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, Removal of Ureteral Calculus, and Treatment of Vesical Neck Constriction.

Device Description

The Vista CTR Bipolar Loop Electrode is a double loop bipolar electrosurgical device, designed to work with currently marketed Electrosurgery Systems. These systems consist of an electrosurgical generator (the Controller), a reusable or disposable Cable (Bipolar Active Cord) and a Bipolar Resectoscope System.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "ACMI Vista CTR Bipolar Loop Electrode." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics commonly seen in software or AI/ML device submissions.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, or specific study designs (MRMC or standalone).

Here's why the requested information isn't present in this document:

Device Type: This is a physical electrosurgical device, not a software or AI/ML-based device that would typically involve performance metrics like sensitivity, specificity, or the impact of AI on human reader performance.
Regulatory Pathway: A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This is often achieved through comparative testing (e.g., bench testing, material compatibility) and a review of intended use and technological characteristics, not necessarily through clinical studies with quantifiable performance metrics against a defined standard.
Focus of this specific 510(k): This particular submission is a "Special 510(k)" which proposes modifications (materials, packaging, sterilization, labeling) to an existing device. It explicitly states that "The indications for use, principles of operation, of the Vista CTR Bipolar Loop Electrode remain the same as in the predicate devices. The proposed modifications... are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This means the focus is on showing the modifications don't negatively impact the established performance, rather than proving new performance criteria.

In summary, the provided text does not describe a study that establishes acceptance criteria and then proves the device meets those criteria in the way a performance study for a diagnostic or AI-driven device would.

Summary

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Ko 31001

MAY 21 2003

510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI VISTA CTR BIPOLAR LOOP ELECTRODE (Page 1 of 2)

General Information

Manufacturer:

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

2020483

March 28, 2003

FDA Establishment Registration:

Contact Person:

Gabriel J. Muraca, Jr. Senior Regulatory Affairs Specialist

Date Prepared:

Device Description

Classification Name:

21CFR 878.4400 -Electrosurgical cutting and coagulation device and accessories.

Trade Name:

Generic/Common Name:

ACMI Vista CTR Bipolar Loop Electrode

Electrosurgical cutting and Coagulation device and Accessories

Predicate Devices

ACMI USA Elite System Right Angle Cutting Loop Electrode	K973820
ACMI Bipolar Resectoscope & Loop Electrode	K021166

Intended Uses

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510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI VISTA CTR BIPOLAR LOOP ELECTRODE (Page 2 of 2)

Product Description

Summary of Safety and Effectiveness

This Special 510(k) proposes a modification in two materials of the electrode, a change in the packaging, sterilization method, and a change in the labeling to indicate the new sterilization method. The indications for use, principles of operation, of the Vista CTR Bipolar Loop Electrode remain the same as in the predicate devices.

The proposed modifications for the Vista CTR Bipolar Loop Electrode, as described in this submission, are substantially equivalent to the predicate devices. The proposed modification in materials, packaging, sterilization, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.

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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" around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2003

Gabriel J. Muraca, Jr. Senior Regulatory Affairs Specialist ACMI Corporation 136 Turnpike Road SOUTHBOROUGH MA 01772-2104

Re: K031001

Trade/Device Name: ACMI® Vista CTR Bipolar Loop Electrode Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: 78 FAS Dated: April 30, 2003 Received: May 1, 2003

Dear Mr. Muraca:

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 above) 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 contact the 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 your 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,

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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Device Name: ACMI VISTA CTR BIPOLAR LOOP ELECTRODE 03/001 510(k) Number:

Indications for Use:

(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 C. Brogdon

(Division (Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

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).