PMS 750 FINGERSWITCH

K991669 · Wallach Surgical Devices, Inc. · GEI · Aug 12, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991669
• Device Name: PMS 750 FINGERSWITCH
• Applicant: Wallach Surgical Devices, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The PMS750 Reusable (Autoclavable) Fingerswitch Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during electrosurgical procedures. It is provided non-sterile and is intended to be autoclavable for 100+ cycles.

Device Story

PMS750 Fingerswitch is a non-sterile, reusable electrosurgical handcontrol pencil; accessory to electrosurgical unit (ESU). Device features insert-molded body housing printed circuit board; yellow button activates CUT circuit; blue button activates COAG circuit. Used by physicians in clinical surgical settings. Provides manual control for electrosurgical energy delivery; facilitates tissue cutting and coagulation. Benefits include reusable design (autoclavable for 100+ cycles) for surgical utility.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by design, operation, and performance testing comparisons to predicate devices.

Technological Characteristics

Polypropylene construction; autoclavable. Encapsulated printed circuit board for switching. Manual button-actuated electrical switching for ESU control. Form factor: electrosurgical pencil.

Indications for Use

Indicated for use in general electrosurgical applications for cutting and coagulating during surgical procedures. Intended for use by physicians.

Regulatory Classification

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.

Predicate Devices

• Aaron Electrosurgical Handcontrol Pencil, Reusable (K983761)
• Medtrex's Encore™ Electrosurgical Pencil (35001-), Reusable (K970039)
• E & M Engineering's Reusable Hand Controlled ESP (K936075)
• Conmed's Tech-Switch Electrosurgical Pencil, Reusable (K932518)

Submission Summary (Full Text)

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AUG 12 1999

# K991669

## 510(k) Safety and Effectiveness Summary

| Applicant: | Wallach Surgical Devices, Inc. |
|----------------------|---------------------------------------------------------------|
| | 235 Edison Road |
| | Orange, CT 06477 |
| Registration #: | 1219739 |
| Contact: | Michael Malis |
| Phone: | 203-799-2000 |
| Fax: | 203-799-2002 |
| Trade Name: | PMS750 Fingerswitch |
| Device Generic Name: | Fingerswitch or Handswitch Pencil. |
| Classification Name: | Device, Electrosurgical, Cutting & Coagulation & Accessories. |

### Predicate Devices to which we are claiming substantial equivalence:

- 1. Aaron Electrosurgical Handcontrol Pencil, Reusable, K983761, 12/30/98.
- 2. Medtrex's Encore™ Electrosurgical Pencil (35001-), Reusable, K970039, 02/26/97.
- 3. E & M Engineering's Reusable Hand Controlled ESP, Reusable, K936075, 06/06/94.
- Conmed's Tech-Switch Electrosurgical Pencil, Reusable, K932518, 10/12/93. র্ব

### Product Description:

The PMS750 Fingerswitch Pencil is a non-sterile, limited reusable electrosurgical handcontrol pencil. It utilizes an insert-molded body that houses a printed circuit board; depression of the yellow button will activate the CUT circuit and depression of the blue button will activate the COAG circuit. It is an accessory to an ESU (electrosurgical unit or generator).

### Indications for Use:

The PMS750 Fingerswitch is intended to be used in general electrosurgical applications for cutting and coagulating during surgical procedures. It is provided non-sterile and is intended for limited reuse.

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510(k) Premarket Notification Submittal Wallach Surgical Devices, Inc. PMS750 Fingerswitch SECTION 2 - Page 3 of 3 May 1999

#### Safety and Performance:

Substantial equivalence for this device is based on design, operation, intended use, materials, components and performance claims. Testing that was performed on the PMS750 Fingerswitch indicates that the devices are substantially equivalent in their performance and design of operation.

Hazard analysis evaluations performed on the PMS750 Fingerswitch indicated that there were no new hazards presented with the use of the PMS750 Fingerswitch as compared to the predicate devices.

| | Wallach Surgical | Aaron | Medtrex | E & M Engineering | Conmed |
|---------------|-------------------------------|-----------------|------------------|-------------------|-----------------|
| | PMS750 | Electrosurgical | Encore™ | Reusable, | Tech-Switch |
| | Fingerswitch, | Handcontrol | Electrosurgical | Hand Controlled | Electrosurgical |
| | Reusable | Pencil, | Pencil (35001-), | ESP, | Pencil, |
| | K 991669 | Reusable, | Reusable, | K936075, | Reusable, |
| | [this 510(k)] | K983761, | K970039, | 06/06/94 | K932518, |
| | | 12/30/98. | 02/26/97. | | 10/12/93 |
| Materials | polypropylene | similar | similar | similar | similar |
| Sterilization | autoclavable | equivalent | equivalent | equivalent | equivalent |
| Design | Encapsulated<br>circuit board | equivalent | equivalent | equivalent | equivalent |
| Intended Use | With an ESU for<br>CUT & COAG | equivalent | equivalent | equivalent | equivalent |
| Where Used | By a Physician | equivalent | equivalent | equivalent | equivalent |

## SUBSTANTIAL EQUIVALENCE CHART

### Conclusion:

Based on the indications for use, technological characteristics and comparison to currently marketed devices, the PMS750 Fingerswitch has been shown to be safe and effective for its intended use.

Summaryfingerswitch.doc

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 12 1999

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

Re: K991669 Trade Name: PMS 750 Fingerswitch Regulatory Class: II Product Code: GEI Dated: May 11, 1999 Received: May 14, 1999

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.

い

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 (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 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.

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#### 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 [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/dsmamain.html".

Sincerely vours.

Sincerely yours,

C. Seth Keller, Ph.D., M.D.

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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Wallach Surgical Devices, Inc. SECTION 7

Page_1__of_1_

510(k) Number (if known):_ K 991669

Device Name:__PMS750 Fingerswitch Pencil

Indications For Use:

The PMS750 Reusable (Autoclavable) Fingerswitch Pencil is intended to be used in The PMS 750 Keusable (Autoclavations for cutting and coagniating during electrosurgical
general electrosurgical applications for cutting and coagnerable for 100+ cvcl general electrosurgical applications for cuting and occagations and good
procedures. It is provided non-sterile and is intended to be autoclavable for 100+ cycles.

(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 | K991669 | |
| Prescription Use<br>(Per 21 CFR 801.105) | OR | Over-The-Counter Use |
| | | (Optional Format 1-2-96) |