(211 days)
No reference devices were used in this submission.
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on mechanical and electrical components and modifications.
No.
The device is a power wheelchair indicated for mobility and positioning for individuals limited to a sitting position, which is assistive for daily living but not a therapeutic treatment.
No
The device description clearly states it is a "motor-driven wheelchair" and its intended use is to "provide mobility and positioning." There is no mention of it being used to diagnose any medical condition.
No
The device description clearly outlines a physical power wheelchair with mechanical and electrical components, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility and positioning to persons limited to a sitting position. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a power wheelchair. It's a mechanical and electrical device for transportation and support, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention anything related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Diagnosing diseases or conditions based on laboratory tests
The device is clearly a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Invacare AVIVA Storm RX Power Wheelchair is indicated to provide mobility and positioning to persons limited to a sitting position.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The subject device is a rearward drive wheel version substantially equivalent to the previously cleared forward drive wheel Invacare® AVIVA FX Power Wheelchair (K192216) with LiNX Electronics and Ultra Low Maxx Seating System. The subject device version consists of the following changes:
- . Rearward drive wheel placement
- . Modification to suspension system
- . Modification to battery box design and seat interface brackets
- Minor changes to mechanical components such as new rims and colors .
The Invacare® AVIVA Storm RX Power Wheelchair is a 24V DC system, motor-driven wheelchair, utilizing the predicate device LiNX® control system. The subject device consists of a rigid or "non-folding" type power wheelchair base with rearward drive wheel placement with two (2) casters in the front and two anti-tippers in the rear. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
International Organization of Standardization (ISO) testing, California Technical (CAL), American National Standards Institute (ANSI) and European (EN) standards testing were performed to demonstrate that the subject Invacare® AVIVA Storm RX Power Wheelchair meet the performance requirements and is substantially equivalent to the predicate device identified throughout this submission and do not raise questions of safety and effectiveness.
Key results: The subject device components met the performance requirements and is substantially equivalent to the predicate device identified throughout this submission and do not raise different questions of safety and effectiveness. The different technological characteristics do not raise different questions of safety and effectiveness as compared to the predicate device. The design verification testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device. The data generated from the subject device design verification test reports support a finding of substantial equivalence regarding device comparison, device specifications, and design characteristics and to provide mobility and positioning to persons limited to a sitting position.
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.
Invacare AVIVA FX Power Wheelchair (K192216)
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.
No reference devices were used in this submission.
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
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
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 and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" in a larger font size and "ADMINISTRATION" in a smaller font size below.
March 19, 2021
Invacare Corporation Elijah Wreh Regulatory Affairs Manager One Invacare Way Elyria, Ohio 44035
Re: K202379
Trade/Device Name: Invacare AVIVA Storm RX Power Chair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 10, 2021 Received: February 16, 2021
Dear Elijah Wreh:
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.
1
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); 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 (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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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.
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202379
Device Name Invacare AVIVA Storm RX Power Wheelchair
Indications for Use (Describe)
The Invacare AVIVA Storm RX Power Wheelchair is indicated to provide mobility and positioning to persons limited to a sitting position.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Submitter Information per 21 CFR 807.92(a)(1)
| SPONSOR: | Invacare Corporation
One Invacare Way
Elyria, OH 44035 |
| ---------- | -------------------------------------------------------------- |
|---|
| PRIMARY CONTACT: | Elijah Wreh |
|---|---|
| Regulatory Affairs Manager | |
| Phone: (440) 329-6840 | |
| Email: ewreh@invacare.com |
| MANUFACTURER: | Invacare Corporation
1200 Taylor Street
Elyria, Ohio 44035 |
| --------------- | ------------------------------------------------------------------ |
|---|
| DATE PREPARED per 21 CFR 807.92(a)(1): | March 19, 2021 |
|---|---|
| ---------------------------------------- | ---------------- |
Device Information per 21 CFR 807.92(a)(2)
| NAME OF SUBJECT DEVICE: | Invacare® AVIVA Storm RX Power Wheelchair |
|---|---|
| COMMON/USUAL NAME: | Power Wheelchair |
| CLASSIFICATION NAME: | Powered Wheelchair [21 CFR §890.3860] |
| REGULATORY CLASS: | 2 |
| PRODUCT CODE: | ITI: Wheelchair, Mechanical |
| PREDICATE DEVICES: | Primary: Invacare AVIVA FX Power Wheelchair |
| (K192216) | |
| No reference devices were used in this submission. |
4
Device Description per 21 CFR 808.92(a)(4)
The subject device is a rearward drive wheel version substantially equivalent to the previously cleared forward drive wheel Invacare® AVIVA FX Power Wheelchair (K192216) with LiNX Electronics and Ultra Low Maxx Seating System. The subject device version consists of the following changes:
- . Rearward drive wheel placement
- . Modification to suspension system
- . Modification to battery box design and seat interface brackets
- Minor changes to mechanical components such as new rims and colors .
