(242 days)
Not Found
Not Found
No
The 510(k) summary describes a natural male latex condom, a physical barrier device, and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is described as being used for "contraception and prophylactic purposes" to "help prevent pregnancy and transmission of sexually transmitted infection," which are preventative uses rather than therapeutic (treatment) uses.
No
The device is a condom, intended for contraception and prophylactic purposes, not for diagnosing any condition.
No
The device is a condom, which is a physical medical device, not software. The 510(k) summary describes a physical product for contraception and STI prevention.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or to monitor health. Examples include blood tests, urine tests, and tissue biopsies.
- This device is a condom. Its intended use is for contraception and preventing the transmission of sexually transmitted infections. It is a physical barrier used externally and does not involve the examination of bodily specimens for diagnostic purposes.
The provided information clearly states the intended use is for contraception and prophylaxis, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
Nulatex Natural Male Latex Condom is used for continception and prophylactic purposes. (To help provent pregnancy and iransmission of sexually transmitted infection)
Product codes
HIS
Device Description
Nale, Later, Condom(Naural Vanilla, Natural Banning, Orange, Continer, Clange, Elavor, Yellow (Singna)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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)
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 the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2014
Nulatex Sdn. Bhd. Teo Ai Siang OA Manager Lot 1870, 4th Mile, Jalan Mengkibol Kluang, Johor 86000 Malaysia
Re: K132107
Trade/Device Name: Male Latex Condom (Natural Vanilla, Natural Banana, Orange Condom. Orange with Orange Flavor, Yellow Condom, Yellow Banana Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: January 28, 2014 Received: January 31, 2014
Dear Teo Ai Siang,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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,
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Page 2 - Teo Ai Siang
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/7 description: The image shows the name "Benjamin Fisher-S" with a logo in the middle. The logo appears to be a stylized version of the letters "FDA". The text is in a simple, sans-serif font and is easy to read. The logo is more intricate and detailed than the text.
Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Indications for Use
Form'Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013 See PRA: Statement on last page .
510(k) Number (if known) K132107
it
・
Device Name
Device Name.
Nale, Later, Condom(Naural Vanilla, Natural Banning, Orange, Continer, Clange, Elavor, Yellow (Singna) (
Indications for Use (Describe)
Nulatex Natural Male Latex Condom is used for continception and prophylactic purposes.
(To help provent pregnancy and iransmission of sexually transmitted infection)
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Benjamin R Fisher-S
2014.03.07 18:31:28 -05'00'
| FORM FDA 3881 (9/13) | Page 1 of 2 |
|---|---|
| ---------------------- | ------------- |
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Allery Comment ..............................................................................................................................................................................
This section applies only to requirements of the Papenwork Reduction Act of 1986.
-DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
. 이 역사
The burden time for this collection of Information is asserge 79 hours per response, including the and review the collection of information. Send comments regarding this burden estimate of any other aspect, of this information collection, theluding suggestions for reducing this burden, to:
Department of Health and Human Services Food and Orug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStatt@fda:hhs.gov
"An agency may not conduct or sponsor, and a parson is not required to respond to, a collection of .
Information unless it displays a currently valid OMB number."
Page 2 of 2
FORM FDA 3881 (9/13)