(360 days)
Not Found
No
The device description and performance studies focus on the physical properties and USP compliance of a surgical suture, with no mention of AI or ML.
No.
A surgical suture is used to approximate tissue and assist in the healing process, but it does not treat a disease or condition itself, rather it is a tool used in a therapeutic procedure.
No
The device is a surgical suture used for approximating and ligating soft tissue, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a physical surgical suture made from polyethylene terephthalate, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures." This describes a device used within the body during surgery, not a device used to test samples outside the body (in vitro).
- Device Description: The description details a surgical suture, a physical thread used to close wounds or tie off vessels. This is a surgical implant/device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
This device is a surgical suture, which falls under the category of medical devices used for surgical procedures.
N/A
Intended Use / Indications for Use
TRUBOND™ Non-absorbable Polyethylene Terephthalate Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
“TRUBOND" is a Nonabsorbable (Poly cthylene terephthalate) Surgical Suture, is a multifilament nonabsorbable, sterile, flexible thread prepared from fibres of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. Polycster Nonabsorbable Surgical Suture meets united states "TRUBOND" (U.S.P.) requirements as described in the U.S.P monograph for pharmacopcia Nonabsorbable surgical sutures"; it is coated with a highly adherent biologically inert polybutylate and it may be undyed or dyed with D&C green no-5, conforming to U.S.Code of Federal Regulations 21 CFR 74.1205 or with Logwood extract black, conforming to U.S.Code of Federal Regulations 21 CFR 73.1410 . The suture may be provided with or without a standard needle attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of suture diameter, suture length, knot pull tensile strength, extractable color, needle attachment strength and sterility to methods outlined in USP 26 demonstrates Suture India "TRUBOND" Polyester Nonabsorbable Surgical Suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned 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
JUN 2 - 2005
SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYESTER SURGICAL SUTURE
SECTION NO: 16 · PAGE NO: -16-1
510K SUMMARY as required by: 21CFR 807.92
A. APPLICANT INFORMATION
| Name | : SUTURES INDIA PVT. LTD |
|---|---|
| Address | : Sutures India Pvt. Ltd. |
| 118, 3rd Phase, Peenya Industrial Area, | |
| Bangalore–560058. | |
| PH.NO. | : 91-80-28395150 / 28370367 / 28377850 |
| FAX NO | : 91-80-28392280. |
| : sutures@vsnl.com | |
| Web address | : www.suturesin.com |
B. Contact Person : L.G.Chandrasekhar : MANAGING DIRECTOR
C. Date Prepared : May 15,2004
D. DEVICE NAME
- Trade Name . : TRUBOND
- . Common name : Nonabsorbable Surgical Suture,U.S.P. (Coated and Braided Polyester)
- Classification Name : Nonabsorbable (Poly ethylene Terephthalate) Surgical Suture .
E. PREDICATE DEVICES
- Polyester Nonabsorbable Surgical Suture, 510(k) Number K001172, C.P.Medical, . Portland, OR 97232.
- Polyester Nonabsorbable Surgical Suture, 510(k) Number K961925. R.K.Medical . L.L.C, Danbury, CT 06810
K041512
Page 1 of
8
1
K041512
page 2 of 4
SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYESTER SURGICAL SUTURE
PAGE NO: -16-2 SEC.LION NO:16
F. DESCRIPTION OF THE DEVICE
·TRUBOND" is a Nonabsorbable (Poly cthylene terephthalate) Surgical Suture, is a multifilament nonabsorbable, sterile, flexible thread prepared from fibres of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component.
Polycster Nonabsorbable Surgical Suture meets united states "TRUBOND" (U.S.P.) requirements as described in the U.S.P monograph for pharmacopcia **Nonabsorbable surgical sutures"; it is coated with a highly adherent biologically inert polybutylate and it may be undyed or dyed with D&C green no-5, conforming to U.S.Code of Federal Regulations 21 CFR 74.1205 or with Logwood extract black, conforming to U.S.Code of Federal Regulations 21 CFR 73.1410 . The suture may be provided with or without a standard needle attached.
