(244 days)
Not Found
No
The device description and performance studies focus on the physical properties and testing of natural rubber latex condoms, with no mention of AI or ML.
No.
The device's stated intended use is for contraception and prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections), which are preventative rather than therapeutic.
No
Explanation: The device description clearly states that SKORE Male Natural Rubber Latex Condoms are "used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections)". This indicates a preventative and contraceptive function, not a diagnostic one. Diagnostic devices are used to identify a disease, condition, or infection.
No
The device description clearly states it is a natural rubber latex sheath, which is a physical hardware component. The performance studies also focus on biocompatibility and mechanical properties of the physical condom.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Description and Intended Use: The description clearly states that SKORE Male Natural Rubber Latex Condoms are a physical barrier device used for contraception and preventing the transmission of sexually transmitted infections. They are applied to the body (the penis) and function as a physical barrier, not by analyzing samples taken from the body.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or any of the typical characteristics of an IVD device.
Therefore, based on the provided information, the SKORE Male Natural Rubber Latex Condom is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
SKORE Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Product codes (comma separated list FDA assigned to the subject device)
HIS
Device Description
The subject SKORE Male Natural Rubber Latex Condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane and used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted infections. The subject device in this submission consists of
- SKORE Smooth, Dotted &Thin Condoms
- SKORE Smooth Condoms -SKORE Blues Vanilla Scented. These condoms are straight walled, smooth, blue colored, teat ended, natural rubber latex having a length of 190 ± 10 mm, width of 53±2mm and a thickness of 0.060 to 0.074 mm, meeting the requirements as specified in ASTM D3492 and ISO 4074. The subject device includes the color blue and flavor vanilla.
- SKORE Dotted Condoms -SKORE Warm Belgian Chocolate & SKORE Dots Vanilla Scented; These condoms are straight walled, raised dots, teat ended, natural rubber latex condoms having a length of 190 ± 10 mm, width of 53 ±2 mm and a thickness of 0.060 to 0.080 mm, meeting the requirements as specified in ASTM D3492 and ISO 4074. The subject device includes the color brown and flavors Belgium chocolate and vanilla.
- SKORE Thin Condoms - SKORE NOTHING Chocolate, SKORE NOTHING Strawberry & SKORE SKINTHIN Ultra fine Condoms. These condoms are straight walled, smooth, thin, teat ended, natural rubber latex condoms having a length of 190 ± 10 mm. width 53±2mm and a thickness of 0.045 to 0.055 mm. meeting the requirements as specified in ASTM D3492 and ISO 4074. The subject device includes the flavors strawberry and chocolate.
- SKORE Bulbous Condoms
- SKORE WARM and SKORE COOL Condoms - These condoms are bulbous dotted, ribbed, and colored natural rubber latex condoms having a length of 190 ± 10 mm, width 56±2mm, meeting the requirements as specified in ASTM D3492 and ISO 4074. The subject device includes the colors orange and blue and flavors warming lubricant and cool tropic mint.
- SKORE Benzocaine Condoms .
- SKORE NOTHING Climax Delay - These condoms are straight walled, thin, teat ended, natural rubber latex condoms having a length of 190 ± 10 mm, width 53 ±2 mm and a thickness of 0.050 to 0.060, mm meeting the requirements as specified in ASTM D3492 and ISO 4074.
- SKORE Duo Max - These condoms are bulbous transparent dotted & ribbed, teat ended, natural rubber latex condoms having a length of 190 ± 10 mm, width of 56±2 mm meeting the requirements as specified in ASTM D3492 and ISO 4074.
- SKORE NOT OUT - These condoms are straight walled, raised dots, red colored, teat ended, natural rubber latex condoms having a length of 190 ± 10 mm, width of 53 ±2 mm and a thickness of 0.060 to 0.080 mm meeting the requirements as specified in ASTM D3492 and ISO 4074. The subject device includes the color red.
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:
Biocompatibility testing was performed on the SKORE Male Natural Rubber Latex Condoms in accordance with ISO 10993-1: Biological Evaluation of Medical Devices.
Tests performed:
- Acute Systemic Toxicity Reactivity (ISO 10993-11:2017)
- In vitro Cytotoxicity (ISO 10993-5:2009)
- Skin Sensitization (ISO 10993-10:2021)
- Vaginal Irritation Test (ISO 10993-23:2021)
The results demonstrate that the subject devices are biocompatible.
Mechanical Performance Testing:
Three lots of subject devices, SKORE Male Natural Rubber Latex Condoms were tested at baseline and met specifications of ISO 4074:2015 - Natural rubber latex male condoms -Requirements and test methods and ASTM D3492-16- Standard Specification for Rubber Contraceptives.
The results demonstrate that the subject devices meet the standard specifications.
