V-soft Line Barbed Surgical Suture (Various)
Device Facts
| Record ID | K250107 |
|---|---|
| Device Name | V-soft Line Barbed Surgical Suture (Various) |
| Applicant | Feeltech Co., Ltd. |
| Product Code | NEW · General, Plastic Surgery |
| Decision Date | Oct 15, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4840 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The V Soft Line with needle device comprised of dyed polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.
Device Story
V-Soft Line™ is a synthetic, absorbable, monofilament polydioxanone (PDO) surgical suture with a stainless steel needle. It features bi-directional or unidirectional barbs along the long axis to embed in tissue, eliminating the need for surgical knots. Used by clinicians in dermatological settings for soft tissue approximation. The device is supplied sterile (EO gas) and degrades over time in vivo. It functions by anchoring into tissue via barbs to fix the suture position. Benefits include improved fixation and approximation of skin tissues without knot-tying.
Clinical Evidence
No clinical data. Bench testing included USP 43-NF 38 standards for diameter, needle attachment, and tensile strength, plus barb holding strength. Animal study (Sprague-Dawley rats) over 12 weeks compared biodegradation, tensile strength, and mass loss against the predicate; results showed no significant differences.
Technological Characteristics
Material: Polydioxanone (PDO) with D&C Violet No.2 dye. Needle: Stainless Steel Type 304L (ASTM/cleared in K092831). Form: Monofilament with bi-directional or unidirectional barbs. Sterilization: Ethylene Oxide. Sizes: 2, 2-0, 3-0. Connectivity: None.
Indications for Use
Indicated for soft tissue approximation in dermatological applications on the skin. Not for interior body cavity use or tissue lifting/support. Appropriate for patients requiring absorbable sutures.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Miracu™ Barbed Surgical Suture (K172602)
Related Devices
- K160705 — Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, · Y. Jacobs Medical, Inc. · Nov 23, 2016
- K210871 — PDO Max Suture with Dual Needle · Pdo Max, Inc. · Dec 17, 2021
- K242571 — Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 · Hyundae Meditech Co., Ltd. · Sep 27, 2024
- K201139 — WEGO-PDO Barbed Suture · Foosin Medical Supplies Inc., Ltd. · Oct 20, 2020
- K240389 — Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) · Hyundae Meditech Co., Ltd. · Mar 27, 2024
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
October 15, 2025
Feeltech Co., Ltd
% Albert Rego
Consultant
Albert Rego PhD, Inc (d.b.a Rego Associates)
25401 Cabot Road, # 122
Laguna Hills, California 92653
Re: K250107
Trade/Device Name: V-soft Line™ Barbed Surgical Suture (Various)
Regulation Number: 21 CFR 878.4840
Regulation Name: Absorbable Polydioxanone Surgical Suture
Regulatory Class: Class II
Product Code: NEW
Dated: April 25, 2025
Received: April 29, 2025
Dear Albert Rego:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K250107 - Albert Rego
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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. 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K250107 - Albert Rego
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assistance/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,
TEK N. LAMICHHANE -S
Tek N. Lamichhane, Ph.D.
Assistant Director
DHT4B: Division of Plastic and
Reconstructive Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250107 | |
| Device Name V-soft Line™ Barbed Surgical Suture (Various) | |
| Indications for Use (Describe) The V Soft Line with needle device comprised of dyed polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues. | |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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510(k) Summary (K250107)
I. SUBMITTER:
Feeltech Co., Ltd.
4 Floor, Standard Factory 5-dong, part of 1 Floor, Standard Factory 1-dong, part of 3, 4 Floor, Standard Factory 2-dong,15, Jayumuyeok 2-gil, Gunsan-si, Jeonbuk-do, Korea
Phone: +82 63 468-6626, Fax: +82 63 468-6623
Email: yettos@empas.com
Contact Person:
Albert Rego, Ph.D. Inc.
