OLYMPUS ENDOARM

{0}------------------------------------------------ K043128 September 2. 2004 # SMDA 510(k) SUMMARY OLYMPUS EndoArm This summary of 510(k) safety and effectiveness information is being submitted in accordance with This Gammary of OTO(1) Salesy and 21CFR, Part 807, Subpart E, Section 807.92. # A. General Information | 1. Applicant:<br>& Manufacture | OLYMPUS Corporation<br>5128 Ooaza Ina, Ina-shi, Nagano, Japan, 396-0021<br>(Registration Number : 9614612 ) | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. Submission Correspondent: | Masao Wada<br>OLYMPUS Corporation<br>2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan, 192-8507<br>Telephone : 81-426-42-2891<br>Facsimile : 81-426-42-2291<br>E-mail : m_wada@ot.olympus.co.jp<br>(Registration Number : 8010047 ) | | 3. Initial Importer : | OLYMPUS AMERICA INC.<br>Two Corporate Center Drive, Melville, NY 11747-9058<br>(Registration Number : 2429304 ) | | 4. Official Correspondent: | Laura Storms-Tyler<br>Director Regulatory Affairs and Quality Assurance<br>OLYMPUS AMERICA INC.<br>Two Corporate Center Drive, Melville, NY 11747-9058<br>Telephone : 631-844-5688<br>Facsimile : 631-844-5554<br>E-mail : Laura Storms-Tyler@olympus.com<br>(Registration Number : 2429304 ) | # B. Device Identification - 1. Common/Usual Name : Neuroendoscope - OLYMPUS EndoArm 2. Device Name : #### 3. Classification Name : | CFR Number | Classification Name | Class | Product Code | |------------|------------------------|-------|--------------| | 882.1480 | Neurological endoscope | II | 84 GWG | # C. Identification of the predicate or legally marketed device(s) The following listed devices are the predicate medical devices; {1}------------------------------------------------ | Model | 510(k)# | Manufacturer | Class | Product<br>Code | |----------------------------------------------------------------------|----------|-----------------------|-------|-----------------| | A7594A, A7595A, A7597A<br>Neuroendoscope | #K971340 | OLYMPUS Co., | II | GWG | | Endoscopic system for<br>Lumber hernia discectomy | #k982133 | OLYMPUS Co., | II | HRX | | Point Setter<br>Holder for rigid endoscope<br>and flexible endoscope | #K991989 | Mitaka Kohki Co., Ltd | II | GWG | # D. Device Description ## 1. Summary Subject device is a neurological endoscopy system, which consists of EndoArm, a stabilizing fixation component (adapter) and a family of rigid neurological endoscope. A number of component and accessories are also necessary for this system. ## (1) EndoArm: #### Mechanical The Endoarm counter balance arm is designed to deliver smooth endoscope movement and steady fixation by use of compressed nitrogen gas to control the arm movement. The shape of the stand differs from the predicate device in that the predicate device is a bedside fixed design and subject device is a floor stand type. This allows physicians to move the endoscope near the target site only. #### Illumination The illumination is supplied by the Neuroendoscope through the light guide cable connected to the separate high intensity light source, OLYMPUS CLV-S40. This light source utilizes a Xenon 300W bulb. #### Imaging Another significant difference from the predicate device is the ability of the EndoArm to manage image data from the Neuroendoscope and allow the user to adjust zoom, focus and manage intego adda resiste the EndoArm from fine adjustment of the endoscope potion to image adjustment by one hand. This feature is accomplished by the connection of the Neuroendoscope through the adapter (A81020A) on the EndoArm. The image from the distal end of Neuroendoscope is transmitted to the monitor via the CCD of OTV-S7V camera head, mounted in the EndoArm. # (2) Neuroendoscope ( model: A81000A, A81001A, A81002A,A81010A, A81011A, A81012A, A81031A, A81032A, A81041A, A81042A) Ten telescope models are discussed in this premarket notification. The range of specifications covers two different insertion diameters ( ø 2.7mm / ø 4mm), five different working lengths (107mm/ 110mm / 112mm/134mm/ 137mm) and five different fields of view (0/ 30/ 70/ -30/-70 ( rorme). The crank shaped endoscope offers the largest operation space and microscopic dog. The craint on onail. In one doscope models are substantially equivalent to the predicate Neuroendoscope (#k971340). #### (3) Adapter ( model: A81020A) of The subject device is an adapter for connecting the Neuroendoscope A810**A series to {2}------------------------------------------------ the EndoArm stabilizing fixation device. ### 2. Design EndoArm has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC60601-1, IEC60601-1-1and IEC60601-2-18. ### 3. Materials All the patient contacting materials used in this Telescope and ancillary equipment are identical materials that had cleared the past 510(k) submissions. And all materials have been confirmed with ISO 10993-1. #### 4. Intended Use of the device The EndoArm system consists of the EndoArm, a stabilizing fixation(adapter), Neuroendoscope(A1**A series). A number of components and accessories are also necessary for this system. ## (1) EndoArm This product has been designed for manipulation and positioning of the Neuroendoscope during neurosurgery and spinesurgery. - (2) Neuroendoscopes (A81000A, A81001A, A81002A, A81010A, A81011A, A81012A, A81031A, A81032A, A81041A, A81042A) The Neuroendoscopes are intended for use in observation and diagnosis of the brain ventricles and brain parenchyma, such as observation and diagnosis of cerebral aneurysms, hypophysis tumors, hematomas, brain tumors, cerebral vascular systems, cranial nerve and vascular compression syndromes as well as observation and diagnosis of lumber and cervical spine, such as herniated disc material, nerve roots and nucleus material #### 5. Comparison Technological Characteristics #### (1) EndoArm | Items | EndoArm<br>(Predicate Device) | Point Setter K991989<br>(Predicate Device) | Lumber hernia discectomy K982133<br>(Predicate