(259 days)
The Sonara and Sonara/tek Transcranial Doppler are medical ultrasound devices for measuring the blood flow velocities in arteries and in veins noninvasively, consistent with the FDA Ultrasound System and Transducer Indication for Use forms cleared with the 510(k).
The Sonara device is a Transcranial and peripheral vascular Doppler system, which is designed to measure blood flow velocities and other hemodynamic parameters in a non-invasive manner, in intracranial, extracranial and peripheral blood vessels. The Sonara system includes an integrated 15" touch screen color LCD display, integrated PC board and hard disk for data management and display. The Sonara/tek is the same device, utilizing a personal computer for its opcration (via USB connection). The TCD system supports 2MHz, 4MHz and 8MHz ultrasound probe frequencies, either in a unilateral or bilateral configuration. For monitoring purpose, a special 2MHz monitoring probe (which fits into a headset) is provided. Online and Offline modes of operation are available. The system also includes a remote control and footswitch as accessories.
The Sonara and Sonara/tek Transcranial Doppler (TCD) systems are medical ultrasound devices designed to non-invasively measure blood flow velocities and other hemodynamic parameters in intracranial, extracranial, and peripheral blood vessels.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria for device performance (e.g., specific accuracy, sensitivity, or specificity thresholds). Instead, the performance assessment focuses on compliance with general safety and functional specifications, and substantial equivalence to predicate devices. The "reported device performance" is summarized as meeting these functional specifications and being comparable to predicate devices.
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Functional Specifications | The device must meet all its functional specifications. (No specific quantitative metrics for these specifications are detailed in the provided text.) | "Final testing of the Sonara device included various performance tests designed to ensure that the device met all its functional specifications." |
| Safety Standards | The device must comply with industry and safety standards, specifically: - IEC/EN-60601-1: Medical Electrical Equipment; Part 1: General Requirements for Safety. - IEC/EN 60601-1-2: Electromagnetic Compatibility. - IEC/EN 60601-2-37: Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment. | "Tests have been performed to ensure the device complies with industry and safety standards." The design "conforms to the following voluntary standards" listed in the criteria. |
| Acoustic Output | Acoustic output reporting in compliance with FDA Ultrasound Guidance (1997). Maximum acoustic output levels below pre-amendment levels for acoustic intensity and Mechanical Index. Power levels displayed at all times during scanning. | "Acoustic output reporting for the Sonara devices was carried in compliance with 'Information for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers', September 30, 1997 (FDA Ultrasound Guidance (1997), Table 6-3, Page 6-9." "Maximum acoustic output levels are below pre-amendment levels for acoustic intensity for this application, and for Mechanical Index for all applications. Power levels are displayed at all times during scanning." A post-clearance special report for acoustic output measurements on production units is required. |
| Substantial Equivalence | The device must be substantially equivalent to legally marketed predicate devices in safety and efficacy. Features and data provided should be similar. | "The Sonara and Sonara/tek TCD are similar to currently distributed pulsed Doppler Ultrasound systems with 2MHz, 4MHz and 8MHz transducers intended for transcranial and peripheral Doppler applications." "A standard spectrum display is shown in both viewing display. The device includes an M-mode image. All of the above features are similar to these features in the predicate devices." "The conclusions drawn from the above Performance Testing and comparison to Predicate devices is that the Sonara and Sonara/tek... are substantially equivalent in safety and efficacy to the predicate devices listed above." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document states: "Final testing of the Sonara device included various performance tests designed to ensure that the device met all its functional specifications." However, no specific sample size (e.g., number of patients, cases, or measurements) for any test set is provided.
The data provenance (e.g., country of origin, retrospective or prospective nature) is not mentioned in the provided summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention using experts to establish ground truth for a test set. The validation appears to be based on engineering performance tests and comparison to specifications and predicate devices, rather than a clinical study requiring expert ground truth.
4. Adjudication Method for the Test Set
Since no specific test set requiring expert interpretation or ground truth is described, an adjudication method is not applicable and not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. The submission is focused on demonstrating substantial equivalence through performance testing and comparison to predicate devices, not on quantifying human reader improvement with or without AI assistance. The device itself is a diagnostic ultrasound system, not an AI-assisted interpretation tool in the context of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a diagnostic ultrasound system intended to be used by a human operator, not an algorithm providing interpretations independently. Therefore, a standalone (algorithm only) performance study as typically understood for AI algorithms was not performed or is not applicable in the context of this submission. The "standalone" performance testing refers to the device's functional integrity.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document extensively refers to "performance testing" and "functional specifications" to ensure the device operates as intended and "acoustic output measurements" to comply with safety standards. The "ground truth" in this context is the adherence to engineering specifications, safety standards, and the capabilities of predicate devices. There is no mention of ground truth established by expert consensus, pathology, or outcomes data as would be typical for studies evaluating diagnostic accuracy against clinical endpoints.
