(261 days)
No
The summary describes a standard endoscopic ultrasound device and its components, focusing on image transmission and processing via traditional methods (fiber bundle, CCD). There is no mention of AI, ML, or any related concepts in the provided text.
No
The device is described as an instrument for diagnostic imaging (endoscopic real-time ultrasound imaging) and for guiding needle aspiration, but it does not directly treat or cure any condition.
Yes
The "Intended Use / Indications for Use" states that the instrument is "designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration." This process is used to diagnose conditions by obtaining tissue samples.
No
The device description explicitly states it is a flexible video endoscope consisting of physical parts (control section, insertion section, and connector section) and mentions hardware components like a fiber bundle and CCD unit. Performance studies also include hardware-related testing (Ultrasound output display, Reprocessing validation, Biocompatibility, Electrical safety and EMC, Bench testing).
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. They are used outside of the body.
- Device Function: The description clearly states that this device is an endoscope used for real-time ultrasound imaging and guided needle aspiration within the airways, tracheobronchial tree, and esophagus. This is an in vivo procedure, meaning it is performed inside the living body.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its primary function is imaging and guiding a procedure within the body.
Therefore, while it is a diagnostic tool, it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, EndoTherapy accessories such as an aspiration biopsy needle. This instrument is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus.
Product codes
PSV, ITX
Device Description
The BF-UC190F has been designed to be used with the video system center, light source, documentation equipment, display monitor, and Endo Therapy accessories such as an aspiration biopsy needle. The BF-UC190F is intended for endoscopic real-time ultrasound imaging for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus.
The BF-UC190F is a flexible video endoscope and a modification of the XBF-UC180F-DT8 which was previously cleared under K070983.
The BF-UC190F consists of three parts: the control section, the insertion section, and the connector section. The control section contains an UP/DOWN angulation control lever connected to the tip of the bending section by wires, allowing vertical bending for guiding the distal end. It also contains a cylinder for a suction valve to suction fluids and an instrument channel for therapeutic instruments. The insertion section includes an image guide, light guide, instrument channel, balloon channel, and ultrasound transducer. The light guides illuminate the area, the instrument channel allows for tool insertion, the balloon channel feeds water to the balloon, and the ultrasound transducer emits and receives ultrasound waves. The connector section connects the endoscope with the light source (CLV-190) and contains the ultrasound cable connector for the ultrasound system. The BF-UC190F is equipped with a CCD unit in the control section and a fiber bundle in the insertion tube, which transmit images and convert them to video signals, identical to the predicate model.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
airways, tracheobronchial tree, and esophagus.
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
The following performance data were provided in support of the substantial equivalence determination:
- Ultrasound output display: Conducted in accordance with the FDA Guidance Document, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." The subject device conforms to the IEC 60601-2-37 Edition 2.0 2007.
- Reprocessing validation testing: Reprocessing instruction and reprocessing method validation testing were conducted and documentation provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling."
- Biocompatibility testing: Conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
- Software verification and validation testing: Conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
- Electrical safety and electromagnetic compatibility (EMC): Testing was conducted on the BF-UC190F. The system complies with the ANSI/AAMI ES60601-1:2005/A2:2012/(R)2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2007 standards for EMC.
- Performance testing - Bench: Bench testing for the BF-UC190F was conducted to ensure that the subject device performs as intended and meet design specifications. Device performance was assessed against design requirements, and included process verification, design verification, and design validation. Tests included Thermal safety test and Mechanical durability test.
- Risk analysis: Risk analysis for the BF-UC190F was conducted in accordance with established inhouse acceptance criteria based on ISO 14971:2007 and the human factors validation was conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices."
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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September 6, 2019
Olympus Medical Systems Corp. % Sheri Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610
Re: K183525
Trade/Device Name: EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: PSV, ITX Dated: August 8. 2019 Received: August 9, 2019
Dear Sheri Musgnung:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183525
Device Name
EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UC190F
Indications for Use (Describe)
This instrument has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, EndoTherapy accessories such as an aspiration biopsy needle. This instrument is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus.
