LUBRICATED BAGGY TACTYLON CONDOM by SENSICON CORP.

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 Description

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.

AI/ML Overview

Here's an analysis of the provided text to extract information about acceptance criteria and supporting studies for the LUBRICATED BAGGY CONDOM:

Note: The provided document is a 510(k) summary for a condom, which focuses on demonstrating substantial equivalence to a predicate device rather than setting a new performance standard. Therefore, the "acceptance criteria" discussed here are mainly related to demonstrating equivalence and safety/efficacy, not necessarily numerical performance targets in the way one might expect for a diagnostic or AI device. Many of the requested fields (like MRMC studies, expert qualifications, etc.) are not applicable to this type of medical device submission.

Acceptance Criteria and Supporting Study for LUBRICATED BAGGY CONDOM

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Requirement	Reported Device Performance
Material Toxicity	Conformity to FDA Class VI materials for nontoxicity; absence of primary skin irritation, vaginal mucosal irritation, irritation/toxicity in surgical mucosal implantation, delayed dermal sensitization, mutagenic changes, and cytotoxicity.	TACTYLON® block copolymer meets FDA Class VI requirements. Studies on non-lubricated (K911431) and lubricated (K953583) condoms showed: - No primary skin irritation or vaginal mucosal irritation in rabbits.- No irritation/toxicity in 3-day, 7-day, or 90-day surgical mucosal implantation in rabbits.- No delayed dermal sensitization in guinea pigs.- No mutagenic changes in Salmonella typhimurium.- No positive indicators in cytotoxicity tests (USP elution method) for real-time aged and oven-conditioned samples.
Material Allergenicity	Absence of natural rubber latex protein allergens or sensitizing chemicals; non-irritating and non-sensitizing in human subjects, including latex-sensitive individuals.	The synthetic TACTYLON® condom contains neither NRL protein allergens nor sensitizing chemicals. - Modified Draize test (200 human subjects): nonirritating and nonsensitizing in all subjects.- Use tests and skin prick tests (20 latex-sensitive individuals): no adverse reactions.
Barrier Efficacy to Viral Surrogates	Substantial equivalence to NRL products in preventing passage of viral surrogates (e.g., φ X174) to simulate HIV.	In vitro challenge with viral surrogate (φ X174) demonstrated barrier properties "substantially equivalent to NRL" and "as impermeable to a viral surrogate as NRL in nonclinical studies."
Clinical Breakage & Slippage Rates	Clinical breakage and slippage rates of the lubricated Baggy TACTYLON® condoms should be similar to predicate TACTYLON® condoms (Standard TACTYLON® K953583 and High Elongation K971590).	Clinical trials showed that "clinical breakage of the Baggy TACTYLON® condoms were similar to the Standard TACTYLON® condom cleared by 510(k) K953583 and the High Elongation condom cleared by 510(k) K971590."
Resistance to Environmental Factors	Resistance to conditions such as ultraviolet radiation, ozone, oxygen, heat, and humidity, that can accelerate aging and adversely affect barrier properties, demonstrating advantage over NRL in terms of shelf-life.	The copolymer's chemical structure (no unsaturated bond) makes it "resistant to conditions such as ultraviolet radiation, ozone, oxygen, heat and humidity" and confers "a distinct advantage over NRL in terms of potential shelf-life." This is intrinsic material property, not a measured performance criterion in this document.
Physical Properties & General Form	Physical properties (e.g., strength, elasticity, and tactility) and general form substantially equivalent to a NRL condom.	The TACTYLON® condom "has physical properties (e.g., strength, elasticity, and tactility) and general form that are substantially equivalent to a NRL condom." (Stated as a characteristic, implied to be verified but specifics not detailed).

2. Sample Size Used for the Test Set and Data Provenance

Toxicity/Irritation (Rabbit Models): Not explicitly stated, but implies multiple animals for vaginal irritation, surgical mucosal implantation, and primary skin irritation. Data provenance: Pre-clinical animal models.
Delayed Dermal Sensitization (Guinea Pig Model): Not explicitly stated, but implies multiple animals. Data provenance: Pre-clinical animal model.
Mutagenicity (Salmonella typhimurium): Not explicitly stated. Data provenance: In-vitro lab tests.
Cytotoxicity (USP elution method): Not explicitly stated. Data provenance: In-vitro lab tests.
Draize Test (Human Subjects): 200 human subjects. Data provenance: Clinical trial.
Latex-Sensitive Individuals Test: 20 latex-sensitive individuals. Data provenance: Clinical trial.
Viral Surrogate Challenge (φ X174): Not explicitly stated, but in-vitro lab tests. Data provenance: In-vitro lab tests.
Clinical Breakage & Slippage Trial (Lubricated Condoms): Not explicitly stated, but referred to as a "large clinical trial" (implied to be significant enough to compare rates to predicate devices). The reference Contraceptive Research and Development Program Final Report, April 18, 1997 suggests this was a prospective clinical study. Data provenance: Clinical trial.

Overall, the studies encompass both pre-clinical (in-vitro and animal) and clinical (human) data. The clinical data appears to be prospective in nature.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device (condom). Ground truth for condom performance primarily relies on objective measurements in lab tests (e.g., material properties, viral penetration) and observed clinical outcomes (breakage/slippage rates, irritation/sensitization in human subjects). There isn't a "ground truth" established by experts in the context of interpretation, like there would be for an AI diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies where expert (often subjective) interpretation is involved. For condom performance, the outcomes are generally objective (e.g., presence/absence of irritation, breakage occurrence, material measurements).

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 information is not applicable. This is a medical device for contraception and STD prevention, not an AI-assisted diagnostic tool. No MRMC studies were performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

Toxicity/Irritation/Sensitization: Direct observation of physiological responses in animal models and human subjects (e.g., absence of lesions, allergic reactions). For in-vitro tests, adherence to established laboratory protocols and measurement thresholds (e.g., USP requirements for cytotoxicity).
Barrier Efficacy: Objective measurement of viral surrogate penetration in an in-vitro setup.
Clinical Breakage & Slippage: Observed events during clinical use (direct outcome data).
Material Properties: Objective measurements of physical characteristics (strength, elasticity) against predetermined specifications (implied, not fully detailed but stated as "substantially equivalent").

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning device that requires a "training set." The development of the TACTYLON® material and condom design would involve iterative testing and refinement, but not in the context of machine learning training data.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no "training set" in the machine learning sense. The material development and device design would be based on engineering principles, materials science, and previous pre-clinical and clinical data on similar devices or materials, guided by regulatory requirements for safety and performance (e.g., ISO standards for condoms, FDA guidance).

Summary

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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 = ===

Submitted by:	Sensicon Corporation
Address:	2595 Commerce WayVista, CA 92083
Telephone:	(760) 734-6690
Contact:	Jeff D. Grant

1. 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
1. 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,

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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.

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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 (301) 594-4613. 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 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,

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

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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)

Regulation Number and Section

§ 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.