The LIGA-LOOP Suture Applicator is intended for use in the suturing of soft tissue and ligation of blood vessels during open and guidance-assisted surgical procedures. The LIGA-LOOP Suture Applicator with polyglycolic acid (PGA) suture and the LIGA-LOOP Suture Applicator with gut suture (plain and chromic) are intended for the same use, excluding cardiovascular and neurological procedures.

Device Description

The LIGA-LOOP™ Suture Applicator is an instrument designed for ligation of soft tissue and blood vessels during surgical procedures. The device also incorporates a central lumen for use in irrigation and/or imaging to increase patient safety during suturing. The LIGA-LOOP™ Suture Applicator contains similar materials, is of similar design, and has the same operating principle as the predicate devices.

AI/ML Overview

The provided document describes the LIGA-LOOP™ Suture Applicator, a surgical instrument designed for ligation of soft tissue and blood vessels. The summary of safety and effectiveness mainly focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific acceptance criteria and performance data from a standalone study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for the LIGA-LOOP™ Suture Applicator or specific performance metrics against those criteria. Instead, it focuses on qualitative comparisons to predicate devices and general statements about "reliable performance."

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Not explicitly stated in quantitative terms. The primary acceptance criterion was likely demonstrating substantial equivalence to predicate devices in terms of intended use, operating principle, and material characteristics, and ensuring no new safety or performance issues.	"Test results indicate reliable performance when the device is used in accordance with the Instructions for Use. Manipulation of the suture material does not affect suture diameter or knot pull-strength. The LIGA-LOOP™ Suture Applicator does not raise any new safety, effectiveness, or performance issues." (This is a general statement, not quantitative performance against a specific criterion).
Knot pull strength of suture material	"Manipulation of the suture material does not affect... knot pull-strength." (Implies meeting an unstated threshold relative to the predicate or industry standards).
Suture diameter	"Manipulation of the suture material does not affect suture diameter..." (Implies meeting an unstated threshold relative to the predicate or industry standards).

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for the tests performed on the LIGA-LOOP™ Suture Applicator.
The data provenance is not mentioned, but given the nature of the device (surgical instrument), the tests would have been conducted in a laboratory or simulated environment, likely in the US, as the applicant is a US company. The tests are non-clinical.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The tests described are "Knot pull strength testing and diameter measurements of suture materials," which are objective physical measurements rather than assessments requiring expert judgment for ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the tests involved objective physical measurements, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The device is a surgical instrument, not an AI or imaging diagnostic tool that would typically involve such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:

Not applicable. The device is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth for the tests (knot pull strength and suture diameter) would be the objective measurements obtained from standardized testing methods.

8. The Sample Size for the Training Set:

Not applicable. The LIGA-LOOP™ Suture Applicator is a physical medical device, not an AI/machine learning model, so there is no training set in this context.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the number '993695'. The characters are written in a bold, handwritten style, with some variations in stroke thickness.

LIGA-LOOP™ Suture Applicator

SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and cffectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 80.192.

Submitter's name, address, telephone number, contact person, and date 1. summary prepared:
- Submitter: ಡಿ HysteRx™, Inc. 32236-E Paseo Adelanto San Juan Capistrano, CA 92675 (949) 488-8701
- b. Contact Person: Judy F. Gordon, D.V.M. Official Correspondent for HysteRx™, Inc. ClinReg Consulting Services, Inc. 18732 Saginaw Irvine, CA 92612 (949) 854-6314 (phone) (949) 854-9652 (fax)
- c. Date Summary Prepared: March 29, 2000
1. Name of device, including trade name and classification name:
- Trade/Proprietary Name: a. LIGA-LOOP™ Suture Applicator
- b. Classification Name: Instrument, Ligature Passing & Knot Tying

Identificution of the predicate device or legally marketed device or devices to 3. which substantial equivalence is being claimed:

a.	Company:	Advanced Surgical, Inc.
	Device:	Endoscopic Ligation Device
	510(k):	K950126
	Date Cleared:	April 13, 1995

b. Company: Olympus Corporation Device: Resectoscope Sheath 510(k): K931994/A
LIGA-LOOP Sulure Applicator K993695 Summary of Safety and Effectiveness March 30, 2000 1 of 4

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Date Cleared: February 17, 1994

4. A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

છે. Statement of intended use:

The T.IGA-LOOP™ Suture Applicator is indicated for use in the ligation of soft tissue and blood vessels during open and guidance-assisted surgical procedures. The LIGA-LOOP Suture applicator with polyglycolic acid (PGA) suture and the LIGA-LOOP Suture Applicator with gut suture (plain and chromic) are intended for the same use, excluding cardiovascular and neurological procedures.

6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.