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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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. There is a registered trademark symbol to the right of the word. There is a yellow line underneath the word.
September 3, 2019
510(k) Summary
1 GENERAL INFORMATION
- 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-machi, Hachioji-shi, Tokyo, Japan 192-8507
- Contact Person: Sheri Musgnung Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 Fax: 484-896-7128 Email: sheri.musgnung@olympus.com
2 DEVICE IDENTIFICATION
| ■ Device Name | EVIS EUS ULTRASOUND
BRONCHOFIBERVIDEOSCOPE OLYMPUS BF
UC190F |
|------------------------|--------------------------------------------------------------------|
| ■ Common Name | Ultrasound Bronchoscope |
| ■ Regulation Number | 892.1550 |
| ■ Regulation Name | Ultrasonic pulsed doppler imaging system. |
| ■ Regulatory Class | II |
| ■ Product Code | PSV, ITX |
| ■ Classification Panel | Ear, Nose, and Throat |
3 PREDICATE DEVICE
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| XBF-UC180F-DT8 | ||
| (AKA BF-UC180F) | OLYMPUS MEDICAL SYSTEMS CORP. | K070983 |
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Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly blurred, giving them a soft, three-dimensional effect. A registered trademark symbol is located in the upper right corner of the word.
The predicate device. XBF-UC180F-DT8. has been name changed after 510(k) clearance. It is marketed as BF-UC180F.
4 DEVICE DESCRIPTIONN
EVIS EUS BRONCHOVIDEOFIBERSCOPE OLYMPUS BF-UC190F
1) General Description of the subject device
The BF-UC190F has been designed to be used with the video system center, light source, documentation equipment, display monitor, and Endo Therapy accessories such as an aspiration biopsy needle. The BF-UC190F is intended for endoscopic real-time ultrasound imaging for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus.
The BF-UC190F is a flexible video endoscope and a modification of the XBF-UC180F-DT8 which was previously cleared under K070983.
2) Principle of Operation
The BF-UC190F consists of three parts: the control section, the insertion section, and the connector section.
The control section
The UP/DOWN angulation control lever on the control section is connected to the tip of the bending section by a series of wires. By operating the UP/DOWN angulation control lever, the bending section at the distal end bends vertically to guide the distal end for insertion and observation within the airways, tracheobronchial tree, and esophagus.
The endoscope contains a cylinder to attach a suction valve for suction. Depressing the suction valve will allow the doctor to use the endoscope to suction any fluids which are obscuring a good view of the tissue. Therapeutic instruments can be passed through the instrument channel for performing endoscopic biopsy and other therapies.
The insertion section
The insertion section has main parts including the image guide the light guide, the instrument channel, the balloon channel and the ultrasound transducer.
The light guides bring light from the light source through the endoscope.
The instrument channel outlet (also the suction opening) can be pushed in and out for withdrawing and inserting the therapeutic tools.
The balloon channel feed water to the balloon.
The ultrasound transducer emits and receives the ultrasound wave.
The connector section
The connector section connects the endoscope with the light source (CLV-190).
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This connector contains the ultrasound cable connector to attach the ultrasound cable for connecting the ultrasound system.
The BF-UC190F is equipped with the CCD unit in the control section, as well as the fiber bundle in the insertion tube. Images are transmitted through the fiber bundle, and the CCD unit in the control section changes them to video signals. This feature is identical to the predicate models (XBF-UC180F-DT8; K070983).
Ultrasound Operation
Operating controls with ultrasound systems
The primary interface between the device and the user is the console's keyboard. The software controlling the keyboard has been designed as the user cannot set the machine to over-ride any of the internally set controls (such as maximum acoustic power).
In any mode, the keyboard menu will only accept valid inputs. Keys and/or commands are not available in a particular mode.
A trackball or a trackpad are provided for calipers, other graphic and imaging adjustments/ controls.
US CONNECTOR CAP MAJ-2295
This is US connector cap. This is attached to the ultrasound cable connector on the endoscope to protect the ultrasound cable connector and the endoscope from water penetration during reprocessing.
