HR12000 ULTRASOUND SYSTEM

K961229 · International Ultrasound Corp. · IYO · May 29, 1997 · Radiology

Device Facts

• Record ID: K961229
• Device Name: HR12000 ULTRASOUND SYSTEM
• Applicant: International Ultrasound Corp.
• Product Code: IYO · Radiology
• Decision Date: May 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The HRI2000 system connected with a probe enables real time two dimensional diagnostic ultrasound imaging. The system offers optional probes each type optimized to image structure and orientation of tissues during specific clinical applications. These include general abdominal, small organ, gynecological and urological, vascular and cardiac anatomy.

Device Story

HRI 2000 Ultrasound System provides real-time 2D diagnostic ultrasound imaging. System utilizes interchangeable transducers (GA-3.5, TV-6.5, TR-6.5, PV-12.5) to acquire acoustic signals from human tissue. Signals processed to generate visual images for clinical assessment of abdominal, cardiac, gynecological, urological, and vascular anatomy. Operated by clinicians in clinical settings. Output displayed on monitor for physician interpretation to support diagnostic decision-making. Benefits include non-invasive visualization of internal structures and tissue orientation.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by acoustic output measurements and adherence to FDA diagnostic ultrasound guidance.

Technological Characteristics

Ultrasound imaging system with four transducer models: GA-3.5 (3.5 MHz), TV-6.5 (6.5 MHz), TR-6.5 (6.5 MHz), and PV-12.5 (12.5 MHz). Operates via piezoelectric sensing. System supports B-mode and Doppler analysis. Compliance with 21 CFR 820 (GMP) and acoustic output standards required.

Indications for Use

Indicated for diagnostic ultrasound imaging or Doppler analysis of the human body, including abdominal, cardiac (adult/pediatric), transvaginal, transrectal, and peripheral vessel applications. Prescription use only.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 29 1997

Raul Gutierrez, R.T., R.D.M.S.
President
International Ultrasound Corporation
14 West Forest Avenue
Englewood, NJ 07631

Re: K961229
HRI 2000 Ultrasound System
Dated: March 28, 1997
Received: March 28, 1997
Regulatory class: II
21 CFR 892.1560/Procode: 90 IYO

Dear Mr. Gutierrez:

We have reviewed your section 510(k) 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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Ultrasound Imaging System, as described in your premarket notification:

| Transducer Model Number | | | |
| --- | --- | --- | --- |
| GA-3.5 | (CLI 7900) | 3.5 MHz | General Purpose |
| TV-6.5 | (CLI 4000) | 6.5 MHz | Transvaginal |
| TR-6.5 | (CLI 5000) | 6.5 MHz | Transrectal |
| PV-12.5 | (CLI 6000) | 12.5 MHz | Peripheral Vascular |

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Page 2 - Raul Gutierrez

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the *Federal Register*. *Please note*: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for *in vitro* fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for *in vitro* fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA’s position on this use.

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 February 17, 1993 “Revised 510(k) Diagnostic Ultrasound Guidance for 1993.” 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.

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Page 3 - Raul Gutierrez

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone] or at its Internet address “http://www.fda.gov/cdrh/dsmamain.html”.

If you have any questions regarding the content of this letter, please contact Paul Gammell, Ph.D. at [phone].

Sincerely yours,


Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices
Office of Device Evaluation

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510(k) Number (if known): K961229

Device Name: HRI2000 Ultrasound System

## Applications For Use:

The HRI2000 system connected with a probe enables real time two dimensional diagnostic ultrasound imaging. The system offers optional probes each type optimized to image structure and orientation of tissues during specific clinical applications. These include general abdominal, small organ, gynecological and urological, vascular and cardiac anatomy.

(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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

David A. Segura

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K961229

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03/01/90 10:41 000 400 400

Page ___ of ___

510(k) Number (if known): K961229

Device Name: CLT 7900 GP 3.5 MHz Probe

Fill out one form for each ultrasound system or transducer.

Indications For Use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | X | B | M | MAD | CWD | Color Doppler | Power (A-1000) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | X | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | X | | | | | | | | |
| Cardiac Pediatric | | X | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Leparoscopic | | | | | | | | | | |

Other Indications or Modes:

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

Concurrence of CBX, Office of Device Evaluation (ODA)

Prescription Use (Per 21 CFR 801.109)

David G. Segura

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K961229

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MAY-09-97 FRI 03:41 PM INTL ULTRASOUND
FAX NO. 2018168777
P. 04

510(k) Number (if known): K961229
Page ___ of ___
Device Name: CLI 4000 TV 6.5 MHz Probe

Fill out one form for each ultrasound system or transducer.

Indications For Use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | H | PND | CND | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ophthalmic | | | | | | | | | | |
| Focal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | X | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ENOTHEA PAGE IF NEEDED)
Concurrent of CMR. Office of Division Evaluation (OD)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K961229

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MAY-09-97 FRI 03:42 PM INTL ULTRASOUND
FAX NO. 2018168777
P. 07

510(k) Number (if known): K961129
Device Name: CLI 5000 6.5 MHz Probe

Fill out one form for each ultrasound system or transducer.

Indications For Use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | N | PVD | CVD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans- esophageal | | | | | | | | | | |
| Trans-rectal | | X | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON AMOUNT PAGE IF NEEDED)
Conductance of CNW, Office of Device Evaluation (OEE)

Prescription Use (Per 21 CFR 801.109)


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MAY-09-97 FRI 03:42 PM INTL ULTRASOUND FAX NO. 2018168777
05/03/90 10:41 0401.400 5229
Page ___ of ___
510(k) Number (if known): K961229
Device Name: CLI 6000 PV 12.5 MHz Probe
Fill out one form for each ultrasound system or transducer.
Indications For Use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Mode of Operation
| Clinical Application | A | B | M | PND | CND | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | X | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | X | | X | | | | | | |
| Laparoscopic | | | | | | | | | | |
Other Indications or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON AROTERA PAGE IF NEEDED)
Conductance of CBRL, Office of Device Evaluation (OBE)
Prescription Use (Per 21 CFR 601.109)
David L. Segman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K961229