(38 days)
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.
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.
The provided document describes the acceptance criteria and the study that proves the TephaFLEX Braided Suture meets these criteria. Since this is a medical device (suture) and not an AI/ML device, many of the requested fields (e.g., sample size for training set, number of experts, MRMC studies, standalone performance) are not applicable.
Here's the information extracted from the document:
Acceptance Criteria and Device Performance
| Acceptance Criteria / Characteristic | TephaFLEX Braided Suture Performance (Reported Device Performance) |
|---|---|
| Physical/Mechanical Properties | |
| Suture Diameter | Meets USP 33 requirements, except for diameter (specific deviation not precisely quantified, but noted to meet overall criteria). |
| Knot Pull Tensile Strength | Meets USP 33 requirements. |
| Needle Attachment Strength | Meets USP 33 requirements. |
| Biocompatibility | |
| Cytotoxicity | Non-toxic response. |
| Intracutaneous Irritation | Non-toxic response. |
| Sensitization | Non-toxic response. |
| Acute Systemic Toxicity | Non-toxic response. |
| Pyrogenicity | Non-toxic response. |
| Genotoxicity | Non-toxic response. |
| Subcutaneous Implantation (12, 26, 52, 78 weeks) | Non-toxic response. |
| In Vivo Performance | |
| Tensile Strength Retention | Equivalent to the published strength retention of predicate devices with the same clinical indications over the critical healing period. (Specific approximate % strength remaining (BSR) is given for Size 2: "2 - 4 weeks:", "8 - 12 weeks:", "26 weeks:", but the percentages are blank in the table. However, a general statement of equivalence to predicates is made.) |
| Mass Loss Rate | Demonstrated. (Specific rates not detailed, but results supported equivalence.) |
Study Details
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Biocompatibility: Not explicitly stated as "sample size" but involved "12, 26, 52 and 78 week Subcutaneous Implantation studies in rabbits." This implies a cohort of rabbits used over these time points.
- In vivo implantation for strength/mass loss: Conducted in "rabbits." The exact number of rabbits is not specified in the provided text.
- Physical/Mechanical testing: Not specified, but generally follows standardized testing procedures for medical devices.
- Data Provenance: The studies were conducted by Tepha, Inc. and are retrospective in nature, as they involve testing of a manufactured device. The origin of the animal subjects (rabbits) is not specified but is assumed to be within a controlled lab environment.
- Test Set Sample Size:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a medical device (suture) and the assessment criteria are based on standardized physical, mechanical, chemical, and biological tests, rather than expert interpretation of images or clinical data. The "ground truth" is defined by compliance with USP and ISO standards and observed biological responses.
-
Adjudication method for the test set:
- Not Applicable. As the assessment is based on objective laboratory and in vivo testing against established standards, an adjudication method for conflicting expert opinions is not relevant.
-
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:
- Not Applicable. This is a medical device, not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant here.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. There is no algorithm involved; this is a physical medical device.
-
The type of ground truth used:
- Laboratory Testing and Standards Compliance: The ground truth is established by meeting predefined threshold values for physical and mechanical properties as outlined in USP 33 (<861> Suture Diameter, <881> Knot Pull Tensile Strength, and <871> Needle Attachment Strength) and demonstrating non-toxic responses and equivalent in vivo performance according to ISO-10993 for biocompatibility studies and in vivo strength retention studies.
-
The sample size for the training set:
- Not Applicable. This is a medical device for which "training set" is not a relevant concept. The device's characteristics are inherent to its design and manufacturing process, not learned from a dataset.
-
How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
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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 360Lexington, 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: NWJAbsorbable Poly(hydroxybutyrate) Surgical Suture Produced byRecombinant DNA Technology |
| Classification: | According to Section 13 of the Federal Food, Drug and CosmeticAct, the device classification is Class II, Performance Standards. |
| Predicate Devices: | Tepha, Inc., TephaFLEX Absorbable Suture - K052225, K082178Tornier, Inc., BioFiber Suture – K122487, K130422Ethicon, Inc., Perma-Hand Silk Braided Suture - K930360U.S. Surgical (Covidien), Dexon S Suture - K972566Ethicon, Inc., Vicryl Suture - K022269Please see attached Substantial Equivalence table comparingthe TephaFLEX Braided suture to the predicate devices. |
| Device Description: | TephaFLEX suture is a sterile, braided, surgical sutureconstructed of poly-4-hydroxybutyrate (P4HB). The sutureconsists of an inner core of multifilament fibers covered by abraided sheath made of multifilament fibers. The suture isprovided dyed (D&C Violet No. 2) or un-dyed and is offered in avariety of cut lengths, with or without needles attached. |
| Indications for Use: | The TephaFLEX sutures are indicated for use in general softtissue approximation and/or ligation, but not for use incardiovascular or neurological tissues, microsurgery, orophthalmic surgery. |
| Safety and Performance: | All testing was performed in compliance with the FDA Guidance:Class II Special Controls Guidance: AbsorbablePoly(hydroxybutyrate) Surgical Suture Produced by RecombinantDNA Technology. |
SEP 0 5 2013309
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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.
