(336 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a knotless suture, with no mention of AI or ML.
No
The device is a knotless wound closure device, which is an absorbable suture used for soft tissue approximation. It is not described as providing therapy or treatment; rather, it facilitates the physical closure of wounds.
No
The device description clearly states it is a "knotless wound closure device" comprised of "absorbable monofilament undyed-suture" used for "soft tissue approximation," which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a physical knotless wound closure device comprised of a synthetic absorbable monofilament suture, a surgical needle, and a stopper. It is a tangible hardware product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the MONOFIX PGCL is a "knotless wound closure device" comprised of a suture and needle. Its intended use is for "soft tissue approximation." This is a surgical device used directly on the body to close wounds, not to analyze specimens.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic purposes, or any of the typical components or functions of an IVD (e.g., reagents, assays, analyzers).
Therefore, the MONOFIX PGCL is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MONOFIX PGCL, knotless wound closure device is indicated for use in soft tissue approximation where the use of absorbable suture is appropriate. MONOFIX PGCL, knotless wound closure device should not be used to approximate tissue under tension and the use of barbed suture has not been shown to be safe in the closure of hernias, laparotomy incisions, bowel anastomosis or suture lines, vascular suture lines, and vaginal cuff closure in controlled clinical or preclinical studies for minimally invasive or open surgery.
Product codes (comma separated list FDA assigned to the subject device)
GAM
Device Description
MONOFIX PGCL, knotless wound closure device, comprised of Poly(glycolide-co-carprolactone)(PGA-PCL) is a synthetic absorbable monofilament undyed-suture. It is available sterile, developed by Samyang Holdings Corp., Ltd. The MONOFIX PGCL, knotless wound closure device consists of a Barb-type suture and a surgical needle, with a suture at one end and a stopper shaped end for tissue anchoring at the stopper is attached to the end of the suture and has a triangular shape with one side length of 1.8 to 3.3 mm and a thickness of 0.7 to 1.0 mm. The device is designed with small uni-directional barbs in size 0.18-0.55 mm along the length and stopper that eliminate the need to tie knots during approximation. The device is available in lengths of 15 to 60cm and diameter sizes 1 through 3-0 with needles in 1/2 circle, 5/8 circle, 1/2 curved and straight shapes attached to each end.
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
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)
Bench tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device complies with the following standards:
Class II Special Controls Guidance Document: Surgical Sutures: Guidance for Industry and FDA
USP Suture Diameter
USP Suture-Needle attachment
USP Tensile Strength Surgical Suture
USP Monographs: Absorbable Surgical Suture
EP Monographs: Sutures, Sterile Synthetic Absorbable Monofilament
Sterilization:
ISO 11135:2014, Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development. validation and routine control of a sterilization process for medical devices
ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Sterile barrier system testing:
ASTM F 88, Standard Test Method for Seal Strength of Flexible Barrier Materials
Accelerated aging stability testing:
ASTM F 1980, Standard Guide For Accelerated Aging Of Sterile Barrier Systems For Medical Devices. (Sterility)
Biocompatibility testing:
-
Suture Needle
ISO 10993-5: Test for Cytotoxicity
ISO 10993-10: Test for Irritation and Sensitization
ISO 10993-11: Test for Systemic Toxicity
ISO 10993-4: Selection of tests for interactions with blood
ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials -
Suture
ISO 10993-1: Selection of Tests
ISO 10993-2: Animal Welfare
ISO 10993-12: Sample Preparation
ISO 10993-5: Test for Cytotoxicity
ISO 10993-10: Test for Irritation and Sensitization
ISO 10993-11: Test for Systemic Toxicity
ISO 10993-3: Tests for Genotoxicity
ISO 10993-6: Test for Local Effects after Implantation
ISO 10993-4: Selection of tests for interactions with blood
ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials
In vivo tensile strength of Monofix PGCL was performed to evaluate the tensile strength retention rate.
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.
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
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 5, 2022
Samyang Holdings Corp., Ltd. % Sanglok Lee Manager Wise Company Inc. #507,#508 166, Gasan digital 2-ro Geumcheon-gu, Seoul 08503 Korea, South
Re: K212810
Trade/Device Name: MONOFIX PGCL, knotless wound closure device Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: August 30, 2021 Received: September 3, 2021
Dear Sanglok Lee:
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.
1
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 and Part 809 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 Deborah Fellhauer, RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212810
Device Name MONOFIX PGCL, knotless wound closure device
Indications for Use (Describe)
MONOFIX PGCL, knotless wound closure device is indicated for use in soft tissue approximation where the use of absorbable suture is appropriate. MONOFIX PGCL, knotless wound closure device should not be used to approximate tissue under tension and the use of barbed suture has not been shown to be safe in the closure of hernias, laparotomy incisions, bowel anastomosis or suture lines, vascular suture lines, and vaginal cuff closure in controlled clinical or preclinical studies for minimally invasive or open surgery.
