DRG REACTION CHAMBER/SAFETY TIP

K012003 · Doctor'S Research Group, Inc. · HEI · Feb 12, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K012003
• Device Name: DRG REACTION CHAMBER/SAFETY TIP
• Applicant: Doctor'S Research Group, Inc.
• Product Code: HEI · Obstetrics/Gynecology
• Decision Date: Feb 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Indications for Use

The DRG Reaction Chamber/Safety Tip is indicated for use as an accessory to standard ablation electrosurgical wands which do not have irrigation and vacuum extraction attached to them. The device provides continuous irrigation and vacuum extraction at the ablation site.

Device Story

DRG Reaction Chamber/Safety Tip functions as an accessory for Coblation electrosurgical wands; creates a sealed chamber at the ablation site; provides continuous irrigation and vacuum extraction for wands lacking these integrated features; used by clinicians during electrosurgical procedures; improves site management by maintaining a controlled environment for ablation; benefits patient by facilitating debris removal and fluid management during surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Accessory device for electrosurgical wands; provides mechanical irrigation and vacuum extraction; non-powered, passive fluid management component.

Indications for Use

Indicated for use as an accessory to standard ablation electrosurgical wands lacking integrated irrigation and vacuum extraction, providing continuous irrigation and suction at the ablation site.

Regulatory Classification

Identification

A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.

Predicate Devices

• ArthroCare Electrosurgery Systems (ENTec® Surgery System with ENTec™ Plasma Scalpel™ ArthroCare® Orthopedic Electrosurgery System, ArthroCare® Electrosurgery System) (K001936)

Submission Summary (Full Text)

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K012003 1/2

## Premarket Notification 510(k) Summary of Safety and Effectiveness DRG Reaction Chamber/Safety Tip

#### Company Information

Doctors Research Group, Inc. 143 Wolcott Road Wolcott, CT 06716 (p) 203-879-9422 (f) 203-879-2835

Contact: Richard Deslauriers, MD

Registration Number: 1226001

### Summary Preparation Date

June 20, 2001

## Device Information

| Trade name: | DRG Reaction Chamber/Safety Tip |
|------------------------------|-------------------------------------------------------------------|
| Common name: | Electrosurgical Device and Accessories |
| Classification name: | Electrosurgical Cutting and Coagulation Device and<br>Accessories |
| Device Classification Panel: | General and Plastic Surgery |
| Regulation number: | 21CFR Part 878.4400 |
| Class: | II |
| Product Code: | GEI |

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### Predicate Device

Kol 2003 2/2

ArthroCare Electrosurgery Systems (ENTec® Surgery System with ENTec™ Plasma Scalpel™ ArthroCare® Orthopedic Electrosurgery System, ArthroCare® Electrosurgery System) (K001936)

#### Device Description

The DRG Reaction Chamber/Safety Tip is an accessory for Coblation® electrosurgical devices. It creates a sealed chamber during ablation, ensuring continuous liquid supply and suction.

#### Indications For Use

The DRG Reaction Chamber/Safety Tip is indicated for use as an accessory to standard ablation electrosurgical wands which do not have irrigation and vacuum extraction attached to them. The device provides continuous irrigation and vacuum extraction at the ablation site.

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Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2002

Richard K. Deslauriers, M.D. President Doctor's Research Group, Inc. 143 Wolcott Road Wolcott, Connecticut 06716

Re: K012003

Trade/Device Name: DRG Reaction Chamber/Safety Tip Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 28, 2001 Received: November 29, 2001

Dear Dr. Deslauriers:

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.

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Page 2 - Richard K. Deslauriers, M.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis loter will and in yourse 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

iriam 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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# Doctors Research Group, Inc. 143 Wolcott Road Wolcott, CT 06716 [phone]

# Statement of Indications For Use

510(k) Number (if Known): K012003

Device Name: DRG Reaction Chamber/Safety Tip

Indications for use:

The DRG Reaction Chamber/Safety Tip is indicated for use as an accessory to The DRG Reaction Chamber/Galexy Tip is Indiana thave irrigation and vacuum
standard ablation electrosurgical wands which do not hingtion and standard ablation electrosurgiour wande miller as continuous irrigation and vacuum extraction at the ablation site.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDE! J NOT WRITE BEEO of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number *k012003*

Prescription Use צ (Per 21 CFR 801.109)

OR

Over-The-Counter Use