ACCURO 3000 ULTRASOUND SCANNER

K132736 · Rivanna Medical, LLC · IYO · Mar 11, 2014 · Radiology

Device Facts

• Record ID: K132736
• Device Name: ACCURO 3000 ULTRASOUND SCANNER
• Applicant: Rivanna Medical, LLC
• Product Code: IYO · Radiology
• Decision Date: Mar 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Accuro 3000 ultrasound scanner is intended for diagnostic ultrasound imaging of the human body in the following clinical applications: Abdominal, Musculoskeletal (Conventional and superficial), Cardiac, Peripheral vascular. A typical examination using the Accuro 3000 is guidance of neuraxial anesthesia.

Device Story

Accuro 3000 is a hand-held, compact ultrasound system providing real-time B-mode imaging. Operated by clinicians, it is used for diagnostic imaging in abdominal, musculoskeletal, cardiac, and peripheral vascular applications, with a primary use case of guiding neuraxial anesthesia. The device captures ultrasound signals, processes them, and displays real-time B-mode images on an integrated interface. By providing visual guidance, the device assists clinicians in needle placement and anatomical visualization, potentially improving procedural accuracy and patient outcomes. It is designed for point-of-care use.

Clinical Evidence

Bench testing only. Verification and validation activities were performed to demonstrate compliance with pre-determined performance specifications and recognized international standards, including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-2, and NEMA UD-3.

Technological Characteristics

Hand-held diagnostic ultrasound system; B-mode imaging only. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-4 (programmable electrical medical systems), and IEC 60601-2-37 (ultrasonic diagnostic equipment). Acoustic output measured per NEMA UD-2 and UD-3. Compact form factor with simple user interface.

Indications for Use

Indicated for diagnostic ultrasound imaging of the human body, specifically abdominal, musculoskeletal (conventional and superficial), cardiac, and peripheral vascular applications. Includes guidance for neuraxial anesthesia. No specific age or gender restrictions provided.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system 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

• BladderScan BVI 9400 Ultrasound System (K071217)
• Voyager Ultrasound Imaging System (K050551)
• MobiUS Ultrasound Imaging System (K102153)

Submission Summary (Full Text)

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MAR 1 1 2014

K132736
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# 510 (k) Summary 21 CFR 807.92