G. INTENDED USE OF THE DEVICE
Sutures India's "TRUBOND" a Nonabsorbable Surgical Suture (Polyester) is indicated for use in soft tissue approximation and / or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
| Comparison items | Sutures
India
Pvt.ltd | CP Medical | R.K.Medical |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------|----------------------|
| Polyester Nonabsorbable 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. | Same | Same | Same |
| The sutures are inert, noncollageneous and
nonantigenic. | Same | Same | Same |
| Polyester Nonabsorbable Surgical Suture is
available undyed or dyed. | D & C
Green
No. 5 or
Logwood | D & C
Green No.6 | D & C Green
No. 6 |
| Polyester Nonabsorbable Surgical Suture is
offered both uncoated and treated with
biocompatible coatings to enhance its
handling properties. | Same | Same | Same |
| Comparison items | Sutures
India Pvt.
Ltd | CP Medical | R.K.Medical |
| Polyester Nonabsorbable Surgical Suture is
indicated for use in soft tissue approximation
and/ or ligation, including use in
cardiovascular, ophthalmic and neurological
procedures. | Same | Same | Same |
| Polyester Nonabsorbable Surgical Suture is
supplied for single use only. | Same | Same | Same |
| Polyester Nonabsorbable Surgical Suture is
sterilized by EO method | Same | Same | Same |
| Polyester Nonabsorbable Surgical Suture is
packaged in the same or equivalent manner,
and has the same or equivalent labeling
claims as the predicate devices including
indications, warnings, cautions and
precautions | Same | Same | Same |
| Finished suture material meets the
performance requirements defined in the
United States Pharmacopeia current edition
USP26 for Diameter | Same | Same | Same |
| Finished suture material meets the
performance requirements defined in the
United States Pharmacopeia current edition
USP26 for Tensile strength | Same | Same | Same |
| Finished suture material meets the
performance requirements defined in the
United States Pharmacopeia current edition
USP26 for Needle attachment | Same | Same | Same |
| Polyester Nonabsorbable Surgical Suture
meets the Official Monograph of the United
States Pharmacopeia current edition USP26
for extractable color | Same | Same | Same |
| Polyester Nonabsorbable Surgical Suture
meets the Official Monograph of the United
States Pharmacopeia current edition USP26
for Sterility | Same | Same | Same |
| Comparison items | Sutures
India Pvt.
Ltd | C.P. Medical | R.K.Medical |
| Finished suture material meets the
performance requirements defined in the
United States Pharmacopeia current edition
USP26 for Finish suture Length Requirement
(95% of stated label length) | Same | Same | Same |
| Finished suture material packaged in a same
or equivalent manner with sterile single or
double packing having labeling conforming
to 21CFR and USP 26 | Same | Same | Same |
| Polyester Nonabsorbable Surgical Suture is
biologically compatible when tested as per
ISO-10993 | Same | Same | Same |
COMPARISON TABLE SUTURES INDIA 'S "TRUBOND" POLYESTER NONABSORBABLE SURGICAL SUTURE TO PREDICATE DEVICES
2
147012
Page 394
SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR MISSION OF TREF POLYESTER SURGICAL SUTURE
SECTION NO: 16
PAGE NO: -16-3
3
K041512
. page 4 of 4
SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYESTER SURGICAL SUTURE
PAGE NO: -16-4 SECTION NO:16
CONCLUSION
Sutures India's "TRUBOND" Polyester Nonabsorbable Surgical Suture is composed of the same material, as are the predicated devices and has the same design, as do the predicate devices. The suture is manufactured in a manner typical of the industry and equivalent to that used to produce predicate devices. Further the subject device is offered with the same colorant Logwood extract or D & C Green 5 at a concentration that conforms to the requirements of FDA.
Testing of suture diameter, suture length, knot pull tensile strength, extractable color, needle attachment strength and sterility to methods outlined in USP 26 demonstrates Suture India "TRUBOND" Polyester Nonabsorbable Surgical Suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices.
Duff
L.G.Chandrasekhar Managing Director
4
Image /page/4/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 AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 - 2005
Mr. L.G. Chandrasekhar Managing Director Sutures India Private Limited 472 D, 13th Cross, 4th Phase Peenya Industrial Area, Bangalore 560058, India
Re: K041512
Trade/Device Name: TRUBOND™ Non-absorbable Polyethylene Terephthalate Surgical Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: May 3, 2005 Received: May 6, 2005
Dear Mr. Chandrasekhar:
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.
5
Page 2 - Mr. L.G. Chandrasekhar
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 (240) 276-0115 . 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/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
K041512 510(k) Number (if known):
Device Name: TRUBOND™ Non-absorbable Polyethylene Terephthalate Surgical Suture
Indications For Use:
TRUBOND™ Non-absorbable Polyethylene Terephthalate Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ortive . . . ... ... ... ... ... ....................................................................................................................................................