(193 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and standards compliance of latex condoms, with no mention of AI or ML technology.
No
The device is described as a contraceptive and for prevention of sexually transmitted diseases, which fall under public health devices rather than therapeutic.
No
The device is a contraceptive for the prevention of pregnancy and transmission of sexually transmitted diseases, not for diagnosing conditions.
No
The device description clearly indicates it is a physical latex sheath, not software.
No, 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, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description clearly states it's a latex sheath that covers the penis. This is a physical device, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information about a disease or condition
The device is a medical device, specifically a contraceptive and barrier for disease prevention, but it operates through a physical mechanism, not through in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Condomi brand latex condoms are intended to be used as a contraceptive (for the prevention of pregnancy) and/or for the prevention of the transmission of sexually transmitted diseases.
Product codes (comma separated list FDA assigned to the subject device)
85 HIS, LTZ
Device Description
Like other natural latex condoms on the market, the Condomi brand condoms are latex sheaths, which completely cover the penis with a closely fitting membrane. The following condom styles, colors, and flavors will be offered:
- a) Standard transparent lubricated with silicon oil
- b) Colored pink, studded, lubricated with silicon oil
- c) Colored gold, lubricated with silicon oil, and vanilla flavor.
- d) Transparent, form-fitting condom, lubricated with spermicidal lubricant N-9
- e) Extra large condom transparent, lubricated with silicon oil
- f) Extra strong condom, transparent, lubricated with silicon oil
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)
Non-Clinical Tests: The Agency has recognized ASTM D3492-97, Standard Specifications for Rubber Contraceptives (male condoms); ISO Standard 4074, Requirements for Rubber Condoms, parts 1,2,3,5,6,7,9 1996; and ISO 10993, Biological Evaluation of Medical Devices as Consensus standards. The Condomi brand condoms meet these standards. Methods and results were provided.
Clinical Tests: No clinical testings were completed.
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.
Not Found
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
OCT 2 5 2002
Attachment #1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: KoZ צום 6
1. Submitter's Identification:
Condomi Erfert Prdoktionsgesellschaft mbH Tiergartenstafße2, DF-99089 Erfert, Germany
Date Summary Prepared:
April 11, 2002
2. Name of the Device:
Condomi Nature condoms, transparent, lubricated with silicon oil
Condomi Stimulation condoms, colored pink, studded, lubricated with silicon oil
Condomi vanilla Gold condoms, colored gold, lubricated with silicon oil, and vanilla flavor.
Condomi SuperSafe condoms, transparent, form-fittinq, lubricated with spermicide, N-9.
Condomi XXL condoms, transparent, extra large condom, lubricated with silicon oil
Condomi Strong, condoms, transparent, extra thick condom, lubricated with silicon oil
3. Predicate Device Information: Comparison to Legally Marketed Device:
Exhibit 6 are lists of recently submitted and cleared 510(k) s for male latex condoms (part 1), and male latex condoms with spermicidal lubricant (part 2) These lists were obtained from the FDA/CDRH 510(k) database and include condoms that are transparent, colored, flavored and lubricated with silicone or N-9 spermicidal lubricant. The Condomi brand condoms are similar in design,
1
composition, function, technological characteristics, and intended use to these condoms.
- Device Description: Like other natural latex condoms on the market, the 4. Condomi brand condoms are latex sheaths, which completely cover the penis with a closely fitting membrane. The following condom styles, colors, and flavors will be offered:
- a) Standard transparent lubricated with silicon oil
- b) Colored pink, studded, lubricated with silicon oil
- c) Colored gold, lubricated with silicon oil, and vanilla flavor.
- d) Transparent, form-fitting condom, lubricated with spermicidal lubricant N-9
- e) Extra large condom transparent, lubricated with silicon oil
- f) Extra strong condom, transparent, lubricated with silicon oil
- Intended Use: : Condomi brand latex condoms are intended to be used as a 5. contraceptive (for the prevention of pregnancy) and/or for the prevention of the transmission of sexually transmitted diseases.
- Comparison to Predicate Devices: There are no significant differences 6. between Condomi brand condoms and the predicates.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The Agency has recognized ASTM D3492-97, Standard Specifications for Rubber Contraceptives (male condoms); ISO Standard 4074, Requirements for Rubber Condoms, parts 1,2,3,5,6,7,9 1996; and ISO 10993, Biological Evaluation of Medical Devices as Consensus standards. The Condomi brand condoms meet these standards. Methods and results were provided.
8. Discussion of Clinical Tests Performed: No clinical testings were completed
-
- Conclusions: The Condomi brand condoms are safe and effective for the intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three overlapping wing shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
OCT 2 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carolann Kotula Vice President RA/QA mdi Consultants, Inc. 55 Northern Blvd. GREAT NECK NY 11021
Re: K021186
Trade Name/Device: Condomi® Brand Male Latex Condoms Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulation Number: 21 CFR 884.5310 Regulation Name: Condom with spermicidal lubricant Regulatory Class: II Product Code: 85 HIS and LTZ Dated: July 30, 2002 Received: August 5, 2002
Dear Ms. Kotula:
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 (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.
3
Page 2 - Ms. Kotula
:
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.
Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR §884.5300 and 8884.5310) 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(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, 8801.435(c) 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, International and Consumer 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.
Claird A. Seymour
for Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Attachment # 3
| 1 | ||
|---|---|---|
510(k) Number (if known): K021186
Device Name: Condomi brand male latex condoms
Indications For Use: Condomi brand latex condoms are intended to be used as a contraceptive (for the prevention of pregnancy) and/or for the prevention of 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 ✔ (Optional Format 1-2-96)
David M. Heggem
(Division Sign-Off)
Division of Reproductive Andominal, and Radiological Devices 510(k) Number