K Number
K972072
Device Name
SURGITRON MODEL FFPF-EMC
Manufacturer
Date Cleared
1997-06-19

(16 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indication For Use is idendical to the Surgitron as a preammendment device such as: * Culling Skin Incisions. Biopsy. Cysts. Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps. SkinTags, Envi, Keratusis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection. * Blended Curring and Coagulation Skin Tags, Papilloma Kelvido, Keratosis, Verrucac, Dasal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmenc Repairs, Cysts, Absecsses, Development of Skin Flaps, Oculoplastic Procedures * Ilemostasıs Control of Blocding, Epilation, Telangectasia * Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Vernicae, Hemostasis. * Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry).
Device Description
Not Found
More Information

Not Found

Not Found

No
The document does not mention AI, ML, image processing, or any related technologies. The intended use and device description (though not found) are focused on surgical procedures using electrosurgery, which is a traditional medical technology.

No.
The 'Intended Use/Indications for Use' section describes surgical procedures like skin incisions, biopsy, tumor removal, and hemostasis, which are common applications for electrocautery or electrosurgical units. These devices are used for surgical intervention rather than solely for therapy.

No

The device is indicated for various surgical procedures involving cutting, coagulation, and tissue destruction, but none of the listed indications involve diagnosing a medical condition.

No

The 510(k) summary describes a device with indications for use related to surgical procedures (cutting, coagulation, hemostasis, fulguration, bipolar coagulation) typically performed by an electrosurgical unit (ESU). The predicate device is listed as "Surgitron," which is a brand of ESUs. The summary lacks any description of software or its function, and the indications strongly suggest a hardware-based energy delivery device.

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

Here's why:

  • Intended Use: The intended use describes various surgical procedures performed directly on the patient's body (skin incisions, tumor removal, cosmetic repairs, etc.). IVDs are used to examine specimens (blood, urine, tissue) outside the body to diagnose or monitor conditions.
  • Device Description: While not found, the procedures listed in the intended use strongly suggest a surgical device, not a diagnostic one.
  • Lack of IVD-specific information: There is no mention of analyzing biological samples, diagnostic markers, or any other activities typical of an IVD.

The device appears to be an electrosurgical unit or similar device used for cutting and coagulating tissue during surgical procedures.

N/A

Intended Use / Indications for Use

Indication For Use is idendical to the Surgitron as a preammendment device such as:

  • Cutting
    Skin Incisions. Biopsy. Cysts. Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps. SkinTags, Envi, Keratusis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection.
  • Blended Cutting and Coagulation Skin Tags, Papilloma Kelvido, Keratosis, Verrucac, Dasal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Absecsses, Development of Skin Flaps, Oculoplastic Procedures
  • Hemostasis Control of Bleeding, Epilation, Telangectasia
  • Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.
  • Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry).

Product codes

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

Not Found

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

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three intertwined strands, representing health, and a human profile facing right, symbolizing human services. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 1997

Mr. Frank Lin Director of Engineering Ellman International, Inc. 1135 Railroad Avenue Hewlett, New York 11557-2316

� Re:

K972072 Trade Name: Surgitron Model: FFPF-EMC Regulatory Class: II Product Code: GEI Dated: May 30, 1997 Received: June 3, 1997

Dear Mr. Lin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufaciuring Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

1

Page 2 - Mr. Frank Lin

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

focsellez

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

Enclosure

2

Page __ |__ of __ of _________________________________________________________________________________________________________________________________________________________

510(k) Number (if known) K972072

Device Namie SURGITRON MODEL FFPF - EMC

Indication For Use is idendical to the Surgitron as a preammendment device such as:

  • Culling

Skin Incisions. Biopsy. Cysts. Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps. SkinTags, Envi, Keratusis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection.

    • Blended Curring and Coagulation Skin Tags, Papilloma Kelvido, Keratosis, Verrucac, Dasal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmenc Repairs, Cysts, Absecsses, Development of Skin Flaps, Oculoplastic Procedures
  • Ilemostasıs Control of Blocding, Epilation, Telangectasia
    • Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Vernicae, Hemostasis.
    • Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry).

( F. F. S. DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NFFDFD)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative DevicesK972072
510(k) Number
Prescription Use (Per 21 CFR 801.109)X
------------------------------------------------------------------------------------------

OR
Over-The-Counter Use ______(Optional Format 1-2-96)