(99 days)
Not Found
No
The device description and intended use are solely focused on the physical properties and materials of surgical sutures. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
No
The device is a surgical suture used for approximation and/or ligation of soft tissues, which is a supportive rather than therapeutic function.
No
The device description clearly states that these are surgical sutures, which are materials used for approximating and/or ligating tissues, not for diagnosing conditions.
No
The device description clearly states that the device is a physical surgical suture made of various materials like UHMWPE, polyglycolic acid, etc. It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these are surgical sutures used for "approximation and/or ligation of soft tissues." This describes a device used in vivo (within the body) during a surgical procedure.
- Device Description: The description details the materials and construction of surgical sutures, which are physical devices used to hold tissue together.
- 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 compatibility testing.
IVD devices are specifically designed to be used in vitro (outside the body) for diagnostic purposes. Surgical sutures are used in vivo for therapeutic purposes (tissue repair).
N/A
Intended Use / Indications for Use
Force Fiber® Non-absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopedic surgeries.
Force Fiber®OrthoTape® Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Bondek® and Bondek® Plus Synthetic Absorbable Surgical Sutures are intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in and neurological procedures.
Monodek Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Monodek® suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.
Polyglytone*6211™ Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular surgery, neurological surgery, or microsurgery.
Product codes (comma separated list FDA assigned to the subject device)
GAT, GAM, NEW
Device Description
Force Fiber Suture is a non-absorbable, sterile, surgical suture composed of Ultra High Molecular Weight Polyethylene (UHMWPE). It is available in various colors (White, Blue, White/Blue, White/Black, White/Green) and USP sizes (5-0 through 5 for some colors, 0, 1, 2 for others). The colored sutures use specific colorants per 21 CFR regulations. Force Fiber surgical sutures meet all surgical suture requirements established by the USP for non-absorbable surgical sutures except for oversized diameter.
Force Fiber OthoTape Suture is an uncoated braid that is flat in shape and differs from USP requirements (not USP). It is available in 1mm, 1.5mm, 2.5mm, 3.5mm, 4mm and 5mm tape sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), or UHMWPE/ Green Polyester co-braid. Force Fiber OrthoTape suture sizes meet USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture.
Bondek and Bondek Plus Suture is an absorbable, braided multifilament suture composed of a homopolymer of glycolic acid, polyglycolic acid. The Bondek suture material is coated with polycaprolactone-glycerol monostearate solution, and is available in green and beige (undyed) USP sizes 8-0 through 2. The Bondek Plus suture material is coated with polycaprolactone-co-polygolycolic acid, and is available in violet, green or beige (undyed) USP sized 6-0 through2.
Monodek Absorbable Surgical Suture is a monofilament suture that meets all USP requirements except for oversize diameter. Monodek is available in sizes 6-0 through 0 (metric sizes 0.7 through 3.5), undyed and dyed (violet). The suture may be supplied on ligating reels.
Polyglytone* 6211 suture, U.S.P size 2-0, is available, undyed (natural). The suture is monofilament, and may be provided with or without plegets.
The Teleflex surgical sutures are provided sterile (EO), for singe use only and may be provided in a variety of cut lengths with or without needles. A variety of attached needles are available from either 300 or 400 series stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissues, cardiovascular surgeries, allograft tissue for orthopedic surgeries, ophthalmic procedures, pediatric cardiovascular 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
Non-clinical testing was completed to demonstrate the "MR Safe" claim.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was completed to demonstrate the "MR Safe" claim. Teleflex Surgical Sutures are "MR Safe" and pose no known hazards in MR environments. The Indication for Use (IFU) inserts are being updated to include the "MR Safe" claim. Based upon the comparative test results, the proposed Teleflex Surgical Sutures are substantially equivalent in performance to the legally marketed 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.
