(42 days)
Not Found
Not Found
No
The description focuses on standard electrosurgical generator features like power settings, current monitoring, and safety standards, with no mention of AI or ML.
Yes
The device is described as an electrosurgical generator used to supply RF signals to handpieces for use on soft body tissues, indicating it is directly involved in a medical procedure to treat or modify tissue.
No
The device is described as a "general purpose solid state bipolar generator to supply the RF signal to electrosurgical handpieces." This indicates it is used for surgical procedures (electrosurgery), specifically to apply energy to tissues, not to diagnose conditions.
No
The device description clearly details hardware components such as a generator, digital display, bar graph display, handswitch, and power supply, indicating it is a physical medical device, not software-only.
Based on the provided information, the KIRWAN MODEL 28 1000 Generator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to supply an RF signal to electrosurgical handpieces for use on soft body tissues. This is a therapeutic/surgical application performed on the patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the technical aspects of generating and monitoring the RF signal for surgical purposes. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing diagnostic information about a disease or condition
Therefore, the KIRWAN MODEL 28 1000 Generator is an electrosurgical generator used for therapeutic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The KIRWAN MODEL 28 1000 Generator is a general purpose solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.
Product codes
GEI
Device Description
A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- 5watts, full scale (@ 100 ohms). A bar graph display output current monitor provides the operator a relative measure of the output current amplitude and to denote the presence of output energy during activation. The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply. Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines. RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) ipolar coagulators. This device is identical to an existing approved device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft body tissues
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.
Not Found
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
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
0
S. Food and Drug Administration 0K Document Mail Center HFZ-401 Center for Medical Devices 1390 Piccard Drive Rockville, Maryland 20850
MAY 2 2 1997
K 971341
To: Document Control Clerk
This summary of 510K safety and effectiveness for the Kirwan 28 1000 Coagulator is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807,92.
A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- Swatts, full scale (@ 100 ohms).
A bar graph display output current monitor provides the operator a relative measure of the output current amplitude and to denote the presence of output energy during activation.
The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply.
Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines.
IF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) ipolar coagulators.
This device is identical to an existing approved device.
Sincerely,
Kembra Pfahler
Kevin Prario Manager, Regulatiory Affairs Kirwan Surgical Products Inc. 180 Enterprise Drive Box 427 Marshfield, Massachusetts 02050
4/9/97
Date
Date
1
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 image of a human figure with three flowing lines extending from the head, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 1997
Mr. Kevin Prario Manager, Regulatory Affairs Kirwan Surgical Products, Inc. 180 Enterprise Drive Marshfield, Massachusetts 02050
Re: K971341 Trade Name: Kirwan Model 28 1000 Biopolar Generator Regulatory Class: II Product Code: GEI Dated: April 9, 1997 Received: April 10, 1997
Dear Mr. Prario:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Kevin Prario
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
ﺍﻟﻤﺴﺘﻘ
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page__________________________________________________________________________________________________________________________________________________________________________
971341 510(k) Number (if known)
Device Name: KIRWAN MODEL 28 1000 BIPOLAR GENERATOR
Indications for use:
The KIRWAN MODEL 28 1000 Generator is a general purpose solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Divisier) Stan-
Division of General Restorative Devices (471341
510(k) Number
Prescription Use
X(Per 21 CFR 801.109)
OR
Over The Counter Use
(Optional Format 1-2-96)
5