The Next Generation iBOT is intended to provide indoor and outdoor mobility to persons restricted to a sitting position who meet the requirements of the user assessment and training certification program. The device is intended to climb stairs. Companions who are required to provide assistance during Assisted Stair Climbing Mode must meet the requirements of the training certification program.

Device Description

The proposed device is a multi-mode powered wheelchair that enables users to maneuver in confined spaces, climb curbs, stairs, and other obstacles. The device is intended to provide indoor and outdoor mobility, including stair climbing, to persons limited to a seated position who are capable of operating a powered wheelchair. The Next Gen iBOT includes active stabilization in multiple driving modes and allows for traversing aggressive and difficult terrain and operation at an elevated seat height. This elevated seat height offers benefits in activities of daily living (e.g., accessing higher shelves) and interaction with other people at "eye level" while either stationary or moving. The proposed device incorporates updates to the iBOT 4000 design to take advantage of advances in component and process technology while maintaining the same fundamental capabilities.

AI/ML Overview

The provided text is a 510(k) summary for the DEKA Research & Development Corp's "Next Generation iBOT" stair-climbing wheelchair. It primarily focuses on demonstrating substantial equivalence to a predicate device (iBOT 4000 Mobility System) rather than details about a comparative effectiveness study with AI assistance or a standalone algorithm. Therefore, many of the requested details about acceptance criteria, study design for AI-driven devices, and human reader performance are not present in this document.

However, I can extract the information relevant to the device's performance characteristics and the testing conducted to support its safety and effectiveness relative to its predicate.

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" for an AI or algorithmic medical device in the typical sense (e.g., AUC > X, Sensitivity > Y). Instead, it provides a comparison table of the proposed device ("Next Generation iBOT") with its predicate device ("iBOT 4000") across various characteristics, including performance metrics. The implicit acceptance criterion is that the proposed device performs comparably or better than the predicate for relevant metrics, thereby demonstrating substantial equivalence.

Characteristic	Predicate (iBOT 4000) Performance	Proposed (Next Generation iBOT) Performance	Assessment of difference (if applicable)
Device Performance
Driving Range	15.5 miles	15.5 miles (with 4 batteries)	No change
Dynamic Stability	5 degrees (standard)10 degrees (4 wheel)5 degrees (balance)	10 degrees (standard)12 degrees (4 wheel)8 degrees (balance)	The change represents equivalent or increased dynamic stability when compared to the predicate device.
Max Speed Settings by Mode	Standard: 6.8 mph4-Wheel: 4.8 mphBalance: 3.2 mph	Standard: 6.7 mph4-Wheel: 5.2 mphBalance: 3.3 mph	Maximum speed is comparable to the predicate device.
Maximum user weight capacity	250 lb.	300 lb.	Update allows additional users. All testing performed with expanded weight range.
Obstacle Climbing	5 in. (in 4 wheel mode)	5 in. (in 4 wheel mode)	No change
Turning Radius	29.5 in. - 38.6 in. (dependent on mode)	24.5 in. – 33.8 in. (dependent on mode)	Turning radius is comparable to the predicate device.
Weight (including batteries)	280 lb.	242.5 lb.	The weight is comparable to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes bench testing against various ISO and IEC standards, software testing according to FDA guidance and IEC 62304, and usability testing. It does not specify a "test set" in the context of an AI/ML algorithm's performance on human data (e.g., patient images). Instead, the performance evaluations are for the physical device itself.

Sample Size for Bench Testing: Not specified in terms of units tested. It indicates that "the proposed device has been demonstrated to comply with the following standards." This implies standard compliance testing rather than a statistical sample size from a patient population.
Data Provenance: Not applicable in the context of patient data. The testing is described as occurring within the manufacturer's development and validation processes. No country of origin for "data" is mentioned, as it's physical device performance rather than patient data. The testing appears to be prospective in the sense of being performed on the newly developed device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This concept is not applicable to the type of device and testing described in the document. The device is a stair-climbing wheelchair, not an AI/ML diagnostic or prognostic tool that interprets patient data requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this relates to expert review and ground truth establishment for diagnostic/prognostic AI models, which is not the subject of this submission. The "test sets" here are the physical device itself and its components.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was conducted or is mentioned. The device is a physical medical device (wheelchair), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to an AI algorithm's performance without human interaction. This is not relevant to a stair-climbing wheelchair. The device itself (the "Next Generation iBOT") is analogous to the "standalone" product being evaluated, and its performance is assessed against engineering standards and comparison to a predicate, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established through adherence to recognized international standards (e.g., ISO, IEC, UL, UN), internal DEKA research and development testing protocols, and comparison to the performance of the previously approved predicate device. For example:

