Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states that the modifications "do not affect the intended use or alter the fundamental scientific technology of the device" and lists specific hardware and software changes that do not indicate AI/ML. While it mentions "Automatic registration of the group's images," this is a common image processing technique and not necessarily indicative of AI/ML without further context. The document also lacks any mention of AI, ML, training data, or performance metrics typically associated with AI/ML devices.

Therapeutic

No
The device is an MR system intended for imaging and producing diagnostically useful information, not for treating or rehabilitating.

Diagnostic

Yes
The document states that S-scan images, "When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information." This explicitly indicates its role in diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components like a patient table, coil cable, and limb protection, indicating it is a physical MR system with associated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The S-scan is a Magnetic Resonance (MR) system. It produces images of internal body structures (limbs, joints, spinal column) by using magnetic fields and radio waves. It does not analyze specimens taken from the body.
Intended Use: The intended use is to produce images that, when interpreted by a medical expert, can provide diagnostically useful information. This is consistent with an imaging device, not an IVD.
Device Description: The description focuses on the hardware and software of the MR system, including patient table features, pulse sequences, and software releases. It does not mention any components or processes related to analyzing biological specimens.

Therefore, the S-scan is an imaging device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

S-scan is a Magnetic Resonance (MR) system that produces transverse, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.

S-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.

The indications for use of the S-scan system, as described in its labeling, are the same as those of the unmodified S-scan system cleared via K063207.

Product codes

LNH

Device Description

The changes performed on the modified S-scan device, with respect to the cleared version - S-scan K063207 -, are due to the improvement of the system performance. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

1. A device that locks the patient table in the current position, unless the user disconnects the coil cable.
1. A limb protection for patient table.
1. Modified pulse sequences.
1. A new software release.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Magnetic Resonance (MR)

Anatomical Site

limbs, joints and spinal column, portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and portions of the spinal column, including the cervical and lumbo-sacral sections.

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K063207, K042236, K043030

Reference Device(s)

K061429, K010938

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

K080968

APR 2 9 2008

510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).

Submitter Information 807.92(a)(1)

Carri Graham, Official Correspondent 11460 N. Meridian St., Suite 150 Carmel, IN 46032 Phone: (317) 569-9500 X 103 Facsimile: (317) 569-9520

Contact Person: Carri Graham

Date: April 3, 2008

807.92(a)(2)

Trade Name: S-scan System, Nuclear Magnetic Resonance Imaging Common Name: Classification Name(s): Magnetic resonance diagnostic device Classification Number: 90LNH

807.92(a)(3)	Predicate Device(s)
Esaote	S-scan	K063207
Esaote	G-scan	K042236
Siemens	Magnetom C!	K043030
Esaote	Dynamic MRI
Software for
C-scan, E-scan XQ,
& E-scan Opera	K061429
Siemens	Syngo Multimodality
Workstation	K010938

1

807.92(a)(4)

Device Description

Summary of S-scan modifications

The changes performed on the modified S-scan device, with respect to the cleared version - S-scan K063207 -, are due to the improvement of the system performance. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

1. A device that locks the patient table in the current position, unless the user disconnects the coil cable.
1. A limb protection for patient table.
1. Modified pulse sequences.
1. A new software release.

2

807.92(a)(5)

Intended Use(s)

S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.

S-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.

3

807.92(a)(6)

.

