SKORE (Colors & Flavors), SKORE (Colors)
Device Facts
| Record ID | K202403 |
|---|---|
| Device Name | SKORE (Colors & Flavors), SKORE (Colors) |
| Applicant | Ttk Healthcare Limited |
| Product Code | HIS · Obstetrics/Gynecology |
| Decision Date | Apr 15, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5300 |
| Device Class | Class 2 |
Indications for Use
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 Story
SKORE condoms are male natural rubber latex sheaths designed for contraception and prophylaxis against sexually transmitted diseases. The device consists of a parallel straight-walled, teat-ended sheath with either a smooth or dotted surface. Available in various colors (Red, Yellow, Brown, Orange) and flavors (Strawberry, Cherry, Banana, Pinacolada, Tangerine, Chocolate, Cool Mint). The device is intended for over-the-counter use by the general population. It functions as a physical barrier to prevent the exchange of bodily fluids during sexual intercourse. The healthcare provider does not interact with the device; it is a patient-selected, self-use product. Benefits include effective contraception and reduction in disease transmission risk when used correctly.
Clinical Evidence
Bench testing only. Biocompatibility testing (ISO 10993-5, -10, -11) confirmed the device is non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic. Mechanical performance testing (air burst volume and pressure) met ISO 4074:2015 and ASTM D3492:2016 specifications. Shelf-life testing supports a 5-year duration.
Technological Characteristics
Material: Natural rubber latex. Lubricant: Silicone oil. Dusting powder: Magnesium carbonate and calcium carbonate. Dimensions: 190±10 mm length, 53±2 mm width, 0.065±0.010 mm thickness. Standards: ASTM D3492:2016, ISO 4074:2015. Packaging: Aluminum foil laminate. No electronic or software components.
Indications for Use
Indicated for use by males for contraception and the prevention of pregnancy and sexually transmitted diseases.
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
- SKORE Natural & Bulbous & Dots (K132490)
Submission Summary (Full Text)
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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
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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)
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).
| 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.<br>12, K P Natham Road, Thiruvandar Koil,<br>Puducherry, INDIA 605 102<br>Telephone: +91 413 2261 401/402 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | J.S. Daniel<br>Head - Corporate RA/QA [Medical Devices]<br>TTK Healthcare Ltd.<br>No.6, Cathedral Road,<br>Chennai, Tamilnadu, INDIA – 600 086<br>Phone: +91 44 4200 8200<br>Email: 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 Proprietary<br>or Model Name | 510(k) |
|----------------------|---------------------|---------------------------------------|---------|
| Primary<br>Predicate | TTK Healthcare Ltd. | SKORE Natural & Bulbous<br>& 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
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).
### SUBSTANTIAL EQUIVALENCE DISCUSSION
The table below includes a comparison of the intended use and technological characteristics of the subject and predicate devices.
| Device & Predicate<br>Device | K202403 (SKORE (Colors<br>& Flavors) & SKORE<br>(Colors)) | K132490 (SKORE Natural,<br>SKORE Dots Natural,<br>SKORE Bulbous Natural<br>and SKORE Bulbous Dots)<br>& Ribs Natural - Male<br>Natural Rubber Latex<br>Condoms. |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | SKORE Red, SKORE<br>Yellow, SKORE Brown,<br>SKORE Orange & SKORE<br>Strawberry, SKORE<br>Cherry, SKORE Banana,<br>SKORE Pinacolada,<br>SKORE Tangerine,<br>SKORE Chocolate and<br>SKORE Cool Mint, Male<br>Natural Rubber Latex | SKORE Natural, SKORE<br>Dots Natural, SKORE<br>Bulbous Natural, SKORE<br>Bulbous Dots & Ribs<br>Natural-Male Natural<br>Rubber Latex Condoms are<br>used for contraception and<br>for prophylactic purposes<br>(to help prevent pregnancy<br>and the transmission of |
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| | Condoms are used for<br>contraception and for<br>prophylactic purposes (to<br>help prevent pregnancy and<br>the transmission of<br>sexually transmitted<br>diseases). | sexually transmitted<br>diseases) |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dusting Powder | Magnesium Carbonate &<br>Calcium Carbonate | Magnesium Carbonate &<br>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,<br>Orange, Blue | No Colors |
| Flavor Additives | Strawberry, Cherry,<br>Banana, Pinacolada,<br>Tangerine, Chocolate, Cool<br>Mint | No Flavors |
| Packaging Material | Laminate consisting of a<br>layer of suitable<br>impermeable flexible<br>aluminum foil, and layers<br>of plastic materials suitable<br>for the mechanical<br>protection of the metal foil<br>and or printing and sealing. | Laminate consisting of a<br>layer of suitable<br>impermeable flexible<br>aluminum foil, and layers<br>of plastic materials suitable<br>for the mechanical<br>protection of the metal foil<br>and 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-<br>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.
