K Number
K042604
Device Name
VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS
Date Cleared
2004-10-22

(28 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electro-Surgical accessories: Hand-Switching Pen for the removal of tissue and Electro-Surgical accessories: Hand Officening vising high frequency (RF) current.
Device Description
Plastic disposable finger operated bipolar electro-surgical instruments with either blade, ball or loop tips.
More Information

Not Found

No
The summary describes a simple electro-surgical instrument and does not mention any AI or ML related terms, image processing, or data-driven performance studies.

Yes
The device is described as an "Electro-Surgical instrument" used for "removal of tissue" using "high frequency (RF) current," which indicates a medical intervention intended to treat or alleviate a condition.

No
The device description states its use is "for the removal of tissue," which indicates a therapeutic rather than a diagnostic function.

No

The device description explicitly states it is a "Plastic disposable finger operated bipolar electro-surgical instruments with either blade, ball or loop tips," which are physical hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the "removal of tissue" using high-frequency current. This is a surgical procedure performed directly on a patient's body.
  • Device Description: The device is described as "electro-surgical instruments" with tips for tissue manipulation. This aligns with surgical tools, not devices used to examine specimens outside the body.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.

IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to perform a surgical action (tissue removal) directly on the patient.

N/A

Intended Use / Indications for Use

The Valley Forge Scientific Malis™ Bipolar Disposable Electro-Surgical Pen is indicated for use with the Valley Forge Scientific 300 Bipolar System.

Electro-Surgical accessories: Hand-Switching Pen for the removal of tissue and Electro-Surgical accessones: Hand Officening vising high frequency (RF) current.

Product codes

GEI

Device Description

Plastic disposable finger operated bipolar electro-surgical instruments with either blade, ball or loop tips.

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)

K910510, K896626, K955764, K982742, K973554, K982884, K932345, K850297

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.

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510(k) Summarv for the Malis Bipolar Disposable Electro-Surgical Pens

OCT 2 2 2004

Valley Forge Scientific Corp. 136 Green Tree Rd., Suite 100, P. O. Box 1179 Oaks, PA 19456

Contact Person:Jerry L. Malis, President
Phone Number:610-666-7500
Fax Number:610-666-7565
Date Prepared:September 21, 2004
Proprietary Name:Valley Forge Scientific Malis™ Bipolar Disposable Electro-Surgical Pens
Common Name:Bipolar Disposable Electro-Surgical Pens
Classification Name:Electrosurgical Cutting and Coagulation Accessory
Device Classification:This device is Class II per CFR § 878.4400-

Electrosurgical Cutting and Coagulation Instruments

Predicate Devices:

K910510Valley Forge Scientific Corp.K896626Conmed Corp.
K955764Valley Forge Scientific Corp.K982742New Deantronics
K973554Valley Forge Scientific Corp.K982884New Deantronics
K932345Conmed Corp.K850297Birtcher Corp.

Intended Use: The Valley Forge Scientific Malis™ Bipolar Disposable Electro-Surgical Pen is indicated for use with the Valley Forge Scientific 300 Bipolar System.

Device Description: Plastic disposable finger operated bipolar electro-surgical instruments with either blade, ball or loop tips.

Performance Standards: Pursuant to Section 514 of the FD&C Act and 21 CFR 888, no performance standards have been established for this device

Substantial Equivalence:

The Valley Forge Scientific Malis bipolar instruments are similar in use to Bovietype mono-polar instruments which have been marketed for the past 25-30 years (prior to May 28, 1976). Both the mono-polar and the bipolar instruments depend on an electro-surgical generator to deliver RF current to the tips of the instruments for cutting and coagulation.

The difference between the two methods can be found in the fact that with the mono-polar systems, the current passes from an active electrode through the patient to a grounding pad. The bipolar method eliminates the electrical current being passed through the patient and the use of grounding pads and their inherent safety hazards. Bipolar technology also permits the surgeon to work in a wet or irrigated surgical field without current shunting.

The physical construction of both the mono-polar and bipolar instruments are essentially identical. The switch mechanisms on both are liquid sealed with buttons molded in place.

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Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2004

Mr. Jerry L. Malis President and CEO Valley Forge Scientific Corporation 136 Green Tree Road, Suite 100 P.O. Box 1179 Oaks, Pennsylvania 19456

Re: K042604

Trade/Device Name: Valley Forge Scientific MALIS™ Bipolar Disposable Hand-Switching Electro-Surgical Pencil, Loops, and Ball Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 21, 2004 Received: September 24, 2004

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

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Page 2 - Mr. Jerry L. Malis

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This ictier with anow you to ough maine of substantial equivalence of your device to a legally prematicated predicated. The 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 11 you desire specific acries at (240) 276-0115. Also, please note the regulation entitled, Connact the Office of Coach to premarket notification" (21CFR Part 807.97). You may obtain Whisolaining of Yererence to premessionsibilities under the Act from the Division of Small other general mionnation 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,

Miriam C. Provost

Celia M. 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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INDICATIONS FOR USE

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name

Valley Forge Scientific MALIS ™ Bipolar Disposable Hand-Switching Electro-Surgical Pencils, Loops, and Ball.

Indications for Use

Electro-Surgical accessories: Hand-Switching Pen for the removal of tissue and Electro-Surgical accessones: Hand Officening vising high frequency (RF) current.

| Prescription Use:

(Per 21 CFR 801 Subpart D)✓_________________
AND/OR Over-the-Counter Use:
(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)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number K042604