SKORE Red, SKORE Yellow, SKORE Brown, SKORE Orange & SKORE Strawberry, SKORE Cherry, SKORE Banana, SKORE Pinacolada, SKORE Tangerine, SKORE Chocolate and SKORE Cool Mint, Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Description

SKORE Condoms (Colors & Flavors) and SKORE Condoms (Flavors) are made of a natural rubber latex sheath and are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. The subject devices in this submission consists of

SKORE Colors SKORE Red; SKORE Yellow; SKORE Brown; SKORE Orange. . These condoms are parallel straight walled, teat ended, with a smooth surface Natural Rubber Latex Condoms in the colors Red. Yellow, Brown, and Orange; having a length of 190 ± 10 mm, width of 53±2mm and a thickness of 0.065 ±0.010 mm, per ASTM D3492:2016 and ISO 4074:2015.
SKORE Colors & Flavors SKORE Strawberry; SKORE Cherry; SKORE . Banana; SKORE Pinacolada; SKORE Tangerine; SKORE Chocolate; SKORE Cool Mint. These condoms are parallel straight walled, teat ended, with a dotted surface having a length of 190 ± 10 mm, width of 53 ± 2 mm and a thickness of 0.065 ± 0.010 mm, per ASTM D3492:2016 and ISO 4074:2015.

AI/ML Overview

The provided text describes a 510(k) summary for male natural rubber latex condoms (SKORE Colors & Flavors, SKORE Colors). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel efficacy or safety through clinical trials comparing a device to a human interpretation. Therefore, the information typically requested regarding acceptance criteria, study design for proving those criteria, human reader involvement, ground truth establishment, and training set details as they would apply to an AI/ML powered device, are not directly applicable in this context.

However, I can extract the relevant performance criteria and testing performed to demonstrate the device's conformance to established condom standards, which serve a similar function to "acceptance criteria" for a medical device of this type.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (Specifications) and Reported Device Performance:

Feature/Test	Acceptance Criteria (Predicate)	Reported Device Performance (Subject Device)
Nominal Width	53 ± 2 mm	53 ± 2 mm
Nominal Length	190 ± 10 mm	190 ± 10 mm
Nominal Thickness	0.070 ± 0.010 mm	0.065 ± 0.010 mm
Air Burst Test Pressure	> 1.0 kPa	> 1.0 kPa
Air Burst Test Volume	18 dm³	18 L
Shelf Life	5 Years	5 Years
Biocompatibility (Acute Systemic Toxicity)	Non-toxic	Non-toxic
Biocompatibility (Cytotoxicity)	Non-cytotoxic	Non-cytotoxic
Biocompatibility (Vaginal Irritation)	Non-irritating	Non-irritating
Biocompatibility (Penile Irritation)	Non-irritating	Non-irritating
Biocompatibility (Skin Sensitization)	Non-sensitizing	Non-sensitizing
Material	Natural Rubber Latex	Natural Rubber Latex
Dusting Powder	Magnesium Carbonate & Calcium Carbonate	Magnesium Carbonate & Calcium Carbonate
Lubricant	Silicone Oil	Silicone Oil
Texture	Plain & Dotted	Plain & Dotted
Packaging Material	Laminate (Al foil + plastic)	Laminate (Al foil + plastic)

Study to Prove Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Non-Clinical Performance Testing."

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

Sample Size: "Three lots of the subject devices" were tested for mechanical performance. The specific number of individual condoms tested within these three lots is not provided. For biocompatibility, the number of samples used for each test (e.g., for cytotoxicity, irritation, sensitization) is not specified.
Data Provenance: Not explicitly stated regarding country of origin for the samples. The submission is from TTK Healthcare Ltd. in Puducherry, INDIA. The testing appears to have been conducted as part of the regulatory submission process. The testing would be considered prospective for the purpose of demonstrating compliance.

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

This question is not applicable as the device is a physical product (condom), not an AI/ML powered diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" is determined by established engineering standards and biological testing protocols.

4. Adjudication Method for the Test Set:

This question is not applicable for the same reasons as #3.

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 question is not applicable as the device is a physical product, not an AI-assisted diagnostic tool.

