Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ultrasound device and does not mention any AI or ML capabilities, image processing, or details about training/test sets typically associated with AI/ML devices.

Therapeutic

No
The device is described as a "Diagnostic ultrasound imaging or fluid flow analysis" device and its function is to support "blood flow evaluation," indicating it is used for diagnosis, not treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body".

SaMD (Software as a Medical Device)

No

The device description explicitly states it "applies ultrasound probes" and lists specific probe frequencies, indicating it includes hardware components (the probes) in addition to any potential software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The intended use is "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device that interacts directly with the patient's body to obtain information, not a device that analyzes samples taken from the body (which is the hallmark of an IVD).
Device Description: The description details the application of ultrasound probes to the human body for blood flow evaluation. This is consistent with an in-vivo diagnostic device.
Anatomical Site: The specified anatomical sites (Adult Cephalic, Peripheral Vascular) are locations on the human body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are typical components of IVD descriptions.

Therefore, this device is a diagnostic ultrasound device used for in-vivo examination, not an in-vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body

Product codes (comma separated list FDA assigned to the subject device)

90 IYN, ITX

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Adult Cephalic, Peripheral Vascular

Indicated Patient Age Range

Adult

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.

K993939

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

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.

Summary

0

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

1

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)

2

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional
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 _

3

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)
1
C
A 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

4

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional
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

5

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

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

6

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional
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

8

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional
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