(115 days)
The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal
Modes of operation include: B, M, PW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode and Combined modes: B/M, B/Color, B/Color/PWD, B/Power/PWD. The Voluson E10 is intended to be used in a hospital or medical clinic.
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.
I am sorry, but the provided text is a 510(k) premarket notification submission from GE Healthcare for their Voluson E10 ultrasound system. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards.
The document explicitly states: "The subject of this premarket submission, Voluson E10 did not require clinical studies to support substantial equivalence." (Page 7)
Therefore, it does not contain information regarding:
- Acceptance criteria for device performance in a clinical study.
- A study proving the device meets specific acceptance criteria based on clinical performance.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance metrics related to clinical effectiveness.
The "Summary of Non-Clinical Tests" (Page 6) mentions evaluations for acoustic output, biocompatibility, cleaning, disinfection, and thermal/electrical/electromagnetic/mechanical safety, conforming to applicable medical device safety standards. However, these are non-clinical technical safety and performance evaluations, not clinical performance studies with acceptance criteria for diagnostic accuracy or effectiveness.
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October 22, 2020
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GE Healthcare % Mr. Bryan Behn Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226
Re: K201768
Trade/Device Name: Voluson E10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 16, 2020 Received: September 17, 2020
Dear Mr. Behn:
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/cfpmp/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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
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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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
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Indications for Use
510(k) Number (if known) K201768
Device Name Voluson E10
Indications for Use (Describe)
The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal
Modes of operation include: B, M, PW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode and Combined modes: B/M, B/Color, B/Color/PWD, B/Power/PWD. The Voluson E10 is intended to be used in a hospital or medical clinic.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K201768
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | June 24, 2020 |
| Submitter: | GE Healthcare [GE Healthcare Austria GmbH & Co OG]Tiefenbach 15Zipf, Austria 4871 |
| Primary ContactPerson: | Bryan BehnRegulatory Affairs DirectorGE Healthcare9900 Innovation DrWauwatosa, WI 53226T:(262)247-5502F:(414)918-8275 |
| Secondary ContactPerson: | Roland KuntscherRegulatory Affairs SpecialistGE Healthcare Austria GmbH & Co OGTiefenbach 15Zipf, Austria 4871T:(+43)7682-3800-660F:(+43)7682 3800-47 |
| Device:Trade Name: | Voluson E10Models: Voluson E10 |
| Common/UsualName: | Ultrasound system |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Primary PredicateDevice(s): | K192159 Voluson E6_E8_E10 Diagnostic Ultrasound System |
| Secondary PredicateDevice(s): | K173555 LOGIQ E10 Diagnostic Ultrasound System |
K181685 Vivid E95 Diagnostic Ultrasound System
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GE Healthcare 510(k) Premarket Notification Submission
- Device Description: The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.
- The device is a general-purpose ultrasound system intended for use by Intended Use: qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculoskeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal
Modes of operation include: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The Voluson E10 is intended to be used in a hospital or medical clinic.
- The Voluson E Series (Voluson E10) employs the same fundamental Technology: scientific technology as its predicate devices.
Determination of Comparison to Predicates Substantial Equivalence:
- The proposed Voluson E10 is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
- The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
- The proposed Voluson E10 and predicate Voluson E Series systems have the same clinical intended use.
- The proposed Voluson E10 and predicate Voluson E Series systems have the same imaging modes.
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GE Healthcare
510(k) Premarket Notification Submission
- The proposed Voluson E10 and predicate Voluson E Series . systems transducers are equivalent. Two new transducers 12S-D and eM6CG3 were added and 10 transducers removed to the proposed system.
- There is no change to the system indications for use. ●
- . The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
- The systems have acoustic power levels which are below . the applicable FDA limits.
- The proposed Voluson E10 and predicate Voluson E Series systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- . The proposed Voluson E10 and predicate systems have been designed in compliance with approved electrical and physical safety standards.
- . There proposed Voluson E10 and predicate Voluson E series Software Features are equivalent. Some minor improvements to the existing Software features have been implemented into the proposed system.
- The proposed Voluson E10 adds additional measurements of ● existing software feature SonoBiometry (workflow improvement).
- The proposed Voluson E10 adds Image Analysis of existing ● software feature Scan Assistant (workflow improvement).
- The proposed Voluson E10 adds Fetal Heart Screening (workflow improvement).
- . The proposed Voluson E10 adds functionality check of probe crystals/elements to existing e-PAT (electronic probe assessment tool) acc. FDA guideline (modified for customer access add.to previous service tool).
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GE Healthcare 510(k) Premarket Notification Submission
Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. The Voluson E Series and its applications comply with voluntary standards:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment Part o 1: General Requirements for Safety, 2005/(R)2012 And A1:2012
- IEC60601-1-2 Medical Electrical Equipment Part 1-2: ● General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2014
- IEC60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015
- ISO10993-1, Biological Evaluation of Medical Devices- Part 1: . Evaluation and Testing- Third Edition, 2009
- . ISO14971, Application of risk management to medical devices: Second edition 2007
- NEMA PS 3.1 3.20 (2016), Digital Imaging and ● Communications in Medicine (DICOM) Set. (Radiology)
The following quality assurance measures are applied to the development of the system:
- Risk Analysis
- Requirements Reviews ●
- Design Reviews ●
- Testing on unit level (Module verification) ●
- Integration testing (System verification) ●
- . Performance testing (Verification)
- Safety testing (Verification)
- Final Acceptance Testing (Validation) .
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, Voluson E10 did not require
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GE Healthcare 510(k) Premarket Notification Submission
clinical studies to support substantial equivalence.
Conclusion: GE Healthcare considers the Voluson E10 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).
§ 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.