K Number
K043036
Device Name
NON-STICK ELECTRODE
Date Cleared
2005-05-06

(183 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is an electrosurgical cutting and coagulating device intended to remove tissues and control bleeding by means of high frequency electrical current.
Device Description
Not Found
More Information

Not Found

Not Found

No
The summary describes a standard electrosurgical device and contains no mention of AI, ML, or related concepts like image processing or performance metrics typically associated with AI/ML algorithms.

Yes
The device is intended to remove tissues and control bleeding, indicating a direct therapeutic action on the body.

No
The device is described as an electrosurgical cutting and coagulating device, which is a therapeutic function, not a diagnostic one. It removes tissues and controls bleeding using electrical current, indicating a treatment purpose rather than a purpose of identifying or characterizing a disease or condition.

No

The intended use describes an electrosurgical device, which is a hardware-based technology. There is no mention of software as the primary or sole component.

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

Here's why:

  • Intended Use: The intended use describes a device that removes tissues and controls bleeding using high frequency electrical current. This is a description of a surgical or therapeutic device that acts directly on the patient's body.
  • Lack of IVD Characteristics: The description does not mention any of the key characteristics of an IVD, such as:
    • Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
    • Providing information about a patient's health status, diagnosis, or disease.
    • Using reagents or assays.

IVDs are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is to perform a surgical procedure directly on the patient.

N/A

Intended Use / Indications for Use

It is an electrosurgical cutting and coagulating device intended to remove tissues and control bleeding by means of high frequency electrical current.

Product codes (comma separated list FDA assigned to the subject device)

GEI

Device Description

Not Found

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): 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.

Not Found

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

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services (HHS). The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four abstract human profiles facing to the right, with flowing lines above them that could represent hair or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 6 2005

Modern Medical Equipment MFG., Ltd. C/o Mr. Robert Stillman E & M Engineering Incorporated 1705 Dabney Road Richmond, Virginia 23230

Re: K043036

Trade/Device Name: Modern Medical Non Stick Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 23 , 2004 Received: April 12, 2005

Dear Mr. Stillman:

We have reviewed your Section 510(k) premarket notification of intent to market the device w 6 nave ro rowed your ve determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated) 7 the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de nees mat have been that do not require approval of a premarket approval application (PMA). and Cosmetic fore, market the device, subject to the general controls provisions of the Act. The r ou may, are ex vrovisions 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 your doviee is elassified (disalated). Existing major regulations affecting your device it may of subject to saon af Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA oun or found in the announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r tease be advisou that I Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must of any I ederal 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 El It i at 6077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quinny by our of provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

Page 2 - Mr. Robert Stillman

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will and w you to begin mating of substantial equivalence of your device to a legally premation notificate 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), please If you desire specific aarroliance at (240) 276-0115 . Also, please note the regulation entitled, Contact the Oriece of Collect of Colling to the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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.

Sincerely yours,

image.png

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indication for Use Statement

Applicant:Modern Medical Equipment Mfg. Ltd.
510(k) NumberNot assigned yet K043036
Device Name:Modern Medical Non Stick Electrode

Indications For Use:


It is an electrosurgical cutting and coagulating device intended to remove tissues and control bleeding by means of high frequency electrical current.

Prescription Use V AND/OR Over-The-Counter Use (Part 21 CFR 807 sub-part C (Part 21 CFR 801 sub-part D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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043036