LYNX ULTRASOUND SYSTEM

K991872 · Ecton, Inc. · IYN · Jun 16, 1999 · Radiology

Device Facts

• Record ID: K991872
• Device Name: LYNX ULTRASOUND SYSTEM
• Applicant: Ecton, Inc.
• Product Code: IYN · Radiology
• Decision Date: Jun 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: The Ecton Lynx with Pulsed Wave Doppler is intended for the previously cleared clinical indications of adult and pediatric cardiac, intraoperative cardiac, peripheral vascular, abdominal, fetal, pediatric and neonatal cephalic imaging.

Device Story

Portable digital ultrasound system; transmits/receives ultrasound waves via piezoelectric transducers; converts reflected sound waves into electrical signals; processes signals for display as Doppler spectrum analysis. Used in clinical settings by healthcare professionals for diagnostic imaging. Provides real-time display of thermal and mechanical acoustic indices (AIUM/NEMA 1996) to assist ALARA-compliant scanning. Output aids clinicians in diagnostic decision-making for cardiac, vascular, and fetal assessments. Does not support combined scanning modes.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by comparison of technological characteristics, acoustic output measurements, and adherence to AIUM/NEMA 1996 standards for thermal and mechanical indices.

Technological Characteristics

Portable digital ultrasound system; piezoelectric transducer material; modes include 2D, M-Mode, Color Flow, Doppler Tissue Imaging, Continuous Wave, and Pulsed Wave Doppler. Conforms to AIUM/NEMA 1996 for thermal/mechanical indices. Acoustic output: ISPTA max 720 mW/cm², Mechanical Index max 1.9. No combined scanning modes.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in adult and pediatric patients, including fetal, abdominal, intraoperative cardiac, peripheral vascular, and neonatal cephalic applications. Not intended for ophthalmic use.

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

• Sonos 2500 Ultrasound System (K934041)
• HDI 3000 Ultrasound System (K935009)

Submission Summary (Full Text)

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₹991872

JUN 1 6 1999

ecton

Ecton, Inc. Suite 100 110 West Butler Avenue Ambler, Pennsylvania 19002 215 283-1800 Fax [phone]

4 . 2

Safety and Effectiveness of 510 (k) Summary 807.92 2 1 CFR

Name/Address/Phone/Contact Person: Submitter's 1)

> Christopher B. Knell Director of Engineering Ecton, Inc. Suite 100 110 West Butler Avenue Ambler, Pennsylvania 19002 215 283 1800 215 283 1809 (fax) [e-mail] (email)

April 28,1999 Date Summary Was Prepared:

of the device, including the trade or 2) Name the common or usual proprietary name if applicable, if known : name, and the classification name,

Common/Usual Name:

Diagnostic Ultrasound System

Proprietary Name:

Ecton Lynx Ultrasound System (K982800: The commercial product name for the Lynx is Ecton Sonnet Ultrasound System.)

Classification Names:

The FDA has classified Ultrasound Imaging Systems as Class II in 21 CFR:

FR #/ Product Code

892.1550/90IYN Ultrasonic Pulsed Doppler Imaging System 892.1560/90IYO Ultrasonic Pulsed Echo Imaging System 892.1570/ 90ITX Diagnostic Ultrasound Transducer

ਤੇ 4.2 Summary of Safety and Effectiveness 4.2 Summary p.

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#### Predicate Devices: 3)

In this 510(k) submission, the legally marketed devices to which we claim substantial equivalence are:

| Manufacturer | Product | K Number |
|---------------------|---------------------------------|----------|
| Hewlett Packard Co. | Sonos 2500 Ultrasound<br>System | K934041 |
| ATL, Inc. | HDI 3000 Ultrasound<br>System | K935009 |

#### 4 ) Device Description

The Ecton Lynx Ultrasound System is a general purpose and cardiac diagnostic ultrasound system. It is a highly portable digital system. Its function is to transmit and acquire ultrasound image data and display it on a monitor. The system has been cleared to operate in 2D, M-Mode, Color Flow Doppler, Doppler Tissue Imaging, and Continuous Wave Doppler modes (K982800).

current submission is for the addition of The the device. Pulsed Wave Doppler mode to

#### Indications for Use / Intended Use 5 )

The Ecton Lynx with Pulsed Wave Doppler is intended for the previously cleared clinical indications of adult and pediatric cardiac, intraoperative cardiac, peripheral vascular, abdominal, fetal, pediatric and neonatal cephalic imaging.

