(89 days)
Not Found
No
The summary describes standard ultrasonic pulse echo technology and image processing techniques, with no mention of AI, ML, or related concepts.
No
The device is described as a "diagnostic system" intended to "visualize" and "measure" structures within the eye, which are diagnostic functions, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application." The "Device Description" also refers to it as a "diagnostic ultrasound system."
No
The device description explicitly states it consists of an interface module and optional ultrasound probes, which are hardware components.
Based on the provided information, the Scanmate Flex is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves tests performed on samples like blood, urine, tissue, etc., outside of the living body.
- Scanmate Flex Function: The Scanmate Flex is an ultrasonic diagnostic system that visualizes and measures structures inside the eye using ultrasound technology. It directly interacts with the patient's body (the eye) to obtain information.
Therefore, the Scanmate Flex falls under the category of an in vivo diagnostic device, as it performs diagnostic procedures within the living body.
N/A
Intended Use / Indications for Use
The Scanmate Flex is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The Scanmate Flex is intended for the examination of adult patients.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The Scanmate Flex is a diagnostic ultrasound system that allows eyecare professionals to visualize and measure internal structures of the eye. The technology is based on ultrasonic pulse echo technology, whereby short bursts of ultrasonic energy are transmitted and the resulting echoes are captured, amplified, filtered and processed. The timing of the echoes is analyzed and converted into distance information (when the A-Scan probe is used) or images (when the B-Scan and UBM probes are used). The distance information and images are displayed on a PC screen. The Scanmate Flex consists of an interface module (which is connected to a standard Windows PC, not included with the Scanmate Flex system) and one or more optional ultrasound probes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Eye / Ophthalmic
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Eyecare professionals
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)
Acoustic output testing was performed by Acertara Acoustic Laboratories and Sonora Medical Systems. Performance testing was verified using precision test blocks and monofilament phantoms. Thermal, mechanical, and electrical performance conforms to AAMI / ANSI ES60601-1:2005/(R)2012, IEC 60601-1-2 Edition 4.0 2014-02, IEC 60601-2-37 Edition 2.0 2007, NEMA UD 2-2004 (R2009), NEMA UD-3 2004, and AAMI / ANSI / ISO 10993-1:2009/(R)2013. Biocompatibility testing was performed on patient-contacting elements and found to be biocompatible. Software verification and validation testing was conducted in accordance with internally developed test plans.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Sonomed VuPad (K140199), DGH 6000 Scanmate A (K093371)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/2 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 symbol featuring three human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2017
DGH Technology, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services. LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K171301
Trade/Device Name: Scanmate Flex Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: July 25, 2017 Received: July 26, 2017
Dear Mr. Job:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael D. O'Hara
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171301
Device Name Scanmate Flex
Indications for Use (Describe)
The Scanmate Flex is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The Scanmate Flex is intended for the examination of adult patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| System: | Scanmate Flex: Ultrasound System |
|---|---|
| Probe(s): | DGH6006: A-Scan Probe |
| DGH1912: B-Scan Probe (12.5 MHz) | |
| DGH1920: B-Scan Probe (20 MHz) | |
| DGH1500: UBM Probe (35 MHz or 50 MHz) |
Intended Use: The Scanmate Flex is a multi-purpose computer-based ultrasonic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The Scanmate Flex is intended for the examination of adult patients.
| Clinical Application | | Mode of Operation | | | | | | Other
(A-Mode) |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-------------------|
| General
(Track 1 Only) | Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | |
| Ophthalmic | Ophthalmic | N | | | | | | N |
| Fetal
Imaging
& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-Operative (Specify) | | | | | | | |
| | Intra-Operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal
(Conventional) | | | | | | | |
| | Musculo-skeletal
(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral Vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
4
Probe: DGH6006: A-Scan Probe
Intended Use: The DGH6006 probe is used for measuring the Axial Length (AXL), Anterior Chamber Depth (ACD), Lens Thickness (LT), and the Vitreous Chamber Depth (VCD). The probe contacts the cornea directly.
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other | |||||||
| (A-Mode) | ||||||||
| P (K093371) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-Operative (Specify) | ||||||||
| Intra-Operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral Vessel | |||||||
| Other (Specify) |
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Probe: DGH1912: B-Scan Probe (12.5 MHz)
Intended Use: The DGH1912 probe is used for imaging the posterior segment of the globe. The probe contacts the cornea directly.
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | Combined | Other | |
| (Track 1 Only) | (Tracks 1 & 3) | Doppler | (Specify) | (A-Mode) | |||||
| Ophthalmic | Ophthalmic | N | |||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-Operative (Specify) | |||||||||
| Intra-Operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal | Adult Cephalic | ||||||||
| Imaging | Trans-rectal | ||||||||
| & Other | Trans-vaginal | ||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral Vessel | ||||||||
| Vessel | Other (Specify) |
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Probe: DGH1920: B-Scan Probe (20 MHz)
Intended Use: The DGH1920 probe is used for imaging the posterior segment of the globe. The probe contacts the cornea directly.
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | Combined | Other | ||
| (Track 1 Only) | (Tracks 1 & 3) | Doppler | (Specify) | (A-Mode) | ||||||
| Ophthalmic | Ophthalmic | N | ||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-Operative (Specify) | ||||||||||
| Intra-Operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal | Adult Cephalic | |||||||||
| Imaging | Trans-rectal | |||||||||
| & Other | Trans-vaginal | |||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Specify) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Cardiac | Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (Specify) | ||||||||||
| Peripheral | Peripheral Vessel | |||||||||
| Vessel | Other (Specify) |
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Probe: DGH1500: UBM Probe
Intended Use: The DGH1500 is used for imaging the anterior segment of the globe. The probe may operate at a nominal frequency of 50 MHz or 35 MHz, depending on transducer selected.
The DGH1500 is an open probe and must be with the FDA-cleared ClearScan probe cover.
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other | |||||||
| (A-Mode) | ||||||||
| Ophthalmic | Ophthalmic | N | ||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-Operative (Specify) | ||||||||
| Intra-Operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral Vessel | |||||||
| Vessel | Other (Specify) |
8
Image /page/8/Picture/0 description: The image shows the logo for DGH Technology, Inc. The logo consists of the letters "DGH" in a bold, sans-serif font, followed by three horizontal lines that curve slightly upwards. Above the lines, the words "TECHNOLOGY, INC." are written in a smaller, sans-serif font. The overall design is simple and modern.
510(k) Summary (21 CFR 807.92)
I. Submitter
DGH Technology, Inc. 110 Summit Drive, Suite B Exton, PA 19341
Contact Person: David E. Henderson Telephone: 610-594-9100 Fax: 610-594-0390 Email: david@dghtechnology.com
Date Prepared: July 17th, 2017
II. Device
Name of Device: Scanmate Flex Common or Usual Name: Diagnostic ophthalmic ultrasound system Classification Name: System, imaging, pulsed echo, ultrasonic Regulatory Class: II 21 CFR 892.1560 Product Code: IYO, ITX
III. Predicate Devices
Predicate devices: Sonomed VuPad (K140199) and DGH 6000 Scanmate A (K093371).
Neither of these predicates has been subject to a design-related recall.
IV: Device Description
The Scanmate Flex is a diagnostic ultrasound system that allows eyecare professionals to visualize and measure internal structures of the eye. The technology is based on ultrasonic pulse echo technology, whereby short bursts of ultrasonic energy are transmitted and the resulting echoes are captured, amplified, filtered and processed. The timing of the echoes is analyzed and converted into distance information (when the A-Scan probe is used) or images (when the B-
9
TECHNOLOGY, INC.
Image /page/9/Picture/1 description: The image shows the letters DGH in a bold, sans-serif font. The letters are black, except for a gray horizontal bar that extends from the middle of the G to the middle of the H. The letters are large and take up most of the frame.
Scan and UBM probes are used). The distance information and images are displayed on a PC screen.
The Scanmate Flex consists of an interface module (which is connected to a standard Windows PC, not included with the Scanmate Flex system) and one or more optional ultrasound probes. The Scanmate Flex supports the following probe types:
- DGH6006 A-Scan Probe (10 MHz)
- DGH1912 B-Scan Probe (12.5 MHz) ●
- DGH1920 B-Scan Probe (20 MHz)
- DGH1500 UBM Probe (35 MHz and 50 MHz)
V. Intended Use
Scanmate Flex Indications for Use
The Scanmate Flex is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The Scanmate Flex is intended for the examination of adult patients.
| Predicate
Manufacturer and
Device Name | Predicate
510(k) | Indications for Use |
|----------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sonomed
VuPad | K140199 | The VuPad ultrasound system is a multi-purpose
computer-based ultrasonic diagnostic system for
ophthalmic application, intended to both visualize the
interior of the eye by means of ultrasound and to make
measurements inside the eye, including the
measurement of axial length for determination of IOL
Power. |
| DGH Technology, Inc.
DGH 6000 Scanmate A | K093371 | The intended use of the DGH 6000 is the measurement
of AL, ACD, LT of the human eye. The DGH 6000 is
also intended to calculate the optical power of an IOL
that is to be implanted during cataract surgery. |
Comparison to Predicate Device Indications for Use
The Scanmate Flex Indications for Use are identical to the Predicate Device (Sonomed VuPad K140199), except for the device name and the restriction that it be used with adult patients. There are no clinically significant differences between the Scanmate Flex and the DGH 6000 (K093371) Indications for Use related to A-Mode operation.
10
TECHNOLOGY, INC.
VI. Comparison of Technological Characteristics with the Predicate Devices
DGH Technology believes that the technological characteristics incorporated in the Scanmate Flex are substantially equivalent to those of the Sonomed VuPad and DGH 6000 Scanmate A. The DGH 6000 only supports A-Mode operation, so characteristics related to B-Mode functions are only compared to the Sonomed VuPad. Both the subject and predicate devices are based on the same ultrasound imaging and measurement principles. The major technological aspects they have in common are the following:
- Ophthalmic A-mode and B-mode scanning for imaging and measurement. ●
- . Ultrasound frequencies ranging from 10 MHz to 50 MHz.
- Windows PC or tablet for operator controls and display of measurements and images.
- Database for storage of measurements and images.
- ClearScan disposable cover for UBM probe.
- Standard power calculations for intra-ocular lens selection.
The following primary technological differences exist between the subject and predicate devices:
- . The subject device has a battery and can be operated without being plugged into A/C power; the predicate devices require mains power.
- The subject device and DGH 6000 Scanmate A predicate can be used with an existing . Windows computer; the Sonomed VuPad predicate must be used with a dedicated tablet computer.
VII. Performance Data
The following tests were performed to demonstrate substantial equivalence.
Acoustic Output Testing
Acoustic output testing of the Scanmate Flex was performed by Acertara Acoustic Laboratories and Sonora Medical Systems.
Performance Testing
The measurement performance of the Scanmate Flex was verified using precision test blocks and monofilament phantoms.
11
Thermal, Mechanical, and Electrical Performance
The DGH Scanmate Flex conforms to the following standards:
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,, c1:2009/(r)2012 and . a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod). (General II (ES/EMC)
- IEC 60601-1-2 Edition 4.0 2014-02. Medical Electrical Equipment Part 1-2: General ● Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests. (General II (ES/EMC))
- IEC 60601-2-37 Edition 2.0 2007, Medical Electrical Equipment - Part 2-37: Particular Requirements For The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment. (Radiology)
- NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard For Diagnostic . Ultrasound Equipment - Revision 3. (Radiology)
- . NEMA UD-3 2004 Standard for real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- . AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological Evaluation Of Medical Devices -Part 1: Evaluation And Testing Within A Risk Management Process. (Biocompatibility)
Biocompatibility Testing
The Scanmate Flex has four patient-contacting elements: the A-Scan Probe, the B-Scan Probe, the ClearScan disposable cover of the UBM probe, and the immersion shell of the A-Scan Probe (if used). In all cases, the patient-contacting materials were found to be biocompatible.
Software Verification and Validation Testing
The software of the Scanmate Flex was verified and validated in accordance with internally developed test plans.
12
Image /page/12/Picture/1 description: The image shows the logo for DGH. The letters D, G, and H are in bold, black font. There is a gray rectangle that connects the G and the H.
VIII. Conclusions
In summary, the documentation provides evidence to make the reasonable conclusion that:
- The intended uses for the subject and predicate devices are the same.
- The indications for uses for the subject and predicate devices are substantially equivalent ● raising no new questions of safety or effectiveness.
- The functionality of the subject and predicate devices are substantially equivalent raising no new questions of safety or effectiveness.
- . In the area of safety, the Scanmate Flex is shown to be as safe as the predicate devices for hazards of EMI, acoustic output, and biocompatibility raising no new questions of safety or effectiveness.
- . In the area of effectiveness, the Scanmate Flex provides essentially the same features as the predicate devices, along with a number of software enhancements. Thus, it is at least as effective as its predicate devices, raising no new questions of efficacy when compared to the predicate devices.
DGH Technology believes the comparisons above support the substantial equivalence of the Scanmate Flex, the subject device, to its predicate devices.