(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological safety of a surgical suture, with no mention of AI or ML.
No
A therapeutic device intends to treat or cure a disease or condition. This device is a surgical suture used for approximation and ligation of tissues, which is a supportive function during a medical procedure, not a treatment in itself.
No
The device is a surgical suture used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device is a physical surgical suture made of polypropylene, not software.
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 in cardiovascular, and neurological procedures." This describes a device used within the body during surgery to physically hold tissues together.
- Device Description: The description details a "sterile surgical suture composed of a strand of polypropylene." This is a physical material used for surgical procedures.
- 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 text does not mention any testing of biological samples or diagnostic purposes.
Therefore, the Deknatel® Deklene® MAXX™ Polypropylene Surgical Suture is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Deknatel® Deklene® MAXX™ Polypropylene Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, and neurological procedures, but not for use in ophthalmic procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAW
Device Description
Deknatel® Deklene® Maxx™ Polypropylene Suture is a nonabsorbable, sterile surgical suture composed of a strand of polypropylene, a synthetic linear polyolefin. Deknatel® Deklene® MAXX™ Polypropylene Surgical Suture is available dyed (blue) or undyed (colorless).
Deknatel® Deklene® Maxx™ Polypropylene Surgical Suture meets all nonabsorbable surgical suture requirements established by the United States Pharmacopeia (USP) except for suture sizes 7-0 and 8-0 which differ from USP in diameter only.
Deknatel® Deklene® Maxx™ Polypropylene Surgical Suture is available in USP sizes 8-0 through 0. The suture is provided in a variety of lengths, with and without 300 or 400 series stainless steel needles, with and without PTFE felt pledgets, and may be supplied in a variety of cut lengths. Finished suture may be packaged in cartons as single packs, multipacks or procedure packs.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Deknatel® Deklene® Maxx™ Polypropylene Suture is tested in accordance with the requirements of USP – non-absorbable surgical sutures for suture diameter, , tensile strength and needle attachment, and meet the requirements of Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003.
All materials used in the fabrication of the Deknatel® Maxx™ Polypropylene Suture were evaluated through biological qualification safety tests as outlined in ISO 10993-1:2018 – Biological Evaluation of Medical Devices - Part I: Evaluation and Testing.
Deknatel® Deklene® Maxx™ Polypropylene Suture is tested to demonstrate it is "MR Safe" and poses no hazards in an MR environment with any needles removed.
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.
Not Found
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
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.
0
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March 19, 2020
Teleflex Medical Robin Haden Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
Re: K193530
Trade/Device Name: Deklene MAXX Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: December 19, 2019 Received: December 20, 2019
Dear Robin Haden:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193530
Device Name
Deknatel® Deklene® MAXX™ Polypropylene Surgical Suture
Indications for Use (Describe)
Deknatel® Deklene® MAXX™ Polypropylene Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, and neurological procedures, but not for use in ophthalmic procedures.
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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3
510(K) Summary
| Submission Date:
| K193530 | 12/20/2019 |
|---|---|
| SUBMITTER INFORMATION: | |
| Company Name: | Teleflex Medical, Inc. |
| Company Address: | 3015 Carrington Mill Blvd, Morrisville, NC 27560 |
| Contact Person: | Robin Haden |
| Phone: 919-544-8000 | |
| robin.haden@teleflex.com | |
| Device Trade Name: | Deknatel® Deklene® Maxx™ Polypropylene Surgical Suture |
| Device Common Name: | Polypropylene nonabsorbable surgical suture |
| Class: | Class II |
| Classification: | 21 CFR 878.5010 |
| Product Code: | GAW |
Predicate Devices:
The predicate is Deknatel® Deklene® Maxx™ Polypropylene Suture devices cleared under K930738 (July 26, 1994) and K153076 (June 16, 2016).
Device Description:
Deknatel® Deklene® Maxx™ Polypropylene Suture is a nonabsorbable, sterile surgical suture composed of a strand of polypropylene, a synthetic linear polyolefin. Deknatel® Deklene® MAXX™ Polypropylene Surgical Suture is available dyed (blue) or undyed (colorless).
Deknatel® Deklene® Maxx™ Polypropylene Surgical Suture meets all nonabsorbable surgical suture requirements established by the United States Pharmacopeia (USP) except for suture sizes 7-0 and 8-0 which differ from USP in diameter only.
Deknatel® Deklene® Maxx™ Polypropylene Surgical Suture is available in USP sizes 8-0 through 0. The suture is provided in a variety of lengths, with and without 300 or 400 series stainless steel needles, with and without PTFE felt pledgets, and may be supplied in a variety of cut lengths. Finished suture may be packaged in cartons as single packs, multipacks or procedure packs.
4
Intended Use:
Deknatel® Deklene® Maxx™ Polypropylene Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and neurological procedures, but not for use in ophthalmic procedures.
5
Technological Characteristics
The proposed Deknatel® Deklene® Maxx™ Polypropylene Suture is substantially equivalent to its predicate Deknatel® Deklene® Maxx™ Polypropylene Suture devices because there are no differences in technological or performance characteristics between the proposed and predicate devices. The difference between the proposed device and the predicate device is the supplier from which the resin used for extrusion is acquired. The resin from the new supplier is equivalent to that from the current supplier and does not introduce any new issues of safety and effectiveness. The results of the comparison between the technological characteristics of Deknatel® Deklene® Maxx™ Polypropylene Suture manufactured with the proposed and predicate material demonstrate that the proposed Deknatel® Deklene® Maxx™ Polypropylene Sutures are equivalent to the marketed predicate devices in performance characteristics.
Materials
All patient contacting materials are in compliance with the requirements of ISO 10993-1. The proposed modification is replacing the source of the polypropylene resin used to manufacture the Deknatel® Deklene® Maxx™ Polypropylene Suture.
Summary of Testing
Deknatel® Deklene® Maxx™ Polypropylene Suture is tested in accordance with the requirements of USP – non-absorbable surgical sutures for suture diameter, , tensile strength and needle attachment, and meet the requirements of Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003.
All materials used in the fabrication of the Deknatel® Maxx™ Polypropylene Suture were evaluated through biological qualification safety tests as outlined in ISO 10993-1:2018 – Biological Evaluation of Medical Devices - Part I: Evaluation and Testing.
Deknatel® Deklene® Maxx™ Polypropylene Suture is tested to demonstrate it is "MR Safe" and poses no hazards in an MR environment with any needles removed.
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Substantial Equivalence:
The proposed Deknatel® Deklene® Maxx™ Polypropylene Surgical Suture is substantially equivalent in intended use and fundamental scientific technology to the Deknatel® Deklene® Maxx™ Polypropylene Suture devices cleared under K930738 (July 26, 1994) and K153076 (June 16, 2016). The substantial equivalence table for the comparison of the previously cleared devices and the proposed devices is included in the Table below.
| Comparative
Characteristics | Predicate Device
(K153076, K930738) | Proposed Device | Explanation
of Differences |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|--------------------------------------|
| Manufacturer | Teleflex Medical | | Identical |
| Product Code | GAW | | Identical |
| Regulation | 878.5010 | | Identical |
| Device Class | 2 | | Identical |
| Indications for Use | Polypropylene Surgical Sutures are indicated for use in
general soft tissue approximation and/or ligation, including
use in cardiovascular, and neurological procedures, but not for
use in ophthalmic procedures. | | Identical |
| Contraindications | None known. | | Identical |
| Trade Names | Deklene® Maxx™ | | Identical |
| Deklene®
Maxx™ USP
Size | 8-0 to 2 | 8-0 to 0 | Equivalent
within stated
range |
| Suture Diameter | All sizes except 7-0 and 8-0 meet USP requirements
for nonabsorbable surgical suture | | Identical |
| Suture Tensile
Strength | All sizes meet USP requirements for nonabsorbable
surgical suture | | Identical |
| Needle Attachment
Strength | All sizes meet USP requirements for nonabsorbable
surgical suture | | Identical |
| Material | Polypropylene (synthetic linear polyolefin) | | Identical |
| Suture Construction | Monofilament | | Identical |
| Coated | No | | Identical |
| Uncoated | Yes | | Identical |
| Undyed White | Yes | | Identical |
| Dyed Blue with
[phthalocyaninato(2
-)] copper | Yes | | Identical |
| Impregnated PTFE
Pledget | Yes | | Identical |
| Pledget Material | polytetrafluoroethylene (PTFE) | | Identical |
| Needle Material | | 300 or 400 Series Stainless Steel | Identical |
| Package Materials | Solid Sulfite Board (SBS)/ Uncoated Tyvek Pouch | | Identical |
| Sterility Method | Ethylene Oxide (EO);
SAL 10-6 | | Identical |
| Biocompatibility | Per ISO 10993-1 | | Identical |
| Shelf Life | | 5 Years | Identical |
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Clinical Tests Performed:
No clinical trials were conducted
Conclusion:
The proposed Deknatel® Deklene® Maxx™ Polypropylene Suture is substantially equivalent to its predicate Deknatel® Deklene® Maxx™ Polypropylene Suture devices because there are no differences in technological or performance characteristics between the proposed and predicate devices.
The proposed modification is replacing the source of the polypropylene resin used to manufacture the Deknatel® Deklene® Maxx™ Polypropylene Suture. It also has the same design being a sterile, flexible, monofilament nonabsorbable thread meeting the requirements of the United States Pharmacopeia.
The biocompatibility data and the results of performance testing presented, demonstrate the substantial equivalence of Deklene® Maxx™ Polypropylene Suture to that of the predicate devices. It further demonstrates conformance with the USP, ISO 10993 and FDA Guidance for Surgical Suture 510(k).
The new device Deknatel® Deklene® MAXX™ Polypropylene Surgical Suture is substantially equivalent in intended use and fundamental scientific technology to the predicate devices Deknatel® Deklene® Maxx™ Polypropylene Suture cleared under K930738 and K153076.