Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transcranial (Adult Cephalic) and Peripheral Vascular Diagnostic Device

Device Description

The 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 to support Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation.

AI/ML Overview

This document is primarily a 510(k) cleared device notification letter, which indicates the device, Pioneer TC8080, is substantially equivalent to legally marketed predicate devices. It also lists the intended uses and associated transducers.

Crucially, this document does NOT describe specific acceptance criteria or an analytical study with performance metrics. The tables provided are "Diagnostic Ultrasound Indications for Use Forms," which specify the clinical applications and modes of operation for various transducers. They do not contain any quantitative performance data, sample sizes, expert qualifications, or details about ground truth establishment.

Therefore, many of the requested items cannot be answered from the provided text.

Here's an attempt to answer what can be gleaned from the document, with explicit indications of missing information:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The tables are "Indications for Use" forms, not performance results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

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

This information is not provided in the document.

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

This information is not provided in the document. The device is an ultrasound system with transducers, not an AI software.

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

This information is not provided in the document. The device is a hardware ultrasound system with transducers.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary of what the document does provide:

The document is a 510(k) clearance letter from the FDA for the Pioneer TC8080 Ultrasonic pulsed doppler imaging system and associated diagnostic ultrasonic transducers.

Device Name: Pioneer TC8080
Device Type: Ultrasonic pulsed doppler imaging system and diagnostic ultrasonic transducers
Intended Uses (as per the "Diagnostic Ultrasound Indications for Use Form"):
- Diagnostic ultrasound imaging or fluid flow analysis of the human body.
- Specific clinical applications and modes of operation (PWD = Pulsed Wave Doppler, CWD = Continuous Wave Doppler) are indicated by 'N' (new indication), 'P' (previously cleared by FDA), or 'E' (added under Appendix E).
Here's a summary of the indicated uses for various transducers:

For the Pioneer TC8080 system generally (implied for various transducers due to overall statement):
- Adult Cephalic: PWD (N)
- Peripheral Vascular: PWD (N), CWD (N)
Specific Transducer Applications:
- 1.6 MHz Pulsed Wave (PW): Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (Indicated as "E" for Adult Cephalic PWD in one form).
- 2 MHz PW: Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (Not explicitly shown as an 'N', 'P', or 'E' in the provided tables for specific clinical applications, but mentioned in the general comments).
- 4 MHz PW and Continuous Wave (CW): Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (One form indicates "P" for Adult Cephalic PWD, referring to previous clearance K993939).
- 8 MHz PW/CW: Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (One form indicates "P" for Peripheral Vascular PWD and CWD, referring to previous clearance K993939).
- 16 MHz PW: Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (One form indicates "N" for Peripheral Vascular PWD, for a microvascular transducer with 1.5mm and 2.0mm crystal diameters).
- 20 MHz PW: Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (One form indicates "N" for Peripheral Vascular PWD, for a microvascular transducer with 1.5mm and 2.0mm crystal diameters).
Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices. This typically means the device has the same intended use and technological characteristics as a predicate, or if there are differences, they do not raise different questions of safety and effectiveness. The specifics of the comparison to predicate devices are not in this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

APR 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nicolet Vascular Division of VIASYS Healthcare % Mr. Gary Syring Regulatory Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane STOUGHTON WI 53589

Re: K020754

Trade Name: Pioneer TC8080 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: 90 IYN and ITX Dated: February 3, 2003 Received: February 5, 2003

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, as described in your premarket notification:

Transducer Model Number

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

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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 (OS) 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 contact the Office of Compliance at (301) 594-4591. Additionally, for 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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

Sincerely vours.

David A. Lyman

for

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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System: Pioneer TC8080 Transcranial (Adult Cephalic) and Peripheral Vascular Diagnostic Device

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)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic				N
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				N	N
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: The 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 to support Transcranial Doppler (TCD) Adult Cephalic and

Peripheral Vascular blood flow evaluation.

(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)

David R. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiglogical Devices 510(k) Number _

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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)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic				E
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)1CA 1	******************************************************************************************************************************************************************************			-1 ------- -1 L. Pro A .	ﺎ	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	A	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------L

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

Additional Comments: E - 1.6 MHz Pulsed Wave

(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)

Division Sign-Off

Division of Reproductive, Abdomina ge B-3 cal Devices

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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)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic				P
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficiai
Other (specify)

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

Additional Comments: P - Same probe (Transducer) cleared to market by K993939

Two (2) crystal diameters are indicated: 10 mm diameter and 15 mm diameter.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Eyalfuation

Daniel R. Logemann
Division Sign Off

of Reproductive, Abdomina and Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

F-3

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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:

	A	PWD	CWD
Clinical Application	Mode of Operation
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
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 - Same probe (Transducer) cleared to market by K993939

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109)

Page B-5

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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)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
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 - Same probe (Transducer) cleared to market by K993939

(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)

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

{7}------------------------------------------------

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)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				N
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: N - 16 MHz PW microvascular transducer for peripheral

vascular blood flow evaluation.

Two (2) crystal diameters are indicated: 1.5 mm and 2.0 mm.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERL
Concurrence of CDRH, Office of Device Evaluation (ODM)

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

Prescription Use (Per 21 CFR 801.109)

Page B-7

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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)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				N
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: N - 20 MHz PW microvascular transducer for peripheral vascular blood flow evaluation.

Two (2) crystal diameters are indicated: 1.5 mm and 2.0 mm.

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

Daniel A. Lyman
(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Devices Page B 510(k) Number _

Prescription Use (Per 21 CFR 801.109)

F-3

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.