(361 days)
Not Found
No
The device description and performance studies focus on the physical properties and performance of a surgical suture, with no mention of AI or ML.
No
A surgical suture is used for approximation and ligation of tissues but does not provide any therapeutic effect on the body itself.
No
The device, TRULENE Non-absorbable Polypropylene Surgical Suture, is used for soft tissue approximation and/or ligation in surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical surgical suture made of polypropylene, a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures." This describes a surgical tool used in vivo (within the body) to physically join or tie off tissues.
- Device Description: The description details a surgical suture, a physical thread used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests. It is a physical implant/tool used during a surgical procedure.
Therefore, based on the provided information, the TRULENE™ Non-absorbable Polypropylene Surgical Suture is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
TRULON™ Non-absorbable Polypropylene 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)
GAW
Device Description
TRULENE Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene.
The polypropylene surgical suture meets united states pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it is dyed with an FDA approved color additive (Phthalocyaninato (2-) copper); and the suture is provided with 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 Sutures India "TRULENE" Polypropylene 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
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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 3 - 2005
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. India | |
| PH.NO. | : 91-80-28395150 / 28370367 / 28377856 |
| FAX NO | : 91-80-28392280. |
| E mail | : sutures@vsnl.com |
| Web address | : www.suturesin.com |
| B. Contact Person | : L.G.Chandrasekhar |
| : MANAGING DIRECTOR | |
| C. Date Prepared | : May 07,2004 |
D. DEVICE TRADE NAME
- Trade Name . : TRULENE Common name : Nonabsorbable Surgical Suture, U.S.P. . (Monofilament Polypropylene)
- . Classification Name : Nonabsorbable Polypropylene Surgical Suture
E. PREDICATE DEVICES
- . Polypropylene Nonabsorbable surgical suture, 210(K) Number K001185, C.P.Medical, Portland, OR 97232.
- Nonabsorbable surgical ● Polypropylene suture, 510(k) Number K961389. R.K.Medical L.L.C. Danbury, CT 06810
Page 1 of 4
641511
1
Page 2 of 4
| SECTION NO:16 | PAGE NO: -16-2 |
|---|---|
| --------------- | ---------------- |
F. DESCRIPTION OF THE DEVICE
TRULENE Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene.
The polypropylene surgical suture meets united states pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it is dyed with an FDA approved color additive (Phthalocyaninato (2-) copper); and the suture is provided with a standard needle attached.
G. INTENDED USE OF THE DEVICE
Sutures India TRULENE Polypropylene Nonabsorbable Surgical Suture 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 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------------|-------------|
| Nonabsorbable polypropylene surgical suture
is a monofilament, nonabsorbable, sterile,
flexible thread prepared from long-chain
polyolefin polymer known as polypropylene. | Same | Same | Same |
| The sutures are inert, noncollageneous and
nonantigenic. | Same | Same | Same |
| Polypropylene Nonabsorbable Surgical
Suture is available undyed or dyed with
(Phthalocyaninato (2-) copper) | Same | Same | Same |
| Polypropylene Nonabsorbable Surgical
Suture may be provided with or without a
standard needle attached. | Same | Same | Same |
| Polypropylene 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 |
| Comparison items | Sutures
India Pvt.
Ltd | C.P. Medical | R.K.Medical |
| Polypropylene Nonabsorbable Surgical
Suture is supplied for single use only. | Same | Same | Same |
| Polypropylene Nonabsorbable Surgical
Suture is sterilized by EO method | Same | Same | Same |
| Polypropylene 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 |
| Polypropylene Nonabsorbable Surgical
Suture meets the Official Monograph of the
United States Pharmacopeia current edition
USP26 for Extractable color | Same | Same | Same |
| 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 |
| Polypropylene Nonabsorbable Surgical
Suture is biologically compatible when tested | Same | Same | Same |
COMPARISON TABLE SUTURES INDIA "TRULENE" NONABSORBABLE SURGICAL SUTURE (POLYPROPYLENE) TO PREDICATE DEVICES
2
SECTION NO:16
3
page 1
PAGE NO: -16-4 SECTION NO: 16
CONCLUSION
Sutures India "TRULENE" Polypropylene 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 (Phthalocyaninato (2-) copper) at a concentration that conforms to the requirements of Title 21 CFR § 73.8045, as are of the predicate devices.
Testing of suture diameter, suture length, knot pull tensile strength, extractable color, needle attachment strength and sterility to methods outlined in USP 26 demonstrates Sutures India "TRULENE" Polypropylene nonabsorbable surgical suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices.
$\rightarrow$ - $\vdash$ $\vdash$
L.G.Chandrasekhar Managing Director
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which is a stylized human figure with three arms reaching upwards. The logo is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The seal is black and white.
Public Health Service
3 2005 JUN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. L.G. Chandrasekhar Managing Director Sutures India Private Limited 472 D, 13th Cross, 4th Phase Peenya Industrial Area, Bangalore 560058, India
Re: K041511
Trade/Device Name: TRULENE™ Non-absorbable Polypropylene Surgical Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: May 26, 2005 Received: June 1, 2005
Dear Mr. Chandrasekhar:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclobate) to region) the enactment date of the Medical Device Amendments, or to conimered proc to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, uc vices that have been require approval of a premarket approval application (PMA). and Costlictic 71ct (71ct) that to not requent of the general controls provisions of the Act. The I ou may, mercerere, market the Act include requirements for annual registration, listing of general controls provisions 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 your device is etablineal controls. Existing major regulations affecting your device it may be subject to sach additions, 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 Teast of advised that I Dris Sussantes over device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I caeral statutes and regarments, including, but not limited to: registration and listing (21 Comply with an the Her Frequirements)01); good manufacturing practice requirements as set Of I latt 0077, adoning (21 CFR Part 820); and if applicable, the electronic form in the quality byocally (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) I mis iction will and w you'ls cognifiading of substantial equivalence of your device to a legally prematics notification - The sults 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 If you desire specific durile for your aco) 276-0115 . Also, please note the regulation entitled, eonider and of Crise of Cremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,
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
510(k) Number (if known): K041511
Device Name: TRULENE™ Non-absorbable Polypropylene Surgical Suture
Indications For Use:
TRULON™ Non-absorbable Polypropylene 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)
f
Neurological Devices
Restorative
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