(361 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
The device is a surgical suture used for tissue approximation and ligation, which is a structural or supportive function, not a therapeutic treatment of a disease or condition.
No
Explanation: The device is a surgical suture used for tissue approximation and/or ligation, which are therapeutic functions. There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly states it is a "natural nonabsorbable silk surgical suture," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures." This describes a surgical tool used directly on a patient's body.
- Device Description: The description details a "surgical 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) outside of the body to provide information about a patient's health status, which is the defining characteristic of an IVD.
Therefore, the TRUSILK Non-absorbable Silk Surgical Suture is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TRUSILK" Non-absorbable Silk Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Product codes
GAP
Device Description
TRUSH.K is a natural nonabsorbable silk surgical suture, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural Nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for "Nonabsorbable Surgical Suture" . Natural Nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive. It will be available with and with out 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
Testing of suture diameter, suture length, knot pull tensile strength and needle attachment strength, extractable color and sterility to methods outlined in USP 26 demonstrates Sutures India's TRUSILK, Natural Nonabsorbable silk suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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
K0415/4
page 1074
3 2005 JUN
SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NATURAL NONABSORBABLE SILK 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. India | |
| PH.NO. | |
| FAX NO | : 91-80-28395150 / 28370367 / 28377856 |
| :91-80-28392280. | |
| E mail | |
| Web address | : sutures@vsnl.com |
| : www.suturesin.com | |
| B. Contact Person | : L.G.Chandrasekhar |
| : MANAGING DIRECTOR | |
| C. Date Prepared | : May 15,2004 |
D. DEVICE TRADE NAME
- . Trade Name : TRUSILK Common name . : Nonabsorbable Surgical Suture, U.S.P.
- (Black Braided Silk)
- Classification Name :Natural Nonabsorbable Silk Surgical Suture. .
E. PREDICATI: DEVICES
- Silkam Nonabsorbable surgical suture, 510(k) Number K990089, AESCULAP, . South San Fransisco, California.
- Silk Nonabsorbable surgical suture, 510(k) Number K960328. R.K.Medical . L.L.C. Danbury , CT06810
1
SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NATURAL NONABSORBABLE SILK SURGICAL SUTURE
PAGE NO: -16-2 SECTION NO: 16
F. DESCRIPTION OF THE DEVICE
TRUSH.K is a natural nonabsorbable silk surgical suture, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural Nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for "Nonabsorbable Surgical Suture" . Natural Nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive. It will be available with and with out a standard needle attached.
G. INTENDED USE OF THE DEVICE
Sutures India TRUSH.K Natural nonabsorbable silk 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 | Aesculap | R.K.Medical |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|----------|-------------|
| Natural Nonabsorbable silk surgical suture is
a nonabsorbable, sterile,
flexible
multifilament thread composed of an organic
protein called fibroin. This protein is derived
from the domesticated species Bombyx mori
(B. mori) of the family Bombycidae. | Same | Same | Same |
| The sutures are inert, noncollageneous and
nonantigenic. | Same | Same | Same |
| Natural nonabsorbable silk surgical suture is
available undyed or dyed with logwood
extract | Same | Same | Same |
| Natural nonabsorbable silk surgical suture is
offered both uncoated, and treated with
biocompatible coatings to enhance its
handling properties. | Same | Same | Same |
| Natural Nonabsorbable silk suture is
indicated for use in soft tissue approximation
and/ or ligation, including use in
cardiovascular, ophthalmic and neurological
procedures. | Same | Same | Same |
| SECTION NO:16 | PAGE NO: -16-3 | | |
| Comparison items | Sutures
India
Pvt.ltd | Aesculap | R.K.Medical |
| Natural nonabsorbable sterile silk suture is
supplied for single use only. | Same | Same | Same |
| Natural nonabsorbable sterile silk suture is
sterilized by EO method | Same | Same | Same |
| Natural nonabsorbable silk 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 |
| Natural nonabsorbable silk 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 |
| Natural nonabsorbable silk suture meets the
Official Monograph of the United States
Pharmacopcia current edition USP26 for
Sterility | 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 |
| Nonabsorbable Surgical Suture (Braided
Silk Black) is biologically compatible when | Same | Same | Same |
COMPARISON TABLE SUTURES INDIA `S "TRUSILK" NATURAL SILK NONABSORBABLE SURGICAL SUTURE TO PREDICATE DEVICES
2
K04514
page 3 of 4
SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NATURAL NONABSORBABLE SILK SURGICAL SUTURE
3
K041514 page 494
SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NATURAL NONABSORBABLE SILK SURGICAL SUTURE
SECTION NO: 16 PAGE NO: - 16-4
CONCLUSION
Sutures India's TRUSILK is Natural Nonabsorbable silk suture, 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, as are of the predicate devices.
Testing of suture diameter, suture length, knot pull tensile strength and needle attachment strength, extractable color and sterility to methods outlined in USP 26 demonstrates Sutures India's TRUSILK, Natural Nonabsorbable silk suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices.
Robert F
L.G.Chandrasekhar Managing Director
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping figures suggesting community or support.
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: K041514
Trade/Device Name: TRUSILK™ Non-absorbable Silk Surgical Suture Regulation Number: 21 CFR 878.5030 Regulation Name: Natural nonabsorbable silk surgical suture Regulatory Class: II Product Code: GAP 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 we have teviewed your becalled by (4) personally equivalent (for the indications for use stated in above and nave determined the ad predicate devices marketed in interstate commerce prior to the chelosure) to regary mantowe of the Medical Device Amendments, or to devices that have been May 20, 1770, the chartinent and on the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require upproval or a premails provisions of the Act. The general controls provisions of the device, dolor to the gallery 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 be subject to such 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 that I case or advised that 12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I DA ilas made a deceminations administered by other Federal agencies. You must comply with all the I caral states and regarding, 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) (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) 276-0120 . 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
510(k) Number (if known): K041514
Device Name: TRUSILK™ Non-absorbable Silk Surgical Suture
Indications For Use:
TRUSILK" Non-absorbable Silk 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) Page 1 of 1