(201 days)
No
The device description and performance studies focus on the physical properties and performance of surgical sutures, with no mention of AI or ML.
Yes.
The device is a surgical suture used for tissue approximation and ligation in various medical procedures, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a surgical suture used for approximation and/or ligation of soft tissue. Its intended use is to mechanically join or hold tissues together, not to diagnose a condition or disease.
No
The device description clearly states it is a physical surgical suture made of polyester fibers, available in various configurations with or without needles and pledgets. It is a tangible medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general soft tissue approximation and/or ligation" and various surgical procedures. This describes a device used in vivo (within the body) during surgery.
- Device Description: The description details a surgical suture made of polyester fibers, designed to physically hold tissue together. This is a mechanical function performed directly on the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical tool used in vivo.
N/A
Intended Use / Indications for Use
Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.
TEVDEK® II NextStitch® and 'silky' II POLYDEK® NextStitch® cardiovascular valve suture are indicated for use for soft tissue approximation and/or ligation in cardiovascular valve replacement procedures.
Deknatel Polyester Surgical Sutures (i.e. Dacron®, Polydek, and Tevdek) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
The Deknatel® Polyester Surgical Suture is a non-absorbable surgical suture composed of twisted or braided Polyethylene Terephthalate fibers. Deknatel® Polyester Surgical Suture is available undyed (white) or dyed (green) and is offered in a variety of cut lengths, with or without needles, and with or without pledgets. Product labeling carries the following specific information on the suture: material (including color, number and length of sutures in the package); USP size (diameter, including any difference in diameter); the number, profile and size of any attached needles; and the number, size and density of pre-attached pledgets.
The Deknatel® Polyester Surgical Suture meets all nonabsorbable surgical suture requirements established by the United States Pharmacopeia (USP) for tensile strength, diameter and needle attachment, except for suture size 7-0 which differs from USP in diameter only.
Deknatel® Polyester Surgical Suture is available in USP sizes 7-0 to 9 in the following configurations:
- . 'cottony' II: Uncoated (Not PTFE impregnated)
- "silky II" or Polydek®: Lightly coated (PTFE impregnated) .
- Tevdek® II: Heavily coated (more PTFE impregnated than "silky")) .
The Deknatel® Polyester Surgical Sutures are also available in the following product-specific configurations with or without needles, and with or without pledgets:
- Surgical Suture Tape as uncoated 'cottony' II in flat braid sizes of 1/8", 1mm, 2 mm, ● 3mm, 4mm and 5mm.
- . NextStitch® Cardiovascular Valve Suture is comprised of "silky" II POLYDEK and/or TEVDEK II polyester suture. NextStitch is a continuous chain of linked sutures designed to provide an alternative suturing technique for cardiovascular valve replacement procedures. NextStitch Sutures are available in USP Sizes 4-0, 3-0, 2-0 and 0 (metric sizes 1.5 through 3.5).
- Readi-Cut TEVDEK® II Bulk Non-Sterile Polyester Surgical Suture is bulk, non-● sterile Tevdek® II polyester suture available in USP Size 2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, cardiovascular, ophthalmic, orthopedic, neurological
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)
Non-clinical testing has been conducted in accordance with USP (United States Pharmacopeia) 40-NF 35 Sutures – Diameter, Sutures- Needle Attachment, and Tensile Strength in order to verify the new polyester suture resin and polytetrafluoroethylene (PTFE) coating of the proposed Deknatel Polyester Surgical Sutures are substantially equivalent to the predicate devices in performance Additional non-clinical testing was conducted to confirm substantial equivalence with regards to stability, MR safety and biocompatibility (per ISO 10993-1).
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
March 30, 2020
Teleflex Medical Robin Haden Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
Re: K192490
Trade/Device Name: Tevdek II, "Silky" II Polydek, 'Cottony' II, NextStitch Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: February 21, 2020 Received: February 24, 2020
Dear Ms. 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 (OS) 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 medical devices and radiation-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) K192490
Device Name
"silky" II POLYDEK®, 'cottony' II, TEVDEK® II Polyester Surgical Suture
Indications for Use (Describe)
Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K192490
Device Name
'cottony' II Polyester Surgical Suture Tape
Indications for Use (Describe)
Polyester Surgical Suture Tapes are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K192490
Device Name
TEVDEK® II NextStitch® and "silky" II POLYDEK® NextStitch® Cardiovascular Valve Suture
Indications for Use (Describe)
TEVDEK® II NextStitch® and 'silky' II POLYDEK® NextStitch® cardiovascular valve suture are indicated for use for soft tissue approximation and/or ligation in cardiovascular valve replacement 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) SUMMARY
Deknatel® Polyester Surgical Suture
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560
Phone: 919-544-8000 919-433-3914 Fax:
B. Contact Person
Robin Haden Surgical Business Unit Tel – (919) 433-8046 Fax - (919) 433-3914 Email – robin.haden@teleflex.com
C. Date Prepared
March 18, 2020
D. Device Name
| Trade Name(s) | Deknatel® Polyester Surgical Sutures, including: | ||
|---|---|---|---|
| – "silky" II POLYDEK® Polyester Surgical Suture | |||
| – 'cottony' II Polyester Surgical Suture and Tape | |||
| – TEVDEK® II Polyester Surgical Suture | |||
| – TEVDEK® II NextStitch® Cardiovascular Valve Suture | |||
| – "silky" II POLYDEK® NextStitch® Cardiovascular | |||
| Valve Suture | |||
| Product Code | GAT (Suture, Nonabsorbable, Synthetic, Polyethylene) | ||
| Regulation | 21 CFR 878.5000 | ||
| Classification Name | Nonabsorbable poly(ethylene terephthalate) surgical suture |
6
E. Device Description
The Deknatel® Polyester Surgical Suture is a non-absorbable surgical suture composed of twisted or braided Polyethylene Terephthalate fibers. Deknatel® Polyester Surgical Suture is available undyed (white) or dyed (green) and is offered in a variety of cut lengths, with or without needles, and with or without pledgets. Product labeling carries the following specific information on the suture: material (including color, number and length of sutures in the package); USP size (diameter, including any difference in diameter); the number, profile and size of any attached needles; and the number, size and density of pre-attached pledgets.
The Deknatel® Polyester Surgical Suture meets all nonabsorbable surgical suture requirements established by the United States Pharmacopeia (USP) for tensile strength, diameter and needle attachment, except for suture size 7-0 which differs from USP in diameter only.
Deknatel® Polyester Surgical Suture is available in USP sizes 7-0 to 9 in the following configurations:
- . 'cottony' II: Uncoated (Not PTFE impregnated)
- "silky II" or Polydek®: Lightly coated (PTFE impregnated) .
- Tevdek® II: Heavily coated (more PTFE impregnated than "silky")) .
The Deknatel® Polyester Surgical Sutures are also available in the following productspecific configurations with or without needles, and with or without pledgets:
- Surgical Suture Tape as uncoated 'cottony' II in flat braid sizes of 1/8", 1mm, 2 mm, ● 3mm, 4mm and 5mm.
- . NextStitch® Cardiovascular Valve Suture is comprised of "silky" II POLYDEK and/or TEVDEK II polyester suture. NextStitch is a continuous chain of linked sutures designed to provide an alternative suturing technique for cardiovascular valve replacement procedures. NextStitch Sutures are available in USP Sizes 4-0, 3-0, 2-0 and 0 (metric sizes 1.5 through 3.5).
- Readi-Cut TEVDEK® II Bulk Non-Sterile Polyester Surgical Suture is bulk, non-● sterile Tevdek® II polyester suture available in USP Size 2.
F. Indications for Use and Contraindications
Sterile Deknatel® Polyester Suture, previously cleared under K153076 and K153089. carries the following indications and contraindications:
"silky" II POLYDEK®, 'cottony' II, TEVDEK® II Polyester Surgical Suture and Tape
Indications:
Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.
7
Contraindications: None known.
TEVDEK® II NextStitch® and "silky" II POLYDEK® NextStitch® Cardiovascular Valve Suture
Indications:
TEVDEK II NextStitch and "silky" II POLYDEK NextStitch cardiovascular valve suture are indicated for use for soft tissue approximation and/or ligation in cardiovascular valve replacement procedures.
Contraindications: None known.