Shelf Life:
Shelf-life testing was conducted per ISO 4074:201521 and 21 CFR 801.435. The accelerated (7 days at 70°c, 90 days at 40-50°c) and real-time stability (5 Years at 28°C to 35° C) of the SKORE Male Natural Rubber Latex Condoms supports a shelf-life of five years as per the requirements.
Conclusion:
The results of the performance testing described above demonstrate that the SKORE Male Natural Rubber Latex Condoms are as safe and effective as the predicate device and supports a determination of substantial equivalence.
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.
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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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 7, 2023
TTK Healthcare Limited Daniel J S Head - Corporate RA/OA [Medical Devices] 6. Cathedral Road Chennai, Tamil Nadu 600086 India
K230049 Re:
Trade/Device Name: SKORE Male Natural Rubber Latex Condoms Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: August 3, 2023 Received: August 8, 2023
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,
Monica D. Garcia -S
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) K230049
Device Name
SKORE Male Natural Rubber Latex Condoms
Indications for Use (Describe)
SKORE Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
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 - K230049
TTK Healthcare Ltd.
SKORE Male Natural Rubber Latex Condoms
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 |
| General Manager & Head - Corporate RA/QA | |
| TTK Healthcare Ltd. | |
| No.6, Cathedral Road, | |
| Chennai, Tamilnadu, INDIA – 600 086 | |
| Ph: +91 44 4200 8200 | |
| Email: daniel.js@ttkhealthcare.com | |
| Date prepared: | September 6, 2023 |
DEVICE NAME AND CLASSIFICATION
SKORE Male Natural Rubber Latex Condoms Trade/Proprietary Name: Common Name: Male Natural Rubber Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name Condom Regulatory Class: II Product Code: HIS (condom)
PREDICATE DEVICE
K211152: Durex Condom with Benzocaine
The predicate device has not been subject to a design-related recall.
DEVICE DESCRIPTION
The subject SKORE Male Natural Rubber Latex Condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane and used
4
for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted infections. The subject device in this submission consists of
. SKORE Smooth, Dotted &Thin Condoms
SKORE Smooth Condoms -SKORE Blues Vanilla Scented. These condoms are straight walled, smooth, blue colored, teat ended, natural rubber latex having a length of 190 ± 10 mm, width of 53±2mm and a thickness of 0.060 to 0.074 mm, meeting the requirements as specified in ASTM D3492 and ISO 4074. The subject device includes the color blue and flavor vanilla.
SKORE Dotted Condoms -SKORE Warm Belgian Chocolate & SKORE Dots Vanilla Scented; These condoms are straight walled, raised dots, teat ended, natural rubber latex condoms having a length of 190 ± 10 mm, width of 53 ±2 mm and a thickness of 0.060 to 0.080 mm, meeting the requirements as specified in ASTM D3492 and ISO 4074. The subject device includes the color brown and flavors Belgium chocolate and vanilla.
SKORE Thin Condoms - SKORE NOTHING Chocolate, SKORE NOTHING Strawberry & SKORE SKINTHIN Ultra fine Condoms. These condoms are straight walled, smooth, thin, teat ended, natural rubber latex condoms having a length of 190 ± 10 mm. width 53±2mm and a thickness of 0.045 to 0.055 mm. meeting the requirements as specified in ASTM D3492 and ISO 4074. The subject device includes the flavors strawberry and chocolate.
● SKORE Bulbous Condoms
SKORE WARM and SKORE COOL Condoms - These condoms are bulbous dotted, ribbed, and colored natural rubber latex condoms having a length of 190 ± 10 mm, width 56±2mm, meeting the requirements as specified in ASTM D3492 and ISO 4074. The subject device includes the colors orange and blue and flavors warming lubricant and cool tropic mint.
SKORE Benzocaine Condoms .
SKORE NOTHING Climax Delay - These condoms are straight walled, thin, teat ended, natural rubber latex condoms having a length of 190 ± 10 mm, width 53 ±2 mm and a thickness of 0.050 to 0.060, mm meeting the requirements as specified in ASTM D3492 and ISO 4074.
5
SKORE Duo Max - These condoms are bulbous transparent dotted & ribbed, teat ended, natural rubber latex condoms having a length of 190 ± 10 mm, width of 56±2 mm meeting the requirements as specified in ASTM D3492 and ISO 4074.
SKORE NOT OUT - These condoms are straight walled, raised dots, red colored, teat ended, natural rubber latex condoms having a length of 190 ± 10 mm, width of 53 ±2 mm and a thickness of 0.060 to 0.080 mm meeting the requirements as specified in ASTM D3492 and ISO 4074. The subject device includes the color red.
