(90 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 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.
Here's an analysis of the provided text regarding the TephaFLEX Absorbable Suture, addressing your requested information:
Analysis of Acceptance Criteria and Study for TephaFLEX® Absorbable Suture (K082178)
This document describes a 510(k) submission for a medical device (TephaFLEX® Absorbable Suture), which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel efficacy through a clinical trial with specific acceptance criteria in the context of AI/diagnostic devices. Therefore, many of your requested points regarding AI device studies are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (an absorbable surgical suture), the "acceptance criteria" are typically defined by recognized standards and benchmarks for physical properties and biocompatibility. The "reported device performance" refers to the results of testing against these standards.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Physical Properties | USP 28 <861> Suture Diameter: To ensure consistent thread width and proper surgical handling. | Performed; Conformed to USP 28 standards. |
| USP 28 <871> Suture Needle Attachment: To evaluate the secureness of the suture to the needle, preventing detachment during surgery. | Performed; Conformed to USP 28 standards. | |
| USP 28 <881> Tensile Strength: To measure the breaking strength of the suture, ensuring it can withstand surgical tension during approximation and ligation. | Performed; Conformed to USP 28 standards. | |
| Biocompatibility | ISO 10993 (Biocompatibility): A series of standards evaluating the biological response to medical devices, ensuring the material is not toxic, allergenic, or otherwise harmful to tissue. | Performed; Conformed to ISO 10993 standards (e.g., cytotoxicity, sensitization, irritation, systemic toxicity). |
| In Vivo Performance | Implant Studies (Tensile Strength Loss Rate): To demonstrate the rate at which the suture loses its strength over time when implanted in living tissue, which is critical for absorbable sutures. | Performed; Demonstrated acceptable rates of tensile strength loss in vivo. |
| Implant Studies (Mass Loss Rate): To demonstrate the rate at which the suture material is absorbed and degrades in living tissue. | Performed; Demonstrated acceptable rates of mass loss in vivo. | |
| Substantial Equivalence | Comparison to Predicate Devices (TephaFLEX Absorbable Suture, ENTrigue Surgical BioElast™ Absorbable Suture, Ethicon PDS II Absorbable Suture): Demonstrated that the device has similar indications for use, technological characteristics, and safety and performance as legally marketed predicate devices. | Concluded to be substantially equivalent based on testing and characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (number of sutures, number of animal subjects) used for each individual test. It generally states that "Physical testing was performed" and "Animal testing was performed."
- Data Provenance:
- Country of Origin: Not explicitly stated, but assumed to be from studies conducted under US regulatory oversight for submission to the FDA.
- Retrospective or Prospective: These types of tests (physical and animal implant studies) are generally considered prospective experiments specifically designed and conducted to evaluate the device against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not directly applicable to the evaluation of a surgical suture in this context. The "ground truth" for suture performance is established by:
- Standards bodies: (e.g., USP, ISO) defining the acceptable limits for physical properties.
- Industry best practices and scientific understanding: Guiding the design and interpretation of biocompatibility and in-vivo degradation studies.
- Qualified laboratory personnel and veterinarians/researchers: Conducting the tests and evaluating the results against established scientific protocols. No specific "experts" for ground truth adjudication in the sense of image interpretation for AI are mentioned.
4. Adjudication Method for the Test Set
Not applicable. This concept (e.g., 2+1, 3+1 for clinical disagreement) is relevant to studies involving human interpretation or clinical outcomes where there might be subjectivities. For physical and animal tests, the results are typically quantitative and objective measurements or histological assessments compared directly against predetermined criteria, not subject to adjudication in this manner.
5. 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 device is a surgical suture, not an AI diagnostic or assistance device. Therefore, no MRMC study involving human readers and AI assistance was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical surgical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this device evaluation is primarily:
- Standardized Measurement: Quantitative results from physical tests (e.g., suture diameter, tensile strength) compared against USP 28 specifications.
- Histopathological and Clinical Observation: For biocompatibility and implant studies, assessing tissue response, inflammation, strength loss, and mass loss over time based on established biological and pathological criteria.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of evaluating a physical medical device like a surgical suture. This concept applies to machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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K082178
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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 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 sutures are sterile, monofilament,absorbable surgical sutures constructed of poly-4-hydroxybutyrate. The TephaFLEX sutures are indicatedfor use in general soft tissue approximation and/orligation, but not for use in cardiovascular or neurologicaltissues, 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 forconformance to ISO 10993 for biocompatibility andimplant studies were conducted to demonstrate rates oftensile strength and 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 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)
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Division S Division of General, Restorative, and Neurological Devices
510(k) Num or $K_{0} 8^{2}17f$
§ 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).