(360 days)
Not Found
No
The document describes a standard diagnostic ultrasound system and does not mention any AI or ML capabilities.
No
The device is described as a "diagnostic ultrasound imaging system" and its function is to "acquire ultrasound data and display it" for "clinical diagnosis purposes". There is no mention of treating or alleviating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system provides analysis packages for "clinical diagnosis purposes" and also describes "Diagnostic ultrasound imaging and Doppler." Additionally, the "Device Description" refers to it as a "diagnostic ultrasound system." The predicate devices are also explicitly named as "Diagnostic Ultrasound System."
No
The device description explicitly states it is a "diagnostic ultrasound system" and describes hardware components like a CRT display and modes of operation (B-Mode, M-Mode, etc.) which are inherent to ultrasound hardware.
Based on the provided information, the SONOLINE Versa 555 ultrasound imaging system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body. The SONOLINE Versa 555 is an ultrasound system that performs imaging on the human body.
- The intended use and device description clearly state that it is a diagnostic ultrasound system for imaging and analyzing structures within the human body. It uses ultrasound waves to create images and perform Doppler analysis directly on the patient.
- There is no mention of analyzing biological specimens.
Therefore, the SONOLINE Versa 555 falls under the category of a diagnostic imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The SONOLINE Versa 555 ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative (abdominal and neurosurgical), Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal Cephalic, Urology, Vascular, Peripheral Vascular, and Transesophageal Echocardiography (TEE) applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Diagnostic ultrasound imaging and Doppler analysis of the human body as follows:
Mode of Operation: B, M, PWD, CWD, C (Color Maps), Combined (B,C,D) for Clinical Application Cephalic Adult and Cephalic Neonatal.
Mode of Operation: B, M, PWD, CWD, Combined (B,C,D) for Clinical Application Cardiac Adult and Cardiac Pediatric.
Product codes (comma separated list FDA assigned to the subject device)
90 YIN, 90 IYO
Device Description
The SONOLINE Versa 555 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Flow Modes, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
General Radiology, Abdominal, Intraoperative (abdominal and neurosurgical), Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal Cephalic, Urology, Vascular, Peripheral Vascular, and Transesophageal Echocardiography (TEE) applications.
Cephalic Adult, Cephalic Neonatal, Cardiac Adult, Cardiac Pediatric.
Indicated Patient Age Range
Adult, Neonatal, Pediatric
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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.
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MAY 2 9 1997
510(K) SUMMARY
容 时间: 前一条
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SONOLINE Versa 555 Diagnostic Ultrasound System
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
Submitted By: 1. Siemens Medical Systems, Inc., Ultrasound Group 22010 SE 51st Street . Issaquah, WA 98027-7002
Contact Person: Steve Hesler Manager of Regulatory Affairs (206) 557-1629
Date Prepared: May 30, 1996
- Proprietary Name: 2. SONOLINE Versa 555 Diagnostic Ultrasound System
Common/ Usual Name: Diagnostic Ultrasound System with Accessories
Classification Name:
Ultrasonic Pulsed Doppler Imaging System (Product Code 90 YIN, 21 CFR 892.1550)
Predicate Device: 3.
Siemens SONOLINE Versa Diagnostic Ultrasound System (K945773), 8/7/95. Siemens SONOLINE Elegra Diagnostic Ultrasound System (K945072), 11/21/95.
Device Description: 4.
The SONOLINE Versa 555 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Flow Modes, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display .
1
The SONOLINE ® Versa 555 has been designed to meet the following product safety standards:
- UL 2601, Safety Requirements for Medical Equipment ●
- CSA 22.2 No. 601-1, Safety Requirements for Medical Equipment ●
- Standard for Real Time Display of Thermal and Mechanical Indices on . Diagnostic Ultrasound Equipment, AIUM/NEMA, 1992.
- 93/94/EEC Medical Devices Directive .
