The intended use of the Invacare INT /DL40i Controller is to activate and control powered wheelchair motion. Additionally, it provides a method of selecting the type of operational parameters which best suit the particular control needs of the wheelchair user.

Device Description

The INT /DL40i controller is an electronic microcomputer based motor control device for power wheelchairs intended to activate and control the wheelchair motion. It also provides the means for selecting, adjusting and programming the type of wheelchair operation parameters and performance characteristics to meet the particular control needs of the wheelchair user.

The INT/DL40i controller consists of a single module that includes both the joystick and the motor controller. It has two drive modes and twelve performance adjustment settings in its program menu. Programming the controller requires the use of a separate programming device since it does not have "Through the Joystick Programming" (TTJP) capability. Also, the INT/DL40i controller does not include any additional motion control activation devices such as "Sip N Puff" or seat reclining.

AI/ML Overview

This document describes the Invacare INT/DL40i Micro Computer Control for Power Wheelchairs. The submission is a Special 510(k) to allow the use of the controller on a different model of Invacare's Pronto wheelchairs, the M41, while maintaining substantial equivalence to the predicate device (K950724).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy for an AI device). Instead, the acceptance criteria are met by demonstrating conformance to a set of recognized standards and showing that the modified device performs as intended and is substantially equivalent to the predicate device.

Acceptance Criteria (Related to Standards/Performance)	Reported Device Performance
Intended Use: To activate and control powered wheelchair motion and provide selection of operational parameters.	Meets: The modified INT/DL40i Controller's intended use remains the same as the predicate device.
Electronics: Digital Based	Meets: Modified INT/DL40i is Digital Based.
Drive Control: Microprocessor	Meets: Modified INT/DL40i uses a Microprocessor.
PC Boards: Surface and Through Hole Mounted	Meets: Modified INT/DL40i uses Surface and Through Hole Mounted PC Boards.
Drive Modes: (Modified has 2)	Differs, but acceptable due to improved functionality: The modified device has 2 drive modes, an increase from the predicate's 1. This is considered an enhancement, not a compromise in safety or effectiveness.
Controller Module: Integrated with Joystick	Meets: Modified INT/DL40i is Integrated with Joystick.
Sip 'N' Puff Module Option: No	Meets: Modified INT/DL40i does not have this option.
ECU Module Option: No	Meets: Modified INT/DL40i does not have this option.
Recliner Module Option: No	Meets: Modified INT/DL40i does not have this option.
RIM Control Option: No	Meets: Modified INT/DL40i does not have this option.
Remote Programmer Option: Yes	Meets: Modified INT/DL40i supports Remote Programmer.
LCD Joystick Option: No	Meets: Modified INT/DL40i does not have this option.
TTJP Capability: No	Meets: Modified INT/DL40i does not have TTJP Capability.
Performance Adjustments: (Modified has 12)	Differs, but acceptable due to improved functionality: The modified device has 12 performance adjustments, an increase from the predicate's 6. This is considered an enhancement.
Enclosures: Pressure Die Cast Aluminum - Bottom, Injection Molded Polymer - Top	Differs, but acceptable: The modified device uses Pressure Die Cast Aluminum - Bottom and Injection Molded Polymer - Top, whereas the predicate used only Pressure Die Cast Aluminum. This is a design change, but the performance data concludes it performs as intended.
Manufacturer: Dynamic Controls, Ltd., Christchurch, New Zealand	Meets: Same manufacturer.
Conformance to ANSI/RESNA WC/Vols. 1&2, 1998 (Sections 1-10, 14, 21): Various standards related to stability, braking, energy consumption, dimensions, speed, strength, climatic tests, obstacle climbing, power/control, and electromagnetic compatibility.	Meets: The document implies that testing was conducted to allow the use of the controller on the M41 wheelchair, which would encompass these safety and performance aspects. The conclusion states "The performance data found in this submission shows that the INT/DL40i Controller performs as intended."
Conformance to CISPR 11: Industrial, Scientific and Medical (ISM) Radio Frequency Equipment-Electromagnetic Disturbance Characteristics-Limits and Methods of Measurement.	Meets: As implied by the general performance data statement.

