The AMS Coaguloop™ Resection Electrode is an electrosurgical device designed for use with commercially available resectoscopes and general purpose monopolar electrosurgical generators. The Coaguloop™ Resection Electrode is designed to remove and coagulate soft tissue by means of radio frequency electrical current.

AI/ML Overview

This specific 510(k) summary for the AMS Coaguloop™ Resection Electrode does not contain information about acceptance criteria or a study proving the device meets them in the context of device performance testing.

The document primarily focuses on establishing substantial equivalence to predicate devices (AMS Coaguloop™ Resection Electrode K971512 and Circon/ACMI Vaportome™ Resection Loop Electrode K973820) rather than presenting a performance study with specific acceptance criteria. This is common for 510(k) submissions, where the principal method of demonstration is often comparison to an already cleared device.

Therefore, the requested information (points 1-9) cannot be extracted from the provided text for device performance.

However, I can provide information on other aspects as presented in the document:

Regarding "Acceptance Criteria" in the context of regulatory compliance (not performance):

The document implies that the "acceptance criteria" for the device, from a regulatory standpoint, were demonstrating substantial equivalence to predicate devices based on:

Similar Indications for Use: The Coaguloop™ Resection Electrode is intended for "resection, ablation, and fulguration in the prostate gland and the bladder," which aligns with the predicate devices.
Similar Design and Features: The device is described as an electrosurgical device designed for use with commercially available resectoscopes and general purpose monopolar electrosurgical generators, consistent with predicate devices.
Sterilization Methodology: The sterilization method (gamma radiation to achieve a minimum SAL of 10^-6) and its adherence to ANSI/AAMI and ISO 11137 guidelines serve as "acceptance criteria" for sterility.
Biocompatibility: Following the recommendations of FDA Blue Book Memorandum #G95-1 and ISO-10993 serves as "acceptance criteria" for biocompatibility.

Absence of Performance Study Details for the AMS Coaguloop™ Resection Electrode in this document:

The provided 510(k) summary does not include a study demonstrating specific performance metrics (e.g., cutting efficiency, coagulation depth, tissue damage profiles) with associated acceptance criteria. This type of detailed performance testing might have been conducted by the manufacturer but is not reported in this summary.

In summary, as per the provided text:

Table of acceptance criteria and reported device performance: Not available for device performance metrics. The document's closest equivalent is a statement of substantial equivalence to predicate devices based on indications, design, and features.
Sample size used for the test set and data provenance: No performance test set specified.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no performance test set is described.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable (this is a physical medical device, not an AI algorithm).
Type of ground truth used: Not applicable for performance. For regulatory acceptance, the "ground truth" was the characteristics and performance of the legally marketed predicate devices.
Sample size for the training set: Not applicable (no AI algorithm or typical "training set" in the machine learning sense).
How the ground truth for the training set was established: Not applicable.

Summary

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JUN 2 9 1999

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AMERICAN MEDICAL SYSTEMS

510(k) SUMMARY

SUBMITTER I.

Name and Address:

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

2183959

David Worrell

April 15, 1999

2183959

Establishment Registration Number:

Contact Person:

Date of Summary Preparation:

II. MANUFACTURER

Name and Address:

Device Trade Name:

Classification Name:

American Medical Systems 10700 Bren Road West Minnetonka, MN 55343-9679

Establishment Registration Number

III. DEVICE NAME

Device Common or Usual Name:

Resection Loop or Resection Electrode

AMS Coaguloop™ Resection Electrode

Endoscopic electrosurgical unit with accessories (21 CFR 876.4300)

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DEVICE DESCRIPTION IV.

V. INDICATION FOR USE

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

SUBSTANTIAL EQUIVALENCE SUPPORT VI.

American Medical Systems' Coaguloop™ Resection Electrode is similar in indications, design, and features to various resectoscope electrodes that are in commercial distribution. The predicate devices that AMS is claiming substantial equivalence to are the AMS Coaguloop™ Resection Electrode K971512 and the Circon/ACMI Vaportome™ Resection Loop Electrode K973820.

STERILIZATION METHODOLOGY VII.

Sterilization is based on the recommendations in ANSI/AAMI and ISO 11137 Guideline for the Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization. The devices are terminally sterilized by exposure to gamma radiation. This gamma radiation sterilization cycle will achieve a minimum Sterility Assurance Level (SAL) of 10°.

VIII. -BIOCOMPATIBILITY

Biocompatibility testing generally followed the recommendations of FDA Blue Book Memorandum #G95-1 entitled "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."

CONCLUSION

In summary, the data and information provided within this 510(k) Premarket Notification adequately support that the AMS Coaguloop™ Resection Electrode is substantially equivalent to the AMS Coaguloop™ Resection Electrode K971512 and the Circon/ACMI Vaportome™ Resection Loop Electrode K973820.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 1999

Mr. David Worrell Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343

Re: K991314 AMS Coaguloop™ Resection Electrode Dated: April 15, 1999 Received: April 16, 1999 Requlatory Class: II 21 CFR §876.4300/Procode: 78 FAS

Dear Mr. Worrell:

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 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, 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 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 requirements, as set forth in the Quality System Regulation (QS) 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 requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compilance 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological 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): ____________________________________________________________________________________________________________________________________________________

AMS Coaguloop™ Resection Electrode Device Name:

Indications For Use:

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

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use	/
(Per 21 CFR 801.109)

Over-The-Counter Use	_________________
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K991314

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).