The Disposable Bipolar Cord connects the electrode that is inserted into the Resectoscope Working Element to an Electrosurgery unit (ESU). It allows RF power to be conductively transmitted from the ESU to the resectoscope electrode. It is intended to be sold as a sterile, single use disposable device.

Device Description

The ACMI Bipolar Disposable Cord, Catalogue # DBC, interconnects electrosurgical unit (ESU) (source of RF power) to the Electrode that is inserted into the Bipolar Resectoscope Working Element. It allows RF power to be conductively transmitted from the ESU to the resectoscope electrode. The Bipolar Disposable Cord is a component or accessory of the ACMI Bipolar Resectoscope System. It is sold as a sterile, single use disposable device. The Bipolar Disposable Cord consists of the following: a. Cord: containing a twisted wire pair that transmits power from the proximal two-pin connector to contacts in the distal molded connector part. The cable is shielded within an outer insulating jacket. b. Distal Connector: Two "c-spring" contacts with polyurethane over-mold and "T" shaped strain relief. The distal connector contacts the electrode, which is inserted into the Resectoscope Working Element. c. Proximal Connector: Two-pin (female) connector over-molded with polyvinyl chloride strain relief.

AI/ML Overview

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

Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness, which is a premarket notification to the FDA. It asserts substantial equivalence to a predicate device and describes the device. It does not present a detailed study report or specific acceptance criteria with quantifiable results. The document focuses on showing that modifications to an existing device are not substantial enough to require a new Pre-Market Approval (PMA) or a more rigorous 510(k). Therefore, many of the requested details about specific studies, sample sizes, and expert qualifications are not present in this type of document.

Acceptance Criteria and Device Performance (Based on available information)

The document primarily focuses on demonstrating that modifications to the ACMI Disposable Bipolar Cord do not significantly affect its safety or efficacy compared to a predicate device, the ACMI Disposable Active Cord (Preamendment & K890328). This implies that the acceptance criteria are largely centered on maintaining the performance and safety characteristics of the predicate device.

Acceptance Criteria Category	Reported Device Performance (Summary)
Design Specifications	Proposed modifications did not significantly affect safety or efficacy. The new design includes a twisted wire pair, shielded cable, new distal connector (c-spring contacts with polyurethane over-mold), and new proximal connector (two-pin female with PVC strain relief).
Performance Specifications	Proposed modifications did not significantly affect safety or efficacy. The device still allows RF power to be conductively transmitted from the ESU to the resectoscope electrode.
Dimensional Specifications	Proposed modifications did not significantly affect safety or efficacy. (No specific dimensions provided).
Material Specifications	Proposed modifications did not significantly affect safety or efficacy. (No specific material changes detailed beyond the connectors).
Intended Use	Remains the same: connects an electrode to an ESU for RF power transmission, sterile, single-use disposable.
Indications for Use	Remains the same.
Principles of Operation	Remains the same.
Packaging Materials	Remains the same.
Sterilization Parameters	Remains the same.

Summary of the "Study" (or Basis for Equivalence)

The document itself is not a report of a new clinical or preclinical study with pre-defined acceptance criteria and quantified outcomes. Instead, it's a Special 510(k) Notification which argues for substantial equivalence based on modifications to an already cleared device. The "study" in this context is the analysis and comparison of the modified device against its predicate device, focusing on demonstrating that the changes are minor and do not alter the fundamental safety or effectiveness.

Here's how the requested points relate to the provided information:

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided. This document does not describe a test set in the sense of a clinical trial or a formal performance study with a specific sample size of patients or devices. The equivalence is based on engineering assessment and comparison.
- Data Provenance: Not applicable/Not provided in the sense of geographical origin or retrospective/prospective study. The comparison is against the predicate device description and established performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. There was no "test set" in the sense of clinical data requiring expert review to establish ground truth. The evaluation was internal to the manufacturer, asserting equivalence based on design and technical specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/None. No formal adjudication process of clinical data is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a medical device (cord for electrocautery), not an AI-powered diagnostic or imaging device. There are no human "readers" or AI involved in its direct function.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the clinical sense. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate device. The modified device is asserted to meet this "ground truth" by maintaining similar design, performance, and operational characteristics.
The sample size for the training set:
- Not applicable/Not provided. This device is not an AI/ML algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable.

