B-SCAN PLUS

K070943 · Accutome Ultrasound, Inc. · IYO · Apr 19, 2007 · Radiology

Device Facts

• Record ID: K070943
• Device Name: B-SCAN PLUS
• Applicant: Accutome Ultrasound, Inc.
• Product Code: IYO · Radiology
• Decision Date: Apr 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The instrument is used for imaging the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye.

Device Story

B-Scan Plus is an ophthalmic ultrasound imaging system using pulsed echo technology. It utilizes an eye-contact probe to transmit and receive ultrasound pulses, which are processed to generate a graphic display of internal ocular structures. The device is intended for use by clinicians to visualize opaque media and posterior pathology, aiding in the diagnosis of traumatic or pathological eye conditions. The output is a visual representation of the eye's internal anatomy, which the physician uses to inform clinical decision-making regarding patient ocular health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pulsed echo ultrasound imaging system; eye-contact probe transducer; 21 CFR 892.1560 (Ultrasonic pulsed echo imaging system) and 21 CFR 892.1570 (Diagnostic ultrasonic transducer).

Indications for Use

Indicated for patients requiring diagnostic imaging of the internal eye structure, including opaque media and posterior pathology, to diagnose pathological or traumatic ocular conditions.

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

• Advent A/B System (K960765)

Submission Summary (Full Text)

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K 070943

# 510(k) SUMMARY B-Scan Plus

APR 1 9 2007

| Applicant: | Accutome Inc. |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 263 Great Valley Parkway<br>Malvern, PA 19355 |
| Contact Person: | Jeffrey L. Wright<br>Manager, Engineering, Manufacturing & QC |
| Telephone: | [phone]<br>[phone] fax |
| Preparation Date: | July 18, 2006 |
| Device Name: | B-Scan Plus |
| Common Name: | Ultrasound B-Scan |
| Classification: | System, Imaging, Pulsed Echo, Ultrasonic<br>(see: 21 CFR 892.1560) Product Code: IYO Panel: 90 |
| Legally Marketed<br>Predicate Devices: | Advent A/B System (K960765) |
| Description of the Device: | The B-Scan Plus device is designed as an ultrasound B-<br>Scan which uses pulsed echo ultrasound to image the<br>internal structure of the eye. It utilizes an eye-contact<br>probe to generate and receive the ultrasound pulses, and<br>provides graphic display of returning pulse echoes to image<br>these structures. |
| Indications for Use: | The instrument is used for imagine the internal structure of<br>the eye including the opaque media and posterior pathology<br>for the purpose of diagnosing pathological or traumatic<br>conditions in the eye. |

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Image /page/1/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem in the center, which consists of a stylized caduceus-like symbol with three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

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

APR 1 9 2007

Re: K070943

Trade/Device Name: B-Scan Plus 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 30, 2007 Received: April 4, 2007

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.

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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/1/Picture/10 description: The image shows a circular logo with the letters "FDA" in a bold, stylized font. Above the letters, the years "1906-2006" are printed, indicating a centennial celebration. Below the letters, the word "Centennial" is written in a cursive font, and three stars are aligned beneath it.

Protecting and Promoting Public Health

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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 letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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

Enclosure

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## B-Scan Plus 510(k) Notification

4.3 Indications for Use

510(k) Number (if known):_K070 943

Device Name: B-Scan Plus

Indications for Use:

The instrument is used for imaging the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

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OR

Over-The Counter Use_

Daniel A. Seymon

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

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## B-Scan Plus 510(k) Notification

#### Diagnostic Ultrasound Indications for Use Form

#### Fill out one form for each ultrasound system and each 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<br>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 . GON TINUE ON ANOTHER PAGE IF NEEDED) Coneurgence of CDGH, Office of Device Evaluation (ODE)

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

Radiological Devices
510(k) Number K070943

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