- EN60601 = (IEC 601-1-1 + IEC 601-1-2), Safety and EMC , Requirements for . Medical Equipment
-
- Intended Uses:
The SONOLINE Versa 555 ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative (abdominal and neurosurgical), Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal Cephalic, Urology, Vascular, Peripheral Vascular, and Transesophageal Echocardiography (TEE) applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
6. Technological Comparison to Predicate Device:
The SONOLINE Versa 555 is similar to the SONOLINE Versa in that both incorporate software controlled electronics to transmit ultrasonic pulses, via a transducer, into a patient, then receive return (echo) pulses and to convert those pulses into a visual display, to be provide information for use in the diagnosis of various disease states as well as normal conditions such as pregnancy and physical development. The operating principles of both systems are identical. However, the SONOLINE Versa 555 supports phased array transducers.
Both systems incorporate an on-screen display of Mechanical (MI) and Thermal (IT) Indices. in compliance with the Standard for Real Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound Equipment, AIUM/NEMA, 1992.
End of 510(k) Summary
Page 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1997
Steve Hesler Manager Regulatory Affairs Siemens Medical Systems 22010 S.E. 51st St.: . . . - -- ---Issaquah, WA 98027-7002
Re: K962142
Sonoline Versa 555 Dated: April 10, 1997 Received: April 11, 1997 Regulatory class: II 21 CFR 892.1550/Procode: 90 IYO
Dear Mr. Hesler:
We have reviewed your section 510(k) 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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Sonoline Versa 555, as described in your premarket notification:
Transducer Model Number 2.5 MHZ 2.5P20 Phased Linear Array 3.5 MHZ 3.5P14 Phased Linear Array 3.5 MHZ 3.5C20 Curved Array 3.5 MHZ 3.5C40 Curved Array 3.5 MHZ 3.5C60 Curved Array 3.5 MHZ 3.5C80 Curved Array 5.0 MHZ TEE 5.0 MHZ 5.0P10 Phased Linear Array 5.0 MHZ 5.0L45 Linear Array 5.0 MHZ 5.0C50 Curved Array
3
and the the
5.0 MHZ 5.0L90 Linear Array 6.5 MHZ 6.5F13 Curved Array 6.5 MHZ 6.5EV 13 Curved Array 7.5 MHZ 7.5C30 Curved Array 7.5 MHZ 7.5L40 Linear Array 7.5 MHZ 7.5L501 Linear Array 7.5 MHZ 7.5L50Q Linear Array 7.5 MHZ 7.5L70 Linear Array 10.0 MHZ 10.0L25 Linear Array
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the investigational device exemptions (IDE) regulations. 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.
This determination of substantial equivalence is granted on the prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's February 17, 1993 "Revised 510(k) Diaguestic Ultrasound Guidance for 1993." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
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Page 3 - Mr. Steve Hesler
2011 - 11
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 and additionally 809.10 If you desire specific abvice for your device on our labeling (21 CFR Par 80) . Additionally 609 .
for in vitro diagnostic device of your device of Compiance at (30) . 94-459 questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "dsmo@fdadr.cdrh.fda.gov".
If you have any questions regarding the content of this letter, please contact Maureen Butler at (301) 594-1212.
Sincerely yours,
David A. Sejerson
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
Ultrasound Device Indications Statement
K962142 510 (k) Number (if known)
Device Name
2.5P20 transducer for use with the SONOLINE Versa 555
Indications For Use
Diagnostic ultrasound imaging and Doppler analysis of the human body as follows:
| Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|
| Clinical | |||||||
| Application | B | M | PWD | CWD | C | ||
| (Color Maps) | Combined | ||||||
| (B,C,D) | Other | ||||||
| (Specify) | |||||||
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intraoperative | |||||||
| Abdominal | |||||||
| Neurosurgical | |||||||
| Pediatric | |||||||
| Small Organ | |||||||
| Cephalic | |||||||
| Adult | |||||||
| Neonatal | √ | √ | √ | √ | √ | ||
| Cardiac | |||||||
| Adult | |||||||
| Pediatric | √ | √ | √ | √ | √ | ||
| Trans- | |||||||
| esophageal | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Intra-luminal | |||||||
| Trans- | |||||||
| urethral | |||||||
| Peripheral | |||||||
| vessel | |||||||
| Laparoscopic |
(Other Indications or Modes)
Concurrence of CDPH, Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801 109)
Elinor W. Hepburn
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
5.0 k) Number K962142