NEMIO XG, SAA-580A by TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

The Nemio XG system 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, musculo-skeletal (both conventional and superficial).

Device Description

The Nemio XG will be offered in one variation which is a mobile system. It is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.

AI/ML Overview

This document is a 510(k) summary for the Toshiba Nemio XG, SSA-580A Ultrasound Imaging System. It declares substantial equivalence to a predicate device (Toshiba SSA-550A/NEMIO, K010631) rather than presenting a study to prove new acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for a novel device is not applicable or not provided in this 510(k) summary.

The document primarily focuses on establishing equivalence and listing the intended uses and associated transducers.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present quantitative acceptance criteria or device performance data for the Nemio XG, SSA-580A. Instead, it relies on demonstrating substantial equivalence to a previously cleared device (K010631). The premise of a 510(k) submission is that if a new device is substantially equivalent to a legally marketed predicate device, it meets the same safety and effectiveness standards.

The acceptance criteria implicitly refer to the continued satisfactory performance of the predicate device (SSA-550A/NEMIO) and the new device's ability to maintain that level of performance for its stated intended uses.

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Device is substantially equivalent to predicate device K010631	"This unit is similar to that of the Toshiba SSA-550A/NEMIO and engineering assessments identify no new issues of risk or safety."
Meets safety standards	"The device is designed and manufactured in conjunction with the Quality System Regulation, IEC- 60601 (applicable portions), and IEC 60601-2-37. international standard for ultrasound safety." (This is a statement of compliance with standards, not performance results).
Performs for stated intended uses	The device is intended for the same types of studies as the predicate device, including fetal, abdominal, pediatric, small organs, neonatal/adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (conventional and superficial). The numerous transducer tables show that existing indications ("P") for the predicate are maintained.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This is a 510(k) submission asserting substantial equivalence, not a clinical study with a test set of data. The "test" for this type of submission involves demonstrating that the new device's technological characteristics, intended use, and safety/effectiveness are comparable to the predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable for this 510(k) submission. This process does not involve expert adjudication of a test set for a new algorithm's performance. The "ground truth" here is the established safety and effectiveness of the predicate device.

4. Adjudication Method for the Test Set:

Not applicable. No test set was used in the context of comparing a new device's performance against ground truth created by expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This document pertains to an ultrasound imaging system, not an AI-assisted diagnostic tool. No MRMC study is mentioned or implied.

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

Not applicable. This is not an AI algorithm but an ultrasound imaging system.

7. The Type of Ground Truth Used:

The ground truth implicit in a 510(k) substantial equivalence submission is the established safety and effectiveness of the legally marketed predicate device (Toshiba SSA-550A/NEMIO, K010631). The new device is deemed "substantially equivalent" if it can demonstrate it performs as safely and effectively as this predicate, without raising new questions of safety or effectiveness.

8. The Sample Size for the Training Set:

Not applicable. The Nemio XG is an ultrasound system and does not involve AI/machine learning requiring a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As above, there is no AI component or training set discussed in this 510(k) summary.

Summary

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JUN 2 2 2006

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

Submitter's Name:	Toshiba America Medical Systems, Inc.
Address:	P.O. Box 2068,2441 Michelle Drive Tustin, CA 92781-206
Contact:	Paul Biggins, Regulatory Affairs Specialist
Telephone No.:	(714) 730-5000
Device Proprietary Name:	Nemio XG, SSA-580A
Common Name:	Ultrasound Imaging System
Classification:
Regulatory Class:	II
Review Category:	Tier II
	Ultrasonic Pulsed Doppler Imaging System - Procode: 90-IYN[Fed.Reg.No.:892.1550]
	Ultrasonic Pulsed Echo Imaging System - Procode: 90-IYO[Fed.Reg.No.:892.1560]
	Diagnostic Ultrasonic Transducer - Procode: 90-ITX

[Fed. Reg. No .: 892.1570]

Identification of Predicate Devices:

Toshiba America Medical Systems believes that this device is substantially equivalent to the Following device; SSA-550A/NEMIO Diagnostic Ultrasound System, 510(k) control number K010631.

Device Description:

Intended Use:

Safety Considerations:

The device is designed and manufactured in conjunction with the Quality System Regulation, IEC- 60601 (applicable portions), and IEC 60601-2-37. international standard for ultrasound safety. This unit is similar to that of the Toshiba SSA-550A/NEMIO and engineering assessments identify no new issues of risk or safety.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 222 2006

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

Re: K061605

Trade Name: NEMIO XG SSA-580A Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 6, 2006 Received: June 9, 2006

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 NEMIO XG SSA-580A Diagnostic Ultrasound System as described in your premarket notification:

Image /page/1/Picture/11 description: The image is a circular logo with the letters "FDA" in a stylized font at the center. Above the letters, the text "THE THE" is arranged in an arc. Below the letters, the word "Centennial" is written in a cursive font. The entire logo is surrounded by a dotted circle, with additional text following the curve of the circle. The text is difficult to read due to the image quality.

oling Public . I

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Transducer Model Number

PLM-703AT
PC-19M
PSM-20CT
PSM-30BT
PEF-510MB
PVM-651VT
PSM-375AT
PLM-1202S
PVM-740RT

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

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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

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

Sincerely yours.

