(326 days)
Not Found
No
The device description is for a standard latex condom and does not mention any AI or ML components or functionalities.
No
The device is described as being used for contraception and prophylaxis against sexually transmitted diseases, not for treating a disease or condition.
No
The device, a male latex condom, is intended for contraception and prophylactic purposes, not for diagnosing any condition.
No
The device description clearly states it is a physical condom made of natural rubber latex, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Richter Male Latex Condom is a barrier device used externally on the body for contraception and disease prevention. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states contraception and prophylactic purposes, not diagnostic testing.
Therefore, based on the provided information, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic.
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, including HIV.
The Richter Male Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
Product codes (comma separated list FDA assigned to the subject device)
HIS
Device Description
This condom is made of a natural rubber latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is colorless, non flavored, non scented; straight walled with a reservoir tip. The nominal length is 185 mm, nominal width, 54 mm and nominal thickness 0.07mm. It is lubricated with silicone (viscosity 250 cps), and cornstarch is used as a dressing material. This condom conforms to current established national and international voluntary standards including ASTM D3492 and ISO 4074.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
UNIDUS Male Latex Condom - K023059
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JAN 1 4 2008
Kd7 4511
Abbreviated 510 (k) Notification for a Male Latex Condom
Page 5 of 13
I. 510(k) SUMMARY
| Submitted By: | Richter Rubber Technology SBN BHD
Plot 33, Kuala Ketil Industrial Estate
09300 Kuala Ketil, Kedah
Malaysia |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eli J. Carter, Consultant
PO Box 12139
Durham, NC 27709
Tel: 919 544 4098; Fax: 919 544 5849
Email: carterej@aol.com |
| Date Prepared: | December 26, 2007 |
| Proprietary Name: | None |
| Common Name: | Male Latex Condom: 54 mm (nominal width), 185 mm (nominal
length), straight-wall with reservoir tip, silicone lubricated, colorless,
flavorless, unscented |
| Classification Name: | Male Latex Condom |
| Predicate Devices: | UNIDUS Male Latex Condom - K023059 |
| Description of Device: | This condom is made of a natural rubber latex sheath, which
completely covers the erect penis with a closely fitted membrane. This
condom is colorless, non flavored, non scented; straight walled with a
reservoir tip. The nominal length is 185 mm, nominal width, 54 mm
and nominal thickness 0.07mm. It is lubricated with silicone (viscosity
250 cps), and cornstarch is used as a dressing material. This condom
conforms to current established national and international voluntary
standards including ASTM D3492 and ISO 4074. |
| 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, including HIV. |
User Instructions and Precautions are provided to insure proper
use and disposal of the product after use. See Package Labeling
and Insert - (Attachment 2).
| Technological Characteristics: | This condom has the same technological characteristics as the predicate
condoms identified above. It is made from natural rubber latex and |
| -------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
the design is in conformance with ASTM D3492 and ISO 4074 Male
Latex Condom Standards.
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JAN 1 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richter Rubber Technology SBN BHD % Eli J. Carter, Ph.D. Consultant Family Health International P.O. Box 12139 DURHAM NC 27709
Re: K070511
Trade/Device Name: Richter Male Latex Condom: 54 mm (nominal width), 185 mm (nominal length), straight-wall with reservoir tip, silicone lubricated, colorless, flavorless, unscented
Regulation Number: 21 CFR 884.5300
Regulation Name: Condom
Regulatory Class: II Product Code: HIS
Product Code. 115
Dated: December 26, 2007 Received: December 31, 2007
Dear Dr. Carter:
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 (PMA), 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.
2
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Information for a Male Latex Condom 510(k) Submission
Page 11 of 13
II. INDICATIONS FOR USE STATEMENT
:
| 510(k) Number: | K070511 |
|---|---|
| Device Name: | Richter Male Latex Condom |
| 54mm (nominal width), 185 mm (nominal length), straight-wall | |
| with reservoir tip, silicone lubricated, colorless, flavorless, | |
| unscented | |
| Indications for Use: | The Richter Male Latex Condom is used for contraception and for |
| prophylactic purposes (to help prevent pregnancy and the transmission | |
| of sexually transmitted diseases) |
.
の 2007年 10月 2007 10:00 PM 100 100 100 100 100 100
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | ||
|---|---|---|
| OR Over-the-Counter Use | ||
| (Division Sign-Off) |