DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 by KIRWAN SURGICAL PRODUCTS, INC.

The Disposable Irrigation Bipolar Cord Assembly is a single-use product sold sterile, and is intended for use with standard bipolar irrigating forceps, and the Codman & Shurtleff, Malis™ CMC - Bipolar System. This device is to be used to deliver electrical energy from a Malis™ CMC®-III (or equivalent) Generator to the bipolar forceps (handpiece), as well as, provide the system with an integrated delivery conduit, for carrying an irrigating solution from its collapsible reservoir to the forceps, via gravity feed.

Device Description

The Disposable Irrigation Bipolar Cord Assembly is a single-use product sold sterile, and is intended for use with standard bipolar irrigating forceps, and the Codman & Shurtleff, Malis™ CMC -Bipolar System. This device is to be used to deliver electrical energy from a Malis ™ CMC -III (or equivalent) Generator to the bipolar irrigating forceps (handpiece), as well as, provide the system with an integrated delivery conduit, for carrying an irrigating solution from its collapsible reservoir to the forceps, via gravity feed.

AI/ML Overview

The provided text describes the regulatory clearance for a medical device, the "Disposable Irrigation Bipolar Cord Assembly for Malis™ System CMC®-II." However, it does not contain a study that demonstrates the device meets specific acceptance criteria in the way a clinical or performance study would for a novel AI/software device. Instead, it details the testing performed to assure safety and substantial equivalence to predicate devices.

Therefore, many of the requested elements for an AI device study (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or cannot be extracted from this document, as it pertains to a physical medical device and its predicate comparison for regulatory approval.

Here's an analysis based on the provided text, focusing on the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance / Compliance
Biological Safety	Biocompatibility	Selection of irrigating lumen materials demonstrating appropriate levels of biocompatibility. Tested in accordance with ISO Standard 10993-1 (external communicating device, blood path indirect, contact duration category "A").
Sterilization Safety	Sterility Assurance Level (SAL) of 10⁻⁶	Sterility validated in accordance with and in compliance with AAMI/ISO 11137 and EN 552 (current editions) for radiation sterilization.
Performance Safety	Electrical Safety, High Frequency Surgical Equipment Safety, Electrosurgical Devices Standards	Testing in accordance with and in compliance with IEC 601-1-2 (1988), IEC 601-2-2 (1991), and ANSI/AAMI HF 18 (1993).
Substantial Equivalence	Function & Intended Use Equivalent to Predicate Devices	Determined to be substantially equivalent in function and intended use to: - 80-1163, Malis™ Integrated Irrigation Tubing and Bipolar Cord Set - NU1060, Irrigation / Bipolar Set, for Malis System CMC-II

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This document refers to engineering and quality assurance testing of a physical device, not an AI model requiring a test set of data. The "test set" here would refer to the physical units tested for biocompatibility, sterility, and electrical performance. The exact number of units tested is not specified but would typically follow established standards for medical device validation (e.g., n=3 for certain types of testing, or larger batches for sterility validation).
Data Provenance: Not applicable in the context of clinical/imaging data. The "provenance" here relates to the manufacturing process, material sourcing, and lab conditions under which the safety and performance tests were conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device does not involve expert-labeled ground truth for an AI algorithm. The "ground truth" for the device's performance is defined by adherence to established ISO, IEC, and ANSI/AAMI standards, which are determined by technical specifications and material properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study assessing human or AI diagnostic performance. Compliance with standards is determined by objective measurements and validated procedures rather than expert adjudication of cases.

5. 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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an irrigation bipolar cord assembly, not an AI or imaging diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance aligns with technical standards and validated test procedures.
- For biocompatibility: ISO 10993-1 defines the accepted methods and criteria.
- For sterility: Sterility Assurance Level (SAL) of 10⁻⁶ as per AAMI/ISO 11137 and EN 552.
- For performance: Compliance with IEC 601-1-2, IEC 601-2-2, and ANSI/AAMI HF 18 through specific electrical and functional tests.
- For substantial equivalence: Comparison of functional and intended use specifications against existing legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device documentation does not involve a training set for an AI model.

9. How the ground truth for the training set was established

Not applicable. There is no training set mentioned in this document.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY for Malis™ System CMC®-II

The Disposable Irrigation Bipolar Cord Assembly is a single-use product sold sterile, and is intended for use with standard bipolar irrigating forceps, and the Codman & Shurtleff, Malis™ CMC -Bipolar System. This device is to be used to deliver electrical energy from a Malis ™ CMC -III (or equivalent) Generator to the bipolar irrigating forceps (handpiece), as well as, provide the system with an integrated delivery conduit, for carrying an irrigating solution from its collapsible reservoir to the forceps, via gravity feed.

Biological safety will be assured through the selection of irrigating lumen materials, which demonstrate appropriate levels of biocompatibility. The materials will be tested in accordance with ISO Standard 10993-1, Biological Evaluation of medical devices, part 1 (external communicating device, blood path indirect, contact duration category "A").

Sterilization safety will be assured to a sterility assurance level (SAL) of 10°. Sterility will be validated in accordance with, and in compliance with the requirements of the applicable sections of the following standards:

배 AAMI / ISO 11137 (current edition) Sterilization of health care productsrequirements for validation and routine control-radiation sterilization, and,
트 EN 552 (current edition) Sterilization of medical devices - Validation and routine control of sterilization by irradiation.

Performance safety will be assured via testing in accordance with, and in compliance with the requirements of the applicable sections of the following standards;

에 IEC 601-1-2 (1988), Medical Electrical Equipment Part 1; General Requirements for the Safety.
트 IEC 601-2-2 (1991), Medical Electrical Equipment Part 2; particular Requirements for the safety of High Frequency Surgical Equipment.
로 ANSI/AAMI HF 18 (1993), American National Standard for Electrosurgical Devices

The Disposable Irrigation Bipolar Cord Assembly is substantially equivalent in function and intended use to both the;

80-1163, Malis™ Integrated Irrigation Tubing and Bipolar Cord Set, and 트
마 NU1060, Irrigation / Bipolar Set, for Malis System CMC-II

TM Malis is a trademark of Leonard I. Malis, M.D.

® CMC is a registered trademark of Johnson & Johnson Professional, Inc.

Kirwan Surgical Products, Inc. Marshfield, MA 02050

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Image /page/1/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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, represented by curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Mr. Kevin P. Prario Regulatory Affairs Manager Kirwan Surgical Products, Inc. 180 Enterprise Drive P.O. Box 427 Marshfield, Massachusetts 02050

K992218 Re:

Trade Name: Disposable Irrigation Bipolar Cord Assembly Regulatory Class: II Product Code: GEI Dated: June 30, 1999 Received: July 1, 1999

Dear Mr. Prario:

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 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 misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or 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 Ouality System Regulation (OS) 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 regulations.

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Page 2 - Mr. Kevin P. Prario

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) 594-4595. 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,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):	K992218
Date:	6/30/99

Disposable Irrigation Bipolar Cord Assembly for Malis™ System CMC -II Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For use:

(Division Sian-Off of General Restorative Devices x 992218 510(k) Number

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

------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.