(291 days)
Not Found
No
The document describes a surgical suture and pledgets, which are physical medical devices. There is no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on physical properties and packaging.
No.
The device is a nonabsorbable surgical suture tape and pledget used for soft tissue approximation, ligation, and suture reinforcement, which are supportive functions during surgical procedures rather than directly treating a disease or condition.
No
The device is a nonabsorbable, sterile surgical suture and pledget, indicated for general soft tissue approximation, ligation, reinforcement, and buttressing; it is not designed to diagnose diseases or conditions.
No
The device description clearly states it is composed of physical materials (Poly(ethylene terephthalate) and polytetrafluoroethylene fabric) and is a surgical suture and pledget, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as a surgical suture tape and pledgets used for soft tissue approximation, ligation, and suture reinforcement/buttressing during surgical procedures. This is a direct interaction with the patient's body during surgery.
- Device Description: The description details the materials and form of the suture tape and pledgets, which are physical implants used in surgery.
- 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 treatment.
IVD devices are used outside the body to analyze samples, while this device is used inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
'cottony'TM II Polyester Suture Tape is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.
Deknatel Pledgets are indicated as sterile, single use, implantable devices for general suture reinforcement and suture buttressing.
Product codes (comma separated list FDA assigned to the subject device)
GAT, DXZ
Device Description
Deknatel Polyester Suture Tapes are nonabsorbable, sterile surgical sutures composed of Poly(ethylene terephthalate). They are prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. Deknatel Polyester suture tapes are provided braided, undyed (white) and dyed
Deknatel Pledgets are precut pieces from a sheet of polytetrafluoroethylene (PTFE) fabric used to spread the load the suture against host tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 performed in accordance with ISO11607-1:2006. Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and USP (United States Pharmacopeia) 36-NF 31 Sutures- Needle Attachment, and Tensile Strength to demonstrate substantially equivalent to the predicate devices.
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
§ 878.5000 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other to create a sense of depth. The profiles are connected to a symbol that resembles a bird's wing or a flowing ribbon. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2016
Teleflex Medical, Inc. Ms. Natalie Hichak Sr. Regulatory Affairs Specialist 3015 Carrington Mill Blvd. Morrisville, North Carolina 27560
Re: K153089
Trade/Device Name: 'cottony' II Polyester Suture Tape, Pledgets Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT, DXZ Dated: July 14, 2016 Received: July 15, 2016
Dear Ms. Hichak:
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.
1
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
2
Indications for Use
510(k) Number (if known) K153089
Device Name 'cottony'TM II Polyester Tape
Indications for Use (Describe)
'cottony IM II Polyester Suture Tape is 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)
| 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) K153089
Device Name Pledgets
Indications for Use (Describe)
Deknatel Pledgets are indicated as sterile, single use, implantable devices for general suture reinforcement and suture buttressing.