INDICATIONS FOR USE
SKORE Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
PREDICATE DEVICE COMPARISON
The table below compares the intended use and technological characteristics of the subject and predicate device.
| Subject Device
& Predicate
Device | SKORE Male Natural Rubber Latex
Condoms | K211152 (Durex Condoms
with Benzocaine) | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Indications for
Use | SKORE Male Natural Rubber Latex
Condoms are used for contraception
and for prophylactic purposes (to help
prevent pregnancy and the
transmission of sexually transmitted
diseases). | The Durex Condom with
Benzocaine is used for
contraception and for
prophylactic purposes ( to
help reduce the risk of
pregnancy and the
transmission of sexually
transmitted infections,
STIs) | |
| Dusting Powder | Magnesium Carbonate & Calcium
Carbonate | - | |
| Condom
Material | Natural Rubber Latex | Natural Rubber Latex | |
| Nominal Width | Thin | $53 \pm 2$ mm | |
| | Bulbous | $56 \pm 2$ mm | |
| | Dotted | $53 \pm 2$ mm | |
| | Smooth | $53 \pm 2$ mm | |
| | | $56\pm2$ mm | |
| Nominal
Length | 190±10 mm | | 195±10 mm |
| Nominal
Thickness | Thin | 0.045- 0.055
mm | 0.065±0.010 mm |
| | Dotted | 0.060 - 0.080
mm | |
| | Smooth | 0.060- 0.074
mm | |
| | Nothing Climax
Delay | 0.050-0.060
mm | |
| | NOT OUT | 0.060-0.080
mm | |
| | DUO MAX | 0.075-0.095
mm | |
| | Lubricant | Silicone Oil/ Zeus Odor Masker
flavoring, benzocaine cream, or
warming. | |
| Lubricant
Quantity | Smooth, dotted, thin
, and vanilla
condoms | 500 ± 50 mg | 480 ± 50 mg |
| | Belgian chocolate,
strawberry,
chocolate, and
skinthin | 400 ± 50mg | |
| | Warm | 600 ± 50 mg | |
| | Cool tropical mint | 600 ± 50mg | |
| | Benzocaine
condoms | 400 ± 50 mg &
480 ± 50 mg | |
| | Benzocaine
Quantity | 120- 160 mg (4.75 - 5.25 %)
Benzocaine cream / Retardant solution | |
| Air Burst Test
Pressure | > 1.0 kPa | | > 1.0 kPa |
| Air Burst Test
Volume | 18 dm3 | | 18 dm3 |
| Texture | Smooth, dotted & thin | | - |
| Shelf Life | 5 Years | | 5 Years |
| Color Additives | Blue, Brown, Orange, Red & Blue | | - |
| Flavor Additives | Vanilla, Belgian Chocolate, Vanilla, Strawberry Chocolate, Warming Lubricant (Orange), & Cool Tropic Mint flavor (Blue) | - | |
| Prescription or
Over-The-
Counter use | Over- The- Counter | Over- The- Counter | |
| 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. | |
Substantial Equivalence Table:
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7
The subject and predicate device have similar indications for use and have the same intended use. The technological characteristics of the subject device and predicate device are similar in that they are natural rubber latex-based, are lubricated with silicone, have the same shelf-life duration, and for the SKORE Benzocaine Condoms, they have the same amount of benzocaine. The subject and predicate devices have different technological characteristics, including different lubricant quantities, dimensions, and specifications. However, the different technological characteristics of the subject devices do not raise different questions of safety and effectiveness.
PERFORMANCE TESTING
Biocompatibility:
Biocompatibility testing was performed on the SKORE Male Natural Rubber Latex Condoms in accordance with ISO 10993-1: Biological Evaluation of Medical Devices.
| Test Performed | Standard |
|---|---|
| Acute Systemic Toxicity Reactivity | ISO 10993-11:2017 |
| In vitro Cytotoxicity | ISO 10993-5:2009 |
| Skin Sensitization | ISO 10993-10:2021 |
| Vaginal Irritation Test | ISO 10993-23:2021 |
The results of demonstrate that the subject devices are biocompatible.
8
Mechanical Performance Testing:
Three lots of subject devices, SKORE Male Natural Rubber Latex Condoms were tested at baseline and met specifications of ISO 4074:2015 - Natural rubber latex male condoms -Requirements and test methods and ASTM D3492-16- Standard Specification for Rubber Contraceptives
The results demonstrate that the subject devices meet the standard specifications.
Shelf Life:
Shelf-life testing was conducted per ISO 4074:201521 and 21 CFR 801.435. The accelerated (7 days at 70°c, 90 days at 40-50°c) and real-time stability (5 Years at 28°C to 35° C) of the SKORE Male Natural Rubber Latex Condoms supports a shelf-life of five years as per the requirements.
CONCLUSION
The results of the performance testing described above demonstrate that the SKORE Male Natural Rubber Latex Condoms are as safe and effective as the predicate device and supports a determination of substantial equivalence.