(181 days)
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No
The summary describes a software for image format translation and display, with no mention of AI or ML technologies, training data, or performance metrics typically associated with AI/ML devices.
No
The device is described as software that translates medical image formats for display on a standard PC and does not directly provide therapy or therapeutic interventions.
No
The AccessPoint™ software is intended for translating medical image formats for display on a PC and does not perform any diagnostic analysis of the images.
Yes
The device is explicitly described as a "software product" and states that "No special image processing hardware is required," indicating it functions solely through software on a standard PC.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "translate different medical image formats into a single format suitable for display on a standard Personal Computer." This is a data processing and display function, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on software for image format translation and secure transport of images and reports. It doesn't mention any interaction with biological specimens or the generation of diagnostic results from such specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely related to the handling and display of medical images, which are typically generated by imaging modalities like ultrasound and nuclear medicine, not from in vitro testing.
N/A
Intended Use / Indications for Use
The AccessPoint™ software is intended to translate different medical image formats into a single format suitable for display on a standard Personal Computer.
Product codes
90ITX
Device Description
Generally speaking, AccessPoint is a software product designed to provide the translation of different medical image formats into a form compatible to be displayed on a standard PC. Connection between sites including hospitals, out reach clinics, physician home and office are provided through the use of e-mail. The images and reports (patient studies) may be transported via e-mail in a secure manor (encryption of data) following standards used by the Internet and local LAN (Intranet), transport systems. A description of the various elements follow: The AccessPoint™ software conforms to DICOM V3 service classes in the role of Service Class Reader.
Mentions image processing
No special image processing hardware is required.
Mentions AI, DNN, or ML
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Input Imaging Modality
Commercial Ultrasound Image Formats: Biosound/Esaote AU3 and AU4 digital formats Hewlett Packard DSR Tiff format TomTec version 5 and P90 versions MicroSonics DSR, DataVue, ImageVue formats
Anatomical Site
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Indicated Patient Age Range
Patient Demographics Display: Window contains age, heart rate, BP, study type and date
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
TomTec P90 K950279
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.2010 Medical image storage device.
(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
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Image /page/0/Picture/0 description: The image shows the text "K963936/" above the words "BIOSOUND ESAOTE". The text "BIOSOUND" is in a bold, sans-serif font, while "ESAOTE" is in a similar font but with a lined design. The text "K963936/" is handwritten and appears to be a serial number or code.
Safety and Effectiveness Summary AccessPoint™ Biosound, Inc.
MAR 31 1997
Biosound, Inc. 8000 Castleway Drive Indianapolis. IN 46250 317 849.1793 800 428.4374 tax 317 841.8616 http://www.biosound.com/
HA oo Ol IZ
Safety and Effectiveness Summary
The following safety and effectiveness summary has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR 1807.92(a).
807.92(a)(1)
Submitter Information
Wayne Nethercutt Director, Regulatory Affairs 8000 Castleway Drive Indianapolis, IN 46250 Phone: (317) 849-1793 Facsimile: (317) 841-8616 Contact Person: Wayne Nethercutt Date: 09/27/96
Our mission is to enhance the quality of life lis providing diagnostic medical equipment and services of superior quality and value for the early detection and management of disease.
1
K963936/A1
Safety and Effectiveness Summarv AccessPointM Biosound, Inc.
807.92(a)(2)
Trade Name: AccessPoint ™ Med E-mail DICOM Reader
Common Name: Medical Image Reading and Transport Software
Classification Name(s): Diagnostic Ultrasound 90ITX .
807.92(a)(3)
Predicate Device(s)
- TomTec P90 K950279 .
Additional Substantial Equivalence information is provided in the attached Substantial Equivalence Comparison Table.
807.92(a)(4)
Device Description
- Generally speaking, AccessPoint is a software product designed to provide the translation of different medical image formats into a form compatible to be displayed on a standard PC. Connection between sites including hospitals, out reach clinics, physician home and office are provided through the use of e-mail. The images and reports (patient studies) may be transported via e-mail in a secure manor (encryption of data) following standards used by the Internet and local LAN (Intranet), transport systems. A description of the various elements follow:
The AccessPoint™ software conforms to DICOM V3 service classes in the role of Service Class Reader.
2
Safety and Effectiveness Summary AccessPoint™ Biosound. Inc.
Communications
Modems supported by Microsoft windows 95 and Windows NT Network communications utilizing TCP/IP Internet Protocol definitions E-mail utilizing POP3 and SMTP (simple mail transfer protocol) standard as implemented in the Microsoft Windows 95, and windows NT operating system Telecommunications standard Integrated Services Digital Network (ISDN) Internet Service access through TCP/IP connection.
Storage
Floppy disk, hard disk, tape, and optical storage supported by Windows 95 or NT operating system.
Image Formats
AccessPoint™ supports the requirement in the Ultrasound Application Profile (APL-US) in the role of file set - Reader as incorporated in the DICOM version 3 definition.
- Commercial Ultrasound Image Formats:
Biosound/Esaote AU3 and AU4 digital formats Hewlett Packard DSR Tiff format TomTec version 5 and P90 versions MicroSonics DSR, DataVue, ImageVue formats
Data Compression
Standard compression techniques used include:
Run Length encoding as published in DICOM V3 supplement 5 also referred to as Tiff Pack bits compression.
ISO/IEC 10918-1 JPEG baseline lossy, and Baseline lossless Compression Audio compression ADPCM adaptive pulse code modulation supplied standard in Windows 95 and Windows NT.
The compression ratio is displayed on the status bar of each window showing the operator and reader that the images displayed have been compressed.
Lossy compression is noted on each display screen.
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Safety and Effectiveness Summary AccessPoint™ Biosound, Inc.
Workstation
Monitor
Standard SVGA monitors are used which comply with the requirements of the Radiation Control and Health and Safety Act.
Processors and Storage
No special image processing hardware is required. Storage requirements vary based on the source of the image data as follows:
With Biosound/Esaote AU3 Ultrasound System, 128/230 MB Magneto optical 3.5" disk drive (internal)
With Tom Tec version 5 acquisition systems, one compatible disk drive 128/230 MB Magneto optical 3.5" disk drive (internal) SCSI controller compatible with Windows 95 or 650/1.3 MB Magneto optical disk drive SCSI controller compatible with Windows 95.
With MicroSonics DSR acquisition, one compatible disk drive 230 MB Magneto optical 3.5" disk drive (internal) SCSI controller compatible with Windows 95 or 650/1.3 MB Magneto optical disk drive, SCSI controller compatible with Windows વેરું.
With Hewlett Packard DSR acquisition, one compatible disk drive, 650 MB Magneto optical disk drive, SCSI controller compatible with Windows 95.
Operator Interface
Standard input devices supported by Microsoft Windows 95, and Windows NT 3.51. No special devices are required. Common implementation includes a keyboard and MS compatible mouse.
Software
1
The workstation uses: Microsoft Office Professional Edition Microsoft Windows 95, windows NT 3.51 or greater Microsoft Plus Pack Microsoft Internet Explorer 3.0
807.92(a)(5)
Intended Use(s)
The AccessPoint™ software is intended to translate different medical image formats into a single format suitable for display on a standard Personal Computer.
4
Safety and Effectiveness Summary AccessPointM Biosound. Inc. 807.92(a)(6)
Substantial Equivalence Table
Feature
Access Point™
TomTec P90 K950279
| Real-Time Image Playback | Yes | Yes |
|---|---|---|
| Slow Motion or Frame by Frame | ||
| Review | Yes | Yes |
| Image Zoom | Variable from .5 to SVGA size | 2X only |
| Study Comparison | Windows 95, NT facilities | Windows 3.11 Facilities |
| ECG Synchronized Playback | Yes | Yes |
| ECG Display | Yes | Yes |
| Patient Demographics Display | Window contains age, heart | |
| rate, BP, study type and date | Heart rate, BP, study | |
| phase | ||
| Modem Transmission | Windows 95 Windows NT | |
| standard | Custom software | |
| Windows Messaging, | ||
| Exchange, SMTP | No | |
| Network Support | Windows 95, Windows NT | |
| TCP/IP standard | Windows 3.11 | |
| Comprehensive Image Serial | ||
| Study Review | DICOM V3.0, TomTec, | |
| Microsonics, HP, | ||
| Esaote/Biosound acquired | TomTec, MicroSonics | |
| acquired | ||
| Different Modalities Review | DICOM US, NM | Proprietary format with |
| DICOM support | ||
| Audio Capture & Playback | Windows 95, NT facilities | Windows |
| Patient Data Storage | DICOM Version 310 Lossy | Proprietary patient roster |
| Compression | JPEG baseline, Lossless REL | |
| Lossless JPEG baseline | JPEG lossy, JPEG | |
| lossless |
Differences
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| Feature | Access Point™ | TomTec P90 |
|---|---|---|
| Acquisition of Ultrasound Images | Does not acquire images from | |
| analog composite video | ||
| sources. Reads images | ||
| formatted and acquired by | ||
| other systems, i.e., TomTec | ||
| P90, Nova Microsonics, | ||
| DICOM, AU3, AU4, HP | Analog composite video | |
| NTSC/PAL, SVHS, RGB | ||
| Integration Into Ultrasound | ||
| System | No | All manufacturers |
| ultrasound systems | ||
| Proprietary Hardware | None | Digital Echo Bus™ |