PLASMAJET SYSTEM

K030819 · Plasma Surgical, Ltd. · GEI · Aug 5, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K030819
• Device Name: PLASMAJET SYSTEM
• Applicant: Plasma Surgical, Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PlasmaJet™ system is a neutral plasma coagulator that is designed for coagulation in open surgery and laparoscopic surgery.

Device Story

PlasmaJet™ system is a neutral plasma coagulator for open and laparoscopic surgery. System components include a console, service module (argon tank interface), footswitch, and single-use handpieces. Operation involves generating a neutral plasma beam within the handpiece using a series of electrodes and argon gas; no ground plate is required as the circuit is contained within the handpiece. The plasma beam, consisting of excited argon atoms, ions, and electrons, is directed at bleeding tissue. Kinetic energy from the plasma removes liquid blood and creates eschar layers to seal the tissue surface. Used by surgeons in clinical settings to achieve hemostasis. Benefits include effective coagulation without current passing through the patient, reducing risk of alternate site burns.

Clinical Evidence

Animal and clinical studies were conducted to evaluate the effectiveness of the neutral plasma coagulator. Results indicated that the device provides more effective coagulation compared to the predicate devices.

Technological Characteristics

Neutral plasma coagulator; utilizes argon gas and a series of electrodes to generate a plasma beam. Operates at low voltage (~30V). System includes console, service module, and single-use open/laparoscopic handpieces. No grounding plate required. Standalone system.

Indications for Use

Indicated for coagulation of tissue during open and laparoscopic surgical procedures. Prescription use only.

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

• Bard EMS System 6000 (K871435)
• Valleylab Force GSU™ System / Force GSU™ Handset (K904545)
• Erbe APC300 Argon Plasma Coagulator and Accessories (K963189)

Submission Summary (Full Text)

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AUG - 5 2004

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# KO30819

## 510(k) Summary

October 30th 2003

### Submitter 1

Plasma Surgical Ltd First Floor Albemarle House 1 Albemarle Street London W1X 3HF United Kingdom

| Contact Person: | Prof. Peter F Gibson |
|-----------------|----------------------------------|
| Telephone: | [phone] |
| Facsimile: | [phone] |
| E-mail: | [e-mail] |

### Name of Device 2

| Proprietary Name: | PlasmaJet™ system, comprising:<br>a) PlasmaJet™ console<br>b) PlasmaJet™ service module<br>c) PlasmaJet™ open surgery handpieces<br>d) PlasmaJet™ laparoscopic surgery handpieces |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Neutral Plasma Coagulator |
| Device Classification: | Electrosurgical coagulation devices have been placed in Class<br>II as per 21 CFR Regulation Number 878.4400 and assigned<br>the Product Code GEI. |

### Predicate Devices 3

The components of the PlasmaJet™ system are substantially equivalent to the following legally marketed devices:

| K871435 | Bard EMS System 6000 |
|---------|-----------------------------------------------------|
| K904545 | Valleylab Force GSUTM System / Force GSU™ Handset |
| K963189 | Erbe APC300 Argon Plasma Coagulator and Accessories |

This statement is based on the similarity of the subject device to the predicate I his statement is bases exaterials, design and principles of operation.

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### Device Description 4

The PlasmaJet™ system consists of a range of single-use open or laparoscopic The Plasmajer - system consisted of a carea. In and argon plasma. A console is nandpieces that are assured for obagains.
used to power the handpiece and a footswitch and a service module (providing a used to power the handplose for an argon tank) completes the system.

In the PlasmaJet™ system, as in a bipolar electrosurgery system, both anode and In the Plasmajet - System, as in a spissma are contained within the handpices, and cathode used to generate the argon partic no ground plate is used. "Decated bour the patient and no more of alternate the liandpiece there is no carrent no niece, a specially designed series of electrodes
site burns. In the PlasmaJet™ handpiece, a specially designed series and allows a relatively low voltage (of about 30V) to generate a more energetic and allows a relatively 101. PlasmaJet™ plasma uses a much lower flow of argon gas than is used in the argon I lasmarco - plasma ases a mis electrically neutral and comprises a mixture of excited Deall Coagulator, the plasma is crocere....)
argon atoms, argon ions, and electrons that emerge from the tip of the handpiece in an intense pale blue jet or beam.

When the plasma jet reaches the bleeding tissue, it gives up its kinctic energy as heat which the plasma fer reasies in the bleeding surface by a series of processes. First, the allu causes coaganacon of the broom of argon plasma removes liquid blood from the tissue surface or vessel. Secondly, the energy dissipated from the plasma to the tissue ussuc surface of recom of corm a series of layers of eschar that seal the tissue surface and prevent further bleeding.

### Intended Use 5

The PlasmaJet™ system is a neutral plasma coagulator that is designed for coagulation in open surgery and laparoscopic surgery.

### Summary of Substantial Equivalence 6

The PlasmaJet™ system is similar in design, intended use and performance The Flashajet - System is sammar ines. It differs in combining the electrodes used to characterisues to the predicate the handpiece, and does not require the use of an electrosurgical grounding plate, nor does a current pass through the patient as in conventional electrosurgery or argon beam coagulation. Animal and clinical studies conventional ciccurosurgery of arget stablished that the neutral plasma coagulator have been pore effective coagulation than the predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 2004

Professor Peter F. Gibson Plasma Surgical Ltd First Floor Albemarle House 1 Albemarle Street London W1X 3HF United Kingdom

Re: K030819

Trade/Device Name: PlasmaJet™ System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 25, 2004 Received: May 27, 2004

Dear Professor Gibson:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained homeon (tor the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the clebosure) to regally mannet date of the Medical Device American be and Ford. For d. Ford, Drug commerce prof to May 20, 1976, the enature with the provisions of the Federal Food, Drug, devices that have been recalismed in acceracy val of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appli and Cosment Act (Act) that do not require approvine controls provisions of the Act. The You may, therefore, market the devices, books of the more of registration, listing of general controls provisions of the free hoteling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is crassified (sociation major regulations affecting your device can
may be subject to such additional controls. Existing major regulations EDA move may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the Out of Peach oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuance of a based in a complies with other requirements of the Act that FDA has made a decermination that Jour Secret by other Federal agencies. You must or any Federal statutes and regarations annuding, but not limited to: registration and listing (21 l CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Part 607), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Q5) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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Page 2 - Professor Peter F. Gibson

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin hankemig your avince of your device of your device to a legally premarket notification. The FDA mining of substantial organisation of your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
s an interest of the may not a come of the collection antiled If you desire specific advice for your de rice of var accesse note the regulation entitled, and comact the Office of Complaned at (301) 37 - 40 m (21CFR Part 807.97). You may obtain "Misbranding by relefence to premantee nowlite as and released on the Division of Small other general mioritation on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance of Armanaio Attril Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia 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 (if Known): K030819

PlasmaJet™ System Device Name:

The PlasmaJet™ System is a neutral plasma Indications for Use: THC Placmator that is designed for coagulation in open surgery and laparoscopic surgery.

X = Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFGR 801 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

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

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**510(k) Number** K030819