(23 days)
Not Found
No
The summary describes a standard electrosurgical system with a generator, footswitch, cable, and LCD panel. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes.
The device is indicated for medical procedures such as cutting, coagulation of tissue, and sealing of blood vessels, which are actions performed to treat a patient's condition.
No
Explanation: The device is an electrosurgical system used for cutting, coagulation, and sealing of tissue, which are therapeutic rather than diagnostic functions.
No
The device description explicitly lists hardware components such as a generator, footswitch, connecting cable, and LCD panel.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "cutting and coagulation of tissue and sealing of blood vessels in all types of surgery." This describes a device used on the patient's body during a surgical procedure, not a device used to test samples from the body (like blood, urine, or tissue) in a laboratory setting.
- Device Description: The description details a surgical system with a generator, footswitch, and connecting cables for surgical tools. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device performs a surgical function directly on the patient.
N/A
Intended Use / Indications for Use
The Malis 2000 Electrosurgical Generator is indicated for use in micro, macro and endoscopic bipolar cutting and coagulation of tissue and sealing of blood vessels in all areas of surgery.
The MALIS 2000 Bipolar Electrosurgical system is indicated for use in micro, macro and endoscopic bipolar cutting and coagulation of tissue and sealing of blood vessels in all types of surgery.
Product codes
GEI
Device Description
The Malis 2000 Bipolar Electrosurgical System includes the generator, a Bipedal footswitch for operating the cutting and coagulation functions, a connecting cable to allow the use of a MALIS irrigator with the MALIS 2000 generator. The unit incorporates the use of a LCD panel to make it easier for the surgeon to see the setting.
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)
Not Found
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
MAR 9 2005
K 050364
Summary of Safety & Effectiveness
This 510 K Summary is being submitted in accordance with the requirements of 1990 and 21CFR807.92.
General Information
| Date Prepared: | March 7, 2005 |
|---|---|
| Submittor: | Valley Forge Scientific Corp. |
| P. O. Box 1179 | |
| Oaks, PA 19456 | |
| Contact: | Jerry Malis, M.D. |
| (610) 666-7500 | |
| Fax (610) 666-7565 |
General Provisions
| Trade name | Malis Bipolar 2000 Electrosurgical System |
|---|---|
| Classification: | Electro Surgical Device |
| Predicate Device: | K955346, VFS 300 |
| Classification: | Class II |
| Performance Standard: | Pursuant to Section 1990 CFR 870.92, no |
| performance standards have been | |
| established for this device. | |
| Intended Use: | The Malis 2000 Electrosurgical Generator is |
| indicated for use in micro, macro and endoscopic | |
| bipolar cutting and coagulation of tissue and | |
| sealing of blood vessels in all areas of surgery. |
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Page 2 of 2
Device Description:
The Malis 2000 Bipolar Electrosurgical System includes the generator, a Bipedal footswitch for operating the cutting and coagulation functions, a connecting cable to allow the use of a MALIS irrigator with the MALIS 2000 generator. The unit incorporates the use of a LCD panel to make it easier for the surgeon to see the setting.
Substantial Equivalence: _
| Item | Existing Device
K 955346 | Modified Device |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | VFS 300 Bipolar Electro-
surgical Generator | Malis 2000 Bipolar Electro-
surgical Generator |
| Intended Use | The Valley Forge Scientific
Malis Bipolar Generator is
indicated for use in surgical
procedures for cutting
tissue and coagulating
blood vessels. | The Valley Forge Scientific
Malis Bipolar Generator is
indicated for use in surgical
procedures for cutting
tissue and coagulating
blood vessels. |
| Control Circuitry | Digital | Digital |
| Method of Operation | Delivery of RF power for
cutting and coagulating. | Delivery of RF power for
cutting and coagulating. |
| RF Output Range | 5 watts to 300 watts | 5 watts to 300 watts |
| Blend Cut/Coag | Three (3) levels | Three (3) levels |
| Activation | By Footpedal | By footpedal and finger
operated instruments. |
| Output power controls | Up/down rocker switches | Rotary Switches |
| Power Display for Outputs | Segmental digital indicators | LED Display Screen |
| Sterilization | Non sterile | Non sterile |
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three wavy lines below the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 9 - 2005
Jerry L. Malis, M.D. President Valley Forge Scientific Corporation P.O. Box 1179 Oaks, Pennsylvania 19456
Re: K050364
Trade/Device Name: Malis Bipolar 2000 Electrosurgical System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 8, 2005 Received: February 14, 2005
Dear Dr. 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 10 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 (IPMA). 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Jerry L. Malis, M.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse Fig. finding of substantial equivalence of your device to a legally premative notificated. " 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), please If you desire specific auries 10. 90% (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.
Sinccrely yours,
for Miriam C. Provost, Ph.D.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Malis 2000 Bipolar Electrosurgical System
INDICATIONS FOR USE
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name
Valley Forge Scientific MALIS ™ 2000 Bipolar Electrosurgical Generator.
Indications for Use
The MALIS 2000 Bipolar Electrosurgical system is indicated for use in micro, macro and endoscopic bipolar cutting and coagulation of tissue and sealing of blood vessels in all types of surgery.
| Prescription Use: | X | AND/OR | Over-the-Counter Use: |
|---|---|---|---|
| (Per 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(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 | K050364 |
|---|---|
| --------------- | --------- |