(65 days)
Not Found
No
The description focuses on basic electronic sensing and activation, with no mention of AI/ML terms or functionalities.
No.
The device is used for cutting and coagulating during surgical procedures, which are interventional actions rather than therapeutic. It acts as an accessory to an electrosurgical generator, which performs the actual cutting and coagulating.
No
The device is described as an electrosurgical handcontrol pencil used for cutting and coagulating during surgical procedures. Its function is to activate an electrosurgical generator, not to diagnose a condition.
No
The device description explicitly states it is a "sterile, limited reuse electrosurgical handcontrol pencil" with an "insert-molded body that encapsulates a printed circuit board," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "general electrosurgical applications for cutting and coagulating during surgical procedures." This describes a device used on a patient during surgery, not a device used to test samples from a patient in a lab setting.
- Device Description: The description details a handcontrol pencil that activates an electrosurgical generator. This is consistent with a surgical tool, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, the Aaron Electrosurgical Handcontrol Pencil is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Aaron Electrosurgical Handcontrol Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during surgical procedures. It is provided sterile and is intended for limited reuse.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Aaron Electrosurgical Handcontrol Pencil is a sterile, limited reuse electrosurgical handcontrol pencil. It utilizes an insert-molded body that encapsulates a printed circuit board used to sense either CUT or COAG button activation thus activating an electrosurgical generator. It is an accessory to an electrosurgical generator.
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)
Testing which has been performed on the Aaron Electrosurgical Handcontrol Pencil indicates that the devices are substantially equivalent in their performance and method of operation.
Hazard analysis evaluations where performed on the Aaron Electrosurgical Handcontrol Pencil. Test results indicated that there are no new hazards presented with the use of the Aaron Electrosurgical Handcontrol Pencil as compared with the predicate devices.
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
§ 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
AARON MEDICAL INDUSTRIES, INC. Aaron Electrosurgical Handcontrol Pencil 510(K) NOTIFICATION
K983761
510(k) SAFETY AND EFFECTIVENESS SUMMARY
TRADE NAME: Aaron Electrosurgical Handcontrol Pencil COMMON NAME: Electrosurgical Handcontrol Pencil CLASSIFICATION NAME: Electrosurgical cutting and Coagulation Devices and Accessories (21 CFR 878:4400)
The Aaron Electrosurgical Handcontrol Pencil is a sterile, limited reuse electrosurgical handcontrol pencil. It utilizes an insert-molded body that encapsulates a printed circuit board used to sense either CUT or COAG button activation thus activating an electrosurgical generator. It is an accessory to an electrosurgical generator.
The Aaron Electrosurgical Handcontrol Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during surgical procedures. It is provided sterile and is intended for limited reuse.
The Aaron Electrosurgical Handcontrol Pencil is IDENTICAL to the Medtrex Encore Electrosurgical Handcontrol Pencil, cleared under K970039 dated February 26, 1997. It is substantially equivalent to the Valleylab Model E2502B cleared under 510(k) K914400, and the Aaron Medical Industries, Inc Model A801 monopolar handpiece cleared under 510(k) K955681in design, operation, intended use, materials, components and performance claims.
Testing which has been performed on the Aaron Electrosurgical Handcontrol Pencil indicates that the devices are substantially equivalent in their performance and method of operation.
Hazard analysis evaluations where performed on the Aaron Electrosurgical Handcontrol Pencil. Test results indicated that there are no new hazards presented with the use of the Aaron Electrosurgical Handcontrol Pencil as compared with the predicate devices.
In conclusion, the Aaron Electrosurgical Handcontrol Pencil is substantially equivalent to the predicate devices, the Medtrex Encore Model 35001-001, the Aaron Medical Industries, Inc Model A801 monopolar handpiece and the Valleylab Model #2502B.
Submitted By: J. Robert Saron President & CEO Official Correspondent
1
Image /page/1/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of a human figure, with three faces in profile, one behind the other. The figure is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 30 1998
Mr. J. Robert Saron President and Chief Executive Officer Aaron Medical Industries, Inc. 7100 30th Avenue North St. Petersburg, Florida 33710-2902
K983761 Re: Trade Name: Aaron Electrosurgical Handcontrol Pencil Regulatory Class: II Product Code: GEI Dated: October 23, 1998 Received: October 26, 1998
Dear Mr. Saron:
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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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. J. Robert Saron
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,
Murle M. Millerson
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
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of 1 Page_ 1
510(k) Number (if known):
Aaron Electrosurgical Handcontrol Pencil Device Name:
Indications For Use:
The Aaron Electrosurgical Handcontrol Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during surgical procedures. It is provided sterile and is intended for limited reuse.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
Mark N melkein
(Optional Format 1-2-96)
for (Division Sign-Off)
CMW Division of General Restorative Devices
510(k) Number __