(24 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance testing summary.
No
The device is described as an "ultrasound imaging system" intended for "diagnostic imaging," which means it's used to identify conditions rather than treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic imaging" and "indicated for diagnostic ultrasound imaging and fluid flow analysis."
No
The device description explicitly states that the system comprises wireless transducers/scanners and accessories like a charger and fan, in addition to the software. This indicates the device includes hardware components beyond just the software running on an off-the-shelf device.
Based on the provided information, the Clarius Ultrasound Scanner is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body.
- Clarius Ultrasound Scanner Function: The Clarius Ultrasound Scanner is an imaging system that uses ultrasound waves to create images of structures inside the body. It is used for diagnostic imaging and fluid flow analysis in vivo (within the living body).
- Intended Use: The intended use clearly states it's for "diagnostic imaging" and "fluid flow analysis" in various anatomical sites within the patient.
- Device Description: The description details how it acquires and displays real-time ultrasound data from within the body.
The device's function and intended use are entirely focused on non-invasive imaging of the internal structures of the body, which is not the purpose of an IVD.
N/A
Intended Use / Indications for Use
The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body.
The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The Clarius Ultrasound Scanner is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-shelf (OTS) iOS or Android device. The Clarius Ultrasound Scanner comprises a series of wireless transducers employing Bluetooth and Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range of portable personal devices.
The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals, including the emergency medical services (EMS) environment.
The Clarius Ultrasound Scanner is intended for use by qualified healthcare practitioners (e.g., doctors, nurses, sonographers) who are trained in the use of ultrasound imaging technology.
The Clarius Ultrasound Scanner comprises the following:
Transducers/ Scanners (various models): C3 HD3, C7 HD3, EC7 HD3, L7 HD3, L15 HD3, PA HD3, L20 HD3
Software: Clarius Ultrasound App (Clarius App) for iOS; Clarius Ultrasound App (Clarius App) for Android
Accessories: Clarius Charger; Clarius Fan
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid.
Indicated Patient Age Range
Adult, pediatric.
Intended User / Care Setting
Trained healthcare professionals in environments where healthcare is provided by trained healthcare professionals, including the emergency medical services (EMS) environment. Qualified healthcare practitioners (e.g., doctors, nurses, sonographers) who are trained in the use of ultrasound imaging technology.
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)
Non-Clinical Performance Testing of the Clarius Ultrasound Scanner:
The HD3 scanners of the Clarius Ultrasound Scanner family of devices were designed and developed by Clarius Mobile Health Corp. in accordance with the applicable requirements and standards to establish performance and safety of the device. The device's safety and performance were verified by tests conducted by Clarius and accredited third-party laboratories. Validation testing was performed to ensure that the final product is capable of meeting the requirements for the specified clinical applications and performs as intended to meet users' needs, while demonstrating substantial equivalence to the predicate device.
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.
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
§ 892.1550 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Clarius Mobile Health Corp. % Ms. Agatha Szeliga Director, Regulatory Affairs 130-2985 Virtual Way Vancouver, British Columbia V5M 4X7 CANADA
Re: K213436
Trade/Device Name: Clarius Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN Dated: October 21, 2021 Received: October 22, 2021
November 15, 2021
Dear Ms. Szeliga:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- 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 (QS) 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
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213436
Device Name Clarius Ultrasound Scanner
Indications for Use (Describe)
The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body.
The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary - K213436
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.