The Invacare® AVIVA Storm RX Power Wheelchair is a 24V DC system, motor-driven wheelchair, utilizing the predicate device LiNX® control system. The subject device consists of a rigid or "non-folding" type power wheelchair base with rearward drive wheel placement with two (2) casters in the front and two anti-tippers in the rear. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors.
Intended Use per 21 CFR 807.92(A)(5)
The intended use of the device is to provide mobility and positioning to persons limited to a sitting position.
Indications for Use per FORM FDA 3881
The Invacare® AVIVA Storm RX Power Wheelchair is indicated to provide mobility and positioning to persons limited to a sitting position.
Indications for Use Characteristics Comparison
Both the subject and predicate device share the same Indications for Use and Intended use.
Technological Characteristics Comparison with the predicate device per 21 CFR 807.92(a)(6)
The technological characteristics comparison demonstrates that the subject device is substantially equivalent in intended use, design, materials, and operational principles to the previously cleared predicate device.
5
COMPARISON of TECHNOLOGICAL CHARACTERISTICS with the PREDICATE DEVICE per 21 CFR 807.92(a)(6)
The device comparison shows that the subject device is substantially equivalent in intended use, design, materials, and operational principles to the previously cleared predicate device. The subject and predicate devices are intended to provide mobility and positioning to persons limited to a sitting position. The subject device components met the performance requirements and is substantially equivalent to the predicate device identified throughout this submission and do not raise different questions of safety and effectiveness. The different technological characteristics do not raise different questions of safety and effectiveness as compared to the predicate device.
Basis of Substantial Equivalence per 21 CFR 807.100(b)(2)(ii)(A)
The substantial equivalence of the subject device was determined as per the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" and the technological characteristics which include materials, design, energy source, and other device features, as defined in section 513(i)(1)(B) of the FD&C Act and 21 CFR 807.100(b)(2)(ii)(A). The design verification testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device. The data generated from the subject device design verification test reports support a finding of substantial equivalence regarding device comparison, device specifications, and design characteristics and to provide mobility and positioning to persons limited to a sitting position.
Summary of the Nonclinical Testing used for Substantial Equivalence
The performance testing, device comparison, and dimensional analysis demonstrate that the subject device components and features are the same or substantially equivalent to the predicate device regarding the following:
- . Static Stability
- Dynamic Stability of Electric Wheelchairs ●
- . Effectiveness of Brakes
- . Energy Consumption of Electric Wheelchairs and Scooters for Determination of Theoretical Distance Range
- . Dimensions Mass and Maneuvering Space
- . Maximum Speed Acceleration and Deceleration of Electric Wheelchairs
- . Seating and Wheel Dimensions
- Methods for Static Impact and Fatigue Strengths .
6
- Climatic Tests for Electric Wheelchairs ●
- Climbing Ability of Electrically Powered Wheelchairs ●
- Power and Control Systems for Electrically Powered Wheelchairs and Scooters ●
- Information Disclosure Documentation and Labeling ●
- Wheeled Mobility Devices for Use as Seats in Motor Vehicles
- Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and ● Scooters and Battery Chargers
- Batteries and chargers for powered wheelchairs ●
- Software Life Cycle ●
- Flammability Testing .
- Assessment of the Ignitability of Upholstered Furniture Ignition Source Smoldering ● Cigarette
- Wireless Coexistence
The data generated from the subject Invacare® AVIVA Storm RX Power Wheelchair design verification test reports support a finding of substantial equivalence regarding the device comparison, dimensional analysis, device specifications, design characteristics and to provide mobility and positioning to persons limited to a sitting position.
