(62 days)
Not Found
No
The document describes a standard surgical suture and does not mention any AI or ML capabilities.
No
The device is a surgical suture used for tissue approximation, which aids in the healing process but does not directly cure or mitigate a disease or condition in the way a therapeutic device would.
No
Explanation: The document describes MONOGLYDE as a synthetic absorbable surgical suture used for "general soft tissue approximation." There is no mention of the device collecting, analyzing, or interpreting biological data to identify a disease, condition, or information related to health. It is a therapeutic device for closing wounds.
No
The device description clearly states it is a synthetic absorbable surgical suture, which is a physical, hardware medical device. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation" in surgical procedures. This is a direct interaction with the patient's body during surgery, not a test performed on a sample taken from the body.
- Device Description: The device is a "synthetic absorbable surgical suture." This is a physical implant/material used to hold tissue together.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a surgical tool.
N/A
Intended Use / Indications for Use
Sutures India's MONOGLYDE Absorbable Poliglecaprone suture, is indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures.
MONOGLYDE IS A SYNTHETIC ABSORBABLE (POLIGLECAPRONE 25) SURGICAL SUTURE; STERILE FLEXIBLE STRAND, PREPARED AND SYNTHESIZED FROM THE MONOMERS, POLYGLYCOLIC ACID 75% AND CAPROLACTONE 25% AND IS INDICATED FOR USE IN GENERAL SOFT TISSUE APPROXIMATION, BUT NOT FOR USE IN OPHTHALMIC SURGERY, CARDIO-VASCULAR AND NEUROLOGICAL TISSUES
Product codes
GAM
Device Description
MONOGLYDE is synthetic absorbable surgical suture, (Monofilament Poliglecaprone 25). Monoglyde is a sterile flexible monofilament thread, composed of Caprolactone. The sutures are inert, non collageneous and non antigenic.
MONOGLYDE is dyed with D&C Violet #2 and it is available undyed also.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, ophthalmic procedures, cardio vascular and neurological procedures (not for use)
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, needle attachment strength, extractable color and sterility to methods outlined in USP 29 demonstrates Sutures India's MONOGLYDE, Absorbable (Poliglecaprone 25) suture meets or exceeds In-house 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
§ 878.4493 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.
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SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR ABSORBABLE (POLIGLECAPRONE 25) SUTURE
JUN - 9 2008
PAGE No: 17.0-1 SECTION No: 17.0
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. | : 91-80-41868000 (30 lines) |
| FAX NO. | : 91-80-41171056 |
| E mail | : sales@suturesin.com |
| Web Address | : www.suturesin.com |
| B. Contact Person | : L.G.Chandrasekhar |
| MANAGING DIRECTOR | |
| C. Date Prepared | : 1.4.2008 |
| D. DEVICE NAME | : |
- : MONOGLYDE Trade Name .
- : Absorbable Surgical Suture, Synthetic (Poliglecaprone 25) Common name
- : Absorbable (Poliglecaprone 25) suture Classification Name .
F. PREDICATE DEVICES
- A. Monocryl, Absorbable (Poliglecaprone 25) sutures, 510(k) Number K930772, Ethicon Incorporation, Somerville, NJ 088760151
B. Unicaprone Absorbable (Poliglecaprone 25) Suture, 510(k) Number K072646, United Medical Industries Co.Ltd (UNIMED), Riyadh, SA 11553
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SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR ABSORBABLE (POLIGLECAPRONE 25) SUTURE
KO81002
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PAGE No: 17.0-2 SECTION No: 17.0
F. DESCRIPTION OF THE DEVICE
MONOGLYDE is synthetic absorbable surgical suture, (Monofilament Poliglecaprone 25). Monoglyde is a sterile flexible monofilament thread, composed of Caprolactone. The sutures are inert, non collageneous and non antigenic.
MONOGLYDE is dyed with D&C Violet #2 and it is available undyed also.
G. INTENDED USE OF THE DEVICE
Sutures India's MONOGLYDE Absorbable Poliglecaprone suture, is indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures.