5 INDICATIONS FOR USE
This instrument has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, Endo Therapy accessories such as an aspiration biopsy needle.
This instrument is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus.
6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE
The BF-UC190F has the same technological characteristics and design as the predicate device except for the following new features:
- Outer diameter of the insertion portion a.
- b. Outer Diameter of Distal End
- Direction of view. C.
- d. Angulations
- Electrical connector (transmit CCD image signal) e.
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- f. More sterilization methods become applicable for endoscope.
- g. Irrigation port angle
- h. Outlet shape of the balloon channel
- i. The compatible cleaning brush is changed from reusable BW-7B and MH-507 to single-use BW-400B and BW-411B
- j. Clarification of cleaning procedure and the brush to be used for Balloon groove
- k. The shape of transducer
Validation from non-clinical testing demonstrated as defined in the performance data below show that these technological features do not raise any new issues of safety or effectiveness of the subject device.
All other technological characteristics of both the subject and predicate devices are identical.
| Item | Subject Device:
BF-UC190F | Predicate Device:
XBF-UC180F-DT8, K070983 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General information | | |
| Indication for Use | This instrument has been designed to
be used with diagnostic ultrasound
system, video system center, light
source, documentation equipment,
display monitor, Endo Therapy
accessories such as aspiration biopsy
needle.
This instrument is designed for
endoscopic real-time ultrasound
imaging, for performing endoscopic
ultrasound guided needle aspiration
within the airways, tracheobronchial
tree, and esophagus. | This instrument has been designed to
be used with a diagnostic ultrasound
system (ALOKA CO., LTD), video
system center, light source,
documentation equipment, video
monitor, endo-therapy accessories and
other ancillary equipment.
This instrument is designed for
endoscopic real-time ultrasonic image,
ultrasound guided needle aspiration
and other endoscopic procedures
within the airways, tracheobronchial
tree, esophagus and surrounding
organs. |
| Clinical Application | Used with EU-ME1:
- Transesophageal (non-cardiac)
- Intraluminal ultrasound for upper
airways and tracheobronchial tree
Used with EU-ME2 / EU-ME2
PREMIR PLUS: - Transesophageal (non-cardiac)
- Intraluminal ultrasound for upper
airways and tracheobronchial tree | Used with SSD-Alpha5/10: - Transesophageal (non-cardiac)
- Airways and tracheobronchial tree |
| Regulation name | Ultrasonic endoscope, its accessories
and ancillary equipment | Ultrasonic Endoscope, its accessories
and ancillary equipment |
| Regulation number | 892.1550 | 892.1550 |
| Product code | PSV (ultrasound bronchoscope)
ITX (transducer, ultrasonic, diagnostic) | PSV (ultrasound bronchoscope)
IYN (system, imaging, pulsed doppler,
ultrasonic)
ITX (transducer, ultrasonic, diagnostic) |
| Ultrasound specifications | | |
Table 1.1.5-2 Comparison with Predicate Device
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ULTRASOUND BRONCHOFIBERVIDEOSCOPE BF-UC190F
| Nominal
Ultrasonic
Frequencies Of
The Transducer
| Assembly | 7-10MHz | 7-10MHz |
|---|---|---|
| ----------------------------------------------------------------------- | --------- | --------- |
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| Item | Subject Device:
BF-UC190F | Predicate Device:
XBF-UC180F-DT8, K070983 |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mode | Used with EU-ME1:
B, Color doppler | Used with SSD-Alpha5/10:
B, M, PWD, Color doppler, Amplitude
Doppler, Combined |
| | Used with EU-ME2 / EU-ME2
PREMIR PLUS: | |
| | B, PWD, Color Doppler, Combined,
Harmonic imaging | |
| Applicable Ultrasound
system | EU-ME1
EU-ME2
EU-ME2 Premier Plus | ALOKA SSD-Alpha5 Diagnostic
ultrasound system
ALOKA SSD-Alpha10 Diagnostic
ultrasound system |
| Scanning Direction | Parallel to the Axis of
the Insertion Tube | Parallel to the Axis of
the Insertion Tube |
| Scanning Field of View | Used with EU-ME1: 60°
Used with EU-ME2 / EU-ME2
PREMIR PLUS: 65° | 60° |
| Scanning Method | Electrical curved linear array
Scanning | Electrical curved linear array Scanning |