Static and Dynamic Stability: Measured against the requirements of ISO 7176-1 and ISO 7176-2.
Speed, Acceleration, Retardation: Measured against ISO 7176-6.
Obstacle Climbing: Measured against ISO 7176-10.
Battery Performance: Measured against IEC 62133, UL 2054, and UN 38.3.
Software Validation: Assessed per IEC 62304 and FDA guidance on software validation.
Usability: Evaluated directly for human factors and user interaction changes.

8. The sample size for the training set

The concept of a "training set" is not applicable. This is a physical device submission, not an AI/ML model.

9. How the ground truth for the training set was established

Not applicable. There is no training set in the context of AI/ML. All "testing" and "evaluation" refers to physical and software verification and validation of the manufactured device.

Summary

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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" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

March 2, 2018

DEKA Research & Development Corp Roger Leroux Director of Regulatory and Clinical Affairs 340 Commercial St. Manchester, New Hampshire 03101

Re: K172601

Trade/Device Name: Next Generation iBOT Regulation Number: 21 CFR 890.3890 Regulation Name: Stair-Climbing Wheelchair Regulatory Class: Class II Product Code: IMK Dated: January 31, 2018 Received: February 1, 2018

Dear Roger Leroux:

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172601

Device Name Next Generation iBOT

Indications for Use (Describe)

The Next Generation iBOT is intended to provide indoor mobility to persons restricted to a sitting position who meet the requirements of the user assessment and training certification program. The device is intended to climb stairs. Companions who are required to provide assistance during Assisted Stair Climbing Mode must meet the requirements of the training certification program.

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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6. 510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR 807.92.

Date Prepared: January 25, 2018

Submitter's Information

510(k) Sponsor:	DEKA Research & Development340 Commercial StreetManchester, NH 03101
Contact Person:	Roger LerouxRegulatory Affairs Project ManagerDEKA Research & Development Corporation
	Phone: (603) 669-5139Fax: (603) 624-0573
	rleroux @dekaresearch.com

Device Information

Common/Usual Name:	Stair-climbing wheelchair
Trade/Proprietary Name:	Next Generation iBOT
Classification Name:	Stair-climbing wheelchair
Device Classification:	890.3890
Product Code:	IMK
Device Panel:	Physical Medicine

Predicate Device

The Next Generation iBOT (Next Gen iBOT) is substantially equivalent to the iBOT 4000 Mobility System (iBOT 4000), which was previously approved under PMA #P020033/S002. Stair-climbing wheelchairs were reclassified into Class II, effective April 14, 2014.

Device Description

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The Next Gen iBOT includes active stabilization in multiple driving modes and allows for traversing aggressive and difficult terrain and operation at an elevated seat height. This elevated seat height offers benefits in activities of daily living (e.g., accessing higher shelves) and interaction with other people at "eye level" while either stationary or moving.

The proposed device incorporates updates to the iBOT 4000 design to take advantage of advances in component and process technology while maintaining the same fundamental capabilities.

Indications for Use

Comparison to Predicate Device

The Next Gen iBOT has similar technological characteristics as compared to the predicate device. The proposed device offers substantially the same mobility functions as the iBOT 4000. Many of the design modifications were done to take advantage of improvements in technology since the iBOT 4000 was originally released in 2005. Where appropriate, component design has been maintained from the iBOT 4000; the overall system architecture and fundamental technology from the iBOT 4000 has been maintained. The table below shows the similarities and differences between the predicate and proposed devices. We believe the proposed modifications from the predicate device do not raise new questions regarding safety or effectiveness of the device.