| Subject Device Trade Name: | Clarius Ultrasound Scanner |
|---|---|
| Subject Device Model Numbers: | C3 HD3, C7 HD3, EC7 HD3, L7 HD3, L15 HD3, PA HD3, L20 HD3 |
| Common Name: | Diagnostic Ultrasound System and Accessories |
Regulation Number, Name and Product Codes:
| Regulation Number | Regulation Name | Product Code |
|---|---|---|
| 21 CFR § 892.1550 | Ultrasonic Pulsed Doppler Imaging System | IYN |
| 21 CFR § 892.1560 | Ultrasound Pulsed Echo Imaging System | IYO |
| 21 CFR § 892.1570 | Diagnostic Ultrasonic Transducer | ITX |
| FDA 510(k) Review Panel: | Radiology |
|---|---|
| Classification: | Class II |
| Manufacturer: | Clarius Mobile Health Corp. |
| 130-2985 Virtual Way | |
| Vancouver, BC V5M 4X7 Canada | |
| Contact Name: | Agatha Szeliga |
| Director, Regulatory Affairs | |
| agatha.szeliga@clarius.com | |
| Date 510(k) Summary Prepared: | October 20, 2021 |
Predicate Device Information:
| Device Trade Name: | Clarius Ultrasound Scanner |
|---|---|
| 510(k) Reference: | K192107 |
| Submitter Name: | Clarius Mobile Health Corp. |
| Regulation Name: | Ultrasonic Pulsed Doppler Imaging System |
| Classification Product Code(s): | IYN |
| Subsequent Product Codes | IYO, ITX |
| Regulation Number: | 21 CFR § 892.1550; 21 CFR § 892.1560; 21 CFR § 892.1570 |
| Classification: | Class II |
Note: The predicate device has not been subject to a design-related recall.
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Device Description
The Clarius Ultrasound Scanner is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an offthe-shelf (OTS) iOS or Android device. The Clarius Ultrasound Scanner comprises a series of wireless transducers employing Bluetooth and Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range of portable personal devices.
The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals, including the emergency medical services (EMS) environment.
The Clarius Ultrasound Scanner is intended for use by qualified healthcare practitioners (e.g., doctors, nurses, sonographers) who are trained in the use of ultrasound imaging technology.
| Transducers/ Scanners (various models) | C3 HD3, C7 HD3, EC7 HD3, L7 HD3, L15 HD3, PA HD3, L20 HD3 |
|---|---|
| Software | Clarius Ultrasound App (Clarius App) for iOS; |
| Clarius Ultrasound App (Clarius App) for Android | |
| Accessories | Clarius Charger |
| Clarius Fan |
The Clarius Ultrasound Scanner comprises the following:
Indications for Use for the Clarius Ultrasound Scanner
The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body.
The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals.
| Criteria | SUBJECT DEVICE | PREDICATE DEVICE |
|---|---|---|
| Clarius Ultrasound Scanner | Clarius Ultrasound Scanner | |
| 510(k) Holder/ | ||
| Manufacturer | Clarius Mobile Health Corp. | Clarius Mobile Health Corp. |
| Submission | ||
| Reference | Current Submission | K192107 |
| 510(k) Track | Track 3 | Track 3 |
| Product Codes | IYN1, IYO2, ITX3 | IYN1, IYO2, ITX3 |
| Criteria | SUBJECT DEVICE | PREDICATE DEVICE |
| Clarius Ultrasound Scanner | Clarius Ultrasound Scanner | |
| Regulation | 21 CFR 892.15501 | 21 CFR 892.15501 |
| Number | 21 CFR 892.15602 | 21 CFR 892.15602 |
| 21 CFR 892.15703 | 21 CFR 892.15703 | |
| Regulation Name | Ultrasonic Pulsed Doppler Imaging System1; | Ultrasonic Pulsed Doppler Imaging System1; |
| Ultrasonic Pulsed Echo Imaging System2; | Ultrasonic Pulsed Echo Imaging System2; | |
| Diagnostic Ultrasonic Transducer3 | Diagnostic Ultrasonic Transducer3 | |
| Transducer | C3 HD3, C7 HD3, EC7 HD3, L7 HD3, L15 HD3, | C3 HD, C7 HD, EC7 HD, L7 HD, L15 HD, PA HD, |
| Models | PA HD3, L20 HD3 | L20 HD |
| Transducer Types | Convex Array | Convex Array |
| Linear Array | Linear Array | |
| Phased Array | Phased Array | |
| Intracavity | Intracavity | |
| Intended Use | Diagnostic ultrasound imaging and fluid flow | Diagnostic ultrasound imaging and fluid flow |
| Indications for | analysis of the human body | |
| The Clarius Ultrasound Scanner is a software- | analysis of the human body | |
| The Clarius Ultrasound Scanner is a software- | ||
| Use and Clinical | based ultrasound imaging system and | based ultrasound imaging system and |
