PENRITH ELETTRA ULTRASOUND SYSTEM

K100598 · Penrith Corporation · IYN · Nov 19, 2010 · Radiology

Device Facts

• Record ID: K100598
• Device Name: PENRITH ELETTRA ULTRASOUND SYSTEM
• Applicant: Penrith Corporation
• Product Code: IYN · Radiology
• Decision Date: Nov 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Elettra Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), and Musculoskeletal (Superficial).

Device Story

Compact diagnostic ultrasound system; includes console, display, power supply, user controls, and transducers. Transmits ultrasonic energy into patient; receives echoes; performs post-processing to generate real-time anatomic and fluid flow images. Transducers operate in cabled or wireless configurations. Used by physicians for diagnostic imaging and flow analysis. Output displayed on-screen for clinical assessment of structures and hemodynamics. Benefits include non-invasive visualization of internal anatomy and blood flow to aid clinical decision-making.

Clinical Evidence

Bench testing only. Evaluated for acoustic output, biocompatibility, cleaning, disinfection, and sterilization effectiveness. Thermal, electrical, and mechanical safety, and electromagnetic compatibility testing performed. Conforms to applicable medical device safety standards.

Technological Characteristics

Compact ultrasound system; includes system console and transducers (L8-3 Linear, L12-5 Linear, C5-2 Curvilinear). Supports B-mode, Color Doppler, and Amplitude Doppler. Operates via ultrasonic pulsed echo/Doppler. Supports cabled or wireless transducer configurations. Complies with Track 3 acoustic output methods. Materials are biocompatible. Designed to meet electrical and physical safety standards.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ (e.g., breast, testes, thyroid, penis), neonatal cephalic, cardiac, peripheral vessel, and musculoskeletal (conventional and superficial) applications. For use by qualified physicians. Prescription use only.

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

• Acuson Sequoia (K022567)
• Acuson Cypress (K052331)
• Philips Avalon CTS (K023931)

Submission Summary (Full Text)

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K/00598

### Summary of Safety and Effectiveness

NOV 1 9 2010

This summary of 510(k) safety and effectiveness information is submitted as a part of this Premarket Notification in accordance with the requirements of the Safe Medical Devices Act of 1990 as implemented in 21 CFR 807.92.

#### 1) Submitter's information:

Penrith Corporation 5170 Campus Drive Suite 2 Plymouth Meeting, PA 19462 USA

Corresponding official: Email: Telephone: Fax:

Lawrence Engle [e-mail] 610 834 1220 610 834 1220

Date Summary Prepared:

February 10, 2010

### 2) Device Information

The proprietary name of the device is the Penrith Elettra Diagnostic Ultrasound System.

The Elettra is classified as follows:

90 IYN Ultrasonic Pulsed Doppler Imaging System

Ultrasonic Pulsed Echo Imaging System 90 IYO

90 ITX Diagnostic Ultrasound Transducer

The Penrith Elettra is a compact diagnostic ultrasound device. It includes a system console housing electronic circuitry, a video display, power supply, and user controls. This connects to the transducers and together these generate the ultrasound image.

The Penrith Elettra is intended to be used by a qualified physician for diagnostic imaging or fluid flow analysis of the human body including: Fetal,

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Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), and Musculoskeletal (Superficial).

The Company believes that the Penrith Elettra is substantially equivalent to the Acuson Sequoia, K022567, the Acuson Cypress K052331, and the Philips Avalon CTS, K023931.

The Penrith Elettra system and transducers function in a manner that is substantially equivalent to the previously cleared devices: Predicate device systems and the Elettra transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. The Elettra and the predicate devices share basic scanning modalities. Some or all predicate device systems allow for measurements of structures and flow, and calculations. Some or all predicate devices and the Elettra follow the Track 3 method for acoustic output. Patient contact materials used in the Elettra are used in equivalent formulations in the predicate devices. All indications for use claimed for the Elettra are cleared indications found on some or all of the predicate devices. The Elettra ultrasound transducer may be used in a wireless configuration or in a cabled configuration. The Elettra and the predicate devices have been designed and manufactured under comparable electrical and physical safety standards.

The Penrith Elettra has been evaluated for acoustic output, biocompatibility, cleaning, disinfection, and sterilization effectiveness, as well as thermal, electrical and mechanical safety, and electromagnetic compatibility. It has been found to conform with applicable medical device safety standards.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Penrith Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Servies, LLC 1394 25th Street NW BUFFALO MN 55313

NOV 1 9 2010

Re: K100598

Trade/Device Name: Penrith Elettra Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: October 18, 2010 Received: October 19, 2010

Dear Mr. Job:

We have reviewed your Section 510(k) premarket 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 Penrith Elettra Ultrasound System, as described in your premarket notification:

Transducer Model Number

L8-3 Linear L12-5 Linear C5-2 Curvilinear

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

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can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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.

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), 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.

If you have any questions regarding the content of this letter. please contact Shahram Vaezy at [phone].

Sincerely yours,

David C. Rainer, Ph.D.

David G. Brown, Ph.D. Acting Director . Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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## Section 1.3 Indications for Use

K100598

# NOV 1 9 2010

The Elettra Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial). See Indications for Use Forms below. The following tables provide details regarding clinical applications and modes of operation for the system and individual transducers.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(k) K100598

. .