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Characteristic	Predicate(iBOT 4000)(P020033/S002)	Proposed(Next Generation iBOT)	Assessment of difference(if applicable)
General Characteristics
Indications for Use	The device is indicated forindividuals who have mobilityimpairments and the use of atleast one upper extremity. Thedevice is intended to providemobility on smooth surfacesand inclines at home, at work,and in other environments;movement across obstacles,uneven terrain, curbs, grass,gravel and other soft surfaces;mobility in a seated position at anelevated height; ascent anddecent of stairs with or withoutassistance; and mobility andtransportation.	The Next Generation iBOT isintended to provide indoor andoutdoor mobility to personsrestricted to a sitting positionwho meet the requirements of theuser assessment and trainingcertification program. The deviceis intended to climb stairs.Companions who are required toprovide assistance duringAssisted Stair Climbing Modemust meet the requirements ofthe training certificationprogram.	The Indications for Use has beenmodified slightly from thatpreviously cleared in thepredicate device to align with theintended use stated in the deviceregulation (21 CFR 890.3890)and with other poweredwheelchairs. These wordingchanges in the intended use donot alter the therapeutic ordiagnostic effect and do notaffect safety and effectiveness ofthe device.
Manufacturer	Independence Technology	DEKA Research & Development	N/A
Characteristic	Predicate(iBOT 4000)(P020033/S002)	Proposed(Next Generation iBOT)	Assessment of difference(if applicable)
Rx/OTC designation	Rx	Rx	No change
	Physical Characteristics
Drive wheel type	Pneumatic. Single mountingpoint.	Pneumatic or foam-filled. 5 boltpattern, split rim design.	The change allows for additionaltire options, which is standard inthe wheelchair industry. Thefunctionality of the wheels hasnot changed and the change doesnot affect safety andeffectiveness of the device.
Caster assembly	Tweel® mounted to caster arm	Standard caster wheel withsuspension assembly	This change allows for increasedavailability of the caster wheels. The driving and suspensionfunctions are maintained. Thecaster assembly functionality hasnot changed and does not affectthe safety and effectiveness ofthe device.
Characteristic	Predicate(iBOT 4000)(P020033/S002)	Proposed(Next Generation iBOT)	Assessment of difference(if applicable)
Batteries	67.2 VDC 7.2Ah NiCd (2batteries)	Four or Six Li-ion batteries, eachrated 57.6 VDC, 5.1 Ah	Li-ion batteries provide lighterweight, higher specific energy,and are the current optimalbattery technology. The Li-ionbatteries provide similar voltageand current characteristics as theNiCd batteries. A full suite oftesting for the Li-ion batterieshas been conducted anddemonstrates the change inbattery type does not affectsafety and effectiveness of thedevice.

