(118 days)
PTFE (polytetrafluoroethylene) suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries
The LOOK™ PTFE Suture is a monofilament, synthetic, non-absorbable, sterile surgical suture composed of high-density polytetraflouroethylene (PTFE). PTFE Suture is provided undyed (White).
This document pertains to the 510(k) premarket notification for the LOOK™ PTFE Suture (K160744). The information provided focuses on the substantial equivalence of this device to predicate devices concerning its physical characteristics and biocompatibility, as confirmed through performance and biocompatibility testing. It is not a clinical study of an AI-powered device, therefore, many of the requested elements are not applicable.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the LOOK™ PTFE Suture are based on conformance to the USP (United States Pharmacopeia) monograph for nonabsorbable sutures for tensile strength and needle attachment, as well as adherence to biocompatibility standards.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Testing | ||
| Suture Diameter | Conforms to USP <861> | All acceptance criteria were met at all testing intervals. |
| Needle Attachment | Conforms to USP <871> | All acceptance criteria were met at all testing intervals. |
| Tensile Strength | Conforms to USP <881> | All acceptance criteria were met at all testing intervals. |
| Shelf Life (5 years) | Maintains USP conformance for tensile strength and needle attachment. | All acceptance criteria were met for the entire shelf life. |
| Biocompatibility Testing | ||
| Cytotoxicity | Pass (according to ISO Elution Method) | All acceptance criteria were met. |
| Intracutaneous Reactivity | Pass (according to ISO Intracutaneous Study in Rabbits) | All acceptance criteria were met. |
| Sensitization | Pass (according to ISO Guinea Pig Maximization Sensitization Test) | All acceptance criteria were met. |
| Endotoxin | Pass | All acceptance criteria were met. |
| Pyrogenicity | Pass (according to Material-mediated Rabbit Pyrogen Test) | All acceptance criteria were met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for the performance and biocompatibility testing. The testing was conducted internally by Surgical Specialties Corporation, a company based in Mexico. The studies are non-clinical laboratory performance and biocompatibility tests, not human clinical trials. Thus, the concept of "data provenance" in terms of country of origin of patient data or retrospective/prospective human study is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the studies are non-clinical, laboratory-based tests comparing physical properties and biological reactions against established standards (USP monographs, ISO 10993-1). No human "experts" are establishing a "ground truth" in the diagnostic sense; rather, the "ground truth" is defined by the established regulatory and scientific standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple human readers, not for laboratory performance and biocompatibility testing of a medical device's physical properties.
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
This is not applicable. This document describes a traditional medical device (suture), not an AI-powered device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document describes a physical medical device (suture), not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests were the quantitative specifications defined in the United States Pharmacopeia (USP) monographs for nonabsorbable sutures (specifically USP <861> for diameter, USP <871> for needle attachment, and USP <881> for tensile strength).
The "ground truth" for the biocompatibility tests were the standards and acceptable limits defined in International Standard ISO 10993-1:2009 "Biological Evaluation of Medical devices- Part 1: Evaluation and testing within a risk management process" and the specific test protocols derived from it.
8. The sample size for the training set
This is not applicable. This document describes a traditional medical device (suture), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable since there is no training set for this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2016
Surgical Specialties Corporation Ms. Karen Sanchez Regulatory Affairs Specialist Corredor Tijuana-Rosarito 2000, #24702-B Ejido Francisco Villa Tijuana, B.C., C.P. 22235 Mexico
Re: K160744
Trade/Device Name: LOOKTM PTFE Suture Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture Regulatory Class: Class II Product Code: NBY Dated: June 22, 2016 Received: June 24, 2016
Dear Ms. Sanchez:
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. 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 either 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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)
Device Name LOOK™ PTFE Suture
Indications for Use (Describe)
PTFE (polytetrafluoroethylene) suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5 - 510(k) Summary
| Date Prepared: | June 30, 2016 | ||
|---|---|---|---|
| Company: | Surgical Specialties CorporationCorredor Tijuana-Rosarito 2000#24702-B, Ejido Francisco VillaTijuana, B.C., C.P. 22235, Mexico | ||
| Contact: | Karen SanchezRegulatory Affairs SpecialistPhone: 484-557-4996Fax: 610-404-3905Email: ksanchez@surgicalspecialties.com | ||
| Device trade name: | LOOK™ PTFE Suture | ||
| Device Common Name: | PTFE Nonabsorbable Surgical Sutures | ||
| Device classification: | Non-absorbable expanded polytetrafluoroethylene surgical sutureProduct Code, NBY21 CFR 878.5035Class II | ||
| Legally marketed devices to which the device is substantially equivalent: | K072076 | Cytoplast PTFE Suture | |
| K140415 | MonoTex PTFE Suture | ||
| Description of the device: | The LOOK™ PTFE Suture is a monofilament, synthetic, non-absorbable, sterile surgical suture composed of high-density polytetraflouroethylene (PTFE). PTFE Suture is provided undyed (White). | ||
| Indications for Use: | The LOOK™ PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. |
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Substantial Equivalence:
The LOOK™ PTFE Suture is substantially equivalent to the predicates Cytoplast PTFE suture and MonoTex PTFE Suture in which the basic features and intended uses are the same. Any differences between the LOOK™ PTFE Suture and the predicates are considered minor and do not raise questions concerning safety and effectiveness.
