SKORE Vanilla, SKORE Strawberry, SKORE Banana, SKORE Tangerine 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 Smooth Condoms - SKORE Colors & Flavors and SKORE Smooth Condoms -SKORE Vanilla 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 device is an update to the SKORE (Colors & Flavors) condoms cleared under K202403 to modify the texture (dotted to smooth), use a different yellow pigment, and introduce a new flavor (vanilla). The subject devices in this submission consists of

SKORE Colors & Flavors SKORE Strawberry; SKORE Banana; SKORE . Chocolate; SKORE Tangerine; These condoms are parallel straight walled, teat ended, with SMOOTH surface Natural Rubber Latex having a Length of 190 ±10 mm, Width of 53 ± 2 mm and a Thickness of 0.06 ± 0.01 mm meeting the requirements as specified in ASTM D 3492 and ISO 4074. The subject devices include the colors, Red; Yellow; Brown; Orange; and flavors Strawberry, Banana, Chocolate and Tangerine.
SKORE Flavors SKORE Vanilla; This condom is parallel straight walled, teat ● ended, with SMOOTH surface Natural Rubber Latex having a Length of 190 ±10 mm, Width of 53 ± 2 mm and a Thickness of 0.06 ± 0.01 mm meeting the requirements as specified in ASTM D 3492 and ISO 4074. The subject device include the flavor Vanilla and has a natural (no pigment) color.

AI/ML Overview

This report refers to a 510(k) premarket notification for TTK Healthcare Limited's SKORE Smooth Condoms (SKORE Colors & Flavors, and SKORE Vanilla). The document indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to a predicate device by meeting established international and national standards for condom quality.

Acceptance Criteria (Standard / Test)	Reported Device Performance
Biocompatibility (ISO 10993)	Acute Systemic Toxicity (ISO 10993-11:2006/(R)2010): Device found non-systemically toxic.
	Cytotoxicity (ISO 10993-5:2009): Device found non-cytotoxic.
	Vaginal Irritation (ISO 10993-10:2010): Device found non-irritating.
	Skin Sensitization (ISO 10993-10:2010): Device found non-sensitizing.
Mechanical Performance (ISO 4074:2015 & ASTM D3492:2016)	Baseline testing: Three lots of the subject devices (SKORE Smooth Condoms - SKORE Colors & Flavors, and SKORE Vanilla) met the specified requirements of ISO 4074:2015 and ASTM D3492:2016.
Shelf Life (21 CFR 801.435)	Established a shelf-life of five years based on testing data.
Nominal Width (as compared to predicate)	53 ± 2 mm (Matches predicate)
Nominal Length (as compared to predicate)	190 ± 10 mm (Matches predicate)
Nominal Thickness (as compared to predicate)	0.06 ± 0.01 mm (Slightly different from predicate's 0.065 ± 0.010 mm, but implied to be within acceptable range based on overall equivalence conclusion)
Air Burst Test Pressure (as compared to predicate)	> 1.0 kPa (Matches predicate)
Air Burst Test Volume (as compared to predicate)	18 L (Matches predicate)

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

Mechanical Performance Testing: "Three lots of the subject devices" were tested. The exact number of individual condoms tested within these lots is not specified.
Shelf Life Testing: The sample size is not explicitly stated, but it's based on "testing data" to support a 5-year shelf life.
Biocompatibility Testing: The specific sample sizes for each biocompatibility test are not provided in this document.
Data Provenance: The manufacturer is TTK Healthcare Ltd. located in Puducherry, India. The studies were likely conducted internally or by contracted labs, but the specific country of origin for the data generation beyond the manufacturer's location is not further detailed. The testing appears to be prospective as it was conducted specifically to support this 510(k) submission.

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

This document describes performance testing against established standards (ISO, ASTM, CFR). It does not involve establishing ground truth through expert consensus in the way a clinical study for an AI algorithm would. The "ground truth" for these tests is defined by the objective metrics and thresholds within the cited standards.

4. Adjudication Method:

Not applicable. This is not a study requiring adjudication of expert opinions or classifications. The performance is measured against objective standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is not a medical imaging device or an AI algorithm where human reader performance is a factor. This document concerns the physical and biological properties of a condom.

6. Standalone Performance Study (Algorithm Only):

No. This is not an AI algorithm. The performance studies evaluate the physical product itself.

7. Type of Ground Truth Used:

The ground truth used is based on established international and national standards and specifications for condoms, such as:

ISO 10993 (Biological Evaluation of Medical Devices) for biocompatibility.
ISO 4074:2015 (Natural rubber latex male condoms - Requirements and test methods) for mechanical performance.
ASTM D3492:2016 (Standard Specification for Rubber Contraceptives (Male Condoms)) for mechanical performance.
21 CFR 801.435 for shelf life.

