7250 (MEGAS)

K994369 · Biosound Esaote, Inc. · IYN · Feb 24, 2000 · Radiology

Device Facts

• Record ID: K994369
• Device Name: 7250 (MEGAS)
• Applicant: Biosound Esaote, Inc.
• Product Code: IYN · Radiology
• Decision Date: Feb 24, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

ESAOTE's Mod. 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies.

Device Story

Compact ultrasound system for non-invasive diagnostic imaging; performs B-Mode, M-Mode, Doppler, Color Flow Mapping, Amplitude Doppler, and Tissue Harmonic Imaging (TEI). Inputs: annular array, phased, convex, and linear array probes. Features volumetric scan converter for simultaneous control of two independent scan planes (Bi-Scan); enables volumetric datasets for omni-directional 2D sectioning and volume computation via Simpson rule. Operated by clinicians in clinical settings. Output: real-time ultrasound images on LCD or 15" monitor; data stored via floppy disk, optical disk, or LAN. Assists clinicians in diagnostic assessment and measurement of anatomical structures. Benefits: rapid, non-invasive visualization and volumetric analysis of irregular structures without geometric assumptions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Compact ultrasound system; supports annular, phased, convex, linear, and Bi-Scan probes. Imaging modes: B, M, Doppler, CFM, Amplitude Doppler, TEI. Connectivity: LAN port, floppy/optical disk drives. Display: LCD or 15" monitor. Safety: EN60601-1, Track 3 acoustic output display. Software-based volumetric scan conversion and Simpson rule volume computation.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, pediatric, small organ (thyroid, breast, testicles), neonatal cephalic, adult cephalic, cardiac, transesophageal, transrectal, transvaginal, and peripheral vascular applications. Contraindications not specified.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• 7250 (Megas) (K982444)

Submission Summary (Full Text)

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K994369

510(k) 7250 Ultrasound Imaging System Biosound Esaote

# 510(k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 807.92(a).

807.92(a)(1)

# Submitter Information

| Colleen Hittle, Official Correspondent | | |
|----------------------------------------|-----------------------------------------------------------------------------------|----------------------|
| 8000 Castleway Drive | | |
| Indianapolis, IN 46250 | | |
| Phone: | [phone] | |
| Facsimile: | [phone] | |
| Contact Person: | Colleen Hittle | |
| Date: | December 23, 1999 | |
| 807.92(a)(2) | | |
| Trade Name: | 7250 Ultrasound Imaging System (Megas)<br>(Addition of 2nd Harmonic Imaging Mode) | |
| Common Name: | Ultrasound Imaging System | |
| Classification Name(s): | Ultrasonic pulsed doppler imaging system<br>Ultrasonic pulsed echo imaging system | 892.1550<br>892.1560 |
| Classification Number: | 90IYN<br>90IYO | |
| 807.92(a)(3) | | |
| | Predicate Device(s) | |
| Esaote | 7250 (Megas) | K982444 |

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

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510(k) 7250 Ultrasound Imaging System Biosound Esaote

### Device Description

ESAOTE's 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies. Its primary modes of operation are the following: B-Mode, M-Mode, Doppler, Color Flow Mapping, Harmonic Imaging (TEI) and Amplitude Doppler. The 7250 can be equipped with an LCD Color Display (Portable Configuration) or with a 15" Color Monitor and a cart (Mainframe Configuration). The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations.

The 7250 can drive annular array, phased, convex and linear array probes. In addition, the 7250 is equipped with a volumetric scan converter and the ability to control simultaneously two independent scan planes. This technological characteristic allows to manage Bi-Scan Probes, to obtain volumetric datasets; these datasets can then be used to display "omni-directional" 2D images (anyplane sectioning) as well as multiple parallel equidistant sections (paraplane sectioning). This Bi-Scan approach is ideal for volume computations through the Simpson rule; specifically, it can be used to measure volumes of irregular structures since it does not require a geometrical assumption.

The 7250 is designed for ease of use. The user interface allows the operator to perform an examination quickly and efficiently. Clearly labeled mode selection keys are easily accessed, and the system's "pop-up" menus allow the operator to change parameters with ease. The user may also access special function menus and perform calculations with a minimal number of kev strokes. The 7250 offers a vast selection of calculations and measurements which can be performed quickly and easily.

The MOD.7250 is equipped with a 3.5" floppy disk drive to simplify software modifications and provide fast, cost effective system upgrades. This drive (or an optional Optical Disk Drive) can also be used for image storage. Moreover, this unit can store data directly to a Personal Computer via a LAN (Network) port.

In addition, the 7250 can be equipped with recording devices, including a S-VHS video recorder and a black-and-white or color printer, which are controlled through the keyboard.

807.92(a)(5)

# Intended Use(s)

ESAOTE's Mod. 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies.

