(392 days)
Not Found
No
The description focuses on remote control of a physical device (ultrasound transducer) by a human expert, not on automated analysis or decision-making using AI/ML. There is no mention of AI, ML, or related terms, nor is there a description of training or test data sets for an AI/ML model.
No.
The device is intended to manipulate an external ultrasound transducer to obtain diagnostic images, not to provide therapy.
No
The MELODY is a robotic system that manipulates an external ultrasound transducer remotely. It enables an expert sonographer to control cleared ultrasound equipment from a distance to obtain ultrasound views. The device itself is not performing the diagnostic assessment but rather facilitating the remote operation of an ultrasound system, which is the diagnostic device. The text explicitly states it's "intended to hold the external ultrasound transducer of cleared ultrasound equipment" and helps "obtain the ultrasound views required to assess the patient," indicating it's a tool for a diagnostic process, not the diagnostic device itself.
No
The device description explicitly states "The MELODY robot frame at the remotely-located patient is prepared and positioned by a trained assistant..." and "The objective of the MELODY, Remote Control System for Ultrasound Probe, is to allow an expert sonographer to manipulate the transducer of a third-party ultrasonic device remotely...". This indicates the device includes a physical robotic frame and system for manipulating the ultrasound probe, which are hardware components.
Based on the provided information, the MELODY 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. They are used to examine these samples outside of the body.
- MELODY's Function: The MELODY device is a robotic system designed to manipulate an ultrasound transducer on a patient's body. It facilitates remote control of an ultrasound examination, which is an in vivo (within the living body) imaging technique.
- Intended Use: The intended use clearly states that the MELODY is for holding and manipulating an external ultrasound transducer to obtain ultrasound views of the patient. This is a direct interaction with the patient's body, not a test performed on a sample taken from the body.
Therefore, the MELODY device falls under the category of medical devices used for imaging and diagnosis in vivo, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MELODY is intended to hold the external ultrasound transducer of cleared ultrasound equipment and provide a remotely-located, expert sonographer the ability to manipulate the transducer in real time through an Internet connection to obtain the ultrasound views required to assess the patient. The MELODY robot frame at the remotely-located patient is prepared and positioned by a trained assistant at the direction of the expert sonographer through a suitable third-party videoconferencing system. Sonograms are transmitted from the pation from cleared ultrasound equipment through digital telecommunication to the expert sonographer. Indications for the MELODY are tabulated in the Diagnostic Ultrasound Indications table. MELODY may also be used when a physician wants to have a colleague not onsite provide a second opinion.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX, IYN
Device Description
The objective of the MELODY, Remote Control System for Ultrasound Probe, is to allow an expert sonographer to manipulate the transducer of a third-party ultrasonic device remotely and in real time over an internet or similar connection. The remote expert manipulates the precession, nutation, and intrinsic rotation of the transducer, replicating the motions of the hand, to obtain the exact sonography views that he or she requires. The MELODY solves the problem of a lack of imaging experts in isolated areas, e.g., small or rural hospitals or clinics, remote military medical facilities, ships or oil drilling platforms, prison environment, etc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, Fetal, Abdominal, Intra-operative (Specify), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (Specify), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vessel, Pelvic, Urology
Specifically for the device's indications: pelvic, abdominal, cardiac, and vascular organs.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Remotely-located, expert sonographer; trained assistant at the remotely-located patient; small or rural hospitals or clinics, remote military medical facilities, ships or oil drilling platforms, prison environment, etc.
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)
Biocompatibility testing: The biocompatibility evaluation for the MELODY device was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the MELODY device, consisting of the patient and expert modules. The system complies with the IEC 60601-1, standard for safety, and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern because ultrasound device software is considered to be a moderate level of concern and because a failure or latent flaw in the software could directly result in minor injury to the patient or operator. The level of concern is also moderate if a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Mechanical Performance Validation: The MELODY expert system was tested to validate the performance of position orders generated and the MELODY patient system was tested to validate the performance for applying the position orders from the expert system. The testing demonstrated that the MELODY performed within predetermined specifications for all three rotational motions for positioning the MELODY robot. Additionally, the maximal delay for orders processing met the predetermined specification.
Clinical Studies: The MELODY was tested in several clinical studies reported in the scientific literature. Separate examinations were performed on over 500 patients of abdominal, pelvic, fetal, cardiac, or vascular organs. Results from distance sonograms were compared to sonograms done on location at the patient's side by a second expert sonographer and during resulting examinations and procedures. Patients with pathologic conditions and those that were scanned. Organs were both visualized and measured.
