(22 days)
Not Found
R002750
No
The summary describes a standard condom and explicitly states that AI, DNN, or ML are "Not Found".
No.
Explanation: The device is intended for contraception and prevention of sexually transmitted diseases, which are prophylactic measures, not therapeutic (treatment of an existing condition).
No
Explanation: The intended use of the device, a condom, is for contraception and disease prevention, not for diagnosing any medical condition.
No
The device description clearly states it is a "Male Natural Rubber Latex Condom," which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and prevention of sexually transmitted diseases. This is a physical barrier method used in vivo (on the body), not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: It's a male natural rubber latex condom, which is a physical device.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information about a disease or condition
IVDs are devices used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This condom does not fit that description.
N/A
Intended Use / Indications for Use
The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Product codes
HIS
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
R002750
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal lines above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT - 5 2006
Sri Mahendra Sathiacama General Manager Biogreen Medical Sdn. Bhd. Lot 138201, Off ¼ Mile Jalan Bercham, Kawasan Eot 150201, Bercham, Ipoh Perak 31400, Malaysia
Re: K062730
R002750
Trade/Device Name: Male Natural Rubber Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Non-Spermicidal Male Latex Condom Regulatory Class: II Product Code: HIS Dated: Sept. 1, 2006 Received: Sept. 13, 2006
Dear Sri Sathiacama:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally breaks is substantially equivalent (for the indications for referenced above and nave acteminar arteted predicate devices marketed in interstate commerce use stated in the enorobard to regard that of the Medical Device Amendments, or to devices that proof to way 20, 1770, and claims. and 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 increisions of the Act include requirements for annual registration, listing of devices, good Condors provisions of also not morade prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket IT your device is classinos (500 additional controls. Existing major regulations affecting your Apploval), it thay be subject to Judi adant Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image is a circular seal with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are in the center of the seal. There are three stars below the word "Centennial". The seal appears to be a commemorative emblem for the centennial of the Food and Drug Administration.
Protecting and Promoting Public Health
1
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.
Sincerely vours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
VII. INDICATIONS FOR USE STATEMENT
510(k) Number:
name]
Device Name:
Male Natural Rubber Latex Condom [No particular brand
Indications For Use:
The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR §801.109)
OR
Over-The-Counter Use
David le Hyrm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.