The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (abdominal, vascular), Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Intravascular, Peripheral vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

Device Description

The Siemens Acuson X300 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACUSON X300™ Ultrasound System, based on your requested information:

This device is a diagnostic ultrasound system and as such, the submission primarily focuses on meeting regulatory safety and performance standards for ultrasound devices, not on diagnostic accuracy for specific conditions (which AI/ML devices typically address). Therefore, many of your requested items regarding AI/ML clinical study specifics are not applicable or explicitly stated in this type of submission.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance (Compliance)
Product Safety Standards	UL 60601-1	Met
	IEC 60601-2-37	Met
	CSA C22.2 No. 601-1	Met
	AIUM/NEMA UD-3	Met
	AIUM/NEMA UD-2	Met
	93/42/EEC Medical Devices	Met
EMC Requirements	EN/IEC 60601-1	Met
	EN/IEC 60601-1-1	Met
	EN/IEC 60601-1-2	Met
Acoustic Power	IEC 61157 Declaration	Met
Biocompatibility	ISO 10993-1	Met
Substantial Equivalence	Intended Use	Substantially Equivalent
	Technological Characteristics	Substantially Equivalent
General Controls	Annual registration	Complies
	Listing of devices	Complies
	Good manufacturing practice	Complies
	Labeling	Complies
	Prohibitions against misbranding and adulteration	Complies
Post-clearance Special Report	Acoustic output measurements based on production line devices (Appendix G of Center's document)	A condition for marketing; to be submitted post-clearance.

Study Information (as applicable to a conventional ultrasound device 510(k) submission):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This submission does not describe a clinical study in the sense of testing image interpretations or diagnostic accuracy on a patient data set. The performance data mentioned is related to engineering verification and validation against regulatory safety and performance standards. Therefore, an explicit "test set" sample size or data provenance for patient data is not provided. The testing would involve engineering and physics measurements on the device itself.
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):
- Not applicable. This device is an ultrasound system, not an AI/ML diagnostic aid that relies on expert ground truth for image interpretation. The "ground truth" here would be established by validated engineering tests and compliance with recognized standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no clinical test set requiring adjudication in this type of submission.
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:
- No MRMC study was done. This is not an AI/ML device, and no AI assistance is mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-only device. It's a complete ultrasound system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" as described in the submission is compliance with established engineering, safety, and performance standards (e.g., UL, IEC, NEMA, ISO). These standards define acceptable acoustic output, electrical safety, EMC, and biocompatibility, as well as the system's ability to perform its intended imaging and measurement functions reliably.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set in that context. The "training" here refers to the engineering design and development process that ensures the device meets its specifications.
How the ground truth for the training set was established:
- Not applicable. As above, there is no AI/ML training set. The "ground truth" for the device's design and development comes from the aforementioned regulatory and engineering standards.

Summary of the K072676 Submission:

This 510(k) submission for the Siemens ACUSON X300™ Ultrasound System is a "Special 510(k) Submission," indicating it's for modifications to an already cleared device (K071036, K061946). The core of the submission is to demonstrate that the modified device remains substantially equivalent to its predicate device in terms of intended use and technological characteristics.

The "Performance Data" section explicitly states: "The Acuson X300 modifications are verified and validated according to the company's design control process." This indicates that the performance criteria are primarily engineering and regulatory compliance, ensuring the device continues to meet all relevant safety (e.g., electrical, acoustic output, biocompatibility) and functional standards for diagnostic ultrasound systems. The FDA's clearance letter also emphasizes compliance with general controls, and notably, requires a post-clearance special report for acoustic output measurements, which is a critical safety parameter for ultrasound devices.

Summary

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K072676

Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON X300™ Ultrasound System Special 510(k) Submission

Product Code 74-DQO

SECTION 11

510(k) Summary

Sponsor:	Siemens Medical Solutions USA, Inc.,Ultrasound Division1230 Shorebird WayMountain View, California 94043
Contact Person:	Martina Vogt
	Telephone:	(425) 557 1434
	Fax:	(425) 391 9198
Submission Date:	September 19, 2007
Device Name:	ACUSON X300™ Diagnostic Ultrasound SystemSONOVISTA X300 Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:
Regulatory Class:	II
Review Category:	Tier II
Classification Panel:	Radiology
Ultrasonic Pulsed Doppler Imaging System	FR # 892.1550	Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System	FR # 892.1560	Product Code 90-IYO
Diagnostic Ultrasound Transducer	FR # 892.1570	Product Code 90-ITX

A. Legally Marketed Predicate Devices

Diagnostic Intravascular Catheter

The Siemens Acuson X300 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens Acuson X300 ultrasound system (K071036, K061946).

FR # 870.1200

B. Device Description:

The Siemens Acuson X300 has been designed to meet the following product safety standards:

동 UL 60601-1, Safety Requirements for Medical Equipment
E IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
I AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
I 93/42/EEC Medical Devices Directive
Safety and EMC Requirements for Medical Equipment
- 트 EN/IEC 60601-1
- . EN/IEC 60601-1-1
- EN/IEC 60601-1-2
트 IEC 61157 Declaration of Acoustic Power
1 ISO 10993-1 Biocompatibility

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C. Intended Use

D. Substantial Equivalence

The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.

E. Performance Data

The Acuson X300 modifications are verified and validated according to the company's design control process.

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Image /page/2/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, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2007

Ms. Martina Vogt Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 1230 Shorebird Way MOUNTAIN VIEW CA 94043

Re: K072676

Trade/Device Name: ACUSON X300 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and DQO Dated: November 14, 2007 Received: November 15, 2007

Dear Ms. Vogt:

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 ACUSON X300 Diagnostic Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

P5-1 Phased Array

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

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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 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 Lauren Hefner at (240) 276-3666.

Sincerely yours,

Nancy C. Brogdon

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

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SECTION 7

Intended Use of the Device

Intended Use:

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

forui Thihhay

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _ HO72 Co

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Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

Diagnostic 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		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Intraoperative(Note 6)		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
IntraoperativeNeurological		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Transesophageal		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transurethral
Intravascular		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Other (specify)		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10

N = new indication; P = previously cleared by K071036; E = added under Appendix E

For example: breast, testes, thyroid, penis, prostate, etc Note 1

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging
Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

SieClear multi-view spatial compounding Note 8
Tissue Equalization Technology Note 9
Note 10 Intracardiac imaging

etc.
(Division Sign-Off)

Division of Reproductive, Abdominal Radiological Devices 510(k) Number J KO + 26

(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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Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

P5-1 Phased Array Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems Diagnostic 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		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,9
Abdominal		N	N	N	N	N	N		BMDC	Note 2,3,5,6,7,8,9
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)
Neonatal Cephalic		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,9
Cardiac		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)
N = new indication; P = previously cleared by FDA; E = added under Appendix/ENote 1 For example: breast, testes, thyroid, penis, prostate, etc.Note 2 Ensemble tissue harmonic imagingNote 3 3D imaging

vote B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Note 8 SieClear multi-view spatial compounding

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

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

Radiological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

(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)

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.