Effectiveness: Visualization scores ranged from 81% to 100% versus the on-site sonograms. Measurements were not found to differ statistically significantly from on-site measurements. In a few instances, self-imposed time limits did not provide the time to complete measurements. Compression and decompression of the internet signal affected the contrast and resolution of the images. Consequently some small lesions were not observable and low contrast images were harder to diagnose. Patients that presented sonography difficulties, e.g., obesity, were harder to diagnose at a distance.
Safety: No adverse effects were experienced from the MELODY itself. It is designed to apply no more than 20 N of pressure to the skin surface. The weight MELODY frame itself is supported by a floor mounted stand.
Summary: Based on the clinical performance as documented in the reported clinical studies, the MELODY system was found to be safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Visualization scores ranged from 81% to 100%.
Measurements were not found to differ statistically significantly from on-site measurements.
No adverse effects were experienced from the MELODY itself.
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.
K082543, SonoCiné Adjunctive Breast Ultrasound System (ABU), Model 100
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.
Not Found
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
§ 892.1560 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a caduceus, a traditional symbol of medicine, but with three figures instead of one.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2017
ADECHO TECH C/O THOMAS KNOTT SENIOR REGULATORY ADVISOR 810 LANDMARK DRIVE SUITE 126 GLEN BURNIE MD 21061
Re: K161354
Trade/Device Name: Melody, Remote Control System for Ultrasound Probe Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX, IYN Dated: May 8, 2017 Received: May 10, 2017
Dear Mr. Knott:
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 (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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161354
Device Name
Melody, Remote Control System for Ultrasound Probe
Indications for Use (Describe)
The MELODY is intended to hold the external ultrasound transducer of cleared ultrasound equipment and provide a remotely-located, expert sonographer the ability to manipulate the transducer in real time through an Internet connection to obtain the ultrasound views required to assess the patient. The MELODY robot frame at the remotely-located patient is prepared and positioned by a trained assistant at the direction of the expert sonographer through a suitable third-party videoconferencing system. Sonograms are transmitted from the pation from cleared ultrasound equipment through digital telecommunication to the expert sonographer. Indications for the MELODY are tabulated in the Diagnostic Ultrasound Indications table. MELODY may also be used when a physician wants to have a colleague not onsite provide a second opinion.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | N | N | N | N | N | N | N |
| Abdominal | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N | N | |
| Small Organ (Specify) | N | N | N | N | N | N | N | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | N | N |
| Other (Specify) | ||||||||
| Pelvic | N | N | N | N | N | N | N | |
| Urology | N | N | N | N | N | N | N |
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
4
l. SUBMITTER
| Submitted By: | Benjamin L. England And Associates, LLC |
|---|---|
| Address: | 810 Landmark Drive Suite 126 |
| Glen Burnie, MD 21061 | |
| Phone: | (410) 220-2800 |
| Fax: | (443) 583-1464 |
| E-mail: | tcknott@fdaimports.com |
| Contact: | Thomas C. Knott, Senior Regulatory Consultant |
| On Behalf of: | AdEchoTech |
|---|---|
| Address: | Le Vivier |
| 41310 Huisseau en Beauce | |
| France | |
| Phone: | |
| Fax: | |
| E-mail: | |
| Contact: | Nicolas Lefebvre |
II. DEVICE
| Proprietary Name: | MELODY, Remote Control System for Ultrasound Probe |
|---|---|
| Common Name: | Robotic tele-sonography device |
| Classification: | Accessory to: |
- Ultrasonic pulsed echo imaging system
- Transducer, Ultrasonic, Diagnostic
- System, Imaging, Pulsed Doppler, Ultrasonic |
| Classification Regulation: | 1. 21 CFR 892.1560; - 21 CFR 892.1570;
- 21 CFR 892.1550 |
| Product Code: | 1. IYO, - ITX,
- IYN |
| Review Panel: | Radiology |
| FDA Document Numbers Related To Melody | Q150951 |
| Predicate Device(s): | K082543, SonoCiné Adjunctive Breast Ultrasound System (ABU), Model 100 |
III. PREDICATE DEVICE
K082543; SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100 cleared under (System, Imaging, Pulsed Echo, Ultrasonic; product code: IYO).
5
This predicate has not been subject to a design-related recall.2
IV. DEVICE DESCRIPTION
The objective of the MELODY, Remote Control System for Ultrasound Probe, is to allow an expert sonographer to manipulate the transducer of a third-party ultrasonic device remotely and in real time over an internet or similar connection. The remote expert manipulates the precession, nutation, and intrinsic rotation of the transducer, replicating the motions of the hand, to obtain the exact sonography views that he or she requires. The MELODY solves the problem of a lack of imaging experts in isolated areas, e.g., small or rural hospitals or clinics, remote military medical facilities, ships or oil drilling platforms, prison environment, etc.
V. INDICATIONS FOR USE
The MELODY is intended to hold the external ultrasound transducer of cleared ultrasound equipment and provide a remotely-located, expert sonographer the ability to manipulate the transducer in real time through an Internet connection to obtain the ultrasound views required to assess the patient. The MELODY robot frame at the remotely-located patient is prepared and positioned by a trained assistant at the direction of the expert sonographer through a suitable third-party videoconferencing system. Sonograms are transmitted from the patient location from cleared ultrasound equipment through digital telecommunication to the expert sonographer. Indications for the MELODY are tabulated in the Diagnostic Ultrasound Indications table. MELODY may also be used when a physician wants to have a colleague not on-site provide a second opinion.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
MELODY is substantially equivalent to SonoCiné Adjunctive Breast Ultrasound System (ABU) Model 100. The technological characteristics are equivalent. MELODY and SonoCiné both secure the transducer for most FDA-cleared ultrasound systems. The transducer is secured to a robotic support mechanism that moves by signals from computer-driven servo motors. When MELODY or SonoCiné are not in use, the ultrasound system can be used for any other indicated ultrasound scans.
In both devices an assistant technologist positions and prepares the patient and the MELODY or SonoCiné robotic mechanism. In both, the assistant minimally guides or prepositions that is holding transducer. The technologist maintains the angle and contact pressure of the SonoCiné transducer. The technologist positions and steadies the MELODY frame on the patient at the direction of the distant sonographer.
The SonoCiné robotic arm movement is computer controlled by the SonoCiné software. SonoCiné is programmed to move in parallel and contiguous rows across the patient's breast and surrounding areas. SonoCiné Image Acquisition Station Model 100 records and stores the ultrasound images for viewing by
් On July 9, 2012, section 605 of FDASIA (Pub. L. 112-144) added section 518A to the FD&C Act, which directs FDA to establish a program to routinely and systematically assess information regarding device recalls, and to use that information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. FDA believes that one way to carry out this directive is to provide greater transparency on recalled devices. ldentifying whether a predicate was recalled is optional, but doing so would help the Agency achieve this FDASIA directive.
6
the radiologist at a later time. The MELODY robotic tilts and rotates at the distant sonographer's command in real time. The software in the ultrasound device transmits the image to the radiologist in real time over the Internet connection. In neither device does the sonographer directly perform the scan in the presence of the patient.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the MELODY device was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the MELODY device, consisting of the patient and expert modules. The system complies with the IEC 60601-1, standard for safety, and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern because ultrasound device software is considered to be a moderate level of concern and because a failure or latent flaw in the software could directly result in minor injury to the patient or operator. The level of concern is also moderate if a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Mechanical Performance Validation
The MELODY expert system was tested to validate the performance of position orders generated and the MELODY patient system was tested to validate the performance for applying the position orders from the expert system. The testing demonstrated that the MELODY performed within predetermined specifications for all three rotational motions for positioning the MELODY robot. Additionally, the maximal delay for orders processing met the predetermined specification.
Clinical Studies
The MELODY was tested in several clinical studies reported in the scientific literature. Separate examinations were performed on over 500 patients of abdominal, pelvic, fetal, cardiac, or vascular organs. Results from distance sonograms were compared to sonograms done on location at the patient's side by a second expert sonographer and during resulting examinations and procedures. Patients with pathologic conditions and those that were scanned. Organs were both visualized and measured.
7
Primary effectiveness endpoint:
The distance sonogram yielded the same visualization, diagnosis, and/or measurement as a sonogram performed at the patient's side.
Effectiveness
Visualization scores ranged from 81% to 100% versus the on-site sonograms. Measurements were not found to differ statistically significantly from on-site measurements. In a few instances, self-imposed time limits did not provide the time to complete measurements. Compression and decompression of the internet signal affected the contrast and resolution of the images. Consequently some small lesions were not observable and low contrast images were harder to diagnose. Patients that presented sonography difficulties, e.g., obesity, were harder to diagnose at a distance.
Safety
No adverse effects were experienced from the MELODY itself. It is designed to apply no more than 20 N of pressure to the skin surface. The weight MELODY frame itself is supported by a floor mounted stand.
Summary
Based on the clinical performance as documented in the reported clinical studies, the MELODY system was found to be safe and effective.
VIII. CONCLUSIONS
MELODY is substantially equivalent to the predicate device. The technological characteristics of MELODY and the predicate devices are essentially equivalent. The robotic control differs, but both are designed to obtain sonograms through third party ultrasound devices. The indication for the sonograms differs. While both obtain sonograms, the predicate is indicated for the breast only, but MELODY is indicated for pelvic, abdominal, cardiac, and vascular organs, but not the breast.
--- END OF 510(k) SUMMARY ---