(20 days)
Not Found
No
The summary describes a surgical suture and does not mention any AI or ML components or functionalities.
No
The device is a surgical suture used for approximation and/or ligation of soft tissues, which is a supportive function during the healing process rather than a direct therapeutic intervention.
No
The device is described as a surgical suture for soft tissue approximation and/or ligation, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a surgical suture composed of UHMWPE, which is a physical material, 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 "approximation and/or ligation of soft tissues" during surgery. This is a direct surgical intervention on the patient's body.
- Device Description: The device is a surgical suture, a physical material used to close wounds or tie off vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory tests.
Therefore, the Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture is intended to approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgeries.
Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopaedic surgeries.
Product codes
GAT
Device Description
The Force Fiber Blue Co-Braid Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in sizes 2-0 through 2 meeting USP requirements except for oversized diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Force Fiber Polyethylene Non-Absorbable Surgical Suture
Reference Device(s)
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
MAR 1 5 2004
SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Teleflex Medical submits this summary of safety and effectiveness.
Submitter Name, Address, and Date of Submission 1.
Angela Tran Regulatory Affairs Supervisor Teleflex Medical 2917 Weck Drive Research Triangle Park, NC 27709 (919) 361-4008 Telephone: (919) 361-3966 Facsimile: Submitted: February 23, 2004
Name of the Device, Common, Proprietary (if known), and Classification 2.
| Classification Narne: | Suture |
|---|---|
| Common Name: | Suture |
| Proprietary Name: | Force Fiber Blue Co-Braid Polyethylene Non- |
| Absorbable Surgical Suture | |
| Classification: | Class II, 21CFR §878.5000 |
3. Identification of the legally marketed device to which the submitter claims equivalence
The Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture described in this submission is substantially equivalent to previously cleared suture, Force Fiber Polyethylene Non-Absorbable Surgical Suture.
4. Description of the Device
The Force Fiber Blue Co-Braid Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in sizes 2-0 through 2 meeting USP requirements except for oversized diameter.
5. Intended Use of the Device
The Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture is intended to approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgeries.
6. Summary of Technological Characteristics
The technological characteristics are the same as or equivalent to the predicate device. The dimensional specification change does not adversely affect safety and effectiveness.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare organizations.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2004
Ms. Angela Tran Regulatory Affairs Supervisor Teleflex Medical 2917 Weck Drive Research Triangle Park, North Carolina 27709
Re: K040472 Trade/Device Name: Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: February 16, 2004 Received: February 24, 2004
Dear Ms. Tran:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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); 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.
2
Page 2 - Ms. Angela Tran
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The IDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K040472
Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Device Name: Surgical Suture
Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Indications For Use: Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopaedic surgeries.
| Prescription Use | ✓ |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE: BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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age | l
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| ---------- | --------- | -- |
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510(k) Number_K040472