25401 Cabot Road
Suite 122
Laguna Hills, CA 92653
Phone: (949) 770-8710
Email: albert@regoassociates.com
Date Prepared: April 25, 2025
II. DEVICE:
Trade Name: V-Soft Line™ Barbed Surgical Suture
Common Name: Absorbable Polydioxanone Suture with Needle
Regulation Number Code: 21 CFR 878.4840
Device Class: Class II
Panel Review: General & Plastic Surgery
Product Code: NEW
III. PREDICATE DEVICE:
510(k) Number: K172602
Trade Name: 21 CFR 878.4840
Device Class: Class II
Panel Review: General & Plastic Surgery
Product Code: NEW
Manufacturer: Feeltech Co., Ltd.
IV. DEVICE DESCRIPTION:
The V-Soft Line™ synthetic absorbable PDO suture with needle is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. The V-Soft Line™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. The barbed sutures are pre-loaded and are not attached to the needle.
Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament with needle attachment. The V-Soft Line™ Synthetic Absorbable PDO suture with needle
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approximates tissue without the need to tie surgical knots, by using the opposing barbs on the surface to embed in the tissues after the surgeon precisely places the suture within the tissues.
The proposed suture is available in 2, 2-0, and 3-0 suture sizes, which are the sizes identified in the currently recognized Unites States Pharmacopeia.
The V-Soft Line™ is barbed to two sections on suture and the barbs on each section are opposite direction each other. The reason that this suture has each opposite barb direction is not to slide and move to forth and back and to fix well. Therefore, the effectiveness of suture for treatment can be improved.
# V. INDICATIONS FOR USE
The V-Soft Line™ barbed device comprised of dyed polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.
# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The direct comparison of the predicate device to the subject device addresses all of the physical characteristics.
The comparison of features and operation principles between V-Soft Line™ (PDO) Suture from Feeltech Co. Ltd. and Miracu™ (PDO) Barbed Surgical Suture (K172602) is listed as follows:
| Category | Subject Device V-Soft Line™ Barbed Surgical Suture | Predicate Device Miracu™ Barbed Surgical Suture (K172602) | Substantially Equivalent or Not Substantially Equivalent |
| --- | --- | --- | --- |
| Common Name | Suture Absorbable Synthetic Polydioxanone with Needle Suturing Disposable | Suture Absorbable Synthetic Polydioxanone with Needle Suturing Disposable | Substantially Equivalent |
| Manufacturer | Feeltech Co., Ltd. | Feeltech Co., Ltd. | Not Applicable |
| 510(k) Number | N/A | K172602 | Not Applicable |
| Indication For Use | The V-Soft Line™ barbed surgical suture is comprised of dyed polydioxanone is indicated for soft tissue approximation where use of an absorbable suture is appropriate. | The Miracu™ barbed surgical suture is comprised of dyed polydioxanone is indicated for soft tissue approximation where use of an absorbable suture is appropriate. | Indications for Use Subject device, predicate device are similar with respect to usage on soft tissue approximation. Substantially Equivalent Design |
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| Category | Subject Device | Predicate Device | Substantially Equivalent or Not Substantially Equivalent |
| --- | --- | --- | --- |
| | V-Soft Line™ Barbed Surgical Suture | Miracu™ Barbed Surgical Suture
(K172602) | |
| | The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues. | The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues. | Similar in usage of suture type (absorbable, biodegradable) and application.
Substantially Equivalent |
| Sterile | Ethylene Oxide | Ethylene Oxide | Substantially Equivalent |
| Configuration | PDO Suture and Needle. predicate suture being swaged to a standard suturing needle | PDO Suture and Needle. predicate suture being swaged to a standard suturing needle | Design
Similar in usage of suture type (absorbable, biodegradable) and application.
Substantially Equivalent |
| Materials | Poly (dioxanone) | Poly (dioxanone) | Identical
Substantially Equivalent |
| Color | Dyed (violet) | Dyed (violet) | Identical
Substantially Equivalent |
| Absorbable | Absorbable | Absorbable | Identical
Substantially Equivalent |
| Braid/Monofilament | Monofilament | Monofilament | Substantially Equivalent |
| Suture Size | 3-0, 2-0, 2, | 4-0, 3-0, 2-0, 0 | Design
Similar in usage of suture type (absorbable, biodegradable) and application.
