This 510(k) premarket notification for the LSI Suture Placement Device and Accessories does not contain specific acceptance criteria or an associated study proving the device meets criteria using performance metrics. This submission relies on substantial equivalence to a predicate device rather than performance testing against defined metrics.

Here's a breakdown of why the requested information cannot be fully provided based on the given text:

A table of acceptance criteria and the reported device performance:
- No specific acceptance criteria or performance metrics are listed. The submission focuses on comparing the LSI Suture Placement Device and its accessories to a predicate device (AUTO SUTURE* Suture Closure** device and accessories, K954853) based on "design, function, and indicated use."
- The comparison table lists functional aspects (delivering suture materials, approximating soft tissue, biocompatible materials, sterilization method, packaging) and states they are the "same" between the subject and predicate devices. These are not quantitative performance metrics with associated acceptance criteria.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No test set or performance evaluation data are described. The submission is a premarket notification based on substantial equivalence, not a clinical trial or performance study report.
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 test set or ground truth established for performance evaluation within this document. The "ground truth" for the submission's purpose is the established safety and effectiveness of the predicate device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or related adjudication method is mentioned.
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. This device is a manual surgical instrument, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or is relevant here.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a hardware surgical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of a performance study. The basis for approval is substantial equivalence to a legally marketed predicate device, implying that the predicate's established safety and effectiveness serve as the "ground truth" for the new device's comparable attributes.
The sample size for the training set:
- Not applicable. This device does not involve machine learning or a training set.
How the ground truth for the training set was established:
- Not applicable. This device does not involve machine learning or a training set.

Summary based on the provided text:

The LSI Suture Placement Device and Accessories received 510(k) clearance based on its substantial equivalence to a predicate device (AUTO SUTURE* Suture Closure** device and accessories, K954853). The submission argues that both devices share the same:

Design
Function (deliver suture materials, approximate soft tissue)
Indicated Use (approximation of soft tissue)
Materials (biocompatible)
Sterilization method (ethylene oxide, 10-6 lethality)
Packaging (disposable, thermoformed blister with TYVEK™ cover)

Therefore, no specific performance acceptance criteria or study results are presented within this document because the regulatory pathway chosen (510(k) premarket notification for substantial equivalence) does not typically require novel clinical or performance studies for devices considered substantially equivalent to already marketed devices. The FDA's letter states that the device can be marketed subject to general controls, and assumes compliance with Good Manufacturing Practice (GMP) requirements.

Summary

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K981531

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LSI SOLUTIONS 510(k) Premarket Notification LSI Suture Placement Device and Accessories

JUL 1 3 1998

Premarket Notification [510(k)] Summary

LSI SOLUTIONS
2144 Brighton-Henrietta Town Line Road
Rochester, New York 14623
Phone:	716-427-7979
Fax:	716-427-7482
Contact:	Jude. S. Sauer, M.D., President and CEO orNicholas Reitter IV, Director of Regulatory Compliance
April 28, 1998
Common Name:	Needle Guide
Trade Name:	The trademark name has not yet been determined.
Classification Name:	Manual Surgical Instrument for General Use (per 21 CFR,§878.4800) and an accessory to an endoscope (per 21 CFR§876.1500).
Predicate Device:	AUTO SUTURE* Suture Closure** device and accessories(K954853)
Description:	The LSI Suture Placement device and accessories intended forthe approximation of surgical wounds by passing ligaturethrough soft tissue.
Intended Use:	The LSI Suture Placement device and accessories are intendedfor use in the approximation of soft tissue.

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LSI SOLUTIONS 510(k) Premarket Notification LSI Suture Placement Device and Accessories

Comparison

Summary of how the device and accessories of this application compare to the predicate device. Both the subject device and accessories and the predicate device and accessories use the same technology.

Function	The LSI SOLUTIONS SuturePlacement device and accessoriesdeliver suture materials to thesite of application.	The AUTO SUTURE* SutureClosure** device and accessoriesdeliver suture materials to the siteof application.
Indication	The LSI SOLUTIONS SuturePlacement device and accessoriesapproximate soft tissue.	The AUTO SUTURE* SutureClosure** device and accessoriesapproximate soft tissue.
Materials	The LSI SOLUTIONS SuturePlacement device and accessoriesuse biocompatible materials.	The AUTO SUTURE* SutureClosure** device and accessoriesuse biocompatible materials.
Sterilization	The LSI SOLUTIONS SuturePlacement device and accessoriesare sterilized with ethylene oxide(EtO) such that a minimumlethality of 10-6 (a MSI of 6) isachieved.	The AUTO SUTURE* SutureClosure** device and accessoriesare sterilized with ethylene oxide(EtO) such that a minimumlethality of 10-6 (a MSI of 6) isachieved.
Packaging	The LSI SOLUTIONS SuturePlacement device and accessoriesare disposable devices that arepackaged in a thermoformedblister with a TYVEK™ cover.	The AUTO SUTURE* SutureClosure** device and accessoriesare disposable devices that arepackaged in a thermoformedblister with a TYVEK™ cover.

Summary

The LSI SOLUTIONS Suture Placement device and accessories are substantially equivalent to the AUTO SUTURE* Suture Closure** device and accessories (K954853). Both devices have the same design, function, and indicated use.

Description

The LSI Suture Placement device and accessories are intended for the approximation of soft tissue.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, with the head facing to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

.111 13 1998

Jude S. Sauer, M.D. President LSI Solutions 2144 Brighton-Henrietta Town Line Road Rochester, New York 14623

Re: K981531 Trade Name: Suture Placement Device and Accessories Regulatory Class: II Product Code: GCJ Dated: April 28, 1998 Received: April 29, 1998

Dear Dr. Sauer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Jude S. Sauer, M.D.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510 (k) NUMBER (IF KNOWN) : K981531

SUTURE PLACEMENT DEVICE AND ACCESSORIES DEVICE NAME:

INDICATIONS FOR USE:

The LSI Suture Placement device and accessories are intended for use in the approximation of soft tissue.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON -ANOTHER - PAGE - --IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number

K98153/

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.