In conclusion, this particular 510(k) document is a regulatory submission for a modified medical device, not a report of a new, detailed performance study with comprehensive acceptance criteria and ground truth validation as one might find for an AI or diagnostic device. The "proof" of meeting acceptance criteria lies in the argument of "substantial equivalence" to a predicate device, meaning the modifications do not introduce new questions of safety or effectiveness.

Summary

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ACMI Disposable Bipolar Cord ACMI Corporation 136 Turnpike Rd. Southborough, MA 01772

AUG 2 2 2002

Special 510(k) Notificatio Summary of Safety and Effectiveness July 26, 2002

K022480
Page 1 of 2

510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI DISPOSABLE BIPOLAR CORD

General Information

Manufacturer:

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

Establishment Registration Number:

9920160

July 26, 2002

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

Date Prepared:

Contact Person:

Device Description

Classification Name:

Endoscope and accessories (21CFR 876.1500) Gynecologic Electrocautery and Accessories (21CFR 884.4120)

Trade Name:

ACMI Disposable Bipolar Cord

Generic/Common Name:

Predicate Devices

ACMI Disposable Active Cord

Preamendment & K890328

Endoscope and accessories

Intended Uses

The Disposable Bipolar Cord connects the electrode that is inserted into the Resectoscope Working Element (WE) to an Electrosurgery unit (ESU). It allows RF power to be conductively transmitted from the ESU to the resectoscope electrode. It is intended to be sold as a sterile, single use disposable device.

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Special 510(k) Notification Summary of Safety and July 26, 2002

K022480
Page 2 of 2

Product Description

The Bipolar Disposable Cord is a component or accessory of the ACMI Bipolar Resectoscope System. It is sold as a sterile, single use disposable device. The Bipolar Disposable Cord consists of the following:

a. Cord: containing a twisted wire pair that transmits power from the proximal two-pin connector to contacts in the distal molded connector part. The cable is shielded within an outer insulating jacket.

b. Distal Connector: Two "c-spring" contacts with polyurethane over-mold and "T" shaped strain relief. The distal connector contacts the electrode, which is inserted into the Resectoscope Working Element.

c. Proximal Connector: Two-pin (female) connector over-molded with polyvinyl chloride strain relief.

This Special 510(k) proposes a modification in the design, performance, dimensional, and materials specifications for Disposable Bipolar Cord. The indications for use, principles of operation, the packaging materials, and the sterilization parameters of the Disposable Binolar Cord remain the same as in the predicate device.

Summary of Safety and Effectiveness

The proposed modifications for the Disposable Bipolar Cord, as described in this submission, are substantially equivalent to the predicate device. The proposed modification in design specifications, performance specifications, dimensional specifications, and materials specifications 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

Public Health Service

AUG 2 2 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 136 Turnpike Road SOUTHBOROUGH MA 01772-2104

Re: K022480

Trade/Device Name: ACMI Disposable Bipolar Cord Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: 85 HIH Regulation Number: 21 CFR §884.4120 Regulation Name: Gynecologic electrocautery and accessories Regulatory Class: II Product Code: 85 HGI Dated: July 26, 2002 Received: July 26, 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 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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ACMI Disposable Bipolar Cord ACMI Corporation 136 Turnpike Road Southborough, MA 01772

Special 510(k) Notification Statement of Intended Use July 26, 2002

Device Name: ACMI Disposable Bipolar Cord

510(k) Number: K022480

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:

OR Over-the-Counter Use:

(Per 21 CFR 801.109)

Nancy C. Broadon

of Renmonu 510kl N

Regulation Number and Section

§ 884.1690 Hysteroscope and accessories.

(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.