Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intraoperative (Transcranial and Intracranial Doppler Monitoring, Carotid Monitoring, Microvascular Blood Flow, Emboli Detection, Extracranial carotid monitoring), Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

Device Description

The modified Pioneer TC 8080 and Companion III are Doppler ultrasound systems. Both systems utilize the well-understood principle of Doppler shift to detect the flow of blood within the body. The ultrasound probe generates ultrasonic energy, which is coupled to the body. The ultrasonic energy, which is reflected from the moving blood in blood vessels and the returning signal, is detected as a frequency shifted signal. The amount of frequency shift is a function of the velocity of the flowing blood. These systems generate, transmit and receive an ultrasonic signal, then process and display the Doppler signal returning from the anatomy.

The Pioneer TC8080 can be used with up to four Doppler ultrasound probes simultaneously. The Companion III, applying the same software and hardware as the Pioneer TC8080, can be used with up to two Doppler ultrasound probes simultaneously.

AI/ML Overview

Here's an analysis of acceptance criteria and supporting study details based on the provided text:

The provided text is a 510(k) Summary for a medical device (Pioneer TC8080 and Companion III Doppler Ultrasound Systems). A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a rigorous clinical study with novel data. The "study" here is essentially the demonstration of substantial equivalence by comparing the device to legally marketed predicate devices.

Therefore, many of the typical clinical study components (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance with ground truth for test/training sets, and the way ground truth was established for training) are not applicable in the context of this 510(k) submission. There isn't an independent clinical performance study described in the way a new, non-substantially equivalent device would require.

The "acceptance criteria" for a 510(k) submission largely revolve around demonstrating that the new device has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness, compared to the predicate device.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated Equivalence to Predicate)	Reported Device Performance (as demonstrated in 510(k))
Intended Use: Device indicates blood flow using Doppler ultrasound technology, with specific clinical applications.	The modified Pioneer TC8080 and Companion III are applied to indicate blood flow by application of Doppler ultrasound technology. The indications for use are identical or substantially similar to predicate devices (K020754, K864695, K011224) across various clinical applications (Adult Cephalic, Peripheral Vascular, Intraoperative: Transcranial/Intracranial Doppler Monitoring, Carotid Monitoring, Microvascular Blood Flow, Emboli Detection, Ophthalmic, Neonatal Cephalic, Pediatric, etc., depending on the specific probe).
Technological Characteristics: Utilizes Doppler shift principle to detect blood flow; generates, transmits, processes, and displays ultrasonic signals; compatible with various Doppler ultrasound probes (1.6 MHz, 2 MHz, 4 MHz, 8 MHz, 16 MHz, 20 MHz, unfocussed PW/CW modes).	Both systems utilize the well-understood principle of Doppler shift. They generate, transmit, receive an ultrasonic signal, then process and display the Doppler signal. The systems are compatible with the described range of probes and modes, which are consistent with the predicate device.
Safety and Effectiveness: Does not raise new questions of safety or effectiveness compared to predicate devices.	"The indications, intended use and technology of the modified Pioneer TC8080 and Companion III devices are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised." This is the concluding statement of the 510(k) summary.

2. Sample size used for the test set and the data provenance

Sample size for test set: Not applicable. This 510(k) likely did not involve a specific "test set" of patient data for performance evaluation in the way a de novo device would. The evaluation focused on comparing specifications and intended use to predicate devices.
Data provenance: Not applicable for a traditional test set. The data provenance would be the technical specifications, design documents, and regulatory clearances of the predicate devices (K864695, K020754, K011224).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There was no "ground truth" derived from expert consensus on patient data described in this 510(k) for a standalone performance study. The ground truth for substantial equivalence is based on the legally marketed status and specifications of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication method for a test set is described.

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

Not applicable. This device is an ultrasonic pulsed Doppler imaging system, not an AI-assisted diagnostic tool for which an MRMC study comparing human readers with and without AI assistance would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a Doppler ultrasound system, not an algorithm, so a "standalone" algorithm performance study is not relevant in this context. Its performance is inherent in its physical and technological capabilities as a medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the conventional sense of a clinical study. The "ground truth" here is regulatory: the predicate devices are legally marketed and considered safe and effective for their intended uses. The new device demonstrates equivalence to these established predicate devices.

