HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM

K033089 · Gyrus Ent LLC · GEI · Feb 5, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033089
• Device Name: HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM
• Applicant: Gyrus Ent LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hemostatix Model 2400Z Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut, with minimum tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.

Device Story

The Hemostatix Model 2400Z Thermal Scalpel System is a surgical instrument designed to provide precise cutting while minimizing blood loss. It functions by delivering heat via thermal conduction from an elevated-temperature blade directly to the tissue, simultaneously sealing blood vessels during the cutting process. This mechanism aims to reduce tissue damage and muscle stimulation compared to traditional electrosurgical devices. The device is intended for use by surgeons in clinical or operating room environments. By sealing vessels during the incision, the device assists in maintaining a clear surgical field and reducing patient blood loss.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Thermal scalpel system utilizing heat conduction for cutting and hemostasis. Complies with UL 2601-1, CSA 22.2 No. 601, IEC 601-1-1, IEC 601-1-2, IEC 601-1-4, IEC 61000-4-2/3/4/5, IEC 529, ISO 10993-1, and EN 55011 Class B standards. Features internal processors for unit control.

Indications for Use

Indicated for use as a surgical instrument for cutting tissue and simultaneous hemostasis via thermal conduction. Intended for use by clinicians in surgical settings.

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

• Oximetrix Shaw Hemostatic Surgical System

Submission Summary (Full Text)

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EB = 5 2004

## KO33089 (pg 1 of 1 510(k) Summary of Safety and Effectiveness

| Trade Name:<br>Common Name:<br>Classification Name: | Hemostatix Model 2400Z Thermal Scalpel System<br>Thermal Scalpel<br>Electrosurgical cutting and coagulation device and<br>accessories (§ 874.4400) |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Gregory Sredin<br>Manager of Regulatory Affairs<br>Gyrus ENT<br>2925 Appling Road<br>Bartlett, TN 38133 |
| Telephone:<br>Telefax: | [phone]<br>[phone] |
| Date Prepared: | September 19, 2003 |

The Hemostatix Model 2400Z Thermal Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut, with minimum tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.

The Hemostatix Model 2400Z Thermal Scalpel System that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate device. The intended uses are substantially equivalent to the described predicate Oximetrix Shaw Hemostatic Surgical System. The Hemostatix Model 2400Z Thermal Scalpel System is designed to meet UL 2601-1 including Australian deviations, CSA 22.2 No. 601, IEC 601-1-1 (EN 60601-1), IEC 601-1-2 (EN 60601-1-2), IEC 601-1-4 (EN 60601-1-2), IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 529, ISO 10993-1, EN 55011, Class B.

The Hemostatix Model 2400Z Thermal Scalpel System is substantially equivalent to the Oximetrix Shaw Hemostatic Surgical System and the difference of the processors that control the units should not affect the safety or effectiveness of the device.

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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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. Above the caduceus, the words "HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 2004

Mr. Gregory Sredin Manager of Regulatory Affairs Gyrus ENT LLC 2925 Appling Road Bartlett, Tonnessee 38133

Rc: K033089

Trade/Device Name: Hemostatix Model 2400Z Thermal Scalpel System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 21, 2004 Received: January 22, 2004

Dear Mr. Sredin:

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 Cl·R 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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Page 2 - Mr. Gregory Sredin

This letter will allow you to begin marketing your device as described in your Section 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 [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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

forCelia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: K033089

Device Name: Hemostatix Model 2400Z Thermal Scalpel System

Indications For Use:

The Hemostatix Model 2400Z Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut, with minimum tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.

Prescription Use X (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)

Miriam C Provost

· ivision Sign-Off) Oivision of General, Restorative Neurological Devices

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