(62 days)
Not Found
No
The device description focuses on traditional electrosurgery technology with waveform selection and power control via physical buttons and displays. There is no mention of AI, ML, or any form of intelligent processing or learning.
Yes
The device is intended for "resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels," and for treating various medical conditions such as snoring, epistaxis, and tumors, indicating its therapeutic purpose.
No
Explanation: The device description and intended use clearly state that the Surgi-Max Electrosurgery Generator is used for surgical procedures like resection, ablation, coagulation, and hemostasis, which are all treatment functions. There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly details a hardware component, the "Surgi-Max Electrosurgery Generator," which is a source of high radio-frequency energy and includes 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:
- Intended Use: The intended use clearly describes surgical procedures involving the resection, ablation, and coagulation of soft tissues and blood vessels. These are direct interventions on the human body.
- Device Description: The device is an electrosurgery generator that produces radio-frequency energy for surgical procedures. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to provide diagnostic information. This device operates in vivo (inside the body) for surgical treatment.
N/A
Intended Use / Indications for Use
For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, turnors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty,
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinonia, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.
Control of bleeding, Epilation, Telangiectasia
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.
Product codes
GEI, HRX
Device Description
The Surgi-Max Electrosurgery Generator is a compact source of high radio-frequency RF energy to be employed for a variety of radiosurgery procedures. This action is actieved 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. The display is interlocked with controls to prevent operation when FAILS is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are offered.
The power output in the CW (Cut) mode is 120 watts into (500 ohms) a matched load. The output frequency is maintained at 4.0 MHz +/- 400Hz over all service and loading conditions includingshort and open for monopolar mode.
Three output waveforms are provided:
CW CUT -- Continuous wave output with average power equal to the maximum with no deliberate modulation.
CUT / COAG – Deeply modulated envelope with average to peak power ratio approximately 50%. Modulation occurring at 120 or 100 Hz rate.
HEMO - Deeply modulated wave with average to peak ratio approximately 50%. Modulation occurring at 120 or 100 Hz rate of square wave.
| Mode | Output Waveform | Max Output Power | Activation |
|---|---|---|---|
| CUT | 4.0 MHz CW sinusoid | 120W @ 500 Ohms | Via footswitch or |
| fingerswitch | |||
| CUT / COAG | 4.0 MHz w/ rectified full | ||
| wave envelope | 90W @ 500 Ohms | Via footswitch or | |
| fingerswitch | |||
| HEMO | 4.0 MHz w/ square wave | ||
| rectified envelope | 60W @ 500 Ohms | Via footswitch or | |
| fingerswitch | |||
| BIPOLAR HEMO | 1.7 MHz w/ square wave | ||
| rectified envelope | 40W @ 200 Ohms | Via footswitch | |
| BIPOLAR TURBO | 1.7 MHz w/ modulated | ||
| envelope | 120W @ 200 Ohms | Via footswitch |
Physical Characteristics
Size: 9" (W) x 5" (H) x 13" (D) Weight:18 lbs / 8.16 kg
The subject device is packaged with the following items:
- Ellman Surgi-Max Radiofrequency Generator .
- . Power Cord
- . Footswitch & Cable
- . Foot controlled Handpiece
- . Bipolar Cable
- t Disposable Neutral Plate
- . Instruction Manual
- 0 Fingerswitch Handpiece
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissues, blood vessels, knee, shoulder, ankle, elbow, hip and wrist, palate, ear, nose, skin, telangiectasia.
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)
The Ellman Surgi-Max complies with IEC 60601-1 and IEC 60601-2-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ellman Surgitron IEC 120 / 4.0 DU K013255
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
JUN 2 8 2006
Page 1 of 4
K 06 1174
510 (k) Summary
Date Prepared
4/30/06 (Revised 6/25/06)
Submitter's Information
Ellman International Inc. is located at 3333 Royal Avenue, Oceanside, NY 11572. Contact Name: Dr. Jon Garito
Establishment Registration for Ellman International Inc. is 2428235
Device Trade Or Proprietary Names
Possible device trade names are:
- Surgi-Max .
Device Common, Usual, or Classification Names
Electrosurgical Unit and Accessories, Electrosurgical Cutting and Coagulation and Accessories
Classification Panel
Classification of this device would fall under the responsibility of the Division of General, Restorative, and Neurological Devices.
