(360 days)
TRUBOND™ Non-absorbable Polyethylene Terephthalate Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
"TRUBOND" is a Nonabsorbable (Poly cthylene terephthalate) Surgical Suture, is a multifilament nonabsorbable, sterile, flexible thread prepared from fibres of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. Polycster Nonabsorbable Surgical Suture meets united states "TRUBOND" (U.S.P.) requirements as described in the U.S.P monograph for pharmacopcia "Nonabsorbable surgical sutures"; it is coated with a highly adherent biologically inert polybutylate and it may be undyed or dyed with D&C green no-5, conforming to U.S.Code of Federal Regulations 21 CFR 74.1205 or with Logwood extract black, conforming to U.S.Code of Federal Regulations 21 CFR 73.1410 . The suture may be provided with or without a standard needle attached.
The provided documents describe a 510(k) submission for a nonabsorbable polyester surgical suture called "TRUBOND". The submission aims to demonstrate substantial equivalence to existing predicate devices rather than proving novel effectiveness. Therefore, the information provided focuses on comparative testing against recognized standards (USP 26) rather than a clinical study with human readers or AI.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the TRUBOND suture are defined by meeting or exceeding the specifications outlined in the United States Pharmacopeia (USP) current edition USP26. The reported device performance indicates that the TRUBOND suture meets or exceeds these USP specifications.
| Acceptance Criteria (from USP26) | Reported Device Performance (TRUBOND) |
|---|---|
| Diameter <861> | Meets or exceeds USP specifications |
| Tensile strength <881> | Meets or exceeds USP specifications |
| Needle attachment <871> | Meets or exceeds USP specifications |
| Extractable color | Meets or exceeds USP specifications |
| Sterility | Meets or exceeds USP specifications |
| Finish suture Length Requirement (95% of stated label length) | Meets or exceeds USP specifications |
| Packaged in a same or equivalent manner with sterile single or double packing having labeling conforming to 21CFR and USP 26 | Same or equivalent manner, conforming to 21CFR and USP 26 |
| Biologically compatible (as per ISO-10993) | Biologically compatible |
Study Information
The document describes no clinical study in humans or AI performance study that meets the criteria of your request (e.g., MRMC, standalone algorithm performance). The "study" referenced is a series of tests performed on the device to comply with regulatory standards and demonstrate equivalence to predicate devices.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Testing of suture diameter, suture length, knot pull tensile strength, extractable color, needle attachment strength and sterility". This implies that multiple samples of the TRUBOND suture were tested for each characteristic, but the exact number of samples (test set size) is not provided.
- Data Provenance: The tests were conducted internally by Sutures India Pvt. Ltd. to demonstrate compliance with USP 26 standards for their TRUBOND suture. The data origin is thus the manufacturing and testing facility of the applicant. It is a prospective set of tests designed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- No experts were explicitly mentioned for establishing ground truth in the context of clinical interpretation or diagnostic accuracy.
- The ground truth for the test set characteristics (e.g., diameter, tensile strength) is defined by the objective, quantitative specifications of the USP 26 monograph. The "experts" in this context would be the technicians or engineers performing the physical and chemical tests according to established USP methodologies. Their qualifications are not specified but would typically involve training in quality control and laboratory testing procedures for medical devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, where there's a need to resolve discrepancies between human readers. For the physical and chemical tests performed on the suture, the results are quantitative and objective, based on standardized measurement techniques. Discrepancies would involve re-testing or calibration issues rather than expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices involving human interpretation of data. The TRUBOND suture is a physical medical device, not a diagnostic algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This applies to AI algorithms and is not relevant for a surgical suture.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the device's characteristics (diameter, tensile strength, sterility, etc.) is the objective, quantitative specifications and methodologies defined by the United States Pharmacopeia (USP) current edition USP26. For biological compatibility, the ground truth is established by ISO-10993 standards. These are established, recognized regulatory standards for medical device properties.
8. The sample size for the training set:
- Not applicable. There is no mention of an algorithm or AI model, thus no training set or sample size for training is relevant. The manufacturing process of the suture itself might be considered "trained" through years of industrial practice, but this is not a "training set" in the context of AI.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/algorithm, no ground truth was established for it.
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JUN 2 - 2005
SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYESTER 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. |
| PH.NO. | : 91-80-28395150 / 28370367 / 28377850 |
| FAX NO | : 91-80-28392280. |
| : sutures@vsnl.com | |
| Web address | : www.suturesin.com |
B. Contact Person : L.G.Chandrasekhar : MANAGING DIRECTOR
C. Date Prepared : May 15,2004
D. DEVICE NAME
- Trade Name . : TRUBOND
- . Common name : Nonabsorbable Surgical Suture,U.S.P. (Coated and Braided Polyester)
- Classification Name : Nonabsorbable (Poly ethylene Terephthalate) Surgical Suture .
E. PREDICATE DEVICES
- Polyester Nonabsorbable Surgical Suture, 510(k) Number K001172, C.P.Medical, . Portland, OR 97232.
