LUBRICATED BAGGY TACTYLON CONDOM

K974121 · Sensicon Corp. · MOL · Jan 29, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K974121
• Device Name: LUBRICATED BAGGY TACTYLON CONDOM
• Applicant: Sensicon Corp.
• Product Code: MOL · Obstetrics/Gynecology
• Decision Date: Jan 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

For Latex Sensitive Condom Users: This is a TACTYLON® condom. This is not a latex condom. You may use this TACTYLON ® condom if you or your partner are allergic to latex. You should know: - The risks of pregnancy and sexually transmitted diseases (STDs), including AIDS . (HIV infection), are not known for this condom. A study is being done. - There are laboratory tests on this TACTYLON® material. These tests show that . organisms even as small as sperm and viruses like HIV cannot pass through it. Latex condoms for men, if used correctly with every act of vaginal intercourse are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection).

Device Story

TACTYLON® condom; synthetic thermoplastic elastomer block copolymer (styrene-ethylene-butylenestyrene); non-latex alternative for individuals with Type I or Type IV hypersensitivity to Natural Rubber Latex (NRL). Device functions as physical barrier during vaginal intercourse; prevents transmission of sperm and viruses (e.g., HIV). Material properties (strength, elasticity, tactility) equivalent to NRL; resistant to UV, ozone, oxygen, heat, and humidity. Used by patients; over-the-counter availability. Clinical trials confirm non-irritating, non-sensitizing, and non-toxic profile; breakage and slippage rates comparable to predicate TACTYLON® models.

Clinical Evidence

Clinical trials included a modified Draize test (n=200) showing no irritation or sensitization. Use tests and skin prick tests on latex-sensitive individuals (n=20) showed no adverse reactions. Comparative clinical trial (n=not specified) evaluated breakage and slippage rates against predicate TACTYLON® condoms (K953583, K971590), demonstrating similar clinical performance.

Technological Characteristics

Material: Styrene-ethylene-butylenestyrene thermoplastic elastomer block copolymer. Meets FDA Class VI requirements for nontoxicity. Barrier properties tested via viral surrogate (φ X174) assay. Resistant to UV, ozone, oxygen, heat, and humidity. Form factor: Baggy design, high elongation (low modulus).

Indications for Use

Indicated for individuals with latex sensitivity or allergy requiring a non-latex barrier contraceptive for the prevention of pregnancy and STDs.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Standard TACTYLON® condom (K953583)
• High Elongation condom (K971590)

Reference Devices

• Standard condom (K911431)

Submission Summary (Full Text)

{0}------------------------------------------------

SENSICON CORPORATION 510(k) SUBMISSION 8974121 Page 1 of 2 SUMMARY OF SAFETY AND EFFECTIVENESS

## LUBRICATED BAGGY CONDOM SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is being submitted in accordance with the requirements of the SMDA of 1990.

- (A) Substantial Equivalence:
L = ===

l

| Submitted by: | Sensicon Corporation |
|---------------|--------------------------------------|
| Address: | 2595 Commerce Way<br>Vista, CA 92083 |
| Telephone: | [phone] |
| Contact: | Jeff D. Grant |

- 2. Natural Rubber Latex products present a risk of anaphylaxis for individuals with Type I immediate hypersensitivity to Natural Rubber Latex (NRL) and can cause less dangerous, but uncomfortable, symptoms in individuals with Type IV delayed hypersensitivity. The synthetic TACTYLON® condom contains neither NRL protein allergens nor sensitizing chemicals. It therefore represents a suitable alternative for latex sensitive individuals. Furthermore, muscle exposure to NRL appears to be one of the primary routes of sensitization for Type I allergies.1
- 3. The TACTYLON® condom is made from styrene-ethylene-butylenestyrene thermoplastic elastomer block copolymer but has physical properties (e.g., strength, elasticity, and tactility) and general form that are substantially equivalent to a NRL condom.
- (B) The safety and efficacy of TACTYLON® involves two major issues: the potential allergenicity and toxicity of the material and the efficacy of the material's barrier.
- 1. The TACTYLON® block copolymer is a compound that meets the FDA requirements for Class VI materials, the most stringent category for nontoxicity. The plasticizer used is a USP recognized by the FDA as safe for human consumption. Toxicity is therefore not a relevant safety issue as evidenced by the following studies of the non-lubricated Standard condom (K911431). Neither primary skin irritation nor vaginal mucosal irritation was found in a rabbit model. There was no evidence of irritation or toxicity in a 3-day, 7-day, or 90-day surgical mucosal implantation study in a rabbit model. Furthermore, no delayed dermal sensitization occurred in a guinea pig model. No mutagenic changes were found in histidine dependent mutant strains of Salmonella typhimurium when exposed to

