UBM PLUS

K103471 · Accutome, Inc. · IYN · Mar 14, 2011 · Radiology

Device Facts

• Record ID: K103471
• Device Name: UBM PLUS
• Applicant: Accutome, Inc.
• Product Code: IYN · Radiology
• Decision Date: Mar 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The UBM Plus is designed for imaging the internal structure of the eye including opaque media and anterior segment pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye.

Device Story

UBM Plus is a high-frequency ultrasound B-Scan system for imaging the anterior segment of the eye. It uses a non-contact probe with a Scleral immersion shell to generate and receive pulsed echo ultrasound. The system processes returning echoes to provide a graphic display of ocular structures. Operated by clinicians in a clinical setting, the device provides tools for pan, zoom, annotation, A-Vector, and distance/area/angle measurements. Output is displayed on a screen for the clinician to visualize internal structures, aiding in the diagnosis of pathological or traumatic eye conditions. The device benefits patients by enabling non-invasive visualization of ocular anatomy, particularly when media is opaque.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and acoustic output measurements (IEC 60601-2-37, NEMA UD2, NEMA UD3). Accuracy testing using Gammex Lesion and proprietary phantoms showed <1% error for line, area, and angle measurements.

Technological Characteristics

High-frequency (48 MHz) ultrasound B-Scan system. Features an open-tip probe design requiring a Scleral immersion shell. Provides 256 grey scale levels. Connectivity includes standard display output. Complies with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD2, and NEMA UD3 standards.

Indications for Use

Indicated for ophthalmic imaging of internal eye structures, including opaque media and anterior segment pathology, to diagnose pathological or traumatic eye conditions. No specific age or gender restrictions noted.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Accutome B-Scan Plus (K070943)
• OTI-Scan 3000 (K092837)

Submission Summary (Full Text)

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K103471

Image /page/0/Picture/1 description: The image shows the logo for Accutome. The logo features a stylized number 4 inside of a circle. The text "ACCUTOME" is written in all capital letters below the logo.

MAR 1 4 2011

# 510(k) SUMMARY: UBM Plus

Applicant:

Contact Person:

Preparation Date:

Trade Name:

Common Name:

Classification Name:

Telephone:

Address:

Accutome, Inc.

3222 Phoenixville Pike Malvern, PA 19355

Brian T. S. Barrett Manager QA/QC

[phone] [phone] Fax

October 13, 2010

UBM Plus

Ultrasound B-Scan

System, Imaging, Pulsed Echo, Ultrasonic (21 CFR 892.1560, Product Code: IYO)

Diagnostic Ultrasound Transducer (21 CFR 892.1570, Product Code: ITX)

Accutome B-Scan Plus (K070943) OTI-Scan 3000 (K092837)

The UBM Plus device is designed as a high frequency ultrasound B-Scan, which uses pulsed echo ultrasound to image the anterior segment of the eye. It utilizes a noncontact probe via a contact Scleral shell to generate and receive the ultrasound pulses, and provides a graphic display of returning pulse echoes to indicate the various structures.

Accutome, Inc. Fax: [phone] Phoenixville Pike Malvern, PA 19355 Email: [e-mail]

Phone: [phone] www.accutome.com Page 1 of 4

Legally Marketed Predicate Devices:

Description of the Device:

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Image /page/1/Picture/0 description: The image shows the logo for Accutome. The logo features a black circle with a white number 1 inside of it. Below the circle is the word "ACCUTOME" in all capital letters.

Indications for Use:

Comparison of Technological Characteristics:

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

The UBM Plus and B-Scan Plus are similar devices in that they are both ultrasonic B-Scans used to image the eye. The UBM Plus has an open tip design with an ultrasonic crystal that resonates at a frequency of 48 MHz, while the B-Scan Plus uses a closed tip design with a single crystal resonating at frequencies of 12 MHZ and 15 MHz. The open tip design of the UBM Plus requires the use of a Scleral Immersion Shell to capture measurements, while the closed tip design of the B-Scan Plus allows for direct contact between the probe and patient without potential injury. The UBM Plus range is fixed at 30mm, while the B-Scan Plus ranges are adjustable with ranges of 30, 50, 60 and 100mm. The UBM Plus runs using an updated software version of the B-Scan Plus. The UBM Plus offers the user the functionality of pan, zoom, annotation, A-Vector, distance/area/angle measurements, 256 grey scale levels, image annotation and gain controls. All of the listed functions are available on the B-Scan Plus, except angle measurements.

