(189 days)
Not Found
No
The device description and performance studies do not mention any AI or ML capabilities. The focus is on real-time B-mode ultrasound imaging and standard performance testing.
No
The device is described as an "ultrasound scanner" and an "Ultrasound Imaging Device" used for "diagnostic ultrasound imaging." Its intended use is for "guidance of neuraxial anesthesia," which indicates it is used for imaging and guidance, not for direct therapeutic treatment.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for diagnostic ultrasound imaging of the human body."
No
The device description explicitly states it is a "hand-held device" and mentions hardware-related standards (IEC 60601 series, UL 60601-1, NEMA UD series) in the performance studies, indicating it includes hardware components.
Based on the provided information, the Accuro 3000 ultrasound scanner is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue samples, etc.
- The Accuro 3000 is used for direct imaging of the human body. It uses ultrasound waves to create images of internal structures.
The intended use and device description clearly state that the Accuro 3000 is for "diagnostic ultrasound imaging of the human body" in various clinical applications. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro (in glass/outside the living body) diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
IYO,ITX
Device Description
The Accuro 3000 Ultrasound Imaging Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Real-time B-mode ultrasound imaging
Anatomical Site
Human body, Abdominal, Musculoskeletal (Conventional and superficial), Cardiac, Peripheral vascular.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Verification and Validation activities were designed and performed to demonstrate that the Accuro 3000 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: IEC 60601-1:1988/91/95, Medical Electrical Equipment – Part 1: General Requirements for Safety IEC 60601-1-1:2000, Medical Electrical Equipment – Part 1-1: General Requirements for Safety – Collateral Standard: Safety Requirements for Medical Electrical Systems IEC 60601-1-2:2007, Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests IEC 60601 1-4:2000, Medical Electrical Equipment – Part 1-4: General Requirements for Safety – Collateral Standard: Programmable Electrical Medical Systems IEC 60601-2-37:2008, Medical Electrical Equipment – Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment UL 60601-1:2003, Medical Electrical Equipment, Part 1: General Requirements for Safety 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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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MAR 1 1 2014
K132736
page 1 of 3
510 (k) Summary 21 CFR 807.92
์ Accuro 3000 Ultrasound System
| General Provisions | Submitter Name: | Rivanna Medical, LLC |
|---|---|---|
| Submitter Address: | 1304 Stonegate Court | |
| Crozet, VA 22932 | ||
| Contact Person: | Will Mauldin, PhD | |
| Chief Technology Officer | ||
| (t) 828.612.8191 | ||
| (e) wmauldin@rivannamedical.com | ||
| Date of Preparation: | 3 February 2014 | |
| Subject Device | Trade Name: | Accuro 3000 Ultrasound System |
| Classification Name: | IYO21 CFR892.1560 Ultrasonic Pulsed Echo | |
| system | ||
| ITX21 CFR892.1570 Diagnostic Ultrasound | ||
| Transducers | ||
| Predicate Device | Trade Name: | BladderScan BVI 9400 Ultrasound System |
| Classification Name: | IYO21 CFR892.1560 Ultrasonic Pulsed Echo | |
| System | ||
| ITX21 CFR892.1570 Diagnostic Ultrasound | ||
| 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 | |
| System | ||
| ITX21 CFR892.1570 Diagnostic Ultrasound | ||
| 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 | |
| System | ||
| ITX21 CFR892.1570 Diagnostic Ultrasound | ||
| Transducers | ||
| Premarket Notification: | K102153, January 20th 2011 | |
| Manufacturer: | Mobisante, Inc. | |
| Device Description | The Accuro 3000 Ultrasound Imaging Device 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 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. | ||
| Technological Characteristics | Technological characteristics of the Accuro 3000 are equivalent with | |
| respect to the basic design and function of the predicate devices. The | ||
| Accuro 3000 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 3000 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: | ||
| IEC 60601-1:1988/91/95, Medical Electrical Equipment – Part 1: General Requirements for Safety | ||
| IEC 60601-1-1:2000, Medical Electrical Equipment – Part 1-1: General Requirements for Safety – | ||
| Collateral Standard: Safety Requirements for Medical Electrical Systems | ||
| IEC 60601-1-2:2007, Medical Electrical Equipment – Part 1-2: General Requirements for Safety – | ||
| Collateral Standard: Electromagnetic Compatibility – Requirements and Tests | ||
| IEC 60601 1-4:2000, Medical Electrical Equipment – Part 1-4: General Requirements for Safety – | ||
| Collateral Standard: Programmable Electrical Medical Systems | ||
| IEC 60601-2-37:2008, Medical Electrical Equipment – Part 2-37: Particular Requirements for the | ||
| Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment | ||
| UL 60601-1:2003, Medical Electrical Equipment, Part 1: General Requirements for Safety | ||
| 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 |
1
Summary of Substantial Equivalence Based on the indications for use, technological characteristics, and safety and performance testing, the subject Accuro 3000,
2
KB2736
Page 3 of 3
et
for i
prin
devi
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.
3
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.
4
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
5
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
6
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 | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| (Track 1 Only) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | N | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | N | |||||||
| Musculo-skeletal | ||||||||
| (Superficial) | N | |||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | N | ||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| 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