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

K020668 · Aloka Co., Ltd. · IYO · Jul 10, 2002 · Radiology

Device Facts

• Record ID: K020668
• Device Name: ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124
• Applicant: Aloka Co., Ltd.
• Product Code: IYO · Radiology
• Decision Date: Jul 10, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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

Device Story

The Aloka ASU-1003, UST-9121, and UST-9124 are diagnostic ultrasound transducers designed for use with the Aloka SSD-1000 system. These devices function by emitting ultrasonic pulses into the body and receiving reflected echoes to generate real-time images. They support B-mode and M-mode imaging, including mixed-mode operation. The transducers are operated by trained healthcare professionals in clinical settings to visualize internal structures and assist in diagnostic decision-making. The output is displayed on the ultrasound system monitor, allowing clinicians to assess anatomy and pathology, thereby facilitating patient diagnosis and management.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, including acoustic output measurements and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Diagnostic ultrasound transducers; B-mode and M-mode operation; compatible with Aloka SSD-1000 system. Technical specifications include acoustic output parameters compliant with FDA guidance. Sterilization/disinfection requirements follow standard clinical protocols for ultrasound probes.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, intraoperative, pediatric, small organ, neonatal/adult cephalic, cardiac, transrectal, transvaginal, and peripheral vascular applications. Intended for prescription use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ASU-1000C-3.5 (K012253)
• UST-9114-3.5 (K012080)
• UST-9103-5 (K012253)

Submission Summary (Full Text)

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|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|----|---------------|
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|----|---------------|

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## 510(k) Summary

る。

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

| Submitter's Name and Address | Aloka Co., Ltd.<br>10 Fairfield Boulevard<br>Wallingford, CT 06492 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact's Name, Title, Address and Telephone Number | Kelvin Burroughs<br>Regulatory Affairs/Quality Assurance Coordinator<br>Aloka Co., Ltd.<br>10 Fairfield Boulevard<br>Wallingford, CT 06492<br>[phone] |
| Device Proprietary Name | ASU-1003<br>UST-9121<br>UST-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 of<br>predicate<br>devices | 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 Transducer<br>510(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-<br>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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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 [phone].

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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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

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

| 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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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 _