The AMS Coaguloop™ Resection Electrode has the same intended use as the Olympus™ Resectoscope Loop Electrode. These products are intended to be used for the resection, ablation, and fulguration of soft tissue.
The AMS Coaguloop™ Resection Flectrode is intended to be used for the resection, ablation, and fulguration in the prostate gland.

Device Description

The Coaguloop™ consists of either a single or double conductor. The conductor(s) either form or are in electrical communication with a cutting loop that is designed to concentrate the current and cut and coagulate soft tissue as it is drawn along. The grooves at the tip of the electrode are designed with the intent to further enhance the current density at the tip of the grooves. This allows for cutting, and the utilization of the larger surface area on the underside of the grooves and loop, which generates the heat required for the coagulation of resected tissue.
The AMS Coaguloop™ Resection Electrode is designed for use in several resectoscope designs with general purpose monopolar electrosurgical generators. The AMS Coaguloop™ Resection Electrode is manufactured in four (4) configurations designed for use with the following manufactured resectoscopes: Storz™, Circon/ACMI™, Olympus™, and Richard Wolf™.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AMS Coaguloop™ Resection Electrode, which seeks substantial equivalence to the Olympus™ Resectoscope Loop Electrode. The submission focuses on demonstrating the new device's similarity to the predicate device in terms of intended use, principle of operation, application, materials, design, and sterility.

Here's an analysis of the acceptance criteria and study information based on the provided text, formatted to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative "acceptance criteria" in the format of specific thresholds for metrics like sensitivity or specificity, as one might find in an AI/software device submission. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device through various bench tests and comparisons of characteristics. The "performance" is reported as meeting specifications or being comparable to the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance
Functional Equivalence	The AMS Coaguloop™ Resection Electrode has the same intended use (resection, ablation, and fulguration of soft tissue) and principle of operation (electrocautery current conducted through a loop) as the Olympus™ Resectoscope Loop Electrode. It is also designed for similar application with standard endoscopic electroscopes and electrosurgical power sources.
Biocompatibility	The device is manufactured from materials widely used in the medical device industry (primarily Molybdenum, with Tungsten/Molybdenum wire and non-conducting shrink wrap) that have undergone extensive biocompatibility testing. The predicate device uses Tungsten wire with non-conducting shrink wrap.
Reliability & Adherence to Performance Specifications	Bench testing was performed including: Fit Test, Destructive Test, Biocompatibility Test, Dielectric/Continuity Test, Metallurgical Analysis, Loop Area Calculations, Animal Test, Coaguloop Histopathology Analysis of Lapine and Canine Tissue Samples, Current Distribution Test, Packaging Test I, and Packaging Test II. "The results of the testing determined that the electrodes performed per specification."
Manufacturing Quality	"All components are manufactured using rigid conformance standards to ensure the safe and effective performance of the finished product. Frequent, detailed quality checks are carried out at each phase of the assembly process to verify that only those units meeting all parameters are released for sale."
Sterility	The electrode is delivered sterile and is designed for single-use only, sterilized by Gamma radiation. This is comparable to the predicate device which is "Sterile/disposable."
Material Composition	The AMS Coaguloop™ uses "Tungsten/Molybdenum wire insulated with non-conducting shrink wrap." The predicate uses "Tungsten wire insulated with non-conducting shrink wrap." (A slight difference in material, but not presented as a non-conformance for substantial equivalence within the context of the document.)
Design Characteristics	The AMS Coaguloop™ has a "Flat loop with multiple shallow grooves." The predicate has "A circular loop." (Again, a difference in design, but one that the manufacturer argues does not negate substantial equivalence, implying performance is maintained.) The grooves are intended to "further enhance the current density at the tip of the grooves" for cutting, and the larger surface area for coagulation.

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

The document does not specify a distinct "test set" in the context of clinical trials or data for an AI/software device. The evaluations were primarily conducted through a series of bench tests and animal tests.

Bench Tests: The document lists several bench tests (Fit, Destructive, Dielectric/Continuity, Metallurgical Analysis, Loop Area Calculations, Current Distribution, Packaging Tests I & II). The sample sizes for these tests are not provided, nor is their provenance (e.g., country of origin). These are typically laboratory studies.
Animal Test and Histopathology: The document mentions an "Animal Test" and "Coaguloop Histopathology Analysis of Lapine and Canine Tissue Samples." This indicates that animal models (rabbits - lapine, and dogs - canine) were used for in-vivo testing to assess tissue effects. The specific number of animals or tissue samples used is not specified.