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| Characteristic | Tepha, Inc.TephaFLEX Braided Suture | Tepha, Inc.TephaFLEX Absorbable SutureK052225, K081099, K082178 | Ethicon, Inc., Perma-Hand SilkSutureK930360 | Covidien/US SurgicalDexon Braided SutureK972566 |
|---|---|---|---|---|
| Indications for Use | Indicated for use in softtissue approximationand/or ligation but not foruse in cardiovascular orneurological surgery,microsurgery orophthalmic surgery. | Indicated for use in soft tissueapproximation and/or ligation but notfor use in cardiovascular orneurological surgery, microsurgeryor ophthalmic surgery.These sutures are particularly usefulwhere the combination of anabsorbable suture and extendedwound support (up to six months) isdesirable. | Perma-Hand sutures are indicatedfor use in general soft tissueapproximation and/or ligation,including use in cardiovascular,ophthalmic and neurologicalprocedures. | Braided Dexon S sutures areindicated for use as absorbablesutures in general soft tissueapproximation and/or ligation,including use in ophthalmicprocedures, but not for use incardiovascular or neural tissue. |
| Material | Poly-4-hydroxybutyrate(P4HB) | Poly-4-hydroxybutyrate (P4HB) | Organic fibroin protein derivedfrom domesticated speciesBombyx mor (B. mori). Dyedblack and coated with a specialwax mixture | Composed of the homopolymerof glycolic acid. Coated withPolycaprolate, a co-polymer ofglycoloide and epsilon-caprolactone. |
| Dyed, UndyedFilament Type | Dyed and Un-dyedMultifilament | Dyed and Un-dyedMonofilament | DyedMultifilament | Dyed & Un-dyedMultifilament |
| Size | 2 (various lengths)with or w/out needlesattached | 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 DiameterKnot Pull StrengthNeedle AttachmentStrengthAbsorption Profile | All characteristics meetUSP Requirements,except for diameter.Approximate % Strengthremaining (BSR) | All characteristics meet USPRequirements, except for diameter.Approximate % Strength remaining(BSR): | All characteristics meet USPRequirements, except fordiameter.From IFU | All characteristics meet USPrequirements.Approximate % strengthremaining (BSR): |
| Size 22 - 4 weeks:8 - 12 weeks:26 weeks: | Sizes: 5-0, 4-0 3-0, 2-0 0, 1, 24 weeks: ~60% ~60% ~90%8 weeks: ~30% ~50% ~80%12 weeks: ~20% ~40% ~60%26 weeks: ~0% ~30% ~30% | While silk sutures are notabsorbed, per se, progressivedegradation of the proteinaceoussilk fiber in vivo may result ingradual loss of all of the suture'sstrength 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 essentiallycomplete within 12-18months | Absorption essentially completewithin 12 - 24 months | From Ethicon Wound ClosureManual: | Absorption is essentiallycomplete between 60 and 90days | |
| Packaging | Foil packaging withremovable Tyvek header | Foil packaging with removableTyvek header | Tyvek with foil inner pack | Foil package / Tyvek |
| Sterilization | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Ethylene Oxide (EO) |
| CharacteristicIndications for Use | Table 10 (continued)Ethicon - Vicryl Braided Suture - K022269Coated Vicryl suture is indicated for use in general soft tissueapproximation and/or ligation, including use in ophthalmicprocedures, but not for usue in cardiovascular and neurologicaltissues | Tornier - BioFiber Suture -K122487, K130422Indicated for use in soft tissue approximation and/or ligation but not foruse in cardiovascular or neurological surgery, microsurgery orophthalmic surgery. | ||
| Material | Co-polymer of 90% glycolide and 10% L-lactide. Coating ofequal parts of co-polymer of glycolide and lactide with calciumstearate | 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 DiametorKnot Pull StrengthNeedle AttachmentStrengthAbsorption 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 | |||
| PackagingSterilization | Tyvek with foil inner packEthylene Oxide (EO) | Tyvek with foil inner packEthylene Oxide (EQ) |
Table 10 Table 10 Table 10
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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
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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
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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
§ 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
(a)
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.(b)
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).