| Usage | accessories, intended for diagnostic imaging. | accessories, intended for diagnostic imaging. |
| It is indicated for diagnostic ultrasound | It is indicated for diagnostic ultrasound | |
| imaging and fluid flow analysis in the | imaging and fluid flow analysis in the | |
| following applications: ophthalmic, fetal, | following applications: ophthalmic, fetal, | |
| abdominal, intra-operative (non- | abdominal, intra-operative (non- | |
| neurological), pediatric, small organ, cephalic | neurological), pediatric, small organ, cephalic | |
| (adult), trans-rectal, trans-vaginal, musculo- | (adult), trans-rectal, trans-vaginal, musculo- | |
| skeletal (conventional, superficial), urology, | skeletal (conventional, superficial), urology, | |
| gynecology, cardiac (adult, pediatric), | gynecology, cardiac (adult, pediatric), | |
| peripheral vessel, carotid, and procedural | peripheral vessel, carotid, and procedural | |
| guidance of needles into the body. | guidance of needles into the body. | |
| The system is a transportable ultrasound | The system is a transportable ultrasound | |
| system intended for use in environments | system intended for use in environments | |
| where healthcare is provided by trained | where healthcare is provided by trained | |
| healthcare professionals. | healthcare professionals. | |
| Ophthalmic Fetal Abdominal Intraoperative (Ab/Vasc) Pediatric Small Organ Adult cephalic Trans-rectal Trans-vaginal Musculoskeletal (conventional) Musculoskeletal (superficial) Urology Gynecology Cardiac adult | Ophthalmic Fetal Abdominal Intraoperative (Ab/Vasc) Pediatric Small Organ Adult cephalic Trans-rectal Trans-vaginal Musculoskeletal (conventional) Musculoskeletal (superficial) Urology Gynecology Cardiac adult | |
| Criteria | SUBJECT DEVICE | PREDICATE DEVICE |
| Clarius Ultrasound Scanner | Clarius Ultrasound Scanner | |
| Cardiac pediatric Peripheral vessel Carotid Needle guidance | Cardiac pediatric Peripheral vessel Carotid Needle guidance | |
| Principle of | ||
| Operation | Piezoelectric material in the system's | |
| transducer transmits high frequency, non- | ||
| ionizing sound waves to the designated | ||
| region of the body and converts the | ||
| subsequent echoes detected to electronic | ||
| signals in order to construct an image of the | ||
| internal structures of an anatomical field. The | ||
| image is sent wirelessly from the transducer | ||
| to an external iOS or Android viewing device | ||
| on which the image can be displayed. | Piezoelectric material in the system's | |
| transducer transmits high frequency, non- | ||
| ionizing sound waves to the designated | ||
| region of the body and converts the | ||
| subsequent echoes detected to electronic | ||
| signals in order to construct an image of the | ||
| internal structures of an anatomical field. The | ||
| image is sent wirelessly from the transducer | ||
| to an external iOS or Android viewing device | ||
| on which the image can be displayed. | ||
| Power Source | Internal integrated built-in (non-removable) | |
| lithium-ion battery | Removable lithium-ion battery | |
| Display | iOS or Android mobile device | iOS or Android mobile device |
| Wireless | ||
| Capability | Communicates wirelessly via Wi-Fi and | |
| Bluetooth | Communicates wirelessly via Wi-Fi and | |
| Bluetooth | ||
| Portability | Portable ultrasound system | Portable ultrasound system |
| System | ||
| Components | Transducers/scanners | |
| Software (Clarius App) | ||
| Accessories (Charger and Fan) | Transducers/scanners | |
| Software (Clarius App) | ||
| Accessories (Charger and Fan) | ||
| Modes of | ||
| Operation | B-mode | |
| M-mode | ||
| Color Doppler | ||
| Power Doppler | ||
| Pulse-Wave Doppler (PWD) | ||
| Combined (B+M; B+CD; B+PD; B+PWD) | B-mode | |
| M-mode | ||
| Color Doppler | ||
| Power Doppler | ||
| Pulse-Wave Doppler (PWD) | ||
| Combined (B+M; B+CD; B+PD; B+PWD) | ||
| Safety Standards | The Clarius Ultrasound Scanner complies with | |
| the following safety standards: | ||
| 60601-1 | ||
| 60601-1-2 | ||
| 60601-1-6 | ||
| 60601-1-12 | ||
| 60601-2-37 | The Clarius Ultrasound Scanner complies with | |
| the following safety standards: | ||
