WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)

• K Number: K983840
• Device Name: WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
• Manufacturer: WALLACH SURGICAL DEVICES, INC.
• Date Cleared: 1999-05-20 ( 202 days)
• Product Code: HGI
• Regulation Number: 884.4120

Intended Use

Indications for use: The intended use of the Quantum 500 Electrosurgical Generator is for in-office high frequency, electrosurgical OB/GYN procedures. Some OB/GYN indications for applications include: 1) Cervical Conization. 2) Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias. 3) External Anogenital Lesions. 4) Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions. 5) Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field, wet or dry.

Device Description

Not Found

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or any other indicators typically associated with AI/ML technology in medical devices. The description focuses on the electrosurgical function and intended uses.

Therapeutic

Yes
The device is an electrosurgical generator intended for medical procedures like Cervical Conization and treatment of dysplasias, indicating its use in treating diseases or conditions.

Diagnostic

No

The device is an electrosurgical generator used for treatment procedures (excision, coagulation) in OB/GYN, not for diagnosing conditions.

SaMD (Software as a Medical Device)

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 describe surgical procedures performed with such a device. There is no mention of software being the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is an electrosurgical generator for performing procedures (cervical conization, LLETZ, etc.) on patients.
• Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information based on in vitro testing.
• Focus on Surgical Intervention: The indications for use describe surgical interventions and treatments, not diagnostic tests.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to perform surgical procedures directly on the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The intended use of the Quantum 500 Electrosurgical Generator is for in-office high frequency, electrosurgical OB/GYN procedures. Some OB/GYN indications for applications include:

1. Cervical Conization.
2. Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias.
3. External Anogenital Lesions.
4. Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.
5. Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field, wet or dry.

Product codes

85 HGI

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Cervical, Anogenital, Vaginal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

in-office

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)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 884.4120 Gynecologic electrocautery and accessories.

(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).

Summary

0

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 20 1999

Mr. Michael Malis General Manager Wallach Surgical Devices, Inc. 235 Edison Road Orange, Connecticut 06477

K983840 Re: Wallach Quantum 500 Electrosurgical Generator - for Gynecologic Indications Dated: February 17, 1999 Received: February 22, 1999 Requiatory Class: II 21 CFR 881.4120/ Procode: 85 HGI

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 legally marketed predicate 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). 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 requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requiation (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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal. Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

1

oSECTION 4 - Page 1 of 1 Page

K983840

510(k) Number (if known):

Device Name:

WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR FOR OB/GYN

Indications For Use:

Indications for use: The intended use of the Quantum 500 Electrosurgical Generator is for in-office high frequency, electrosurgical OB/GYN procedures. Some OB/GYN indications for applications include:

• 1. Cervical Conization.
• 2. Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias.
• 3. External Anogenital Lesions.
• 4. Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.
• 5. Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field, wet or dry.

510kform\g5obgyn\intnduseob#2.doc, February 17, 1999

(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 801.105)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K983840/S⁰⁰¹