E-SCAN XQ

K020164 · Biosound Esaote, Inc. · LNH · Feb 12, 2002 · Radiology

Device Facts

• Record ID: K020164
• Device Name: E-SCAN XQ
• Applicant: Biosound Esaote, Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 12, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The E-scan XQ is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

Device Story

E-Scan XQ is a magnetic resonance imaging (MRI) system for extremity diagnostics. Device captures proton density and relaxation signals (T1, T2) to generate cross-sectional images (transverse, sagittal, coronal, oblique) of limbs and joints. Operated by trained medical professionals in clinical settings. Output images are interpreted by medical experts to assess internal anatomical structures, aiding in clinical diagnosis. System provides non-invasive visualization of musculoskeletal tissues.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Magnetic resonance diagnostic device; produces cross-sectional images based on proton spatial distribution, T1/T2 relaxation times, nuclei density, flow velocity, and chemical shift. System is designed for extremity imaging.

Indications for Use

Indicated for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, and forearm in patients requiring cross-sectional imaging of limbs and joints.

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.

Predicate Devices

• Artoscan M (K963262)
• E-Scan (K990968)
• E-Scan (K001894)
• Hip Coil (K012728)

Submission Summary (Full Text)

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## FEB 1 2 2002

510(k) Summary E-Scan × 9 Biosound Esaote

# 510(k) Summary

K020164

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).

807.92(a)(1)

## Submitter Information

| Colleen Densmore, Official Correspondent | | |
|------------------------------------------|--------------------------------------------|---------|
| 8000 Castleway Drive | | |
| Indianapolis, IN 46250 | | |
| Phone: | [phone] | |
| Facsimile: | [phone] | |
| Contact Person: | Colleen Densmore | |
| Date: | January 4, 2002 | |
| 807.92(a)(2) | | |
| Trade Name: | E-Scan XQ | |
| Common Name: | Magnetic resonance diagnostic device | |
| Classification Name(s): | System, Nuclear Magnetic Resonance Imaging | |
| Classification Number: | 90LNH | |
| 807.92(a)(3) | | |
| Predicate Device(s) | | |
| Esaote | Artoscan M | K963262 |
| Esaote | E-Scan | K990968 |
| Esaote | E-Scan | K001894 |
| Esaote | Hip Coil | K012728 |

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#### 807.92(a)(5)

#### Intended Use(s)

XQ The E-scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

807.92(a)(6)

#### Technological Characteristics

\$\mathbb{Q}\$

The E-Scan MRI system is substantially equivalent to the currently available E-Scan system cleared via K012728.

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Image /page/2/Picture/1 description: The image is a black and white logo. The logo is circular in shape and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the logo is a symbol that resembles three stylized, curved lines, possibly representing a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2002

Esaote, S.P.A. % Ms. Colleen J. Densmore Official Correspondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250 Re: K020164

Trade/Device Name: E-Scan XQ MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: January 4, 2002 Received: January 17, 2002

Dear Ms. Densmore:

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 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 (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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 If you dosho specific at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on by receibled to premainter the Act may be obtained from the Division of Small Manufacturers, International 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. Hogdin

Nancv 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):

KO 20164

Device Name:

E-Scan XQ

Indications for Use:

The E-scan XQ is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. The device produces transverse, sagittal, coral and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

Norris Burleson

(Division Sign-O)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K20264