E3 MICROPROBE

{0}------------------------------------------------ MARTIN URAM, M.D. Disorders of the Retina 39 Sycamore Avenue Little Silver, New Jersey 07739 (908) 530-7730 Fax (908) 530-5344 225 East 64th Street New York, New York 10021 (212) 628-0032 K97487P MAR 2 7 1998 #### Summary 510 (k) For the E3 MicroProbe 1. - Date Summary Prepared: December 15, 1997 2. - Submitter's Name and Address: Martin Uram, MD 39 Sycamore Avenue Little Silver, NJ 07739-1208 Contact Person: Keith Hertz Fax: 732-530-5344 Tel.: 732-530-6762 E-mail: mail@monmouth.com ### 3. - Device Name: Trade / Proprietary Name: E3 MicroProbe / 2 e David Zoser Common Name: Integrated Surgical Laser and Endoscope System Classification Name: Surgical Diode Laser Fiber Optic Endoscope {1}------------------------------------------------ 39 Sycamore Avenue Little Silver, New Jersey 07739 (908) 530-7730 Fax (908) 530-5344 225 East 64th Street New York, New York 10021 (212) 628-0032 #### 10 (K) Probe For ## 4. - Predicate Devices: The legally marketed devices to which equivalence is being claimed are: Pentax Video Colonoscope MicroProbe Pentex Video Duodenoscope Family of Endoscopes Pentax Video Gastroscope Value Pack Pentax Video Sigmoidoscope Endoscope w. Cannula Pentax Bronchofiberscope Transtympanic Endoscope Storz Flexible Fiberscope Diomed (15, 30, 60) Surgical Diode Laser Storz Flexible Rhino-Pharyngo-Coherent Surgical Laser Laryngo-Fiberscope Storz Flexible Hysteroscope ASI Uroplasty Cystoscope Storz Hopkins Telescope Olympus Arthroscopy System Stryker Arthroscopy System Olympus Laparo-Thoraco Videoscope Stryker Sinuscope Olympus Oratracheal Intubation Endoscope Olympus Endoscope System {2}------------------------------------------------ 39 Sycamore Avenue Little Silver, New Jersey 07739 (908) 530-7730 Fax (908) 530-5344 225 East 64th Street New York, New York 10021 (212) 628-0032 # 510 (k) Summarv For the E3 MicroProbe # 5. - Device Description: The Endo Optiks E3 MicroProbe System consists of a laser, endoscope, console and footpedal. The treatment laser is a solid state diode laser system operating at 810 nanometers ± 2 nanometers and continuous wave power of up to 60 Watts. A visible solid state diode laser operating at a nominal wavelength of 640 nm and a variable continuous wave output from 0 to 1.5 milliwatts is incorporated as an aiming device. The end of the endoscope consists of a 0.25 milimeter diameter fiberoptic for viewing, a 0.10 millimeter diameter fiberoptic for delivery of the laser energy and fiberoptics that transmit the illumination light. Laser energy is delivered via a single timed continuous wave pulse with the time preset at the operator console and the pulse initiated by the footpedal. Laser power is also preset at the console. The E3 MicroProbe is a modification to the maximum power output rating of the original MicroProbe. Labeling: The MicroProbe will be renamed (relabeled) the E3 MicroProbe. This change is being made to be consistant with the industry practice of designating a laser's power based on the output power at the laser port rather than that at the tissue site. There is no change in construction or performance of this device. Power Output: An additional model will be created by increasing the output power to produce the E3 MicroProbe. The same basic design is retained. The 60 Watt model uses sixteen 4 Watt laser diodes. The power supply and cooling designs of the new model have been appropriately scaled, while the mechanical design and user interface remain unchanged. {3}------------------------------------------------ #### MARTIN URAM, M.D. Disorders of the Retina 39 Sycamore Avenue Little Silver, New Jersey 07739 (988) 530-7730 Fax (998) 530-5344 225 East 64th Street New York, New York 10021 (212) 628-0032 737 #### 510 (k) Summary For the E3 MicroProbe Indication For Use: The indications are expanded to include both contact and non-contact ablation, incision, excision, coagulation and vaporization for the following soft tissue applications: - General Surgery ● - . Ophthalalmology / Oculoplastic - . Urology - . Gastroenterology - . Gynecology - Otorhinolaryngology . - . Pulmonary / Thoracic - Dermatology / Plastic Surgery � - Neurosurgery ● - . Orthopedic # 6. - Intended Use: The E3 MicroProbe delivers up to 60 Watts of continuous wave radiation to a flexible optical fiber for use in open and endoscopic procedures. # 7 . - Comparison of Technological Charateristics This modification replaces the original MicroProbe with four models, the Full Featured MicroProbe, the E3 MicroProbe - 15, the E3 MicroProbe - 30 and the E3 MicroProbe - 60. Modifications are to offer models with different maximum output powers (15, 30 and 60 Watts at the output port), in order to provide sufficient power when it is required, and to provide a more cost effective device for applications that do not require the higher power capabilities. The original MicroProbe currently operates with a maximum power of 15 Watts. In addition, indications for use have been expanded to include both contact and non-contact treatment of soft tissue applications for which leqally marketed lasers are currently available. {4}------------------------------------------------ 39 Svcamore Avenue Little Silver, New Jersey 07739 (908) 530-7730 Fax (908) 530-5344 225 East 64th Street New York, New York 10021 (212) 628-0032 #### Summarv 510 (k) E3 MicroProbe For ## 8. - Nonclinical Tests Used in Determination of Substancial Equivalence The design of the E3 MicroProbe has been thoroughly validated at the unit and system level. The tests showed that all system specifications are satisfied. # 9. - Conclusions From Nonclinical Testing The testing of the modified devices demonstrates that the performance is substantially equivalent to the predicate prior to the modifications. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized human figure with three arms or lines extending from the head. The symbol is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. The text is in all caps and is arranged to follow the curve of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 27 1998 Martin Uram, M.D. Disorders of the Retina 39 Sycamore Avenue 07739 Little Silver, New Jersey Re: K974878 E3 MicroProbe Series of Diode Lasers Trade Name: and Accessories Regulatory Class: II Product Code: GEX Dated: December 22, 1997 December 30, 1997 Received: Dear Dr. Uram: 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, Druq, 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 requlations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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. {6}------------------------------------------------ Page 2 - Dr. Uram 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 diaqnostic 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, f 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 {7}------------------------------------------------ K974878/12 DUPLICATE 225 East 64th Street New York, New York 10021 (212) 628-0032 39 Sycamore Avenue a Silver, New Jersey 07739 (908) 530-7730 Fax (908) 530-5344 ### 510(k) Number: K974878 ### Device Name: E3 MicroProbe ### Indications For Use Contact and non-contact excision, hemostasis, incision and vaporization for the following soft tissue applications: General Surgery Ophthalmology / Oculoplastic Urology Gastroenterology Gynecology Otorhinolaryngology Pulmonary / Thoracic Dermatology / Plastic Surgery Neurosurgery Orthopedic Concurrent of CDRH, Office of Device Evaluation (ODE) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Prescription Use (Per21 CFR 801.109) OR Over-The-Counter-Use (Optional Format 1-2-96) (Division Sign-Off) Division of General Restorative Devices צרף רק צוצרף 510(k) Number -