A comparison of the technological characteristics of the device and its predicate is shown in the following table:

LIGA-L()OP Suture Applicator K993695 Summary of Safety and Effectiveness March 30, 2000 2 of 4

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CHARACTERISTICS	LIGA-LOOPT™ SutureApplicatorHysteRx™, Inc.	Endoscopic LigationDeviceAdvanced Surgical	Resectoscope SheathOlympus Corporation
Intended Use	For ligation of soft tissueand blood vessels duringopen and guidance-assisted surgicalproceduresFor LIGA-LOOP withPGA or gut suture,cardiovascular andneurological proceduresare excluded	For tying sutures aroundstructures such as bloodvessels and ducts duringminimally invasive(laparoscopic) surgery	For insufflation, irrigationand aspiration
Operating Principle	Passes suture aroundtargeted tissue and/orvessel using snare deviceto complete ligationNo suture needles used.Central lumen providesfor fluid managementand/or imaging duringsuturing	Passes suture aroundtargeted tissue and/orvessel using snare deviceto complete ligationNo suture needles used.	Allows for fluidmanagement duringhysteroresectionprocedures
Performance Testing	Knot pull strength testingand diametermeasurements of suturematerials	Knot pull strength testing,diameter measurements ofsuture materials, ligationleakage testing	N/A
Handpiece and TipConfiguration:	Slide-type handpiece, J-shaped tip for graspingtissue and/or vessel	Stapler-type handpiece,with J-shaped tip forgrasping tissue and/orvessel	N/A
Dimensions:Cannula (Fr):	Outer shaft is available in2 sizes: 30 Fr and39 Fr	Made to fit within 7, 10,11, and 12 mm trocarcannulas	Outer diameter is18.9 Fr to 28 Fr
Cannula Shaft Length(cm):	Available in 2 sizes, 12cm and 24 cm	Unknown	N/A
Lumen Diameter(mm):	Irrigation/ Aspiration/Imaging lumen isavailable in 2 sizes, 4.8mm and 9 mm in diameter	N/A	Lumen diameter is 4-6mm
Patient contact portionof device*	Outer Shaft, Jaws, Snare,and Suture	Outer Shaft, FunctionalTip, Snare, and Suture	Sheath
Materials:
Handle	ABS	Stainless steel oraluminum	N/A
Outer shaft	Stainless steel	Stainless steel oraluminum	Stainless steel
Tips	Stainless steel, nitinol	Polycarbonate, stainlesssteel	Zirconium oxide ceramic
Suture Cartridge	N/A	Polycarbonate, stainlesssteel	N/A
Sutures	Plain gut, chromic gut,silk, PGA	Chromic Gut, silk,polypropylene	N/A
Potting	Epoxy	N/A	N/A
Central Lumen	Stainless steel	N/A	Stainless steel
Sterilization method	Gamma radiation, 25-40kgy	Chromic gut and silkcartridges: gammaradiation:polypropylene:EOHandle: autoclave.	Unknown
Disposable/Reusable	Single use, disposable	Suture cartridges: singleuse, disposableHandle: reusable,autoclavable	Reusable

Comparative Technological Characteristics

17-11-

CLINERO

LIGA-LOOP Suture Applicator K993692 Summary of Safety and Effectiveness March 30, 2000

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Brief summary of nonclinical tests and results: 7.

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The LIGA-I.OOP™ Suture Applicator was tested to ensure that manipulation during installment of the suture to the applicator does not significantly affect suture diameter or knot pull-strength of the suture material. Test results indicate rcliable performance when the device is used in accordance with the Instructions for Use. Manipulation of the suture material does not affect suture diameter or knot pull-strength. The LIGA-LOOP™ Suture Applicator does not raise any new safety, effectiveness, or performance issues.

LIGA-LOOP Suture Applicator K993692 Summary of Safety and Effectiveness March 30, 2000 4 of 4

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal, there is an emblem that appears to be three stylized birds in flight.

APR 1 3 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

HysteRx™ c/o Judy F. Gordon, D.V.M. ClinReg Consulting Services, Inc. 18732 Saginaw Irvine, California 92612

Re: K993695 Trade Name: LIGA-LOOPTM Suture Applicator Regulatory Class: II Product Code: GAL, GAM, GAP, GEA Dated: February 15, 2000 Received: February 17, 2000

Dear Dr. Gordon:

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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 - Judy F. Gordon, D.V.M.

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,

Dina R Lochner.

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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K993695

Page __ l__ of__l_

510(k) Number (if known):

Device Name: LIGA-LOOP Suture Applicator

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Vochner.
Sign-Off

ion of General Restorative Devices
Number K993695

Image /page/6/Picture/10 description: The image shows the words "Perscription Use" in a simple, sans-serif font. To the right of the words, there is a large "X" mark. The "X" mark appears to be hand-drawn, with slightly uneven lines.

()ver-lihe-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 878.4830 Absorbable surgical gut suture.

(a)
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.(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.