Different in Predicate Device suture size however no impact to form, fit, function, or safety of the suture. |
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| Category | Subject Device V-Soft Line™ Barbed Surgical Suture | Predicate Device Miracu™ Barbed Surgical Suture (K172602) | Substantially Equivalent or Not Substantially Equivalent |
| --- | --- | --- | --- |
| | | | Substantially Equivalent |
| Overall suture design | 1) non-barbed section → 1stbarbed section → Space between barbed sections → 2ndbarbed section → non-barbed section | 1) non-barbed section → 1stbarbed section → Space between barbed sections → 2ndbarbed section → non-barbed section | Substantially Equivalent |
| | 2) non-barbed section → 1stbarbed section → Space between barbed sections | 2) non-barbed section → 1stbarbed section → Space between barbed sections | |
| | 3) 1stbarbed section → non-barbed section → 2stbarbed section → non-barbed section → 3ndbarbed section | 3) 1stbarbed section → non-barbed section → 2stbarbed section → non-barbed section → 3ndbarbed section | |
| Length of Suture1 | 50mm, 80mm, 110mm, 150mm, 160mm, 180mm, 185mm | 90mm, 110mm, 150mm | Design Similar in usage of suture type (absorbable, biodegradable) and application. Similar in suture lengths. Different in Predicate Device lengths however no impact to form, fit, function, or safety of the suture. Substantially Equivalent |
| Length of barb section (1stbarbed section x 2ndbarbed section) | 110mm (24mmx24mm), 150mm (35mmx35mm), 150mm (20mmx29mm), 160mm (37.5mmx37.5mm), | 110mm (24mmx24mm), 130mm (25mmx25mm), 150mm (35mmx35mm), 150mm (20mmx29mm), 160mm (37.5mmx37.5mm), | Substantially Equivalent |
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| Category | Subject Device
V-Soft Line™ Barbed Surgical Suture | Predicate Device
Miracu™ Barbed Surgical Suture
(K172602) | Substantially Equivalent
or Not Substantially Equivalent |
| --- | --- | --- | --- |
| | 180mm( 48mmx48mm),
180mm( 32mmx44mm),
185mm (35mmx47mm) | 165mm(44mmx48mm),
180mm( 48mmx48mm),
180mm( 32mmx44mm),
185mm (35mmx47mm) | |
| Length of barb section
(1st barbed section) | 50mm (24mm),
160mm (63mm),
185mm (90mm) | 50mm (24mm),
160mm (63mm),
185mm (90mm) | Substantially Equivalent |
| Number of barb per the linear length of suture | barbs per 10mm
(various, typical, average)
2.2 barbs per 10mm
3.5 barbs per 10mm
4.5 barbs per 10mm
5 barbs per 10mm | 7 barbs per 10mm | *Design*
Similar in usage of suture type (absorbable, biodegradable) and application.
Similar in suture lengths.
*Different* in Predicate Device number of barb per unit linear length of sutures however no impact to form, fit, function, or safety of the suture.
Substantially Equivalent |
| Barb (Cog) angle | 2~45°
25~35 °
30~40 ° | 35° ± 5° | *Design*
Similar in usage of suture type (absorbable, biodegradable) and application.
Similar in suture lengths.
*Different* in Predicate Device barb (cog) angle however no impact to form, fit, function, or safety of the suture.
Substantially Equivalent |
| Barb (Cog) length | Various
1.7mm ± 10% | 1mm ± 0.1mm | *Design* |
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| Category | Subject Device | Predicate Device | Substantially Equivalent or Not Substantially Equivalent |
| --- | --- | --- | --- |
| | V-Soft Line™ Barbed Surgical Suture | Miracu™ Barbed Surgical Suture (K172602) | |
| | 1.1~2.3mm
1.7~2.3mm
2.7~3.3mm
4.2~4.7mm | | Similar in usage of suture type (absorbable, biodegradable) and application.
Similar in suture lengths.
Different in Predicate Device barb (cog) length however no impact to form, fit, function, or safety of the suture.
Substantially Equivalent |
| Barb (Cog) spacing | Various
1.8~2.2 mm
1.7~2.3 mm
2.7~3.3 mm
4.2~4.7 mm | 2mm ± 0.1mm | Design
Similar in usage of suture type (absorbable, biodegradable) and application.
