(134 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard MR imaging principles and components.
No
The device is described as an imaging system (MRI) used for diagnosis, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the images produced by the O-scan, "When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information." This indicates its role in providing information for diagnosis.
No
The device description explicitly lists hardware components such as a magnetic unit, electronic unit, console (PC, keyboard, mouse, monitor), patient seat, and receiving coils, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- O-scan Function: The O-scan is a Magnetic Resonance (MR) system that produces images of the internal structures of the patient's limbs and joints. It works by using magnetic fields and radio waves to create images, not by analyzing biological samples.
- Intended Use: The intended use clearly states it is for "imaging portions of the arm... and imaging portions of the leg..." and that the images "can provide diagnostically useful information" when interpreted by a medical expert. This describes an imaging device used for diagnosis based on visual interpretation of internal structures, not laboratory analysis of samples.
Therefore, the O-scan falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
O-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, calf and knee, but excluding the thigh.
O-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
Product codes (comma separated list FDA assigned to the subject device)
90LNH
Device Description
O-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.
The system comprises three main parts:
-
Magnetic unit, containing a permanent magnet
-
Electronic unit
-
Console, comprising a PC, Keyboard, mouse, monitor and operating table.
-
Patient seat
-
Receiving coils
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
limbs and joints; portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm; portions of the leg, including the foot, ankle, calf and knee, but excluding the thigh.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical expert trained in the use of MR equipment
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)
Non-clinical testing of the O-Scan system demonstrated that it met performance requirements and is as safe and effective as the predicate devices.
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.
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
510(k) Summary O-Scan Esaote S.p.A.
510(k) Summary
· The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
Submitter Information
DEC 2 3 2009
Allison Scott, Official Correspondent 11460 N. Meridian St., Suite 150 Carmel, IN 46032 (317) 569-9500 x106 Phone: Facsimile: (317) 569-9520
Contact Person: Allison Scott, RAC
Date: August 7, 2009
Trade Name: O-Scan
Common Name: System, Nuclear Magnetic Resonance Imaging
Classification Name(s): Magnetic Resonance Diagnostic Device
Classification Number: 90LNH
Predicate Device(s)
| Tradename | Common name | Class | Product code | Manufacturer | K number |
|---|---|---|---|---|---|
| C-scan | System, nuclear magnetic resonance imaging | II | LNH | ESAOTE S.P.A. | K040877 |
| S-scan | System, nuclear magnetic resonance imaging | II | LNH | ESAOTE S.P.A. | K080968 |
| AIRIS II | System, nuclear magnetic resonance imaging | II | LNH | HITACHI MEDICAL SYSTEMS | K001334 |
page 1 of 2
O-Scan 510(k)
8/7/2009
Page 10 of 905
1
510(k) Summary O-Scan Esaote S.p.A.
Device Description
O-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.
The system comprises three main parts:
-
Magnetic unit, containing a permanent magnet
-
Electronic unit
-
Console, comprising a PC, Keyboard, mouse, monitor and operating table.
-
Patient seat
-
Receiving coils
Intended Use(s)
O-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, calf and knee, but excluding the thigh.
O-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
Technological Characteristics
The technological characteristics of the O-Scan are substantially equivalent to those of the predicate devices.
Performance Data
Non-clinical testing of the O-Scan system demonstrated that it met performance requirements and is as safe and effective as the predicate devices.
page 2 of 2
O-Scan 510(k)
8/7/2009
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Esaote, S.p.A. % Ms. Allison Scott, RAC Consultant The Anson Group, LLC 11460 N. Meridian St., Suite 150 CARMEL IN 46032
DEC 2 3 2009
Re: K092469
Trade/Device Name: O-Scan MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 17, 2009 Received: November 18, 2009
Dear Ms. Scott:
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. Ilsting 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 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); medical device reporting (reporting of medical
3
Page 2 -
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K092469
Device Name: O-Scan MR System
Indications for Use:
O-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, calf and knee, but excluding the thigh.
O-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (TI), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
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)
Lozano Mtz
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev
510(k) Number K072462
O-Scan 510(k)
8/7/2009