Who is the manufacturer of MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL?

Resorba Medical GmbH filed the 510(k) submission for MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL (K143582).

What is the FDA product code for MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL?

GAW. It is classified under 21 CFR 878.5010 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL?

Premilene (K980703); Pronova (K001625); Silkam (K990089); Riversilk (K100006); WG-Surgical (K080684); Cottony II (K021019); Dermalon (K081582); Cardionyl (K913102); Supramid (K904052); Dermalon (K981582); Flexon (K955723); FerroFibre (K140127); Stainless steel medical suture (K030351).

Who can help prepare an FDA 510(k) submission like MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL

K143582 · Resorba Medical GmbH · GAW · Oct 29, 2015 · General, Plastic Surgery

Device Facts

Record ID	K143582
Device Name	MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL
Applicant	Resorba Medical GmbH
Product Code	GAW · General, Plastic Surgery
Decision Date	Oct 29, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.5010
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

Non-absorbable surgical sutures; used for soft tissue approximation/ligation; available in monofilament, twisted, or braided forms; supplied sterile with or without needles. Materials include polypropylene, PVDF, silk, polyester, polyamide, and stainless steel. Operated by surgeons in clinical settings (OR). Sutures provide mechanical support to wound sites; facilitate healing by holding tissue edges together. Benefits include secure wound closure and reduced risk of dehiscence.

Clinical Evidence

Bench testing only. Compliance with USP monographs for non-absorbable sutures (diameter, tensile strength, needle attachment). Biocompatibility testing per ISO 10993-1, 10993-10, and 10993-6. Rabbit pyrogen and LAL testing performed. Real-time stability testing supports shelf life.

Technological Characteristics

Materials: Polypropylene, PVDF, Silk (Bombyx Mori L.), Polyester (PET), Polyamide 6-6.6, Stainless Steel (AISI 316L/ASTM F138-13). Forms: Monofilament, twisted, or braided. Sizes: USP 11-0 to 7. Sterilization: Ethylene Oxide. Meets USP requirements for synthetic non-absorbable sutures.

Indications for Use

Indicated for general soft tissue approximation/ligation in cardiovascular, ophthalmic, and neurological procedures. MOPYLEN/RESOLON also for microsurgery; POLYESTER also for orthopaedic surgery. Steel indicated for abdominal wound closure, hernia repair, sternal closure, and orthopaedic procedures (cerclage/tendon repair).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Premilene (K980703)
Pronova (K001625)
Silkam (K990089)
Riversilk (K100006)
WG-Surgical (K080684)
Cottony II (K021019)
Dermalon (K081582)
Cardionyl (K913102)
Supramid (K904052)
Dermalon (K981582)
Flexon (K955723)
FerroFibre (K140127)
Stainless steel medical suture (K030351)