8. The Sample Size for the Training Set
Since the Sonara TCD system is described as a diagnostic ultrasound device designed to measure physical parameters of blood flow, and not as an AI or machine learning model that requires a training set, the concept of a "training set" with a specific sample size does not apply to this submission.
9. How the Ground Truth for the Training Set Was Established
As the concept of a training set is not applicable, the method for establishing its ground truth is also not applicable and not mentioned.
{0}------------------------------------------------
NOV - 3 2006
510(K) SUMMARY
SONARA TCD SYSTEM (INCLUDING SONARA AND SONARA/TEK)
510(k) Number: K060421
| Applicant's Name: | VIASYS Healthcare, Inc.227 Washington St., Suite 200Conshohocken, PA 19428 |
|---|---|
| Sponsor Contact: | Mr. Glen HermansonGlobal Manager, Quality EngineeringVIASYS NeuroCare, Inc.5225 Verona RoadMadison, WI 53711Phone: 608 441-2065Fax: 608 441-2007 |
| Date Prepared: | September 29, 2006 |
| Trade Name: | Sonara and Sonara/tek Transcranial Doppler (TCD) System |
| Classification Name: | CFR Classification section 892.1550 (Product code IYN); CFRClassification section 892.1570 (Product code ITX) |
| Classification: | Class II medical Device |
| Predicate Device: | The Sonara and Sonar/tek TCD devices are comparable to the followingpredicate devices: |
| - Doppler-Box (K051085) manufactured by Compumedics Gmbh(DWL). Doppler-Box is a Transcranial Doppler Ultrasound device,providing similar data to the Sonara/tek device. | |
| - TCD 100M (K002533) manufactured by Spencer Technologies. TCD100M is a Transcranial Doppler Ultrasound device, providing similardata to the Sonara device. | |
| - TC8080 Pioneer /Companion III (K053648) manufactured by VIASYSHealthCare, Inc., Neurocare Group.The TC8080 Pioneer /Companion III are TCD devices with equivalent indications for use. | |
| Device Description: | The Sonara device is a Transcranial and peripheral vascular Dopplersystem, which is designed to measure blood flow velocities and otherhemodynamic parameters in a non-invasive manner, in intracranial,extracranial and peripheral blood vessels.The Sonara system includes an integrated 15" touch screen color LCDdisplay, integrated PC board and hard disk for data management and |
| Performance Standards: | None.The design of the Sonara and Sonara/tek Transcranial Doppler (TCD)devices conforms to the following voluntary standards:IEC/EN-60601-1: Medical Electrical Equipment; Part 1: GeneralRequirements for Safety. Second edition (1990), including amendments#1(1993), #2(1995), #13(1996).IEC/EN 60601-1-2: Medical Electrical Equipment; Part 1-2: CollateralStandard: Electromagnetic Compatibility- Requirements and Tests(2001)IEC/EN 60601-2-37: Medical Electrical Equipment; Part 2: ParticularRequirements for the Safety of Ultrasonic Medical Diagnostic andMonitoring Equipment (2001) |
| Acoustic Output: | Acoustic output reporting for the Sonara devices was carried incompliance with "Information for manufacturers seeking marketingclearance of diagnostic ultrasound systems and transducers", September30, 1997 (FDA Ultrasound Guidance (1997), Table 6-3, Page 6-9. |
| Test Data: | The Sonara and Sonara/tek Transcranial and vascular Doppler deviceshave been subjected to extensive safety, performance testing, andvalidation before release. Final testing of the Sonara device includedvarious performance tests designed to ensure that the device met all itsfunctional specifications. Tests have been performed to ensure thedevice complies with industry and safety standards. |
| Substantial Equivalence: | The Sonara and Sonara/tek TCD are similar to currently distributedpulsed Doppler Ultrasound systems with 2MHz, 4MHz and 8MHztransducers intended for transcranial and peripheral Dopplerapplications. Maximum acoustic output levels are below pre-amendmentlevels for acoustic intensity for this application, and for MechanicalIndex for all applications. Power levels are displayed at all times duringscanning. A standard spectrum display is shown in both viewing |
{1}------------------------------------------------
display. The Sonara/tek is the same device, utilizing a personal computer for its opcration (via USB connection). The TCD system supports 2MHz, 4MHz and 8MHz ultrasound probe frequencies, either in a unilateral or bilateral configuration. For monitoring purpose, a special 2MHz monitoring probe (which fits into a headset) is provided. Online and Offline modes of operation are available. The system also includes a remote control and footswitch as accessories.
