The Diasus Ultrasound Imaging system is intended for performing no-invasive diagnostic general ultrasound studies. Such uses include the following; Abdominal, Cardiac, Paediatric, Small organs including, Thyroid, Parathyroid, Breast and Testes, Neonatal / adult cephalic, Peripheral vascular, and Conventional / Superficial Musculoskeletal.

Diagnostic Ultrasound imaging of the human body as follows: Abdominal, Pediatric, Small Organ (Thyroid, Parathyroid, Breast and Testes in adult, paediatric and neonatal patients), Neonatal Cephalic, Adult Cephalic, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Includes imaging for needle guidance.

Device Description

Diagnostic Ultrasound System with Accessories

AI/ML Overview

The provided text is a 510(k) summary for the Diasus Diagnostic Ultrasound System. It primarily focuses on establishing "substantial equivalence" to predicate devices, rather than detailing a specific clinical study with acceptance criteria and performance metrics for a novel AI device.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as it describes a traditional medical device clearance process based on technological equivalence.

However, I can extract the information that is present and indicate where the requested information is not available in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Characteristic	Acceptance Criteria (Predicate Device K#990360, K#980468, K#944485)	Reported Diasus Performance
Transducer types	Annular Array, Mechanical Sector, Linear, Convex, Phased Array	Same as predicate
Frequency (MHz)	2.5 to 20 MHz	5 to 22 MHz
Imaging Modes (B, M, PWD, CWD, Color Doppler CFM, Amplitude Doppler PD, Colour Velocity Imaging (only K#944485), Combined)	Yes for specified modes	Yes for specified modes
Cine Loop Facility	Yes	Yes
Biopsy attachments	Linear Array, Convex (for AU6, AU5) / Linear Array (for AU4)	Linear Array
Measurements (Distance, Area, Circumference)	Yes	Yes
Monitor Size (nominal)	15 inches / 14 or 12 inches	15 inches
Programmability	10 or 6 presets	Only limited by hard disk size
Computer interface	Centronics output	Centronics output, SCSI in/out port
Printer	Yes	Yes
DICOM communications	N/A (not explicitly listed for predicates)	Yes (optional)
External Dimensions (Width, Height, Depth)	Similar ranges	500mm, 1268mm, 804mm
Standards	IEC601-1	IEC601-1, IEC601-1-2, EN61157, Medical Device Directive CE marked

Note: The acceptance criteria here are implicitly defined by the characteristics of the predicate devices. The "reported device performance" is the Diasus's characteristics, which are presented as being "comparable" and "substantially equivalent" to the predicates. Specific performance metrics (e.g., sensitivity, specificity, accuracy) are not provided, as this is an ultrasound system and not an AI diagnostic device in the modern sense.

2. Sample size used for the test set and the data provenance

Not applicable. This document describes a 510(k) clearance based on substantial equivalence to predicate ultrasound devices. It does not contain information about a test set with patient data for assessing AI algorithm performance. The comparison focuses on hardware specifications, imaging modes, and intended uses.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As above, no test set with ground truth is described.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

Not applicable. This is a hardware ultrasound system, not a standalone algorithm.

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

Not applicable. No specific ground truth methodology is described or required for this type of 510(k) submission focusing on substantial equivalence of a general ultrasound system.

8. The sample size for the training set

Not applicable. This document does not describe an AI system with a training set.

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

Not applicable. This document does not describe an AI system with a training set.

