Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text does not mention AI, ML, or any related concepts like deep learning or neural networks. The description focuses on standard ultrasound technology and its applications.

Therapeutic

No.
The device is an ultrasound system intended for diagnostic imaging, not for treatment.

Diagnostic

Yes.
Justification: The predicate device, "Toshiba SSA-790A, Aplio XG Version 2.00 Diagnostic Ultrasound," includes "Diagnostic Ultrasound" in its name, indicating that the Xario XG, as a substantially equivalent device, is also a diagnostic device. The "Intended Use" also lists various types of studies that are typically performed for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "mobile system" and employs "a wide array of probes," which are hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device description: The Xario XG is described as an Ultrasound System. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
Intended Use/Indications for Use: The intended uses listed are all related to imaging different parts of the body (fetal, abdominal, cardiac, etc.) using ultrasound. This is consistent with a diagnostic imaging device, not an in vitro diagnostic device.

Therefore, the Xario XG Ultrasound System is a diagnostic imaging device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Xario XG is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

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

90-IYN, 90-IYO, 90-ITX

Device Description

The Xario XG Ultrasound System is a mobile system is a Track 3 device that employs a wide array of probes including, flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System

Anatomical Site

transrectal, transvaginal, transesophageal, fetal, abdominal, intraoperative, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, musculo-skeletal, pediatric, small organs

Indicated Patient Age Range

pediatric, neonatal, adult, fetal

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.

K072000

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

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

Summary

0

K072918

357 9 8 1034

510(k) Summary of Safety and Effectiveness: 21 CFR 807.92

	Submitter's Name: Toshiba America Medical Systems, Inc.
Address:	PO Box 2068, 2441 Michelle Drive Tustin, CA 92781-2068
Contact:	Paul Biggins, Director Regulatory Affairs
Telephone No .:	(714) 730-5000

Device Proprietary Name:	SSA-680A, Xario XG Version 1.00
Common Name:	Diagnostic Ultrasound System

Classification:

Regulatory Class:	II
Review Category:	Tier II

. Ultrasonic Pulsed Doppler Imaging System - Product Code: 90-IYN [Fed. Reg. No.: 892.1550]
. Ultrasonic Pulsed Echo Imaging System - Product Code: 90-IYO [Fed. Reg. No.: 892.1560]
Diagnostic Ultrasonic Transducer Product Code: 90-ITX . [Fed. Reg. No .: 892.1570]

Identification of Predicate Devices:

Toshiba America Medical Systems believes that this device is substantially equivalent to:

Toshiba SSA-790A, Aplio XG Version 2.00 Diagnostic Ultrasound; 510(k) K072000

Device Description:

The Xario XG Ultrasound System is a mobile system is a Track 3 device that employs a wide array of probes including, flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.

Intended Use:

The Xario XG is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

Safety Considerations:

This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-2 (applicable portion), IEC60601-2-37 (applicable portions), and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.

1

Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

27 2 2 2 2

Toshiba America Medical System, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K072918

Trade/Device Name: Xario XG SSA-680A Version 1.0 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: October 11, 2007 Received: October 15, 2007

Dear Mr. Job:

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 Xario XG SSA-680A Version 1.0, as described in your premarket notification:

Transducer Model Number

PVT-375BT PVT-661VT PLT-1202S PC-20M PET-510MB PST-25BT PVT-575MV

2

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 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

3

If you have any questions regarding the content of this letter, please contact Lauren Hefner at . (240) 276-3666.

Sincerely yours,

Vorque M. Whay

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

Enclosure(s)

4

System X Transducer Model_Xario XG SSA-680A Version 1.0 510(k) Number(s)

| Clinical Application | B | THI | M | Color
Doppler | Power | Dynamic
Flow | TDI | PW | CW | CHI
2D | CHI
Dynamic
Flow | Combined
(Specify) |
|----------------------------------|---|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|-----------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | N | N | N | N | N | N | N | N | | | | N |
| Abdominal | N | N | N | N | N | N | N | N | N | | | N |
| Intraoperative (Specify) | N | N | N | N | N | | N | | | | | N |
| Intraoperative
Neurological | | | | | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | N | N | | | N |
| Small Organ (Specify)* | N | N | N | N | N | | N | | | | | N |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | | | N |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | | | N |
| Cardiac | N | N | N | N | N | N | N | N | N | N | | N |
| Transesophageal | N | N | N | N | | | N | N | N | | | N |
| Transrectal | N | N | N | N | N | N | N | N | | | | N |
| Transvaginal | N | N | N | N | N | N | N | N | | | | N |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | N | N | N | N | N | | N | N | | | | N |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal
Superficial | N | N | N | N | N | | N | | | | | N |
| Musculo-skeletal
Conventional | N | N | N | N | N | | N | | | | | N |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments: Combined Modes: B/M; B/PWD; BDF/RWD: BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF

: For example: thyroid, parathyroid, breast, scrotum and penis

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

(Division Sign-off)

Division of Reproductive, Abdominal
Radiological Devices
510(k) Number K0729

A-4

5

Transducer _X System _

PVT-375BT Model_ 510(k) Number(s)

		Mode of Operation
Clinical Application	B	THI	M	Color
Doppler	Power	Dynamic
Flow	TDI	PW	CW	CHI
2D	CHI
Dynamic
Flow	Combined
(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P	P	P
Abdominal	P	P	P	P	P	P	P	P	P
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletal
Conventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previously Cleared 510(k): K072000

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEBDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Amne 7. Wz

Division of Reproductive, Abdomina Radiological Device 510(k) Number

6

Transducer X System __

PVT-661VT_ Model_ 510(k) Number(s)

D-T6 (m) T-mine T2 (-)

		Mode of Operation
Clinical Application	B	THI	M	Color
Doppler	Power	Dynamic
Flow	TDI	PW	CW	CHI
2D	CHI
Dynamic
Flow	Combined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P	P
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletal
Conventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previously Cleared 510(k): K072000

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

Aonald M. White

7

Transducer X System _ PLT-1202S Model

510(k) Number(s)

	Mode of Operation
Clinical Application	B	THI	M	Color
Doppler	Power	Dynamic
Flow	TDI	PW	CW	CHI
2D	CHI
Dynamic
Flow	Combined
(Specify)
Ophthalmic
Fetal
Abdominal						P	P
Intraoperative (Specify)	P	P	P	P	P	P	P
Intraoperative
Neurological
Pediatric						P	P
Small Organ (Specify)*	P	P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P
Laparoscopic
Musculo-skeletal
Superficial	P	P	P	P	P	P	P
Musculo-skeletal
Conventional	P	P	P	P	P	P	P

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previously Cleared 510(k): K072000

(PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

louis m. why

ductive. Abdominal a

A-7

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Transducer X System _

Model_ PC-20M

510(k) Number(s)

	Mode of Operation
Clinical Application	B	THI	M	Color Doppler	Power	Dynamic Flow	TDI	PW	CW	CHI 2D	CHI Dynamic Flow	Combined (Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric									P
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac									P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular									P
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletal
Conventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments:

Previously Cleared 510(k): K072000

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

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Aslon Sign-Off) Division of Reproductive, Abdominal and Radlological Devices 510(k) Number

A-8

9

Transducer X System _ PET-510MB

Model_ 510(k) Number(s)

	Mode of Operation
Clinical Application	B	THI	M	Color
Doppler	Power	Dynamic
Flow	TDI	PW	CW	CHI
2D	CHI
Dynamic
Flow	Combined
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletal
Conventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD;

Previously Cleared 510(k): K072000

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

Aorry M. Wly

bdominal and GA BE REDFE

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Transducer _X System _ PST-25BT Model 510(k) Number(s)

	Mode of Operation
Clinical Application	B	THI	M	Color
Doppler	Power	Dynamic
Flow	TDI	PW	CW	CHI
2D	CHI
Dynamic
Flow	Combined
(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P	P		P
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	P	P	P		P
Small Organ (Specify)*
Neonatal Cephalic	P	P	P	P	P	P		P	P		P
Adult Cephalic	P	P	P	P	P	P		P	P		P
Cardiac	P	P	P	P	P	P		P	P	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletal
Conventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF;

Previously Cleared 510(k): K072000

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

Harry M. Whay

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

11

System __ Transducer X

PVT-575MV Model_ 510(k) Number(s)

STO(k) Number(s)

	Mode of Operation
Clinical Application	B	THI	M	Color
Doppler	Power	Dynamic
Flow	TDI	PW	CW	CHI
2D	CHI
Dynamic
Flow	Combined
(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P	P
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletal
Conventional

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

Previously Cleared 510(k): K072000

(PLEASE DO NOT WRITE BEILOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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