(246 days)
The DW-1 C comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
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.
The provided text describes Dongwon Medical Co., Ltd.'s DW-1C absorbable polydioxanone surgical suture and its substantial equivalence to the predicate device, MINT. The document primarily focuses on demonstrating the safety and performance of the DW-1C through various tests.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document provides two main tables for performance data: "Biocompatibility test" on page 5 and "Bench (performance) testing" on page 6.
Table: Biocompatibility Test Acceptance Criteria and Results
| Test Identification | Criteria | Reported Device Performance |
|---|---|---|
| Cytotoxicity MEM Elution Method (Cytotoxicity) | No evidence of causing cell lysis or toxicity to fibroblast cells | Not Cytotoxic (PASS) |
| ISO Guinea Pig Maximization Sensitization Test | No delay in dermal contact sensitization | No evidence SC and CSO extracts causing delayed dermal contact sensitization (PASS) |
| ISO Acute Intracutaneous Reactivity Study | No irritation | Primary Irritation Index Characterization SC extract = 0.0 CSO extract = 0.0 (PASS) |
| ISO Systemic Toxicity Study in Mice | No reaction, No Mortality during this study or evidence of systemic toxicity | No Mortality or Evidence or Significant Systemic toxicity (PASS) |
| Bacterial Reverse Mutation study (Ames test) | 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) |
| Genotoxicity: In Vitro Chromosomal Aberration | Whether the extract would cause genotoxicity in Chinese Hamster Ovary cells | Not considered genotoxic (Pass) |
| Mouse Bone Marrow Micronucleus | No cellular toxicity | Not considered to be genotoxic (Pass) |
| 4 Week Subchronic Toxicity | No signs of behavioral change or toxicity in rats | No significant evidence of systemic toxicity from the subcutaneous article into rats. (Pass) |
| ISO Muscle Implantation Study in Rabbits | 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) |
Table: Bench (Performance) Testing Acceptance Criteria and Results
| No. | Title | Criteria | Result Summary |
|---|---|---|---|
| 1 | USP 32:2009 Absorbable Surgical Suture | Implicit criteria based on similar absorbable sutures, no explicit numerical criteria provided | In vivo absorption of absorbable suture were observed at 10, 80, 120, 220 days after implantation. Absorption time of MONOSORB was 180-220 days. |
| 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. |
| 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. |
| 4 | Holding forces | No explicit numerical criteria provided, but implied to be comparable to reference samples. | There was no significant difference between test samples and reference samples. |
| 5 | Weights | Implied criteria would be a expected decrease over time as degradation occurs. | 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). |
| 6 | Biodegradation (absorption rate) | Implied criteria would be a expected increase in biodegradation over time. | 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). |
| 7 | Mechanical property (Tensile strengths) | Implied criteria would be a expected decrease in tensile strength over time, and becoming unmeasurable as degradation completes. | 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. |
| 8 | Endotoxin test | Endotoxin concentration of the test sample is less than 0.1 EU/device. | Endotoxin concentration of the test sample is less than 0.1 EU/device. |
| 9 | Pyrogen test | Implied criteria is absence of pyrogenicity. | There was non-pyrogenicity to the extraction solution. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not explicitly state a specific sample size for each individual test within the "Biocompatibility test" and "Bench (performance) testing" sections. For some tests like "4 Week Subchronic Toxicity" and "ISO Muscle Implantation Study in Rabbits", it mentions rats and rabbits but not the exact number used. For the "Bench (performance) testing," it refers to "test samples" without specifying quantities.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the document describes a physical medical device (surgical suture) and its performance through laboratory and in-vivo animal testing, not an AI/imaging device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reason as point 3. The performance is assessed by standardized laboratory procedures and observation of biological responses, not human expert adjudication of diagnostic findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable as the document describes a physical medical device (surgical suture), not an AI-powered diagnostic or decision support system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a surgical suture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of the surgical suture is established through:
- Standardized Test Methods: Adherence to international standards (ISO 10993, USP monographs) for biocompatibility, physical dimensions, tensile strength, absorption rates, and sterility.
- Biological Responses: Observation of animal models (mice, rabbits, guinea pigs, rats) for cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and implantation reactions.
- Quantitative Measurements: Direct measurements of properties like diameter, tensile strength, weights, and biodegradation levels in a controlled laboratory setting.
8. The sample size for the training set
This section is not applicable, as this is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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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.
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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
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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)
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510(k) Summary
[as required by 807.92(c)]
1. Applicant
-
- Company : Dongwon Medical Co.,Ltd.
-
- Address : 6F-601, 79-1, Mongnyeon-ro 153beon-gil, Gwangsan-gu, Gwangju, Korea
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- Tel : 82-62-430-6521
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- Fax : 82-62-430-6520
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- Contact person : Peter Chung, 412-687-3976
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- Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
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- Submission date : Oct. 17, 2016
2. Device Information
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- Trade Name : DW-1C
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- Common Name : Absorbable polydioxanone surgical suture
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- Classification Name : Suture, Surgical, Absorbable, Polydioxanone
-
- Product Code : NEW
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- Regulation Number : 21 CFR 878.4840
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- Class of device : Class II
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- 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.
