Intended for use in patients requiring endoscopic surgery for general urological tissue resection, ablation, and excision and hemostasis of blood vessels. These procedures include Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resection, and Treatment of Vesical Neck Constriction.

Device Description

The USA Elite Bipolar Resectoscope consists of a Telescope, Sheath, Bipolar Working Element, and Obturator. The USA Elite Bipolar Resectoscope is designed to work with currently marketed Electrosurgery Systems consisting of a electrosurqical generator called the Controller, a disposable Bipolar Loop, and a reusable or disposable Loop Cable or Cord.

AI/ML Overview

Here's an analysis of the provided text regarding the ACMI Bipolar Resectoscope, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a modification to an existing device, not a de novo clearance or a 510(k) for a completely new device. This means the primary evidence presented is for substantial equivalence to a predicate device, rather than extensive clinical efficacy or performance studies with specific numerical acceptance criteria. Therefore, many of the requested data points (like sample sizes for test/training sets, expert ground truth details, MRMC studies, standalone performance studies with quantitative metrics) are not typically present or required in a 510(k) of this nature and are absent from this document.

The "acceptance criteria" here refer to demonstrating that the modified device remains as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Status / Reported Performance
Safety and Effectiveness	Demonstrated to be substantially equivalent to the predicate device. The modifications (performance specifications, dimensional specifications, materials, labeling) are not substantial changes or modifications and do not significantly affect the safety or efficacy of the devices.
Indications for Use (General)	Remains the same as the predicate device. Intended for endoscopic surgery for general urological tissue resection, ablation, excision, and hemostasis of blood vessels.
Indications for Use (Specific Procedures)	Remains the same as the predicate device. Includes Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resection, and Treatment of Vesical Neck Constriction.
Principles of Operation	Remains the same as the predicate device. Designed to work with currently marketed Electrosurgery Systems (controller, disposable Bipolar Loop, reusable/disposable Loop Cable/Cord).
Packaging Materials	Remains the same as the predicate device.
Sterilization Parameters	Remains the same as the predicate device.
Performance Specifications (as modified)	The modifications to performance specifications are considered not substantial and do not significantly affect safety or efficacy. (Specific values for performance are not provided in this summary, but would have been part of the full submission to justify equivalence.)
Dimensional Specifications (as modified)	The modifications to dimensional specifications are considered not substantial and do not significantly affect safety or efficacy. (Specific values for dimensions are not provided in this summary, but would have been part of the full submission to justify equivalence.)
Materials (as modified)	The modifications to materials are considered not substantial and do not significantly affect safety or efficacy. (Specific new materials are not detailed, but would have been part of the full submission to justify equivalence, e.g., biocompatibility testing data if new patient-contacting materials were introduced.)
Labeling (as modified)	The modifications to labeling are considered not substantial and do not significantly affect safety or efficacy. (Details of labeling changes are not provided, but they would be consistent with the modified specifications and maintain clarity regarding safe and effective use.)

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

Not Applicable / Not Provided. This 510(k) is for a modification to a mechanical/electrical surgical instrument, not an AI/software device that typically uses "test sets" of data. The "test" here refers to demonstrating safety and performance equivalence through engineering verification and validation, rather than data-driven clinical prediction on a patient cohort. The document emphasizes that the modifications do not significantly affect safety or efficacy, implying internal company testing (e.g., bench testing, biocompatibility for material changes) rather than clinical studies on patient data.

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

Not Applicable / Not Provided. See point 2. Ground truth in this context would likely refer to engineering specifications or validated performance characteristics rather than expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided. See point 2 and 3.

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

No. This is not an AI/software device; it's a surgical instrument. An MRMC study is not relevant here.

