DW-1C

• K Number: K160761
• Device Name: DW-1C
• Manufacturer: DONGWON MEDICAL CO., LTD.
• Date Cleared: 2016-11-22 ( 246 days)
• Product Code: NEW
• Regulation Number: 878.4840

Intended Use

The DW-1 C comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

Device Description

DW-1C synthetic absorbable PDO suture is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. The DW-1C is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament without needle attachment. The DW-1C Synthetic Absorbable PDO suture approximate 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.

Predicate Devices

K130191

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and mechanical function of a surgical suture, with no mention of AI or ML.

Therapeutic

Yes

The device is a surgical suture used for soft tissue approximation, which falls under the definition of a therapeutic device as it is intended to treat a condition (e.g., incisions, wounds) by providing physical support for healing.

Diagnostic

No

Explanation: The device is a surgical suture used for soft tissue approximation. Its function is to hold tissues together, which is a therapeutic rather than a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a synthetic absorbable PDO suture made of polydioxanone, which is a physical material, not software.

IVD (In Vitro Diagnostic)

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 sutures is appropriate." This describes a surgical procedure performed directly on the patient's body.
• Device Description: The device is a surgical suture made of polydioxanone with barbs. It is designed to physically approximate tissue.
• Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on samples. It is a physical implant used during surgery.

Therefore, the DW-1 C suture is a surgical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DW-1 C comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

Product codes

NEW

Device Description

DW-1C synthetic absorbable PDO suture is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. The DW-1C is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue.

Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament without needle attachment. The DW-1C Synthetic Absorbable PDO suture approximate 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.

While the formation of barbs in the DW-1C reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduce their effective strength. For this reason, the strength of the DW-1C can be compared with USP knot strength of nonbarbed suture and the USP size of DW-1C is 1

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)

Laboratory testing regarding characteristics was performed on the DW-1C to verify its safety and performance. A biocompatibility assessment was performed on the patient contact materials of DW-1C.

Summary of various bench tests:

1. USP 32:2009 Absorbable Surgical Suture: In vivo absorption of absorbable suture were observed at 10, 80, 120, 220days after implantation. Absorption time of MONOSORB was 180-220days.
2. Dimension Test USP 37-NF 32:2014 Sutures - Diameter: Acceptance Criteria for this testing ±5%. No failed results were performed in any DW-1C during the performing period.
3. Tensile Strength USP 37-NF 32: 2014 Tensile Strength: Acceptance Criteria for this testing Not less than 300gf. No failed results were performed in any DW-1C during the performing period.
4. Holding forces: There was no significant difference between test samples and reference samples.
5. Weights: The weights of test samples in 1st (G1, Week 2), 2nd (G2, Week 4), 3rd (G3, Week 6), 4th (G4, Week 8), 5th (G5, Week 10), 6th (G6, Week 12) and 7th (G7, Week 14) necropsy groups were statistically significantly lower than that of the test samples in before implantation (p

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three overlapping profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 22, 2016

Dongwon Medical Co., Ltd. % Mr. Peter Chung Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K160761

Trade/Device Name: Dw-1c Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: October 17, 2016 Received: October 24, 2016

Dear Mr. Chung:

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. 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K160761

Device Name DW-IC

Indications for Use (Describe)

The DW-1 C comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

Type of Use (Select one or both, as applicable)

X 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 [e-mail]

"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

510(k) Summary

[as required by 807.92(c)]

1. Applicant

• 1. Company : Dongwon Medical Co.,Ltd.
• 2. Address : 6F-601, 79-1, Mongnyeon-ro 153beon-gil, Gwangsan-gu, Gwangju, Korea
• 3. Tel : [phone]
• 4. Fax : [phone]
• 5. Contact person : Peter Chung, 412-687-3976
• 6. Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
• 7. Submission date : Oct. 17, 2016

2. Device Information

• 1. Trade Name : DW-1C
• 2. Common Name : Absorbable polydioxanone surgical suture
• 3. Classification Name : Suture, Surgical, Absorbable, Polydioxanone
• 4. Product Code : NEW
• 5. Regulation Number : 21 CFR 878.4840
• 6. Class of device : Class II
• 7. Panel : General & Plastic Surgery

3. The legally marketed device to which we are claiming equivalence : K130191 MINT

4. Device description :

DW-1C synthetic absorbable PDO suture is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. The DW-1C is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue.

Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament without needle attachment. The DW-1C Synthetic Absorbable PDO suture approximate 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.

While the formation of barbs in the DW-1C reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduce their effective strength. For this reason, the strength of the DW-1C can be compared with USP knot strength of nonbarbed suture and the USP size of DW-1C is 1

5. Indication for Use :

DW-1C comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

6. Technological characteristics

DW-1C, absorbable polydioxanone surgical suture has the same fundamental scientific technology as the MINT, absorbable polydioxanone surgical suture, K130191.

4

7. Comparison of technological characteristics with the predicate device

The comparison of features and operation principles between DW-1C, absorbable polydioxanone surgical suture from Dongwon Medical Co., Ltd., and MINT, absorbable polydioxanone surgical suture from HansBiomed Corporation is listed as follows:

| Proprietary | Submission Device | Predicate Device | Substantially
Equivalent or Not
Substantially
Equivalent |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| 510(k) Number | N/A | K130191 | N/A |
| Common Name | Absorbable polydioxanone
surgical suture | Absorbable polydioxanone
surgical suture | Substantially
Equivalent |
| Trade name | DW-1C | MINT™ | N/A |
| Manufacturer | Dongwon Medical Co., Ltd. | HansBiomed Corporation | N/A |
| Product Classification | Absorbable polydioxanone
surgical | Absorbable polydioxanone
surgical | Identical |
| Indication for use | DW-1C comprised of PDO is
indicated for use in soft tissue
approximation where use of
absorbable sutures is
appropriate. | MINT comprised of PDO is
indicated for use in soft
tissue approximation
where use of absorbable
sutures is appropriate. | Identical |
| Raw Material | Polydioxanone suture,
Samyang Corporation | Polydioxanone suture,
Samyang Corporation | Identical |
| Suture Characteristic | Synthetic Absorbable
Monofilament | Synthetic Absorbable
Monofilament | Identical |
| Technique of
Deployment | Needles are not attached | Needles are not attached | Identical |
| Technological
Characteristic | Bi-directional barbs along the
long axis of the suture
monofilament | Bi-directional barbs along the
long axis of the suture
monofilament | Identical |
| Material | Polydioxanone | Polydioxanone | Identical |
| Sterilization | EO gas | EO gas | Identical |
| Size (USP) | 1 | 1 | Identical |
| Absorbable | Absorbable | Absorbable | Identical |
| Patient contact | Implant | Implant | Identical |
| Duration of contact | Over 30 Days | Over 30 Days | Identical |
| Braid/Monofilament | Monofilament | Monofilament | Identical |
| Number of barbs per
linear length of suture | 85 | 82 | Similar |
| Barb shape | Cog shape | Cog shape | Identical |
| Barb size | 0.567mm | 0.601mm | Similar |
| Barb direction | A section and B section are
opposite direction | A section and B section are
opposite direction | Identical |
| Pattern of the barbs | bi-directional barbs along the
long axis of the suture | bi-directional barbs along the
long axis of the suture | Identical |

Substantial equivalence summary

The DW-1C has a substantially equivalent intended use as the identified predicate, MINT comprised of PDO (Polydioxanone) manufactured by HansBiomed corporation and is made of polydioxanone intended for soft tissue approximation. The subject and predicate are composed of the same material (PDO) and

5

have bi-directional barbs, and have the same indications for use.

8. Performance data:

Laboratory testing regarding characteristics was performed on the DW-1C to verify its safety and performance. A biocompatibility assessment was performed on the patient contact materials of DW-1C.

