← Product Code [NEW](/productcode/NEW) · K160761 # DW-1C (K160761) _Dongwon Medical Co., Ltd. · NEW · Nov 22, 2016 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K160761 ## Device Facts - **Applicant:** Dongwon Medical Co., Ltd. - **Product Code:** [NEW](/productcode/NEW.md) - **Decision Date:** Nov 22, 2016 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4840 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## 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. ## Device Story DW-1C is a synthetic, absorbable, monofilament surgical suture composed of polydioxanone (PDO). The device features bi-directional barbs along the long axis of the monofilament, allowing for tissue approximation without the need for surgical knots. The suture is dyed with D&C Violet No. 2 and is provided sterile via ethylene oxide (EO) gas. It is intended for use by surgeons for soft tissue approximation. The barbs embed into the tissue upon placement, providing holding force. The device degrades or dissolves over time in the body. It is a mechanical implant device used in clinical settings. ## Clinical Evidence Bench testing only. Biocompatibility testing (ISO 10993) included cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, genotoxicity (Ames, chromosomal aberration, micronucleus), and 12-week muscle implantation. Performance testing included USP 32/37-NF 32 monographs for diameter, tensile strength, and absorption. In vivo absorption observed at 10-220 days. Holding forces, biodegradation rates, and mechanical properties were evaluated, showing no significant differences from reference samples and meeting all acceptance criteria. ## Technological Characteristics Synthetic absorbable monofilament suture; material: polydioxanone (PDO); bi-directional cog-shaped barbs; EO gas sterilization; USP size 1; implantable; duration of contact >30 days. ## Regulatory 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 - MINT ([K130191](/device/K130191.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 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}------------------------------------------------ ## 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 : 82-62-430-6521 - 4) Fax : 82-62-430-6520 - 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 <861>
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
<881>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<0.001). | 16-KE-126 | | 6 | Biodegradation
(absorption rate) | The biodegradation levels of test samples in 1st, 2nd, 3rd
4th, 5th, 6th and 7th necropsy groups were significantly
lower than that of the test samples in before
implantation (p<0.001). | 16-KE-126 | | 7 | Mechanical
property (Tensile
strengths) | The tensile strengths of test samples in 3rd, 4th, 5th and
6th necropsy groups were significantly lower than that of
test samples in 1st necropsy group (p<0.05, p<0.05,
p<0.05 and p<0.01). In case of 7th necropsy groups, the
test samples were degraded into small particles, so it
was not possible to measure the tensile strengths. | 16-KE-126 | | 8 | Endotoxin test | Endotoxin concentration of the test sample is less than
0.1EU/device. | CT16-074111 | | 9 | Pyrogen test | There was non-pyrogenicity to the extraction solution. | CT16074112 | ## Safety and performance Testing was performed per FDA's Class II Special Controls Guidance Document : Surgical Sutures, including testing in accordance with the USP monograph for absorbable sutures, in vitro and in vivo resorption testing, biocompatibility testing in accordance with ISO 10993, and a barb holding strength evaluation. Holding forces, Weights, Biodegradation (absorption rate), Mechanical property (Tensile strengths), Endotoxin test and Pyrogen test were performed. No failed results were noted in any product evaluations. The test results satisfied all the acceptance {7}------------------------------------------------ criteria. ### 9. Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification MINT™ comprised of PDO(Polydioxanone) (K130191) concludes that the DW-1C is substantially equivalent to predicate device as described herein. --- **Source:** [https://fda-staging.innolitics.com/device/K160761](https://fda-staging.innolitics.com/device/K160761) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com