(315 days)
Each non-absorbable suture is used as a surgical suture to support wound closure/soft tissue approximation, with the following indications: Except Steel, each non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures*. *MOPYLEN is also indicated for microsurgery * POLYESTER is also indicated for orthopaedic surgery *RESOLON is also indicated for microsurgery Steel wire is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.
The subject devices are non-absorbable surgical sutures. They are available undyed and dyed. The sutures are supplied sterile, in monofilament, twisted and braided forms in sizes USP 11-0 to 7 (depending on suture type), with or without needles in a variety of cut lengths.
This document is a 510(k) premarket notification for surgical sutures, not an AI/ML device. Therefore, the requested information (acceptance criteria and study details for an AI-powered device) is not present in the provided text.
The document describes traditional medical devices (surgical sutures) and asserts their substantial equivalence to predicate devices based on:
- Intended use
- Material
- Design
- Performance (Diameter, Needle attachment, and Tensile strength)
- Sterilization method
- Biocompatibility evaluation
The performance testing summarized indicates that the sutures meet the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Non-absorbable Sutures. It also mentions biocompatibility evaluation, rabbit pyrogen and LAL testing, and compliance with ASTM F138-13 for steel sutures.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2015
Resorba Medical GmbH Mr. Karl-Josef Beck Quality Assurance/Regulatory Affairs Manager Am Flachmoor 16 Nuremberg, 90475 Germany
Re: K143582
Trade/Device Name: MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLY AMIDE PSEUDO, STEEL Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GAW, MXW, GAP, GAT, GAR, GAQ Dated: September 2, 2015 Received: September 8, 2015
Dear Mr. Beck:
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
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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
- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5.0 TRADITIONAL 510(K) SUMMARY
| Submitted by: | Resorba Medical GmbHAm Flachmoor 1690475 NurembergGermanyTel: +49 9128-9115-0Fax: +49 9128-9115-10 |
|---|---|
| --------------- | ------------------------------------------------------------------------------------------------------------------------ |
Contact Person: Karl-Josef Beck
Date of Summary: 01 September 2015
| Trade Name | Common Name | ClassificationName | RegulationClassification | ProductCode | Classofdevice | Predicatedevice |
|---|---|---|---|---|---|---|
| MOPYLEN® | Non absorbablesuture:Polypropylene | Nonabsorbablepolypropylenesurgical suture | 21 CFR §878.5010 | GAW | II | Premilene,Aesculap,K980703 |
| RESOPREN® | Non absorbablesuture:Polyvinylidenediflouride | Nonabsorbablepolypropylenesurgical suture | 21 CFR §878.5010 | MXW | II | Pronova,Ethicon,K001625 |
| SILK | Non absorbablesuture: Silk | Naturalnonabsorbablesilk surgicalsuture | 21 CFR §878.5030 | GAP | II | Silkam,Aesculap,K990089Secondarypredicate1:RiversilkRiverpointMedicalK100006Secondarypredicate2:WG-SurgicalFoosinMedicalsupplies Inc.K080684 |
| POLYESTER | Non absorbablesuture: Polyester | Nonabsorbablepoly(ethyleneterephthalate)surgical suture | 21 CFR §878.5000 | GAT | II | Cottony II,TevdekK021019 |
| NYLON | Non absorbablesuture: Polyamide | Nonabsorbablepolyamidesurgical suture | 21 CFR §878.5020 | GAR | II | Dermalon,Davis&Geck,K081582 |
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| RESOLON® | Non absorbablesuture: Polyamide | Nonabsorbablepolyamidesurgical suture | 21 CFR §878.5020 | GAR | II | Cardionyl,PromedicaK913102 |
|---|---|---|---|---|---|---|
| POLYAMIDEPSEUDO | Non absorbablesuture: Polyamide | Nonabsorbablepolyamidesurgical suture | 21 CFR §878.5020 | GAR | II | Supramid,S Jackson,K904052Secondarypredicate:Dermalon,Davis&Geck,K981582 |
| STAINLESSSTEEL | Non absorbablesuture: Steel | Stainless Steelsuture | 21 CFR §878.4495 | GAQ | II | Flexon,Davis&Geck,K955723Secondarypredicate1:FerroFibrePontisOrthopaedicsLLCK140127Secondarypredicate 2:Stainless steelmedicalsutureCP Medicalinc.K030351 |
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Device Description: The subject devices are non-absorbable surgical sutures. They are available undyed and dyed. The sutures are supplied sterile, in monofilament, twisted and braided forms in sizes USP 11-0 to 7 (depending on suture type), with or without needles in a variety of cut lengths.
