(28 days)
Approximation of soft tissue
The LSI "R" Series Suturing Device and Accessories Product, like the predicate, is intended for the approximation or ligation of soft tissue by passing ligature through said soft tissue.
This looks like a 510(k) premarket notification for a surgical instrument, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and ground truth establishment (which are typical for AI/ML device evaluations) are not present in the provided document.
The document describes a traditional medical device submission for the LSI "R" Series Suture Placement Device and Accessories Product. Its purpose is to demonstrate substantial equivalence to a predicate device (LSI Suture Placement Device and Accessories (K981531)).
Here's how to interpret the provided information in the context of a traditional device submission:
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A table of acceptance criteria and the reported device performance: This type of table is not directly applicable to this traditional device submission. For such devices, acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of:
- Indications for Use: Both the new device and the predicate device have the same indication: "Approximation of soft tissue."
- Technological Characteristics: The new device, like the predicate, is described as a "Manual surgical instrument for general use" intended for "passing ligature through said soft tissue." The submission would contain detailed comparisons of materials, design, manufacturing processes, and performance characteristics (e.g., tensile strength, biocompatibility, sterilization validation) to support this claim, but these details are not provided in the summary.
- Safety and Effectiveness: Substantial equivalence implies that the new device is as safe and effective as the predicate. This is typically established through non-clinical bench testing, and sometimes animal studies, but generally not human clinical trials for simple instruments compared to highly similar predicates.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of submission. There isn't a "test set" in the AI/ML sense. Substantial equivalence is often supported by engineering tests and comparisons.
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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): Not applicable. There is no ground truth in the sense of expert annotation for a medical image or diagnostic task.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable, as this is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a traditional surgical instrument would be its ability to perform its intended function safely and effectively, as demonstrated by engineering tests and conformance to standards, not by comparison to expert-labeled data.
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The sample size for the training set: Not applicable, as there is no AI/ML model to train.
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How the ground truth for the training set was established: Not applicable.
Summary based on the provided document:
The LSI "R" Series Suture Placement Device and Accessories Product gained FDA clearance (K040232) based on its substantial equivalence to a previously legally marketed predicate device (LSI Suture Placement Device and Accessories, K981531). The key elements for this determination were:
- Identical Intended Use: Both devices are intended for "Approximation of soft tissue."
- Similar Device Description: Both are manual surgical instruments for general use for passing ligatures through soft tissue.
The "acceptance criteria" implicit in this type of submission are that the new device must share the same intended use and similar technological characteristics with a predicate device, and any differences in technological characteristics must not raise new questions of safety or effectiveness. The "study that proves the device meets the acceptance criteria" would have been a comparative analysis (not a clinical study in the AI/ML sense) demonstrating this substantial equivalence, likely through bench testing and detailed engineering comparisons, the specifics of which are not detailed in this summary document.
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MAR - 1 2004
LSI SOLUTIONS, Inc. 510(k) Premarket Notification LSI "R" Series Suture Placement Device and Accessories Product
11. Premarket Notification [510(k)] Summary
LSI SOLUTIONS, Inc. Submitted By: 7796 Victor-Mendon Road Victor, New York 14564 Phone: (585) 869-6600 Fax: (585) 742-3398 Contact: Christopher A. Klaczyk, Regulatory Compliance Manager
Needle Guide; Manual surgical instrument for general use Common Name:
LSI "R" Series Suture Placement Device and Accessories Product Trade Name:
21 CFR 878.4800; Manual Surgical Instrument for General Use Classification:
Predicate Device: LSI Suture Placement Device and Accessories (K981531)
The LSI "R" Series Suturing Device and Accessories Product, like Description: the predicate, is intended for the approximation or ligation of soft tissue by passing ligature through said soft tissue.
- Approximation of soft tissue. Intended Use:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 2004
Mr. Christopher A. Klaczyk Regulatory Compliance Manager LSI Solutions, Inc. 7796 Victor-Mendon Road Victor, New York 14564
Re: K040232
Ro-N232
Trade/Device Name: LSI "R" Series Suturing Device and Accessories Product Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, HCF Dated: January 28, 2004 Received: February 2, 2004
Dear Mr. Klaczyk:
We have reviewed your Scction 510(k) premarket notification of intent to market the device we have reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases of the enactment date of the Medical Device Amendments, or to conniner of they 2011-12-11 accordance with the provisions of the Federal Food, Drug, de nees mat have not require approval of a premarket approval application (PMA). and Cosmetic (110) that the device, subject to the general controls provisions of the Act. The r ou may, arovisions 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 (sec 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 may be builted to been 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 1 least be device a determination that your device complies with other requirements of the Act that I Dr has Internations and regulations administered by other Federal agencies. You must or car) x 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 Cr R Part 677, aberting (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. Christopher A. Klaczyk
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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LSI SOLUTIONS, Inc. 510(k) Premarket Notification LSI "R" Series Suture Placement Device and Accessories Product
Statement of Indications For Use 7.
Page 1_ of 1
510(k) Number (if known): K040232
LSI "R" Scries Suturing Device and Accessories Product Device Name:
Approximation of soft tissue Indications For Use:
X Over-The Counter Use Prescription Use AND/OR (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K040232
Section 7 - Page 1 of 1
CONFIDENTIAL
§ 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.