Daniel A. Segrem

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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Diagnostic Ultrasound Indications for Use Form

System _X Transducer Model Nemio XG, SSA-580A 510(k) Number(s)

K$\phi$61 6$\beta$S

Mode of Operation PWD CWD Amplitude B M Color Color A Combined Harmonic Clinical Application Doppler Doppler Velocity (Specify) Imaging Imaging Ophthalmic N N Z N Fetal N N N N ત્ત્વ N N N N N N Abdominal N N પ N N Intraoperative (Specify) N N N N N N Intraoperative Neurological Pediatric N N N N N N N N N Small Organ (Specify) N N N N N N N N N N N N N Neonatal Cephalic N N N N N N Adult Cephalic N N N N N N N N N N N N N Cardiac N N N N N N N N N N N Transesophagea! N N N N N N N N N Transrectal N N N N N N N N Transvaginal Transurethral Intravascular N N N N Peripheral Vascular N N N N Laparoscopic Musculo-skeletal Superficial N N N N N N N N N N N N N Musculo-skeletal N N N Conventional N N N N N N N Endoscopic Other (specify)

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; B-TDI; M-TDI

RI EASE DO NOT VIRTIE REI OW THIS LINE. CONTINUE ON OTHER RAGES IC Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Daniel B. Ingram

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DUCER TABLE
Kp616ø2

Transducer Model Number: PLM-703AT 510(k) Control Number:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric
Small Organ (Specify)		P	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	P
Laparoscopic
Musculo-skeletal Superficial		P	P	P		P	P	P	P	P
Musculo-skeletal		P	P	P		P	P	P	P	P
Conventional
Other (specify)

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; B-TDI; M-TDI

Previous 510(k) control # K010361

Concurrence of CDRHI, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Eavid H. Legman

(Division Sign-Off) Division of Reproductive, At ാൻ Radiological Devices != 10(k) Number

{6}------------------------------------------------

Transducer Model Number: PC-19M 510(k) Control Number:

Kp616ø5

		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					P
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac					P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletalConventional
Other (specify)

N= new indication: P = Previously Cleared by FDA = E = Added under Appendix 8 (510(k)

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

Additional Comments:

Previous 510(k) control # K010361

EDO Concurrence of CDRH, Office of Device Eve

David A. Hanson

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

Prescription Use (Per 21 CFR 801.109)

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

Transducer Model Number: PSM-20CT 510(k) Control Number:

Kg616øS

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric
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
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletalConventional
Other (specify)

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

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

Previous 510(k) control # K010361

Previous 510(k) Control # k01036 1
(Previous Province of CDRH, Office of Device of Device Evaluation (ODE)
Concurrence of CDRH, Office of DRH, Office of Device Evaluation (OD

David h. Ayerson

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

Prescription Use (Per 21 CFR 801.109)

{8}------------------------------------------------

Transducer Model Number: PSM-30BT 510(k) Control Number:

Kp614øS

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal		E	E	E	E	E	E	E	E	E
Intraoperative (Specify)
Intraoperative Neurological
Pediatric		E	E	E	E	E	E	E	E	E
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		E	E	E	E	E	E	E	E	E
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

Added under appendix E to 510(k) control # K010361 ow This Ling CONTINUE ON OTHE

TE DO NOT WATE BEL Concurrence of CDRH, Office of Device Evaluation

David A. Hanson

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices >10(k) Number _

Prescription Use (Per 21 CFR 801.109)

{9}------------------------------------------------

Transducer Model Number: PEF-510MB 510(k) Control Number:

K461605
---------

			Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
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	P
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

Additional Comments: ______________________________________________________________________________________________________________________________________________________ TDI; M-TDI ___________________________________________________________________________________________________________________________________________________________________

Previous 510(k) control # K010361

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Leggett

(Division Sign-Off)
Division of Reproductive, Abdominal,
And Radiological Devices
K Number
K0610

Prescription Use (Per 21 CFR 801.109)

.. ...

14.00

{10}------------------------------------------------

11661609

Transducer Model Number: PVM-651VT 510(k) Control Number:

		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		P	P	P		P	P	P	P	P
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal
Conventional
Other (specify)

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

Previous 510(k) control # K010361 C

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

David A. Seymann

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

Prescription Use (Per 21 CFR 801.109)

{11}------------------------------------------------

Transducer Model Number: PSM-375AT 510(k) Control Number:

Kd616b5

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal		P	P	P		P	P	P	P	P
Abdominal		P	P	P		P	P	P	P	P
Intraoperative (Specify)
Intraoperative Neurological
Pediatric		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
Other (specify)
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

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

Previous 510(k) control # K010361

Previous 510(k) control # k01036 1
Previous S10(k) Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Sypon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K06160

Prescription Use (Per 21 CFR 801.109)

...

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Transducer Model Number: PLM-1202S 510(k) Control Number:

/124ાજ	0	વિત્ત1
----------------	---	------------

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic
Fetal
Abdominal
Intraoperative		P	P	P		P	P	P	P	P
Intraoperative Neurological
Pediatric
Small Organ (Specify)		P	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	P
Laparoscopic
Musculo-skeletal Superficial		P	P	P		P	P	P	P	P
Musculo-skeletal		P	P	P		P	P	P	P	P
Conventional
Other (specify)

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

Previously Cleared by FDA; E dication; } e Added under Appendix E (L

Previous 510(k) control # K010361

Previous 510(k) control # K010361
(ELLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER EAGES IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Leggett

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices . 04:10 Number - ---------

Prescription Use (per 21 CFR 801.109)

{13}------------------------------------------------

Transducer Model Number: PVM-740RT 510(k) Control Number:

ER TABLE

Kf616ф5

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

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

Combined Modes: B/M; B/EWD; BDF/EWD; BDF/MDF; B-Additional Comments: TDI; M-TDI

Previous 510(k) control # K010361

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

David Ch. Wegman

(Division Sign-Off) Amsion of Reproductive, Abdomina " Dadiological Devices : 99kj Number

Prescription Use (per 21 CFR 801.109)

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.