Non-sterile Deknatel® Polyester Suture, previously cleared under K930739, carries the following indications and contraindications:
READI-CUT TEVDEK® II Non-Sterile Polyester Surgical Suture
Indications:
Deknatel Polyester Surgical Sutures (i.e. Dacron®, Polydek, and Tevdek) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
Contraindications: None known.
G. Substantial Equivalence
The proposed Deknatel Polyester Surgical Suture is substantially equivalent to the predicate devices cleared below:
| Predicate Device | Manufacturer | 510(k) | Clearance
Date |
|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------|-------------------|
| "silky" II POLYDEK, 'cottony' II,
TEVDEK II, NextStitch, DEKLENE
II, DEKLENE MAXX Gabbay-Frater,
NYLON, SILK, STAINLESS STEEL | Teleflex Medical,
Inc. | K153076 | June 16, 2016 |
| 'cottony' II Polyester Suture Tape | Teleflex Medical,
Inc. | K153089 | July 15, 2016 |
8
The following reference device information is included to support the inclusion of the nonsterile Deknatel® Polyester Surgical Suture. The proposed non-sterile device is substantially equivalent to the reference non-sterile Deknatel® Polyester Surgical Suture cleared below:
| Reference Device | Manufacturer | 510(k) | Clearance Date |
|---|---|---|---|
| SUTURES POLYPROP., | |||
| POLYETHYLENE, NYLON & SILK | Teleflex Medical, | ||
| Inc. | K930739 | July 26, 1994 |
H. Comparison To Predicate Devices
The proposed sterile Deknatel® Polyester Surgical Suture is substantially equivalent in intended use and fundamental scientific technology to the Deknatel® Polyester Surgical Suture predicate devices cleared under K153076 on June 16, 2016 and K153089 on July 15, 2016. The proposed non-sterile Deknatel® Polyester Surgical Suture is substantially equivalent in intended use and fundamental scientific technology to the non-sterile Deknatel® Polyester Surgical Suture devices cleared under reference K930739 on July 26, 1994. Nonclinical testing on functionality, stability, biocompatibility, and MR safety was conducted to confirm that the supplier changes did not negatively impact device performance. The testing results concluded that the only difference between the subject and predicate sutures are the sources for the PET resin and the PTFE impregnation/dispersion coating materials.
The following tables contain the technological characteristics of the proposed devices in comparison to the predicate and reference devices.
| Comparative
Characteristics | Predicate Device | Proposed Device | Explanation
of Differences |
|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|---------------------------------------------|
| Manufacturer | Teleflex Medical | | Identical |
| 510(k) Number | K153076, K153089 | K192490 | N/A |
| Product Code | GAT | | Identical |
| Regulation | 878.5000 | | Identical |
| Device Class | 2 | | Identical |
| Indications for
Use
('cottony' II,
"silky" II
POLYDEK,
TEVDEK II
Sutures) | Polyester Surgical Sutures are indicated for use in general soft
tissue approximation and/or ligation, including use in
cardiovascular, ophthalmic, orthopedic and neurological
procedures. | | Identical |
| Comparative
Characteristics | Predicate Device | Proposed Device | Explanation
of Differences |
| Indications for
Use
('cottony' II
Suture Tapes) | Polyester Surgical Suture Tapes are indicated for use in general
soft tissue approximation and/or ligation, including use in
cardiovascular, ophthalmic, orthopedic and neurological
procedures. | | Identical |
| Indications for
Use
(NextStitch) | TEVDEK II NextStitch and "silky" II POLYDEK NextStitch
cardiovascular valve suture are indicated for use for soft tissue
approximation and/or ligation in cardiovascular valve
replacement procedures. | | Identical |
| Contraindications | | None known. | Identical |
| Trade Names | "silky" II POLYDEK®
'cottony' II, TEVDEK® II, NextStitch® | | Identical |
| USP Size
('cottony' II,
"silky" II
POLYDEK,
TEVDEK II) | 9-0 to 9 | 7-0 to 9 | Equivalent,
within cleared
size range |
| USP Size
(NextStitch) | 4-0 to 0 | | Equivalent |
| Size
'cottony II'
Suture Tape | 1/8", 1mm, 2mm, 3mm, 4mm, 5mm | | Equivalent |
