(161 days)
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No
The document does not mention AI, ML, or any related terms, nor does it describe features or functionalities typically associated with AI/ML in medical devices (e.g., image analysis, predictive algorithms, automated decision support based on complex data patterns). The description focuses solely on the electrosurgical functions and intended uses.
Yes
The device is used for electrosurgical procedures like cutting, coagulation, and hemostasis for various medical conditions, indicating its therapeutic intent.
No
The device is an electrosurgical generator used for various surgical procedures, primarily involving cutting, coagulation, and hemostasis of tissues; it does not mention any diagnostic capabilities.
No
The device is described as an "Electrosurgical Generator," which is a hardware device used to generate high-frequency electrical currents for surgical procedures. The indications for use clearly describe surgical procedures performed with such a device, not software functionalities.
Based on the provided information, the Quantum 500 Electrosurgical Generator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The intended use of the Quantum 500 is for performing surgical procedures directly on the patient's body (in vivo) using high-frequency electrical currents for cutting, coagulation, and hemostasis.
- The indications for use clearly describe procedures performed on the skin and other tissues on the patient, not on specimens from the patient.
Therefore, the Quantum 500 Electrosurgical Generator is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
Indications for use: The intended use of the Quantum 500 Electrosurgical Generator is for all General & Plastic Surgery related in-office high frequency, electrosurgical procedures. Some indications for applications include: - 1) Cutting skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, nevi, keratosis, oculoplastic procedures, blepharoplasty, aponeurotic repair, and levator resection. - 2) Blended Cutting and Coagulation skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, skin tags, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps, and oculoplastic procedures. - 3) Hemostasis control of bleeding, epilation, and telangiectasia. - 4) Fulguration basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, and hemostasis. - 5) Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field; wet or dry.
Product codes
GEI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
in-office
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a stacked formation. The profiles are connected and appear to be emerging from a single form. The image is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 1999
Mr. Michael Malis General Manager Wallach Surgical Devices, Inc. 235 Edison Road Orange, Connecticut 06477
Re: K983208
Trade Name: Wallach Quantum 500 Electrosurgical Generator Regulatory Class: II Product Code: GEI Dated: December 4, 1998 Received: December 10, 1998
Dear Mr. Malis:
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.
1
Page 2 - Mr. Michael Malis
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.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Premarket Notification Submittal for Wallach Quantum 500
SECTION 8 - Page 1 of 1
Page
12/2/98
pñ.
510(k) Number (if known) K983208
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Indications for use: The intended use of the Quantum 500 Electrosurgical Generator is for all General & Plastic Surgery related in-office high frequency, electrosurgical procedures. Some indications for applications include:
-
- Cutting skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, nevi, keratosis, oculoplastic procedures, blepharoplasty, aponeurotic repair, and levator resection.
-
- Blended Cutting and Coagulation skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, skin tags, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps, and oculoplastic procedures.
-
- Hemostasis control of bleeding, epilation, and telangiectasia.
-
- Fulguration basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, and hemostasis.
-
- Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field; wet or dry.
510kform\quantum5\IndicForUse2.doc, Dec. 1998
(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 K983208
Prescription Ser (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96).