Indications for Use Comparison Table
| Device | Subject Device | Predicate Device |
|---|---|---|
| Invacare® AVIVA Storm RX Power Wheelchair | Invacare AVIVA FX Power Wheelchair | |
| (K192216) | ||
| Indications for | ||
| Use | To provide mobility and positioning to persons | |
| limited to a sitting position | Same | |
| Intended Use | To provide mobility and positioning to persons | |
| limited to a sitting position | Same | |
| Type of Use | Prescription (RX Only) | Same |
7
| Component | Description | Invacare® AVIVA FX Power Wheelchair (K192216) Predicate Device | Invacare® AVIVA Storm RX Power Wheelchair Subject Device |
|---|---|---|---|
| SEATING | |||
| UltraLow | |||
| Maxx | Powered Positioning Configurations | Fixed, Combinations of Tilt/Recline/Elevate | Combinations of Tilt/Recline |
| Seat Widths | 16" to 24" | Same | |
| Seat Depths | 16" to 23" | Same | |
| Back Heights | 18" to 25" (tilt) or 20" to 27" (tilt and recline) | Same | |
| Upholstery | Meshtex, Startex, Spacetex, O-Vinyl, Polyester | Same | |
| Tilt Range | 50° | Same | |
| Recline Range | 168° | Same | |
| Patient Support Surfaces | Ref subject device 'Essential Equivalence' section | Same | |
| System Name | LiNX | Same | |
| CONTROL | |||
| SYSTEM | |||
| LiNX | Cables | Variable cable lengths | |
| A range of standard cable lengths available | Same | ||
| System Architecture | Microprocessor Controlled | Same | |
| Non-Expandable Options | Yes | Same | |
| Expandable Options | Yes | Same | |
| Wireless Devices | Bluetooth | Same | |
| Power Source | 24V nominal | Same | |
| Bus Interface | CAN | Same | |
| BASE | Base Configuration | Forward Drive Wheel Placement | Rearward Drive Wheel Placement |
| Base Width | 24.3" | 24.8" | |
| Base Length | 42.7" | 33.5" | |
| Ground Clearance | 2.6" | 2.8" | |
| Batteries | (2) 12V Sealed VRLA Gel Batteries | Same | |
| Braking System | Electro-mechanical Friction Brake | Same | |
| Drive Wheel Size | 14" x 3" | Same | |
| Incline Capability | 9° | Same | |
| Maximum Speed | 5.8mph | Same | |
| Motors | 4-Pole SSD | Same | |
| Occupant Weight | |||
| Cap | Up to 300lbs. | Same | |
| Suspension | Four Bar Linkage Suspension System | Four Bar Linkage Suspension System | |
| Four Bar Linkage Suspension System | |||
| (Front Drive Wheel) | Four Bar Linkage Suspension System | ||
| (Rear Drive Wheel) |
Design and Technological Characteristics Comparison – Finished Device
8
9
| Description | Subject Device
Invacare® A VIVA StormRX Power Wheelchair | Predicate Device
Invacare A VIVA FX Power Wheelchair (K192216) |
|------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------|
| Base Configuration | Rear Wheel Drive | Front Wheel Drive |
| Base Width | 24.8" | 24.3" |
| Base Length | 33.5" | 42.7" |
| Seat-to-Floor Heights | 16.75"
17.25"
18.25"
19.25" | 16.75"
17.75"
18.75"
19.75" |
| Ground Clearance | 2.8" | 2.6" |
| Batteries | (2) 12V Sealed VRLA Gel Batteries | (2) 12V Sealed VRLA Gel Batteries |
| Braking System | Electro-mechanical Friction Brake | Electro-mechanical Friction Brake |
| Castor Size | 8" x 2.5" | 8" x 2.5" |
| Control System | LiNX | LiNX |
| Drive Wheel Size | 14" x 3" | 14" x 3" |
| Incline Capability | 9° | 9° |
| Maximum Speed | 5.8 mph | 5.8 mph |
| Motors | 4-Pole SSD | 4-Pole SSD |
| Maximum Weight
Bearing Capacity | 300lbs. | 300lbs. |
| Range | >12 miles | >12 miles |
| Suspension | Four Bar Linkage Independent Suspension System
(Rear Drive Wheel) | Four Bar Linkage Independent Suspension System
(Front Drive Wheel) |
Performance Characteristics Comparison – Finished Device
10
| LiNX Control System- Modules | Description | AVIVA Storm RX | AVIVA FX | Wireless Technology | Impact to Safety and Effectiveness |
|---|---|---|---|---|---|
| Primary Driver Controls | Drive Only Remote | Yes | Yes | Bluetooth LE Wireless: Diagnostics | The versions are the same. |
| Remotes with LED Display | Yes | Yes | Bluetooth LE Wireless: Diagnostics | The versions are the same. | |
| Rehabilitation Remote with Colour LCD Display and Touch | Yes | Yes | Bluetooth LE Wireless: Mouse Mover and Diagnostics | The versions are the same. | |
| Alternative Driver Controls (LiNX) | Compact Remote | Yes | Yes | Bluetooth LE Wireless: Mouse Mover and Diagnostics | The versions are the same. |
| Sip 'N' Puff (SNP) | Yes | Yes | No Wireless | ||
| Attendant Driver Control | Yes | Yes | No Wireless | ||
| Power Modules | 120A, Dual Motor, Power Controller with Lights and 2 Actuator Channels | Yes | Yes | No Wireless | The versions are the same. |
| Actuator Modules | Actuator Controls only modules: 4 Channel | Yes | Yes | ||
| Stability Control | G-Trac / Gyro | Yes | Yes | No Wireless | The versions are the same. |