Device) | |----------------------------------|------------------------------------|--------------------------------------------|--------------------------------------------------------| | Manufacture | OLYMPUS | Mitaka Kohki Co., Ltd | OLYMPUS | | Materials contacts<br>to patient | None | None | None | | Support system | Floor stand | Mounted on bed side | Mounted on bed side | | Driving power | Compressed<br>Nitrogen gas | Compressed Nitrogen<br>gas | Manual | | Attachment of TV<br>camera | Attached to the<br>Grip of the Arm | Attached to Endoscope directly | Attached to Endoscope directly | | Zooming | 2 times | Not equipped | Not equipped | | Image rotation | 360 degrees | Not equipped | Not equipped | {3}------------------------------------------------ #### (2) Neuroendoscopes (Telescopes) | Item | Subject Device<br>(A810***A series) | Predicate Device<br>(A7594A,A7595A,A7597A) | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | Direction of<br>View | 0° : A81000A, A81010A<br>30° : A81001A, A81011A<br>70° : A81002A, A81012 A<br>-30° : A81031A, A81041A<br>-70° : A81032A, A81042A | 0° : A7594A<br>30° : A7595A<br>70° : A7597A | | Working Length | 112mm : A81000A<br>110mm : A81001A, A81031A<br>107mm : A81002A, A81032A<br>137mm : A81010A ,A81011A, A81012 A,<br>134mm : A81041A, A81042A | 158mm : A7594A, A7595A<br>155mm : A7597A | | Outer Diameter | 4mm : A81000A, A81001A, A81002A,<br>A81031A, A81032A<br>2.7mm : A81010A, A81011A, A81012A,<br>A81041A, A81042A | 4mm: A7594A, A7595A,<br>A7597A | #### 6. Conclusion When compared to the predicate devices, EndoArm does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness. Therefore the clinical data is not necessary for its evaluation of safety or effectiveness of the subject device. {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 1 2004 Olympus Corporation c/o Mr. Neil E. Devine Entela, Inc. 3033 Madison Avenue SE Grand Rapids, Michigan 49548 Re: K043128 Trade/Device Name: Olympus EndoArm Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: December 14, 2004 Received: December 16, 2004 Dear Mr. Devine: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) prematice is substantially equivalent (for the indications referenced above and have determined the device is substantially interests to felerenced above and nave uctoringed in acketed predicate devices marketed in interstate for use stated in the enclosure) to regarly marketed produced Device Amendments, or to commerce prior to May 26, 1970, the charactiven asso of the Federal Food. Drug, devices that have been recure approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, merelore, market the devices, basjos, bases were mements for annual registration, listing of eneral controls provisions of the Act include requirements for annual re general controls provisions of the frectiners and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it (PMA), it If your device is classified (see above) mis existing major regulations affecting your device can may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controller "Entrologiations" on the 898. In addition, FDA may be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In a be found in the Ood of I outstal concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substantial other requirements of the Act that FDA has made a determination that your device complies with other requirements of t that FDA has made a delemination that Jour as 100 received agencies. You must of any Pederal Statutes and regulations adminitered or registration and listing (21 l comply with all the Act's requirements, including, but not limited to: ret comply with all the Act Stequirements, mercessed ing practice requirements as set CFR Parl 807); labelling (21 CFR Part 820); good if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1050 form in the quality systems (QD) regalantin (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1 {5}------------------------------------------------ Page 2 - Mr. Neil E. Devine This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting your antial equivalence of your device to a legally premits in the around . The PDA midning of backander 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 If you desire specific advice for your ac not the career note the regulation entitled, Colliact the Office of Comphaller and (21 the Part 807.97). You may obtain Missuranting by relevelse to premainters in the Act from the Division of Small other general information on your roppoints. Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Miriam C. Provost for Gail McWhirter, Ph.D., M.D. 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 Enclosure {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: OLYMPUS EndoArm Indications For Use: The EndoArm system consists of the EndoArm, a stabilizing fixation(adapter), Neuroendoscope The EndoAthl System consists of the Enoon int, a stablians mater (casples), in this system. ● EndoArm EndoArm This product has been designed for manipulation and positioning of the Neuroendoscope during Neurosurgery and spinesurgery. ● Neuroendoscopes (A81000A, A81001A, A81002A, A81010A, A81011A, A81012A, A81031A, A81032A. A81041A, A81042A) The Neuroendoscopes are intended for use in observation and diagansis of the brain ventine hypophytonic I he Neuroenchyma, such as observation and diagnosis of cerebral aneurysms, hypophysis and brain patenchyma, such as observation and diegries, cranial nerve and vascular tumors, nematornas, brain tumors, cercorary of observation and diagnosis of the lumber compression syndrones as won as monounter in the move roots and nucleus material. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR x Over - The - Counter-Use (Part 21 CFR 801 Subpart C) (Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Muriam C. Provost (Division Sign-Off) Division of General, Restorative, and Neurological Devices K043128 510(k) Number. 7 Page 1 of 1