| Description | Primarymaterial | Form | Colour and Colourantfor primary material | Coating | Sizes (USP) |
|---|---|---|---|---|---|
| MOPYLEN | Polypropylene(PP) | Monofilament | Blue(Phthalocyaninato{2})copper | None | 10-0 to 2 |
| RESOPREN | Polyvinylidenediflouride(PVDF) | Monofilament | Blue(Phthalocyaninato{2})copper | None | 8-0 to1 |
| SILK | SilkBombyx Mori L. | Braided | BlackLogwood ExtractWhiteUndyed | Silicone | 10-0 to 6 |
| POLYESTER | Polyester (PET) | Braided | WhiteUndyedGreenD&C Green | None | 7-0 to 7 |
| NYLON | Polyamide6-6.6(PA) | Monofilament | WhiteUndyedBlackLogwood Extract | None | 11.0 to 2 |
| RESOLON | Polyamide6-6.6(PA) | Monofilament | Blue(Phthalocyaninato{2})copper | None | 11-0 to 2 |
| POLYAMIDEPSEUDO | Polyamide6-6.6(PA)With polyamide6 sheath | Monofilamentor twistedwithpolyamidesheath | WhiteUndyed | None | 7-0 to 7 |
| STEEL | Stainless Steel1.4404 - AISI316 L | Monofilamentor twisted | NA | None | 6.0 to 7 |
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| Indication for Use: | Each non-absorbable suture is used as a surgical suture to support woundclosure/soft tissue approximation, with the following indications: |
|---|---|
| Except Steel, each non-absorbable suture is indicated for use in general softtissue approximation and/or ligation including use in cardiovascular,ophthalmic and neurological procedures*. | |
| MOPYLEN is also indicated for microsurgery POLYESTER is also indicated for orthopaedic surgery*RESOLON is also indicated for microsurgery | |
| Steel wire is indicated for use in abdominal wound closure, hernia repair,sternal closure and orthopaedic procedures including cerclage and tendonrepair. | |
| Substantial Equivalence: | Each Non-absorbable suture has the same intended use and similar design,materials, labeling, performance characteristics to their predicate device. |
| Technologicalcharacteristics | Each Non-absorbable suture is substantially equivalent to the predicatedevice listed when compared to the technological characteristics and aresupplied sterile for single use. All meet USP requirements. |
Comparison of technological characteristics to predicate device:
| Intended use | Material | Design | PerformanceDiameter,Needleattachmentand Tensilestrength | Sterilisationmethod | |
|---|---|---|---|---|---|
| MOPYLEN | Intended for usein general softtissueapproximationand/or ligationincluding use incardiovascular,microsurgery,ophthalmic andneurologicalprocedures. | Material:PolypropyleneCoating: NoneDye:(Phthalocyaninato{2})copper | Non-absorbable,monofilament,dyed, uncoated,provided sterilewith or withoutneedles | Meets U.S.P | EthyleneOxide |
| Predicate | Same | Same | Same | Same | Same |
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| RESOPREN | Intended for usein general softtissueapproximationand/or ligationincluding use incardiovascular,ophthalmic andneurologicalprocedures. | Material:PolyvinylidenediflourideCoating: NoneDye:(Phthalocyaninato{2})copper | Non-absorbable,monofilament,dyed, uncoated,provided sterilewith or withoutneedles | Meets U.S.P | EthyleneOxide |
|---|---|---|---|---|---|
| Predicate | Same | Same | Same | Same | Same |
| SILK | Intended for usein general softtissueapproximationand/or ligationincluding use incardiovascular,ophthalmic andneurologicalprocedures. | Material:Silk BombyxMoriCoating:SiliconeDye:LogwoodExtract | Non-absorbable,multifilament,dyed and undyed,coated, providedsterile with orwithout needles | Meets U.S.P | EthyleneOxide |
| Predicate | Same | Same | Same | Same | Gamma |
| EachSecondarypredicate | Same | Same | Same | Same | Same |