| LOOKTM PTFEBraided Suture | Cytoplast PTFESuture(K072076) | MonoTex PTFESuture(K140415) | |
|---|---|---|---|
| Product Code | NBY | Identical | Identical |
| SutureCharacteristic | Non-absorbableexpandedpolytetrafluoroethylenesurgical suture | Identical | Identical |
| Intended Use | Approximation orligation of soft tissues | Identical | Identical |
| TechnologicalCharacteristic | Monofilament, uncoated,synthetic nonabsorbablesurgical sutures | Identical | Identical |
| Material | High-densitypolytetrafluoroethylene(PTFE) | Identical | Identical |
| Sizes | 2-0, 3-0, 4-0, 5-0, 6-0 in18" lengths | 2-0, 3-0, 4-0 in 18"lengths | Identical to proposeddevice |
| Sterilization | EO | Identical | Identical |
| Packaging | Device wound onto innersupport card, within aTyvek/Poly PrimaryPouch; inside a Tyvek /Poly secondary pouch | Device wound ontoinner support card,within a Tyvek /Poly pouch | Device packaged inracetrack design |
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| Performance tests: | Non-clinical laboratory performance testing was conducted to confirm that theLOOKTM PTFE Suture conforms to the USP monograph for nonabsorbablesutures for tensile strength and needle attachment. This testing was alsoconducted to show that the candidate device is substantially equivalent to thepredicate devices. This testing was performed in accordance with FDA's ClassII Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003.Testing was conducted on the LOOKTM PTFE Suture to establish the deviceexpiration date of five years. This testing was performed on both acceleratedand real-time aged products. Accelerated aging was performed in accordancewith ASTM F1980. The testing of the candidate device was conducted toconfirm that the LOOKTM PTFE Suture conforms to the USP monograph fornonabsorbable sutures for tensile strength and needle attachment for the entireshelf life of the product.Testing performed on the LOOKTM PTFE Suture included the following:• Diameter per USP <861>• Needle Attachment per USP <871>;• Tensile Strength per USP <881>;All of the acceptance criteria were met at all testing intervals. |
|---|---|
| BiocompatibilityTesting | Biocompatibility testing for the LOOKTM PTFE Suture was conducted inaccordance with the International Standard ISO 10993-1:2009 "BiologicalEvaluation of Medical devices- Part 1: Evaluation and testing within a riskmanagement process". A Biological Risk Assessment was conducted for thetesting recommended per ISO 10993-1:2009. As a function of the riskassessment, a subset of biocompatibility testing was performed to ensurecompliance of the candidate device.Per ISO 10993-1:2009, the LOOKTM PTFE Suture is classified as an implant,permanent contact (>30 days) with tissue/bone.Assessments of the candidate device included the following:• Biological Risk Assessment• Cytotoxicity Study Using the ISO Elution Method• ISO Intracutaneous Study in Rabbits• ISO Guinea Pig Maximization Sensitization Test• Endotoxin Test• Material-mediated Rabbit Pyrogen TestAll of the acceptance criteria were met. |
| Summary | The results of the testing demonstrate that the LOOKTM PTFE Suture issubstantially equivalent in safety and performance to the predicate devices. |
§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
(a)
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.