(261 days)
Not Found
Not Found
No
The summary describes a standard condom and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is indicated for contraceptive and prophylactic purposes, not for treating a disease or condition.
No
Explanation: The device is a condom, which is used for contraceptive and prophylactic (preventative) purposes, not for diagnosing medical conditions.
No
The device description clearly states it is a physical product (condom) made of natural rubber latex, which is a hardware component.
Based on the provided information, 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: The description details the physical characteristics of a condom. IVDs typically involve reagents, instruments, or software used to analyze biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical elements associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Diagnostic or monitoring purposes
- Laboratory settings or procedures
Therefore, the Innolatex condom, as described, falls under the category of a medical device used for physical barrier contraception and disease prevention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Innolatex condom used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
Product codes
HIS
Device Description
Male Natural Rubber Latex Condom Straight side or Contoured or Flared in Shape, either Textured or Non-textured, Lubricated or Non-lubricated, Non-color or Colored and Flavored or Non-flavored
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)
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 seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and the country it represents.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
MAY 1 2 2010 INNOLATEX (THAILAND) LIMITED
Lot E1-6 Export Processing Zone Southern Industrial Estate, Village 4, Chalung Sub-District Hatvai District, Songkhla THAILAND 90110
Re: K092586
Mr. Goh Saing
Chief Executive Officer
Trade/Device Name: Male Natural Latex Condom Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: May 2, 2010 Received: May 7, 2010
Dear Mr. Saing:
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.
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 of medical device-related
1
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/Resourcesfor You/Industry/default.htm.
MEDICAL RECORDS REQUEST & CONSENT FOR RELEASE OF INFORMATION
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image contains the text 'LATEX' in a bold, sans-serif font. The letters are slightly distorted, with some pixelation and blurring around the edges. The overall impression is that the text is part of a logo or heading, possibly related to the LaTeX typesetting system.
INNOLATEX (THAILAND) LIMITED
INDICATIONS FOR USE STATEMENT
5:10(k) Number:
Device Name:
Male Natural Rubber Latex Condom Straight side or Contoured or Flared in Shape, either Textured or Non-textured, Lubricated or Non-lubricated, Non-color or Colored and Flavored or Non-flavored]
Indications For Use;
The Innolatex condom used for contraceptive 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
CFR § 801.109)
Hules Reiner
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number