(38 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a surgical suture, with no mention of AI or ML technologies.
No.
The device is a surgical suture used for approximation and/or ligation of soft tissue, which is a supportive rather than a therapeutic function.
No.
The device description and intended use clearly state that TephaFLEX suture is used for "general soft tissue approximation and/or ligation," which are surgical procedures, not diagnostic ones. The performance studies focus on mechanical properties and biocompatibility, not the detection or diagnosis of conditions.
No
The device description clearly states it is a sterile, braided, surgical suture constructed of poly-4-hydroxybutyrate (P4HB), which is a physical material, not software. The performance studies also focus on physical and mechanical properties of the suture.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation." This describes a surgical procedure performed on the body, not a test performed outside the body on a sample.
- Device Description: The device is a "sterile, braided, surgical suture." This is a physical implant used during surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a surgical tool used to repair tissue.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NWJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Physical/mechanical testing performed on the TephaFLEX suture verified conformance to USP 33 for absorbable surgical sutures, including Suture Diameter, Knot Pull Tensile Strength, and 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Approximate % Strength remaining (BSR):
Size 2
2 - 4 weeks:
8 - 12 weeks:
26 weeks:
Absorption essentially complete within 12-18 months
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K052225, K082178, K122487, K130422, K930360, K972566, K022269
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 Suture Diameter, Knot Pull Tensile Strength, and 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
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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
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