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Deknatel® 'cottony'™ II Tape and Pledgets
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560
919-433-8049 Phone: Fax: 919-433-4996
B. Contact Person
Natalie Hichak Sr. Regulatory Affairs Specialist
C. Date Prepared
October 22, 2015
D. Product Classification
| Product Code
Regulation Number
Device Class | GAT
878.5000
II |
|---------------------------------------------------|--------------------------------------------------------------------------|
| Classification Panel | Division of Surgical Devices (DSD)
General Surgery Devices Branch One |
| Product Code | DXZ |
| C.F.R. Section | 870.3470 |
| Device Class | II |
| Classification Panel | Cardiovascular |
E. Device Name
| Trade Name | 'cottony'TM II Tape |
|---|---|
| Common Name | Suture, Nonabsorbable, Synthetic, |
| Polyethylene | |
| Classification Name | Nonabsorbable poly(ethylene terephthalate |
| Surgical Suture |
5
| Product Code | Product Description |
|---|---|
| 8-5037W | 'cottony'™ II TAPE WHITE 3MM C-25 2N 18" |
| 8-5044W | 'cottony'™ II TAPE WHITE 3MM C-25 1N 18" |
| 8-5062W | 'cottony'™ II TAPE WHITE 3MM AC-25 2N 18 |
| 89-5037W | 'cottony'™ II TAPE WHITE 3MM KC-25 2N 18 |
| 89-5044W | 'cottony'™ II TAPE WHITE 3MM KC-25 1N 18" |
| X-3652 | 'cottony'™ II TAPE WHITE 5MM C-25 1N 12" |
| X-4142 | 'cottony'™ II TAPE WHITE 3MM KC-25 2N 30" |
| X-4323 | 'cottony'™ II TAPE WHITE 1MM HC-5 2N 20 |
| X-5032 | 'cottony'™ II TAPE WHITE 2MM HC-5 2N 40" |
| X-5259 | 'cottony'™ II TAPE WHITE 1MM K-61 1N 20" |
| X-5750 | 'cottony'™ II TAPE WHITE 1MM K-61 1N 30" |
| X-5750M4 | 'cottony'™ II TAPE WHITE 1MM K-61 1N 30"X4 |
| X-5798 | 'cottony'™ II TAPE WHITE 1MM HC-5 2N 30" |
| X-5819 | 'cottony'™ II TAPE WHITE 5MM KC-25 1N 40" |
| X-6081 | 'cottony'™ II TAPE WHITE 1MM HC-5 1N 30" |
| X-6464 | 'cottony'™ II TAPE WHITE 2MM 2 X 36” |
| X8-593 | 'cottony'™ II TAPE WHITE 3MM C-25 2N 12" |
Available in the following product codes:
| Trade Name | Pledget |
|---|---|
| Common Name | patch, pledget and intracardiac |
| Intracardiac patch or pledget made of | |
| Classification Name | polypropylene, polyethylene terephthalate, or |
| polytetrafluoroethylene |
Available in the following product codes:
| Product Code | Description |
|---|---|
| EK-705A | PLEDGET SOFT MEDIUM1/4"X1/8"X1/16" |
| EL-705A | PLEDGET SOFT LRG 3/8"X3/16"X1/16" |
| EQ-705 | PLEDGET FIRM MED 1/4"X1/8"X1/16" |
| EW-705 | PLEDGET FIRM SMALL 1/8"X1/8"X1/16" |
| EX-5145 | PLEDGET SOFT 6"X5/16"X1/1 |
| EX-6599 | PLEDGET FIRM 5MMX3MM X1/16" X6 |
| EZ-705 | PLEDGET FIRM LARGE 3/8"X3/16"X1/16" |
| K-705 | PLEDGET SOFT MEDIUM 1/4X1/8X1/16 |
| L-705 | PLEDGET SOFT LG 3/8X3/16X1/16 |
| Q-705 | PLEDGET FIRM MEDIUM 1/4"X1/8"X1/16" |
| W-705 | PLEDGET SMALL FIRM 1/8X1/8X1/16 |
| Product Code | Description |
| X-3523 | PLEDGET SOFT 1/4X3/16X1/16PLEDGET |
| X-4016 | PLEDGET SOFT 10MM X 7MM X 1.6MM |
| X-4340 | PLED SOFT 1/4"X3/16"X1/16" X12 |
| X-4420 | PLEDGET SOFT 1"X1"X1/16" |
| X-4443 | PLEDGET SOFT 6X1X1/16 |
| X-4444 | PLEDGET SOFT 3/4X1/2X1/16 X2 |
| X-4460 | PLEDGET SOFT 3/4"X5/16"X1/16" X6 |