- Polyester Nonabsorbable Surgical Suture, 510(k) Number K961925. R.K.Medical . L.L.C, Danbury, CT 06810
K041512
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K041512
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SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYESTER SURGICAL SUTURE
PAGE NO: -16-2 SEC.LION NO:16
F. DESCRIPTION OF THE DEVICE
·TRUBOND" is a Nonabsorbable (Poly cthylene terephthalate) Surgical Suture, is a multifilament nonabsorbable, sterile, flexible thread prepared from fibres of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component.
Polycster Nonabsorbable Surgical Suture meets united states "TRUBOND" (U.S.P.) requirements as described in the U.S.P monograph for pharmacopcia **Nonabsorbable surgical sutures"; it is coated with a highly adherent biologically inert polybutylate and it may be undyed or dyed with D&C green no-5, conforming to U.S.Code of Federal Regulations 21 CFR 74.1205 or with Logwood extract black, conforming to U.S.Code of Federal Regulations 21 CFR 73.1410 . The suture may be provided with or without a standard needle attached.
G. INTENDED USE OF THE DEVICE
Sutures India's "TRUBOND" a Nonabsorbable Surgical Suture (Polyester) is indicated for use in soft tissue approximation and / or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
| Comparison items | SuturesIndiaPvt.ltd | CP Medical | R.K.Medical |
|---|---|---|---|
| Polyester Nonabsorbable Surgical Suture is amultifilament nonabsorbable, sterile, flexiblethread prepared from fibers of high molecularweight, long chain, linear polyesters havingrecurrent aromatic rings as an integralcomponent. | Same | Same | Same |
| The sutures are inert, noncollageneous andnonantigenic. | Same | Same | Same |
| Polyester Nonabsorbable Surgical Suture isavailable undyed or dyed. | D & CGreenNo. 5 orLogwood | D & CGreen No.6 | D & C GreenNo. 6 |
| Polyester Nonabsorbable Surgical Suture isoffered both uncoated and treated withbiocompatible coatings to enhance itshandling properties. | Same | Same | Same |
| Comparison items | SuturesIndia Pvt.Ltd | CP Medical | R.K.Medical |
| Polyester Nonabsorbable Surgical Suture isindicated for use in soft tissue approximationand/ or ligation, including use incardiovascular, ophthalmic and neurologicalprocedures. | Same | Same | Same |
| Polyester Nonabsorbable Surgical Suture issupplied for single use only. | Same | Same | Same |
| Polyester Nonabsorbable Surgical Suture issterilized by EO method | Same | Same | Same |
| Polyester Nonabsorbable Surgical Suture ispackaged in the same or equivalent manner,and has the same or equivalent labelingclaims as the predicate devices includingindications, warnings, cautions andprecautions | Same | Same | Same |
| Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeia current editionUSP26 for Diameter<861> | Same | Same | Same |
| Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeia current editionUSP26 for Tensile strength<881> | Same | Same | Same |
| Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeia current editionUSP26 for Needle attachment<871> | Same | Same | Same |
| Polyester Nonabsorbable Surgical Suturemeets the Official Monograph of the UnitedStates Pharmacopeia current edition USP26for extractable color | Same | Same | Same |
| Polyester Nonabsorbable Surgical Suturemeets the Official Monograph of the UnitedStates Pharmacopeia current edition USP26for Sterility | Same | Same | Same |
| Comparison items | SuturesIndia Pvt.Ltd | C.P. Medical | R.K.Medical |
| Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeia current editionUSP26 for Finish suture Length Requirement(95% of stated label length) | Same | Same | Same |
| Finished suture material packaged in a sameor equivalent manner with sterile single ordouble packing having labeling conformingto 21CFR and USP 26 | Same | Same | Same |
| Polyester Nonabsorbable Surgical Suture isbiologically compatible when tested as perISO-10993 | Same | Same | Same |
COMPARISON TABLE SUTURES INDIA 'S "TRUBOND" POLYESTER NONABSORBABLE SURGICAL SUTURE TO PREDICATE DEVICES
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SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR MISSION OF TREF POLYESTER SURGICAL SUTURE
SECTION NO: 16
PAGE NO: -16-3
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K041512
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SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYESTER SURGICAL SUTURE
PAGE NO: -16-4 SECTION NO:16
CONCLUSION
Sutures India's "TRUBOND" Polyester 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 Logwood extract or D & C Green 5 at a concentration that conforms to the requirements of FDA.
Testing of suture diameter, suture length, knot pull tensile strength, extractable color, needle attachment strength and sterility to methods outlined in USP 26 demonstrates Suture India "TRUBOND" Polyester Nonabsorbable Surgical Suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices.
Duff
L.G.Chandrasekhar Managing Director
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Image /page/4/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 "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 - 2005
Mr. L.G. Chandrasekhar Managing Director Sutures India Private Limited 472 D, 13th Cross, 4th Phase Peenya Industrial Area, Bangalore 560058, India
Re: K041512
Trade/Device Name: TRUBOND™ Non-absorbable Polyethylene Terephthalate Surgical Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT 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.
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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/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
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Indications for Use
K041512 510(k) Number (if known):
Device Name: TRUBOND™ Non-absorbable Polyethylene Terephthalate Surgical Suture
Indications For Use:
TRUBOND™ Non-absorbable Polyethylene Terephthalate 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ortive . . . ... ... ... ... ... ....................................................................................................................................................
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; 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.