(234 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
No
The device is described as a "Diagnostic Ultrasound System" and its intended uses are for "ultrasound evaluation" and to "acquire and display ultrasound data in various imaging modes." It does not mention any therapeutic functions.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is a "Diagnostic Ultrasound System".
No
The device description explicitly states it consists of a "main unit along with associated transducers," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Acclarix LX9 Series/ Acclarix AX8 Diagnostic Ultrasound System is an ultrasound system. Ultrasound uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes the system being used for "ultrasound evaluation" of various anatomical sites within the body. This is consistent with in-vivo imaging, not in-vitro testing.
Therefore, the device is a diagnostic imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Acclarix LX9 Series/ Acclarix AX8 Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluation in hospitals and clinics. Clinical applications include Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral vascular, Intra-operative, Pediatric, Neonatal and Adult Cephalic.
The Modes of Operation for Acclarix LX9 series include B mode, Doppler mode, Harmonic Imaging, Elastography Imaging, Contrast imaging and their combination modes.
The Modes of Operation for Acclarix AX8 include B mode, M mode, Harmonic Imaging, Elastography Imaging and their combination modes.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
Acclarix AX8/ Acclarix LX9 Series is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral vascular, Intra-operative, Pediatric, Neonatal and Adult Cephalic.
Indicated Patient Age Range
Pediatric, Neonatal and Adult.
Intended User / Care Setting
Qualified physician or allied health professional for ultrasound evaluation in hospitals and clinics.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test:
The Acclarix AX8/ Acclarix LX9 series Diagnostic Ultrasound Systems comply with:
(1) ANSI AAMI ES60601-1 Electrical Safety
(2) IEC 60601-1-2 Electromagnetic Compatibility
(3) IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
(4) Guidance for Industry and FDA Staff—Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued on June 27, 2019
(5) IEC 62359 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
The following biocompatibility standards are conducted on the subject device:
(1) ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12
The tests were selected to show substantial equivalence between the subject devices and the predicate devices.
The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
0
May 21, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION".
Edan Instruments, Inc. % Melody Huang Regulatory Engineer #15 Jinhui Road, Jinsha Community Kengzi Sub-District, Pingshan District Shenzhen, Guangdong 518122 P.R. CHINA
Re: K192879
Trade/Device Name: Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: April 17, 2020 Received: April 20, 2020
Dear Melody Huang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192879
Device Name
Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System
Indications for Use (Describe)
The Acclarix LX9 Series/ Acclarix AX8 Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluation in hospitals and clinics. Clinical applications include Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral vascular, Intra-operative, Pediatric, Neonatal and Adult Cephalic.
The Modes of Operation for Acclarix LX9 series include B mode, Doppler mode, Harmonic Imaging, Elastography Imaging, Contrast imaging and their combination modes.
The Modes of Operation for Acclarix AX8 include B mode, M mode, Harmonic Imaging, Elastography Imaging and their combination modes.
| 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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3
510(k) Summary
| K192879 | Prepared in accordance with the requirements of 21 CFR Part 807.92 |
|---|---|
| 1. Submitter: | Edan Instruments, Inc. |
| #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, | |
| Shenzhen, 518122 P.R.China. | |
| Tel: +86-755-2685 8736 Fax: +86-755-2689 8330 | |
| Contact person: | Melody Huang |
| Preparing date: | Sep. 25, 2019 |
| 2. Device name and | |
| classification: | Device Name: Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series |
| Diagnostic Ultrasound System | |
| Model: Acclarix AX8, Acclarix LX9, Acclarix LX9 Exp, Acclarix LX9 Super, | |
| Acclarix LX85, Acclarix LX88 | |
| Classification Name/ Product code: | |
| 21 CFR 892.1550 System, Imaging, Pulsed Doppler, Ultrasonic / IYN | |
| 21 CFR 892.1560, Ultrasonic, Pulsed echo, Imaging / IYO | |
| 21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic / ITX | |
| Regulatory Class: Class II | |
| 3.Premarket Notification | |
| Class III Certification | |
| and Summary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | 1) Edan Instruments, Acclarix AX8 Diagnostic Ultrasound System, cleared under |
| K180862 (Primary) |
- Shenzhen Mindray, DC-80 Diagnostic Ultrasound System, cleared under K173471
(Reference) |
| 5. Reason for
Submission | By submission of the Traditional 510(k), Edan Instruments is requesting
clearance for an updated version of the Acclarix AX8 Diagnostic Ultrasound Systems
and new models of the Acclarix LX9 series Diagnostic Ultrasound Systems. |
| 6.Pre-Submission,
IDE | Not applicable, there is no pre-submission. |
| 7. Device Description: | Acclarix AX8/ Acclarix LX9 Series is a software controlled Diagnostic Ultrasound
System, which consists of a main unit along with associated transducers. It is
intended for use by a qualified physician or allied health professional for ultrasound
evaluations. This system is a Track 3 device to acquire and display ultrasound data in |
4
various imaging modes.
