(60 days)
Not Found
Not Found
No
The summary describes a device tracking system based on real-time position data during MRI, with no mention of AI, ML, image processing, or related concepts.
No
The device is described as a tracking system for other devices, including therapeutic ones. It does not directly provide therapy.
No
Explanation: The device is intended for tracking the position and orientation of other devices (which may include diagnostic devices) during MRI-guided interventional procedures. It is a guidance tool, not a diagnostic device itself.
Unknown
The provided text describes the intended use of a device called "EndoScout" for tracking medical devices during MRI-guided procedures. It mentions providing real-time position data. However, the "Device Description" section is "Not Found," which is crucial for determining if the device is software-only or includes hardware components for tracking or data acquisition. Without a device description, it's impossible to definitively classify it as software-only.
Based on the provided information, the EndoScout is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the EndoScout is used to track devices during MRI-guided interventional procedures inside the body. This is an in vivo application, meaning it's used within a living organism.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, tissue) taken from the body to provide information for diagnosis, monitoring, or screening. The EndoScout does not perform this function.
The EndoScout is a device used for real-time tracking and guidance within the body during a medical procedure, which falls under the category of an in vivo medical device.
N/A
Intended Use / Indications for 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 realtime the position (location and orientation) of the device during MR scanning. This data enables the users to guide an interventional procedure to a target 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 (including devices used to destroy tissue, like RF ablation, laser ablation or cryo-therapy probes, or devices used to deliver therapeutic agents like drugs, chemotherapy agents, genetic vectors, stem cells, etc.) and various support tools (e.g. suction tips, pointers).
Product codes
LNH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians and surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
JUL - 1 2011
Robin Medical. Inc. % Mr. Raymond Kelly Consultant Arazy Group 56B Shadowbrook Dr. HUDSON NH 03051
Re: K111226
Trade/Device Name: EndoScout Tracking System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 12, 2011 Received: June 14, 2011
Dear Mr. Kelly:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
1
medical device-related adverse events) (21 CFR 803): and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for Robin Medical, Inc. The logo features the company name in a simple, sans-serif font. Above the name is a stylized graphic of two curved lines that meet in the middle, forming a shape reminiscent of a bird in flight or a medical symbol. The overall design is clean and professional.
Robin Medical, Inc. 3502 Gardenview Rd Baltimore, MD 21208
Attachment 2
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: EndoScout Tracking System.
Indications for Use:
The EndoScout is intended to provide physicians and surgeons with the means to track a device during MRI-quided interventional procedures. The EndoScout provides in realtime the position (location and orientation) of the device during MR scanning. This data enables the users to guide an interventional procedure to a target 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 (including devices used to destroy tissue, like RF ablation, laser ablation or cryo-therapy probes, or devices used to deliver therapeutic agents like drugs, chemotherapy agents, genetic vectors, stem cells, etc.) and various support tools (e.g. suction tips, pointers).
Prescription Use V (Part 21 CFR 801 Subpart D Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111226
510(k) Page 8 of 41