(50 days)
Not Found
No
The 510(k) summary describes a surgical suture and its intended use, materials, and performance testing based on established standards. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies rely on standard biological and physical testing, not algorithmic performance metrics.
No
The device is a surgical suture used for tissue approximation and ligation, which is a structural component for closing wounds, not a therapeutic device designed to cure or treat a disease or condition.
No
The device is a synthetic absorbable suture, which is used for soft tissue approximation and ligation, not for diagnosing conditions.
No
The device description clearly describes a physical surgical suture, which is a hardware component, 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 "general soft tissue approximation and/or ligation," which is a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "synthetic absorbable suture," which is a physical material used to close wounds or tie off blood vessels during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside of the body) to provide information about a patient's health.
IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device's function is purely mechanical and surgical.
N/A
Intended Use / Indications for Use
Polyglytone* 6211 sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery but not for use in cardiovascular surgery, neurological surgery, or microsurgery.
Product codes
GAM
Device Description
Polyglytone* 6211 suture, U.S.P. size- 2-0, is available, undyed (natural). The suture is monofilament, may be provided in a variety of lengths, with or without needles, with or without pledgets, and may be supplied in a variety of cut lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft 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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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
Original 510(k) Submission Polyglytone™6211Synthetic Absorbable Suture
July 21, 2004
page 1/2
Section VI
510(k) Summary
SEP 2 8 2004
Substantial Equivalence
TFX Medical, Inc
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 | Steve Astorino
Engineering Manager
Phone: (508) 677-6589
Fax: (508) 677-6663
e-mail: sastorino@teleflexmedial.com |
| Date Prepared | July 21, 2004 |
| Device Information | |
| Trade Name: | Polyglytone*6211™ Synthetic Absorbable
Suture. |
| Common Name: | Absorbable Surgical Suture. |
| Classification Name: | Absorbable Poly(glycolide/L-lactide) Surgical
Suture |
Indications for Use
Polyglytone* 6211 sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery but not for use in cardiovascular surgery, neurological surgery, or microsurgery.
Device Description
Polyglytone* 6211 suture, U.S.P. size- 2-0, is available, undyed (natural). The suture is monofilament, may be provided in a variety of lengths, with or without needles, with or without pledgets, and may be supplied in a variety of cut lengths.
1
KO42141
July 21, 2004
TFX Medical, Inc Original 510(k) Submission Polyglytone*6211Synthetic Absorbable Suture
pay 1/2
Section VI 510(k) Summary
Substantial Equivalence
The device is similar in intended use, materials, design, and performance characteristics to the currently cleared U.S. Surgical Caprosyn™ Monofilament Synthetic Absorbable Suture (K013671 & K032586).
The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices, U.S.P .- Absorbable Surgical Sutures, and the FDA "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA", June 3, 2003.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized symbol of three horizontal lines that curve upwards, resembling a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2004
Mr. Steve Astorino Engineering Manager Teleflex Medical 600 Airport Road Fall River, Massachusetts 02720
Re: K042141
Ko42141
Trade/Device Name: Polyglytone 6211™ Synthetic Absorbable Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: July 21, 2004 Received: August 9, 2004
Dear Mr. Astorino:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave ustimassaly marketed predicate devices marketed in interstate for use statu in the enolosure) to tegains and ment date of the Medical Device Amendments, or to commence prior to May 20, 1978, are encordance with the provisions of the Federal Food, Drug, devices mat nave been recuired in assire approval of a premarket approval application (PMA). and Costience rece (Tree) that as not conserval controls provisions of the Act. The I ou may, merelore, mains of the Act include requirements for annual registration, listing of general controll pro factice, 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 If your device is classinod controls. Existing major regulations affecting your device can may be subject to back access as a coulations, 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 I lease oe advised that I Drivination that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or any I caeaal statutes and regirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT an 007); adoning (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by counts (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Steve Astorino
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-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
SS
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
4
Indications for Use
510(k) Number (if known):
Device Name: Polyglytone*6211™ Synthetic Absorbable Suture
Indications for Use:
Polyglytone*6211™ Synthetic Absorbable Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic Surgery but not for use in cardiovascular surgery, neurological surgery, or microsurgery.
Prescription Use __ X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Page 1 of 1 (Posted November 13, 2003)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________