| Contact Method | Balloon Method
Direct contact method | Balloon Method
Direct contact method |
| Endoscope specifications | | |
| Field of View | 80 ° | 80 ° |
| Depth of Field | 2 - 50mm | 2 - 50mm |
| Direction of View | 20° (forward-oblique) | 35° (forward-oblique) |
| Outer Diameter of
Distal End | φ6.6mm | φ6.9mm |
| Outer Diameter of
Insertion Tube | φ6.3mm | φ6.2mm |
| Angulation
UP/DOWN | 160°/70° | 120°/90° |
| Working Length | 600mm | 600mm |
| Instrument Channel | φ2.2mm | φ2.2mm |
| Combination use with
Electrosurgical
instruments | Not applicable | Not applicable |
| NBI observation | Not available | Not available |
| Scope connector | Electrical connector is integrated to
scope connector. Ultrasound connecter
is separated. Only when combined with
the water-resistant cap, ultrasound
connector is water resistant. | Electrical connector (transmit CCD
image signal) and ultrasound connecter is
separated. When combined with the
water-resistant cap, both connecters are
water resistant. |
| Protect water penetration
during reprocessing. | US connector cap (MAJ-2295) is
attached to the ultrasound cable
connector on the endoscope to protect
the ultrasound cable connector and the
endoscope from water penetration
during reprocessing. | Water resistant cap (MH-553) is attached
to the ultrasound cable connector and the
videoscope cable connector on the
endoscope to protect the both connectors
and the endoscope from water
penetration during reprocessing. |
| Sterilization methods for
reprocessing | -Ethylene oxide gas
-H2O2 (V-PRO maX) | -Ethylene oxide gas |
| Item | Subject Device:
BF-UC190F | Predicate Device:
XBF-UC180F-DT8, K070983 |
| Compatible Olympus
reprocessor for cleaning
and disinfection | Not available | Not available |
| High frequency
accessories | Not available | Not available |
| RFID tag for
communication with
endoscope reprocessor | Available | Available |
| Individual scope
information
(Scope ID) | Available | Available |
| Electric safety | Comply to IEC 60601-1,
IEC 60601-2-18 | Comply to IEC 60601-1,
IEC 60601-2-18 |
| EMC | Comply to IEC 60601-1 | Comply to IEC 60601-1 |
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7 PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
1) Ultrasound output display
The Output Display for the BF-UC190F were conducted in accordance with the FDA Guidance Document, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." The subject device conform to the IEC 60601-2-37 Edition 2.0 2007.
2) Reprocessing validation testing
Reprocessing instruction and reprocessing method validation testing for the BF-UC190F were conducted and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling."
3) Biocompatibility testing
Biocompatibility testing for the BF-UC190F were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
4) Software verification and validation testing
Software verification and validation testing for the BF-UC190F were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
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Image /page/10/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced together. The word is slightly blurred, suggesting that the image may have been taken out of focus or that the original image was of low resolution. There is a registered trademark symbol to the right of the word.
5) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the BF-UC190F. The system complies with the ANSI/AAMI ES60601-1:2005/A2:2012/(R)2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2007 standards for EMC.
6) Performance testing - Bench
Bench testing for the BF-UC190F as listed below was conducted to ensure that the subject device performs as intended and meet design specifications. Device performance was assessed the design requirements, and included process verification, design verification, and design validation.
- Thermal safety test
- Mechanical durability test
7) Risk analysis
Risk analysis for the BF-UC190F was conducted in accordance with established inhouse acceptance criteria based on ISO 14971:2007 and the human factors validation was conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices." The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
8 CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the BF-UC190F raise no new issue of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, effectiveness and performance.