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K0 81002
page 3 of 5
SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR ABSORBABLE (POLIGLECAPRONE 25) SUTURE SECTION No: 17.0
COMPARISON TABLE SUTURES INDIA'S "MONOGLYDE" ABSORBABLE POLIGLECAPRONE SUTURE TO PREDICATE DEVICES
.
| Comparison Parameters | Monoglyde | Monocryl | Unicaprone |
|---|---|---|---|
| Absorbable (Poliglecaprone 25) suture is a synthetic Absorbable surgical suture. It is a sterile flexible monofilament thread, composed of Poliglecaprone. | Same | Same | Same |
| The sutures are inert, noncollageneous and nonantigenic. | Same | Same | Same |
| Absorbable (Poliglycaprone 25) suture is dyed with D&C Violet #2 and being monofilament it is coated | Same | Same | Same |
| Absorbable (Poliglecaprone 25) suture is indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures. | Same | Same | Same |
| Absorbable (Poliglecaprone 25) suture is supplied for single use only. | Same | Same | Same |
| Absorbable (Poliglecaprone 25) suture is sterilized by E.O. gas method | Same | Same | Same |
| Absorbable (Poliglecaprone 25) suture is packaged in the same or equivalent manner, and has the same or equivalent labeling claims as that of the predicate devices including indications, warnings, cautions and precautions | Same | Same | Same |
| Absorbable (Poliglecaprone 25) suture meets the official monograph of the United States Pharmacopeia current edition U.S.P. 29 for extractable color. | Same | Same | Same |
| Absorbable (Poliglecaprone 25) suture meets the performance requirements defined in the United States Pharmacopeia current edition U.S.P. 29 for Diameter | Same | Same | Same |
| Absorbable (Poliglecaprone 25)suture meets the performance requirements defined in the current edition of U.S.P. 29 for Tensile strength | Same | Same | Same |
| Comparison Parameters | Monoglyde | Monocryl | Unicaprone |
| Absorbable (Poliglecaprone 25) suture | |||
| meets the performance requirements defined | |||
| in the ia current edition of U.S.P. 29 for | |||
| Needle attachment | Same | Same | Same |
| Absorbable (Poliglecaprone 25) suture | |||
| meets the performance requirements defined | |||
| in the United States Pharmacopeia current | |||
| edition U.S.P. 29 for finished suture Length | |||
| Requirement (95% of stated label length) | Same | Same | Same |
| Absorbable (Poliglecaprone 25) suture | |||
| meets the performance requirements defined | |||
| in the United States Pharmacopeia current | |||
| edition U.S.P. 29 for sterility | Same | Same | Same |
| Absorbable (Poliglecaprone 25) suture is | |||
| packed in a same or equivalent manner with | |||
| sterile single or double packing having | |||
| labeling conforming to 21CFR & U.S.P. 29 | Same | Same | Same |
| Absorbable (Poliglecaprone 25) suture is | |||
| biologically compatible when tested as per | |||
| ISO-10993 | Same | Same | Same |
| Absorbable (Poliglecaprone 25) suture is | |||
| tested and proved to be non toxic, when | |||
| tested as per ISO-10993 for toxicity | Same | Same | Same |
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K081002
page 4 of 5
:
:
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K081002
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SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR ABSORBABLE (POLIGLECAPRONE 25) SUTURE
PAGE No: 17.0-4 SECTION No: 17.0
CONCLUSION
Sutures India's MONOGLYDE Absorbable (Poliglecaprone 25) suture is composed of the same material, as that of the predicate 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 D&C Violet No.2 at a concentration that conforms to the requirements of Title 21 CFR § 74.3602, as are of the predicate devices.
Testing of suture diameter, suture length, knot pull tensile strength, needle attachment strength, extractable color and sterility to methods outlined in USP 29 demonstrates Sutures India's MONOGLYDE, Absorbable (Poliglecaprone 25) suture meets or exceeds In-house specifications and are equivalent in terms of the above mentioned predicate devices.
For SUTURES INDIA PVT. LTD,
- G. CHANDRASEKHAR
L.G. ChandraselthaECTOR Managing Director
5
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, facing to the left. The eagle is stylized with three lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2008
Sutures India Private Limited % L.G. Chandrasekhar 472 D 13th Cross, 4th Phase Peenya Industrial Area Bangalore-560058 India
Re: K081002
Trade/Device Name: MONOGLYDE Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: May 22, 2008 Received: May 27, 2008
Dear L.G. 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
6
Page 2 - L.G. Chandrasekhar
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Mullan
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number K081002
Device Name: MONOGLYDE
ABSORBABLE SURGICAL SUTURE (SYNTHETIC) (MONOFILAMENT POLIGLECAPRONE 25)
Indications For Use:
MONOGLYDE IS A SYNTHETIC ABSORBABLE (POLIGLECAPRONE 25) SURGICAL SUTURE; STERILE FLEXIBLE STRAND, PREPARED AND SYNTHESIZED FROM THE MONOMERS, POLYGLYCOLIC ACID 75% AND CAPROLACTONE 25% AND IS INDICATED FOR USE IN GENERAL SOFT TISSUE APPROXIMATION, BUT NOT FOR USE IN OPHTHALMIC SURGERY, CARDIO-VASCULAR AND NEUROLOGICAL TISSUES
Neil R.P. O'Flynn for man
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
1081002 510(k) Number__
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