(230 days)
Not Found
No
The summary describes a mechanical accessory for electrosurgical devices that provides irrigation and vacuum. There is no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is described as an "accessory" to standard ablation electrosurgical wands and its function is to provide continuous irrigation and vacuum extraction, not to directly treat a condition or disease.
No
The device is an accessory for electrosurgical wands, providing irrigation and vacuum extraction during ablation. Its function is therapeutic (assisting in tissue removal), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly states it is an "accessory" and creates a "sealed chamber" for "continuous liquid supply and suction," indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an accessory to electrosurgical wands for providing irrigation and vacuum extraction at an ablation site. This is a surgical/procedural use, not a diagnostic test performed on samples outside the body.
- Device Description: The description reinforces its function as an accessory for electrosurgical devices, creating a sealed chamber for irrigation and suction during ablation. This is a physical intervention during a procedure.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic purpose. IVDs are designed to diagnose diseases or conditions based on the analysis of such samples.
Therefore, the DRG Reaction Chamber/Safety Tip is a surgical accessory, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.2660 Fetal ultrasonic monitor and accessories.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 |
| Accessories | |
| Device Classification Panel: | General and Plastic Surgery |
| Regulation number: | 21CFR Part 878.4400 |
| Class: | II |
| Product Code: | GEI |
1
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.
2
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.
3
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
Doctors Research Group, Inc. 143 Wolcott Road Wolcott, CT 06716 (203) 879-9422
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