Related Devices

K221767 — Surgical Sutures with or without Needle · Huaian Seamen Medical Technology Co., Ltd. · Jul 31, 2023
K091574 — SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES · Supplidores Unidos Internacionales, S.A. · Oct 9, 2009
K160623 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture · M/s. Meril Endo Surgery Private Limited. · May 31, 2016
K100006 — HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED · Riverpoint Medical · May 10, 2010
K172149 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture · M/s. Meril Endo Surgery Private Limited. · Oct 20, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three faces overlapping to create a sense of depth and community. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a PDF portfolio icon with the Adobe logo on the cover. Below the icon, there is a message that reads, "For the best experience, open this PDF portfolio in Acrobat X or Adobe Reader X, or later." A button labeled "Get Adobe Reader Now!" is located beneath the message. The image is designed to encourage users to open the PDF portfolio using the recommended software for optimal viewing. {3}------------------------------------------------ ## 5.0 TRADITIONAL 510(K) SUMMARY | Submitted by: | Resorba Medical GmbH Am Flachmoor 16 90475 Nuremberg Germany Tel: +49 9128-9115-0 Fax: +49 9128-9115-10 | |---------------|------------------------------------------------------------------------------------------------------------------------| |---------------|------------------------------------------------------------------------------------------------------------------------| Contact Person: Karl-Josef Beck Date of Summary: 01 September 2015 | Trade Name | Common Name | Classification Name | Regulation Classification | Product Code | Class of device | Predicate device | |------------|-----------------------------------------------------------|---------------------------------------------------------------------|------------------------------|-----------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | MOPYLEN® | Non absorbable suture: Polypropylene | Nonabsorbable polypropylene surgical suture | 21 CFR §878.5010 | GAW | II | Premilene, Aesculap, K980703 | | RESOPREN® | Non absorbable suture: Polyvinylidene diflouride | Nonabsorbable polypropylene surgical suture | 21 CFR §878.5010 | MXW | II | Pronova, Ethicon, K001625 | | SILK | Non absorbable suture: Silk | Natural nonabsorbable silk surgical suture | 21 CFR §878.5030 | GAP | II | Silkam, Aesculap, K990089 Secondary predicate1: Riversilk Riverpoint Medical K100006 Secondary predicate2: WG-Surgical Foosin Medical supplies Inc. K080684 | | POLYESTER | Non absorbable suture: Polyester | Nonabsorbable poly(ethylene terephthalate) surgical suture | 21 CFR §878.5000 | GAT | II | Cottony II, Tevdek K021019 | | NYLON | Non absorbable suture: Polyamide | Nonabsorbable polyamide surgical suture | 21 CFR §878.5020 | GAR | II | Dermalon, Davis&Geck, K081582 | {4}------------------------------------------------ | RESOLON® | Non absorbable suture: Polyamide | Nonabsorbable polyamide surgical suture | 21 CFR §878.5020 | GAR | II | Cardionyl, Promedica K913102 | |---------------------|-------------------------------------|-----------------------------------------------|------------------|-----|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | POLYAMIDE PSEUDO | Non absorbable suture: Polyamide | Nonabsorbable polyamide surgical suture | 21 CFR §878.5020 | GAR | II | Supramid, S Jackson, K904052 Secondary predicate: Dermalon, Davis&Geck, K981582 | | STAINLESS STEEL | Non absorbable suture: Steel | Stainless Steel suture | 21 CFR §878.4495 | GAQ | II | Flexon, Davis&Geck, K955723 Secondary predicate1: FerroFibre Pontis Orthopaedics LLC K140127 Secondary predicate 2: Stainless steel medical suture CP Medical inc. K030351 | {5}------------------------------------------------ ## 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 | Primary material | Form | Colour and Colourant for primary material | Coating | Sizes (USP) | |---------------------|------------------------------------------------------|-----------------------------------------------------------|----------------------------------------------|----------|-------------| | MOPYLEN | Polypropylene (PP) | Monofilament | Blue (Phthalocyaninato{2}) copper | None | 10-0 to 2 | | RESOPREN | Polyvinylidene diflouride (PVDF) | Monofilament | Blue (Phthalocyaninato{2}) copper | None | 8-0 to1 | | SILK | Silk Bombyx Mori L. | Braided | Black Logwood Extract White Undyed | Silicone | 10-0 to 6 | | POLYESTER | Polyester (PET) | Braided | White Undyed Green D&C Green | None | 7-0 to 7 | | NYLON | Polyamide 6-6.6(PA) | Monofilament | White Undyed Black Logwood Extract | None | 11.0 to 2 | | RESOLON | Polyamide 6-6.6(PA) | Monofilament | Blue (Phthalocyaninato{2}) copper | None | 11-0 to 2 | | POLYAMIDE PSEUDO | Polyamide 6-6.6(PA) With polyamide 6 sheath | Monofilament or twisted with polyamide sheath | White Undyed | None | 7-0 to 7 | | STEEL | Stainless Steel 1.4404 - AISI 316 L | Monofilament or twisted | NA | None | 6.0 to 7 | {6}------------------------------------------------ | Indication for Use: | 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. | | Substantial Equivalence: | Each Non-absorbable suture has the same intended use and similar design, materials, labeling, performance characteristics to their predicate device. | | Technological characteristics | Each Non-absorbable suture is substantially equivalent to the predicate device listed when compared to the technological characteristics and are supplied sterile for single use. All meet USP requirements. | Comparison of technological characteristics to predicate device: | | Intended use | Material | Design | Performance Diameter, Needle attachment and Tensile strength | Sterilisation method | |-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------------------------| | MOPYLEN | Intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, microsurgery, ophthalmic and neurological procedures. | Material: Polypropylene Coating: None Dye: (Phthalocyani nato{2}) copper | Non-absorbable, monofilament, dyed, uncoated, provided sterile with or without needles | Meets U.S.P | Ethylene Oxide | | Predicate | Same | Same | Same | Same | Same | {7}------------------------------------------------ | RESOPREN | Intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures. | Material: Polyvinylidene diflouride Coating: None Dye: (Phthalocyani nato{2}) copper | Non-absorbable, monofilament, dyed, uncoated, provided sterile with or without needles | Meets U.S.P | Ethylene Oxide | |--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------|-------------------| | Predicate | Same | Same | Same | Same | Same | | SILK | Intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures. | Material: Silk Bombyx Mori Coating: Silicone Dye: Logwood Extract | Non-absorbable, multifilament, dyed and undyed, coated, provided sterile with or without needles | Meets U.S.P | Ethylene Oxide | | Predicate | Same | Same | Same | Same | Gamma | | Each Secondary predicate | Same | Same | Same | Same | Same | | POLYESTER | Intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, orthopaedic, ophthalmic and neurological procedures. | Material: Polyester Coating: None Dye: D&C Green | Non-absorbable, multifilament, dyed and undyed, uncoated, provided sterile with or without needles | Meets U.S.P | Ethylene Oxide | | Predicate | Same | Same | Same | Same | Same | {8}------------------------------------------------ | NYLON | Intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures | Material: Polyamide Coating: None Dye: Logwood Extract | Non-absorbable, monofilament, dyed and undyed, uncoated, provided sterile with or without needles | Meets U.S.P | Ethylene Oxide | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------------| | Predicate | Same | Same | Same | Same | Same | | RESOLON | Intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, microsurgery and neurological procedures. | Material: Polyamide Coating: None Dye: (Phthalocyani nato{2}) copper | Non-absorbable, monofilament, dyed, uncoated, provided sterile with or without needles | Meets U.S.P | Ethylene Oxide | | Predicate | Same | Same | Same | Same | Same | | POLYAMIDE PSEUDO | Intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures. | Material: Polyamide with polyamide sheath Coating: None Dye: Undyed | Non-absorbable, multifilament with sheath or monofilament undyed, uncoated, provided sterile with or without needles | Meets U.S.P | Ethylene Oxide | | Predicate | Intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures | Same | Same | Same | Same | | Secondary Predicate | Same | Same | Similar. | Same | Same | {9}------------------------------------------------ | | | | sheath. | | | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-----------------------------------------------------------------------------------------------------------------------|-------------|-------------------| | STAINLESS STEEL | Indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair. | Steel 316L | Non-absorbable, monofilament or twisted, undyed, uncoated, provided sterile with or without needles | Meets U.S.P | Ethylene Oxide | | Predicate | Same | Same | Same | Same | Gamma | | Each Secondary predicate | 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.