The Wallach LOOP Electrode is a Sterile, Disposable, Single Use Electrode. Used in conjunction with an ESU (electrosurtical unit or generator) to CUT or COAG during an electorsurgical procedure.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Wallach LOOP Electrode." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through controlled studies with detailed acceptance criteria and performance metrics typically seen for AI/ML or complex diagnostics.

Therefore, the information you've requested regarding acceptance criteria, specific study details, sample sizes, expert involvement, and ground truth establishment, is largely not applicable (N/A) or explicitly detailed in this document. The purpose of this 510(k) is to show that the new device is as safe and effective as existing ones, primarily through comparison of design, materials, and intended use.

Here's a breakdown based on the provided text, indicating where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Derived from Substantial Equivalence to Predicate)	Reported Device Performance (Wallach LOOP Electrode)
Intended Use: With an ESU for CUT and COAG	Equivalent to predicate devices
Sterility: Sterile, Disposable, Single Use	Yes (matches predicate)
Design: Loop and Ball electrodes (Tungsten Wire, Curved Loop, Square Loop, Stainless Steel Ball)	Equivalent to predicate devices
Material: Tungsten Wire, Stainless Steel Shaft, Stainless Steel Ball, Polyolefin Insulation	Equivalent to predicate devices
Conforms with ANSI/AMMI HF18-1993	Yes
Sizes: Range of Ball and Loop sizes	Similar to predicate devices
Safety: No new hazards compared to predicate devices	Hazard analysis indicated no new hazards
Performance: Substantially equivalent in performance and design of operation	Testing performed indicates substantial equivalence

Note: Specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum power output, specific coagulation times) are not provided in this summary document. The "acceptance criteria" here are inferred from the demonstrated equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: N/A. No specific "test set" in the context of an independent clinical study is described. The evaluation is based on design, materials, and a hazard analysis, along with "testing" whose specifics are not detailed.
Data Provenance: N/A. No geographical origin or retrospective/prospective nature of data is provided. The testing mentioned is likely in-house engineering and bench testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

N/A. This 510(k) does not describe a study involving expert-established ground truth as would be relevant for diagnostic devices or those requiring expert interpretation.

4. Adjudication Method for the Test Set

N/A. Not applicable as no expert-reviewed test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is an electrosurgical electrode, not a diagnostic imaging device or AI system, so an MRMC study is not relevant or described.

6. If a Standalone Performance Study (algorithm only without human-in-the-loop) was done

N/A. This device is a physical electrode, not an algorithm. Standalone performance data, if relevant (e.g., specific electrical resistance, thermal properties), is not detailed in this summary.

7. The Type of Ground Truth Used

N/A. The "ground truth" for this device is its physical and functional characteristics matching specified engineering standards and performing equivalently to predicate devices. It does not involve "expert consensus, pathology, or outcomes data" in the typical sense of a diagnostic or therapeutic clinical outcome study for general medical devices. The ground truth essentially relies on established performance characteristics of the predicate devices and conformity to relevant standards (e.g., ANSI/AMMI HF18-1993).

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device, so there is no training set.

9. How the Ground Truth for the Training Set was Established

N/A. Not applicable, as there is no training set.

Summary

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JUN 0 3 2002

510(k) Premarket Notification Submittal 'Wallach LOOP Electrode' By Wallach Surgical Devices, Inc. SUMMARY CERTIFCIATION page of SECTION 2 March 4, 2002 -Page 2 of 3

510(k) Safety and Effectiveness Summary

Applicant:	Wallach Surgical Devices, Inc,235 Edison RoadOrange, CT 06477
Registration:	1219739
Contact:	Michael Malis
Phone:	203-799-2000
Fax:	203-799-2002
Trade Name:	Wallach LOOP Electrode
Devices Generic Name:	Electrosurgical Electrode
Classification Name:	Electrode, Electrosurgical
Classification:	Currently classified as a Class II, under ProductCode 79 GEI, Regulation Number 878.4400, 21 CFR

Predicate Devices to which we are claiming substantial equivalence:

Unimed 'Surgi-Link Eletrosurgical Electrode', K944433, 1
2 Megadyne 'Electrosurgical Electrode, K932102,

Product Description:

The Wallach LOOP Electrode is a Sterile, Disposable, Single Use Electrode. Used in conjunction with an ESU (electrosurtical unit or generator) to CUT or COAG during an electorsurgical procedure.

Indications for Use:

Used to excise target tissue, perform biopsies and control bleeding through a standard Monopolar Electrosurgical Generator.

Safety and Performance:

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

Hazard analysis evaluations performed on the Wallach LOOP Electrodes indicated that there were no new hazards presented with the use of the Wallach LOOP Electrodes as compared to the predicated devices.

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K020711

510(k) Premarket Notification Submittal 'Wallach LOOP Electrode' By Wallach Surgical Devices, Inc. SUMMARY CERTIFCIATION page of SECTION 2

March 4, 2002 -- Page 3 of 3

Comparison Chart:

Feature:	Wallach Surgical Devices,Inc.Wallach LOOP ElectrodesK(pending)Class II, Product Code: GEIRegulation #: 878.4400	UNIMED SurgicalProducts, Inc.Surgi-Link ElectrosurgcialElectrodeK944433Class II, Product Code: GEIRegulation #: 878.4400	Megadyne MedicalProducts, Inc.Electrosurgical ElectrodesK932102Class II, Product Code: GEIRegulation #: 878.4400
		Equivalent	Equivalent
IntendedUse:	With an ESU for CUT andCOAG	Equivalent	Equivalent
Sterile,DisposableSingle Use	Yes	Yes	Yes
Design:	Tungsten WireCurved LoopSquare LoopStainless Steel Ball	Equivalent	Equivalent

Material	Tungsten WireStainless Steel ShaftStainless Steel BallPolyolefin Insulation	Equivalent	Equivalent

ConformswithANSI/AMMIHF18-1993	Yes	Unknown	Unknown
Sizes:	3mm Ball5mm Ball5mm Ball 6cm Shaft10mmX7mm Loop10mmX10mm Loop15mmX5mm Loop15mmX8mm Loop20mmX8mm Loop20mmX10mm Loop20mmX15mm Loop10mmX8mm Square10mmX10mm Square	Similar	Similar

Conclusion:

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

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 0 3 2002

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

Re: K020711

Trade/Device Name: Wallach LOOP Electrode Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 4, 2002 Received: March 5, 2002

Dear Mr. Malis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Michael Malis

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Stypt Rhodes

Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Wallach Surgical Devices, Inc. Section 5

Page 1 of 1 __

510(k) Number (if known): _ 0207 / /

Wallach LOOP Electrode Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Used to excise target tissue, perform biopsies and control bleeding through a standard Monopolar Electrosurgical Generator.

(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
and Neurological Devices

510(k) Number K020711

Prescription Use ✓
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)

Regulation Number and Section

§ 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.