Style 2, Class A) coloredrubber contraceptive device, nonlubricated or lubricated withsilicone. |
| Trade Names: | InnerWear™, Jasmine®, Jimmy-O Raincoat™, Raincoat™,Drink® |
| Equivalent Device: | Applicant Device covered by K963319 (nonlubricated) K963321(lubricated) and Ansell Inc. Condom, colored smooth surfacereservoir end, approximately 180 mm in length and 52 mm in width(Type 1, Style 2, Class A) rubber contraceptive device, lubricatedwith Nonoxynol-9 and silicone. This device is a Class II medicaldevice covered by K901112 and currently sold in interstatecommerce under the trade name Lifestyle® |
| The applicant has received prior authorization to produce medicaldevices for interstate commerce before. This device was grantedpursuant to 21 CFR 800 et seq. a 510(k) number K963319 andK963321 for the basic latex condom covered in this application.This device is also substantially equivalent, except the applicantdevice contains color. | |
| Class of Device: | Class II, Condom (rubber) Contraceptive - 85HIS |
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lillie C. Thomas, M.S. Director of Quality Assurance Custom Services International, Inc. 3111 West Post Road Las Vegas, Nevada 89118
| Re: | K972427 |
|---|---|
| InnerWear™, Jimmy-O Raincoat™, Raincoat™, | |
| Jasmine™, Drink® | |
| Dated: | June 26, 1997 |
| Received: | June 27, 1997 |
| Regulatory class: | II |
| 21 CFR §884.5300/Product code: | 85 HIS |
Dear Ms. Thomas:
AUG 20 1997
We have reviewed vour 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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 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 requirement, 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 vour device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation vou might have under sections 531 through 542 of the Act for devices under 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 marked 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/dsmamain.html".
Sincerely yours.
h.T.Liau Yin
Lillian Yin, Ph.D.
Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number: 长972427
Condom (rubber) Contraceptive 85-HIS Device Name:
Indications for Use:
Nonlubricated rubber male condom for use as a contraceptive and prophylactic.
Image /page/2/Figure/5 description: The image contains a black diagonal line against a white background. The line extends from the upper-left corner towards the lower-right corner of the image. The line appears to be hand-drawn, as it is not perfectly straight and has some slight variations in thickness.
Date Submitted:
June 26, 1997
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Robert R. Sating | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | ||
| 510(k) Number | K972427 |
| Prescription Use (Per 21 CFR 801.109 | OR | Over-The-Counter Use ✓ (Optional Format 1-2-96) |
|---|---|---|
| -------------------------------------- | ---- | ------------------------------------------------- |
§ 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.