Accuro

K171594 · Rivanna Medical, LLC · IYO · Oct 20, 2017 · Radiology

Device Facts

• Record ID: K171594
• Device Name: Accuro
• Applicant: Rivanna Medical, LLC
• Product Code: IYO · Radiology
• Decision Date: Oct 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Accuro is intended for diagnostic ultrasound imaging of the human body in the following clinical applications: Abdominal, Musculoskeletal (conventional and superficial), Cardiac, Peripheral Vascular, Small Organs (e.g. thyroid, breast), and Pediatrics. A typical examination using the Accuro is guidance of neuraxial anesthesia.

Device Story

Hand-held diagnostic ultrasound device; performs real-time B-mode imaging. Inputs: ultrasonic pulsed echo signals. Processing: includes BoneEnhance (image post-processing) and SpineNav3D (image post-processing) for needle/catheter guidance. Output: B-mode ultrasound images displayed on device screen. Used in clinical settings by healthcare providers for diagnostic imaging and procedural guidance. Benefits: provides real-time visualization for needle placement, potentially improving accuracy and patient outcomes during neuraxial anesthesia and other ultrasound-guided procedures.

Clinical Evidence

Bench testing only. Verification and validation activities performed per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, NEMA UD-2, NEMA UD-3, and ISO 10993-1 to confirm device performance and safety.

Technological Characteristics

Hand-held B-mode ultrasound imaging system. Features BoneEnhance and SpineNav3D post-processing. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-2, NEMA UD-3, and ISO 10993-1. Energy source: internal battery/electrical. Connectivity: standalone.

Indications for Use

Indicated for diagnostic ultrasound imaging in abdominal, musculoskeletal, cardiac, peripheral vascular, small organ (thyroid, breast), and pediatric applications. Includes guidance for neuraxial anesthesia needle/catheter placement.

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

• Accuro 3000 Ultrasound Scanner (K132736)
• Vscan Extend (K161588)

Submission Summary (Full Text)

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October 20, 2017

Rivanna Medical, LLC % William Mauldin, Ph.D. Chairman, CEO, and Co-founder 107 East Water Street CHARLOTTESVILLE VA 22902

Re: K171594

Trade/Device Name: Accuro Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: September 15, 2017 Received: September 21, 2017

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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Robert Ochs

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K171594

Device Name Accuro

Indications for Use (Describe)

The Accuro is intended for diagnostic ultrasound imaging of the human body in the following clinical applications: Abdominal, Musculoskeletal (conventional and superficial), Cardiac, Peripheral Vascular, Small Organs (e.g. thyroid, breast), and Pediatrics. A typical examination using the Accuro is guidance of neuraxial anesthesia.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span style="padding-right: 20px;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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### 1.3. Indications for Use

#### 1.3.1. 510(k) Indications for Use Form

## Diagnostic Ultrasound Indications for Use Form Accuro

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

| Clinical Application | | Mode of Operation | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1<br>Only) | Specific<br>(Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | P | | | | | | 2,3 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | | | | | | 2,3,4 |
| | Small Organ[1] (Specify) | N | | | | | | 2,3 |
| | Neonatal Cephalic | | | | | | | |
| Fetal<br>Imaging &<br>Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | | | | | | 2,3,4 |
| | Musculo-skeletal<br>(Superficial) | P | | | | | | 2,3,4 |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | P | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | | | | | | 2,3 |
| | Other (Specify) | | | | | | | |

N = new indication; P = previously cleared by FDA in K132736

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

Notes:

[2] Image guidance for freehand needle/catheter placement

[3] BoneEnhance® (image post-processing)

[4] SpineNav3D™ (image post-processing)

^[1] Small Organ includes thyroid and breast

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# RIVANNA

#### 510 (k) Summary 21 CFR 807.92

#### Accuro

| General Provisions | Submitter Name:<br>Submitter Address: | Rivanna Medical, LLC<br>107 E Water St<br>Charlottesville, VA 22932 |
|--------------------|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Will Mauldin, PhD<br>Chairman, CEO, and Co-founder<br>(t) 800-645-7508 x701<br>(e) [e-mail] |
| | Date of Preparation: | 09 May 2017 |
| Subject Device | Trade Name: | Accuro |
| | Classification Name: | IYO21 CFR892.1560 Ultrasonic Pulsed Echo<br>Imaging System<br>ITX21 CFR892.1570 Diagnostic Ultrasonic<br>Transducers |
| Predicate Device | Trade Name: | Accuro 3000 Ultrasound Scanner |
| | Classification Name: | IYO21 CFR892.1560 Ultrasonic Pulsed Echo<br>Imaging System<br>ITX21 CFR892.1570 Diagnostic Ultrasonic<br>Transducer |
| | Premarket Notification: K132736, March 11th 2014 | |
| | Manufacturer: | Rivanna Medical, LLC |
| Predicate Device | Trade Name: | Vscan Extend |
| | Classification Name: | IYO21 CFR892.1560 Ultrasonic Pulsed Echo<br>Imaging System<br>ITX21 CFR892.1570 Diagnostic Ultrasonic<br>Transducer |
| | Premarket Notification: K161588, August 31nd 2016 | |
| | Manufacturer: | GE Medical Systems Ultrasound & Primary Care<br>Diagnostics, LLC |

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# RIVANNA®

Device Description The Accuro is a hand-held device that features real-time B-mode ultrasound imaging only. Additional features include a compact size and a simple user interface. Indications for Use The Accuro is intended for diagnostic ultrasound imaging of the human body in the following clinical applications: Abdominal, Musculoskeletal (conventional and superficial), Cardiac, Peripheral Vascular, Small Organs (e.g. thyroid, breast), and Pediatrics. A typical examination using the Accuro is guidance of neuraxial anesthesia. Technological Characteristics Technological characteristics of the Accuro are equivalent with respect to the basic design and function of the predicate devices. This 510(K) submission expands the Indications for Use of the Accuro 3000 Ultrasound Scanner (K132736). The Accuro has no technologies, features, or indications for use not commonly used in the practice of diagnostic ultrasound. Safety & Performance Tests Verification and Validation activities were designed and performed to demonstrate that the Accuro met pre-determined performance specifications. The following standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating the performance of the device: IEC60601-1:2005, Medical Electrical Equipment - Part 1: General Requirements for Safety and Essential Performance IEC60601-1-2:2007, Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility Requirements and Tests IEC60601-2-37:2007, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment ISO14971:2007, Application of risk management to medical devices, Second edition NEMA UD-2:2004: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment NEMA UD-3:2004: Standard for Real-Time Display of Thermal and Mechanical Acoustic Output indices on Diagnostic Ultrasound Equipment ISO 10993-1: Biological Evlauation of Medical Devices- Part 1: Evaluation and Testing Within a Risk Management Process Summary of Substantial Equivalence Based on the indications for use, technological characteristics, and safety and performance testing, the subject Accuro, met

devices.

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

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