ASSISTO ARM SYSTEMS

K052745 · Geomed Medizin-Technik GmbH & Co. · GWG · Nov 23, 2005 · Neurology

Device Facts

• Record ID: K052745
• Device Name: ASSISTO ARM SYSTEMS
• Applicant: Geomed Medizin-Technik GmbH & Co.
• Product Code: GWG · Neurology
• Decision Date: Nov 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2

Intended Use

ASSISTO® Arm Systems consist of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 2.7mm to 10mm during general diagnostic and therapeutic procedures. The device is also intended for use by qualified surgeons for holding endoscopes during diagnostic and therapeutic neurologic procedures.

Device Story

Table-mounted, self-retaining endoscope holder system; consists of stainless steel tubular, articulated arms connected to a vertical stand. Device is freely adjustable within an articulating radius to position endoscopes or arthroscopes (2.7mm to 10mm diameter) during surgery. Used in OR by surgeons to maintain scope position, reducing manual fatigue and providing stable visualization. Reusable; requires cleaning and sterilization before use. Benefits include stable, hands-free endoscope positioning during diagnostic and therapeutic procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by design analysis and verification testing.

Technological Characteristics

Stainless steel tubular, articulated arms; vertical stand mount; manual adjustment; reusable; non-sterile (requires sterilization). Accommodates 2.7mm to 10mm diameter endoscopes.

Indications for Use

Indicated for surgeons to hold endoscopes and arthroscopes (2.7mm to 10mm diameter) during general diagnostic/therapeutic procedures and neurologic diagnostic/therapeutic procedures.

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Predicate Devices

• Armand Endoscope Holder (K050051)
• Neuroview Instrument Holder, Model 300-33 (K992006)
• Abdominal Wall Retractor (K950214)

Submission Summary (Full Text)

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## 510(k) summary of safety and effectiveness

| Date: | September 15, 2005 | | | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter: | Name: | Geomed Medizin-Technik GmbH & Co.<br>Ludwigstaler Strasse 27<br>Postfach 4047<br>Tuttlingen, Germany 78532 | NOV 2 3 2005 | | |
| | Contact Person: | Thomas Haug<br>General Manager | | | |
| | Telephone:<br>Fax: | +49.7461.93550<br>+49.7461.935593 | | | |
| Product: | Trade Name: | ASSISTO® Arm Systems | | | |
| | Classification:<br>Common Name:<br>Classification<br>Name: | | | Class II<br>Endoscope Holder<br>Laparoscope, General & Plastic Surgery (GCJ,<br>876.1500)<br>Endoscope, Neurological (GWG, 21 CFR 882.1480)<br>Endoscope and/or Accessories (KOG, 21 CFR<br>876.1500)<br>Arthroscope (HRX, 21 CFR 888.1100) | |
| Predicate<br>Devices: | Name<br>Armand Endoscope Holder<br>Neuroview Instrument Holder, Model<br>300-33 | | Manufacturer<br>KLS-Martin L.P.<br>Integra Neurocare<br>LLC. | K-No.<br>K050051<br>K992006 | |
| | Abdominal Wall Retractor | | Omni-Tract Surgical | K950214 | |
| | ASSISTO® Arm Systems are substantially equivalent to the predicate<br>devices since the basic features and intended uses are the same. | | | | |
| Device<br>Description: | Table-mounted self-retaining endoscope holder system consisting of<br>stainless steel tubular, articulated arms that are connected to a vertical stand<br>and are freely adjustable within the articulating radius according to the<br>requirements of the particular surgical procedure. Accessories include<br>endoscope holders for 2.7mm to 10mm scopes.<br>The device is reusable and provided non-sterile. It must be cleaned and<br>sterilized before use. | | | | |
| Intended<br>Use: | ASSISTO® Arm Systems consist of a table-mounted endoscope holder<br>system intended for use by surgeons to hold endoscopes and arthroscopes<br>with a diameter of 2.7mm to 10mm during general diagnostic and<br>therapeutic procedures. The device is also intended for use by qualified<br>surgeons for holding endoscopes during diagnostic and therapeutic<br>neurologic procedures. | | | | |
| Performance<br>Data: | Design analysis and comparison as well as verification testing confirm that<br>basic functional characteristics are substantially equivalent to the predicate<br>devices cited and raise no new issues of safety and effectiveness. | | | | |
| Conclusion: | Based upon the product technical information provided, intended use and<br>performance information provided in this premarket notification, the<br>ASSISTO® Arm Systems have been shown to be substantially equivalent to | | | | |

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NOV 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Geomed Medizin-Technik GmbH & Company c/o Angelika Scherp Business Support International Amstel 320-I Amsterdam 1017AP Netherlands

Re: K052745

Trade/Device Name: ASSISTO® Arm Systems Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG, GCJ Dated: September 28, 2005 Received: September 30, 2005

Dear Ms. Scherp:

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, 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 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.

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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Varbara Buehel

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

**510(k) Number (if known):** K052745

Device Name: ASSISTO® Arm Systems

## Indications for Use:

ASSISTO® Arm Systems consist of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 2.7mm to 10mm during general diagnostic and therapeutic procedures. The device is also intended for use by qualified surgeons for holding endoscopes during diagnostic and therapeutic neurologic procedures.

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)

Barbara Buehrig

Division of General, Restorative, and Neurological Devices

510(k) Number K052745

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