CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189

K052449 · Codman & Shurtleff, Inc. · GEI · Oct 17, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052449
• Device Name: CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189
• Applicant: Codman & Shurtleff, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Codman Integrated Irrigation Tubing and Bipolar Cord Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation. They are intended to for use with the Codman/Malis CMC®-II and the Codman/Malis CMC® III 1.E.C. Irrigation Modules and the Codman/Malis Bipolar Coagulators.

Device Story

Device integrates irrigation tubing and bipolar electrosurgical cord into single disposable unit; simplifies setup by combining two separate components into one. Used in clinical settings with Codman/Malis irrigation modules and bipolar coagulators. Provides simultaneous delivery of irrigation fluid and electrical energy to specialized bipolar forceps. Benefits include improved organization of electrosurgical equipment during procedures.

Clinical Evidence

Bench testing only. Performance qualification criteria met or exceeded requirements set forth in ANSI/AAMI HF18:2001 for electrosurgical devices.

Technological Characteristics

Integrated disposable tubing and bipolar cord set. Designed for simultaneous delivery of irrigation and electrosurgical energy. Complies with ANSI/AAMI HF18:2001 standards.

Indications for Use

Indicated for use in providing simultaneous irrigation and electrosurgical energy to bipolar forceps designed for irrigation, specifically for use with Codman/Malis CMC-II and CMC III I.E.C. Irrigation Modules and Codman/Malis Bipolar Coagulators.

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

• Codman/Malis Integrated Irrigation Tubing and Bipolar Cord Set

Submission Summary (Full Text)

{0}------------------------------------------------

OCT 17 2005

Page 1 of 2

510(k) Summary Codman Integrated Irrigation Tubing and Bipolar Cord

> Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350

K052449

#### Contact Person

Joan Q. Bartle, RAC Sr. Regulatory Affairs Specialist Telephone Number: [phone] Fax Number: [phone]

#### Name of Device

| Proprietary Name: | Codman Integrated Irrigation Tubing and Bipolar Cord Set |
|----------------------|----------------------------------------------------------------|
| Common Name: | Irrigation Tubing and Bipolar Cord |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and Accessories |

### Device Classification

Electrosurgical Cutting and Coagulation Device and Accessories are Class II devices per 21 CFR § 878.4400 (79 GEI).

# Statement of Substantial Equivalence

Codman Integrated Irrigation Tubing and Bipolar Cord Sets are substantially equivalent to the Codman/Malis Integrated Irrigation Tubing and Bipolar Cord Set based on the device's similarity to the predicate device in intended use, materials, design, and principles of operation.

#### Indications for Use

The Codman Integrated Irrigation Tubing and Bipolar Cord Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.

They are intended to for use with the Codman/Malis CMC®-II and the Codman/Malis CMC® III 1.E.C. Irrigation Modules and the Codman/Malis Bipolar Coagulators.

{1}------------------------------------------------

052449

Page 2 of (2)

# Physical Description

The Codman Integrated Irrigation Tubing and Bipolar Cord Set is designed to rnc Outfiel irrigation and energy simultaneously to bipolar forceps specifically provide infigation and onergy extrusion process integrates a disposable bipolar designed for infigation. A oo extraction pregrated set allows for one unit instead of two units and helps to keep the bipolar electrosurgery organized.

# Device Testing

Substantial equivalence for this device is based upon comparison to predicate Oubstantial oquivalismo vor «rformance testing. Device qualification criteria meet ac nee characterialio and alification criteria for the predicate device. Tests meet or exceed the minimum has forth by the Association for the Advancement of the performance online of tons.in in the ANSI/AAMI HF18: 2001: Electrosurgical devices § 4.2.5.1-3, 5.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a modern, abstract design.

9200 Corp
Rockville

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Codman & Shurtleff, Inc. c/o Patricia L. Murphy Third Party Officials Reviewer KEMA Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914

Re: K052449

Trade/Device Name: Codman Integrated Irrigation Tubing and Bipolar Cord Set Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 7, 2005 Received: October 11, 2005

OCT ] 7 2005

Dear Ms. Murphy:

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 such 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.

{3}------------------------------------------------

Page 2- Patricia L. Murphy

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter natification. The FDA finding of substantial equivalence of your device to a legally premailer noticate 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 doon office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Zack N. McAllister

- Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

K052449

510(k) Number (if known):

Device Name:

Codman Integrated Irrigation Tubing and Bipolar Cord Set

Indications For Use:

The Codman Integrated Irrigation Tubing and Bipolar Cord Sets are intended to The Codman integrated inigation Tobing Sha Expolar forceps specifically designed for irrigation.

They are intended for use with the Codman/Malis CMC®-II and the They are intended for use with the Oodmaninations
Codman/Malis CMC® III I.E.C. Irrigation Modules and the Codman/Malis Bipolar Coagulators.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K052449