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510(k) Number (if known): K100598

Penrith Elettra Ultrasound System

Indications for Use:

Device Name:

Diagnostic Imaging or fluid flow analysis of the human body as follows:

Indications for Use.

| Clinical Application | | Mode of Operation | | | | | | | | | |
|-------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|---------------------------------|----------------------------|--|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)<br>Note 2 | Other: Harmonic<br>Imaging | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | N | | | | N | N | | | | |
| Abdominal | | N | | | | N | N | | | | |
| Intraoperative Note 1 | | N | | | | N | N | | | | |
| Intraoperative Neurological | | N | | | | N | N | | | | |
| Pediatric | | N | | | | N | N | | | | |
| Small Organ Note 3 | | N | | | | N | N | | | | |
| Neonatal Cephalic | | N | | | | N | N | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | | | | N | N | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | N | | | | N | N | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | N | | | | N | N | | | | |
| Musculo-skeletal Superficial | | N | | | | N | N | | | | |
| Other | | | | | | | | | | | |

N: New P: Previously Cleared Blank: Not Claimed

Note 1: for example: cardiac

Note 2: B mode and PWD mode or Color Doppler and PW mode

Note 3: for example: breast, testes, thyroid, penis

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-the-Counter Use _ (21 CFR Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(k) K100598

Page 2 of 5

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510(k) Number (if known): K100598

Device Name: L8-3 Linear Transducer for use with

Penrith Elettra Ultrasound System

Indications for Use:

Diagnostic Imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | | | | |
|-------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|---------------------------------|----------------------------|--|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)<br>Note 2 | Other: Harmonic<br>Imaging | |
| Opthalmic | | | | | | | | | | | |
| Fetal | | N | | | | N | N | | | | |
| Abdominal | | N | | | | N | N | | | | |
| Intraoperative Note 1 | | N | | | | N | N | | | | |
| Intraoperative Neurological | | N | | | | N | N | | | | |
| Pediatric | | N | | | | N | N | | | | |
| Small Organ Note 3 | | N | | | | N | N | | | | |
| Neonatal Cephalic | | N | | | | N | N | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | | | | N | N | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vessel | | N | | | | N | N | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | N | | | | N | N | | | | |
| Musculo-skeletal Superficial | | N | | | | N | N | | | | |
| Other | | | | | | | | | | | |

N: New P: Previously Cleared Blank: Not Claimed

Note 1: for example: cardiac

Note 2: B mode and PWD mode or Color Doppler and PW mode

Note 3: for example: breast, testes, thyroid, penis

| Prescription Use X<br>(Part 21 CFR 801 Subpart D) | AND/OR |
|---------------------------------------------------|--------|
|---------------------------------------------------|--------|

Over-the-Counter Use (21 CFR Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Devices Evaluation and Safety

510(k) K100598

Page 3 of 5

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510(k) Number (if known): K100598

Device Name:

L12-5 Linear Transducer for use with Penrith Elettra Ultrasound System

Indications for Use:

Diagnostic Imaging or fluid flow analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------------------|----------------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)<br>Note 2 | Other: Harmonic<br>Imaging |
| Opthalmic | | | | | | | | | | |
| Fetal | | N | | | | N | N | | | |
| Abdominal | | N | | | | N | N | | | |
| Intraoperative Note 1 | | N | | | | N | N | | | |
| Intraoperative Neurological | | N | | | | N | N | | | |
| Pediatric | | N | | | | N | N | | | |
| Small Organ Note 3 | | N | | | | N | N | | | |
| Neonatal Cephalic | | N | | | | N | N | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | | | | N | N | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | N | | | | N | N | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | N | | | | N | N | | | |
| Musculo-skeletal Superficial | | N | | | | N | N | | | |
| Other | | | | | | | | | | |

N: New P: Previously Cleared Blank: Not Claimed

Note 1: for example: cardiac

Note 2: B mode and PWD mode or Color Doppler and PW mode

Note 3: for example: breast, testes, thyroid, penis

| Prescription Use X<br>(Part 21 CFR 801 Subpart D) | AND/OR |
|---------------------------------------------------|--------|
|---------------------------------------------------|--------|

Over-the-Counter Use (21 CFR Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(k) K100598

Page 4 of 5

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510(k) Number (if known): K100598

Device Name:

C5-2 Curvilinear Transducer for use with Penrith Elettra Ultrasound System

Indications for Use:

Diagnostic Imaging or fluid flow analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------------------|----------------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)<br>Note 2 | Other: Harmonic<br>Imaging |
| Opthalmic | | | | | | | | | | |
| Fetal | | N | | | | N | N | . | | |
| Abdominal | | N | | | | N | N | | | |
| Intraoperative Note 1 | | N | | | | N | N | | | |
| Intraoperative Neurological | | N | | | | N | N | | | |
| Pediatric | | N | | | | N | N | | | |
| Small Organ Note 3 | | N | | | | N | N | | | |
| Neonatal Cephalic | | N | | | | N | N | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | | | | N | N | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vessel | | N | | | | N | N | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | N | | | | N | N | | | |
| Musculo-skeletal Superficial | | N | | | | N | N | | | |
| Other | | | | | | | | | | |

N: New P: Previously Cleared Blank: Not Claimed

Note 1: for example: cardiac

Note 2: B mode and PWD mode or Color Doppler and PW mode

Note 3: for example: breast, testes, thyroid, penis

| Prescription Use X<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
|---------------------------------------------------|--------|------------------------------------------------|
|---------------------------------------------------|--------|------------------------------------------------|

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(k) K100598

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