| Programming tool | LAK: LiNX Access Key | Yes | Yes | Bluetooth LE Wireless: Remote Programming | |
| Switch Input Module | Module used to add separate switched for Power on/off when used with REM 215/216 | Yes - The difference is that the switch input module adds wired remote on/off capability | No | No Wireless | *Differences |
| LiNX Control System- Modules | Description | AVIVA Storm RX | AVIVA FX | Wireless Technology | Impact to Safety and |
| Effectiveness | |||||
| Environmental Control Module | Environmental Control module used for | ||||
| off-chair control of various devices | Yes | Yes | No Wireless | The versions are the | |
| same. | |||||
| Switch Interface Module | Switch Interface Module | Yes – The | |||
| difference is the | |||||
| switch module is a | |||||
| junction box. | No | No Wireless | *Differences | ||
| Light Module | Interface to LED lights on StormRX | ||||
| chair | Yes – The | ||||
| difference is low | |||||
| voltage power | |||||
| supply for LED | |||||
| light. | No | No Wireless | *Differences | ||
| USB Charge Port | Allows charging of Smart pone via | ||||
| USB | Yes | Yes | No Wireless | The versions are the | |
| same. | |||||
| Enhanced DLX-IN500 Input | |||||
| Module | Sip 'N' Puff (SNP) | Yes – Same as the | |||
| regular DLX- | |||||
| IN500 input | |||||
| module, but the | |||||
| difference is that | |||||
| the firmware was | |||||
| updated. | Yes | No Wireless | *Differences |
LiNX® Components and Accessories Specifications
11
*Differences: Differences between the subject device features and the previously cleared predicate device do not raise new issues of safety or effectiveness.
12
Performance Data
Non-Clinical Test per 21 CFR 807.92(b)(1)
International Organization of Standardization (ISO) testing, California Technical (CAL), American National Standards Institute (ANSI) and European (EN) standards testing were performed to demonstrate that the subject Invacare® AVIVA Storm RX Power Wheelchair meet the performance requirements and is substantially equivalent to the predicate device identified throughout this submission and do not raise questions of safety and effectiveness.
13
| Test Standard | Test Description |
|---|---|
| ISO 7176-1:2014 | Wheelchairs Part 1: Determination of Static Stability |
| ISO 7176-2:2017 | Wheelchairs Part 2: Determination of Dynamic Stability of Electrically Powered Wheelchairs |
| ISO 7176-3:2012 | Wheelchairs Part 3: Determination of Effectiveness of Brakes |
| ISO 7176-4:2008 | Wheelchairs Part 4: Energy Consumption of Electrical Wheelchairs and Scooters for Determination of Theoretical Distance Range |
| ISO 7176-5:2008 | Wheelchairs Part 5: Determination of Dimensions, Mass and Maneuvering Space |
| ISO 7176-6:2018 | Wheelchairs Part 6: Determination of Maximum Speed, Acceleration and Deceleration of Electric Wheelchairs |
| ISO 7176-7:1998 | Wheelchairs Part 7: Measurement of Seating and Wheel Dimensions |
| ISO 7176-8:2014 | Wheelchairs Part 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths |
| ISO 7176-9:2009 | Wheelchairs Part 9: Climatic Tests for Electric Wheelchairs |
| ISO 7176-10:2008 | Wheelchairs Part 10: Determination of Obstacle Climbing Ability of Electrically Powered Wheelchairs |
| ISO 7176-11:2012 | Wheelchairs Part 11: Test Dummies |
| ISO 7176-13:1989 | Wheelchairs Part 13: Determination of Coefficient of Friction of Test Surface |
| ISO 7176-14:2008 | Wheelchairs Part 14: Power and Control Systems for Electrically Powered Wheelchairs and Scooters – Requirements and Test Methods |
| ISO 7176-15:1996 | Wheelchairs Part 15: Requirements for Information Disclosure, Documentation and Labeling |
| ISO 7176-16:2012 | Wheelchairs Part 16: Resistance to Ignition of Postural Support Devices |
| ISO 7176-19 | Wheelchairs Part 19: Wheeled Mobility Devices for use as Seats in Motor Vehicles |
| ISO 7176-21:2008 | Wheelchairs Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers |
| ISO 7176-22:2014 | Wheelchairs Part 22: Set-up Procedures |
| ISO 7176-25:2013 | Wheelchairs Part 25: Batteries and chargers for powered wheelchairs |
| IEC 62304:2006 | Medical Device Software – Software Life Cycle |
| ANSI C63.27:2017 | American National Standard for Evaluation of Wireless Coexistence |
14
Performance Data Conclusions per 21 CFR 807.92(b)(3)
The subject device utilizes the same intended use, same material composition, and similar technological characteristics as the predicate device. The non-clinical laboratory data support a finding of substantial equivalence of the subject device and demonstrate that the subject device will perform as intended in the specified use conditions.