Summary

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K013142

Attachment 2	510(k) SummaryDynamic Imaging Diasus
Submitter	Dynamic Imaging Ltd9 Cochrane SquareBrucefield Industrial ParkLivingstonEH54 9DRUK
OCT - 5 2001	Mr Allan Findlay
Telephone:Fax:Email:	011 44 (0) 1506 415282011 44 (0) 1506 410603a.findlay@dynamicimaging.co.uk
Date prepared	7 August 2001
Propriety Name of Device	Diasus
Common or Usual Name	Diagnostic Ultrasound System with Accessories
Classification Name	Ultrasonic Pulsed Echo Imaging System	FR Number Product Code892.1560 90-IYO
Predicate Devices
Trade name	Manufacturer	510(k)
AU4	Biosound Asaote Inc	K#944485
AU5	Biosound Asaote Inc	K#980468
AU6	Biosound Asaote Inc	K#990360
The Diasus is of comparable type and substantially equivalent to the legally marketed Biosound Asaote IncAU4, AU5 and AU6. It has the same technology characteristics, is comparable in key safety and effectivenessfeatures, and all its intended uses and operating modes are available in the predicative devices.
Additional Substantial Equivalence Information is provided in the following Comparison to Predicate Devicetable.
Intended Uses

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Dynamic Imaging Ltd
510(k) - Diasus - Indications for Use

Attachment 2
Page 2 of 2

Comparison to Predicate Devices

General	Dynamic	Esaote	Esaote	Esaote
Characteristics	Imaging Diasus	AU6	AU5	AU4
		K#990360	K#980468	K#944485
Transducer types		Annular Array	Annular Array	Annular Array
		Mechanical	Mechanical	Mechanical
		Sector	Sector	Sector
	Linear	Linear	Linear	Linear
		Convex	Convex	Convex
		Phased Array	Phased Array	Phased Array
Frequency	5 to 22 MHz	2.5 to 20 MHz	2.5 to 20 MHz	2.5 to 20 MHz
Imaging Modes
A
B	YES	Yes	Yes	Yes
M		Yes	Yes	Yes
PWD		Yes	Yes	Yes
CWD		Yes	Yes	Yes
Colour Doppler CFM		Yes	Yes	Yes
Amplitude Doppler PD		Yes	Yes	Yes
Colour Velocity Imaging				Yes
Combined		Yes	Yes	Yes
Cine Loop Facility	Yes	Yes	Yes	Yes
Biopsy attachments	Linear Array	Linear ArrayConvex	Linear ArrayConvex	Linear Array
Measurements
Distance	Yes	Yes	Yes	Yes
Area	Yes	Yes	Yes	Yes
Circumference	Yes	Yes	Yes	Yes
Monitor Size (nominal)	15 inches	15 inches	15 or 14 inches	14 or 12 inches
Programmability	Only limitedbyhard disk size	10 presets	6 presets
Computer interface	Centronicsoutput	Centronicsoutput	Centronicsoutput	Centronicsoutput
	SCSI in/out port
Printer	Yes	Yes	Yes	Yes
DICOM communications	Yes optional
External Dimensions
Width	500mm	580mm	540mm	500mm
Height	1268mm	11440mm	11440mm	1245mm
Depth	804mm	1100mm	690mm	700mm
Standards	IEC601-1IEC601-1-2EN61157	IEC601-1	IEC601-1	IEC601-1
Medical Device DirectiveCE marked	Yes	Yes	Yes	Yes

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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus, featuring three curved lines that suggest a bird or a flowing design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 5 2001

Dynamic Imaging % R. Kent Donohue Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 RESEARCH TRIANGLE PARK NC 27709

Re: K013142

Trade Name: Diasus Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 ITX Dated: September 17, 2001 Received: September 20, 2001

Dear Mr. Donohue:

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 Diasus, as described in your premarket notification:

Transducer Model Number

P75LHF、
P12LHF------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PIELHE

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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

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".

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

Sincerely yours,

Nancy C. Brogdon
Director, Division of Reproductive

Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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4.3.1 510(k) Indications for Use Form

510K number (if Known) :

K 013142

Device:

Diasus, Diagnostic Ultrasound System

Diagnostic Ultrasound imaging of the human body as follows Intended Use :

	Mode of Operations
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined	Other
Opthalmic
Fetal
Abdominal		N								Note 2
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N								Note 2
Small Organ (Specify)		N								Note 1,2
Neonatal Cephalic		N
Adult Cephalic		N
Cardiac		N
Transesophagael
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N								Note 2
Laparoscopic
Musculo-skeletalConventional		N								Note 2
Musculo-skeletal Superficial		N								Note 2
Other