- Indication for Use The Acclarix LX9 Series/ Acclarix AX8 Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluation in hospitals and clinics. Clinical applications include Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal. Peripheral vascular, Intra-operative, Pediatric, Neonatal and Adult Cephalic.
The Modes of Operation for Acclarix LX9 series include B mode, M mode, Doppler mode, Harmonic Imaging, Elastography Imaging, Contrast imaging and their combination modes. The Modes of Operation for Acclarix AX8 include B mode, M mode, Doppler mode, Harmonic Imaging, Elastography Imaging and their combination modes.
9. Predicate Device Comparison
The subject devices Acclarix AX8 and Acclarix LX9 series have technological characteristics, is comparable in key safety and effectiveness features, and has the same intended uses and basic operating modes as the primary predicated device Acclarix AX8 (K180862), except the following main differences.
The main changes of the subject devices Acclarix AX8 and Acclarix LX9 series compared with the primary predicated device Acclarix AX8 (K180862) are as the followings:
-
- Addition of new transducers: C7-2XQ, E10-3BQ, E10-3HQ, C5-1Q, which have similar specifications, same intended use and same modes of operation as the transducers of Acclarix AX8 (K180602).
-
- Addition of Color M mode, which is substantially equivalent to that of the reference predicate device DC-80 (K173471).
-
- Addition of Strain Elastography mode on Linear transducers, including L10-4Q, L12-5Q, L17-7HQ and L17-7SQ, which is substantially equivalent to that of the reference predicate device DC-80 (K173471).
-
- Addition of ECG module to support ECG waveform display on the ultrasound image, which is substantially equivalent to that of the reference predicate device DC-80 (K173471). The ECG function is supported on P5-1Q transducer. The ECG function on Acclarix AX8 is provided by an external ECG module, while the ECC function on Acclarix LX9 series is provided by a built-in ECG module.
-
- Addition of Auto OB and Auto NT measurement function, which is substantially equivalent to the reference predicate device DC-80 (K173471).
5
The additional changes of the subject device Acclarix LX9 series compared with primary predicated device Acclarix AX8 (K180862) are as the followings:
-
- Acclarix LX9 series additionally supports a transducer C6-2MQ for 3D/4D imaging is not a new feature for EDAN device which was cleared in transducer C5-2MQ of Acclarix AX8 (K180602).
-
- Acclarix LX9 series does not support C5-2XQ, L10-40, P5-1XO and C5-2MQ transducers, which were cleared in Acclarix AX8 (K180862).
-
- Acclarix LX9 series additionally supports Contrast Imaging mode for Liver on C5-1Q transducers, and the Contrast Imaging mode is substantially equivalent to the reference predicate device DC-80 (K173471).
The subject and predicate devices have similar design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness.
10. Performance Data:
Clinical test:
Clinical testing is not required.
Non-clinical test:
The Acclarix AX8/ Acclarix LX9 series Diagnostic Ultrasound Systems comply with:
(1) ANSI AAMI ES60601-1 Electrical Safety
(2) IEC 60601-1-2 Electromagnetic Compatibility
(3) IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
(4) Guidance for Industry and FDA Staff—Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued on June 27, 2019
(5) IEC 62359 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
The following biocompatibility standards are conducted on the subject device:
(1) ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12
The tests were selected to show substantial equivalence between the subject devices and the predicate devices.
The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate devices.
11. Conclusion
Verification and validation testing has been conducted on the Acclarix LX9 Series Diagnostic Ultrasound Systems. This premarket notification submission demonstrates that Acclarix LX9 Series
6
Diagnostic Ultrasound Systems are substantially equivalent to the predicate devices.