(133 days)
Not Found
No
The device description and intended use focus on electrosurgical generation and procedures, with no mention of AI/ML terms or functionalities.
Yes
The device is described as an electrosurgical generator intended for medical procedures such as large loop excision and LLETZ, which are therapeutic interventions.
No
The device is described as an electrosurgical generator used for large loop excision and other similar low-powered procedures, indicating its use for treatment, not diagnosis. The indications for the procedure are based on existing diagnostic evidence (abnormal pap smear, colposcopic suspicion of CIN), not generated by the device itself.
No
The device description explicitly states it is a "High Frequency Electrosurgical Generator," which is a hardware device designed to generate electrical current.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Aaron 1200 is an electrosurgical generator. It uses high-frequency electrical current to cut or coagulate tissue during surgical procedures.
- Intended Use: The intended use clearly states it's for surgical procedures (large loop excision, LLETZ) performed on the patient's cervix, not for testing samples from the patient.
- Device Description: The description confirms it's a generator of electrical current, not a device for analyzing biological samples.
The device is a surgical instrument used for treatment, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Aaron 1200 High Frequency Electrosurgical Generator is intended for the removal and destruction of human tissue and the coagulation of bleeders. Modes of operation for this device include: cut, blend, coagulation, bipolar, and fulguration. The Handcontrol pencil is an integral component which is used in conjunction with the Aaron 1200.
The Aaron 1200 is intended to be used for large loop excision of the transformation zone, loop electrosurgical excision procedures and other similar low powered procedures in the area of obstetrics and gynecology. LLETZ is indicated for those patients who have had an abnormal pap smear report with cytologic evidence of CIN, colposcopic examination of the cervix with unsatisfactory findings and who, in the physician's opinion are suitable candidates for the procedure. Indications for the LLETZ procedure include:
- a cytological and colposcopic suspicion of CIN
- a transformation zone which is fully visible and fully confined to the cervix .
- a suspicion (cytological or colposcopic) of glandular abnormalities .
- a recurrent and troublesome cervical infection with persistent atypicality .
- a disparity between the cytological and colposcopic diagnosis .
- . a suspicion supported by evidence (cytological or colposcopic) of microinvasive disease
Product codes
79 GEI, 85 HGI
Device Description
The Aaron 1200 High Frequency Electrosurgical Generator is a non-sterile, reusable electrosurgical generator which is designed to generate high frequencies (RF) of high voltage and low amperage current.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human tissue (general), cervix (for LLETZ)
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 1200 High Frequency Electrosurgical Generator indicates that the devices are substantially equivalent in their performance and method of operation. Hazard analysis evaluations were performed on the Aaron 1200 High Frequency Electrosurgical Generator. Test results indicated that there are no new hazards presented with the use of the Aaron 1200 High Frequency Electrosurgical Generator as compared with the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
AARON MEDICAL INDUSTRIES, INC. Aaron 1200 High Frequency Electrosurgical Generator
510(K) NOTIFICATION Page 132 of 132
510/k) SAFETY AND EFFECTIVENESS SUMMARY
Aaron 1200 High Frequency Electrosurgical Generator and Accessories TRADE NAME: Electrosurgical Generator COMMON NAME: CLASSIFICATION NAME: Gynecologic electrocautery and accessories (21CFR 884.4120)
The Aaron 1200 High Frequency Electrosurgical Generator is a non-sterile, reusable electrosurgical generator which is designed to generate high frequencies (RF) of high voltage and low amperage current.
The Aaron 1200 High Frequency Electrosurgical Generator is intended for the removal and destruction of human tissue and the coagulation of bleeders. Modes of operation for this device include: cut, blend, coagulation, bipolar, and fulguration. The Handcontrol pencil is an integral component which is used in conjunction with the Aaron 1200.
The Aaron 1200 High Frequency Electrosurgical Generator is substantially equivalent to the Aaron 1200 High Frequency Electrosurgical Generator (K980366), the Aaron 800 High Frequency Desicator (K955681) and ValleyLab SSE4 Electrosurgical Generator (K823924) in design, operation, intended use, materials, energy source, components, method of preparation and performance claims.
Testing which has been performed on the Aaron 1200 High Frequency Electrosurgical Generator indicates that the devices are substantially equivalent in their performance and method of operation.
Hazard analysis evaluations were performed on the Aaron 1200 High Frequency Electrosurgical Generator. Test results indicated that there are no new hazards presented with the use of the Aaron 1200 High Frequency Electrosurgical Generator as compared with the predicate devices.
In conclusion, the Aaron 1200 High Frequency Electrosurgical Generator is substantially equivalent to the predicate devices, the Aaron 1200 High Frequency Electrosurgical Generator, the Aaron 800 High Frequency Desiccator and the ValleyLab SSE4 Electrosurgical Generator in methods of operation, intended use, and results derived from operation.
Submitted By:
J. Robert Saron President & CEO Aaron Medical Industries, Inc. 7100 30th Avenue North St. Petersburg, FL 33710-2902 (813) 384-2323
Contact Person: Date:
J. Robert Saron April 29, 1998
J. Menon
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three swooping lines representing the human services aspect of the department. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the caduceus.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. J. Robert Saron President & CEO AARON MEDICAL INDUSTRIES, INC. 7100 30th Avenue North St. Petersburg, FL 33710-2902
Re: K981570 Aaron 1200 HF Electrosurgical Generator Dated: August 11, 1998 Received: August 12, 1998 Regulatory Class: II 21 CFR 878.4400/Procode: 79 GEI 21 CFR 884.4120/Procode: 85 HGI
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 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 requirements, as set forth in the Quality System Regulation (OS) 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 regult 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.
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) 594-4613. 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/cdrb/dsmaldsmam.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page of of
510(k) Number (if known):
Device Name: Aaron 1200 High Frequency Electrosurgical Generator, Models A1200 & A1200/240
Indications For Use:
The Aaron 1200 is intended to be used for large loop excision of the transformation zone, loop electrosurgical excision procedures and other similar low powered procedures in the area of obstetrics and gynecology. LLETZ is indicated for those patients who have had an abnormal pap smear report with cytologic evidence of CIN, colposcopic examination of the cervix with unsatisfactory findings and who, in the physician's opinion are suitable candidates for the procedure. Indications for the LLETZ procedure include::
- a cytological and colposcopic suspicion of CIN
- a transformation zone which is fully visible and fully confined to the cervix .
- a suspicion (cytological or colposcopic) of glandular abnormalities .
- a recurrent and troublesome cervical infection with persistent atypicality .
- a disparity between the cytological and colposcopic diagnosis .
- . a suspicion supported by evidence (cytological or colposcopic) of microinvasive disease
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801 109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
David C. Grayson
(Division Sign-Off) Division of Reproductive. Abdominal, and Radiological D 510(k) Number