Predicate Devices

SSD-5500 (K032875)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard diagnostic ultrasound system and does not mention any AI or ML capabilities.

Therapeutic

No
The device is described as a "diagnostic ultrasound imaging or fluid flow analysis" system, indicating its purpose is for diagnosis, not treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "diagnostic ultrasound system and transducers," 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Description: The description clearly states that the device uses "high frequency sound waves are transmitted into the body" and "reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image." This is a description of an in vivo imaging device, meaning it operates within the living body.
Intended Use: The intended use describes diagnostic ultrasound imaging and fluid flow analysis of the human body, not analysis of samples taken from the body.

Therefore, the Aloka SSD-Alpha 5 Ver. 1.0 diagnostic ultrasound system is a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)
Opthalmic
Fetal	N	N	N	N	N	N	See Below
Abdominal	N	N	N	N	N	N	See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric	N	N	N	N	N	N	See Below
Small Organ (specify)	N	N	N	N	N	N	See Below
Neonatal Cephalic	N	N	N	N	N	N	See Below
Adult Cephalic
Cardiac	N	N	N	N	N	N	See Below
Transesophageal
Transrectal
Transvaginal	N	N	N	N	N	N	See Below
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N	See Below
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial	N	N	N	N	N	N	See Below
Other

N= new indication; P= previously cleared by FDA; E= added under Appendix A
Additional Comments: Mixed mode operation includes BM, BPWD, MCD, B/CD/PWD, B/CD/CWD Applications: Small Parts-breast, testes & thyroid, abdominal, gynecological, fetal, neonatal, cardiac.
Prescription Use (Per 21 CFR 801,109)

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

90 IYN, IYO, and ITX

Device Description

The Aloka SSD-Alpha 5 functions in the same manner as its predicate and other Aloka diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-Alpha 5 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (breast, testes & thyroid), Neonatal Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial

Indicated Patient Age Range

Adult, Pediatric, Neonatal, 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.

SSD-5500 (K032875)

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

§ 892.1550 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.

Summary

0

K04/1916

:

540(k)

Aloka Co., Ltd.

·

・

Model SSD- Alpha 5

้JUL 3 0 2004

Section 4.2.13b

510(k) Summary of S&E

( Immediately follows this page )

12

:

1

Date: 6/8/04

510(k) Summary: Aloka Model SSD- Alpha 5

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

This premarket notification has been submitted by Aloka Co., Ltd. and covers the Aloka SSD-Alpha 5 Ver. 1.0 diagnostic ultrasound system and transducers. The address is:

10 Fairfield Boulevard Wallingford, CT 06492 (203) 269-5088

The contact person is: Richard J. Cehovsky, RA/QA Coordinator

The proprietary name is the Aloka SSD-Alpha 5 diagnostic ultrasound system and transducers. The common name for this type of device is a diagnostic ultrasound system and transducers.

The item in this submission is covered under the following classification:

90 IYN	Ultrasonic Pulsed Doppler Imaging System	21 CFR 892.1550
90 ITX	Diagnostic Ultrasound Transducer	21 CFR 892.1570
90 IYO	Ultrasonic Pulsed Echo Imaging System.	21 CFR 892.1560

The above as stated in 21CFR, part 892.1570.1560 & 1550, has been classified as regulatory Class II.

The Aloka SSD- Alpha 5 and its transducers are substantially equivalent to its predicate; the Aloka SSD-5500 (K032875) and its transducers.

The Aloka SSD-Alpha 5 functions in the same manner as its predicate and other Aloka diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-Alpha 5 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.

The Aloka SSD-Alpha 5, like other Aloka marketed diagnostic ultrasound systems and transducers are indicated for imaging body structures to aid in the diagnosis of disease or abnormality.

The Aloka SSD-Alpha 5 diagnostic ultrasound system and transducers are similar in technological characteristics to its predicate system: SSD-5500 (K032875).

The Aloka SSD-Alpha 5 is indicated for the same diagnostic ultrasound applications to Aloka's . ultrasound system: SSD-5500 (K032875).
The Aloka SSD-Alpha 5 has the same gray-scale and Doppler abilities to Aloka's ultrasound . system as mentioned above.

