(19 days)
The GE Vscan is indicated for ultrasound imaging, measurement and analysis of the human body in clinical applications of Fetal/OB; Abdominal; Pediatric; Urology; Cardiac (adult and pediatric), Peripheral Vessel and Thoracic/Pleural motion and fluid detection; Its compact size, high degree of portability and simplified user interface enable it for adjunctive use for patient examination in primary care and in special care areas.
The GE Vscan is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and fixed wired electronic-array transducer. It has an overall size approximately 73 mm wide, 135 mm deep and 28 mm high in transport configuration, and provides digital acquisition, processing and display capability. The user interface includes an intuitive layout of specialized controls and a color LCD display.
The GE Vscan - Compact Diagnostic Ultrasound System (K092756) is a diagnostic ultrasound system.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated based on its substantial equivalence to predicate devices, rather than a quantifiable performance metric against a specific threshold. The "acceptance criteria" here are essentially meeting established safety standards and having comparable performance to existing, legally marketed ultrasound systems.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Non-clinical Tests | Conformance with applicable medical device safety standards for: | The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, and mechanical safety. It was found to conform with applicable medical device safety standards. The manufacturer's design and development process conforms to 21 CFR 820, ISO 9001, and ISO 13485 quality systems. Compliance is verified through independent evaluation with ongoing factory surveillance. |
| Clinical Tests | Demonstration of safety and effectiveness through clinical trials. | "None required." The submission states that diagnostic ultrasound has a long history of safe and effective performance, and its intended uses and key features are consistent with traditional clinical practice and FDA guidelines. |
| Substantial Equivalence | Comparison to predicate devices (GE Vivid-e, GE Venue 40, Acuson P10) in type, safety, and effectiveness. | The GE Vscan is stated to be of a comparable type and substantially equivalent to the predicate devices. It is a compact and portable unit comparable in key safety and effectiveness features and utilizes the same patient contact materials as currently marketed transducers. It also has the same intended uses as the predicate devices. |
| Intended Use Alignment | Consistency of intended uses with predicate devices and traditional clinical practice. | The device has the same intended uses as the predicate devices, covering Fetal/OB; Abdominal; Pediatric; Urology; Cardiac (adult and pediatric), Peripheral Vessel and Thoracic/Pleural motion and fluid detection. Its compact size, portability, and simplified user interface enable adjunctive use in primary and special care. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: No specific test set sample size is mentioned for a performance study.
- Data Provenance: Not applicable. The submission asserts substantial equivalence based on technical characteristics, established standards, and the known safety and effectiveness history of diagnostic ultrasound, rather than specific performance data from a clinical test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. No ground truth establishment by experts for a specific test set is described. The basis for approval is substantial equivalence to existing devices.
4. Adjudication Method for the Test Set
- Not applicable. There was no specific test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- No MRMC comparative effectiveness study was done. This is a compact diagnostic ultrasound system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Not applicable. This is a standalone diagnostic imaging device, but its "performance" is assessed through substantial equivalence and compliance with safety standards, not a standalone algorithm performance measurement.
7. The Type of Ground Truth Used
- Not explicitly defined as "ground truth" in the context of a clinical study. The "ground truth" implicitly references:
- Established safety standards: Applicable medical device safety standards.
- Predicate device characteristics: The known performance and safety profiles of the GE Vivid-e, GE Venue 40, and Acuson P10 ultrasound systems.
- Historical evidence: The "long history of safe and effective performance" of diagnostic ultrasound in general.
8. The Sample Size for the Training Set
- Not applicable. There is no mention of a training set as this is not an AI/machine learning device undergoing model training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there was no training set.