Test Identification	Method	Criteria	Result PASS/FAIL	Report
Cytotoxicity MEM
Elution Method
(Cytotoxicity)	ISO10993-5 Tests
for Cytotoxicity, in
vitro Methods	No evidence
of causing cell lysis
or toxicity to
fibroblast cells	Not Cytotoxic
(PASS)	R-C-R-8400
ISO Guinea Pig
Maximization
Sensitization Test
(Sensitization)	ISO10993-10
Test for Irritation
and sensitization
6.2 Maximization
sensitization test	No delay in dermal
contact sensitization	No evidence SC and
CSO extracts causing
delayed dermal
contact sensitization
(PASS)	R-C-R-8400
ISO Acute
Intracutaneous
Reactivity Study in
the Rabbit
(Intracutaneous Test)	ISO10993-10
Test for Irritation
and sensitization
5.4 Intracutaneous
reactivity test	No irritation	Primary Irritation
Index
Characterization
SC extract = 0.0
CSO extract = 0.0
(PASS)	R-C-R-8400
ISO Systemic Toxicity
Study in Mice
(Acute systemic
toxicity)	ISO10993-11 Tests
for systemic toxicity	No reaction
No Mortality during
this study or
evidence
of systemic toxicity	No Mortality or
Evidence or
Significant Systemic
toxicity
(PASS)	R-C-R-8400
Bacterial Reverse
Mutation study
(Ames test)	ISO 10993-3 Test for
Genotoxicity,
Carcinogenicity and
Reproductive
Toxicity.	Tester strain char
must exhibit
sensitivity to
crystal violet, UV, no
growth biotin plates
and growth
histatine-biotin
plates...number of
mutation revertants
(including
spontaneous
reversions)
statistically
less than negative
control results	The Saline and dimethyl
sulfoxide test article
extracts were considered
to be non-mutagenic to
Salmonella typhimurium
and Escherichia coli
tester strains.
(PASS)	R-C-R-8400
Genotoxicity : In
Vitro Chromosomal
Aberration.	EN ISO 10993-3 Test
for Genotoxicity,
Carcinogenicity and
Reproductive
Toxicity.	Whether the extract
would cause
genotoxicity in
Chinese Hamster
Ovary cells	Not considered genotoxic
(Pass)	R-C-R-8400
Mouse Bone Marrow
Micronucleus	EN ISO 10993-3 Test
for Genotoxicity,
Carcinogenicity and
Reproductive
Toxicity.	No cellular toxicity	Not considered to be
genotoxic (Pass)	R-C-R-8400
4 Week Subchronic
Toxicity	ISO10993-11 Tests
for systemic toxicity	No signs of
behavioral change
or toxicity in rats	No significant evidence of
systemic toxicity from the
subcutaneous	R-C-R-8400
			article into rats.(Pass)
ISO Muscle
Implantation
Study in Rabbits, 12
Weeks
(Implantation)	ISO 10993-6 Test for
Local Effect After
Implantation.	No significant
macroscopic and
microscopic
reactions nonirritant
compared to USP
Negative Control
Implant Material	Macroscopic
reaction for the test
article device was
not significant as
compared to the
USP negative
control implant material
(PASS)	R-C-R-8400

1) Biocompatibility test

6

Based on the above testing results, the DW-1C is biocompatible.

2) Bench (performance) testing

In the following table, the summary of all the bench tests is provided.

| No. | Title | Result summary | File (Protocol/
Report) |
|-----|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 1 | USP 32:2009 Absorbable
Surgical Suture | In vivo absorption of absorbable suture were observed
at 10, 80, 120, 220days after implantation. Absorption
time of MONOSORB was 180-220days | R-C-R-83e |
| 2 | Dimension Test
USP 37-NF 32:2014
Sutures - Diameter | Acceptance Criteria for this testing ±5%
No failed results were performed in any DW-1C during
the performing period. | BTR 15-11 |
| 3 | Tensile Strength
USP 37-NF 32: 2014
Tensile Strength | Acceptance Criteria for this testing Not less than 300gf.
No failed results were performed in any DW-1C during
the performing period. | BTR 15-11 |
| 4 | Holding forces | There was no significant difference between test
samples and reference samples | 16-KE-126 |
| 5 | Weights | The weights of test samples in 1st (G1, Week 2), 2nd (G2 ,
Week 4), 3rd (G3, Week 6), 4th (G4 , Week 8), 5th (G5,
Week 10), 6th (G6, Week 12) and 7th (G7, Week 14)
necropsy groups were statistically significantly lower
than that of the test samples in before implantation
(p