| Suture Diameter | All sizes meet USP requirements for nonabsorbable
surgical suture except tape which does not conform to USP
Diameter | | 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 | Polyester
[Poly(ethylene terephthalate)] | | Identical |
| Suture
Construction | Braided | | Identical |
| Impregnated/Coat
ed | Yes ("silky" II POLYDEK or TEVDEK II) with
Polytetrafluoroethylene | | Identical |
| Uncoated | Yes ('cottony' II) | | Identical |
| Undyed White | Yes | | Identical |
| D&C Green No. 6 | Yes | | Identical |
| Co-braid
(White/Green) | Yes | | Identical |
| Impregnated | Yes | | Identical |
| Comparative
Characteristics | Predicate Device | Proposed Device | Explanation
of Differences |
| PTFE Pledget | | | |
| 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 |
Substantial Equivalence Summary Table (Sterile Product)
9
10
Substantial Equivalence Summary Table (Non-Sterile Product)
| Comparative
Characteristics | Reference Device | Proposed Device | Explanation
of Differences |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------------------|
| Manufacturer | Teleflex Medical | Teleflex Medical | Identical |
| 510(k) Number | K930709 | K192490 | N/A |
| Product Code | GAT | GAT | Identical |
| Regulation | 878.5000 | 878.5000 | Identical |
| Device Class | 2 | 2 | Identical |
| Indications for
Use
TEVDEK® II | Polyester Surgical Sutures are indicated for use in general soft
tissue approximation and/or ligation, including use in
cardiovascular, ophthalmic, and neurological procedures. | | Identical |
| Contraindications | None known. | | Identical |
| Trade Names | TEVDEK® II | | Identical |
| USP Size
TEVDEK® | 2 | | Identical |
| Suture Diameter | All sizes meet USP requirements for nonabsorbable
surgical suture except tape which does not conform to USP
Diameter | | 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 | Polyester
[Poly(ethylene terephthalate)] | | Identical |
| Suture
Construction | Braided | | Identical |
| Impregnated/Coat
ed | Polytetrafluoroethylene | | Identical |
| D&C Green No. 6 | Yes | | Identical |
| Package Materials | Solid Sulfite Board (SBS)/ Uncoated Tyvek Pouch | | Identical |
| Sterility Method | N/A- Sold Non-Sterile | | Identical |
11
| Comparative
Characteristics | Reference Device | Proposed Device | Explanation
of Differences |
|--------------------------------|-----------------------|-----------------|-------------------------------|
| Biocompatibility | Per ISO 10993-1 | | Identical |
| Shelf Life | N/A- Sold Non-Sterile | | Identical |
12
I. Materials
All patient contacting materials are in compliance with ISO10993-1. The proposed modification is replacing the source of the polyester resin and polytetrafluoroethylene (PTFE) coating used to manufacture the Deknatel® Polyester Surgical Sutures.
J. Technological Characteristics
A comparison of the technological characteristics of the proposed Deknatel® Polyester Surgical Suture and the predicate has been performed. The results of this comparison demonstrate that the Deknatel Polyester Surgical Sutures are equivalent to the marketed predicate devices in performance, stability, biocompatibility and MR safety characteristics.
K. Performance Data
Non-clinical testing has been conducted in accordance with USP (United States Pharmacopeia) 40-NF 35 Sutures – Diameter, Sutures- Needle Attachment, and Tensile Strength in order to verify the new polyester suture resin and polytetrafluoroethylene (PTFE) coating of the proposed Deknatel Polyester Surgical Sutures are substantially equivalent to the predicate devices in performance Additional non-clinical testing was conducted to confirm substantial equivalence with regards to stability, MR safety and biocompatibility (per ISO 10993-1).
L. Conclusion
Based upon the comparative test results, the proposed Deknatel Polyester Surgical Sutures are substantially equivalent in performance, stability, biocompatibility and MR safety to the predicate devices cleared to market via 510(k)s K153076, K153089, and reference 510(k) K930739. The proposed new sources of polyester resin and PTFE coating are the only changes to the product and do not introduce any new issues of safety and effectiveness.