N = New Indication, P = Previously Cleared by FDA, E = Added under Appendix E Additional Comments :

For Example : Note 1

Thyroid, Parathyroid, Breast and Testes in adult, paediatric and neonatal patients

Note 2

Includes imaging for needle guidance

Prescription Use (as per 21CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013142

Page । उ

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Image /page/6/Picture/0 description: The image shows a logo for Dynamic Imaging Ltd. The text "Dynamic Imaging Ltd" is written in a clear, bold font. Below the company name, it says "510(k) - Diasus". The logo is simple and professional, suggesting a company that specializes in imaging technology.

Indications for Use Form

510K number (If Known) :

K013142

Device:

P75LHF, 5-12MHz Ultra wideband Linear Array Probe

Intended Use :

Diagnostic Ultrasound imaging of the human body as follows

Clinical Application	Mode of Operations
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined	Other
Opthalmic
Fetal
Abdominal		N								Note 2
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N								Note 2
Small Organ (Specify)		N								Note 1,2
Neonatal Cephalic		N
Adult Cephalic		N
Cardiac
Transesophagael
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N								Note 2
Laparoscopic
Musculo-skeletalConventional		N								Note 2
Musculo-skeletal Superficial		N								Note 2
Other

N = New Indication, P=Previously Cleared by FDA, E = Added under Appendix E Additional Comments : For Example : Note 1

Thyroid, Parathyroid, Breast and Testes in adult, paediatric and neonatal patients

Note 2

Includes imaging for needle guidance

Prescription Use (as per 21CFR 801.109)

Ad
(DMision Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K013142
510(k) Number

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Image /page/7/Picture/0 description: The image shows a close-up of a letter, possibly 'D' or 'C', in a bold, black font. The letter is large and fills most of the frame, with only a small portion of the surrounding background visible. The black ink is solid and creates a strong contrast against the white background.

Dynamic Imaging Ltd 510(k) - Diasus

Indications for Use Form

510K number (if Known) :

K 013142

Device:

P12LHF, 8-16MHz Ultra wideband Linear Array Probe

Intended Use :

Diagnostic Ultrasound imaging of the human body as follows

Clinical Application	Mode of Operations
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined	Other
Opthalmic
Fetal
Abdominal		N								Note 2
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N								Note 2
Small Organ (Specify)		N								Note 1,2
Neonatal Cephalic		N
Adult Cephalic		N
Cardiac
Transesophagael
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N								Note 2
Laparoscopic
Musculo-skeletal		N								Note 2
Conventional
Musculo-skeletal Superficial		N								Note 2
Other

N = New Indication, P=Previously Cleared by FDA, E = Added under Appendix E

Additional Comments :

Note 1

For Example : Thyroid, Parathyroid, Breast and Testes in adult, paediatric and neonatal patients

Note 2

Includes imaging for needle guidance

Prescription Use (as per 21CFR 801.109)

(Division Sign-Of
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013142

Page

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Indications for Use Form

510K number (if Known) :

K 013142

Device:

P16LHF, 10-22MHz Ultra wideband Linear Array Probe

Intended Use :

Diagnostic Ultrasound imaging of the human body as follows

Clinical Application	Mode of Operations								Other
A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined
Opthalmic
Fetal
Abdominal		N							Note 2
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N							Note 2
Small Organ (Specify)		N							Note 1,2
Neonatal Cephalic		N
Adult Cephalic		N
Cardiac
Transesophagael
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N							Note 2
Laparoscopic
Musculo-skeletal		N							Note 2
Conventional		N							Note 2
Musculo-skeletal Superficial		N							Note 2
Other

N = New Indication, P=Previously Cleared by FDA, E = Added under Appendix E

Additional Comments :

Note 1

For Example : Thyroid, Parathyroid, Breast and Testes in adult, paediatric and neonatal patients

Note 2

Includes imaging for needle guidance

Prescription Use (as per 21CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K013142
510(k) Number

Page ા ર

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.