(203 days)
The Power Stick Male Latex Condom is used for controptive fic fower belen cric purposes (to help prevent pregnancy and for prophylaction of sexually transmitted diseases).
This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. These two types of condoms, ribbed and dotted-ribbed, are at a nominal length of 170mm., a nominal width of 52 mm (±2mm) and are at a nominal thickness of .06 mm (±.02 mm).
The provided text describes a 510(k) premarket notification for a male latex condom device, not an AI/ML powered device. Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable or present in this document.
The document focuses on demonstrating substantial equivalence to a predicate device by conforming to established standards for male latex condoms.
Here's an analysis based on the provided text, using the closest applicable information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| Conformance with ASTM Latex Condom Standard D3492 | "This design is in conformance with ASTM Latex Condom Standard D3492" and "All physical testing and final release testing revealed in conformance with required specifications." |
| Conformance with ISO 4074 | "The condom design conforms to domestic and international regulations: ASTM D3942, ISO 4074 and EN 600." |
| Conformance with EN 600 | "The condom design conforms to domestic and international regulations: ASTM D3942, ISO 4074 and EN 600." |
| Nominal Length: 170mm | Reported as "a nominal length of 170mm." |
| Nominal Width: 52 mm (±2mm) | Reported as "a nominal width of 52 mm (±2mm)" |
| Nominal Thickness: .06 mm (±.02 mm) | Reported as "are at a nominal thickness of .06 mm (±.02 mm)." |
| Same intended use as predicate device (K040185) | "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)." This is an "Indications For Use" statement, not a performance metric directly, but implies the device is expected to meet the same functional criteria as the predicate. |
| Same technological characteristics as predicate device (K040185) | "The condom is made of natural rubber latex and has the same technological characteristics as the predicate condoms identified [510(k) Number K040185]. The condoms described in K040185 are manufactured ribbed and dotted/ribbed Natural Rubber Latex male condoms with a silicone lubricant." This is a descriptive statement, which, paired with the conformance to standards, implies the device performs equivalently to the predicate. |
Study Information (as applicable to a physical device/510(k))
- Sample size used for the test set and the data provenance: Not explicitly stated. The document refers to "All physical testing and final release testing," which implies that a sample of manufactured condoms would have been tested against the specified standards. The provenance of this testing data (e.g., in-house testing by the manufacturer or third-party lab) is not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device like a condom, "ground truth" is established by physical measurement and testing against international and domestic standards, not by expert consensus in an observational or diagnostic context.
- Adjudication method for the test set: Not applicable. The testing would involve objective measurements (e.g., length, width, thickness, burst pressure tests as per standards) rather than subjective interpretation requiring adjudication.
- 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 a physical medical device, not an AI/ML diagnostic or assistive technology.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used: The "ground truth" for this device's performance would be the specifications outlined in the referenced standards (ASTM D3492, ISO 4074, EN 600) and the device's own design specifications (e.g., nominal length, width, thickness). These standards define acceptable ranges for various physical properties and performance characteristics (e.g., integrity under stress, lubricity).
- The sample size for the training set: Not applicable. There is no "training set" in the context of a physical device like a condom. Manufacturing processes are refined through engineering and quality control, not machine learning training.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) submission for a conventional male latex condom, demonstrating conformance to recognized standards for physical devices. It does not contain the types of studies or data relevant to AI/ML powered devices.
{0}------------------------------------------------
041717
JAN 1 3 2005
II. 510(k) SUMMARY
| Submitted By: | A.P. Deauville, LLC.594 Jersey Ave.New Brunswick, NJ 08901(732) 545-0200 |
|---|---|
| Contact Person: | Scott L. Baier |
| Date Prepared: | June 23, 2004 |
| Proprietary Name: | Power Stick® Male Latex Condoms |
| Common Name: | Male Latex Condom |
| Classification Name: | Condom (21 CFR §884.5310) |
| Predicate Device: | Male Latex Lubricated Condom [510(k)Number K040185] |
Description of the Device:_This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. These two types of condoms, ribbed and dotted-ribbed, are at a nominal length of 170mm., a nominal width of 52 mm (±2mm) and are at a nominal thickness of .06 mm (±.02 mm).
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).
Technological Characteristics: This design is in conformance with ASTM Latex Condom Standard D3492 and that the condom is made of natural rubber latex and has the same technological characteristics as the predicate condoms identified [510(k) Number K040185]. The condoms described in K040185 are manufactured ribbed and dotted/ribbed Natural Rubber Latex male condoms with a silicone lubricant. The condom design conforms to domestic and international regulations: ASTM D3942, ISO 4074 and EN 600. All physical testing and final release testing revealed in conformance with required specifications.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott L. Baier Operations Manager A. P. Deauville, LLC 594 Jersey Avenue NEW BRUNSWICK NJ 08901 Re: K041717 Trade/Device Name: Power Stick® Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II - -Product Code: 85 HIS Dated: December 15, 2004 Received: December 27, 2004
Dear Mr. Baier:
We have reviewed your Scction 510(k) premarket notification of intent to market the device referenced we have reviewed your readle 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 reasy 20, 1976, the other with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that reculssitied in accessal of a premarket approval application (PMA). You may, therefore, market the do inc. 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 n your al), it may be subject to such additional controls. Existing major regulations affecting your I ipply rary we 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 Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I toase of a would 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 (2) CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (2) Crice (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
JAN 1 3 2005
{2}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will andw you to ocgin manteing your and equivalence of your device to a legally premarket nothication. The I DA Inting of Sacsamal Price 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 If you desire specific advice ior your cerrest on wind wind of 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 Also, picase note the regulation entires), formation on your responsibilities under the Act from the 807.97). Tou may obtain other general international and Consumer Assistance at its toll-free number (800) DVISION 01 311all Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): K041717
Device Name: Power Stick Male Latex Condoms
Indications For Use: The Power Stick Male Latex Condom is used for controptive fic fower belen cric purposes (to help prevent pregnancy and for prophylaction of sexually transmitted diseases).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
XXX Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Yancey Gordon
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 1 of 1 _
§ 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.