DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601

K992218 · Kirwan Surgical Products, Inc. · GEI · Jul 30, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992218
• Device Name: DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601
• Applicant: Kirwan Surgical Products, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Disposable Irrigation Bipolar Cord Assembly; single-use sterile accessory for Malis CMC-Bipolar System. Device functions as electrical conduit between electrosurgical generator and bipolar irrigating forceps; includes integrated tubing for gravity-fed irrigation from collapsible reservoir to handpiece. Used in clinical/surgical settings by physicians. Provides essential energy delivery and fluid management for bipolar electrosurgery; facilitates tissue coagulation and irrigation during procedures. Benefits patient by enabling controlled electrosurgical intervention with integrated irrigation to maintain surgical site visibility and tissue hydration.

Clinical Evidence

Bench testing only. Compliance with IEC 601-1-2, IEC 601-2-2, and ANSI/AAMI HF 18 standards for electrical safety and performance. Biocompatibility testing per ISO 10993-1.

Technological Characteristics

Single-use sterile cord assembly with integrated irrigation lumen. Materials selected for biocompatibility per ISO 10993-1. Sterilization via irradiation (AAMI/ISO 11137, EN 552). Electrical interface compatible with Malis CMC-III generators. Gravity-fed fluid delivery system.

Indications for Use

Indicated for use with standard bipolar irrigating forceps and the Codman & Shurtleff Malis CMC-Bipolar System to deliver electrosurgical energy and irrigation fluid during surgical procedures.

Regulatory Classification

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.

Predicate Devices

• Malis™ Integrated Irrigation Tubing and Bipolar Cord Set (80-1163)
• Irrigation / Bipolar Set, for Malis System CMC-II (NU1060)

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

(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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)