Table of Comparisons from Predicate Device to Proposed Device

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Characteristic	Predicate(iBOT 4000)(P020033/S002)	Proposed(Next Generation iBOT)	Assessment of difference(if applicable)
Communication withexternalapplications/devices	Infrared	Bluetooth 4.2 Low Energy	Bluetooth has become the widelyavailable wireless technology.The change to Bluetoothcommunication allows for use ofBluetooth encryption andimproved communication withmobile devices (i.e. laptop). Thechange to Bluetooth does notaffect the safety andeffectiveness of the device.
Drive system	Rear wheel drive, 4-wheel drive,2-wheel balancing	Rear wheel drive, 4-wheel drive,2-wheel balancing	No change
Operating modes	Standard, 4-Wheel, Balance,Stair-climbing, Remote	Standard, 4-Wheel, Balance,Stair-climbing, Remote	No change
Characteristic	Predicate(iBOT 4000)(P020033/S002)	Proposed(Next Generation iBOT)	Assessment of difference(if applicable)
Inertial Measurement	Tilt bulbs and early solid stategyros	MEMS based sensors	MEMS sensors have becomewidely available technology tomeasure the same physicalphenomenon as the predicate-providing the body positioninformation to the controlssoftware. The update allowsimproved alignment to improvereliability of the measurement.The change does not affect thesafety and effectiveness of thedevice.
Position monitoring	External homing sensor	Internal absolute position sensor	The change allows for improvedreliability in the homing of thedevice, by moving it inside.The change does not affect thesafety and effectiveness of thedevice.
Characteristic	Predicate(iBOT 4000)(P020033/S002)	Proposed(Next Generation iBOT)	Assessment of difference(if applicable)
System Communication	RS485	CAN bus	The change to CAN Bussupports current electronichardware and communicationwith other power wheelchairoptions. The change does notaffect safety and effectiveness ofthe device.
Weight (includingbatteries)	280 lb.	242.5 lb.	The weight is comparable to thepredicate device.
	Device Performance
Driving Range	15.5 miles	15.5 miles (with 4 batteries)	No change
Dynamic stability	5 degrees (standard)10 degrees (4 wheel)5 degrees (balance)	10 degrees (standard)12 degrees (4 wheel)8 degrees (balance)	The change represents equivalentor increased dynamic stabilitywhen compared to the predicatedevice.
Characteristic	Predicate(iBOT 4000)(P020033/S002)	Proposed(Next Generation iBOT)	Assessment of difference(if applicable)
Max Speed Settings byMode	Standard: 6.8 mph4-Wheel: 4.8 mphBalance: 3.2 mph	Standard: 6.7 mph4-Wheel: 5.2 mphBalance: 3.3 mph	Maximum speed is comparableto the predicate device.
Maximum user weightcapacity	250 lb.	300 lb.	Update allows additional users.All testing performed withexpanded weight range.
Obstacle Climbing	5 in. (in 4 wheel mode)	5 in. (in 4 wheel mode)	No change
Turning Radius	29.5 in. - 38.6 in.(dependent on mode)	24.5 in. – 33.8 in.(dependent on mode)	Turning radius is comparable tothe predicate device
User Interface Features
Seating	Gen 3 seat	Gen 3 seat	No change

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Characteristic	Predicate(iBOT 4000)(P020033/S002)	Proposed(Next Generation iBOT)	Assessment of difference(if applicable)
User controller,joystick, screen, buttons,etc.	User controller with integratedjoystick, display, buttons, andtoggle switches. User assistconfirmation button on the backof the seat. Power off requestbutton located on the power base.	User controller with integratedjoystick, display, buttons, speedsetting reduction wheel, andoptional toggle switches. Theuser controller incorporates userassist confirmation. Power offrequest button located on thepowerbase.	The functions that the usercontroller allows and the numberand type of user input devicesare nearly identical. Changessimplify user tasks, improvevisibility, and improve screenflow. The changes do not affectthe safety and effectiveness ofthe device.

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Performance Data

The following performance testing was conducted to demonstrate that the proposed device complies with the 21 CFR 890.3890, special controls and recognized standards. This testing demonstrates substantial equivalence to the predicate device through:

evaluation to current versions of the standards used in testing of the predicate . device; with modification for updates in battery technology,
software testing per the current version of FDA guidance on software testing, and ●
. usability testing focused in particular on changes in the user interface when compared with the predicate device.

A summary of the testing performed is provided below.

Bench Testing

The proposed device has been demonstrated to comply with the following standards:

1. IEC 62133:2012 Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
1. ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
1. ISO 7176-1:2014 Wheelchairs Part 1: Determination of Static Stability
1. ISO 7176-2:2001 Wheelchairs Part 2: Determination of Dynamic Stability of Electric Wheelchairs
1. ISO 7176-3:2012 Wheelchairs Part 3: Determination of Effectiveness of Brakes
1. ISO 7176-4:2008 Wheelchairs Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
1. ISO 7176-5:2008 Wheelchairs Part 5: Determination of dimensions, mass and maneuvering space
1. ISO 7176-6:2001 Wheelchairs Part 6: Determination of Maximum Speed, Acceleration & Retardation for Electric Wheelchairs