2. Sample size used for the test set and the data provenance:

The document does not specify a distinct "test set" in the context of an AI/ML device where data samples are used to evaluate model performance. Instead, the "testing" refers to the engineering and regulatory verification required for a medical device.

Test Set: The testing was conducted to allow the use of the controller on a "different model of Invacare's Pronto wheelchairs, the M41". The sample size would therefore correspond to the number of M41 wheelchairs or samples tested for compliance with the listed standards. This number is not explicitly stated but would typically be a relatively small number of physical prototype devices.
Data Provenance: Not applicable in the context of AI/ML data sets. The testing is in-house validation and verification by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. For this type of device (power wheelchair controller), "ground truth" is established through physical testing against established international and national standards (e.g., ANSI/RESNA, CISPR). The "experts" involved would be the engineers and technicians conducting the tests and interpreting the results against the standard requirements, rather than clinical experts establishing a diagnosis or outcome.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases to establish ground truth for AI/ML models. For a physical device like a wheelchair controller, compliance is determined by objective measurements and tests against pre-defined specifications and standards.

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:

Not applicable. MRMC studies are specific to AI-assisted diagnostic or interpretive devices where human performance is part of the evaluation. This device is a power wheelchair controller, not a diagnostic AI tool.

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

Not applicable. This device is a physical hardware and software control unit for a wheelchair. Its operation is inherently "standalone" in the sense that the controller executes commands based on user input, but it's not an algorithm that produces interpretations or diagnoses independently.

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

The "ground truth" for this device's performance is objective compliance with the specified international and national physical performance and safety standards, such as:

ANSI/RESNA WC/Vols. 1&2, 1998 (Sections 1-10, 14, 21), covering aspects like stability, braking, energy consumption, dimensions, speed, strength, climatic performance, obstacle climbing, power/control systems, and electromagnetic compatibility.
CISPR 11 (Electromagnetic Disturbance Characteristics).

8. The sample size for the training set:

Not applicable. This device is not an AI/ML model that requires a "training set." It is a traditional embedded control system.

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

Not applicable, as there is no training set for this type of device.

Summary

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K073134

510(K) SUMMARY FOR THE INT/DL40i MICRO COMPUTER CONTROL FOR POWER WHEELCHAIRS

This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92

The assigned 510(k) number is

Date: November 5, 2007

Submitted by: Invacare Corporation Registration No. 1525712 One Invacare Way Elyria, Ohio 44035-4190

NOV 1 6 2007

Telephone: 440-326-6356 Fax: 440-326-3458

Contact Person: Mr. Carroll Martin

Trade Name: INT/DI.40i Micro Computer Control for Power Wheelchairs

Common Name: Power Wheelchair controller and Joystick

Classification Name: Wheelchair, powered per 21 CFR 890.3860

Legally Marketed Predicate Device(s): INT/DL40i Micro Computer Control for Power Wheelchairs; K950724, August 7, 1995

Device Description: The INT /DL40i controller is an electronic microcomputer based motor control device for power wheelchairs intended to activate and control the wheelchair motion. It also provides the means for selecting, adjusting and programming the type of wheelchair operation parameters and performance characteristics to meet the particular control needs of the wheelchair user.

Intended Use: The intended use of the Invacare INT /DL40i Controller is to activate and control powered wheelchair motion. Additionally, it provides a method of selecting the type of operational parameters which best suit the particular control needs of the wheelchair

INVACARE CORPORATION

Special 510(k) for Invacare's INT/DL40i Integrated Controller

Page 16

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Substantial Equivalence:

Features	The Modified Model INT/DL40i	Predicate DeviceModel INT/DL40i
510(k) Number	TBD	K950724
Date Cleared	TBD	08/07/1995
Intended Use	To activate and control powered wheelchairmotion. Additionally, it provides a method ofselecting the type of operational parameters whichbest suit the particular control needs of thewheelchair user.	To activate and control powered wheelchairmotion. Additionally, it provides a method ofselecting the type of operational parameters whichbest suit the particular control needs of thewheelchair user.
Electronics	Digital Based	Digital Based
Drive Control	Microprocessor	Microprocessor
PC Boards	Surface and Through Hole Mounted	Surface and Through Hole Mounted
Drive Modes	2	1
Controller Module	Integrated with Joystick	Integrated with Joystick
Sip 'N' Puff ModuleOption	No	No
ECU Module Option	No	No
Recliner Module Option	No	No
RIM Control Option	No	No
Remote ProgrammerOption	Yes	Yes
LCD Joystick Option	No	No
TTJP Capability	No	No
Performance Adjustments	12	6
Enclosures	Pressure Die Cast Aluminum- BottomInjection Molded Polymer - Top	Pressure Die Cast Aluminum
Manufacturer	Dynamic Controls, Ltd.,Christchurch, New Zealand	Dynamic Controls, Ltd.,Christchurch, New Zealand

INVACARE CORPORATION

Special 510(k) for Invacare's
INT/DL40i Integrated Controller

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As the chart above shows, the modified INT /DL40i Controller is substantially equivalent to the INT /DL40i Controller, cleared on August 7, 1995 under 510(K) Accession Number K950724. The reading subject to this Special 510(k) consists only of testing to allow the use of the controller on a different model of Invacare's Pronto wheelchairs, the M41.

The intended use of activating and controlling powered wheelchair motion and providing a method of selecting the type of operational parameters which best suit the particular control needs of the wheelchair user remains the same.

Standard or Agency	Title
ANSI/RESNA WC/Vols. 1&2, 1998
Section 1	Determination of Static Stability
Section 2	Determination of Dynamic Stability of Electric Wheelchairs
Section 3	Test Methods and Requirements for the Effectiveness of Braking
Section 4	Determination of Energy Consumption of Electric Wheelchairsand Scooters -- Theoretical Range
Section 5	Determination of Overall Dimensions, Mass and Turning Space
Section 6	Determination of Maximum Speed, Acceleration and Retardationof Electric Wheelchairs
Section 7	Method of Measurement of Seating and Wheel Dimensions
Section 8	Requirements and Test Methods for Static, Impact and FatigueStrengths
Section 9	Climatic Tests for Electric Wheelchairs – Requirements and TestMethods
Section 10	Determination of Obstacle Climbing Ability of ElectricWheelchairs
Section 14	Power and Control Systems for Electric Wheelchairs
Section 21	Requirements and Test Methods for ElectromagneticCompatibility

INVACARE CORPORATION

Special 510(k) for Invacare's INT/DL40i Integrated Controller

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Image /page/3/Picture/0 description: The image shows the Invacare logo. The logo is in black and white and features the word "INVACARE" in bold, sans-serif font. The word is enclosed in a black oval shape with white outlines. The logo is simple and recognizable.

CISPR 11

Industrial, Scientific and Medical (ISM) Radio Frequency Equipment-Electromagnetic Disturbance Characteristics-Limits and Methods of Measurement

Performance Data: The performance data found in this submission shows that the INT /DL40i Controller performs as intended and in a manner that is substantially equivalent to the predicate device.

Conclusion: The data presented in this submission shows that the INT /DL40i Controller performs as intended and in a manner that is substantially equivalent to the predicate devices.

INVACARE CORPORATION

Special 510(k) for Invacare's INT/DL40i Integrated Controller

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Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2007

Invacare Corporation % Mr. Carroll Martin One Invacare Way Elyria, OH 44035-4190

Re: K073134

Trade/Device Name: INT/DL40i Micro Computer Control for Power Wheelchairs Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: November 5, 2007 Received: November 7, 2007

Dear Mr. Martin:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Carroll Martin

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Invacare INT /DL40i Controller

Indications for Use: The intended use of the Invacare INT /DL40i Controller is to activate and control powered wheelchair motion. Additionally, it provides a method of selecting the type of operational parameters which best suit the particular control needs of the wheelchair user.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use -------(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number L073134
Special 510(k) for Invacare's
INT/DL40i Integrated Controller
Page 1 of

Regulation Number and Section

§ 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).