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# 510(k) Summary 7250 Ultrasound Imaging System Biosound Esaote

| | 7250 (predicate) | 7250 (new mode) |
|---------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| Electrical Safety | EN60601-1 | EN60601-1 |
| Ultrasound Safety | Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) |
| Intended Use | | |
| • Cardiac (Transthoracic) | YES | YES |
| • Cardiac (Transesophageal) | YES (Multiplane) | YES (Multiplane) |
| • Vascular | YES | YES |
| • Abdominal | YES | YES |
| • Fetal | YES | YES |
| • Adult Cephalic | YES | YES |
| • Neonatal Cephalic/Small organ | YES | YES |
| • Endovaginal | YES (Sagittal & Transverse Planes) | YES (Sagittal & Transverse Planes) |
| • Endorectal | YES (Sagittal & Transverse Planes | YES (Sagittal & Transverse Planes |
| Probe Technology | | |
| • Annual Array | YES | YES |
| • Electronical Array | YES | YES |
| • Bi-Scan Probes | YES | YES |
| • Doppler Probes | YES | YES |
| Modes of operation | 2D, M-Mode, PW, CW, CFM, Amplitude Doppler | 2D, M-Mode, PW, CW, TEI, CFM, Amplitude Doppler |
| Imaging Frequencies | 2.5, 3.5, 5.0, 7.5, 10 MHz | 2.5, 3.5, 5.0, 7.5, 10 MHz |
| CFM/Doppler Frequencies | 2.0, 2.5, 3.3, 5.0, 6.6 MHz | 2.0, 2.5, 3.3, 5.0, 6.6 MHz |
| Biopsy Guidance | YES | YES |
| • ABS11 & ABS13 use | General Purpose | General Purpose |
| • ABS12 use | Transrectal/transvaginal | Transrectal/transvaginal |
| • Biopsy Line Depth marker | 1 cm | 1 cm |
| • Needle guide angle | ABS11: 25-45°<br>ABS12: fixed<br>ABS13: 30-50° | ABS11: 25-45°<br>ABS12: fixed<br>ABS13: 30-50° |
| Display Type | SVGA | SVGA |
| Digital Archival Capabilities | YES | YES |
| VCR/Page Printer | YES | YES |
| M&A Capabilities | Cardiac, Vascular, Fetal and general purpose measurements | Cardiac, Vascular, Fetal and general purpose measurements |

·

# Comparison Chart for Substantial Equivalence

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 2 4 2000

Colleen J. Hittle Official Correspondent Biosound Esaote, Inc. 8000 Castleway Drive Indianapolis, IN 46250

Re: K994369 7250 Ultrasound Imaging System (Addition of Tissue Enhancement Imaging) Regulatory class: II/21 CFR 892.1550 and 21 CFR 892.1560 Product Code: 90 IYN/90 IYO December 23, 1999 Dated: Received: December 27, 1999

Dear Ms. Hittle:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the 7250 Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

PA220E

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Colleen J. Hittle

This letter will allow you to begin marketing your device as described in your 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 market.

If you desire specific advice for your device on our labeling regulation (21
CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" .

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

for

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal and Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Intr

Enclosure

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#### Diagnostic Ultrasound Indications for Use Form

#### Mod.7250

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | | | | | | | | | |
|-----------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | See comments | |
| Abdominal | | P | P | P | | P | P | | See comments | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | See Comments | |
| Small Organ (specify) [1] | | P | P | P | P | P | P | | See Comments | |
| Neonatal Cephalic | | P | P | P | P | P | P | | See Comments | |
| Adult Cephalic | | P | P | P | P | P | P | | See Comments | |
| Cardiac | | P | P | P | P | P | | | See Comments | N[2] |
| Transesophageal | | P | P | P | P | P | | | See Comments | |
| Transrectal | | P | P | P | | P | P | | See Comments | |
| Transvaginal | | P | P | P | | P | P | | See Comments | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | P | P | P | | See Comments | P(3) |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N=new indication; P=previously cleared by FDA; E= added under Appendix E

Additional Comments: [1] Small organs include Thyroid, Breast and Testicles. [2] Tissue Harmonic Imaging, [3] This unit manages Bi-scan probes for volumetric acquisitions from which any 2D tomographic image can be displayed. This unit has been previously cleared by FDA (K982444) for uses indicated as "P". Applicable combined modes: B+M+PW+CW+CFM+PD

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED

concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Thiel h. Segman

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number

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## Diagnostic Ultrasound Indications for Use Form

#### Transducer: PA220E

| | Intelluci USC. Diagnostic univasound miaging of that<br>Mode of Operation | | | | | | | | | |
|-----------------------------|---------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | See Comments | |
| Cardiac | | P | P | P | P | P | | | See Comments | N(2) |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaqinal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

# Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N=new indication; P=previously cleared by FDA; E= added under Appendix E

Additional Comments: [2] Tissue Harmonic Imaging. This probe has been previously cleared by FDA (K982444) for uses indicated as "P". Applicable combined modes: B+M+PW+CW+CFM+PD.

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED

concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 2) CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number

..