(237 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological safety of natural rubber latex condoms, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
A therapeutic device is typically involved in the treatment or cure of a disease or condition. Condoms are primarily used for contraception and the prevention of disease transmission, not for treating an existing medical condition.
No
The device is a condom used for contraception and preventing STDs, not for diagnosing medical conditions.
No
The device description clearly states the device is a physical product made of natural rubber latex (condoms) and describes its physical characteristics and testing. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)." This is a physical barrier method, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details the physical characteristics of a condom (material, shape, dimensions, colors, flavors). This aligns with a physical barrier device, not a diagnostic tool.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a disease or condition.
- Performance Studies: The performance studies focus on biocompatibility, mechanical performance (strength, integrity), and shelf life, which are relevant to a physical barrier device, not a diagnostic test.
Therefore, based on the provided text, the SKORE Condoms described are not IVDs. They are medical devices intended for contraception and disease prevention through physical means.
N/A
Intended Use / 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).
Product codes
HIS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical performance testing was conducted including Biocompatibility and Mechanical Performance Testing.
Biocompatibility testing was performed on the SKORE Condoms (Colors & Flavors) in accordance with ISO 10993-1: Biological Evaluation of Medical Devices. Tests performed include Acute Systemic Toxicity, Cytotoxicity, Vaginal Irritation, Penile Irritation, and Skin Sensitization. The results demonstrate that the subject devices are non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic.
Mechanical Performance Testing was performed on three lots of the subject devices at baseline. The devices 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 was established for five years.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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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3
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 605 102
Telephone: +91 413 2261 401/402 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | J.S. Daniel
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 (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
or Model Name | 510(k) |
|----------------------|---------------------|---------------------------------------|---------|
| Primary
Predicate | 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
4
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
Device | K202403 (SKORE (Colors
& Flavors) & SKORE
(Colors)) | K132490 (SKORE Natural,
SKORE Dots Natural,
SKORE Bulbous Natural
and SKORE Bulbous Dots)
& Ribs Natural - Male
Natural Rubber Latex
Condoms. |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | SKORE Natural, SKORE
Dots Natural, SKORE
Bulbous Natural, SKORE
Bulbous Dots & Ribs
Natural-Male Natural
Rubber Latex Condoms are
used for contraception and
for prophylactic purposes
(to help prevent pregnancy
and the transmission of |
5
| | Condoms are used for
contraception and for
prophylactic purposes (to
help prevent pregnancy and
the transmission of
sexually transmitted
diseases). | sexually transmitted
diseases) |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, Cool
Mint | No Flavors |
| Packaging Material | Laminate consisting of a
layer of suitable
impermeable flexible
aluminum foil, and layers
of plastic materials suitable
for the mechanical
protection of the metal foil
and or printing and sealing. | Laminate consisting of a
layer of suitable
impermeable flexible
aluminum foil, and layers
of plastic materials suitable
for the mechanical
protection of the metal foil
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.
6
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.