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

This question is not applicable as the device is a physical product, not an algorithm.

7. The type of ground truth used:

Mechanical Performance Ground Truth: Established by recognized international and national standards:
- ISO 4074:2015 - Natural rubber latex male condoms - Requirements and test methods
- ASTM D3492:2016 - Standard Specification for Rubber Contraceptives (Male Condoms)
Biocompatibility Ground Truth: Established by recognized international standards:
- ISO 10993-1: Biological Evaluation of Medical Devices.
- ISO 10993-11:2006/(R)2010 (Acute Systemic Toxicity)
- ISO 10993-5:2009 (Cytotoxicity)
- ISO 10993-10:2010 (Vaginal Irritation, Penile Irritation, Skin Sensitization)

8. The sample size for the training set:

This question is not applicable as there is no "training set" for physical product evaluation in this context.

9. How the ground truth for the training set was established:

This question is not applicable for the same reason as #8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

April 15, 2021

TTK Healthcare Limited Daniel J. S. Head - Corporate RA/QA [Medical Devices] Protective Devices Division 6. Cathedral Road Chennai, Tamil Nadu 600086 INDIA

Re: K202403

Trade/Device Name: SKORE (Colors & Flayors). SKORE (Colors) Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: March 15, 2021 Received: March 19, 2021

Dear Daniel S .:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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eral agencies. You must comply with all the Act's
ration and listing (21 CFR Part 807): labeling (21 CFR Part

Page 2

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post marketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Monica D. Garcia. Ph.D. Assistant Director DHT3B: Division of Reproductive Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202403

Device Name SKORE (Colors & Flavors), SKORE (Colors)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY - K202403

TTK Healthcare Ltd.

SKORE (Colors & Flavors), SKORE (Colors)

Date Prepared: 14th, April 2021

ADMINISTRATIVE INFORMATION

Manufacturer:	TTK Healthcare Ltd.12, K P Natham Road, Thiruvandar Koil,Puducherry, INDIA 605 102Telephone: +91 413 2261 401/402
Official Contact:	J.S. DanielHead - Corporate RA/QA [Medical Devices]TTK Healthcare Ltd.No.6, Cathedral Road,Chennai, Tamilnadu, INDIA – 600 086Phone: +91 44 4200 8200Email: daniel.js@ttkhealthcare.com

DEVICE NAME AND CLASSIFICATION

SKORE (Colors & Flavors), SKORE (Colors) Trade/Proprietary Name: Male Natural Rubber Latex Condom Common Name: Regulation Name: Condom Regulation Number 21 CFR 884.5300 Class: II Product Code: HIS (Condom)

PREDICATE DEVICE

Device	Manufacturer	Trade or Proprietaryor Model Name	510(k)
PrimaryPredicate	TTK Healthcare Ltd.	SKORE Natural & Bulbous& Dots	K132490

The predicate device has not been subject to design-related recall.

DEVICE DESCRIPTION

SKORE Condoms (Colors & Flavors) and SKORE Condoms (Flavors) are made of a natural rubber latex sheath and are used for contraception and for prophylactic purposes to

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help prevent pregnancy and the transmission of sexually transmitted diseases. The subject devices in this submission consists of

SKORE Colors SKORE Red; SKORE Yellow; SKORE Brown; SKORE Orange. . These condoms are parallel straight walled, teat ended, with a smooth surface Natural Rubber Latex Condoms in the colors Red. Yellow, Brown, and Orange; having a length of 190 ± 10 mm, width of 53±2mm and a thickness of 0.065 ±0.010 mm, per ASTM D3492:2016 and ISO 4074:2015.
SKORE Colors & Flavors SKORE Strawberry; SKORE Cherry; SKORE . Banana; SKORE Pinacolada; SKORE Tangerine; SKORE Chocolate; SKORE Cool Mint. These condoms are parallel straight walled, teat ended, with a dotted surface having a length of 190 ± 10 mm, width of 53 ± 2 mm and a thickness of 0.065 ± 0.010 mm, per ASTM D3492:2016 and ISO 4074:2015.

INDICATIONS FOR USE

SUBSTANTIAL EQUIVALENCE DISCUSSION

The table below includes a comparison of the intended use and technological characteristics of the subject and predicate devices.