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1. ISO 7176-8:2014 Wheelchairs Part 8: Requirements & Test Methods for Static, Impact & Fatigue Strengths
1. ISO 7176-9:2009 Wheelchairs Part 9: Climatic tests for electric wheelchairs
1. ISO 7176-10:2008 Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
1. ISO 7176-11: 2012 Wheelchairs Part 11: Test dummies
1. ISO 7176-13: 1999 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces
1. ISO 7176-14 2008 Wheelchairs Part 14: Power & Control Systems for Electric Wheelchairs-Requirements & Test Methods
1. ISO 7176-15:1996 Wheelchairs Part 15: Requirements For Information Disclosure, Documentation And Labeling
1. ISO 7176-21:2009 Wheelchairs Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
1. ISO 7176-22:2014 Wheelchairs-Part 22: Set Up Procedures
1. ISO 7176-25:2013 Wheelchairs Part 25: Requirements and test methods for batteries and their chargers for electrically powered wheelchairs and motorized scooters
1. ISO 7176-28:2012 Wheelchairs Part 28: Requirements And Test Methods For Stair-Climbing Devices
1. RESNA WC-1:2009, Section 7 Wheelchairs Method of measurement of seating and wheel dimensions
1. UL 2054:2004 Household and Commercial Batteries
1. UN 38.3 United Nations, New York & Geneva, Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, Subsection 38. 3

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Software Testing

Software development and validation was conducted according to IEC 62304 and the FDA guidance document General Principles of Software Validation – Final Guidance for Industry and FDA Staff.

Software documentation is included according to the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for Major level of concern for the software embedded in the Next Generation iBOT stair-climbing wheelchair.

Cybersecurity risks were assessed and documentation is included based on the FDA's Guidance of Premarket Submissions for Management of Cybersecurity in Medical Device.

Usability Testing

A usability evaluation was conducted on the elements of the device (and particularly the user interaction with the device) which have changed from the iBOT 4000. There have been no changes to the intended use environment, modes of operation or drive architecture.

Conclusion

The performance data included in this premarket notification demonstrate that the proposed device is as safe and effective as the iBOT 4000 Mobility System predicate device. DEKA finds the Next Generation iBOT to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 890.3890 Stair-climbing wheelchair.

(a)
Identification. A stair-climbing wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use.
(2) Performance testing must demonstrate adequate mechanical performance under simulated use conditions and environments. Performance testing must include the following:
(i) Fatigue testing;
(ii) Resistance to dynamic loads (impact testing);
(iii) Effective use of the braking mechanism and how the device stops in case of an electrical brake failure;
(iv) Demonstration of adequate stability of the device on inclined planes (forward, backward, and lateral);
(v) Demonstration of the ability of the device to safely ascend and descend obstacles (i.e., stairs, curb); and
(vi) Demonstration of ability to effectively use the device during adverse temperatures and following storage in adverse temperatures and humidity conditions.
(3) The skin-contacting components of the device must be demonstrated to be biocompatible.
(4) Software design, verification, and validation must demonstrate that the device controls, alarms, and user interfaces function as intended.
(5) Appropriate analysis and performance testing must be conducted to verify electrical safety and electromagnetic compatibility of the device.
(6) Performance testing must demonstrate battery safety and evaluate longevity.
(7) Performance testing must evaluate the flammability of device components.
(8) Patient labeling must bear all information required for the safe and effective use of the device, specifically including the following:
(i) A clear description of the technological features of the device and the principles of how the device works;
(ii) A clear description of the appropriate use environments/conditions, including prohibited environments;
(iii) Preventive maintenance recommendations;
(iv) Operating specifications for proper use of the device such as patient weight limitations, device width, and clearance for maneuverability; and
(v) A detailed summary of the device-related adverse events and how to report any complications.
(9) Clinician labeling must include all the information in the Patient labeling noted in paragraph (b)(8) of this section but must also include the following:
(i) Identification of patients who can effectively operate the device; and
(ii) Instructions on how to fit, modify, or calibrate the device.
(10) Usability studies of the device must demonstrate that the device can be used by the patient in the intended use environment with the instructions for use and user training.