| POLYESTER | Intended for usein general softtissueapproximationand/or ligationincluding use incardiovascular,orthopaedic,ophthalmic andneurologicalprocedures. | Material:PolyesterCoating: NoneDye:D&C Green | Non-absorbable,multifilament,dyed and undyed,uncoated,provided sterilewith or withoutneedles | Meets U.S.P | EthyleneOxide |
| Predicate | Same | Same | Same | Same | Same |
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| NYLON | Intended for usein general softtissueapproximationand/or ligationincluding use incardiovascular,ophthalmic andneurologicalprocedures | Material:PolyamideCoating: NoneDye:LogwoodExtract | Non-absorbable,monofilament,dyed and undyed,uncoated,provided sterilewith or withoutneedles | Meets U.S.P | EthyleneOxide |
|---|---|---|---|---|---|
| Predicate | Same | Same | Same | Same | Same |
| RESOLON | Intended for usein general softtissueapproximationand/or ligationincluding use incardiovascular,ophthalmic,microsurgery andneurologicalprocedures. | Material:PolyamideCoating: NoneDye:(Phthalocyaninato{2})copper | Non-absorbable,monofilament,dyed, uncoated,provided sterilewith or withoutneedles | Meets U.S.P | EthyleneOxide |
| Predicate | Same | Same | Same | Same | Same |
| POLYAMIDEPSEUDO | Intended for usein general softtissueapproximationand/or ligationincluding use incardiovascular,ophthalmic andneurologicalprocedures. | Material:PolyamidewithpolyamidesheathCoating: NoneDye: Undyed | Non-absorbable,multifilamentwith sheath ormonofilamentundyed,uncoated,provided sterilewith or withoutneedles | Meets U.S.P | EthyleneOxide |
| Predicate | Intended for usein general softtissueapproximationand/or ligationincluding use inophthalmicprocedures | Same | Same | Same | Same |
| SecondaryPredicate | Same | Same | Similar. | Same | Same |
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| sheath. | |||||
|---|---|---|---|---|---|
| STAINLESSSTEEL | Indicated for usein abdominalwound closure,hernia repair,sternal closureand orthopaedicproceduresincluding cerclageand tendon repair. | Steel 316L | Non-absorbable,monofilament ortwisted, undyed,uncoated,provided sterilewith or withoutneedles | Meets U.S.P | EthyleneOxide |
| Predicate | Same | Same | Same | Same | Gamma |
| EachSecondarypredicate | Same | Same | Same | Same | Same |
Performance Testing Summary:
As per the FDA's Class II Special Control Guidance Document for Surgical Sutures, the devices were subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Non-absorbable Sutures. Testing included:
- . Diameter <861>
- Tensile strength <881>
- Needle attachment <871>
Biocompatibility evaluation has been performed in accordance with ISO 10993-1, sensitization according to ISO 10993-10, implantation according to ISO 10993-6, data has also been leveraged from the supplier for Mopylen and Resopren. Rabbit pyrogen and LAL testing has successfully been performed on each subject device. Steel suture complies with ASTM F138-13. Real-time stability testing has been performed to support shelf life. With this data, an established history of use in non-US markets and results of performance testing it is demonstrated that each Non-absorbable suture meets the current performance requirements for Non-absorbable sutures and that it is substantially equivalent to each corresponding predicate device listed.
Conclusion Based on the information provided within this 510(k) submission, Resorba Medical GmbH concludes that the proposed suture products are substantially equivalent to each corresponding predicate device listed.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.