ENDOSCOUT

K033485 · Robin Medical, Inc. · LNH · Apr 20, 2004 · Radiology

Device Facts

• Record ID: K033485
• Device Name: ENDOSCOUT
• Applicant: Robin Medical, Inc.
• Product Code: LNH · Radiology
• Decision Date: Apr 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The EndoScout is intended to provide physicians and surgeons with the means to track a device during MRI-guided interventional procedures. The EndoScout provides in real-time the position (location and orientation) of the device inside the body, using minimal invasive approach. Devices and tools to be tracked may include: diagnostic devices (e.g. biopsy needles, aspiration needles), therapeutic devices (e.g. devices used to destroy tissue, like RF ablation, laser ablation or cryo-therapy probes, or devices used to deliver drugs, genetic vectors, stem cells, etc.) and various support tools (e.g. suction tips, pointers).

Device Story

EndoScout Tracking System tracks position and orientation of interventional devices during MRI-guided procedures; provides real-time spatial data to physicians/surgeons. System utilizes electromagnetic tracking technology to monitor tools inside body; supports diagnostic needles, ablation probes, and delivery catheters. Used in clinical settings during MRI scanning; output displayed to clinician to guide minimally invasive interventions. Enhances procedural accuracy and navigation; facilitates precise targeting of tissue for biopsy or therapy.

Clinical Evidence

No clinical data provided; document contains administrative 510(k) clearance information.

Technological Characteristics

Electromagnetic tracking system for MRI-guided interventions. Provides real-time 6-DOF (location and orientation) tracking of interventional tools. Designed for compatibility with MRI environments. Connectivity and specific material standards not detailed in provided text.

Indications for Use

Indicated for physicians and surgeons performing MRI-guided interventional procedures requiring real-time tracking of diagnostic, therapeutic, or support tools within the body.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 0 2004

Robin Medical, Inc. % Mr. Benny Arazy Arazy Group Mizpe Aviv, Industrial Park 13 M. P. Misgav 20187 ISRAEL

Re: K033485

Trade/Device Name: EndoScout Tracking System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: February 16, 2004 Received: February 19, 2004

Dear Mr. Arazy:

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 (OS) 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) I his letter will and w you to ough finding of substantial equivalence of your device to a legally premarket notification. "Theesults 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 If you desire spoolite actros to your of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 10 - 4639. Also, please note the regulation entitled, "Misbranding Other of Othernation as a notification" (21CFR Part 807.97) you may obtain. Other general of recented to promatives under the Act may be obtained from the Division of Small information on Jour responsible and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K033485

Device Name: EndoScout Tracking System

Indications For Use:

The EndoScout is intended to provide physicians and surgeons with the means to track The EndoScout is Intended to provide physically in the EndoScout provides in reala device during MRF-guided intervential procedesice during MR scanning This data time the position (focation and onemation) I the entired inside the body, using minimal invasive approach.

Devices and tools to be tracked may include: diagnostic devices (e.g. biopsy needles, Devices and tools to be tracked may including devices used to destroy tissue, like aspiration necedes), therapouls or cryo-therapy probes, or devices used to deliver RF ablation, fasci abliation of orys inthus, your to, genetic vectors, stem cells, etc.) and various support tools (e.g. suction tips, pointers).

Prescription Use (Part 21 CFR 801 Subpart D) ANDJOR

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)

David R. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

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