(89 days)
TephaFLEX absorbable 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, monofilament, absorbable surgical suture constructed of poly-4-hydroxybutyrate. 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.
The provided text describes the TephaFLEX® Absorbable Suture and its premarket notification (K081099). However, it does not include information about a study proving the device meets acceptance criteria in the context of an AI/ML device. The document details the device's classification, predicate devices, description, and indications for use, focusing on its physical and biological properties.
The "Safety and Performance" section states: "Physical testing was performed on the TephaFLEX sutures to USP 28, including <861> Suture Diameter, <871> Suture Needle Attachment, <881> Tensile Strength. Animal testing was performed for conformance to ISO 10993 for biocompatibility and implant studies were conducted to demonstrate rates of tensile strength and mass loss."
This describes the types of tests conducted, but not an "acceptance criteria and reported device performance" table in the format typically used for AI/ML device evaluation, nor does it refer to a study using sample sizes, ground truth established by experts, or MRMC studies.
Therefore, I cannot provide the requested information for an AI/ML device as it is not present in the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for TEPHA Medical Devices. The logo has a black swoosh above the word TEPHA. Below TEPHA is the text MEDICAL DEVICES.
99 Hayden Avenue Suite 360 Lexington, MA 02421 tel: (781) 357-1700
fax: (781) 357-1701
Section X Summary of Safety and Effectiveness
JUL 1 5 2008
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® Absorbable Suture |
|---|---|
| Sponsor: | Tepha Medical Devices, Inc.99 Hayden Avenue, Suite 360Lexington, MA 02421 |
| Device Classification Name: | CFR §878.4494Absorbable Poly(hydroxybutyrate) Surgical Suture |
| Classification: | According to Section 13 of the Federal Food, Drug andCosmetic Act, the device classification is Class II,Performance Standards. |
| Predicate Devices: | Tepha, Inc., TephaFLEX Absorbable SutureENTrigue Surgical, Inc., BioElast™ Absorbable sutureEthicon, Inc., PDS II Absorbable Suture |
| Device Description: | TephaFLEX suture is a sterile, monofilament, absorbablesurgical suture constructed of poly-4-hydroxybutyrate.The TephaFLEX sutures are indicated for use in generalsoft tissue approximation and/or ligation, but not for usein cardiovascular or neurological tissues, microsurgery,or ophthalmic surgery. |
| Safety and Performance: | Physical testing was performed on the TephaFLEXsutures to USP 28, including <861> Suture Diameter,<871> Suture Needle Attachment, <881> TensileStrength. Animal testing was performed for conformanceto ISO 10993 for biocompatibility and implant studieswere conducted to demonstrate rates of tensile strengthand mass loss. |
| Conclusion: | Based on the indications for use, technologicalcharacteristics, and safety and performance testing, theTephaFLEX Absorbable Suture has been shown to besubstantially equivalent to predicate devices under theFederal Food, Drug and Cosmetic Act. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tepha Medical Devices, Inc. % Ms. Mary P. LeGraw VP, Regulatory Affairs 99 Hayden Avenue Lexington, Massachusetts 02421
JUL 1 5 2008
Rc: K081099
Trade/Device Name: TephaFLEX® Absorbable Suture Regulation Number: 21 CFR 878.4494 Regulation Name: Absorbable poly(hydroxybutyrate) surgical suturc Regulatory Class: II Product Code: NWJ Dated: June 13, 2008 Received: July 13, 2008
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 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Mary P. LcGraw
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Milburn
Mark N. Melkerson Director Division of General, Restorative and Neurological 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® Absorbable Suture
Indications for Use:
TephaFLEX absorbable 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)
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NNN
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K081095
§ 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).