(305 days)
Not Found
No
The 510(k) summary describes a standard surgical suture and contains no mention of AI, ML, or related concepts like image processing or performance metrics typically associated with AI/ML devices.
No
The device is an absorbable surgical suture used for soft tissue approximation, which is a surgical tool rather than a therapeutic device in itself.
No
Explanation: The device is an absorbable surgical suture used for tissue approximation, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is an "Absorbable Surgical Suture, Synthetic (Polyglycolic Acid)", which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a surgical suture for soft tissue approximation. This is a device used in vivo (within the body) during a surgical procedure.
- Device Description: The description confirms it's an absorbable surgical suture.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture is indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures
Product codes
GAM
Device Description
Not Found
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)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/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 "HEALTH AND HUMAN SERVICES. U.S. DEPARTMENT OF" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
JUN - 6 2005
Food and Drug Administration 9200 CorporateBoulevard 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: K041515
Trade/Device Name: TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(glycolide/L-lactide) Surgical Suture Regulatory Class: II Product Code: GAM Dated: March 17, 2005 Received: March 21, 2005
Dear Mr. Chandrasekhar:
This letter corrects our substantially equivalent letter of April 8, 2005 regarding the trade name.
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.
1
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,
R.C.K
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
2
Indications for Use
510(k) Number (if known): K041515
TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture Device Name:
Indications For Use:
TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture is indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular 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)
Concurreace of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
Neurological Devices
3
APR 8 2005
SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR ABSORBABLE POLYGLYCOLIC ACID SUTURE
SECTION NO: 17 PAGE NO: -17-1
1041515
510K SUMMARY as required by: 21CFR 807.92
A. APPLICANT INFORMATION
| Name | : SUTURES INDIA PVT. LTD |
|---|---|
| Address | : 472 D 13 th Cross, 4 th Phase, |
| Peenya Industrial Area, | |
| Bangalore-560058. India | |
| PHONE NO. | : 91-80-51272102 / 51272103 / 51272104 |
| FAX NO. | : 91-80-51171056 |
| E mail | : sutures@vsnl.com |
| Web Address | : www.suturesin com |
| B. Contact Person | : L.G.Chandrasekhar |
| : MANAGING DIRECTOR | |
| C. Date Prepared | : May 15,2004 |
D. DEVICE TRADE NAME
- : TRUGLYDE Trade Name .
- : Absorbable Surgical Suture,Synthetic (Polyglycolic Acid) . Common name
- Classification Name: Absorbable (poly glycolic acid) suture .