This is a premarket notification for a physical medical device (an electrosurgical electrode), not an AI/software device. Therefore, the concept of a "test set" in the context of large datasets for model evaluation is not applicable here. The "data provenance" is laboratory and animal study derived.

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

Since this is a physical medical device with bench and animal testing, the concept of "ground truth" derived from expert consensus on images or similar data is not directly applicable.

Bench Test "Ground Truth": The "ground truth" for bench tests would be the established engineering specifications and physical properties of the materials and device. Compliance is determined against these specifications, likely by engineers and quality control personnel. No specific number or qualifications of 'experts' for this ground truth are mentioned.
Animal Study "Ground Truth": For the "Coaguloop Histopathology Analysis," the ground truth would be established by veterinary pathologists who would examine the tissue samples for specific effects (e.g., degree of cutting, coagulation, tissue damage). The number of pathologists or their specific qualifications (e.g., years of experience) are not provided in this document.

4. Adjudication Method for the Test Set

Not applicable in the context of this 510(k) submission for a physical device. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or expert reviews of diagnostic data, for which this submission does not provide details.

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

No, an MRMC comparative effectiveness study was not done. These studies are typically performed for diagnostic devices or AI algorithms where human readers interpret cases, and improvement with AI assistance is evaluated. This submission is for a surgical electrode.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. "Standalone performance" refers to the performance of an AI algorithm without human involvement. This document describes a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for evaluating this device largely consisted of:

Engineering Specifications and Material Properties: For bench tests (fit, destructive, dielectric, metallurgical analyses, loop area, current distribution, packaging).
Histopathology: For animal studies, where tissue samples were analyzed to determine the effects of cutting and coagulation.
Predicate Device Comparison: The ultimate "ground truth" for the 510(k) submission is the functional and safety profile of the legally marketed predicate device (Olympus™ Resectoscope Loop Electrode), against which the new device seeks to prove "substantial equivalence."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device where "training sets" are used.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device.

Summary

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American Medical Systems, Inc Pfizer Hospital Products Gre 2 933 4666 Fax 612 930 6592 Coll Free 800 328 388

1971512

P 1 87 4

Image /page/0/Picture/3 description: The image shows the Pfizer logo. The logo is in black and white and features the word "Pfizer" in a stylized font. The word is set inside of an oval shape.

merican Medical Systems

SUMMARY OF SAFETY AND EFF

SUBMITTER JUL 2 4 1997 I.

Name and Address:

American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 USA

Establishment Registration Number:

Contact Person:

John M. Otto April 25, 1997

2183959

Date of Summary Preparation:

II. MANUFACTURER

Name and Address:

Establishment Registration Number:

III. DEVICE NAME

Device Common or Usual Name:

Pemstar, Inc. 2535 Highway 14 West Rochester, MN 55901 USA

2133786

Unit, Electrosurgical, Endoscopic (With or Without Accessories)

Device Trade Name:

AMS Coaguloop™ Resection Electrode

IV. PREDICATE DEVICE

Olympus™ Resectoscope Loop Electrode K903323

DEVICE DESCRIPTION V.

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P294 The AMS Coaguloop™ Resection Electrode is designed for use in several resectoscope designs with general purpose monopolar electrosurgical generators. The AMS Coaguloop™ Resection Electrode is manufactured in four (4) configurations designed for use with the following manufactured resectoscopes: Storz™, Circon/ACMI™, Olympus™, and Richard Wolf™. The components of each configuration follows:

INDICATION FOR USE VI.

COMPARISON TO PEDICATE DEVICE VII.

American Medical Systems' Coaguloop™ Resection Electrode is similar in indications, design, and features to various resectoscope electrodes that are in commercial distribution. The predicate device that AMS is claiming substantial equivalence to is the Olympus™ Resectoscope Loop Electrode (K903323).

Intended Use a.

Principles of Operation b.

The basic principle of the function of the Coaguloop™ resection electrode involves developing a circuit consisting of a power generator and an active electrical circuit.

The power generator is the source of electron flow and voltage. The active electrical circuit is composed of the generator , the active resecting electrode, the patient, and the patient return electrode (grounding pad).

The electrode or loop acts as an antenna which transmits electrical current (power in Watts/cm2) of a specific wave form from the generator in a range from 500 KHz - 3.3 MHz (Radio Frequency range).