| X-4473 | PLEDGET SOFT 1/2X1/4X1/16 X6 |
| X-4475 | PLEDGET SOFT 3/4"X3/8"X1/16" X6 |
| X-4520 | PLEDGET SOFT 3"X3"X1/16" |
| X-4527 | PLEDGET SOFT 7/8X3/8X1/16 X2 |
| X-4528 | PLEDGET SOFT 3/4"X3/8"X1/16" X2 |
| X-4543 | PLEDGET SOFT 4"X5/16"X1/16" X2 |
| X-4544 | PLEDGET SOFT 1/2X5/16X1/16 X4 |
| X-4550 | PLEDGET SOFT 3/4X5/16X1/16 X2 |
| X-4563 | PLEDGET SOFT 5/8X3/8X1/16 X6 |
| X-4564 | PLEDGET SOFT 1/2"X5/16"X1/16" X6 |
| X-4612 | PLEDGET SOFT 5/8"X3/8"X1/16" X5 |
| X-4615 | PLEDGET SOFT 1/4"X3/16"X1/16" X5 |
| X-4616 | PLEDGET SOFT 3/4"X3/8"X1/16" X4 |
| X-4625 | PLEDGET SOFT 5/8"X5/16"X1/16" X6 |
| X-4646 | PLEDGET OVAL SOFT 6MMX4.5MMX1/16 |
| X-4675 | PLEDGET SOFT 8MMX8MMX1/16" X6 |
| X-4714 | PLEDGET SOFT 3/8"X3/8"X1/16" X2 |
| X-4827 | PLEDGET SOFT 5/16"X5/16"X1/16" X4 |
| X-4832 | PLEDGET SOFT 3/8"X3/8"X1/16" X8 |
| X-4846 | PLEDGET SOFT 7/8"X1/2"X1/16" X4 |
| X-4874 | PLEDGET SOFT 1/4"X1/4"X1/16" X12 |
| X-5092 | PLEDGET SOFT 1/4"X25/64"X1/16" X4 |
| X-5145 | PLEDGET SOFT 6"X5/16"X1/16" X2 |
| X-5163 | PLEDGET FIRM 3MMX5MMX1/16" X6 |
| X-5437 | PLEDGET SOFT 1/4X1/4X1/16 |
| X-5468 | PLEDGET SOFT LARGE 6"X6" |
| X-5508 | PLEDGET FIRM 3/8"X1/8"X1/16" |
| X-5598 | PLEDGET FIRM 1/8"X1/12"X1/16" X6 |
| Product Code | Description |
| X-6633 | PLEDGET SOFT OVAL 3/8"X5/16" 10PK |
| X-6658 | PLEDGET SOFT 1/2"X1/4"X1/6 X4 |
| X-6745 | PLEDGET SOFT ROUND 6MM |
| X-6788 | PLEDGET SOFT 3" X6" |
| X-6790 | PLEDGET SOFT 6" X 1/2" |
| Z-705 | PLEDGET FIRM LARGE 3/8X3/16X1/16 |
6
7
Additionally, the products listed above are available as part of suture kits in conjunction with the other suture materials cleared under K153076:
| Product
| Code | Code | Qty | Description |
|---|---|---|---|
| Surgical Closure Assortment | |||
| V-1498A | XS-906 | 3 | 2 2 X 60" SILK black braided |
| XS-935 | 1 | 0 12 X 30" SILK black braided | |
| XS-934 | 1 | 2-0 12 X 30" SILK black braided | |
| XS-933 | 1 | 3-0 12 X 30" SILK black braided | |
| XS-932 | 2 | 4-0 12 X 30" SILK black braided | |
| X-6464 | 2 | 2MM 2 X 36" 'cottony' II white braided | |
| Surgical Closure Assortment | |||
| V-3777A | XRNS-537 | 10 | 0 1 X 18" SILK black braided |
| 7-717 | 3 | 2-0 4 X 30" TEVDEK II green braided | |
| C7-717 | 3 | 2-0 1 X 30" TEVDEK II green braided (Soft | |
| Pledget 3/8" x 3/16" x 1/16") | |||
| XRN-5744 | 2 | 2-0 1 X 24" SILK black braided | |
| C7-5320 | 2 | 4-0 1 X 30" TEVDEK II green braided (Soft | |
| Pledget 3/8" x 3/16" x 1/16") | |||
| S-7115B | 2 | 5-0 1 X 24" SILK black braided | |
| XRN-5743 | 8 | 0 1 X 24" SILK black braided | |
| L-705 | 3 | White Soft PLEDGET 3/8" x 3/16" x 1/16" | |
| D-7065A | 2 | 4-0 1 X 36" DEKLENE II blue monofilament | |
| XCD-7065A | 2 | 4-0 1 X 36" DEKLENE II blue monofilament | |
| (Soft Pledget 3/8" x 3/16" x 1/16") | |||
| D-7061M2A | 1 | 5-0 2 X 36" DEKLENE II blue monofilament | |
| RC-1424 | 1 | 2-0 12 X 18" SILK black braided | |
| 1 | 4-0 12 X 18" SILK black braided | ||
| 1 | 4-0 12 X 18" SILK black braided | ||
| 1 | 4-0 12 X 28" SILK black braided |
8
| Product
| Code | Code | Qty | Description |
|---|---|---|---|
| 1 | 5 8 X 24" SILK black braided | ||
