SURGI-MAX

{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<br>fingerswitch | | CUT / COAG | 4.0 MHz w/ rectified full<br>wave envelope | 90W @ 500 Ohms | Via footswitch or<br>fingerswitch | | HEMO | 4.0 MHz w/ square wave<br>rectified envelope | 60W @ 500 Ohms | Via footswitch or<br>fingerswitch | | BIPOLAR HEMO | 1.7 MHz w/ square wave<br>rectified envelope | 40W @ 200 Ohms | Via footswitch | | BIPOLAR TURBO | 1.7 MHz w/ modulated<br>envelope | 120W @ 200 Ohms | Via footswitch | Output Characteristics {2}------------------------------------------------ K061174 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}------------------------------------------------ K061174 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.