(12 days)
90-IYO, 90-ITX
060626
No
The description focuses on conventional ultrasound technology and does not mention any AI or ML components.
No
The device is described as a diagnostic system for visualization and measurement within the eye, not for treating any conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a multi-purpose computer-based ultrasound diagnostic system for ophthalmic applications."
No
The device description explicitly mentions transducers, a motor-driven transducer, and a PC-based system, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The POD B-Scan is an ultrasound system used for visualization and measurement within the eye and orbit. It uses ultrasound waves to create images and take measurements in vivo (within the living body).
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient.
Therefore, the POD B-Scan falls under the category of medical imaging devices rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The POD B-Scan is intended to be used for visualization by ultrasound of the eye and orbit by A-scan and B-scan.
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.
The POD B-Scan 35 MHz Transducer is for use with the POD B-Scan ultrasound.
The POD B-Scan 50 MHz Transducer is for use with the POD B-Scan ultrasound.
Product codes
90-IYO, 90-ITX
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Eye and orbit
Indicated Patient Age Range
Not Found
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
Testing included required ultrasound tests, as well as electrical safety and electromagnetic compatibility tests.
Key Metrics
Not Found
Predicate Device(s)
060626
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.
0
Image /page/0/Picture/1 description: The image shows the word "StarFish" with a star above the word. The word is written in a simple, sans-serif font. The star is a five-pointed star with a slightly irregular shape. The image is in black and white.
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: (250) 388-3537 Fax: (250) 483-1975 Email: dwisdahl@starfishmedical.com
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.
1
Image /page/1/Picture/0 description: The image shows the word "StarFish" in a stylized font. Above the word "StarFish" is a five-pointed star. The star is slightly tilted to the left. The text and star are black against a white background.
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle's head, represented by three curved lines, facing to the left.
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.
3
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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 (240) 276-3666.
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)
4
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
Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(specify) | Other
(specify) |
|----------------------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | 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) | | | | | | | | | | |
| 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
5
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
Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(specify) | Other
(specify) |
|----------------------------------------------------------------------------------------------------|---|---|---|-----|--------|------------------|----------------------|------------------------------------------------|-----------------------|--------------------|
| Ophthalmic | 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) | | | | | | | | | | |
| 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) | | | | | | | | | | |
of think A. Ale (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
6
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
Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(specify) | Other
(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