(188 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and mechanical performance of a barbed suture, with no mention of AI or ML technologies.
No.
The device is a surgical suture used for soft tissue approximation, which is a supportive rather than a therapeutic function.
No
A diagnostic device is used to identify or detect a disease or condition. This device, a surgical suture, is used for soft tissue approximation, which is a treatment or repair function, not a diagnostic one.
No
The device description clearly describes a physical medical device (suture) made of polydioxanone with barbs and attached to a stainless steel needle. 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 "soft tissue approximation where use of absorbable suture is appropriate." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical suture with barbs, designed to hold tissue together. This is a surgical implant/device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is used to physically repair tissue within the body.
N/A
Intended Use / Indications for Use
VIOLA barbed suture comprised of dyed polydoxanone (PDO) is indicated for use in soft tissue approximation where use of absorbable suture is appropriate.
Product codes
NEW
Device Description
The Viola barbed suture is a sterile, synthetic absorbable device that is intended for use in the approximation of soft tissue. It is comprised of over 99.9% of polydioxanone, and dyed with 0.05-0.075% of D&C Violet No 2. The Viola suture has 85 Cog shaped barbs distributed along the suture with a barb size of 0.567mm. The device is designed with small bi-directional barbs along the long axis of the suture monofilament to prevent sliding back and forth of the suture in tissue. VIOLA suture does not need surgical knots after tissue approximation. It is available in diameter size USP 0 through 4-0 in various lengths, and affixed to stainless steel S.S 304 needle size from 19G to 26G. The VIOLA suture is sterilized by ethylene oxide gas and packed each set in a poly bag.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-clinical laboratory performance testing was performed to confirm the VIOLA barbed suture comprised of polydioxanone, conforms to the USP 40-NF35:2017 monograph for absorbable sutures for tensile strength , in vitro barb holding strength, and Sutures Diameter , suture-needle attachment . The testing was performed in accordance with FDA's Class II special controls guidance Document: Surgical Sutures, issued on Jun 3, 2003. Additional performance test was conducted to demonstrate substantial equivalence to the predicate, including in vitro post-hydrolysis tensile testing, needle tensile, elasticity, bending strength, surface structure, and pull-out test. All of the testing results met the acceptance criteria. Endotoxin level testing was conducted and will be performed on each batch of the product. Biocompatibility testing was conducted on the finished final device in accordance with Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Surgical Sutures issued on Dec 19,2003 and ISO10993 Biological Evaluation of Medical Device Part 1: Evaluation and Testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
August 15, 2019
MEDITIME Co., Ltd % Mr. Young Chi CEO Bio-Med USA Inc 27 New England Drive Ramsey, New Jersey 07446
Re: K190264
Trade/Device Name: VIOLA Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: June 8, 2019 Received: June 13, 2019
Dear Mr. Chi:
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
1
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); 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-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 medical devices and radiation-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 Nina Mezu-Nwaba, PharmD., MPH., MSc, CAPT., United States Public Health Service Assistant Director (Acting), Plastic Surgery Implant Devices Team Division of Infection Control and Plastic Surgery Devices Office of Surgical and Infection Control 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) K190264
Device Name VIOLA
Indications for Use (Describe)
VIOLA barbed suture comprised of dyed polydoxanone (PDO) is indicated for use in soft tissue approximation where use of absorbable suture is appropriate
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary as required by CFR 807.92(c)
Date of Preparation: August 15, 2019
| 1. Sponsor | Meditime Co., Ltd.
Medical Device Complex #605,
200, Gieopdosi-ro, Jijeong-myeon, Won Ju, Gangwon Do, Rep of
Korea Tel: 82 31 777 3900
Email: mexpo@daum.net | | | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|----------------------------|--|
| 2. Contact Person | Young Chi
Bio-Med USA Inc.
27 New England Drive,
Ramsey, NJ07446, U.S.A
Tel: 1 973 278 5222
Email: biomedusa@msn.com | | | |
| 2. Device | Device Name: VIOLA Barbed Suture
Device Classification: Suture, Surgical, Absorbable
Polydioxanone Product Code: NEW
Device Class: Class II
Regulation Number: 21 CFR 878.4840 | | | |
| 3. Predicate Device | | | | |
| | K133420 | TransQuill Barbed Suture | Surgical Specialities Corp | |
| 4. Description of the Device | | | | |
| | The Viola barbed suture is a sterile, synthetic absorbable device that is intended for use
in the approximation of soft tissue. It is comprised of over 99.9% of polydioxanone, and
dyed with 0.05-0.075% of D&C Violet No 2. The Viola suture has 85 Cog shaped barbs
distributed along the suture with a barb size of 0.567mm. The device is designed with
small bi-directional barbs along the long axis of the suture monofilament to prevent
sliding back and forth of the suture in tissue. VIOLA suture does not need surgical knots
after tissue approximation. It is available in diameter size USP 0 through 4-0 in various
lengths, and affixed to stainless steel S.S 304 needle size from 19G to 26G. The VIOLA
suture is sterilized by ethylene oxide gas and packed each set in a poly bag. | | | |
| 5. Indication for Use | | | | |
Viola barbed suture comprised of dyed polydioxanone (PDO) is indicated for use in soft tissue approximation where use of absorbable suture is appropriate. 10
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6. Performance
Tests:
Non-clinical laboratory performance testing was performed to confirm the VIOLA barbed suture comprised of polydioxanone, conforms to the USP 40-NF35:2017 monograph for absorbable sutures for tensile strength , in vitro barb holding strength, and Sutures Diameter , suture-needle attachment . The testing was performed in accordance with FDA's Class II special controls guidance Document: Surgical Sutures, issued on Jun 3, 2003. Additional performance test was conducted to demonstrate substantial equivalence to the predicate, including in vitro post-hydrolysis tensile testing, needle tensile, elasticity, bending strength, surface structure, and pull-out test. All of the testing results met the acceptance criteria. Endotoxin level testing was conducted and will be performed on each batch of the product.
7. Biocompatibility Tests:
Biocompatibility testing was conducted on the finished final device in accordance with Guidance for Industry and FDA Staff _ Class II Special Controls Guidance Document: Surgical Sutures issued on Dec 19,2003 and ISO10993 Biological Evaluation of Medical Device Part 1: Evaluation and Testing.
8. Conclusion:
The Viola Barbed Suture is substantially equivalent to the predicate device in respect to the intended use, technological characteristics and performance. The bench performance testing and biocompatibility testing results demonstrated the subject device is as safe and effective as predicate device with the only difference being the predicate device has the suture preloaded with a needle and affixed. This difference does not raise any different questions of safety or effectiveness.
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