8. Sample Size for the Training Set:

Not applicable. This is not an AI product that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

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 and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

December 23, 2021

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

Re: K213547

Trade/Device Name: SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: November 1, 2021 Received: November 8, 2021

Dear Daniel J. S .:

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. 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 statutes and regulations administered by other Federal agencies.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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,

for 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213547

Device Name

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K213547

TTK Healthcare Ltd.

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth

Condoms - SKORE Vanilla

Date Prepared: December 21, 2021

ADMINISTRATIVE INFORMATION

TTK Healthcare Ltd. Manufacturer: 12, K P Natham Road, Thiruvandar Koil, Puducherry, INDIA 605 102 Telephone: +91 413 2261 401/402

Official Contact: Daniel J.S.

Head - Corporate RA/QA [Medical Devices]

TTK Healthcare Ltd.

No.6, Cathedral Road,

Chennai, Tamilnadu, INDIA - 600 086

Phone: +91 44 4200 8200

Email: daniel.js(@ttkhealthcare.com

DEVICE NAME AND CLASSIFICATION

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

PREDICATE DEVICE

Device	Manufacturer	Trade or Proprietaryor Model Name	510(k)
PrimaryPredicate	TTK Healthcare Ltd.	SKORE (Colors & Flavors),SKORE (Colors)	K202403

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

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K213547

DEVICE DESCRIPTION

SKORE Colors & Flavors SKORE Strawberry; SKORE Banana; SKORE . Chocolate; SKORE Tangerine; These condoms are parallel straight walled, teat ended, with SMOOTH surface Natural Rubber Latex having a Length of 190 ±10 mm, Width of 53 ± 2 mm and a Thickness of 0.06 ± 0.01 mm meeting the requirements as specified in ASTM D 3492 and ISO 4074. The subject devices include the colors, Red; Yellow; Brown; Orange; and flavors Strawberry, Banana, Chocolate and Tangerine.
SKORE Flavors SKORE Vanilla; This condom is parallel straight walled, teat ● ended, with SMOOTH surface Natural Rubber Latex having a Length of 190 ±10 mm, Width of 53 ± 2 mm and a Thickness of 0.06 ± 0.01 mm meeting the requirements as specified in ASTM D 3492 and ISO 4074. The subject device include the flavor Vanilla and has a natural (no pigment) color.

INDICATIONS FOR USE

SKORE Vanilla, SKORE Strawberry, SKORE Banana, SKORE Chocolate, and SKORE Tangerine Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

SUBSTANTIAL EQUIVALENCE DISCUSSION

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

Device & PredicateDevice	K213547 SKORE SmoothCondoms - SKORE Colors& Flavors, SKORESmooth Condoms -SKORE Vanilla	K202403 [SKORE (Colors& Flavors), SKORE(Colors)]
Indications for Use	SKORE Vanilla, SKOREStrawberry, SKOREBanana, SKOREChocolate, and SKORE	SKORE Red, SKOREYellow, SKORE Brown,SKORE Orange & SKOREStrawberry, SKORE
	Tangerine Male NaturalRubber Latex Condoms areused for contraception andfor prophylactic purposes(to help prevent pregnancyand the transmission ofsexually transmitteddiseases).	Cherry, SKORE Banana,SKORE Pinacolada,SKORE Tangerine,SKORE Chocolate, andSKORE Cool Mint MaleNatural Rubber LatexCondoms are used forcontraception and forprophylactic purposes (tohelp prevent pregnancy andthe transmission ofsexually 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	0.06 ± 0.01 mm	0.065 ± 0.010 mm
Lubricant	Silicone Oil	Silicone Oil
Air Burst Test Pressure	> 1.0 kPa	> 1.0 kPa
Air Burst Test Volume	18 L	18 L
Texture	Plain (Smooth)	Plain & Dotted
Shelf Life	5 Years	5 Years
Color Additives	Red, Yellow, Brown,Orange	Red, Yellow, Brown,Orange, Blue
Flavor Additives	Vanilla, Strawberry,Banana, Tangerine,Chocolate	Strawberry, Cherry,Banana, Pinacolada,Tangerine, Chocolate, CoolMint
Packaging Material	Laminate consisting of alayer of suitableimpermeable flexiblealuminum foil, and layersof plastic materials suitablefor the mechanicalprotection of the metal foil	Laminate consisting of alayer of suitableimpermeable flexiblealuminum foil, and layersof plastic materials suitablefor the mechanicalprotection of the metal foil

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K213547

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms -SKORE Vanilla 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 Smooth Condoms - SKORE Colors & Flavors, SKORE

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Vanilla 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.

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) and SKORE Vanilla 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
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 Smooth Condoms - SKORE Colors & Flavors, and SKORE Vanilla 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 Smooth Condoms - SKORE Colors & Flavors, and SKORE Vanilla 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.