K063778, K070673, K092533, K100506, K150438, K991191, K992088, K030212, K042141
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 10, 2018
Teleflex Medical Incorporated Ms. Andrea Curria Regulatory Affairs Specialist 375 Forbes Boulevard Mansfield, Massachusetts 02048
Re: K181774
Trade/Device Name: Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures: Force Fiber OrthoTape suture: Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly (Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT, GAM, NEW Dated: June 25, 2018 Received: July 3, 2018
Dear Ms. Curria:
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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Peter L. Hudson -S 2018.10.10 15:42:23 -04'00'
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
510(k) Number (if known) K181774
Device Name Force Fiber® Suture
Indications for Use (Describe)
Force Fiber® Non-absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopedic surgeries.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| ----------------------------------------------------------------------- | ---------------------------------------------------------------------- |
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
3
510(k) Number (if known) K181774
Device Name Force Fiber®OrthoTape® Suture
Indications for Use (Describe)
Force Fiber®OrthoTape® Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
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
4
510(k) Number (if known) K181774
Device Name Bondek® and Bondek® Plus Suture
Indications for Use (Describe)
Bondek® and Bondek® Plus Synthetic Absorbable Surgical Sutures are intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in 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
5
510(k) Number (if known) K181774
Device Name Monodek® Suture
Indications for Use (Describe)
Monodek Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Monodek® suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.
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
6
510(k) Number (if known) K181774
Device Name Polyglytone*6211TM Suture
Indications for Use (Describe)
Polyglytone*6211™ Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular surgery, neurological surgery, or microsurgery.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201 Subpart G) |
| > 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
7
510(k) Summary of Safety and Effectiveness
This 510(k) Summary for Teleflex Surgical Sutures is provided as required by section 807.92(c).
| A. Sponsor/Applicant: | Teleflex Medical Inc.
375 Forbes Boulevard
Mansfield, MA 02048 USA
FDA Establishment Registration #: 1221601 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Date Prepared: | June 20, 2018 |
| C. Contact: | Andrea Curria
Regulatory Affairs Specialist, OEM
Phone: 1-508-964-6030
Mobile 1-401-529-0233
Fax: 1-508-964-6078
Andrea.Curria@teleflex.com |
| D. Device Name | |
| Proprietary Name: | Force Fiber® Suture |
| Common Name: | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Classification Name: | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Regulation Number: | 21CFR § 878.5000 |
| Product Code: | GAT |
| Device Class: | Class II |
| Classification Panel: | General and Plastic Surgery |
| Proprietary Name: | Force Fiber® OrthoTape® Suture |
| Common Name: | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Classification Name: | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Regulation Number: | 21CFR § 878.5000 |
| Product Code: | GAT |
| Device Class: | Class II |
| Classification Panel: | General and Plastic Surgery |
| Proprietary Name: | Bondek® and Bondek® Plus Suture |
| Common Name: | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Classification Name: | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Regulation Number: | 21CFR § 878.4493 |
| Product Code: | GAM |
| Device Class: | Class II |
| Classification Panel: | General and Plastic Surgery |
| Proprietary Name: | Monodek® Suture |
| Common Name: | Suture, Surgical, Absorbable, Polydioxanone |
| Classification Name: | Suture, Surgical, Absorbable, Polydioxanone |
| Regulation Number: | 21CFR § 878.4840 |
| Product Code: | NEW |
| Device Class: | Class II |
| Classification Panel: | General and Plastic Surgery |
| Proprietary Name: | Polyglytone*6211TM Suture |
| Common Name: | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Classification Name: | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Regulation Number: | 21CFR § 878.4493 |
| Product Code: | GAM |
| Device Class: | Class II |
| Classification Panel: | General and Plastic Surgery |
8
E. Device Descriptions
Force Fiber Suture is a non-absorbable, sterile, surgical suture composed of Ultra High Molecular Weight Polyethylene (UHMWPE). It is available as follows:
| Force Fiber
color | Material | Available
USP sizes |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| White | Braided undyed (white) UHMWPE fibers. | 5-0
through 5 |
| Blue | Braided blue UHMWPE fibers. The blue colorant is Chromium-cobalt-
aluminum oxide