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Traditional 510(k) Premarket Notification GE Vscan - Compact Diagnostic Ultrasound System July 14. 2009
Attachment B
510(k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
| SEP | 2 2009 |
|---|---|
| ----- | -------- |
| 1. Submitter: | GE Vingmed Ultrasound ASStrandpromenaden 45N-3183, Horten, Norway |
|---|---|
| Contact Person: | Jan Tore Thollefsen,Regulatory Affairs LeaderTelephone: +47 3302 1269; Fax: 972-4-8519-500 |
| Date Prepared: | July 13, 2009 |
| 2. Device Name: | GE Vscan Diagnostic Ultrasound SystemUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYNUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYODiagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX |
| 200 | |
| 3. Marketed Devices: | GE Vivid-e Ultrasound System, K072797 currently in commercial distribution.GE Venue 40 Ultrasound System, K091164 currently in commercial distribution.Acuson P10 Ultrasound System, K063761 currently in commercial distribution. |
Device Description: The GE Vscan is compact and portable diagnostic ultrasound system with ব integrated keyboard, fold-up LCD type display and fixed wired electronic-array transducer. It has an overall size approximately 73 mm wide, 135 mm deep and 28 mm high in transport configuration, and provides digital acquisition, processing and display capability. The user interface includes an intuitive layout of specialized controls and a color LCD display.
-
Indications for Use: The GE Vscan is indicated for ultrasound imaging, measurement and analysis of the human body in clinical applications of Fetal/OB; Abdominal; Pediatric; Urology; Cardiac (adult and pediatric), Peripheral Vessel and Thoracic/Pleural motion and fluid detection; Its compact size, high degree of portability and simplified user interface enable it for adjunctive use for patient examination in primary care and in special care areas.
-
Comparison with Predicate Device: The modified GE Vscan is of a comparable type and substantially equivalent to the currently marketed GE Vivid e, GE Venue 40 and Acuson P10. It is a compact and readily portable unit comparable in key safety and effectiveness features and with the same patient contact materials as currently marketed transducer. GE Vscan has the same intended uses as the predicate devices.
Section b):
Section a):
-
Non-clinical. Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
-
Clinical Tests: None required.
-
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms to 21 CFR 820, ISO 9001 and ISO13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE Vscan Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 2 8 2009
GE Vingmed Ultrasound AS % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K092756
Trade/Device Name: GE Vscan-Compact Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: TYN, IYO, and ITX Dated: September 8, 2009 Received: September 9, 2009
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the GE Vscan-Compact Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
G3S
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Job
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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely vours.
. Herbert Lehman
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Diagnostic Ultrasound Indications for Use Form
GE Vscan Ultrasound System
Intended Use: Diagnostic Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Track 1 & 3) | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes | HarmonicImaging | CodedPulse | Other |
| Ophthalmic | Ophthalmic | |||||||||||
| Fetal | N | N | N | N | ||||||||
| Abdominal[1] | N | N | N | N | ||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Fetal Imaging& Other | Pediatric | N | N | N | N | |||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph.(non-Card.) | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Intravascular | ||||||||||||
| Other (specify)[2] | N | N | N | N | ||||||||
| Cardiac Adult | N | N | N | N | ||||||||
| Cardiac | Cardiac Pediatric | N | N | N | N | |||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (specify) | ||||||||||||
| PeripheralVessel | Peripheral vessel | N | N | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes Renal.
[2] Other use includes Urology and Thoracic/Pleural detection of fluid and pleural motion/sliding.
[*] Combined mode is B/Color.
[*] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE
Prescription User (Per 21 CFR 801.109) .
E-2
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev
510(k) Number
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Diagnostic Ultrasound Indications for Use Form
GE Vscan Ultrasound System with G3S transducer
Intended Use: Diagnostic Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Track 1 & 3) | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes+ | HarmonicImaging | CodedPulse+ | Other |
| Ophthalmic | Ophthalmic | |||||||||||
| Fetal | N | N | N | N | ||||||||
| Abdominal[1] | N | N | N | N | ||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) . | ||||||||||||
| Laparoscopic | ||||||||||||
| Fetal Imaging& Other | Pediatric | N | N | N | N | |||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph.(non-Card.) | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Intravascular | ||||||||||||
| Other (specify)[2] | N | N | N | N | ||||||||
| Cardiac Adult | N | N | N | N | ||||||||
| Cardiac | Cardiac Pediatric | N | N | N | N | |||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (specify) | ||||||||||||
| PeripheralVessel | Peripheral vessel | N | N | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes Renal.
[2] Other use includes Urology and Thoracic/Pleural detection of fluid and pleural motion/sliding.
[*] Combined mode is B/Color.
[*] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF MEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
HER PAGE IF NEEDED)
uation (ODE)
Division Sign-Off
vision of Reproductive, Abdominal,
and Radiological De 510(k) Number
Prescription User (Per 21 CFR 801.109)
E-3
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.