Device & PredicateDevice	K202403 (SKORE (Colors& Flavors) & SKORE(Colors))	K132490 (SKORE Natural,SKORE Dots Natural,SKORE Bulbous Naturaland SKORE Bulbous Dots)& Ribs Natural - MaleNatural Rubber LatexCondoms.
Indications for Use	SKORE Red, SKOREYellow, SKORE Brown,SKORE Orange & SKOREStrawberry, SKORECherry, SKORE Banana,SKORE Pinacolada,SKORE Tangerine,SKORE Chocolate andSKORE Cool Mint, MaleNatural Rubber Latex	SKORE Natural, SKOREDots Natural, SKOREBulbous Natural, SKOREBulbous Dots & RibsNatural-Male NaturalRubber Latex Condoms areused for contraception andfor prophylactic purposes(to help prevent pregnancyand the transmission of

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	Condoms are used forcontraception and forprophylactic purposes (tohelp prevent pregnancy andthe transmission ofsexually transmitteddiseases).	sexually transmitteddiseases)
Dusting Powder	Magnesium Carbonate &Calcium Carbonate	Magnesium Carbonate &Calcium Carbonate
Condom Material	Natural Rubber Latex	Natural Rubber Latex
Nominal Width	53±2	53±2
Nominal Length	190±10 mm	190±10 mm
Nominal Thickness	0.065±0.010mm	0.070±0.010mm
Lubricant	Silicone Oil	Silicone Oil
Air Burst Test Pressure	> 1.0 kPa	> 1.0 kPa
Air Burst Test Volume	18 L	18 dm³
Texture	Plain & Dotted	Plain & Dotted
Shelf Life	5 Years	5 Years
Color Additives	Red, Yellow, Brown,Orange, Blue	No Colors
Flavor Additives	Strawberry, Cherry,Banana, Pinacolada,Tangerine, Chocolate, CoolMint	No Flavors
Packaging Material	Laminate consisting of alayer of suitableimpermeable flexiblealuminum foil, and layersof plastic materials suitablefor the mechanicalprotection of the metal foiland or printing and sealing.	Laminate consisting of alayer of suitableimpermeable flexiblealuminum foil, and layersof plastic materials suitablefor the mechanicalprotection of the metal foiland or printing and sealing.

SKORE Condoms (Colors & Flavors) and SKORE Condoms (Colors) and the predicate devices are Male Natural Rubber Latex Condoms and used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases). The subject and the predicate devices have the same intended use. SKORE Condoms (Colors & Flavors) and SKORE Condoms (Colors) and the predicate devices have different technological characteristics, including different colors and flavors used and different dimensions. These differences do not raise different questions of safety and effectiveness.

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NON- CLINICAL PERFORMANCE TESTING

The following studies have been performed to support substantial equivalence to the predicate device

Biocompatibility:

Biocompatibility testing was performed on the SKORE Condoms (Colors & Flavors) in accordance with ISO 10993-1: Biological Evaluation of Medical Devices.

Test Performed	Standard
Acute Systemic Toxicity	ISO 10993-11:2006/(R)2010
Cytotoxicity	ISO 10993-5:2009
Vaginal Irritation	ISO 10993-10:2010
Penile Irritation	ISO 10993-10:2010
Skin Sensitization	ISO 10993-10:2010

The results of testing demonstrate that the subject devices are non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic.

Mechanical Performance Testing:

Three lots of the subject devices, SKORE Condoms (Colors & Flavors) and SKORE Condoms (Colors), were tested at baseline and met the specifications of ISO 4074:2015 -Natural rubber latex male condoms - Requirements and test methods and ASTM D3492:2016- Standard Specification for Rubber Contraceptives (Male Condoms).

Shelf Life:

Shelf life of the SKORE Condoms (Colors & Flavors) and SKORE Condoms (Colors) was established from results of testing data to support a shelf-life of five years per the requirements of 21 CFR 801.435.

CONCLUSION:

The results of the performance testing described above demonstrate that the SKORE Condoms (Colors & Flavors) and SKORE Condoms (Colors) are as safe and effective as the predicate device and support a determination of substantial equivalence.

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.