(55 days)
Not Found
Not Found
No
The document describes a surgical suture and does not mention any AI or ML components or functionalities.
No.
Explanation: The device is a surgical suture used for approximation and ligation of soft tissues, not for treating a disease or condition.
No
Explanation: The device description clearly states it is a surgical suture used for approximation and/or ligation of soft tissues, which is a therapeutic function, not diagnostic. There is no mention of it being used to identify or analyze a condition.
No
The device description clearly states it is a surgical suture, which is a physical, hardware medical device. There is no mention of software.
No, 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, including use of allograft tissue for orthopedic surgeries." This describes a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The description details a surgical suture, a physical material used to join tissues. This is a surgical device, not a diagnostic test kit or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Force Fiber™ Polyethylene Nonabsorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Product codes
GAT
Device Description
Force Fiber Nonabsorbable Surgical Suture meets all USP requirements for size 2-0. All other sizes meet USP requirements except for oversized diameter. Force Fiber Nonabsorbable Suture is available in size 2-0 through 2 (metric size 3 through 5) and is provided as undyed (white). The suture is a braided multifilament, is provided in a variety of lengths, with or without needles, with or without pledgets, and may be supplied in a variety of cut lengths or on ligating reels.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KD33654
JAN 1 5 2004
SECTION VI
510(k) Summary
Substantial Equivalence
In accordance with the requirements of 21 CFR § 807, this summary is formatted with the Agency's final rule ".... 510(k) Summaries and 510(k) Statements ... " and can be used to provide equivalence summary to anyone requesting it from the Agency.
| Manufacturer | Teleflex Medical
600 Airport Road
Fall River, MA 02720-4740 |
|----------------------|--------------------------------------------------------------------------------------------------|
| Contact Person | Lynn Matos
Phone: (508) 677-6582
Fax: (508) 677-6663
E-mail: Imatos@teleflexmedical.com |
| Date Prepared | November 20, 2003 |
| Device Information | |
| Trade Name: | Force Fiber™ Polyethylene Nonabsorbable
Surgical Suture. |
| Common Name: | Polyethylene Nonabsorbable Surgical Sutures. |
| Classification Name: | Nonabsorbable Poly(ethylene terephthalate)
Surgical Sutures |
Indications for Use
Force Fiber™ Polyethylene Nonabsorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Device Description
Force Fiber Nonabsorbable Surgical Suture meets all USP requirements for size 2-0. All other sizes meet USP requirements except for oversized diameter. Force Fiber Nonabsorbable Suture is available in size 2-0 through 2 (metric size 3 through 5) and is provided as undyed (white). The suture is a braided multifilament, is provided in a variety of lengths, with or without needles, with or without pledgets, and may be supplied in a variety of cut lengths or on ligating reels.
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
Ms. Lynn Matos Regulatory Affairs Coordinator Teleflex Medical 600 Airport Road Fall River, Massachusetts 02720
Re: K033654
Trade/Device Name: Force Fiber™ Polyethylene Nonabsorbable Surgical Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable suture Regulatory Class: II Product Codc: GAT Dated: November 10, 2003 Received: November 21, 2003
Dear Ms. Matos:
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 10 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 adultcration.
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 (OS) 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. Lynn Matos
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA 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-frec 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. Parrott
fel 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
K.033654
510(k) Number (if known) Device Name
Force Fiber™ Polyethylene Nonabsorbable Surgical Suture
Indications for Use
Force Fiber™ Polyethylene Nonabsorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic 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
Number K633654
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