(54 days)
Not Found
No
The 510(k) summary describes a standard rubber condom and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a contraceptive and prophylactic, not for treating a disease or condition.
No
Explanation: The device is described as a "contraceptive and prophylactic," indicating its use for preventing conception and disease transmission, not for diagnosing medical conditions.
No
The device description clearly states it is a "colored rubber contraceptive device," indicating a physical hardware product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the device is a "Nonlubricated rubber male condom for use as a contraceptive and prophylactic." This is a physical barrier device used externally on the body for preventing pregnancy and the transmission of sexually transmitted infections. It does not involve the analysis of any bodily specimens.
The provided information about the device's physical characteristics, intended use, and predicate devices all point to it being a Class II medical device regulated for contraception and disease prevention, not an IVD.
N/A
Intended Use / Indications for Use
Nonlubricated rubber male condom for use as a contraceptive and prophylactic.
Product codes
85HIS
Device Description
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.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
.
| 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 in |
| length and 52 mm in width (Type 1, Style 2, Class A) colored | |
| rubber contraceptive device, nonlubricated or lubricated with | |
| silicone. | |
| 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 surface | |
| reservoir end, approximately 180 mm in length and 52 mm in width | |
| (Type 1, Style 2, Class A) rubber contraceptive device, lubricated | |
| with Nonoxynol-9 and silicone. This device is a Class II medical | |
| device covered by K901112 and currently sold in interstate | |
| commerce under the trade name Lifestyle® | |
| The applicant has received prior authorization to produce medical | |
| devices for interstate commerce before. This device was granted | |
| pursuant to 21 CFR 800 et seq. a 510(k) number K963319 and | |
| K963321 for the basic latex condom covered in this application. | |
| This device is also substantially equivalent, except the applicant | |
| device contains color. | |
| Class of Device: | Class II, Condom (rubber) Contraceptive - 85HIS |
1
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
2
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) |
|---|---|---|
| -------------------------------------- | ---- | ------------------------------------------------- |