(170 days)
Not Found
None
No
The summary describes a latex condom and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
Condoms are contraceptive devices used to prevent pregnancy and the transmission of sexually transmitted diseases, not to treat a health condition or disease.
No
Explanation: The device, a latex condom, is described for contraception and prophylactic purposes (preventing pregnancy and STDs), which are not diagnostic functions.
No
The device described is a latex condom, which is a physical medical device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as contraception and prevention of sexually transmitted diseases. This is a physical barrier method used externally, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description 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 those samples
- Providing diagnostic or monitoring information
Therefore, this device, a latex condom, falls under the category of a medical device used for physical prevention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This [MULTIPLE BRAND] 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).
Product codes
LTZ, HIS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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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
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Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The eagle is depicted with three curved lines representing its wings and a simple representation of its head and body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 2 1 2007
Ms. Kim L. Lee Head, OA Department Nulatex Sdn Bhd Lot 1870, 4th Miles, Jalan Mengkibol 86000, Kluang, Johor. MALAYSIA
Re: K070937
Trade Name: [MULTIPLE BRAND] of Male Natural Rubber Latex Condom Regulation Number: 21 CFR 884.5310 Regulation Name: Condom with spermicidal lubricant Regulatory Class: II Product Codes: LTZ and HIS Dated: August 16, 2007 Received: August 20, 2007
Dear Ms. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the 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 reclassified in accordance with 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 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 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 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 logo with the text "1906-2006" at the top. Below the text is the abbreviation "PA" in a bold, stylized font. The word "Centennial" is written in a cursive font below the abbreviation. Three stars are arranged in a horizontal line at the bottom of the logo.
relating and Premoting Public Secally
1
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 (OS) 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 yours,
Nancy C Hodgdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
nulatex sdn. bhd. (11871-M)
Lot 1870, 4th Miles, Jalan Mengkibol 86000, Kluang, Johor. Malaysia t +607-7771801 f +607-7771805 e: info@nulatex.com w: www.nulatex.com
Amended page 22
INDICATIONS FOR USE STATEMENT VII.
510(k) Number: K070937
Device Name:
[MULTIPLE BRAND] of Male Natural Rubber Latex Condom
Indications For Use: This {MULTIPLE BRAND] 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).
(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, and Radiological Devices | |
| 510(k) Number | K070937 |
| Prescription Use (Per 21 CFR § 801,109) | OR | Over-The-Counter Use
|
| ----------------------------------------- | ---- | ----------------------------------------------------- |
|---|