(90 days)
Not Found
Not Found
No
The document describes a physical surgical suture and its material properties and testing, with no mention of software, algorithms, or AI/ML terms.
No
The device, TephaFLEX absorbable sutures, is indicated for general soft tissue approximation and/or ligation. This is a surgical tool used to close wounds or join tissues, which falls under the category of a surgical accessory or an implant, not a therapeutic device designed to treat a disease or condition actively.
No.
The device, TephaFLEX sutures, is described as being used for "general soft tissue approximation and/or ligation," which are therapeutic and surgical functions, not diagnostic ones. The performance studies also focus on physical properties and biocompatibility, not on detecting or identifying medical conditions.
No
The device description clearly states it is a physical surgical suture made of poly-4-hydroxybutyrate, which is a hardware component.
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 directly on a patient's body.
- Device Description: The device is a "sterile, monofilament, absorbable surgical suture." This is a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVDs are used to perform tests on samples taken from the body, while this device is a surgical tool used within the body.
N/A
Intended Use / 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.
Product codes
NWJ
Device Description
TephaFLEX sutures are sterile, monofilament, absorbable surgical sutures 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.
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
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Summary of Performance Studies
Physical testing was performed on the TephaFLEX sutures to USP 28, including Suture Diameter, Suture Needle Attachment, 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.
Key Metrics
Not Found
Predicate Device(s)
Tepha, Inc., TephaFLEX Absorbable Suture, ENTrigue Surgical, Inc., BioElast™ Absorbable suture, Ethicon, Inc., PDS II Absorbable Suture
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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K082178
P-1 of 1
Image /page/0/Picture/1 description: The image shows the logo for TEPHA MEDICAL DEVICES. The word "TEPHA" is in large, bold, sans-serif font. Below it, "MEDICAL DEVICES" is in a smaller, sans-serif font. To the left of the word "TEPHA" is a black graphic element that appears to be an abstract shape.
OCT 3 � 2005
99 Hayden Avenue Suite 360 Lexington, MA 02421 tel: (781) 357-1700
fax: (781) 357-1701
Section X Summary of Safety and Effectiveness
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, Inc. |
| 99 Hayden Avenue, Suite 360 | |
| Lexington, MA 02421 | |
| Device Classification Name: | CFR §878.4494 |
| Absorbable Poly(hydroxybutyrate) Surgical Suture | |
| 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 |
| ENTrigue Surgical, Inc., BioElast™ Absorbable suture | |
| Ethicon, Inc., PDS II Absorbable Suture | |
| Device Description: | TephaFLEX sutures are sterile, monofilament, |
| absorbable surgical sutures 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. | |
| Safety and Performance: | Physical testing was performed on the TephaFLEX |
| sutures to USP 28, including Suture Diameter, | |
| Suture Needle Attachment, 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. | |
| Conclusion: | Based on the indications for use, technological |
| characteristics, and safety and performance testing, the | |
| TephaFLEX Absorbable Suture has been shown to be | |
| substantially equivalent to predicate devices under the | |
| Federal 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, with its wings spread and stylized in a flowing, ribbon-like design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tepha Medical Devices, Inc. % Ms. Mary P. LeGraw V.P. Regulatory Affairs 99 Hayden Avenue, Suite 360 Lexington, Massachussetts 02421
OCT 3 0 2008
Re: K082178 Trade/Device Name: TephaFLEX® Absorbable Suture Regulation Number: 21 CFR 878.4494 Regulation Name: Absorbable poly (hydroxybutyrate) surgical suture produced by recombinant DNA technology. Regulatory Class: II Product Code: NWJ Dated: July 31, 2008 Received: August 1. 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
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Page 2 - Ms. Mary P. LeGraw
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. 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 Devicc 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. Millikan
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)
Page 1 of 1
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Division S Division of General, Restorative, and Neurological Devices
510(k) Num or $K_{0} 8^{2}17f$