The natural impedance of living tissue provides heat build-up in the tissues as the electron flow through the electrode overcomes the tissue impedance. When the electrode is brought into contact with the tissue, effectively completing the circuit, and power is applied, current builds along the cutting element of the electrode until the tissue impedance is overcome and energy arcs from the loop to the tissue. This produces intense heat and subsequent tissue vaporization along the cut line. This arching produces maximum current concentration at the cut site.

K 9715 12

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Device Performance C.

Resectoscope electrodes have an extensive history of use in the medical device community. The Coaguloop™ device, and other manufacturer's resectoscope electrodes, are manufactured from materials that are widely used in the medical device industry. The materials have undergone extensive biocompatibility testing. The devices are manufactured primarily of Molybdenum.

All components are manufactured using rigid conformance standards to ensure the safe and effective performance of the finished product. Frequent, detailed quality checks are carried out at each phase of the assembly process to verify that only those units meeting all parameters are released for sale. Table 1 on the folowing page provides a comparison of the proposed device to the predicate device.

d. Bench Testing

The following tests were performed to demonstrate electrode reliability and adherence to performance specifications:

Fit Test a.
Destructive Test b.
C. Biocompatibility Test
Dielectric/Continuity Test d.
e. Metallurgical Analysis
f. Loop Area Calculations
Animal Test g.
Coaguloop Histopathology Analysis of Lapine and Canine Tissue Samples h.
i. Current Distribution Test
Packaging Test I .1.
k. Packaging Test II

The results of the testing determined that the elctrodes performed per specification.

In summary, American Medical Systems has provided information within this 510(k) Premarket Notification to indicate that the AMS Coaguloop™ Resection Electrode is safe and effective for its intended use (for the resection, ablation, and fulguration of soft tissue). Additionally, the AMS Coaguloop™ Resection Electrode has been shown to be comparable in terms of intended use and technological characteristics to the Olympus™ Resectoscope Loop Electrode which has been cleared for commercial distribution. The data and information provided within this 510(k) Premarket Notification adequately support that the Coaguloop™ Resection Electrode is substantially equivalent to the Olympus™ Resectoscope Loop Electrode.

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TABLE 1

Image /page/3/Picture/1 description: The image contains two lines of text. The first line reads "K971512". The second line reads "P41074".

COMPARISON OF PROPOSED DEVICE

Use and Feature	AMS Coaguloop™ ResectionElectrode	Olympus™ ResectoscopeLoop Electrode
Intended Use	To resect, ablate, and fulguratesoft tissue.	To resect, ablate, and fulguratesoft tissue.
Mode of Operation	Electrocautery currentconducted through loop allowsfulguration or cutting by thesurgeon	Electrocautery currentconducted through loop allowsfulguration or cutting by thesurgeon
Application	1. Device to be utilized inconjunction with and as anaccessory to a standardendoscopic electroscope.2. Standard electro-surgicalpower source is used for thecurrent generation through theelectrode.	1. Device to be utilized inconjunction with and as anaccessory to a standardendoscopic electroscope.2. Standard electro-surgicalpower source is used for thecurrent generation through theelectrode.
Material	Tungsten/Molybdenum wireinsulated with non-conductingshrink wrap.	Tungsten wire insulated withnon-conducting shrink wrap.
Design	Flat loop with multiple shallowgrooves.	A circular loop
Sterility	The electrode is deliveredsterile and is designed forsingle-use only. The device issterilized by Gamma radiation	Sterile/disposable

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Image /page/4/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 representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 1997

Mr. John M. Otto Senior Regulatory Affairs Associate ... . ... .. American Medical Systems, Inc. Pfizer Hospital Products Group 10700 Bren Road West Minnetonka, Minnesota 55343

Re: K971512.

AMS Coaguloop™ Resection Electrode

Dated: April 25, 1997
Received: April 28, 1997
Regulatory class: II
21 CFR §876.4300/Product code: 78 FAS

Dear Mr. Otto:

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 inclosure) 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 misbranion.

If your device is classified (see above) into either 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 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 $31 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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) 594-4613. 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

h. William Yu

Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page of

510(k) Number (if Known): K971512

Device Name: AMS Coaguloop™ Resection Electrode

Indications For Use:

The AMS Coaguloop™ Resection Flectrode is intended to be used for the resection, ablation, and fulguration in the prostate gland.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Reter R. Silling/
(Division Sign-Off)

');vision of Reproductive, Abdominal, ENT, nd Radiological Devices 1 ) 710(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

t:\vp\510k\ifuform.doc

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).