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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 | SubstantiallyEquivalent or NotSubstantiallyEquivalent |
|---|---|---|---|
| 510(k) Number | N/A | K130191 | N/A |
| Common Name | Absorbable polydioxanonesurgical suture | Absorbable polydioxanonesurgical suture | SubstantiallyEquivalent |
| Trade name | DW-1C | MINT™ | N/A |
| Manufacturer | Dongwon Medical Co., Ltd. | HansBiomed Corporation | N/A |
| Product Classification | Absorbable polydioxanonesurgical | Absorbable polydioxanonesurgical | Identical |
| Indication for use | DW-1C comprised of PDO isindicated for use in soft tissueapproximation where use ofabsorbable sutures isappropriate. | MINT comprised of PDO isindicated for use in softtissue approximationwhere use of absorbablesutures is appropriate. | Identical |
| Raw Material | Polydioxanone suture,Samyang Corporation | Polydioxanone suture,Samyang Corporation | Identical |
| Suture Characteristic | Synthetic AbsorbableMonofilament | Synthetic AbsorbableMonofilament | Identical |
| Technique ofDeployment | Needles are not attached | Needles are not attached | Identical |
| TechnologicalCharacteristic | Bi-directional barbs along thelong axis of the suturemonofilament | Bi-directional barbs along thelong axis of the suturemonofilament | 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 perlinear 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 areopposite direction | A section and B section areopposite direction | Identical |
| Pattern of the barbs | bi-directional barbs along thelong axis of the suture | bi-directional barbs along thelong 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
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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 MEMElution Method(Cytotoxicity) | ISO10993-5 Testsfor Cytotoxicity, invitro Methods | No evidenceof causing cell lysisor toxicity tofibroblast cells | Not Cytotoxic(PASS) | R-C-R-8400 |
| ISO Guinea PigMaximizationSensitization Test(Sensitization) | ISO10993-10Test for Irritationand sensitization6.2 Maximizationsensitization test | No delay in dermalcontact sensitization | No evidence SC andCSO extracts causingdelayed dermalcontact sensitization(PASS) | R-C-R-8400 |
| ISO AcuteIntracutaneousReactivity Study inthe Rabbit(Intracutaneous Test) | ISO10993-10Test for Irritationand sensitization5.4 Intracutaneousreactivity test | No irritation | Primary IrritationIndexCharacterizationSC extract = 0.0CSO extract = 0.0(PASS) | R-C-R-8400 |
| ISO Systemic ToxicityStudy in Mice(Acute systemictoxicity) | ISO10993-11 Testsfor systemic toxicity | No reactionNo Mortality duringthis study orevidenceof systemic toxicity | No Mortality orEvidence orSignificant Systemictoxicity(PASS) | R-C-R-8400 |
| Bacterial ReverseMutation study(Ames test) | ISO 10993-3 Test forGenotoxicity,Carcinogenicity andReproductiveToxicity. | Tester strain charmust exhibitsensitivity tocrystal violet, UV, nogrowth biotin platesand growthhistatine-biotinplates...number ofmutation revertants(includingspontaneousreversions)statisticallyless than negativecontrol results | The Saline and dimethylsulfoxide test articleextracts were consideredto be non-mutagenic toSalmonella typhimuriumand Escherichia colitester strains.(PASS) | R-C-R-8400 |
| Genotoxicity : InVitro ChromosomalAberration. | EN ISO 10993-3 Testfor Genotoxicity,Carcinogenicity andReproductiveToxicity. | Whether the extractwould causegenotoxicity inChinese HamsterOvary cells | Not considered genotoxic(Pass) | R-C-R-8400 |
| Mouse Bone MarrowMicronucleus | EN ISO 10993-3 Testfor Genotoxicity,Carcinogenicity andReproductiveToxicity. | No cellular toxicity | Not considered to begenotoxic (Pass) | R-C-R-8400 |
| 4 Week SubchronicToxicity | ISO10993-11 Testsfor systemic toxicity | No signs ofbehavioral changeor toxicity in rats | No significant evidence ofsystemic toxicity from thesubcutaneous | R-C-R-8400 |
| article into rats.(Pass) | ||||
| ISO MuscleImplantationStudy in Rabbits, 12Weeks(Implantation) | ISO 10993-6 Test forLocal Effect AfterImplantation. | No significantmacroscopic andmicroscopicreactions nonirritantcompared to USPNegative ControlImplant Material | Macroscopicreaction for the testarticle device wasnot significant ascompared to theUSP negativecontrol implant material(PASS) | R-C-R-8400 |
1) Biocompatibility test
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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 AbsorbableSurgical Suture | In vivo absorption of absorbable suture were observedat 10, 80, 120, 220days after implantation. Absorptiontime of MONOSORB was 180-220days | R-C-R-83e |
| 2 | Dimension TestUSP 37-NF 32:2014 <861>Sutures - Diameter | Acceptance Criteria for this testing ±5%No failed results were performed in any DW-1C duringthe performing period. | BTR 15-11 |
| 3 | Tensile StrengthUSP 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 duringthe performing period. | BTR 15-11 |
| 4 | Holding forces | There was no significant difference between testsamples 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 lowerthan 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, 3rd4th, 5th, 6th and 7th necropsy groups were significantlylower than that of the test samples in beforeimplantation (p<0.001). | 16-KE-126 |
| 7 | Mechanicalproperty (Tensilestrengths) | The tensile strengths of test samples in 3rd, 4th, 5th and6th necropsy groups were significantly lower than that oftest samples in 1st necropsy group (p<0.05, p<0.05,p<0.05 and p<0.01). In case of 7th necropsy groups, thetest samples were degraded into small particles, so itwas not possible to measure the tensile strengths. | 16-KE-126 |
| 8 | Endotoxin test | Endotoxin concentration of the test sample is less than0.1EU/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
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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.
§ 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.