(59 days)
Not Found
No
The device description and intended use are for a standard latex condom, and there is no mention of AI or ML technology in the provided text.
No.
The device (condom) is intended for contraception and prevention of sexually transmitted diseases, which are prophylactic uses, not therapeutic ones.
No
The device, a condom, is described as a contraceptive and prophylactic, preventing pregnancy and protecting against sexually transmitted diseases. It does not diagnose any conditions.
No
The device description explicitly states it is a "latex rubber condom," which is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "contraceptive and prophylactic" for preventing pregnancy and sexually transmitted diseases. This is a direct physical barrier function, not a diagnostic test performed on samples from the body.
- Device Description: The description details a physical device (a latex rubber condom) and its physical properties and standards (ASTM, ISO). It does not describe a test kit, reagent, or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening of diseases
The device is described as a Class II medical device for contraception and disease prevention, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Extra Strength lubricated rubber male condom for use as a contraceptive and prophylactic.
Extra strength nonlubricated rubber male condom for use as a contraceptive and prophylactic.
Product codes (comma separated list FDA assigned to the subject device)
85 HIS
Device Description
The device which is the subject of this application is a latex rubber condom (Class II medical device defined as "Condom (rubber) Contraceptive 85-HIS") and is defined by ASTM 3492-93 as a Type I, Style 2, Class A rubber condom, and further defined by ISO 4074-6 (currently under revision). The device which is defined by these standards can be lubricated or nonlubricated, and for the purposes of selection for labeling as "extra strength" is tested in the strength categories to a higher standard (See Exhibit A in K970767 and K970792 as well as Exhibit 1) with added FDA certified color. The purpose of this medical device is for the prevention of pregnancy and the protection against sexually transmitted diseases, including HIV.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K972428
510(k) Summarv Notification
| Submitter: | Custom Services International, Inc.
3111 Post Rd.
Las Vegas, NV 89118 | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Telephone Number: | (702) 897-1789 | AUG 25 1997 |
| Contact: | Lillie C. Thomas, M.S.
Executive Director of Quality Assurance | |
| Registration Number: | 2951584 | |
| Date Submitted: | June 26, 1997 | |
| Name of the Device: | Condom, smooth surface, reservoir end, approximately 180 mm in
length and 52 mm in width (Type 1, Style 2, Class A) rubber
contraceptive device, lubricated with silicone or nonlubricated,
extra strength and colored. | |
| Trade Names: | ExtraWear TM, Gentlemen's ChoiceTM | |
| Equivalent Device: | Custom Services International Inc. Application K970767
(lubricated) and K970792 (nonlubricated) found to
be substantially equivalent on June 2, 1997 (Type 1, Style 2,
Class A) rubber contraceptive device, lubricated with silicone or
nonlubricated, tested to a higher quality standard for added strength
and colored. | |
| Class of Device: | Class II, Condom (rubber) Contraceptive - 85HIS | |
Description of Device Covered by this Submission
The device which is the subject of this application is a latex rubber condom (Class II medical device defined as "Condom (rubber) Contraceptive 85-HIS") and is defined by ASTM 3492-93 as a Type I, Style 2, Class A rubber condom, and further defined by ISO 4074-6 (currently under revision). The device which is defined by these standards can be lubricated or nonlubricated, and for the purposes of selection for labeling as "extra strength" is tested in the strength categories to a higher standard (See Exhibit A in K970767 and K970792 as well as Exhibit 1) with added FDA certified color. The purpose of this medical device is for the prevention of pregnancy and the protection against sexually transmitted diseases, including HIV.
1
Image /page/1/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle or other bird with its wings spread. The logo is black and white and appears to be a scan or photocopy.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lillie Č. Thomas, M.S. Director of Quality Assurance Custom Services International, Inc. 3111 West Post Road Las Vegas, Nevada 89118
Re: K972428 ExtraWear™, Gentlemen's Choice™ Dated: June 26, 1997 Received: June 27, 1997 Regulatory class: II 21 CFR §884.5300/Product code: 85 HIS
Dear Ms. Thomas:
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 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, 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.
AUG 25 1997
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 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 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 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/dsmamain.html".
Sincerely yours,
W. Niau Yu
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
2
Page 1 of D
510(k) Number:
Device Name: Condom (rubber) Contraceptive 85-HIS
Indications for Use:
. ---
Extra Strength lubricated rubber male condom for use as a contraceptive and prophylactic.
Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested."
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)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K972428 |
| Prescription Use (Per 21 CFR 801.109 | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|
| -------------------------------------- | ---- | ----------------------------------------------- |
3
510(k) Number:
Condom (rubber) Contraceptive 85-HIS Device Name:
Indications for Use:
Extra strength nonlubricated rubber male condom for use as a contraceptive and prophylactic.
Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested."
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)
| Rater R Sathi (Division Sign-Off) | |
|---|---|
| -- | --------------------------------------------------------------------------------------- |
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K97248 |
|---|---|
| --------------- | -------- |
| Prescription Use
| (Per 21 CFR 801.109 | OR | Over-The-Counter Use |
|---|---|---|
| (Optional Format 1-2-96) |