Who is the manufacturer of TEPHAFLEX BRAIDED SUTURE?

Tepha, Inc. filed the 510(k) submission for TEPHAFLEX BRAIDED SUTURE (K132348).

What is the FDA product code for TEPHAFLEX BRAIDED SUTURE?

NWJ. It is classified under 21 CFR 878.4494 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for TEPHAFLEX BRAIDED SUTURE?

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

What are the predicate devices for TEPHAFLEX BRAIDED SUTURE?

TephaFLEX Absorbable Suture (K052225, K082178); BioFiber Suture (K122487, K130422); Perma-Hand Silk Braided Suture (K930360); Dexon S Suture (K972566); Vicryl Suture (K022269).

Who can help prepare an FDA 510(k) submission like TEPHAFLEX BRAIDED SUTURE?

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.

TEPHAFLEX BRAIDED SUTURE

K132348 · Tepha, Inc. · NWJ · Sep 5, 2013 · General, Plastic Surgery

Device Facts

Record ID	K132348
Device Name	TEPHAFLEX BRAIDED SUTURE
Applicant	Tepha, Inc.
Product Code	NWJ · General, Plastic Surgery
Decision Date	Sep 5, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4494
Device Class	Class 2
Attributes	Therapeutic

Intended Use

TephaFLEX braided sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Device Story

TephaFLEX Braided Suture is a sterile, absorbable surgical suture composed of poly-4-hydroxybutyrate (P4HB). The device features a multifilament inner core covered by a braided multifilament sheath. It is available in dyed (D&C Violet No. 2) or undyed forms, with or without attached needles. Used by surgeons for soft tissue approximation and ligation, the suture provides extended wound support. The device is absorbed in vivo over time, with strength retention profiles comparable to predicate absorbable sutures. Clinical benefit includes secure tissue approximation during the healing period followed by gradual absorption, reducing the need for suture removal. The device is provided sterile for clinical use.

Clinical Evidence

No human clinical trials were conducted. Evidence consists of bench testing and in vivo animal studies. Bench testing confirmed compliance with USP 33 standards for diameter, knot pull tensile strength, and needle attachment. Biocompatibility testing (ISO 10993) included cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity, genotoxicity, and subcutaneous implantation in rabbits (12-78 weeks), showing non-toxic responses. In vivo rabbit studies demonstrated tensile strength retention and mass loss rates equivalent to predicate devices.

Technological Characteristics

Material: Poly-4-hydroxybutyrate (P4HB). Construction: Braided multifilament sheath over multifilament core. Sterilization: Ethylene Oxide (EO). Compliance: USP 33 (diameter, knot pull strength, needle attachment), ISO 10993 (biocompatibility). Packaging: Foil with Tyvek header.

Indications for Use

Indicated for general soft tissue approximation and/or ligation. Contraindicated for cardiovascular, neurological, microsurgery, or ophthalmic procedures.

Regulatory Classification

Identification

An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).

Predicate Devices

TephaFLEX Absorbable Suture (K052225, K082178)
BioFiber Suture (K122487, K130422)
Perma-Hand Silk Braided Suture (K930360)
Dexon S Suture (K972566)
Vicryl Suture (K022269)