# ์ Accuro 3000 Ultrasound System

| General Provisions | Submitter Name: | Rivanna Medical, LLC |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | Submitter Address: | 1304 Stonegate Court<br>Crozet, VA 22932 |
| | Contact Person: | Will Mauldin, PhD<br>Chief Technology Officer<br>(t) 828.612.8191<br>(e) [e-mail] |
| | Date of Preparation: | 3 February 2014 |
| Subject Device | Trade Name: | Accuro 3000 Ultrasound System |
| | Classification Name: | IYO21 CFR892.1560 Ultrasonic Pulsed Echo<br>system<br>ITX21 CFR892.1570 Diagnostic Ultrasound<br>Transducers |
| Predicate Device | Trade Name: | BladderScan BVI 9400 Ultrasound System |
| | Classification Name: | IYO21 CFR892.1560 Ultrasonic Pulsed Echo<br>System<br>ITX21 CFR892.1570 Diagnostic Ultrasound<br>Transducers |
| | Premarket Notification: | K071217, May 17th 2004 |
| | Manufacturer: | Verathon, Inc. |
| Predicate Device | Trade Name: | Voyager Ultrasound Imaging System |
| | Classification Name: | IYO21 CFR892.1560 Ultrasonic Pulsed Echo<br>System<br>ITX21 CFR892.1570 Diagnostic Ultrasound<br>Transducers |
| | Premarket Notification: | K050551, March 22nd 2005 |
| | Manufacturer: | Ardent, Inc |
| Predicate Device | Trade Name: | MobiUS Ultrasound Imaging System |
| | Classification Name: | IYO21 CFR892.1560 Ultrasonic Pulsed Echo<br>System<br>ITX21 CFR892.1570 Diagnostic Ultrasound<br>Transducers |
| | Premarket Notification: | K102153, January 20th 2011 |
| | Manufacturer: | Mobisante, Inc. |
| Device Description | The Accuro 3000 Ultrasound Imaging Device is a hand-held device that<br>features real-time B-mode ultrasound imaging only. Additional features<br>include a compact size and a simple user interface. | |
| Indications for Use | The Accuro 3000 ultrasound scanner is intended for diagnostic<br>ultrasound imaging of the human body in the following clinical<br>applications: Abdominal, Musculoskeletal (Conventional and<br>superficial), Cardiac, Peripheral vascular. A typical examination using the<br>Accuro 3000 is guidance of neuraxial anesthesia. | |
| Technological Characteristics | Technological characteristics of the Accuro 3000 are equivalent with<br>respect to the basic design and function of the predicate devices. The<br>Accuro 3000 has no technologies, features, or indications for use not<br>commonly used in the practice of diagnostic ultrasound. | |
| Safety & Performance Tests | Verification and Validation activities were designed and performed to<br>demonstrate that the Accuro 3000 met pre-determined performance<br>specifications. The following standards in conjunction with in-house<br>protocols were used to determine appropriate methods for evaluating<br>the performance of the device: | |
| IEC 60601-1:1988/91/95, Medical Electrical Equipment – Part 1: General Requirements for Safety<br>IEC 60601-1-1:2000, Medical Electrical Equipment – Part 1-1: General Requirements for Safety –<br>Collateral Standard: Safety Requirements for Medical Electrical Systems<br>IEC 60601-1-2:2007, Medical Electrical Equipment – Part 1-2: General Requirements for Safety –<br>Collateral Standard: Electromagnetic Compatibility – Requirements and Tests<br>IEC 60601 1-4:2000, Medical Electrical Equipment – Part 1-4: General Requirements for Safety –<br>Collateral Standard: Programmable Electrical Medical Systems<br>IEC 60601-2-37:2008, Medical Electrical Equipment – Part 2-37: Particular Requirements for the<br>Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment<br>UL 60601-1:2003, Medical Electrical Equipment, Part 1: General Requirements for Safety<br>NEMA UD-2:2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment<br>NEMA UD-3:2004, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output<br>Indices on Diagnostic Ultrasound Equipment | | |

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Summary of Substantial Equivalence Based on the indications for use, technological characteristics, and safety and performance testing, the subject Accuro 3000,

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KB2736
Page 3 of 3

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met the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, principles of operation and indications for use to the predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem of an eagle with three lines extending from its body.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 11, 2014

Rivanna Medical, LLC % William Mauldin, Ph.D. Chief Technology Officer 1304 Stonegate Court CROZET VA 22932

Re: K132736

Trade/Device Name: Accuro 3000 Ultrasound Scanner Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: February 12 2014 Received: February 18, 2014

Dear Dr. Mauldin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Dr. Mauldin

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K132736

#### Device Name Accuro 3000 Ultrasound System

#### Indications for Use (Describe)

The Accuro 3000 ultrasound scanner is intended for diagnostic ultrassund imaging of the himan body in the following clinical applications: Abdominal, Museulosketal (Conventional and superficial). Cardiae. Peripheral vascular. A typical examination using the Accuro 3000 is guidance of neuraxial anesthesia.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

ال Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Michael D. D'Hara

FORM FDA 3881 (1/14)

Polytodom, Sarvices ( Wes) ad 1 A" M

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# Diagnostic Ultrasound Indications For Use

System:

Accuro 3000

Transducer:

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

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| (Track 1 Only) | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | N | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | | | | | | |
| | Musculo-skeletal<br>(Superficial) | N | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | N | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | | | | | | |
| | Other (Specify) | | | | | | | |

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

* Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging