(110 days)
Not Found
No
The description focuses on standard ultrasound technology and image display, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an imaging device for diagnosis, not for treatment or therapy.
Yes
The device's "Intended Use" explicitly states its purpose is "for the purpose of diagnosing pathological or traumatic conditions in the eye."
No
The device description explicitly states it utilizes a noncontact probe and a contact Scleral shell to generate and receive ultrasound pulses, 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 UBM Plus is an ultrasound imaging device that directly images the internal structure of the eye. It does not analyze samples taken from the body.
- Intended Use: The intended use is for imaging and diagnosing conditions within the eye, not for analyzing biological samples.
Therefore, the UBM Plus falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX, IYN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
eye / Ophthalmic
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy Testing (using a Gammex Lesion Phantom and a proprietary measurement phantom)
Results:
Line Accuracy:
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
0
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
(610) 889-0200 (610) 889-3233 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: 610-889-3233 3222 Phoenixville Pike Malvern, PA 19355 Email: eyeopener@accutome.com
Phone: 610-889-0200 www.accutome.com Page 1 of 4
Legally Marketed Predicate Devices:
Description of the Device:
1
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: 610-889-3233 3222 Phoenixville Pike Malvern, PA 19355 Email: eyeopenen@accutome.com
Phone: 610-889-0200 www.accutome.com Page 2 of 4
2
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: 610-889-3233 3222 Phoenixville Pike Malvern, PA 19355 Email: eyeopenen@accutome.com
Phone: 610-889-0200 www.accutome.com Page 3 of 4
Performance Data:
3
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 |