(45 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of latex condoms, with no mention of AI or ML technology.
No
Explanation: The intended use of the device is for contraception and the prevention of sexually transmitted diseases, which are prophylactic purposes, not therapeutic ones.
No
This device is a condom, used for contraception and prophylaxis against sexually transmitted diseases, not for diagnosing any medical condition.
No
The device description explicitly states the device is made of "natural rubber latex sheath" and describes physical characteristics like length, width, and thickness, indicating it is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and prophylactic purposes (preventing pregnancy and STDs). This is a direct physical barrier method, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical product (a condom) made of natural rubber latex. It describes its physical characteristics (shape, size, texture, color, flavor).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a biological sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition
- Using reagents or assays
The device is clearly a medical device, but it falls under a different category than IVDs. It's a barrier contraceptive and prophylactic device.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
HIS
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing was performed on the SKORE Condoms (Colors & Flavors) and SKORE Vanilla in accordance with ISO 10993-1: Biological Evaluation of Medical Devices. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
1
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
2
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)
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).
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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 Proprietary
or Model Name | 510(k) |
|----------------------|---------------------|---------------------------------------------|---------|
| Primary
Predicate | TTK Healthcare Ltd. | SKORE (Colors & Flavors),
SKORE (Colors) | K202403 |
The predicate device has not been subject to design-related recall.
4
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.
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 & Predicate
Device | K213547 SKORE Smooth
Condoms - SKORE Colors
& Flavors, SKORE
Smooth Condoms -
SKORE Vanilla | K202403 [SKORE (Colors
& Flavors), SKORE
(Colors)] |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | SKORE Vanilla, SKORE
Strawberry, SKORE
Banana, SKORE
Chocolate, and SKORE | SKORE Red, SKORE
Yellow, SKORE Brown,
SKORE Orange & SKORE
Strawberry, 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). | 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). |
| 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, Cool
Mint |
| 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 | 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 |
5
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
6
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.