Similar in suture lengths.
Different in Predicate Device interval between barb (Cog) spacing however no impact to form, fit, function, or safety of the suture.
Substantially Equivalent |
| Interval between barbed sections | Various
3 mm
7 mm
10 mm
13.5
15 mm | 10mm | Design
Similar in usage of suture type (absorbable, biodegradable) and application.
Similar in suture lengths.
Different in Predicate Device interval between barbed sections however no impact to form, fit, function, or safety of the suture.
Substantially Equivalent |
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| Category | Subject Device V-Soft Line™ Barbed Surgical Suture | Predicate Device Miracu™ Barbed Surgical Suture (K172602) | Substantially Equivalent or Not Substantially Equivalent |
| --- | --- | --- | --- |
| Direction of barb (Cog) | Direction of barbs of 1st barbed section is reverse direction against x 2nd barbed sectionLSCO Type: Direction of barbs of 1st barbed section is same direction against x 2nd barbed sectionC-Cog Type: 1 barbed section, unidirectionalForte Fix Type: 1 barbed section, unidirectional | Direction of barbs of 1st barbed section is reverse direction against x 2nd barbed section | DesignSimilar in usage of suture type (absorbable, biodegradable) and application.Similar in suture lengths.Different in Predicate Device direction of barb (cog) for LSCO Type, C-Cog Type and Forte Fix Type however no impact to form, fit, function, or safety of the suture.Substantially Equivalent |
| Configuration of barb (Cog) | Two-way (both side) barb forming | Two-way (both side) barb forming | DesignSimilar in usage of suture type (absorbable, biodegradable) and application.Similar in suture lengths.Different in Predicate Device direction of barb (cog)configuration of barb (Cog) for LSCO Type, C-Cog Type and Forte Fix Type however no impact to form, fit, function, or safety of the suture.Substantially Equivalent |
| Needle Material | Stainless Steel Type 304L (cleared in K092831) | Stainless Steel Type 304L (cleared in K092831) | Identical Substantially Equivalent |
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# VII. PERFORMANCE DATA
## BIOCOMPATIBILITY
Per ISO 10993-1 the biological evaluation, testing and biological risk assessment have been completed and lead to the conclusion that the product meets form, fit, function and safety requirements for its intended use.
## PERFORMANCE TESTING-BENCH
USP 43 - NF 38, Section <861> Sutures - Diameter
USP 43 - NF 38, Section <871> Sutures – Needle Attachment
USP 43 - NF 38, Section <881> Sutures - Tensile Strength
Suture Retention - Barb Holding Strength
Feeltech has completed the above stated testing services performed in accordance to applicable standard good practices and/or standards identified within this report. Testing has been completed as described herein. The decision rule applied is simple acceptance of the test results.
# VIII. ANIMAL STUDIES (PERFORMANCE TESTING)
Animal studies were presented under an assessment of In-vivo biodegradation of absorbable V-Soft Line™ (PDO) suture in comparison with the predicate device Miracu™ Barbed Device (reference samples – predicate device) over time in Sprague-Dawley rat animal model system.
The study was carried out to evaluate the biodegradation of absorbable suture in Sprague-Dawley rats for a total of 12 weeks, after multiple 2 week interval examinations following necropsies. This study was performed in accordance with the USP 37 NF:2014 standards: absorbable surgical suture, tensile strength, sutures – diameter, and their acceptance criteria were met. Other parameters under investigation barb holding forces, residual tensile strength, and absorption (loss of mass) were demonstrated to reflect the biodegradation levels (indicators) over time were numerical determined.
No significant differences between all test groups and reference groups (predicate device) in all necropsy groups were evident. The V-Soft Line™ (PDO) suture performance was substantially equivalent to the predicate device.
# IX. CLINICAL STUDIES (PERFORMANCE TESTING)
The V-Soft Line™ (PDO) Barbed Surgical Suture does not require clinical study. There are no clinical study requirements for this Class II product.
# X. CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe and effective as the legal marketed predicate device.
