K Number

Device Name

ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124

Manufacturer

ALOKA CO., LTD.

Date Cleared

2002-07-10

(131 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K012253,K012080

Predicate For

N/A

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

For ASU-1003: Fetal, Transvaginal. Mixed mode operation includes B/M-Mode.

For UST-9121: Abdominal. Mixed mode operation includes B/M.

For UST-9124: Fetal, Transvaginal. Mixed mode operation includes B/M.

The transducers are to be used for diagnostic ultrasound imaging in Urological, Abdominal, Intraoperative, Surgical and Endoscopic applications.

Device Description

Diagnostic Ultrasound Transducers

AI/ML Overview

This document describes a 510(k) premarket notification for diagnostic ultrasound transducers (ASU-1003, UST-9121, UST-9124) manufactured by Aloka Co., Ltd. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

The information provided does not contain details about a study conducted to prove the device meets specific acceptance criteria in the way a clinical trial or performance evaluation of an AI/software device would. Instead, this is a regulatory submission for ultrasound transducers, which are hardware components. The "acceptance criteria" here refer to regulatory compliance and demonstrating substantial equivalence to predicate devices, primarily through technical specifications and intended use.

Therefore, many of the requested points regarding acceptance criteria, study design, expert ground truth, and AI performance are not applicable to this document. The document focuses on regulatory classification and comparison to existing products.

Here's an attempt to answer the questions based on the provided text, acknowledging the limitations for an ultrasound transducer submission:

1. A table of acceptance criteria and the reported device performance

For ultrasound transducers, the "acceptance criteria" and "performance" are typically related to their technical specifications (e.g., frequency range, imaging modes, acoustic output) and their equivalence to predicate devices. The document states that the devices are substantially equivalent to their predicates.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Device Regulatory Classification: Be classified as Class II, Tier II, Code 90 ITX (Diagnostic Ultrasound Transducers)	The devices (ASU-1003, UST-9121, UST-9124) are classified as Class II, Review Category Tier II, Code 90 ITX.
Intended Use: Be suitable for diagnostic ultrasound imaging in specified clinical applications.	Aloka SSD-1000 system with these transducers is intended for Urological, Abdominal, Intraoperative, Surgical, and Endoscopic applications. Specific transducers (ASU-1003, UST-9121, UST-9124) have subsets of these applications (e.g., Fetal, Abdominal, Transvaginal).
Technical Equivalence to Predicate Devices: Demonstrate similar fundamental technology, intended use, and performance characteristics to legally marketed predicate devices.	The document explicitly lists predicate devices for each new transducer (ASU-1003 to ASU-1000C-3.5, UST-9121 to UST-9114-3.5, UST-9124 to UST-9103-5) and states substantial equivalence to these predicates.
Acoustic Output Requirements: Meet acoustic output standards (implied by the FDA's request for a postclearance special report on acoustic output).	The FDA requires a postclearance special report containing acoustic output measurements based on production line devices, implying that these measurements must meet approved levels. (Specific levels are not stated in this document).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a clinical study with a test set of patient data. The "test set" in this context would likely refer to engineering tests of the transducers themselves to confirm design specifications and safety, rather than a dataset for evaluating an algorithm's performance on patient data. No sample size, data provenance, or retrospective/prospective nature regarding clinical data are mentioned.

3. 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. The ground truth for this type of device (ultrasound transducer) would be established through engineering specifications, safety standards, and performance evaluation against those standards, not through expert review of clinical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this document does not describe a study involving expert adjudication of clinical data.

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 is for an ultrasound transducer, not an AI or software device. No MRMC study is mentioned.

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

Not applicable. This is an ultrasound transducer, not an algorithm, so performance is inherently "human-in-the-loop" as it requires a sonographer/clinician.

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

The "ground truth" for this regulatory submission is based on technical specifications, safety standards, and substantial equivalence to legally marketed predicate devices. This includes meeting performance characteristics of the predicates and complying with FDA regulations for diagnostic ultrasound transducers. The FDA's request for a postclearance special report on acoustic output, for instance, implies objective, measurable standards for acoustic power.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set or ground truth for training.

Summary

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510(k) Summary

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This summary statement complies with 21 CFR, section 807.92 as amended March 14, 1995.

Submitter's Name and Address	Aloka Co., Ltd.10 Fairfield BoulevardWallingford, CT 06492
Contact's Name, Title, Address and Telephone Number	Kelvin BurroughsRegulatory Affairs/Quality Assurance CoordinatorAloka Co., Ltd.10 Fairfield BoulevardWallingford, CT 06492(203) 269-5088
Device Proprietary Name	ASU-1003UST-9121UST-9124
Device Common Name	Diagnostic Ultrasound Transducers
Classification	The charts below list the Regulatory Class and Device Codes.

Subject	Description
Regulatory Class	Class II
Review Category	Tier II

Code	Description	Regulation
90 ITX	Transducer, Ultrasonic, Diagnostic	892.1570

Continued on next page

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510(k) Summary, Continued

Identification ofpredicatedevices	The following is a list of probes submitted in this notification, their predicate devices and the 510(k) clearance numbers.
	Subject Transducer	Predicate Transducer	Predicate Transducer510(k)/Appendix E
	ASU-1003	ASU-1000C-3.5	K012253
	UST-9121	UST-9114-3.5	K012080
	UST-9124	UST-9103-5	K012253
Probes	Probes that are the subject of a submitted and cleared 510(k) for the SSD-1400 have already been added to the SSD-1000. New and additional probes for used with the SSD-1000 are the subjects of this submission.
Intended Use	The transducers are to be used for diagnostic ultrasound imaging in Urological, Abdominal, Intraoperative, Surgical and Endoscopic applications.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 2002

Mr. Richard J. Cehovsky Regulatory Affairs/Quality Assurance ALOKA Co., Ltd. U.S.A. 10 Fairfield Boulevard WALLINGFORD CT 06492-7502

Re: K020668

Trade Name: Aloka SSD-1000 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasound pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulaton Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: May 8, 2002 Received: May 9, 2002

Dear Mr. Cehovsky:

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 Aloka SSD-1000, as described in your premarket notification:

Transducer Model Number

ASU-1003
UST-9121
UST-9124

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

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Page 2 - Mr. Cehovsky

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

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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System/Transducer	System
Model	SSD-1000
510(k) Number	Appendix E

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

ly cleared by FDA; E-added under Appendix E;

Additional Comments:

Mixed mode operation includes B/M-Mode

(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)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive and Radiological Devices 510(k) Number

Aloka Company, Ltd.

Additional Probes for SSD-5000

Page

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System/Transducer	Transducer
Model	ASU-1003
510(k) Number

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

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

Additional Comments:

Mixed mode operation includes B/M,

(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)

Nancy Brogdon

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

Aloka Company, Ltd.

Additional Probes for SSD-5000

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System/Transducer	Transducer
Model	UST-9121
510(k) Number	K003739

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal
Abdominal		P	P						See Below
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

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

Additional Comments:

Mixed mode operation includes B/M

(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)

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020667

Aloka Company, Ltd.

Additional Probes for SSD-5000

です
『 Page

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System/Transducer	Transducer
Model	UST-9124
510(k) Number	K003739

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Modes of operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Opthalmic
Fetal		P	P						See Below
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal		P	P						See Below
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other

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

Additional Comments:

Professor Section Monaries & Particular Researce Most Province

Mixed mode operation includes B/M,

(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)

Nancy C Hodgon

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

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.