(90 days)
Not Found
No
The summary describes a simple electrosurgical electrode and does not mention any AI or ML components or functionalities.
Yes
The device is used to perform biopsies and control bleeding through excision, which are therapeutic actions.
No
The device is described as an electrode used to "excise target tissue, perform biopsies and control bleeding," and to "CUT or COAG during an electrosurgical procedure." These are interventional/surgical functions, not diagnostic ones. While biopsies are taken for diagnostic purposes, the device itself is performing the biopsy by excising tissue, not by analyzing or interpreting data for diagnosis.
No
The device description clearly states it is a "Sterile, Disposable, Single Use Electrode," which is a physical hardware component used in conjunction with an electrosurgical unit.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is used to "excise target tissue, perform biopsies and control bleeding" during an electrosurgical procedure. This is a surgical tool used on the patient's body, not for testing specimens taken from the body.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on laboratory tests.
- Using reagents or assays.
The Wallach LOOP Electrode is an electrosurgical accessory used for surgical procedures.
N/A
Intended Use / Indications for Use
Used to excise target tissue, perform biopsies and control bleeding through a standard Monopolar Electrosurgical Generator.
Product codes
GEI
Device 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.
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
Not Found
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, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Road
Orange, 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 Product
Code 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.
1
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 Electrodes
K
(pending)
Class II, Product Code: GEI
Regulation #: 878.4400 | UNIMED Surgical
Products, Inc.
Surgi-Link Electrosurgcial
Electrode
K944433
Class II, Product Code: GEI
Regulation #: 878.4400 | Megadyne Medical
Products, Inc.
Electrosurgical Electrodes
K932102
Class II, Product Code: GEI
Regulation #: 878.4400 |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| | | Equivalent | Equivalent |
| Intended
Use: | With an ESU for CUT and
COAG | Equivalent | Equivalent |
| Sterile,
Disposable
Single Use | Yes | Yes | Yes |
| Design: | Tungsten Wire
Curved Loop
Square Loop
Stainless Steel Ball | Equivalent | Equivalent |
| | | | |
| Material | Tungsten Wire
Stainless Steel Shaft
Stainless Steel Ball
Polyolefin Insulation | Equivalent | Equivalent |
| | | | |
| Conforms
with
ANSI/AMMI
HF18-1993 | Yes | Unknown | Unknown |
| Sizes: | 3mm Ball
5mm Ball
5mm Ball 6cm Shaft
10mmX7mm Loop
10mmX10mm Loop
15mmX5mm Loop
15mmX8mm Loop
20mmX8mm Loop
20mmX10mm Loop
20mmX15mm Loop
10mmX8mm Square
10mmX10mm 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.
2
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.
3
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
4
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)