(168 days)
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Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe functionalities typically associated with AI/ML in medical devices (like image analysis for diagnosis or prediction). The focus is on real-time tracking using MRF-guided technology.
No.
The device itself is a tracking system for other devices, not a therapeutic device. It helps track therapeutic devices, but does not perform therapy itself.
No
Explanation: The device, EndoScout, is designed to track other devices during MRF-guided procedures. While it can track "diagnostic devices" like biopsy needles, EndoScout itself is a tracking device, not a diagnostic one.
Unknown
The provided text does not contain a "Device Description" section, which is crucial for determining if the device is software-only. The "Intended Use" describes tracking a "device" during procedures, implying a physical component is being tracked, but it doesn't clarify if the EndoScout itself is solely software or includes hardware for tracking.
Based on the provided information, the EndoScout is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- EndoScout's Function: The EndoScout is described as a device used to track other devices inside the body during MRF-guided procedures. It provides real-time position information of instruments within the patient.
The EndoScout's function is directly related to guiding procedures within the patient's body, not analyzing samples taken from the body. Therefore, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EndoScout is intended to provide physicians and surgeons with the means to track a device during MRF-guided interventional procedures. The EndoScout provides in real-time the position (location and orientation) of the device during MR scanning, when the device is entirely 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 used to destroy tissue, like RF ablation, laser ablation, cryo-therapy probes, or devices used to deliver substances (e.g. drugs, genetic vectors, stem cells, etc.) and various support tools (e.g. suction tips, pointers).
Product codes
90 LNH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
MR scanning
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Physicians and surgeons
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
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.
1
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 (800) 638-2041 or (301) 443-6597 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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