8. The sample size for the training set

Not applicable. This device does not use an "algorithm" in the sense of machine learning that requires a training set. The development of the device is based on established engineering principles and medical physics.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an algorithm described.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for VIASYS Healthcare. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name is the tagline "Excellence For Life" in a smaller, italicized font.

NEUROCARE GROUP

Nicolet Riomedical • GM • Nicolet Vascular

510(k) Summary

JAN 2 4 2006

Company Name:	VIASYS NEUROCARE5225 Verona RoadMadison, WI 53711
Contact:	Glen Hermanson, Global Manager, Quality Engineering
Phone:	608 441-2065
Fax:	608 441-2007
Summary Date:	December 27, 2005
Trade Name:	Pioneer TC8080, Companion III
Common Name:	Ultrasonic Pulsed Doppler Imaging System
Classification Name:	21 CFR 882.1550: Product Code: IYN21 CFR 892.1579; Product Code: ITX
Predicate Device(s):
	510(k) Number: K864695
	Manufacture: EME
	Trade Name: EME TC2-64B
	510(k) Number: K020754
	Manufacture: Nicolet Biomedical
	Trade Name: Pioneer TC8080
	510(k) Number: K011224
	Manufacture: Advanced Technology Laboratories. Inc.
	Trade Name: HDI* 5000 Ultrasound System

Description of Device 1 .()

Page 1 of 2

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K053649
PRY 2 of 2

the returning signal, is detected as a frequency shifted signal. The amount of frequency shift is a function of the velocity of the flowing blood. These systems generate, transmit and receive an ultrasonic signal, then process and display the Doppler signal returning from the anatomy.

2.0 Intended Use

The modified Pioneer TC8080 and Companion III are applied to indicate blood flow by application of Doppler ultrasound technology. Reference the accompanying Indication for Use Forms.

3.0 Technological

Doppler ultrasound probes with a variety of modes of operation are available for use with the systems. The 1.6 MHz probe is an unfocussed pulsed wave Doppler probe (PW). The 2 MHz probes (15-mm diameter and 10 mm diameter) are unfocussed PW Doppler probes. The 4 MHz and 8 MHz probes are unfocussed probes that operate in continuous wave (CW) or PW Doppler mode. The 16 MHz and 20 MHz Microvascular probes (1.5 mm and 2.0 mm diameter) are unfocussed PW Doppler probes. The ultrasound probes do not directly contact the blood and are not implantable.

4.0 Conclusions

The indications, intended use and technology of the modified Pioneer TC8080 and Companion III devices are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services (USA). The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle's head and neck, composed of three curved lines.

JAN 2 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Viasys Neurocare % Mr. Gary Syring Principle Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane STOUGHTON WI 53589

Re: K053648

Trade Name: Pioneer TC8080 / Companion III Doppler Ultrasound 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: December 27, 2005 Received: December 30, 2005

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 Pioneer TC8080 / Companion III Doppler Ultrasound Systems, as described in your premarket notification:

Image /page/2/Picture/11 description: The image shows the FDA Centennial logo. The logo is a circular seal with the letters "FDA" in the center. The words "Centennial" are below the letters. The text "Protecting and Promoting Public Health" is below the logo.

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Transducer Model Number

1.6 MHz Probe 2 MHz Probe 4 MHz Probe 8 MHz Probe 16 MHz Probe 20 MHz Probe

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

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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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Nancy C Bigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Pioneer TC 8080

ー

: · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

. -- -- -

Appendix F

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic uttrasound imaging or fluid flow anaiysis of the human body as follows:

							Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic				N
Fetal
Abdominal
Intraoperative (specify)				N
Intraoperative Neurological				N
Pediatric				N
Small Organ (specify)
Neonatal Cephalic				N
Adult Cephalic				P
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P	P
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)
N= new indication; P= previously cleared by FDA; E= added under Appendix EAdditional Comments: P = Cleared to market by 510(k) K020754The Pioneer TC8080 applies ultrasound probes of 1.6 MHz Pulsed Wave (PW).2 MHz PW, 4 MHz PW and Continuous Wave (CW), 8 MHz PW/CW.
16 MHz PW and 20 MHz PW. Intraoperative: Transcranial and Intracranial DopplerMonitoring, Carotid Monitoring, Microvascular Blood Flow, Emboli Detection.
							(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)					F-3
(Division Sign-Off)Division of Reproductive, Abdominal,and Radiological Devices510(k) Number

..... . . . .

