(127 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a surgical suture, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a surgical suture used for approximation and ligation of soft tissues, which is a medical device but not inherently a therapeutic device in the sense of actively treating a disease or condition through non-invasive or pharmacological means. It is used in surgical procedures to facilitate healing rather than providing therapy itself.
No
Explanation: The device is a surgical suture used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical, synthetic suture made of polyethylene, 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, including use with allograft tissue for orthopedic procedures." This describes a surgical device used directly on the patient's body for mechanical purposes.
- Device Description: The description details a "synthetic, sterile, flat braided suture composed of dyed and un-dyed, non-absorbable polyethylene." This is a physical material used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of biological samples or diagnostic purposes.
Therefore, PERMATAPE™ Suture is a surgical suture, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PERMATAPE™ Suture is indicated for use in general soft tissue approximation, and/or ligation, including use with allograft tissue for orthopedic procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
PERMATAPE™ Suture is a synthetic, sterile, flat braided suture composed of dyed and un-dyed, non-absorbable polyethylene.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
PERMATAPE™ Suture's performance was tested per USP Tensile Strength for Surgical Sutures and follows FDA's Special Controls Guidance document for Surgical Sutures, however, it does not conform to USP Diameter and size classification due to its flat braiding. The proposed device met requirement of bacterial endotoxin testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads facing right, representing the department's focus on health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2016
Medos International Sarl % Ms. Tatyana Korsunsky Depuy Mitek, A Johnson And Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K162247
Trade/Device Name: Permatape Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: November 14, 2016 Received: November 15, 2016
Dear Ms. Korsunsky:
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 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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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,
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) K162247
Device Name PERMATAPE™
Indications for Use (Describe)
PERMATAPE Suture is indicated for use in general soft tissue approximation, and/or ligation, including use with allograft tissue for orthopedic procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY PERMATAPE™ SUTURE
Date Prepared: 08/08/2016
| Submitter's
Name and
Address | Medos International SARL
Chemin-Blanc 38, Le Locle Neuchatel
CH 2400, Switzerland |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tatyana Korsunsky
Regulatory Affairs Project Lead
DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA |
| Name of
Medical Device | Proprietary Name: PERMATAPE™ SUTURE
Classification Name: Polyethylene, suture, nonabsorbable, synthetic (21 CFR 878.5000)
Common Name: Suture |
| Substantial
Equivalence
Predicate
Devices | The PERMATAPE™ SUTURE is substantially equivalent to:
K040004: ORTHOCORD® Suture (DePuy Mitek) Reference Devices: K130814: RIGIDLOOP™ Cortical Fixation system (DePuy Mitek) K141259: Gryphon™ Anchor with Permacord™ (DePuy Mitek) K150438: Smith & Nephew ULTRATAPE (Smith & Nephew) |
| Device
Description | PERMATAPE™ Suture is a synthetic, sterile, flat braided suture composed of dyed and un-dyed, non-absorbable polyethylene. |
| Indications for
Use | PERMATAPE™ Suture is indicated for use in general soft tissue approximation, and/or ligation, including use with allograft tissue for orthopedic procedures. |
| Technological
Characteristics
and
Performance | The proposed PERMATAPE™ is a non-absorbable surgical suture. The determination of substantial equivalence for this device was based on a detailed device description, performance data, and conformance to consensus and voluntary standards.
PERMATAPE™ Suture is similar in intended use, materials, sterilization method to the |
| | Telephone: 508-828-3122
Facsimile: 508-977-6911
e-mail: tkorsuns@its.jnj.com |
Traditional 510(k) – PERMATAPE™ Suture
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predicate DePuy Mitek's ORTHOCORD® (K040004) suture. Its polyethylene material is also comparable to reference predicates DePuy Mitek's RIGIDLOOP™ Cortical Fixation system (K130814) and Gryphon™ Anchor with Permacord™ (K141259). PERMATAPE™ is a flat type of suture, similar to reference predicate Smith & Nephew's ULTRATAPE (K150438).
PERMATAPE™ Suture's performance was tested per USP Tensile Strength for Surgical Sutures and follows FDA's Special Controls Guidance document for Surgical Sutures, however, it does not conform to USP Diameter and size classification due to its flat braiding. The proposed device met requirement of bacterial endotoxin testing.
Based on the similarities of the intended use, materials, technological characteristics and USP Tensile testing, the PERMATAPE™ suture has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.