Related Devices

K122487 — BIOFIBER SYTURE · Tornier, Inc. · Sep 17, 2012
K082178 — TEPHAFLEX ABSORBABLE SUTURE · Tepha, Inc. · Oct 30, 2008
K130422 — PHANTOM FIBER BIOFIBER SUTURE · Tornier, Inc. · Apr 4, 2013
K081099 — TEPHAFLEX ABSORBABLE SUTURE · Tepha, Inc. · Jul 15, 2008
K072470 — BIOELAST 5-0 SUTURE, MODEL 500100 · Entrigue Surgical, Inc. · Nov 16, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ K132348 page 1/4 Image /page/0/Picture/1 description: The image shows the logo for TEPHA Medical Devices. The logo features a stylized black graphic element above the text. The text "TEPHA" is in large, bold, sans-serif font, with "MEDICAL DEVICES" in a smaller font size below it. 99 Hayden Avenue Suite 360 Lexington, MA 02421 tel: (781) 357-1700 fax: (781) 357-1701 #### Section X 510(k) Summary (Prepared on July 26, 2013) Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Tepha, Inc. is submitting the following summary of information respecting safety and effectiveness: | Trade Name: | TephaFLEX Braided Suture | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | Tepha, Inc. 99 Hayden Avenue, Suite 360 Lexington, MA 02421 | | Contact Person: | Mary P. LeGraw, V.P., Regulatory Affairs | | Telephone: | 781-357-1709 | | Fax: | 781-357-1701 | | Email: | legraw@tepha.com | | Device Classification Name: | CFR §878.4494 - Product Code: NWJ Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology | | Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the device classification is Class II, Performance Standards. | | Predicate Devices: | Tepha, Inc., TephaFLEX Absorbable Suture - K052225, K082178 Tornier, Inc., BioFiber Suture – K122487, K130422 Ethicon, Inc., Perma-Hand Silk Braided Suture - K930360 U.S. Surgical (Covidien), Dexon S Suture - K972566 Ethicon, Inc., Vicryl Suture - K022269 Please see attached Substantial Equivalence table comparing the TephaFLEX Braided suture to the predicate devices. | | Device Description: | TephaFLEX suture is a sterile, braided, surgical suture constructed of poly-4-hydroxybutyrate (P4HB). The suture consists of an inner core of multifilament fibers covered by a braided sheath made of multifilament fibers. The suture is provided dyed (D&C Violet No. 2) or un-dyed and is offered in a variety of cut lengths, with or without needles attached. | | Indications for Use: | The TephaFLEX sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery, or ophthalmic surgery. | | Safety and Performance: | All testing was performed in compliance with the FDA Guidance: Class II Special Controls Guidance: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology. | SEP 0 5 2013309 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for TEPHA MEDICAL DEVICES. The logo features a stylized swoosh above the word "TEPHA" in large, bold, sans-serif font. Below "TEPHA" are the words "MEDICAL DEVICES" in a smaller, sans-serif font. The logo is black and white. K132348 page 2/4 99 Hayden Avenue Suite 360 Lexington, MA 02421 tel: (781) 357-1700 fax: (78) 357-1701 Physical/mechanical testing performed on the TephaFLEX suture verified conformance to USP 33 for absorbable surgical sutures, including <861> Suture Diameter, <881> Knot Pull Tensile Strength, and <871> Needle Attachment Strength. Testing was also performed for conformance to ISO-10993 for biocompatibility. Tepha performed Cytotoxicity, Intracutaneous Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, and 12, 26, 52 and 78 week Subcutaneous Implantation studies in rabbits. All testing yielded a non-toxic response. In vivo implantation studies were conducted in rabbits to demonstrate rates of tensile strength and mass loss. Results show the in vivo strength retention of the TephaFLEX braided suture to be equivalent to the published strength retention of the predicate devices with the same clinical indications over the critical healing period. Therefore, the TephaFLEX braided suture is equivalent to the predicate device in regard to its strength retention profile. Conclusion: Based on the indications for use, technological characteristics, and the results of safety and performance testing described above, the TephaFLEX braided suture has been shown to be substantially equivalent to predicate devices used for the same clinical indications under the Federal Food, Drug and Cosmetic Act. 310 {2}------------------------------------------------ | Characteristic | Tepha, Inc. TephaFLEX Braided Suture | Tepha, Inc. TephaFLEX Absorbable Suture K052225, K081099, K082178 | Ethicon, Inc., Perma-Hand Silk Suture K930360 | Covidien/US Surgical Dexon Braided Suture K972566 | |----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Indicated for use in soft tissue approximation and/or ligation but not for use in cardiovascular or neurological surgery, microsurgery or ophthalmic surgery. | Indicated for use in soft tissue approximation and/or ligation but not for use in cardiovascular or neurological surgery, microsurgery or ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six months) is desirable. | Perma-Hand sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. | Braided Dexon S sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. | | Material | Poly-4-hydroxybutyrate (P4HB) | Poly-4-hydroxybutyrate (P4HB) | Organic fibroin protein derived from domesticated species Bombyx mor (B. mori). Dyed black and coated with a special wax mixture | Composed of the homopolymer of glycolic acid. Coated with Polycaprolate, a co-polymer of glycoloide and epsilon- caprolactone. | | Dyed, Undyed Filament Type | Dyed and Un-dyed Multifilament | Dyed and Un-dyed Monofilament | Dyed Multifilament | Dyed & Un-dyed Multifilament | | Size | 2 (various lengths) with or w/out needles attached | 5-0 through 2 (various lengths) with or w/out needies attached | 9-0 through 5 (various lengths) with or w/out needles attached | 8-0 through 2 (various lengths) | | Suture Diameter Knot Pull Strength Needle Attachment Strength Absorption Profile | All characteristics meet USP Requirements, except for diameter. Approximate % Strength remaining (BSR) | All characteristics meet USP Requirements, except for diameter. Approximate % Strength remaining (BSR): | All characteristics meet USP Requirements, except for diameter. From IFU | All characteristics meet USP requirements. Approximate % strength remaining (BSR): | | | Size 2 2 - 4 weeks: 8 - 12 weeks: 26 weeks: | Sizes: 5-0, 4-0 3-0, 2-0 0, 1, 2 4 weeks: ~60% ~60% ~90% 8 weeks: ~30% ~50% ~80% 12 weeks: ~20% ~40% ~60% 26 weeks: ~0% ~30% ~30% | While silk sutures are not absorbed, per se, progressive degradation of the proteinaceous silk fiber in vivo may result in gradual loss of all of the suture's strength over time. | 2 weeks (6-0 and larger): ~65% 3 weeks (6-0 and larger): ~35% 2 weeks (7-0 and smaller): ~55% 3 weeks (7-0 and smaller): ~20% | | | Absorption essentially complete within 12-18 months | Absorption essentially complete within 12 - 24 months | From Ethicon Wound Closure Manual: | Absorption is essentially complete between 60 and 90 days | | Packaging | Foil packaging with removable Tyvek header | Foil packaging with removable Tyvek header | Tyvek with foil inner pack | Foil package / Tyvek | | Sterilization | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Ethylene Oxide (EO) | | Characteristic Indications for Use | Table 10 (continued) Ethicon - Vicryl Braided Suture - K022269 Coated Vicryl suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for usue in cardiovascular and neurological tissues | | Tornier - BioFiber Suture -K122487, K130422 Indicated for use in soft tissue approximation and/or ligation but not for use in cardiovascular or neurological surgery, microsurgery or ophthalmic surgery. | | | Material | Co-polymer of 90% glycolide and 10% L-lactide. Coating of equal parts of co-polymer of glycolide and lactide with calcium stearate | | Poly-4-hydroxybutyrate (P4HB) | | | Dyed, Undyed | Dyed & Un-dyed | | Dyed & Un-dyed | | | Filament Typo | Multifilament | | Multifilament | | | Size | 6-0 though 3 (various lengths) with or without needles attached | | 2 (various lengths), with or w/out needles attached | | | Suture Diametor Knot Pull Strength Needle Attachment Strength Absorption Profile | All characteristics meet USP requirements, except for diameter | | All characteristics meet USP Requirements, except for diameter | | | | Approximate % Strength remaining (BSR): 2 weeks: ~75% 3 weeks (6-0 and larger): ~50% 3 weeks (7-0 and larger): ~40% 4 weeks (6-0 and larger): ~25% Absorption is essentially complete between 56 and 70 days | | Approximate % Strength remaining (BSR) 2 - 4 weeks: ~60% 8-12 weeks: ~40% 26 weeks: ~20% Absorption essentially complete within 18-24 months | | | Packaging Sterilization | Tyvek with foil inner pack Ethylene Oxide (EO) | | Tyvek with foil inner pack Ethylene Oxide (EQ) | | Table 10 Table 10 Table 10 到新闻 - --- 1 . K132348 page 3/4 {3}------------------------------------------------ . . : K132348 page 4/4 . 312 名田 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 5, 2013 Tepha, Incorporated Ms. Marv P. LeGraw Vice President, Regulatory Affairs 99 Hayden Avenue. Suite 360 Lexington. Massachusetts 02421 Re: K132348 Trade/Device Name: Tephal-LEX Braided Suture Regulation Number: 21 CFR 878.4494 Regulation Name: Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology Regulatory Class: Class II Product Code: NWJ Dated: July 26, 2013 Received: July 29, 2013 Dear Ms. LeGraw: 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 10 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 cither 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 {5}------------------------------------------------ Page 2 - Ms. Mary P. LeGraw 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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, # Mark N. Melkerson -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ### Indications for Use 510(k) Number (if known): Not Assigned Device Name: TephaFLEX Braided Suture ## Indications for Use: TephaFLEX braided sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. Prescription Use: X (21 CFR 801 Subpart D) AND/OR Over-The-Counter (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 /C ## David Krause -S (Division Sign-Off) Division of Surgical Devices 510(k) Number: K132348