Class
Classification: Class 2 Product Code: GEI, 21 CFR 878.4400
1
Page 2 of (4)
Description of the Device
The Surgi-Max Electrosurgery Generator is a compact source of high radio-frequency RF energy to be employed for a variety of radiosurgery procedures. This action is actieved 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. The display is interlocked with controls to prevent operation when FAILS is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are offered.
The power output in the CW (Cut) mode is 120 watts into (500 ohms) a matched load. The output frequency is maintained at 4.0 MHz +/- 400Hz over all service and loading conditions includingshort and open for monopolar mode.
Three output waveforms are provided:
CW CUT -- Continuous wave output with average power equal to the maximum with no deliberate modulation.
CUT / COAG – Deeply modulated envelope with average to peak power ratio approximately 50%. Modulation occurring at 120 or 100 Hz rate.
HEMO - Deeply modulated wave with average to peak ratio approximately 50%. Modulation occurring at 120 or 100 Hz rate of square wave.
| Mode | Output Waveform | Max Output Power | Activation |
|---|---|---|---|
| CUT | 4.0 MHz CW sinusoid | 120W @ 500 Ohms | Via footswitch or |
| fingerswitch | |||
| CUT / COAG | 4.0 MHz w/ rectified full | ||
| wave envelope | 90W @ 500 Ohms | Via footswitch or | |
| fingerswitch | |||
| HEMO | 4.0 MHz w/ square wave | ||
| rectified envelope | 60W @ 500 Ohms | Via footswitch or | |
| fingerswitch | |||
| BIPOLAR HEMO | 1.7 MHz w/ square wave | ||
| rectified envelope | 40W @ 200 Ohms | Via footswitch | |
| BIPOLAR TURBO | 1.7 MHz w/ modulated | ||
| envelope | 120W @ 200 Ohms | Via footswitch |
Output Characteristics
2
Page 3 of 4
Physical Characteristics
Size: 9" (W) x 5" (H) x 13" (D) Weight:18 lbs / 8.16 kg
The subject device is packaged with the following items:
- Ellman Surgi-Max Radiofrequency Generator .
- . Power Cord
- . Footswitch & Cable
- . Foot controlled Handpiece
- . Bipolar Cable
- t Disposable Neutral Plate
- . Instruction Manual
- 0 Fingerswitch Handpiece
Intended Use [21 CFR 807.92(a)(5)]
Orthopedic, arthroscopic, spinal, and neurosurgical
For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.
Cutting
Snoring, Submucosal palatal shrinkage, traditional uvulopalatopiasty (RAUP), myringotony with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, turnors, cosmetic repairs, development of skin flaps, skin tags, 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 Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.
Hemostasis and Nonablative Coagulation
Control of bleeding, Epilation, Telangiectasia
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.
3
Page 4 of (4)
Technological Characteristics [21 CFR 807.92(a)(6)]
Ellman International believes that the subject device is substantially equivalent to the predicate device.
Performance Data [21 CFR 807.92(b)(1)]
The Ellman Surgi-Max complies with IEC 60601-1 and IEC 60601-2-2.
Predicate Device [21 CFR 807.92(a)(3)]
The predicate devices are listed as follows:
- Ellman Surgitron IEC 120 / 4.0 DU K013255 .
Conclusion [21 CFR 807.92(b)(3)]
We believe the differences between the subject device and predicate device are minor and conclude that the subject devices are as safe and effective as the predicate devices.
4
Image /page/4/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" written around the edge. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ellman International Inc. % Jon Garito, Ph.D. President 3333 Royal Avenue Oceanside, New York 11572
JUN 2 8 2006
Re: K061174
Trade/Device Name: Ellman Surgi-Max Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, HRX Dated: April 26, 2006 Received: April 27, 2006
Dear Dr. Garito:
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. Iisting 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 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.
5
Page 2 - Jon Garito, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Harbare Buchins
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use
5 10(k) Number (if known): K061174
Device Name: Ellman Surgi-Max
Orthopedic, arthroscopic, spinal, and neurosurgical
For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.
Cutting
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorthage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, 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 Cell Carcinonia, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.
Hemostasis and Nonablative Coagulation
Control of bleeding, Epilation, Telangiectasia
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.
Prescription Use X (Part 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)
(William Bernard) (William)
and Neurological Devices
510(k) Number.