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Companion HI

.- -

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		PWD CWD	AmplitudeDoppler
	Ophthalmic	N
	Fetal
	Abdominal
	Intraoperative (specify)	N
	Intraoperative Neurological	N
	Pediatric	N
	Small Organ (specify)
	Neonatal Cephalic	N
	Adult Cephalic	F
	Cardiac
	Transesophageal
	Transrectal
	Transvaginal
	Transurethral
	Intravascular
	Peripheral Vascular	E	E
	Laparoscopic
	Musculo-skeletalConventional
	Musculo-skeletal Superficial
	Other (specify)
	N= new indication: P= previously cleared by FDA; E= added under Appendix E

	Additional Comments: E – Cleared to market by 510(k) K020754 as a non-significant change to
	The Pioneer TC8080. The Companion III applies ultrasound probes of 1.6 MHz Pulsed Wave

	2 MHz PW, 4 MHz PW and Continuous Wave (CW), 8 MHz PW/CW,
	16 MHz PW and 20 MHz PW. Intraoperative: Transcranial and Intracranial DopplerMonitoring, Carotid Monitoring, Microvascular Blood Flow, Emboli Detection.

				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)

			1-3
(Division Sign
Division of Re	productive, Abdominaland Radiological Devices

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1.6 MHz Probe for Pioneer TC8080 and Companion III

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	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)				N
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic				P
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo skeletal Conventional
Musculo-skeletal Superficial

Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: P Cleared to market by 510(k) K020754

Intraoperative: Transcranial Doppler Monitoring, Emboli Detection.

(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)

F-3

Nancyc bradon

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices K053648

510(k) Number

Page A - 4

: :

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...

Appendíx 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	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic				N
Fetal
Abdominal
Intraoperative (specify)				N
Intraoperative Neurological
Pediatric				N
Small Organ (specify)
Neonatal Cephalic				N
Adult Cephalic				P
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				N
Laparoscopic
Musculo skeletalConventional
Musculo-skeletal Superficial
Other (specify)

(Division Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

Page A - 5

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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	PWD	CWD
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)	N
Intraoperative Neurological
Pediatric	N
Small Organ (specify)
Neonatal Cephalic	N
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)
N= new indication; P= previously cleared by FDA; E= added under Appendix EAdditional Comments: P-Cleared to market by 510(k) K020754Intraoperative: Extracranial carotid monitoring.

(Division Sign-Off Division of Reproductiv and Radiological Devices 510(k) Number .

Page A - 6

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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)				N
Intraoperative Neurological
Pediatric				N
Small Organ (specify)
Neonatal Cephalic				N
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P	P
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)
N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: P = Cleared to market by 510(k) K020754

Intraoperative: Extracranial carotid monitoring.

(PLEASE DO NOT WRITE BELOW THIS LIKE . CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801 109)

Nancut Snordon
F 3

(Division Sign-Off) Division of Reproductive, Abdon inal, and Radiological Devices 510(k) Number

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。

and Radiological Devices

510(k) Number _

Appendix F

Page A - 8

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)				N
Intraoperative Neurological				N
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)	N= new indication; P= previously cleared by FDA; E= added under Appendix EAdditional Comments: P - Cleared to market by 510(k) K020754Two crystal diameters are indicated: 1.5 mm diameter and 2.0 mm diameterIntraoperative: Microvascular Blood Flow.
(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)

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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)				N
Intraoperative Neurological				N
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:							P - Cleared to market by 510(k) K020751

Two crystal diameters are indicated: 1.5 mm diameter and 2.0 mm diameter

Intraoperative: Microvascular Blood Flow.

(PLEASE DO NOT WRITE HE LOW THIS LINE . CONTINUE ON ANOTHER PAGE IN NEEDED) Concurrence of CDRH, Office of Dovice Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy Broydon

(Division Division of Reproductive, A bdominal and Radiological Devices 510(k) Number

Page A - 9

Regulation Number and Section

§ 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.