(142 days)
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.
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.
This document describes a 510(k) premarket notification for the "Accuro" ultrasonic pulsed echo imaging system. The submission expands the indications for use of a previously cleared device (Accuro 3000 Ultrasound Scanner, K132736). As such, the information provided focuses on the safety and performance validation against standards rather than a clinical study evaluating diagnostic accuracy with acceptance criteria.
Key takeaway: This 510(k) submission primarily focuses on expanding the indications for use of an existing device and demonstrates substantial equivalence through adherence to recognized standards and safety testing, rather than presenting a clinical study with specific diagnostic performance acceptance criteria. Therefore, many of the requested data points related to clinical study design (sample size for test set, expert ground truth, MRMC, etc.) are not explicitly available in this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are not in the form of diagnostic accuracy metrics (e.g., sensitivity, specificity) for a clinical algorithm. Instead, the device's performance is demonstrated through adherence to various international and national safety and performance standards for medical electrical equipment and diagnostic ultrasound.
| Acceptance Criteria (Standards Adhered To) | Reported Device Performance |
|---|---|
| IEC60601-1:2005 (Medical Electrical Equipment - General Requirements for Safety and Essential Performance) | "Verification and Validation activities were designed and performed to demonstrate that the Accuro met pre-determined performance specifications." (Implies compliance) |
| IEC60601-1-2:2007 (Medical Electrical Equipment - General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests) | "Verification and Validation activities were designed and performed to demonstrate that the Accuro met pre-determined performance specifications." (Implies compliance) |
| IEC60601-2-37:2007 (Medical Electrical Equipment - Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment) | "Verification and Validation activities were designed and performed to demonstrate that the Accuro met pre-determined performance specifications." (Implies compliance) |
| ISO14971:2007 (Application of risk management to medical devices) | "Verification and Validation activities were designed and performed to demonstrate that the Accuro met pre-determined performance specifications." (Implies compliance) |
| NEMA UD-2:2004 (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment) | "Verification and Validation activities were designed and performed to demonstrate that the Accuro met pre-determined performance specifications." (Implies compliance) |
| NEMA UD-3:2004 (Standard for Real-Time Display of Thermal and Mechanical Acoustic Output indices on Diagnostic Ultrasound Equipment) | "Verification and Validation activities were designed and performed to demonstrate that the Accuro met pre-determined performance specifications." (Implies compliance) |
| ISO 10993-1: (Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing Within a Risk Management Process) | "Verification and Validation activities were designed and performed to demonstrate that the Accuro met pre-determined performance specifications." (Implies compliance) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. The filing refers to "Verification and Validation activities" and "in-house protocols" but does not detail a clinical test set size, nor the provenance (country of origin, retrospective/prospective) of any data used for such testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given text. As the submission focuses on standard compliance and expanded indications for an existing device rather than a new diagnostic accuracy study, the establishment of ground truth by clinical experts is not mentioned.
4. Adjudication Method (for the test set)
This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission focuses on the device's technical characteristics, safety, and performance standards adherence for expanding its indications of use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The "Accuro" is described as a "hand-held device that features real-time B-mode ultrasound imaging only." It is a diagnostic ultrasound system intended for use by a human operator for image guidance and diagnosis. It does not appear to be an AI algorithm with standalone performance, but rather a tool to be used by a clinician. Therefore, a standalone algorithm performance study as typically understood for AI/ML devices is not applicable and not mentioned.
7. The Type of Ground Truth Used
The text does not specify the type of ground truth used, as it does not detail a clinical study with diagnostic accuracy endpoints. The "ground truth" in the context of this submission would likely relate to the accurate measurement of physical parameters for the engineering validation required by the listed standards (e.g., acoustic output, electromagnetic compatibility, image quality phantoms).
8. The Sample Size for the Training Set
This information is not applicable/provided. The Accuro is an ultrasound imaging device, not an AI/ML algorithm that typically requires a large training set of clinical data. The "training" for such a device would involve its design and calibration against engineering specifications, not statistical learning from a dataset.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided for the same reasons as point 8.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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(Track 1Only) | Specific(Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(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 | ||||||||
| FetalImaging &Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card) | ||||||||
| Musculo-skeletal(Conventional) | P | 2,3,4 | ||||||
| Musculo-skeletal(Superficial) | P | 2,3,4 | ||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | P | ||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | 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:Submitter Address: | Rivanna Medical, LLC107 E Water StCharlottesville, VA 22932 |
|---|---|---|
| Contact Person: | Will Mauldin, PhDChairman, CEO, and Co-founder(t) 800-645-7508 x701(e) wmauldin@rivannamedical.com | |
| Date of Preparation: | 09 May 2017 | |
| Subject Device | Trade Name: | Accuro |
| Classification Name: | IYO21 CFR892.1560 Ultrasonic Pulsed EchoImaging SystemITX21 CFR892.1570 Diagnostic UltrasonicTransducers | |
| Predicate Device | Trade Name: | Accuro 3000 Ultrasound Scanner |
| Classification Name: | IYO21 CFR892.1560 Ultrasonic Pulsed EchoImaging SystemITX21 CFR892.1570 Diagnostic UltrasonicTransducer | |
| Premarket Notification: K132736, March 11th 2014 | ||
| Manufacturer: | Rivanna Medical, LLC | |
| Predicate Device | Trade Name: | Vscan Extend |
| Classification Name: | IYO21 CFR892.1560 Ultrasonic Pulsed EchoImaging SystemITX21 CFR892.1570 Diagnostic UltrasonicTransducer | |
| Premarket Notification: K161588, August 31nd 2016 | ||
| Manufacturer: | GE Medical Systems Ultrasound & Primary CareDiagnostics, 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
63
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.