#### ୧ ) Characteristics Technological

The Ecton Lynx with Pulsed Wave Doppler operates in a manner that is identical to the previously cleared version of the system and the predicate devices. Piezoelectric material in the transducer is used as an ultrasound generator to transmit sound waves into the body. Reflected sound waves are

ব 4.2 Summary p. 4.2 Summary of Safety and Effectiveness

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Inc.. 510(k) Ecton, Lynx Ultrasound System

received by the transducer and converted into electrical signals that are processed and displayed as as a Doppler spectrum analysis.

The Lynx conforms to the Standard for Real-Time Display of Thermal and Mechanical Acoustic Indices on Diagnostic Ultrasound Equipment (AIUM/NEMA 1996) for the on-screen display of mechanical and thermal indices. This feature provides the user with information on potential thermal and cavitation bioeffect mechanisms. A user education program provides information instructing users on machine settings and scanning techniques that allow for examinations to be conducted in accordance with the ALARA (as low as reasonably achievable) principle.

The acoustic output limits of the Lynx with Pulsed Wave Doppler are the same as the previously cleared version of the system and the predicate Track 3 devices:

Acoustic Output Limits*

| ISPTA | 720 mW/cm² | (Maximum) |
|------------------|-------------|-----------|
| TIS/TIB/TIC | 0.1 - 4.0 | (Range) |
| Mechanical Index | 1.9 | (Maximum) |
| ISPPA | 0-700 W/cm² | (Range) |

*the Lynx is not intended for ophthalmic uses.

#### 7 ) Potential Adverse Affects

This device has no known adverse affects on human health when used in the prescribed manner for the intended uses.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

# JUN 1 6 1999

Ecton, Inc. C/O Robert Mosenkis Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298

RE: K991872

Lynx Diagnostic Ultrasound System with Pulsed Wave Doppler Dated: May 28, 1999 Received: June 1, 1999 Regulatory Class: II 21 CFR 892.1550/Procode: 90 IYN 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1570/Procode: 90 ITX

Dear Mr. Mosenkis:

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 registration, 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 Lynx Diagnostic Ultrasound System with Pulsed Doppler as described in your premarket notification:

Transducer Model Number(s):

2.7 MHz External 5.0 MHz External 5.0 MHz Biplane Transesophageal 5.0 MHz Monoplane Transesophageal

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 (OS) for Medical Devices: General (GMP) regulation (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 regulations.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page -2 - Mr. Mosenkis

This determination of substantial equivalence is granted on the condition that prior to shipping the first device. you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free 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 Robert Phillips, Ph.D at [phone].

Sincerely vours.

David A. Egeron

/n

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

Enclosures

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4.2 / 4.3

Indications for Use Form

# Ecton Lynx Ultrasound System

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

System Indications

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(Doppler<br>Tissue<br>Imaging) | Other<br>(specify)<br>Harmonic<br>Imaging |
|------------------------|---|---|-----|-----|------------------|--------------------------------------------------------|-------------------------------------------|
| Fetal | P | P | N | P | P | P | P |
| Abdominal | P | P | N | P | P | P | P |
| Intraoperative-Cardiac | P | P | N | P | P | P | P |
| Pediatric | P | P | N | P | P | P | P |
| Neonatal Cephalic | P | P | N | P | P | P | P |
| Cardiac (Adult) | P | P | N | P | P | P | P |
| Cardiac (Pediatric) | P | P | N | P | P | P | P |
| Transesophageal | P | P | N | P | P | P | P |
| Peripheral Vascular | P | P | N | P | P | P | P |

Additional Comment: The Ecton Lynx does not provide Combined Modes (where more than one scanning mode is active simultaneously.)

4.3 p 1

Prescription Use (Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Hegem

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

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Ecton, Inc. 510(k) Lynx Ultrasound System

4.2 / 4.3

Indications for Use Form

## Ecton Lynx Ultrasound System

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

2.7 MHz External Transducer

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(Doppler<br>Tissue<br>Imaging) | Other<br>(specify)<br>Harmonic<br>Imaging |
|------------------------|---|---|-----|-----|------------------|--------------------------------------------------------|-------------------------------------------|
| Fetal | P | P | N | P | P | P | P |
| Abdominal | P | P | N | P | P | P | P |
| Intraoperative-Cardiac | P | P | N | P | P | P | P |
| Pediatric | P | P | N | P | P | P | P |
| Cardiac (Adult) | P | P | N | P | P | P | P |
| Cardiac (Pediatric) | P | P | N | P | P | P | P |
| Peripheral Vascular | P | P | N | P | P | P | P |

Additional Comment: The Ecton Lynx does not provide Combined Modes (where more than one scanning mode is active simultaneously.)

4.3 p 2

Prescription Use (Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Ingram

(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, ENT, Divisionological Devices 510(k) Number

4.2/4.3 Indications

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#### 4.2 / / 4.3

### Indications for Use Form

## Ecton Lynx Ultrasound System

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

5.0 MHz External Transducer

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(Doppler<br>Tissue<br>Imaging) | Other<br>(specify)<br>Harmonic<br>Imaging |
|------------------------|---|---|-----|-----|------------------|--------------------------------------------------------|-------------------------------------------|
| Fetal | P | P | N | P | P | P | P |
| Abdominal | P | P | N | P | P | P | P |
| Intraoperative-Cardiac | P | P | N | P | P | P | P |
| Pediatric | P | P | N | P | P | P | P |
| Neonatal Cephalic | P | P | N | P | P | P | P |
| Cardiac (Adult) | P | P | N | P | P | P | P |
| Cardiac<br>(Pediatric) | P | P | N | P | P | P | P |
| Transesophageal | P | P | N | P | P | P | P |
| Peripheral Vascular | P | P | N | P | P | P | P |

Additional Comment: The Ecton Lynx does not provide Combined Modes (where more than one scanning mode is active simultaneously. )

4.3 p 3

Prescription Use (Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segner

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

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4.2 / 4.3

Indications for Use Form

## Ecton Lynx Ultrasound System

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

5.0 MHz Biplane Transesophageal Transducer

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(Doppler<br>Tissue<br>Imaging) | Other<br>(specify)<br>Harmonic<br>Imaging |
|------------------------|---|---|-----|-----|------------------|--------------------------------------------------------|-------------------------------------------|
| | | | | | | | |
| Intraoperative-Cardiac | P | P | N | P | P | P | P |
| Cardiac (Adult) | P | P | N | P | P | P | P |
| Cardiac (Pediatric) | P | P | N | P | P | P | P |
| Transesophageal | P | P | N | P | P | P | P |

Additional Comments: Pediatric studies are dependent upon patient size. The Ecton Lynx does not provide Combined Modes (where more than one scanning mode is active simultaneously. )

4.3 p 4

Prescription Use (Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson

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

510(k) Number K971772

{9}------------------------------------------------

4.2 / 4.3

Indications for Use Form

# Ecton Lynx Ultrasound System

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

5.0 MHz Monoplane Transesophageal Transducer

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(Doppler<br>Tissue<br>Imaging) | Other<br>(specify)<br>Harmonic<br>Imaging |
|------------------------|---|---|-----|-----|------------------|--------------------------------------------------------|-------------------------------------------|
| | | | | | | | |
| | | | | | | | |
| Intraoperative-Cardiac | P | P | N | P | P | P | P |
| Cardiac (Adult) | P | P | N | P | P | P | P |
| Cardiac (Pediatric) | P | P | N | P | P | P | P |
| Transesophageal | P | P | N | P | P | P | P |

| Additional Comments: | Pediatric studies are dependent upon patient size. The Ecton Lynx does not provide Combined Modes (where more than one scanning mode is active simultaneously.) |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|

4.3 p 5

Prescription Use (Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

John G. Stymm

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

4.2/4.3 Indications