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."
3
Image /page/3/Picture/0 description: The image shows the word "samyang" in black font. There is a blue dot to the left of the word, and an orange and green dot to the right of the word. The background is white.
The assigned 510(k) Number: K212810
01. Date of Submission: 05.20.2022
02. Applicant
Company name: Samvang Holdings Corp., Ltd. Address: 55, Munpyeongseo-ro, 18beon-gil, Daedeok-gu, Daejeon, 34302, Korea TEL: +82-42-930-3135 FAX: +82-42-931-6439 Email: hyerim.park@samyang.com
03. Submission Correspondent
Sanglok, Lee Wise COMPANY Inc. #507, 166, Gasan digital 2-ro, Geumcheon-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org
04. Subject Device Identification
Trade Name: MONOFIX PGCL, knotless wound closure device Common Name: Absorbable PGA-PCL surgical suture with needle Classification Name: Absorbable poly(glycolide/l-lactide) surgical suture Product Code: GAM Panel: General and Plastic Surgery Devices Regulation Number: 21 CFR 878.4493 Device Class: II
05. Indication for use
MONOFIX PGCL, knotless wound closure device is indicated for use in soft tissue approximation where the use of absorbable suture is appropriate. MONOFIX PGCL, knotless wound closure device should not be used to approximate tissue under tension and the use of barbed suture has not been shown to be safe in the closure of hernias, laparotomy incisions, bowel anastomosis or suture lines, vascular suture lines, and vaginal cuff closure in controlled clinical or preclinical studies for minimally invasive or open surgery.
06. Predicate devices
Predicate device 510(k) Number: K141778 Device Name: Quill™ Monoderm™ Knotless Tissue-Closure(PGA-PCL), Variable Loop Design Manufacturer: Surgical Specialties Corporation
Reference device 510(k) Number: K182873 Device Name: STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device Manufacturer: Ethicon
07. Device Description
MONOFIX PGCL, knotless wound closure device, comprised of Poly(glycolide-co-carprolactone)(PGA-PCL) is a synthetic absorbable monofilament undyed-suture. It is available sterile, developed by Samyang Holdings Corp., Ltd. The MONOFIX PGCL, knotless wound closure device consists of a Barb-type suture and a surgical needle, with a suture at one end and a stopper shaped end for tissue anchoring at the stopper is attached to the end of the suture and has a triangular shape with one side length of 1.8 to 3.3 mm and a thickness of 0.7 to 1.0 mm. The device is designed with small uni-directional barbs in size 0.18-0.55 mm along
4
Image /page/4/Picture/1 description: The image shows the word "samyang" in black font. There is a blue dot to the left of the word, and an orange and green dot to the right of the word. The word is written in lowercase letters.
the length and stopper that eliminate the need to tie knots during approximation. The device is available in lengths of 15 to 60cm and diameter sizes 1 through 3-0 with needles in 1/2 circle, 5/8 circle, 1/2 curved and straight shapes attached to each end.
08. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device complies with the following standards:
Class II Special Controls Guidance Document: Surqical Sutures: Guidance for Industry and FDA USP Suture Diameter USP Suture-Needle attachment USP Tensile Strength Surgical Suture USP Monographs: Absorbable Surgical Suture EP Monographs: Sutures, Sterile Synthetic Absorbable Monofilament
Sterilization
ISO 11135:2014, Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development. validation and routine control of a sterilization process for medical devices ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Sterile barrier system testing ASTM F 88, Standard Test Method for Seal Strength of Flexible Barrier Materials
Accelerated aging stability testing
- ASTM F 1980, Standard Guide For Accelerated Aging Of Sterile Barrier Systems For Medical Devices. (Sterility)
Biocompatibility testing
-
- Suture Needle
- ISO 10993-5: Test for Cytotoxicity
- ISO 10993-10: Test for Irritation and Sensitization
- ISO 10993-11: Test for Systemic Toxicity
- ISO 10993-4: Selection of tests for interactions with blood
- ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials
2) Suture
- ISO 10993-1: Selection of Tests
- ISO 10993-2: Animal Welfare
- ISO 10993-12: Sample Preparation
- ISO 10993-5: Test for Cytotoxicity
- ISO 10993-10: Test for Irritation and Sensitization
- ISO 10993-11: Test for Systemic Toxicity
- ISO 10993-3: Tests for Genotoxicity
- ISO 10993-6: Test for Local Effects after Implantation
- ISO 10993-4: Selection of tests for interactions with blood
- ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials
- In vivo tensile strength of Monofix PGCL was performed to evaluate the tensile strength retention rate.
5
Image /page/5/Picture/0 description: The image shows the word "samyang" in black font. There is a blue dot to the left of the word and an orange and green dot to the right of the word. The background is white.