| 60601-1 | ||
| 60601-1-2 | ||
| 60601-1-6 | ||
| 60601-1-12 | ||
| 60601-2-37 | ||
| Standard | Title of Standard | |
| IEC 60601-1:2012 | Medical electrical equipment – Part 1: General requirements for basic safety | |
| and essential performance | ||
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety | |
| and essential performance - Collateral Standard: Electromagnetic | ||
| Compatibility - Requirements and tests | ||
| IEC 60601-1-6 Edition 3.1 2013- | Medical electrical equipment - Part 1-6: General Requirements for Basic Safety | |
| 10 | and Essential Performance - Collateral Standard: Usability | |
| IEC 60601-1-12 Edition 1.0 2014- | Medical electrical equipment - Part 1-12: General Requirements for Basic | |
| 06 | Safety and Essential Performance - Collateral Standard: Requirements for | |
| Medical Electrical Equipment and Medical Electrical Systems Intended for Use | ||
| in the Emergency Medical Services Environment | ||
| IEC 60601-2-37:2015 | Medical electrical equipment - Part 2-37: Particular requirements for the basic | |
| safety and essential performance of ultrasonic medical diagnostic and | ||
| monitoring equipment | ||
| ISO 10993-1:2018 | Biological evaluation of medical devices – Part 1: Evaluation and testing within | |
| a risk management process | ||
| AIUM/NEMA UD 2-2004 | NEMA Standards Publication UD 2-2004 (R2009) Acoustic Output | |
| Measurement Standard for Diagnostic Ultrasound Equipment Revision 3. | ||
| (Radiology) | ||
| AIUM/NEMA UD 3-2004 | NEMA Standards Publication UD 3-2004 (R2009) Standard for Real-Time | |
| Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic | ||
| Ultrasound Equipment | ||
| IEC 62304:2006/AMD 1:2015 | Medical device software - Software life cycle processes | |
| IEC 62366-1:2015 | Medical devices - Application of usability engineering to medical devices | |
| ISO 15223-1:2016 | Medical devices — Symbols to be used with medical device labels, labelling | |
| and information to be supplied | ||
| ISO 14971:2019 | Medical Devices – Application of Risk Management to Medical Devices | |
| IEC 60529:2013 | Degrees of protection provided by enclosures (IP Code) | |
| IEC 62133:2012 | Secondary cells and batteries containing alkaline or other non-acid electrolytes | |
| - Safety requirements for portable sealed secondary cells, and for batteries | ||
| made from them, for use in portable applications | ||
| IEC 61157:2013 | IEC 61157: Standard means for the reporting of the acoustic output of medical | |
| diagnostic ultrasonic equipment |
Comparison of the Subject Device and Predicate Device for Demonstration of Substantial Equivalence
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6
Non-Clinical Performance Testing of the Clarius Ultrasound Scanner
The HD3 scanners of the Clarius Ultrasound Scanner family of devices were designed and developed by Clarius Mobile Health Corp. in accordance with the applicable requirements and standards to establish performance and safety of the device. The device's safety and performance were verified by tests conducted by Clarius and accredited third-party laboratories. Validation testing was performed to ensure that the final product is capable of meeting the requirements for the specified clinical applications and performs as intended to meet users' needs, while demonstrating substantial equivalence to the predicate device.
7
Non-clinical performance testing of the HD3 transducers of the Clarius Ultrasound Scanner device family demonstrate compliance to the following standards:
Conclusion & Summary of Substantial Equivalence
Based on the information presented in this Special 510(k) premarket notification, and based on the fundamental scientific technology, technological characteristics, principle of operation, intended use, environment of use, and indications for use, the modified Clarius Ultrasound Scanners) has been determined to be substantially equivalent in terms of safety and effectiveness to the predicate device, the Clarius Ultrasound Scanner (510(k)-cleared in K192107).
The differences in design between the subject device and the predicate device do not raise any issues related to safety or effectiveness.