(86 days)
No
The summary describes a physical medical device (condom) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
A therapeutic device is used to treat or cure a disease or condition. This device is primarily for contraception and prevention of disease transmission, not treatment.
No
The document describes a condom as a contraceptive and prophylactic device, not a device used to diagnose a disease or condition.
No
The device description clearly states it is a natural rubber latex sheath, which is a physical hardware component, not software.
Based on the provided information, the Simplex brand condom is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for contraception and prophylactic purposes (reducing the risk of STIs and pregnancy) by physically covering the penis during sexual intercourse. This is a physical barrier method, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical characteristics of the condom (material, dimensions, etc.). It does not describe a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Simplex condom's function is purely mechanical and preventative.
N/A
Intended Use / Indications for Use
This 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).
The Simplex brand condom is a male contraceptive device, fabricated of natural latex, which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraception and for prophylactics purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100 % effectiveness. Failure to use as directed, may further result in loss of protection. Furthermore. sexually transmitted diseases can be transmitted through lesions and various body fluids, during intimate contact. Therefore, the condom should be applied before any such contact.
Product codes
85 HIS
Device Description
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is made of first grade latex material, teatended, single wall and contoured. Its dimensions are: length 170mm minimum, width: 51mm, thickness: 0.04-0.06 mm (single wall), weight: 1.0-1.3 gm/piece
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
б
II 510(K) SUMMARY
| Submitted by: | PT Vonix Latexindo
JI. Balikpapan 21 E Jakarta
Pusat 10160, Indonesia
Phone: 62-21-385 0222/385 0202 |
|----------------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Vijay Mahal (Applicant)
Vineel Enterprises
Phone:617-973-7157 |
| Date Prepared: | November 4th, 1999 |
| Proprietary Name: | Simplex Condoms |
| Common Name: | Latex Condom |
| Classification Name: | Condom (21 CFR 884.5300) |
| Predicate Device: | Ansell/LifeStyle Xtra Pleasure, Latex
Lubricated Condom, 510K# K983518 |
- Description of Device: This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is made of first grade latex material, teatended, single wall and contoured. Its dimensions are: length 170mm minimum, width: 51mm, thickness: 0.04-0.06 mm (single wall), weight: 1.0-1.3 gm/piece
- Intended Use of the Device: This 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).
- Technological Characteristics: This condom has the same technological characteristics as the predicate condoms identified above. This condom is made of first grade natural rubber latex material using a German- made automatic dipping line. The design of this condom is in conformance with WHO, ISO, EN 600, DIN and ASTM D3492-96.
1
Image /page/1/Picture/1 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 a stylized image of an eagle, with three curved lines representing the wings and two curved lines representing the body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2000 FRB
P.T. Vonix Latexindo c/o Vijay Mahal. Ph.D. Vineel Enterprises 7 Riverview Road Framingham, MA 01701
Re: K993781
Simplex Brand Male Latex Condom (Silicon Lubricated) Dated: November 4, 1999 Received: November 8, 1999 Regulatory Class: II 21 CFR §884.5300/Procode: 85 HIS
Dear Dr. Mahal:
We have reviewed your 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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 your device in the Federal Register.
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market
2
Page 2 - Vijay Mahal, Ph.D.
Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR 884.5300 and 884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in 801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the earlier of the two expiration dates. Although supporting data is not to be provided in your 510(k) submission, 801.435(i) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, 801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in 801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4616. 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/dsma/dsmamain.html".
Sincerely yours,
Vaind A. Sypm
CAPT David G. Sypholt, MD
fur
CAPT Daniel G. Schultz M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
INDICATIONS FOR USE STATEMENT VII.
Not available yet K 99378 | 510(k) Number: Simplex brand Male Rubber Latex Condom
(Sill con Lubricated) Device Name: Indications For Use: The Simplex brand condom is a male contraceptive device, fabricated of natural latex, which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraception and for prophylactics purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100 % effectiveness. Failure to use as directed, may further result in loss of protection. Furthermore. sexually transmitted diseases can be transmitted through lesions and various body fluids, during intimate contact. Therefore, the condom should be applied before any such contact.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR Over-The-Counter Use ✓ |
|---|---|
| ------------------ | --------------------------------------------------------------------------- |
(Division Sign-On)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K993781 |
|---|---|
| --------------- | --------- |