09. Substantially Equivalent Conclusion
Table 1: Substantial Equivalence Comparison
| Product Name | Subject Device | Predicate Device | Reference Device | Equivalence
Discussion |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| 510(k) Number | K212810 | K141778 | K182873 | |
| Product Code | GAM | GAM | GAM | same |
| Indications for
use statements | MONOFIX PGCL, knotless
wound closure device is
indicated for use in soft
tissue approximation where
the use of absorbable suture
is appropriate. MONOFIX
PGCL, knotless wound
closure device should not be
used to approximate tissue
under tension and the use of
barbed suture has not been
shown to be safe in the
closure of hernias,
laparotomy incisions, bowel
anastomosis or suture lines,
vascular suture lines, and
vaginal cuff closure in
controlled clinical or
preclinical studies for
minimally invasive or open
surgery. | Quill™ MONODERM™
Device is indicated for use in
soft tissue approximation
where the use of absorbable
sutures is appropriate. | STRATAFIX™ Spiral
MONOCRYL™ Knotless
Tissue Control Device is
indicated for use in soft
tissue approximation where
the use of absorbable
sutures is appropriate. | same |
| Class | II | II | II | same |
| Sterile | Yes | Yes | Yes | same |
| Single Use | Single use | Single use | Single use | same |
| Material | Poly(glycolide-co-ε-
carprolactone)(PGA-PCL) | Poly(glycolide-co-ε-
carprolactone)(PGA-PCL) | Poly(glycolide-co-ε-
carprolactone)(PGA-PCL) | same |
| Color | Undyed | Undyed, Dyed(Violet) | Undyed | Same
Analysis 1 |
| Absorbable/
Non-absorbable | absorbable | absorbable | absorbable | same |
| Braided/
Monofilament | Monofilament | Monofilament | Monofilament | same |
| Barbed/
Not Barbed | Uni-directional barbs | Uni-directional barbs | Uni-directional barbs | same |
| Suture Size | USP size 1 to 3-0 | USP size 1 to 4-0 | unknown | same |
| Needle Material | Stainless steel | Stainless steel | Stainless steel | same |
| Sterilization | EO | EO | EO | same |
| USP Diameter
Requirements | Oversize.
Suture meets requirements
for "Absorbable Surgical
Suture" except diameter. | Suture meets exceeds
requirements for
"Absorbable Surgical Suture" except diameter. | Oversize.
Suture meets requirements
for "Absorbable Surgical
Suture" except diameter. | Same
Analysis 2 |
| Tensile Strength
requirements | Suture meets the
performance requirements
defined for "Tensile strength"
| Suture meets the
performance requirements
defined for "Tensile strength"
| Suture meets the
performance requirements
defined for "Tensile strength"
| same |
| Needle
Attachment
Requirements | Suture meets the
performance requirements
defined for "Needle
Attachment" | Suture meets the
performance requirements
defined for "Needle
Attachment" | Suture meets the
performance requirements
defined for "Needle
Attachment" | same |
6
Image /page/6/Picture/0 description: The image shows the word "samyang" in black font. To the left of the word is a blue dot, and to the right are an orange and a green dot. The dots are smaller than the letters in the word.
Analysis 1 - Color
The suture of predicate device is undyed and dyed. The suture is only available in undyed. K182873 added as a reference device to support the difference in undyed characteristic. This difference does not affect the safety and effectiveness of the product.
Analysis 2 - USP Diameter Requirements
USP designations for diameter are used to describe MONOFIX PDO Device suture after barbing except for minor variation in suture diameter with a maximum average of 0.1 mm.
The actual diameter of the non-barbed section fiber is one size greater size with a maximum overage of 0.1 mm.
The USP and EU Pharmacopoeia sizes of the Proposed Device are further defined in Table 1.
Table 1. Diameter Comparison
| USP Device size
Designation | EU Pharmacopoeia
Device size
(Metric / Ph. Eur.)
Designation | MONOFIX PGCL,
knotless wound closure device | | |
|--------------------------------|-----------------------------------------------------------------------|------------------------------------------------|----------------------|--------------------------|
| | | USP | Metric /
Ph. Eur. | Tensile strength
size |
| 1 | 4 | 1 | 4 | 0 |
| 0 | 3.5 | 0 | 3.5 | 2-0 |
| 2-0 | 3 | 2-0 | 3 | 3-0 |
| 3-0 | 2 | 3-0 | 2 | 4-0 |
STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is oversized barbed suture. K182873 added as a reference device to support the difference in USP Diameter characteristic.
10. Conclusion
The subject device, MONOFIX PGCL, knotless wound closure device, is determined to be Substantially Equivalent (SE) to the predicate devices, QuilI™ Monoderm™ Knotless Tissue-Closure(PGA-PCL), Variable Loop Design (K141778) in respect of safety and effectiveness.