Intended Use / Indication for Use: The Sonara and Sonara/tek Transcranial Doppler are medical ultrasound devices for measuring the blood flow velocities in arteries and in veins noninvasively, consistent with the FDA Ultrasound System and Transducer Indication for Use forms cleared with the 510(k).
Performance Standards: None
{2}------------------------------------------------
| formats. The device includes an M-mode image. All of the above features are similar to these features in the predicate devices. | |
|---|---|
| Conclusions: | The conclusions drawn from the above Performance Testing and comparison to Predicate devices is that the Sonara and Sonara/tek Transcranial and peripheral vascular Doppler device and transducers are substantially equivalent in safety and efficacy to the predicate devices listed above. |
:
:
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2006
VIASYS Healthcare, Inc., NeuroCare Group % Mr. Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane MADISON WI 53711
Re: K060421
Trade Name: Sonara and Sonara/tek Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN and ITX Dated: October 6, 2006 Received: October 10, 2006
Dear Mr. Syring:
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 Sonara and Sonara/tek Systems, as described in your premarket notification:
Transducer Model Number
2 MHz PW Hand-Held Transducer 2 MHz PW Monitoring Transducer 4 MHz Transducer 8 MHz Transducer
Image /page/3/Picture/14 description: The image is a circular logo or emblem. The text "1906-2006" is at the top, and the letters "FDA" are in the center. The word "Centennial" is below the letters. There are three stars below the word "Centennial". The text "Dedicated to Protecting and Promoting Your Health" surrounds the circle.
Protecting and Promoting Public Health
{4}------------------------------------------------
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.
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 determination of substantial equivalence is granted on the condition that 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 September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." 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
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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
{5}------------------------------------------------
If you have any questions regarding the content of this letter, please contact Dr. Ewa Czerska at (240) 276-3666 .
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{6}------------------------------------------------
Sonara System
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | X | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | X | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | X | |||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | X | |||||||||
| Adult Cephalic | X | |||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | X | X | ||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
an her marcanent of the Sonara device can be used during surgery to support Transcranial Doppler
Additional Comments:
Monitoring, Carotid Monitoring, Emboli Detection (HITS).
No associated transducer probes are applied invasively.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices 510k) Number _
{7}------------------------------------------------
Sonara/tek System
Appendix F
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | X | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | X | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | X | |||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | X | |||||||||
| Adult Cephalic | X | |||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | X | X | ||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) | ||||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E |
Additional Comments: The Sonara/tek device can be used during surgery to support Transcranial Doppler
Monitoring, Carotid Monitoring, Emboli Detection (HITS).
No associated transducer probes are applied invasively.
Prescription Use (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. hogdon
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number __
$$\varepsilon \text{-3}$$
Page 210
{8}------------------------------------------------
Appendix F
2 MHz PW Hand-Held Transducer
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | X | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | X | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | X | |||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | X | |||||||||
| Adult Cephalic | X | |||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | X | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
Intraoperative: Noninvasive use during surgery to support Transcranial Doppler Additional Comments:_
Monitoring, Carotid Monitoring, Emboli Detection (HITS).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division S Division of Reproductive, Abd and Radiological Devices F-3 10(k) Number
Page 211
{9}------------------------------------------------
Appendix F
2 MHz PW Monitoring Transducer
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | X | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | X | |||||||||
| Intraoperative Neurological | ||||||||||
| Pedialric | X | |||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | X | |||||||||
| Adult Cephalic | X | |||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | X | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) | ||||||||||
| N= new indication; P= previously cleared by FDA; E= added under Appendix E |
Additional Comments: Intraoperative: Noninvasive use during surgery to support Transcranial Doppler
Monitoring, Carotid Monitoring, Emboli Detection (HITS)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Danay Shrodon
Division Slar of Reproductive. liological Devices 510(k) Numbe --3
{10}------------------------------------------------
4 MHz Transducer
Appendix F
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | X | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | X | |||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | X | |||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | X | X | ||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:_
Prescription Use (Per 21 CFR 801.109)
Intraoperative: Use during surgical procedures to support noninvasive extracranial monitoring.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Broadon
Division S Division of Active, Abdominal, and Radiological Devices 510/k) Number
F-3
Page 213
{11}------------------------------------------------
8 MHz Transducer
Appendix F
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | X | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | X | |||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | X | |||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | X | X | ||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Intraoperative: Use during surgical procedures to support noninvasive extracranial monitoring.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancyc brogdon
(Division Sign-Off) Division of Reproductive, Al ominal and Radiological Device 510(k) Number ....
-- Page 214
E-3
§ 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.