ULTRASONIC BIO-MICROSCOPE, MODEL P60

K050980 · Paradigm Medical Industries, Inc. · IYO · May 26, 2005 · Radiology

Device Facts

• Record ID: K050980
• Device Name: ULTRASONIC BIO-MICROSCOPE, MODEL P60
• Applicant: Paradigm Medical Industries, Inc.
• Product Code: IYO · Radiology
• Decision Date: May 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

To acquire and display high resolution images of the anterior segment of the eye.

Device Story

Model P60 UBM is a PC-based digital ultrasonic imaging system; utilizes ultrasonic energy to generate high-resolution images of the eye's anterior segment. System accepts user input via graphical user interface; pulser circuitry generates signals specific to the connected transducer (10 MHz, 20 MHz, 35 MHz, or 50 MHz probes). Acquired signals are processed and translated into images displayed on an LCD monitor. Used in clinical settings by healthcare professionals to visualize ocular structures; output assists clinicians in diagnostic decision-making regarding anterior segment pathology. Benefits include non-invasive, high-resolution visualization of ocular anatomy.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and compliance with IEC60601-1 safety standards.

Technological Characteristics

PC-based digital ultrasonic pulsed echo imaging system. Transducers: 10 MHz, 20 MHz, 35 MHz, and 50 MHz water-path probes. Connectivity: PC-based with graphical user interface. Safety: Meets IEC60601-1 requirements.

Indications for Use

Indicated for diagnostic ultrasound imaging of the eye (ophthalmic) in patients requiring anterior segment visualization.

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

• Paradigm Medical Model P45 Ultrasonic Bio-Microscope

Submission Summary (Full Text)

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K050980

MAY 2 6 2005

MEDICAL INDUSTRIES, INC.

510(k) Premarket Notification a esta resultado a sempera e Model P60 UBM Ultrasonic Bio-Microscope

### 510(k) SUMMARY

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

Paradigm Medical Industries, Inc. 2355 South 1070 West Salt Lake City, Utah 84119 Phone: [phone] [phone] Fax:

Contact Person: Edward A. Kroll Representative Consultant for Paradigm Medical Industries, Inc. 5905 Fawn Lane Cleveland, Ohio 44141 Phone: [phone] Fax: [phone]

древозможности пристемвати се представления представления продавания по полнения подательного полнения подат

April 15, 2005 Date Prepared

#### Name of Device

Model P60 Ultrasonic Bio-Microscope

#### Common or Usual Name

Ultrasound System

#### Classification Name

Ultrasonic Pulsed Echo Imaging System

#### Predicate Devices

Paradigm Medical Model P45 Ultrasonic Bio-Microscope

#### Intended Use

To acquire and display high resolution images of the anterior segment of the eye.

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## Device Description

The Model P60 UBM is a PC-based digital instrument that utilizes ultrasonic energy to generate various images of the eye. The pulser circuitry is designed to accept information from the user via a graphical user interface provided by the software. The pulser generates signals specific to the probe installed. The signal acquired from the transducer is translated into an image that is displayed on an LCD monitor.

### Performance Data

The Model P60 UBM has been tested to and meets the applicable requirements of IEC60601-1.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned above a series of wavy lines, possibly representing water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Paradigm Medical Industries, Inc. c/o Mr. Edward A. Kroll President Spectre Solutions, Inc. 5905 Fawn Lane CLEVELAND OH 44141

Re: K050980

Trade Name: Paradigm Medical Model P60 Ultrasonic Bio-Microscope Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: IYO Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Regulatory Class: II Dated: April 15, 2005 Received: April 21, 2005

Dear Mr. Kroll:

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 meets as of mirror price s 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 I cachi 1 ood, Drag, and sions of the Act. The general controls provisions of the Act include the general volulens proveels and isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

MAY 2 6 2005

This determination of substantial equivalence applies to the following transducers intended for r ms utth the Paradigm Medical Model P60 Ultrasonic Bio-Microscope as described in your premarket notification:

Transducer Model Numbers

35 MHz Water-Path 50 MHz Water-Path B-Scan (20 MHz) B-Scan (10 MHz)

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

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#### Page 2 - Mr. Edward Kroll

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 r lease be determination that your device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must or any I callated and registments, including, but not limited to: registration and listing (21 Comply with an the Her s requirements, we seen manufacturing practice requirements as set CI IT at 6077, mooning (21 CFR 220), and if applicable, the electronic forth in the quality bystems (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, including acoustic occasio of the Centember 30, 1997 "Information for Manufacturers In Appendix U, (cheroova) of the Standstic Ultrasound Systems and Transducers." If the special Secking Marketing Creatures or macceptable 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 I no special report in a see a mould 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 nontication. The I Drice results in 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 If you ucan't specific advice is 3 % [phone]. Also, please note the regulation entitled, Connact the Office of Court to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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Page 3 – Mr. Edward Kroll

If you have any questions regarding the content of this letter, please contact Mr. Rodrigo C. Perez at [phone].

Sincerely yours,

Daniel A. Syson

first

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

Enclosures

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System: Transducer: Model P60 ____________________________________________________________________________________________________________________________________________________________________

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

| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:<br>Mode Of Operation | | | | | | | | | |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other*<br>(Specify) |
| Ophthalmic | | N | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| 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-skelatal Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

tive (Spear)
N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: _________________________________________________________________________________________________________________________________________________________

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Daniel R. Lynn

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _____________

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| System: | |
|-------------|-----------------|
| Transducer: | B-Scan (10 MHz) |

Transducer:

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

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

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other* (Specify) |
|-------------------------------|---|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|------------------|
| Ophthalmic | | N | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| 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 (Specify) | | | | | | | | | | |

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

Additional Comments: _________________________________________________________________________________________________________________________________________________________

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

David A. Hynn

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

・・ .

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| System: | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ (30 MHz) |
|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

B-Scan (20 MHz) Transducer:

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

| | Mode Of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other*<br>(Specify) |
| Ophthalmic | | N | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| 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-skelatal Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

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

Additional Comments: _________________________________________________________________________________________________________________________________________________________

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

David A. Dyson

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

1

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| System: | |
|-------------|-------------------|
| Transducer: | 35 MHz Water-Path |

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

| | Mode Of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other*<br>(Specify) |
| Ophthalmic | | N | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| 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-skelatal Superficial | | | | | | | | | | |

Other (Specify)

ther (Speary)
N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: _________________________________________________________________________________________________________________________________________________________

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Daniel H. Ingram

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

{9}------------------------------------------------

| System: | |
|---------|--|
|---------|--|

50 MHz Water-Path Transducer:

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

| Clinical Application | Mode 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 | | N | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| 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-skelatal Superficial | | | | | | | | | | |

Other (Specify)

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

Additional Comments: _________________________________________________________________________________________________________________________________________________________

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Daniel R. Syzmanski

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