6. If a Standalone (algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

Not Applicable (in the context of clinical data/AI). For this device, "ground truth" generally refers to:
- Engineering Specifications: Design tolerances, material properties, electrical output specifications, etc.
- Performance Benchmarks: Comparison against the predicate device's known performance characteristics (e.g., cutting efficacy, coagulation properties, structural integrity, electrical safety).
- Regulatory Standards: Adherence to relevant national and international standards for medical devices.
  The document states the modifications are "not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices," implying that internal testing (bench, possibly animal) was performed to show that the modified device performs comparably to the predicate.

8. The Sample Size for the Training Set

Not Applicable / Not Provided. This is not a machine learning or AI device.

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

Not Applicable. There is no training set mentioned or implied for this type of device.

Summary

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MAY 0 9 2002

Bipolar Resectoscope ACMI Corporation 136 Turnpike Road Southborough, MA 02139 Special 510(k) Notification Summary of Safety and Effectiveness April 10, 2002

K021166
Page 1 of 2

510(k) Summary of Safety and Effectiveness ACMI Circon Corporation ACMI Bipolar Resectoscope

General Information

Manufacturer:

ACMI Circon Corporation 136 Turnpike Rd. Southborough, MA 01772-2104

Establishment Registration Number:

9920160

April 10, 2002

Contact Person:

John A. DeLucia VP, Quality Assurance, Regulatory Affairs and Clinical Affairs

Date Prepared:

Trade Name:

Device Description

Classification Name:

Endoscope and accessories (21CFR 876.1500)

ACMI USA Elite Series Bipolar Resectoscope

Generic/Common Name:

Predicate Devices

ACMI USA Elite Resectoscope

with Monopolar Working Element

Preamendment & K951972

Endoscope and accessories

Intended Uses

Product Description

The USA Elite Bipolar Resectoscope consists of a Telescope, Sheath, Bipolar Working Element, and Obturator. The USA Elite Bipolar Resectoscope is

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ACMI Bipolar Resectoscope ACMI Corporation 136 Turnpike Rd. Southborough, MA 01772

Special 510(k) Notification Summary of Safety and Effectiveness April 10, 2002

K021166
Page 2 of 2

designed to work with currently marketed Electrosurgery Systems consisting of a electrosurqical generator called the Controller, a disposable Bipolar Loop, and a reusable or disposable Loop Cable or Cord.

This Special 510(k) proposes a modification in the performance specifications, dimensional specifications, materials, and labeling for The USA Elite Series Bipolar Resectoscope. The indications for use, principles of operation, the packaging materials, and the sterilization parameters of the USA Elite Bipolar Resectoscope remain the same as in the predicate device.

Summary of Safety and Effectiveness

The proposed modifications for the USA Elite Series Bipolar Resectoscope, as described in this submission, are substantially equivalent to the predicate device. The proposed modification in performance specifications, dimensional specifications, materials, and labeling specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the words "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged on a single line, with "Public Health" appearing before "Service".

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

MAY 0 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John A. DeLucia Vice President, Quality Assurance, Regulatory Affairs, Clinical Affairs ACMI Corporation Global Headquarters 136 Turnpike Road SOUTHBOROUGH MA 01772-2104 Re: K021166

Trade/Device Name: ACMI-Circon Bipolar Resectoscopes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FDC and FBO Dated: April 10, 2002 Received: April 11, 2002

Dear Mr. DeLucia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 aboye) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 forth in the quality systems (QS) regulation (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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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), please 11 you action office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on of responsibilities under the Act may be obtained 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,

11 11 11

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Bipolar Resectoscope ACMI Corporation 136 Turnpike Road Southborough, MA 02139 Special 510(k) Notification Statement of Intended Use April 10, 2002

Device Name: ACMI Bipolar Resectoscope

510(k) Number:

Indications for use:

Intended for use in patients requiring endoscopic surgery for general urological intention for aboution, and excision and hemostasis of blood vessels. tissue resocion, abiation, anadder Tumor Diagnosis and Resection, Tresc procedures include Bladder Biopsy, Transurethral Prostatic Resection, and Treatment of Vesical Neck Constriction.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: X __

OR Over-the-Counter Use: ________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

Nancy Crogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and

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.