(75 days)
No
The description focuses on the physical characteristics and function of a surgical electrode, with no mention of AI or ML capabilities.
No
The device is used for cutting and coagulating during surgical procedures, which are actions performed during a therapy but are not therapeutic in themselves. A therapeutic device would deliver a treatment or therapy to a patient.
No
The device is described as an electrode used to "cut and or coagulate during laparoscopic surgical procedures," indicating a therapeutic rather than diagnostic function.
No
The device description clearly states it is a "sterile, single use solid laparoscopic electrode" made of "insulated stainless steel," 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 is "to cut and or coagulate during laparoscopic surgical procedures." This describes a surgical tool used directly on tissue within the body, not a device used to examine specimens (like blood, urine, or tissue samples) outside the body to diagnose or monitor a condition.
- Device Description: The description details a "solid laparoscopic electrode" used as an "accessory to an electrosurgical generator." This further reinforces its role as a surgical instrument.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely surgical.
N/A
Intended Use / Indications for Use
The Aaron SlickTip Solid Laparoscopic Electrode, is intended to be used, in laparoscopic electrosurgical applications for cutting and coagulating during surgical procedures. It is provided sterile and is intended for single use.
The Subject device of this premarket notification submission is indicated for use to cut and or coagulate during laparoscopic surgical procedures.
Product codes
GEI
Device Description
The Aaron SlickTip Solid Laparoscopic Electrode is a sterile, single use solid laparoscopic electrode. It utilizes an insulated stainless steel laparoscopic electrode with the same coating as cleared under K974735. 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 SlickTip Solid Laparoscopic Electrode indicates that the devices are substantially equivalent in their performance and method of operation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K971621, K913281, K904560, K942892
Reference Device(s)
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
2/10/99
KG84239
AARON MEDICAL INDUSTRIES, INC. Aaron SlickTip Solid Laparoscopic Electrodes
510(K) NOTIFICATION
510(k) SAFETY AND EFFECTIVENESS SUMMARY
TRADE NAME: Aaron SlickTip Solid Laparoscopic Electrode COMMON NAME: Laparoscopic Electrode CLASSIFICATION NAME: General and Plastic Surgery (21 CFR 878.4400)
The Aaron SlickTip Solid Laparoscopic Electrode is a sterile, single use solid laparoscopic electrode. It utilizes an insulated stainless steel laparoscopic electrode with the same coating as cleared under K974735. It is an accessory to an electrosurgical generator.
The Aaron SlickTip Solid Laparoscopic Electrode, is intended to be used, in laparoscopic electrosurgical applications for cutting and coagulating during surgical procedures. It is provided sterile and is intended for single use.
The Aaron SlickTip Solid Laparoscopic Electrode is IDENTICAL to the Resistick Solid Laparoscopic Electrodes by Aaron Medical Industries, Inc, cleared under K971621 dated June 20, 1997 with the coating cleared under K974735. It is substantially equivalent to the MegaDyne K913281, the Valleylab K904560, the Conmed K942892 and the WJ Surgical Hi-Tip Laparoscopic electrodes in design, operation, intended use, materials, components and performance claims.
Testing which has been performed on the Aaron SlickTip Solid Laparoscopic Electrode indicates that the devices are substantially equivalent in their performance and method of operation.
Hazard analysis evaluations were performed on the Aaron SlickTip Solid Laparoscopic Electrode. Test results indicated that there are no new hazards presented with the use of the Aaron SlickTip Solid Laparoscopic Electrode as compared with the predicate devices.
In conclusion, the Aaron SlickTip Solid Laparoscopic Electrode is substantially equivalent to the predicate devices, the MegaDyne K913281, the Conmed K942892, the Aaron Medical Industries, Inc Resistick Solid Laparoscopic Electrode K971621, with the Aaron Medical Industries, Inc coating cleared under K974735, the Valleylab K904560 and the WJ Surgical Hi-Tip Laparoscopic electrodes.
Submitted By: J. Robert Saron President & CEO Official Correspondent
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1999
Mr. J. Robert Saron President and Chief Executive Officer, Official Correspondent Aaron Medical Industries, Inc. 7100 30th Avenue North St. Petersburg, Florida 33710
Re: K984239
Trade Name: Slicktip Solid Laparoscopic Electrodes Regulatory Class: II Product Code: GEI Dated: November 25, 1998 Received: November 27, 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 (QS) 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 vour 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,
Sincerely yours,
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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Page 1 _______________________________________________________________________________________________________________________________________________________________________ of 1__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): _
Device Name: SlickTip Solid Laparoscopic Electrodes
Indications For Use:
. .
.
The Subject device of this premarket notification submission is indicated for use to cut and or coagulate during laparoscopic surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K984239 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)