(318 days)
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).
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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Durex Synthetic Polyisoprene Male Condom
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly list numerical acceptance criteria in a dedicated table format. Instead, it relies on demonstrating equivalence to predicate devices and conformance to established standards. The acceptance criteria are implicitly those set by the referenced standards and the performance of the predicate device.
| Acceptance Criteria (Implicit from Standards/Predicate) | Reported Device Performance |
|---|---|
| Physical Properties: | |
| Conformance to ASTM D3942-03 (Male Latex Condoms) | Conforms to relevant sections |
| Conformance to ISO 4074:2002 (Natural Rubber Latex Condoms) | Conforms to relevant sections |
| Conformance to ASTM D6324-05 (Synthetic Condoms) | Conforms to relevant sections |
| Similar performance properties as natural rubber latex condoms | Similar performance properties |
| Biocompatibility: | |
| Conformance to ISO 10993 standard | Meets or exceeds requirements |
| Conformance to FDA Guidance Memorandum G95-1 (1995) | Meets or exceeds requirements |
| Conformance to FDA guidance for testing of male condoms made from new material | Meets or exceeds requirements |
| Viral Penetration: | |
| Acceptable results in viral penetration studies | Acceptable results |
| Clinical Performance (Comparison to Predicate): | |
| No significant difference in clinical breakage | No significant difference |
| No significant difference in clinical slippage | No significant difference |
| Consumer User Evaluation: | |
| Favorable results in comparison to natural rubber and polyurethane condoms | Favorable results |
| Low incidence of consumer complaints in launched markets | Low incidence of complaints |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Investigation: "A clinical investigation was conducted in 2007... using the predicate device... as the control condom." The specific sample size for this clinical study is not explicitly stated in the provided text.
- Consumer User Evaluation: Conducted "in the UK and Italy during 2004". The specific sample size is not explicitly stated.
- Data Provenance:
- Clinical Investigation: Prospective (conducted in 2007) and global (implicitly, as it refers to US FDA guidelines but typical for such studies to have international sites, though specific country not mentioned for this study itself, only for predicate use).
- Consumer User Evaluation: Prospective (conducted in 2004) in the UK and Italy.
- Physical Testing: Performed as part of manufacturing and submission process; provenance is the manufacturer and testing labs.
- Biocompatibility/Viral Penetration: Lab-based studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable in the context of condom testing. Ground truth for condom performance is established through objective physical measurements, viral penetration assays, and clinical outcomes (breakage, slippage) observed by study participants and collected by trained clinical staff. There isn't a need for expert consensus on individual "cases" in the way it applies to image interpretation or diagnosis.
4. Adjudication Method for the Test Set
This is not applicable in the traditional sense of medical device studies involving expert interpretation or diagnostic outcomes. For clinical breakage and slippage, the events are typically recorded by the users and confirmed by study staff. Discrepancies would be resolved through standard clinical trial monitoring and data validation procedures rather than an adjudication panel of experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. This is a device for contraception and disease prevention, not an interpretative medical device or AI-assisted diagnostic tool. Therefore, there are no "human readers" or "AI assistance" in the context of its primary function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This device is a physical product (a condom), not an algorithm or AI system.
7. The Type of Ground Truth Used
- Physical Properties: Objective measurements against international and domestic standards (e.g., tensile strength, burst volume, length, width).
- Biocompatibility: Laboratory test results demonstrating non-toxicity, non-irritation, etc., as per ISO 10993 and FDA guidelines.
- Viral Penetration: Laboratory test results using viral challenge models.
- Clinical Performance: User-reported clinical outcomes (breakage and slippage) during actual use in a controlled clinical setting, compared to the predicate device.
- Consumer User Evaluation: User satisfaction, preference, and comfort reported by study participants.
- Post-Market Surveillance: Real-world consumer complaint data.
8. The Sample Size for the Training Set
This is not applicable in the context of device approval for a physical product like a condom. There isn't a "training set" in the machine learning sense. The device is manufactured based on established specifications and tested against those specifications and performance benchmarks derived from predicate devices and standards.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8. The "ground truth" for manufacturing a condom to a certain standard is the set of specifications and physical properties required by the relevant ASTM/ISO standards and the performance profile of the predicate device, which itself was established through a historical process of testing and clinical use.
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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).
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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.
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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.
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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
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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
Page 12 of 800
§ 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.