| 1 | 5 8 X 24" SILK black braided | ||
| 1 | 5 8 X 24" SILK black braided | ||
| 1 | 1 12 x 24" SILK black braided |
F. Device Description
Deknatel Polyester Suture Tapes are nonabsorbable, sterile surgical sutures composed of Poly(ethylene terephthalate). They are prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. Deknatel Polyester suture tapes are provided braided, undyed (white) and dyed
Deknatel Pledgets are precut pieces from a sheet of polytetrafluoroethylene (PTFE) fabric used to spread the load the suture against host tissue.
G. Indications for Use and Contraindications
| Trade Name | 'cottony' II Tape |
|---|---|
| Indications for | |
| Use | 'cottony' II Polyester Suture Tape is indicated for use |
| in general soft tissue approximation and/or ligation, | |
| including use in cardiovascular, ophthalmic, | |
| orthopedic and neurological procedures. | |
| Contraindication | None known. |
| Trade Name | Pledgets |
| Indications for | |
| Use | Deknatel Pledgets are indicated as sterile, single use, |
| implantable devices for general suture reinforcement | |
| and suture buttressing. | |
| Contraindication | None known. |
H. Substantial Equivalence
The proposed Deknatel 'cottony' II Tape and Pledgets are substantially equivalent the preamendment status of the devices and to the predicate devices:
| Predicate Device | Manufacturer | 510(k)
No. | Date
Cleared |
|---------------------------------------------------------------------------------------------|--------------|---------------|------------------|
| COTTONY' II, “silky” II POLYDEK® &
TEVDEK® II Polyester Nonabsorbable
Surgical Suture | Genzyme Corp | K021019 | June 18,
2002 |
9
l. Comparison To Predicate Devices
The Deknatel 'cottony' II Tape and Pledgets are a modification to the preamendment status of the devices. The modification is to add a stability claim of 5 years and to transfer the ownership from Genzyme to Teleflex Medical.
Additionally, the 'cottony' II Tape indications are being expanded to include the orthopedic indication as cleared in predicate K021019, COTTONY' II, "silky" II POLYDEK® & TEVDEK® II Polyester Nonabsorbable Surgical Suture.
J. Materials
All patient contacting materials are in compliance with ISO10993-1.
K. Technological Characteristics
A comparison of the technological characteristics of the proposed Deknatel 'cottony' II Tape and Pledgets and the predicate has been performed. The results of this comparison demonstrate that the Deknatel 'cottony'™ II Tape and Pledgets are equivalent to the marketed predicate devices in performance characteristics.
L. Performance Data
Non-clinical testing has been performed in accordance with ISO11607-1:2006. Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and USP (United States Pharmacopeia) 36-NF 31 Sutures- Needle Attachment, and Tensile Strength to demonstrate substantially equivalent to the predicate devices.
M. Conclusion
Based upon the comparative test results, the proposed Deknatel 'cottony' II Tape and Pledgets are substantially equivalent in performance to the predicate preamendment devices and devices cleared to market via 510(k) K021019.