2

510(k) Summary: Aloka Model SSD- Alpha 5

The SSD-Alpha 5 uses the same technologies for imaging, Doppler functions and signal processing . as the following product currently marketed by Aloka : SSD-5500 (K032875).
The SSD-Alpha 5 has the same method of use as the following product currently marketed by . Aloka: SSD-5500 (K032875).
The SSD-Alpha 5 acoustic power output levels are below the maximum levels allowed by the . FDA.
The SSD- Alpha 5 is subjected to the same Quality Assurance systems in development and . production as other products including the SSD-5500 (K032875) currently marketed by Aloka.
The patient contact materials used in the SSD-Alpha 5 have been evaluated for safety via the same . standards and methods as the above mentioned product marketed by Aloka. These materials have been found to be safe for their intended uses.
The SSD-Alpha 5 complies with electrical and physical safety standards as other products . currently marketed by Aloka such as the: SSD-5500 (K032875).
Aloka Co., Ltd. Certifies that the SSD-Alpha 5 complies with NEMA-UD2: 1992, AIUM 1994 . "Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment", IEC-60601-1 (2001-09 Class A), UL 2601-1, 200 edition (1997), Part 1, 200 edition including Amendments 1&2 and ISO10993-1:1997. All testing will be completed, prior to distribution, to meet the requirements of the standards listed above.

3

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The logo is black and white and has a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2004

Aloka Co., Ltd. % Mr. Daniel W. Lehtonen Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K041916

Trade Name: Aloka SSD-Alpha 5 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: 90 IYN, IYO, and ITX Dated: July 15, 2004 Received: July 16, 2004

Dear Mr. Lehtonen:

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-Alpha 5 Ultrasound System, as described in your premarket notification:

Transducer Model Number

UST-5410	UST-9128
UST-9118	UST-52101
UST-9126	UST-52108

4

Page 2 - Mr. Lehtonen

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 it inay be subject to sach additional Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Court of receits concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Dr over device complies with other requirements of the Act that I DA has made a active regulations administered by other Federal agencies. You must or any I cachar statutes and regulations and limited to: registration and listing (21 Comply with an the Hot 3 requirements)01); good manufacturing practice requirements as set CFK i at 607), aboning (21 OF X 1 at 800); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping I ms device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested information, merading accepter's September 30, 1997 "Information for Manufacturers m Appendix &, (encrease 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 rne special roperty 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 econotion 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".

5

Page 3 - Mr. Lehtonen

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

Sincerely yours,

David h. byssom
for Nancy C. Brogdon

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

Enclosures

6

4.3.1

Diagnostic Ultrasound Indications for Use Form SSD-Alpha 5

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

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

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

Additional Comments: Mixed mode operation includes BM, BPWD, MCD, B/CD/PWD, B/CWD, B/CD/CWD Applications: Small Parts-breast, testes & thyroid, abdominal, gynecological, fetal, neonatal, cardiac.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (C

Prescription Use (Per 21 CFR 801,109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K041916
510(k) Number

·

7

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

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

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

Additional Comments: Mixed mode operation includes BM, BPWD, MCD, BCDTWD, BCDCWD

Applications: breast, testes and thyroid.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Usc (Pcr 21 CFR 801 109)

FR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041916

8

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Opthalmic
Fetal		P	P	P	P	P	P	See Below
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal		P	P	P	P	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: Mixed mode operation includes BM, BPWD, MCD, B/CD/PWD, B/CD/CWD,

(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-O Division of Reproducti and Radiological Devices 510(k) Number

9

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal		P	P	P	P	P	P	See Below
Abdominal		P	P	P	P	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 BM, BPWD, MCD, BCDTWD, BICWD, BICDCWD.

Applications: Abdominal, Gynecological, Fetal.

(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. Swagdon

Division of Reproduct and Radiological Devic 510(k) Number

10

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Opthalmic
Fetal
Abdominal		P	P	P	P	P	P	See Below
Intraoperative (specify)
Intraoperative Neurological
Pediatric		P	P	P	P	P	P	See Below
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascı·lar
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 BM, BPWD, MCD, B/CD/WD, B/CD/WD,

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

11

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P	See Below
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 BM, BPWD, MCD, B/CD/WWD, B/CWD, B/CWD, B/CWD

(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 Sian-Of Division of Reproductive and Radiological Devices 510(k) Number _

12

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

	Modes of operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Opthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic		P	P	P	P	P	P	See Below
Adult Cephalic		P	P	P	P	P	P	See Below
Cardiac		P	P	P	P	P	P	See Below
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 BAM, BPWD, MCD, B/CD/TWD, B/CD/CWD

Application: Neonatal

(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 hroador

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