(160 days)
K#910284, K#932983
K#910284,K#932983
No
The summary describes a standard condom and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The intended use of the device is for contraception and prophylaxis against venereal diseases, which falls under preventative measures rather than therapeutic treatment of an existing condition.
No
The device is described as a condom, intended for contraception and prophylactic purposes. Its function is to cover the penis, which is a physical barrier function, not a diagnostic one. The performance studies mentioned relate to physical testing and shelf-life, not to the detection or diagnosis of any condition.
No
The device description clearly states it is a physical sheath covering the penis, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Condom Function: The intended use of this device is for contraception and preventing the transmission of venereal diseases. It is a physical barrier applied externally to the body.
- Lack of Biological Sample Testing: The description does not mention any testing of biological samples from the body. The performance studies focus on physical properties and shelf-life.
Therefore, based on the provided information, this condom does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal diseases).
Product codes
85 HIS
Device Description
A condom is a sheath which completely covers the penis with a closely fitting membrane.
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)
All physical testing, air inflation testing and color fastness testing, including all other in-process, and final release testing, revealed results that conformed to the required specifications. In addition, a shelf-life of 5 years is claimed, with real-time testing data to support such claim.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#910284, K#932983
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
EXHIBIT #1
K971132 81072
510(K) SUMMARY
This summary of 5/0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5lO(k) number is: _______________________________________________________________________________________________________________________________________________
SEP - 3 1997
Submitter's Identification: 1.
G. Premiee (USA) Inc. 304 B East Lawrence Blvd. Avondale, Arizona 85323
Date Summary Prepared: March 26, 1997
2. Name of the Device:
Royale ® Brand Latex Condoms - (Silicone)- Colored and Assorted Colors
3. Predicate Device Information:
Suretex Ltd., K#910284, Latex Rubber Condoms (Silicone) Sime Health Ltd., K#932983, Lubricated (Silicone) Latex Condoms (Colored) (Essential ™, Mi Vida™ and Jiffi™).
4. Device Description:
A condom is a sheath which completely covers the penis with a closely fitting membrane.
5. Intended Use:
The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal diseases).
6. Comparison to Predicate Devices:
The Royale ® Brand Latex Condoms - (Silicone) - Colored or Assorted Colors, is identical in all aspects to the Suretex Ltd. Latex Rubber Condoms (Silicone) and similar in design, composition (latex) and function to the Sime Health Ltd. Lubricated (Silicone) Latex Condoms (Colored).
1
The following voluntary standards were adhered to and their device was tested in accordance with all requirements of these standards.
- ASTM-D-3492-96 a.
- ISO 4074, Part 1 and Part 6 b.
- May 1, 1995 FDA Biocompatibility Guidance, FDA Modified C. Matrix of ISO-10893
All physical testing, air inflation testing and color fastness testing, including all other in-process, and final release testing, revealed results that conformed to the required specifications. In addition, a shelf-life of 5 years is claimed, with real-time testing data to support such claim.
Discussion of Clinical Tests Performed: 8.
Not Applicable
9. Conclusions:
The Royale ® Brand Latex Condoms - (Silicone) - Colored and Assorted Colors has the same intended use and similar technological characteristics as the Sime Heath Ltd. Condom and identical technological characteristics as the Suretex Ltd. Condom. All non-clinical testing and biocompatibility testing revealed no new questions of safety or effectiveness. Thus, when compared to the predicate devices, the Royale ® Brand Latex Condoms -(Silicone) - Colored and Assorted Colors did not incorporate any significant changes in intended use, method of operations, material, or design that could affect safety or effectiveness.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized emblem of an eagle with three wavy lines representing the department's mission to promote health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
G. Premjee (USA), Inc. c/o Ms. Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Boulevard, Suite 410 Great Neck, New York 11021
3 1997
Re: K971132 Royale® Brand Latex Condoms (Silicone) Colored or Assorted Colors Sated: July 28, 1997 ........ Received: July 30, 1997 Regulatory class: II 21 CFR §884.5300/Product code: 85 HIS
Dear Ms. Goldstein-Falk:
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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 requirement, as set forth in the Quality System Regulation (OS) 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/dsmamain.html".
Sincerely yours,
W.Lilian Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Nuraber (if Lown):
· EXHIBIT B
Royale ® Brand Latex Condoms (Silicone) - Colored or Assorted Color: Device Name:
Indications For Use:
The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal disease).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF HEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE)
Robert R. Sather
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices K 9 510(k) Number _
Prescription Use (Per 21 CFR 801-109)
OR
Over-The-Counter Use
(Opticed Forced 1-2-96)