(188 days)
VIOLA barbed suture comprised of dyed polydoxanone (PDO) is indicated for use in soft tissue approximation where use of absorbable suture is appropriate
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.
The provided text describes a 510(k) premarket notification for a medical device called "VIOLA barbed suture". It details the device's characteristics, intended use, and the studies conducted to demonstrate its safety and effectiveness for market clearance.
Here is a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria (Not Explicitly Stated, but Implied by Conformance) | Reported Device Performance |
|---|---|---|
| Non-clinical Laboratory Performance Testing | ||
| USP 40-NF35:2017 Tensile Strength <881> | Conformance to USP monograph for absorbable sutures | Conforms to USP monograph |
| In vitro Barb Holding Strength | Conformance to USP monograph for absorbable sutures | Conforms to USP monograph |
| Suture Diameter <861> | Conformance to USP monograph for absorbable sutures | Conforms to USP monograph |
| Suture-Needle Attachment <871> | Conformance to FDA's Class II special controls guidance | Conforms to FDA guidance |
| In vitro Post-Hydrolysis Tensile Testing | Demonstrated substantial equivalence to predicate device | Demonstrated substantial equivalence to predicate device |
| Needle Tensile | Demonstrated substantial equivalence to predicate device | Demonstrated substantial equivalence to predicate device |
| Elasticity | Demonstrated substantial equivalence to predicate device | Demonstrated substantial equivalence to predicate device |
| Bending Strength | Demonstrated substantial equivalence to predicate device | Demonstrated substantial equivalence to predicate device |
| Surface Structure | Demonstrated substantial equivalence to predicate device | Demonstrated substantial equivalence to predicate device |
| Pull-out Test | Demonstrated substantial equivalence to predicate device | Demonstrated substantial equivalence to predicate device |
| Endotoxin Level Testing | Acceptance criteria for endotoxin levels | Will be performed on each batch of product |
| Biocompatibility Testing | ||
| ISO 10993 Biological Evaluation of Medical Device | Conformance to ISO 10993 and FDA's Class II special controls guidance | Performed in accordance with ISO 10993 and FDA guidance for sutures |
Note: The document states that "All of the testing results met the acceptance criteria" but does not explicitly list the quantitative acceptance criteria for each test. Instead, it refers to conformance with standards and substantial equivalence to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the test set or the data provenance for the non-clinical or biocompatibility testing. These studies are typically laboratory-based and would not involve human participants in the same way as clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The studies performed are non-clinical, benchtop, and biocompatibility tests, which do not involve expert interpretation or ground truth establishment by clinical experts in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, which is not the case for the non-clinical and biocompatibility testing described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. This type of study is typically performed for AI-powered diagnostic or assistive devices involving human readers (e.g., radiologists, pathologists). The VIOLA barbed suture is a physical surgical device, and its evaluation does not involve human readers interpreting images with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was done for the device itself through the non-clinical laboratory tests and biocompatibility tests. These tests assess the physical and biological properties of the suture in isolation, without human-in-the-loop performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests (tensile strength, barb holding strength, diameter, attachment strength, etc.), the "ground truth" is established by physical measurements and adherence to established industry standards and regulatory guidance (USP monographs, FDA special controls guidance, ISO 10993). In essence, the ground truth is defined by the specified physical and chemical properties and performance characteristics required for absorbable surgical sutures.
8. The sample size for the training set
This information is not applicable and not provided. The VIOLA barbed suture is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As mentioned above, the device is not an AI/ML algorithm, and therefore there is no "training set" or "ground truth for the training set" in that context.
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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
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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); 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 ofKorea Tel: 82 31 777 3900Email: mexpo@daum.net | |||
|---|---|---|---|---|
| 2. Contact Person | Young ChiBio-Med USA Inc.27 New England Drive,Ramsey, NJ07446, U.S.ATel: 1 973 278 5222Email: biomedusa@msn.com | |||
| 2. Device | Device Name: VIOLA Barbed SutureDevice Classification: Suture, Surgical, AbsorbablePolydioxanone Product Code: NEWDevice Class: Class IIRegulation 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 usein the approximation of soft tissue. It is comprised of over 99.9% of polydioxanone, anddyed with 0.05-0.075% of D&C Violet No 2. The Viola suture has 85 Cog shaped barbsdistributed along the suture with a barb size of 0.567mm. The device is designed withsmall bi-directional barbs along the long axis of the suture monofilament to preventsliding back and forth of the suture in tissue. VIOLA suture does not need surgical knotsafter tissue approximation. It is available in diameter size USP 0 through 4-0 in variouslengths, and affixed to stainless steel S.S 304 needle size from 19G to 26G. The VIOLAsuture 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 <881>, in vitro barb holding strength, and Sutures Diameter <861>, suture-needle attachment <871>. 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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§ 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.