The UBM Plus and OTI-Scan 3000 are similar in that they both ultrasonic B-Scans utilizing high frequency probes. The UBM Plus utilizes a frequency of 48 MHz, while the OTI-Scan 3000 utilizes multiple probes with frequencies of 35 MHz and 50 MHz. Both the UBM Plus OTI-Scan 3000 use an open tip design and therefore both require the use of an Immersion Scleral Shell to capture measurements. This is referred to as an immersion cup in the OTI User Manual. The UBM Plus offers the user the functionality of pan, zoom, annotation, A-Vector, distance/area/angle measurements, 256 grey scale levels,

Accutome, Inc. Fax: [phone] Phoenixville Pike Malvern, PA 19355 Email: [e-mail]

Phone: [phone] www.accutome.com Page 2 of 4

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Image /page/2/Picture/0 description: The image shows a logo with a stylized number "4" inside a black circle. The number "4" is formed by a white shape that cuts into the circle. Below the circle, the word "ACCUTOME" is printed in bold, uppercase letters. The logo appears to be for a company or product named Accutome.

image annotation and gain controls, all functions available on OTI Scan 3000.

Non-Clinical Tests:

- IEC 601-1 Medical Electrical Equipment Part 1: . General Requirements for Safety Result: Compliance with Standard
- IEC 60601-1 Medical electrical equipment Part 1-. General Requirements for Basic Safety and Essential Performance

Result: Compliance with Standard

- IEC 60601-1-1 Medical electrical equipment Part 1-1 . - Collateral Standard: Safety Requirements for Medical Electrical Systems Result: Compliance with Standard
- . IEC EN 60601-1-2:2001 Electromagnetic Compatibility Result: Compliance with Standard
- IEC 60601-2-37 Acoustical Measurements ● Result: Compliance with Standard
- . NEMA UD2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Result: Compliance with Standard
- NEMA UD3 Standard for Real-Time Display of . Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Result: Compliance with Standard

Accutome, Inc. Fax: [phone] Phoenixville Pike Malvern, PA 19355 Email: [e-mail]

Phone: [phone] www.accutome.com Page 3 of 4

### Performance Data:

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Image /page/3/Picture/0 description: The image shows a logo with the word "ACCUTOME" in all caps at the bottom. Above the word is a graphic of a circle with a white number 4 inside. The number 4 is formed by a white shape that cuts through the black circle.

Accuracy Testing (using a Gammex Lesion Phantom . and a proprietary measurement phantom) Results:

| | Accuracy | Accuracy Range |
|-------|----------|----------------|
| Line | <1% | 30mm |
| Area | <1% | 30mm |
| Angle | <1% | 30mm |

Clinical Tests:

- Since the UBM Plus uses the same technology as . existing devices, clinical tests are not required.
The UBM Plus is equivalent in safety and efficacy to the legally-marketed predicate devices. Like the predicate devices the UBM Plus successfully passed all the safety, electromagnetic and acoustic output testing. And the accuracy of the UBM Plus is less than 1%, well within acceptable limits.

Conclusion:

Accutome, Inc. Fax: [phone] Phoenixville Pike Malvern, PA 19355 Email: [e-mail]

Phone: [phone] www.accutome.com Page 4 of 4

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and a circle of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" and is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Accutome, Inc. % Mr. William Sammons Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road; Unit B7 TWINSBURG OH 44087

MAR 1 4 2011

Re: K103471

Trade/Device Name: UBM Plus Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYN and ITX Dated: March 2, 2011 Received: March 3, 2011

Dear Mr. Sammons:

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 devices, 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 UBM Plus, as described in your premarket notification:

#### Transducer Model Number

#### UBM PLUS

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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 895. 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 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

Sincerely yours.

Mary S. Pastel

Mary Pastel, Ph.D Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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UBM Plus 510(k) Notification

1.3 Indications for Use

K103471 510(k) Number (if known):

Device Name: UBM Plus

Indications for Use:

The UBM Plus is designed for imaging the internal structure of the eye including opaque media and anterior segment pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye.

Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR Over-The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Tasts

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k). K103471

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## 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:Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

510K -

Division of Radiological Devices Office of In Ville Ditighostic Device Evaluation and Safety

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