⁴ American Academy of Allergy & Immunology: Task force on allergic reactions to latex (committee report). J. Allergy Clin Immunol 1993; 92:16-18,

{1}------------------------------------------------

either saline or DMSO extracts of TACTYLON®. In addition, there were no positive indicators resulting from a Cytotoxicity test, by the USP elution method (MG 057), on samples which had been real-time aged for 14 Also, the lubricated condom (K953583) was tested for months. Cytotoxicity on unaged, as well as aged (oven conditioned), sample at 70°C for seven (7) days with no positive indicators. The lubricated condom was tested for systemic toxicity using Saline and Cottonseed Oil as well as for vaginal irritation in rabbits using saline extract. These tests both meet the USP requirements.

The barrier properties of TACTYLON® are substantially equivalent to NRL as demonstrated by an in vitro challenge with a viral surrogate (φ X174) to simulate the HIV (AIDS) measured by an extremely sensitive assay. As with NRL products, however, petroleum-based lubricants should be avoided. Because the chemical structure of the copolymer has no unsaturated bond, TACTYLON® is resistant to conditions such as ultraviolet radiation, ozone, oxygen, heat and humidity, that can accelerate aging and adversely affect barrier properties.

- Clinical trials conducted on the non-lubricated TACTYLON® material 2. indicated it is nontoxic, nonirritating, and nonsensitizing. In the modified Draize test conducted in 200 human subjects, TACTYLON® was nonirritating and nonsensitizing in all 200 subjects. When a group of 20 latex-sensitive individuals was subjected to use tests and skin prick tests, TACTYLON® caused no adverse reactions.2
- In a clinical trial of TACTYLON® lubricated condoms, the clinical 3. breakage and slippage rates as well as the subjective perceptions were These trials showed that the clinical breakage of the Baggy studied. TACTYLON® condoms were similar to the Standard TACTYLON® condom cleared by 510(k) K953583 and the High Elongation condom cleared by 510(k) K971590 3
- The results of both the nonclinical and the clinical studies suggest that 4. TACTYLON® material is nonallergenic, nonirritating, and nontoxic when in contact with either the intact dermis or mucosal tissue for clinically relevant periods. Furthermore, the barrier was as impermeable to a viral surrogate as NRL in nonclinical studies and tolerated the stresses associated with use as well as NRL in a large clinical trial. The copolymer's chemistry confers a distinct advantage over NRL in terms of potential shelf-life.

²Labti A, Camarasa JG, Ducombs G, et al: Patch tests with TACTYLON™ in patients with contact allergy to rubber. Contact Dermatitis 1992; 27:188.

³ Contraceptive Research and Development Program Final Report, April 18, 1997. Comparative Evaluation of Three Tactylon® Condoms with a Latex Condom During Vaginal Intercourse: Breakage and Slippage - Table 17.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows a circular 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 of the logo is a stylized representation of an eagle, with its wings forming a series of curved lines.

20196

Jeff D. Grant Vice President Sensicon Corporation 2595 Commerce Way Vista, CA 92083

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K974121 Tactylon® Condom - Lubricated, high elongation (i.e., low modulus) (baggy design) Dated: October 28, 1997 Received: October 31, 1997 Regulatory Class: II 21 CFR 884.5300/Procode: 85 MOL

Dear Mr. Grant:

We have reviewed your Section 510(k) notification of intent to market the device 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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 submission 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 marketd 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Sincerely yours,

N) Kiau hi

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) Number: K974121 Page 1 of 1

Sensicon Corporation Company Name:

Device Name: Male Condom

Indications For Use:

For Latex Sensitive Condom Users:

This is a TACTYLON® condom. This is not a latex condom.

You may use this TACTYLON ® condom if you or your partner are allergic to latex.

You should know:

- The risks of pregnancy and sexually transmitted diseases (STDs), including AIDS . (HIV infection), are not known for this condom. A study is being done.
- There are laboratory tests on this TACTYLON® material. These tests show that . organisms even as small as sperm and viruses like HIV cannot pass through it.

Latex condoms for men, if used correctly with every act of vaginal intercourse are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Datent D (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1974121 510(k) Number _

Prescription Use · (Per 21 CFR 801.109) OR

Over-The-Counter Use\$\checkmark\$

(Optional Format 1-2-96)