Technological Characteristics

| Characteristic | S-scan
modified | S-scan
K063207 | Comments |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulse Sequences | Orthogonal Multi-planar Scout
Spin Echo T1
Spin Echo T2
Spin Echo Proton Density T2
Inversion Recovery
Short TI Inversion Recovery
Spin Echo TI Half Echo
Spin Echo TI Half Fourier
Turbo Spin Echo T2 weighted
(TSE, TSE S, TSE SA, TSE SP)
Turbo Multi Echo
Gradient Echo
Short Time Inversion Recovery
Gradient Echo (Gradient Echo
STIR)
Gradient Echo 3D (Turbo 3D
T1)
Speed - Spin Echo T2 (SSE-
SET2, SSE-SET2 S, SSE-SET2
SA, SSE-SET2 SP)
Speed - Spin Echo T2 (SSE-
SET2 # 1-2-3)
FSE (FSE T1, FSE STIR, FSE
T2)
3D HYCE
XBONE
Real Time | Orthogonal Multi-planar Scout
Spin Echo T1
Spin Echo T2
Spin Echo Proton Density T2
Inversion Recovery
Short TI Inversion Recovery
Spin Echo TI Half Echo
Spin Echo T1 Half Fourier
Turbo Spin Echo T2 weighted
(TSE, TSE S, TSE SA, TSE SP)
Turbo Multi Echo
Gradient Echo
Short Time Inversion Recovery
Gradient Echo (Gradient Echo
STIR)
Gradient Echo 3D (Turbo 3D
T1)
Speed - Spin Echo T2 (SSE-
SET2, SSE-SET2 S, SSE-SET2
SA, SSE-SET2 SP)
Speed - Spin Echo T2 (SSE-
SET2 # 1-2-3)
Real Time | The modified S-scan
pulse sequences are
described in the
Device Modification
Description. |
| Sequence
parameters | Spin Echo T1, TE=16 ms:
TR: from 50 to 5000 ms, step 10
ms
TE: 16 ms
FA: 90°
FOV: from 100 to 300 mm, step
10 mm
Slice thickness: from 2 to 10
mm, step 0.5 mm | See comments | This is a particular
version of standard
Spin echo T1 with TE
fixed at 16 ms, instead
of 18 ms. |
| Sequence
parameters | Speed - Spin Echo T2 #1:
TR: from 200 to 5000 ms, step
10 ms
TE: 130 ms
FA: 90°
FOV: from 250 to 400 mm, step
10 mm
Slice thickness: from 4 to 10
mm, step 0.5 mm
Speed - Spin Echo T2 #2: | See comments | The Speed Spin Echo
T2 #1, 2, 3 are the
Spin Echo T2 #1, 2, 3
sequence with Speed
technique for
reduction of scan
time. |
| Characteristic | S-scan
modified | S-scan
K063207 | Comments |
| | 10 ms
TE: 130 ms
FA: 90°
FOV: from 250 to 400 mm, step
10 mm
Slice thickness: from 4 to 10
mm, step 0.5 mm | | |
| | Speed - Spin Echo T2 #3:
TR: from 200 to 5000 ms, step
10 ms
TE: 130 ms
FA: 90°
FOV from 250 to 400 mm, step
10 mm
Slice thickness: from 4 to 10
mm, step 0.5 mm | | |
| Sequence
parameters | FSE T2
ESP: 20 ms, 30 ms
ETL: from 8 to 12 (depending of
ESP selected), step 2
TR: from 100 to 10000 ms, step
10 ms
TE: from 20 to 300 ms, step 20
ms or 30 ms (depending of ESP
and ETL selected)
FA: 90°
FOV: from 120 to 400 mm, step
10 mm
Slice thickness: from 3 to 7 mm,
step 0.5 mm
Flow compensation: None/Read
/Sel
Relaxation: Yes/No
FSE STIR:
ESP: 20 ms, 30 ms
ETL: from 2 to 6 (depending of
ESP selected), step 2
TR: from 100 to 10000 ms, step
10 ms
TE: from 20 to 120 ms, step 20
ms or 30 ms (depending of ESP
and ETL selected)
TI: from 60 to 300 ms, step 5 ms
FA: 90°
FOV: from 120 to 400 mm, step
10 mm
Slice thickness: from 3 to 7 mm,
step 0.5 mm
Flow compensation: None/Read
/Sel | See comments | See Device
Modification
Description -
Modified pulse
sequences section. |
| Characteristic | S-scan
modified | S-scan
K063207 | Comments |
| | FSE T1
ESP: 20 ms
ETL: 2, 3
TR: from 100 to 10000 ms, step
10 ms
TE: from 20 to 60 ms, step 20
ms (depending of ETL selected)
FA: 90°
FOV: from 120 to 400 mm, step
10 mm
Slice thickness: from 3 to 7 mm,
step 0.5 mm | | |
| Sequence
parameters | GE T2 FC:
TR: from 30 to 5000 ms, step 5
ms
TE: from 22 to 34 ms, step 4 ms
FA: from 10° to 90°, step 5°
FOV: from 120 to 400 mm, step
10 mm
Slice thickness: from 2 to 10
mm, step 0.5 mm | See comments | This is a particular
version of the
Gradient echo T2
standard sequence
with application of
gradient moment
nulling technique for
flow compensation.
See Software
Description -
Software
Requirements
Specifications section. |
| Sequence
parameters | Gradient Echo, TE=6 ms:
TR: from 30 to 5000 ms, step 5
ms
TE: 6 ms
FA: from 10° to 90°, step 5°.
FOV: from 130 to 300 mm, step
10 mm
Slice thickness: from 4 to 10
mm, step 0.5 mm | See comments | This is a Gradient
echo sequence with
fixed TE at 6 ms that
provides "pseudo
Tl"contrast images. |
| Sequence
parameters | STIR T2 S:
TR: from 200 to 10000 ms, step
10 ms
TE: from 120 to 130 ms, step
10 ms
TI: from 50 to 2000 ms, step 5
ms
FA: 90°
FOV: from 120 to 400 mm, step
10 mm
Slice thickness: from 3 to 10
mm, step 0.5 mm | See comments | This is a STIR
standard sequence
with 4 echoes instead
of 3 that are combined
to obtain T2-weighted
contrast images with
better S/N. |
| Sequence
parameters | STIR T2 A:
TR: from 200 to 10000 ms, step
10 ms
TE: from 80 to 120 ms, step 10 ms | See comments | This is a particular
version STIR standar
sequence where the
sequence parameters |
| Characteristic | S-scan
modified | S-scan
K063207 | Comments |
| | ms
TI: from 50 to 2000 ms, step 5
ms
FA: 90°
FOV: from 120 to 400 mm, step
10 mm
Slice thickness: from 3 to 10
mm, step 0.5 mm | | are optimized for joint
visualization. |
| Sequence
parameters | XBONE
TR: from 50 to 5000 ms, step 10
ms
FA: from 10° to 90°, step of 5°
FOV: from 100 to 400 mm, step
10 mm
Slice thickness: from 2 to 10
mm, step 0.5 mm | See comments | See Device
Modification
Description - section
Modified pulse
sequences. |
| Sequence
parameters | 3D HYCE
TR: from 10 to 13 ms
TE: TR/2
FA: from 60° to 90°
FOV: from 200 to 300 mm, step
10 mm
FOV 3D: from 80 to 160 mm,
step 10 mm
Slice thickness: from 0.8 to 20
mm, step 0.1 mm | See comments | See Device
Modification
Description -
Modified pulse
sequences section. |
| Characteristic | S-scan
modified | G-scan
K042236 | Comments |
| Pulse sequences | FSE (FSE T1, FSE STIR, FSE
T2) | Turbo Spin Echo - 7 | See Device
Modification
Description –
Modified pulse
sequences section. |
| Characteristic | S-scan
modified | MAGNETOM C!
K043030 | Comments |
| Pulse sequences | FSE T2 with relaxation
technique | RESTORE sequence | See Device
Modification
Description –
Modified pulse
sequences section. |
| Characteristic | S-scan
modified | MAGNETOM C!
K043030 | Comments |
| Pulse sequences | 3D HYCE | trueFISP | See Device
Modification
Description -
Modified pulse
sequences section. |

4

.

5

6

7

| Characteristic | S-scan
modified | MAGNETOM C!
K043030 | Comments |
|-----------------|--------------------|------------------------|-------------------------------------------------------------------------------------|
| Pulse sequences | XBONE | Dixon Fat Suppression | See Device
Modification
Description –
Modified pulse
sequences section. |

| Characteristic | S-scan
modified | Dynamic MRI Software
K061429 | Comments |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image
Processing
Functions | Dynamic MRI study
environment:

Display by group
Automatic registration of
the group's images
Generate, save and export
of uptake curves and of
comparison between two
different uptake curves
Management of dynamic
acquisition by pedal switch
(identification of the
dynamic acquisition starting
time) | Dynamic MRI study
environment:
Display by group
Generate, save and export of
uptake curves. | The registration
technique is already
in place on many
diagnostic imaging
devices or post-
processing
workstations as, for
instance, syngo
Multimodality
Workstation - feature
Image
Fusion(K010938).
See Software
Description -
Software
Requirements
Specifications
section. |
| Characteristic | S-scan modified | S-scan
K063207 | Comments |
| Networking
functions | Possibility of reading,
writing and update of CD-R
and DVD in DICOM
format, (FSC, FSR, FSU
General Purpose CD-R
Image Interchange Profile,
MR images only).

Possibility of exporting
images both in DICOM and
in jpeg format on the same
removable media (at least
the DICOM format is
always present). | Possibility of reading, writing
and update of CD-R in DICOM
format, (FSC, FSR, FSU
General Purpose CD-R Image
Interchange Profile, MR images
only). | See Software
Description -
Software
Requirements
Specifications section. |
| Access to the
system | Management, only by
system administrator, of
two levels of security.

Possibility, only by system
administrator, to reset the
password of the users. | Management of multiple users
with automatic expiry of
password and account (if not
used). | See Software
Description -
Software
Requirements
Specifications section. |
| Accessories | Viewer Lite: | Viewer Lite: | See Software
Description - |

8

:

.

:

| Characteristic | S-scan
modified | S-scan
K063207 | Comments |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------|
| | - export on a CD/DVD and
display on a commercial PC
of the Esaote's MRI images

copy of the Viewer Lite
user manual on the
CD/DVD | - export on a CD/DVD and
display on a commercial PC
of the Esaote's MRI images. | Software
Requirements
Specifications section. |

and the comments of the comments of the comments of

:

and the comments of the comments of the comments of the comments of

9

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Esaote, S.p.A. % Ms. Carri Graham Official Consultant The Anson Group, LLC 1460 N. Meridian St., Suite 150 CARMEL IN 46032

APR 2 9, 2008

Re: K080968

Trade/Device Name: S-scan MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 3, 2008 Received: April 4, 2008

Dear Ms, Graham:

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.

10

Enclosure

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely vours.

Nancy C. Brogdon

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

11

Indications for Use

510(k) Number (if known):

Device Name: S-scan MRI System

Indications for Use:

S-scan is a Magnetic Resonance (MR) system that produces transverse, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.

S-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.

The indications for use of the S-scan system, as described in its labeling, are the same as those of the unmodified S-scan system cleared via K063207.

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)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080968