POD B-SCAN

K070884 · Starfish Product Engineering, Inc. · IYO · Apr 11, 2007 · Radiology

Device Facts

• Record ID: K070884
• Device Name: POD B-SCAN
• Applicant: Starfish Product Engineering, Inc.
• Product Code: IYO · Radiology
• Decision Date: Apr 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The POD B-Scan System is a multi-purpose computer-based ultrasound diagnostic system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye.

Device Story

POD B-Scan is a PC-based ophthalmic ultrasound system; utilizes motor-driven 35 MHz or 50 MHz transducers with angle encoders to capture ultrasound signals from the eye and orbit. System transforms raw acoustic data into visual images displayed on a computer screen; enables clinicians to perform A-scan, B-scan, and 3D imaging for visualization and internal measurements. Designed for ophthalmic clinical settings; provides high-resolution imaging of the anterior segment due to 11 mm focal depth. Output assists physicians in diagnosing ocular conditions and planning clinical interventions; benefits patients through non-invasive, high-frequency visualization of ocular structures.

Clinical Evidence

Bench testing only. Testing included required ultrasound performance measurements, electrical safety, and electromagnetic compatibility (EMC) testing. No clinical data provided.

Technological Characteristics

PC-based ultrasound system; motor-driven transducers (35 MHz or 50 MHz) with integrated angle encoders. Connectivity via PC interface. Sterilization not specified. Software-based image processing for A-scan, B-scan, and 3D reconstruction.

Indications for Use

Indicated for ophthalmic ultrasound visualization and measurement of the eye and orbit (A-scan, B-scan, and 3D imaging) in patients requiring diagnostic eye exams. 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.

Predicate Devices

• VuMax High Resolution Ultrasound System (K060626)

Submission Summary (Full Text)

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K090884

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APR 1 1 2007

### 510(k) Summary (per 21 CFR 807.92)

#### I. Applicant

StarFish Product Engineering #5, 555 Ardersier Road Victoria, BC V8Z 1C8 Canada

Daryl Wisdahl Contact Person: Tel: [phone] Fax: [phone] Email: [e-mail]

January 24, 2007 Date Prepared:

#### Device Name II.

| Proprietary Name: | POD B-Scan |
|-----------------------|-------------------------------------------|
| Common/ Usual Name: | Ophthalmic ultrasonic A and B scan system |
| Classification Name: | System, Imaging, Ultrasonic, Ophthalmic, |
| Regulation Number: | 892.1560 / 892.1570 |
| Product Codes: | 90-IYO / 90-ITX |
| Classification: | 2 |
| Classification Panel: | Radiology |

#### III. Predicate Device

The VuMax High Resolution Ultrasound System manufactured by Sonomed Inc., cleared by FDA (060626) on April 11, 2006.

#### IV. Intended Use of the Device

The POD B-Scan is intended to be used for visualization by ultrasound of the eye and orbit by A-scan and B-scan.

#### V. Description of the Device

The POD B-Scan is intended to be used for visualization by ultrasound of the eve and orbit by A-scan and B-scan.

The system is PC-based, and can be used with 35 MHz or 50MHz transducers. Because of the higher frequency of the transducers, it is expected that its greatest field of application will be in visualizing the anterior segment, because the focus area is about 11 mm from the transducer plane. The system can visualize other parts of the eye.

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#### Summary of the Technical Characteristics VI.

Summary of the reaconventional ophthalmic A and B-scan system using a motor-driven transducer and angle sensor for scanning. The A-scan is derived from the B-scan. There is a choice of transducer frequency of 35 MHz or 50 MHz. It uses a motor-driven 10 MHz transducer with an attached angle encoder. The system is PC-based, and the display is on the computer screen.

#### VII. Testing

Testing included required ultrasound tests, as well as electrical safety and electromagnetic compatibility tests.

#### VIII. Conclusion

The POD B-Scan is equivalent in safety and efficacy to the legally marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 1 2007

Starfish Product Engineering % Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA. Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K070884

Trade Name: POD B-Scan 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: IYO and ITX Dated: March 29, 2007 Received: March 30, 2007

Dear Mr. Devine:

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 deviness 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 POD B-Scan, as described in your premarket notification:

### Transducer Model Number

### 35 MHz 50 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 be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish futbor announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Devine

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 (OS) 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 he 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Ewa Czerska at [phone].

Sincerely yours,

David A. Leggmm

fm

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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## Diagnostic Ultrasound Indications for Use Form

Page 1_of _3

510(k) Number (if known):

Device Name: POD B-Scan

### Indications for Use:

The POD B-Scan System is a multi-purpose computer-based ultrasound diagnostic system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye.

| Clinical<br>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 | N | | | | | | | | N (3D) |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| N= new indication; P= previously cleared by FDA; E+ added under Appendix E | | | | | | | | | | |

Additional Comments:

Prescription Use_X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Hegmann

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070884

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# Diagnostic Ultrasound Indications for Use Form

Page 2 of 3

510(k) Number (if known):

Device Name: POD B-Scan 35 MHz Transducer

### Indications for Use:

The POD B-Scan 35 MHz Transducer is for use with the POD B-Scan ultrasound.

| Clinical<br>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 | N | | | | | | | | N (3D) |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| N= new indication; P= previously cleared by FDA; E+ added under Appendix E<br>Additional Comments: | | | | | | | | | | |
| Prescription Use X<br>(Part 21 CFR 801 Subpart D) | | | | | AND/OR | | | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | | | |
| Concurrence of CDRH/Office of Device Evaluation (ODE) | | | | | | | | | | |

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

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## Diagnostic Ultrasound Indications for Use Form

Page 3_of _3

510(k) Number (if known):

Device Name: POD B-Scan 50 MHz Transducer

### Indications for Use:

The POD B-Scan 50 MHz Transducer is for use with the POD B-Scan ultrasound.

| Clinical<br>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 | N | N | | | | | | | N (3D) |
| 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) | | | | | | | | | | |

Prescription Use _X (Part 21 CFR 801 Subpart D)

and Radiological Devices

510(k) Number _

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiale