K Number
K013255
Device Name
SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF
Manufacturer
Date Cleared
2001-11-07

(40 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
* Cutting Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Blepharoplasty, * Blended Cutting and Coagulation Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, * Hemostasis Control of Bleeding, Epilation, Telangiectasia * Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis. * Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry), Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage
Device Description
The @Wman Surgitron 120 IEC enhanced capability Electrosurgery Generator described herein is a compact source of high power RF energy to be employed for a variety of radiosurgery procedures. This action is achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. This display is interlocked with the controls to prevent operation when FAIL is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are provided. It is designed to comply with international safety standards.
More Information

Not Found

No
The device description focuses on traditional electrosurgery technology with manual controls and safety features, and there is no mention of AI or ML in the provided text.

Yes.
The device is used for various medical procedures such as cutting, coagulation, hemostasis, and fulguration in the treatment of conditions like snoring, tumors, cysts, and bleeding.

No

The device description and intended use/indications for use solely describe procedures for cutting, coagulation, hemostasis, and fulguration. There is no mention of diagnosis or diagnostic functions.

No

The device description clearly describes a hardware device, an electrosurgery generator, which produces RF energy and has physical controls, displays, and output connections for electrodes.

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

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
  • Device Description and Intended Use: The description and intended uses clearly indicate that this device is an electrosurgery generator used for surgical procedures performed directly on the patient's body (cutting, coagulation, hemostasis, etc.). It generates RF energy for tissue modification and control of bleeding.

The device's function and application are entirely focused on surgical intervention on living tissue, not on analyzing samples taken from the body.

N/A

Intended Use / Indications for Use

4.1 Cutting

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Blepharoplasty,

4.2 Blended Cutting and Coagulation

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps,

4.3 Hemostasis Control of Bleeding, Epilation, Telangiectasia

4.4 Fulguration

Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.

4.5 Bipolar

Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry), Snoring, Pinpoint, Flecise Coagulation, Finpoint Firmiopalatoplasty (RAUP), myringotomy Submucosal palatal sinmkage, traditional availopmants (
with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

Product codes

GEI

Device Description

The @Wman Surgitron 120 IEC enhanced capability Electrosurgery Generator described herein is a compact source of high power RF energy to be employed for a variety of radiosurgery procedures. This action is achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. This display is interlocked with the controls to prevent operation when FAIL is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are provided. It is designed to comply with international safety standards.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

palatal, myringotomy, turbinate, Skin, lungs, Epilation-related

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)

K001253, K933157

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

NOV 0 7 2001

@llman Surgitron 120 IEC 510 (k) Summary 013255

1. Submitter name and address:

Frank Lin, Ph.D. Director of R&D engineering මංගික්ක international 1135 Railroad Avenue Hewlett, New York 11557

2. Device name and classification:

2.1 Device Name:Surgitron 120 IEC (Also known as Surgitron 4.0 Dual RF)
2.2 Classification:Class 2 device, 21 CFR 878.4400

3. Description of the device:

The @Wman Surgitron 120 IEC enhanced capability Electrosurgery Generator described herein is a compact source of high power RF energy to be employed for a variety of radiosurgery procedures. This action is achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. This display is interlocked with the controls to prevent operation when FAIL is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are provided. It is designed to comply with international safety standards.

4. The intended use/indication for use of the device:

4.1 Cutting

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Blepharoplasty,

4.2 Blended Cutting and Coagulation

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps,

4.3 Hemostasis Control of Bleeding, Epilation, Telangiectasia

Page 1 of 2

1

4.4 Fulguration

.4 Fulguration
Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.

4.5 Bipolar

.5 Bipolar
Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry), Snoring, Pinpoint, Flecise Coagulation, Finpoint Firmiopalatoplasty (RAUP), myringotomy Submucosal palatal sinmkage, traditional availopmants (
with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

5. Identification to predicate devices

5.1.Sugitron IEC II with general use indication K001253 5.1.Sugitron IEC If with general use indication K933157
5.2 ERBOTOM ICC 200 with general use indication K933157

6. Summary of the technological characteristics of the new device in comparison to the predicate devices.

| FEATURE | ollman
SURGITRON 120 IEC
(New Application Device) | ollman
SURGITRON IEC II
WITH GENERAL USE
INDICATION K001253
PREDICATE | ERBOTOM
ICC200 WITH
INDICATION
K933157 PREDICATE |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------|
| Indications For Use | Snoring, submucosal
palatal shrinkage,
traditional
uvulopalatoplasty (RAUP),
myringotomy with
effective hemorrhage
control, epistaxis treat, and
turbinate shrinkage. Also,
see page 5 for detail. | Same As New Device | Same As New Device |
| Design Specification | UL544 and IEC601-2-2 | Same As New Device | Same As New Device |
| Output Energy | 120 Watt | 100 Watt | 200 Watt |
| Output Waveform (s) | 4.0 MHz Sin-wave CW,
Fully Rectified, Partially
Rectified, and 1.7 MHz for
Fulgurating Spark-Gap | Same As New Device | 350KHz Sine-Shaped and
1 MHz Pulse-modulated |
| Standards Met | UL2601 and IEC
601-1 601-2-2,
BS15724:2.2 | UL2601 and IEC
601-1 601-2-2,
BS15724:2.2 | IEC 601-1 |
| Delivery system and
configuration | Monopolar and Bipolar | Monopolar and Bipolar | Same As New Device |
| Biocompatibility Test | Electrodes identical to
predicate device | Same As New Device | Same As New Device |
| Sterilization Method(s) | Refer to page 6, Note I | Same As New Device | Not Indicated |

Substantial equivalence In Technological Characteristics comparison

Page 2 of 2

2

Image /page/2/Picture/1 description: The image shows a black and white seal of the Department of Health & Human Services. The seal is circular and contains an emblem of a stylized bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. The emblem is centrally located within the circle.

Public Health Service

DEC 2 2007

Food and Drug Administration 00 Corporate Boulevard Rockville MD 20850

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

Re: K013255

Trade/Device Name: Surgitron 120 IEC Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 27, 2001 Received: September 28, 2001

Dear Mr. Lin:

This letter corrects our substantially equivalent letter of November 7, 2001 regarding the file number.

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). 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 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. Frank Lin

This letter will allow you to continue marketing your device as described in your section 510(k) I his letter will anow you to continue manoling your at economialence of your device to a legally premarket notification. THE PDA midning of backanded of a classification for your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, al (301) 394-4039. Additionally, 10. quest 301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, responstonities under the Act may of country of country toll free number (800) 638-2041 or at (301) International and Consumer I Belodition://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

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

4

NOV 0 7 2001

510K Notification
Surgitron - General & Plastic Surgery Use

page S

@llman international

510(k) Number (if known):K013255
Device Name:SURGITRON 120 IEC
Indication For Use: is idendical to the Surgitron as a preammendment device such as:
* Cutting
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP),
myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate
shrinkage, Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs,
Development of Skin Flaps, SkinTags, Blepharoplasty,
* Blended Cutting and Coagulation
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP),
myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate
shrinkage, Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma,
Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps,
* Hemostasis
Control of Bleeding, Epilation, Telangiectasia
* Fulguration
Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.
* Bipolar
Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry), Snoring,
Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy
with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use/
(Per 21 CFR 801.109)

Susan Walk-

(Division Sign-Off)

Division of General, Restorative-The- Counter Use __________

and Neurological Devices (Optional Format 1-2-96)

510(k) NumberK013255
------------------------