(318 days)
Not Found
No
The summary describes a physical medical device (a condom) and its performance testing, with no mention of software, algorithms, or AI/ML technologies.
No.
The device is used for contraception and the prevention of sexually transmitted diseases, which are prophylactic purposes, not therapeutic.
No
The device, a male condom, is explicitly stated for contraception and prophylactic purposes (to help prevent pregnancy and transmission of sexually transmitted diseases), not for diagnosing conditions or diseases.
No
The device description clearly states it is a physical condom made of synthetic polyisoprene rubber, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and prophylactic purposes (preventing pregnancy and STDs). This is a physical barrier method, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the material and physical form of the condom. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a disease or condition.
The device is clearly described as a physical barrier for preventing pregnancy and disease transmission, which falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The Durex synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Product codes (comma separated list FDA assigned to the subject device)
MOL
Device Description
This condom is made of a synthetic polyisoprene rubber sheath, which completely I his condom is made or lead of the membrane. This device is a shaped, teat ended, lubricated condom. Synthetic polyisoprene is the synthetic form of natural lubricated condom. Bylinene perfisen as natural rubber, a material commonly used for poryisoprono raover of condoms made by SSL from synthetic polyisoprene have been shown to have similar performance properties as natural rubber latex condoms and conform to the relevant physical test requirements of national and international connomi to tare referant patural rubber latex male condoms, ISO 4074:2002, and Volunary Sandards of the synthetic condom standard ASTM D6324-05.
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)
Physical testing of the condom demonstrates that it meets performance standards for natural rubber condoms, which have been safely marketed worldwide for many vears. This condom has also been tested in line with the requirements of the ISO10993 standard on Biological Evaluation of Medical Devices, FDA Guidance Memorandum G95-1 (1995) and FDA guidance for testing of male condoms made from new material. Results of all these biocompatibility studies support the safety of the device. Additional viral penetration studies have also been conducted with acceptable results. A consumer user evaluation study was undertaken on the Durex synthetic polyisoprene condom in comparison with Durex natural rubber and polyurethane condoms in the UK and Italy during 2004 with favourable results for the new condom.
Subsequently a clinical investigation was conducted in 2007, in line with US FDA guidelines for clinical studies on synthetic condoms (Testing Guidance for Male Condoms made from New Material, June 29, 1995). The study was a randomised, cross over, home use study using the predicate device, ( K980319 Durex Ultra Comfort condom) as the control condom. The study found no significant difference between the study condom and control condom with respect to clinical breakage or clinical slippage.
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.
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
Durex Synthetic Polyisoprene Male condom Pre-market Notification 510(k) submission
JUN 1 9 2008
1.4: 510(k) SUMMARY
A. Submitter Information
SSL Americas 3585 Engineering Dr. Suite 200 Norcross, GA 30092-9214 Phone: 770 582 2174 Fax: 770 582 2226
B. Contact Person
Chris Robinson - Head of Regulatory Compliance, SSL Americas.
C. Date Prepared
9 July 2007
D. Proprietary Name
Durex synthetic polyisoprene male condom. (Trade name to be determined later)
E. Common Name Synthetic male condom
F. Classification Name
Condom non-latex ( 21 CFR 884.5300, Product code M-OL)
G. Predicated Device
Durex Ultra Comfort Latex Rubber Condom [510(k) Number K980319] Biogel Skinsense PI surgeons glove [510(k) Number K050184]
H. Description of the Device
This condom is made of a synthetic polyisoprene rubber sheath, which completely I his condom is made or lead of the membrane. This device is a shaped, teat ended, lubricated condom. Synthetic polyisoprene is the synthetic form of natural lubricated condom. Bylinene perfisen as natural rubber, a material commonly used for poryisoprono raover of condoms made by SSL from synthetic polyisoprene have been shown to have similar performance properties as natural rubber latex condoms and conform to the relevant physical test requirements of national and international connomi to tare referant patural rubber latex male condoms, ISO 4074:2002, and Volunary Sandards of the synthetic condom standard ASTM D6324-05.
I. Intended Use of the Device
This synthetic polyisoprene condom has the same intended use as the predicate This syntherie perfisoprene consisted for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
1
Durex Synthetic Polyisoprene Male condom Pre-market Notification 510(k) submission
Physical test data, biocompatibility data, safety and clinical data included in the 510K application indicate that the differences between this condom and the predicate condom device does not adversely affect the safety and effectiveness of the device in its intended use.
J. Technological Characteristics
This condom has many similar characteristics as the predicate condom identified. The condoms described in K980319 are Durex manufactured, shaped natural rubber latex male condoms with silicone lubricant containing 'Zeus' odour masker. The synthetic polyisoprene condom is the same shape and design and uses the same silicone lubricant with 'Zeus' odour masker as the predicate device. The physical properties of the synthetic polyisoprene condom conform to relevant sections of domestic and international regulations: ASTM D3942-03, ISO 4074:2002 and ASTM D6324-05. Physical testing and final release testing revealed results in conformance with required specifications.
The synthetic polyisoprene material used to manufacture these condoms is also the same material used for the production of the predicate device, Biogel Skinsense PI surgical gloves, which are currently marketed in the USA.
The advantages of synthetic polyisoprene over natural rubber latex are the consistency of the synthetically derived material in comparison with the typical variation found in natural polyisoprene, low levels of impurities in the synthetic material and absence of natural rubber latex proteins.
K. Clinical and non clinical performance data.
Physical testing of the condom demonstrates that it meets performance standards for natural rubber condoms, which have been safely marketed worldwide for many vears. This condom has also been tested in line with the requirements of the ISO10993 standard on Biological Evaluation of Medical Devices, FDA Guidance Memorandum G95-1 (1995) and FDA guidance for testing of male condoms made from new material. Results of all these biocompatibility studies support the safety of the device. Additional viral penetration studies have also been conducted with acceptable results. A consumer user evaluation study was undertaken on the Durex synthetic polyisoprene condom in comparison with Durex natural rubber and polyurethane condoms in the UK and Italy during 2004 with favourable results for the new condom.
Subsequently a clinical investigation was conducted in 2007, in line with US FDA guidelines for clinical studies on synthetic condoms (Testing Guidance for Male Condoms made from New Material, June 29, 1995). The study was a randomised, cross over, home use study using the predicate device, ( K980319 Durex Ultra Comfort condom) as the control condom. The study found no significant difference between the study condom and control condom with respect to clinical breakage or clinical slippage.
The Durex synthetic polyisoprene condom has already been launched in other markets worldwide with a low incidence of consumer complaints in these countries. In conclusion it is considered that the Durex synthetic polyisoprene condom is as safe
and effective, and performs at least as well as the predicate condom.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2008
Mr. Chris Robinson Regulatory Affairs Manager Head of Regulatory Compliance SSL Americas, Inc. Office of Regulatory Affairs 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-9214
Re: K072169
Trade/Devices Name: SSL Synthetic Polyisoprene Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MOL Dated: May 16, 2008 Received: May 23, 2008
Dear Mr. Robinson:
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.
3
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" (21CFR 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/cdrh/industry/support/index.html.
Sincerely yours,
NancyCbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Durex Synthetic Polyisoprene Male condom Pre-market Notification 510(k) submission
l.3 Indications for Use
510(k) Number (if known): Not known. KVZZ/ 4 9 Device Name: Durex synthetic polyisoprene male condom Indications for Use:
The Durex synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Prescription Use Over-The-Counter Use (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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