(360 days)
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 technologies.
No
The device is a surgical suture used for approximation and/or ligation of soft tissue, not for treating a disease or condition in itself.
No
The device is a surgical suture used for tissue approximation and ligation, not for diagnosing conditions.
No
The device description clearly states it is a physical surgical suture made of polyamide, 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 to diagnose a condition.
- 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: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information about a patient's health status
This device is a surgical suture, which falls under the category of a medical device used for treatment or repair, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
TRULON™ Non-absorbable Polyamide Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Product codes
GAR
Device Description
TRULON Nonabsorbable Polyamide Surgical Suture is a nonabsorbable, sterile, flexible TKOLON Tronaosoroable Feed of long chain aliphatic polymers Nylon 6 and Nylon 6.6. Monomathen Intead Composed Suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture . Nonabsorbable (0.5.1 ) monograph requee may be dyed Logwood Extract, C.175290 conforming to I oryannae Surgieur Strare may 2017 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, cardiovascular, ophthalmic, neurological
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 tensite strength, extractable color and needle attachment strength and sterility to methods outlined in USP 26 demonstrates Sutures India TRULON Nonabsorbable Polyamide 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide 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 monofilament or multifilament in form; 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.
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KO41510
JUN 2 - 2005
Page 1 of 4
SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYAMIDE SURGICAL SUTURE
PAGE NO: -16-1 SECTION NO: 16
510K SUMMARY as required by: 21CFR 807.92
A. APPLICANT INFORMATION
Name
: SUTURES INDIA PVT. LTD
: Sutures India Pvt. Ltd. 118, 3rd Phase, Peenya Industrial Address Arca, Bangalore-560058. India
: 91-80-28395150 / 28370367 / 28377856 PH.NO. :91-80-28392280. FAX NO
| E mail | : sutures@vsnl.com |
|---|---|
| Web address | : www.suturesin.com |
| B. Contact Person | : L.G.Chandrasekhar |
| : MANAGING DIRECTOR |
: May 07,2004 C. Date Prepared
D. DEVICE TRADE NAME
| Trade Name | : TRULON |
|---|---|
| ------------ | ---------- |
: Nonabsorbable Surgical Suture,U.S.P. Common name (Monofilament Polyamide)
- Classification Name : Nonabsorbable Polyamide Surgical Suture .
E. PREDICATE DEVICES
.
- Nylon Nonabsorbable Surgical Suture, 510(k) Number K001173, C.P.Medical, . Portland, OR 97232.
- Nylon Nonabsorbable Surgical Suture, 510(k) Number K960327. R.K.Medical . L.L.C, Danbury, CT 06810
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SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYAMIDE SURGICAL SUTURE -
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page 2
| SECTION NO:16 | PAGE NO: -16-2 |
|---|---|
| --------------- | ---------------- |
F. DESCRIPTION OF THE DEVICE
TRULON Nonabsorbable Polyamide Surgical Suture is a nonabsorbable, sterile, flexible TKOLON Tronaosoroable Feed of long chain aliphatic polymers Nylon 6 and Nylon 6.6. Monomathen Intead Composed Suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture . Nonabsorbable (0.5.1 ) monograph requee may be dyed Logwood Extract, C.175290 conforming to I oryannae Surgieur Strare may 2017 CFR 73.1410 . The suture may be provided with or without a standard needle attached.
G. INTENDED USE OF THE DEVICE
Suture India TRULON Nonabsorbable Ployamide Surgical suture, is indicated for use in soft tissue approximation and/ or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
COMPARISON TABLE SUTURES INDIA'S "TRULON" POLYAMIDE NONABSORBABLE SURGICAL SUTURE TO PREDICATE DEVICES
| Comparison items | Sutures
India Pvt.
Ltd | C.P.Medical | R.K.Medical |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------------|-----------------------|
| Nonabsorbable Polyamide surgical suture is
a nonabsorbable, sterile, flexible
monofilament thread composed of long chain
aliphatic polymers Nylon 6 and Nylon 6.6. | Same | Same | Same |
| The sutures are inert, noncollageneous and
nonantigenic. | Same | Same | Same |
| Nonabsorbable Polyamide surgical suture is
available dyed with logwood extract | Same | Similar | Similar |
| Nonabsorbable Polyamide surgical suture is
offered uncoated | Same | Coated or
uncoated | Coated or
uncoated |
| Nonabsorbable Polyamide 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.
1.td | C.P.Medical | R.K.Medical |
| Nnonabsorbable sterile Polyamide suture
is supplied for single use only. | Same | Same | Same |
| Nnonabsorbable sterile Polyamide suture
is sterilized by EO method | Same | Same | Same |
| Nnonabsorbable sterile Polyamide 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 |
| Nnonabsorbable sterile Polyamide 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 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 |
| Finished suture material meets the
performance requirements defined in the
United States Pharmacopeia
current
edition USP26 for Sterility | 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 |
| Comparison items | Sutures
India Pvt.
Ltd | C.P.Medical | R.K.Medical |
| 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 |
| Nonabsorbable Polyamide Surgical
suture is biologically compatible when
tested as per ISO-10993 | Same | Same | Same |
2
SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYAMIDE SURGICAL SUTURE
Posse 3 of 4
PAGE NO: -16-3 SECTION NO:16
3
K041570
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SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYAMIDE SURGICAL SUTURE
SECTION NO:16 PAGE NO: -16-4
CONCLUSION
Suture India TRULON Nonabsorbable Polyamide 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 at a concentration that conforms to the requirements of Title 21 CFR & 73.1410 or similar FDA approved color, as are of the predicate devices.
Testing of suture diameter, suture length, knot pull tensite strength, extractable color and needle attachment strength and sterility to methods outlined in USP 26 demonstrates Sutures India TRULON Nonabsorbable Polyamide Surgical suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices.
Datz
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 a stylized eagle with three lines representing its body and wings. The eagle is facing right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circle around the eagle.
JUN 2 - 2005
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: K041510
Trade/Device Name: TRULON™ Non-absorbable Polyamide Surgical Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: II Product Code: GAR 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/cdrl/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): K041510
Device Name: TRULON™ Non-absorbable Polyamide Surgical Suture
Indications For Use:
TRULON™ Non-absorbable Polyamide Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Prescription Use _ _ _ _ x_
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)
Elen
tive
rological Devices
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