(90 days)
Not Found
No
The description focuses on the electromechanical function of the device (buttons activating circuits) and does not mention any computational or learning capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used for cutting and coagulating during surgical procedures, which are therapeutic interventions.
No
The device is described as an electrosurgical handcontrol pencil used for cutting and coagulating during surgical procedures, which are therapeutic actions, not diagnostic.
No
The device description explicitly states it is a "handcontrol pencil" with a "printed circuit board" housed within an "insert-molded body," indicating it is a physical hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting and coagulating during surgical procedures." This describes a surgical tool used directly on a patient's tissue, not a device used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a "handcontrol pencil" that activates "CUT circuit" and "COAG circuit" and is an "accessory to an ESU (electrosurgical unit or generator)." This further confirms its role as a surgical instrument.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing diagnostic information based on sample analysis.
Therefore, the PMS750 Fingerswitch is an electrosurgical accessory used in surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device 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).
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
By a Physician
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K983761, K970039, K936075, K932518
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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:
-
- Aaron Electrosurgical Handcontrol Pencil, Reusable, K983761, 12/30/98.
-
- Medtrex's Encore™ Electrosurgical Pencil (35001-), Reusable, K970039, 02/26/97.
-
- 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.
1
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 | ||||
| circuit board | equivalent | equivalent | equivalent | equivalent | |
| Intended Use | With an ESU for | ||||
| 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
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
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.
3
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 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
4
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 | ||
| (Per 21 CFR 801.105) | OR | Over-The-Counter Use |
| (Optional Format 1-2-96) |