The intended use of the K450 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
The intended use of the K450 series of the powered wheelchair is to provide indoor and outdoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.

Device Description

K450 Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair R-net PM120 amp controller. The user interface is a joystick. The K450 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 26,9 km (16,7 miles), depending on use and the terrain the chair is driven on. The chair frame is a welded steel construction and includes two rear drive wheels with drive units (motor, gear, brake), batteries and front pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

AI/ML Overview

This is a 510(k) summary for a powered wheelchair (K450). The document states that the K450 functioned as intended in all instances but does not provide specific acceptance criteria or details of a study to prove conformance. It primarily focuses on demonstrating substantial equivalence to a predicate device (C350, K071650).

Here's an breakdown based on the provided text, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
(Not explicitly stated in terms of quantitative metrics or specific pass/fail thresholds)	"In all instances, the K450 functioned as intended."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document doesn't detail any specific clinical or non-clinical testing data beyond a general statement of functioning as intended.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This device is a powered wheelchair and the submission does not involve an AI/imaging diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

Not applicable. This device is a powered wheelchair and the submission does not involve an AI/imaging diagnostic device requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is not an AI/imaging diagnostic device.

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

Not applicable. This is not an AI/imaging diagnostic device. The device itself is a powered wheelchair that a human operates.

7. The Type of Ground Truth Used:

Not explicitly defined in the context of "ground truth" as it would be for an AI diagnostic device. For a powered wheelchair, "ground truth" would typically refer to objective performance standards (e.g., speed, range, stability, braking distance) and user functionality, but the document only states "functioned as intended."

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of what is missing/not applicable for an AI device:

The provided document is a 510(k) summary for a powered wheelchair, not a medical imaging or AI diagnostic device. Therefore, many of the requested criteria (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission.

The submission primarily relies on demonstrating substantial equivalence to an existing predicate device (C350, K071650) by stating that the K450 has "the same intended uses and similar indications, technological characteristics and principles of operation." The "performance data" mentioned is very high-level: "In all instances, the K450 functioned as intended." This suggests that internal testing was conducted that validated its functionality, likely against a set of engineering and safety specifications, but these specific criteria and the detailed data are not provided in this summary.

Summary

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ORIGINAL, TRADITIONAL 510(K) NOTIFICATION ORIGINAL, POWERED WHEELCHAIR: K450

Image /page/0/Picture/1 description: The image shows the Permobil logo, which is an oval shape with the word "permobil" written in white letters on a black background. Above the logo, there is some handwritten text that is difficult to read. The logo is simple and easy to recognize, and the black and white color scheme gives it a classic look.

Attachment 11

510(k) Summary

JUL 2 9 2008

Submitter	Permobil ABBox 120S-861 23 TimråSweden
Phone	+46 60 595900
Facsimile:	+46 60 575250
Contact Person:	Jan Åström
e-mail address:	jan.astrom@permobil.se
Date Prepared:	July, 2008
Device name:	K450
Classification Name:	Powered wheelchair
Predicate Devices:	C350( K071650) manufactured by Permobil AB.
Intended use:	The intended use of the K450 powered wheelchair is to provide outdoor andindoor mobility to persons limited to a seated position that are capable ofoperating a powered wheelchair.
Description of device:	K450 Powered Wheelchair is battery powered, rear wheel motor driven andis controlled by the PG power wheelchair R-net PM120 amp controller.The user interface is a joystick.The K450 is powered by two 12VDC 60Ah, Group M34 batteries,approximate driving range on fully charged batteries is up to 26,9 km(16,7 miles), depending on use and the terrain the chair is driven on.The chair frame is a welded steel construction and includes two rear drivewheels with drive units (motor, gear, brake), batteries and front pivotingcasters.Depending on users needs, the joystick motor control is mounted to the leftor right armrest.When the user activates the joystick, the controller receives a signal torelease the brakes.With the brakes released, the chair is allowed to move in the direction thejoystick is actuated.When the user releases the joystick, the chair slows to a stop and the brakesare automatically re-engaged. The solenoid electromechanical brakes allowthe user stop by letting go of the joystick.

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ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: K450

Image /page/1/Picture/1 description: The image shows the logo for Permobil. The logo is in an oval shape with a black background and white text. The text "permobil" is written in a sans-serif font, with the "o" in "mobil" being slightly larger than the other letters.

Performance Data

In all instances, the K450 functioned as intended.

Substantial Equivalence

The K450 is substantially equivalent to the C350(K071650). The K450 has the same intended uses and similar indications, technological characteristics and principles of operation. The minor technological differences between the K450 and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the K450 is as safe and cffective as the C350. Thus, the K450 is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2008

Permobil AB % Ms. Jan Astrom Box 120 Timra Sweden S-861 23

Re: K081964 Trade/Device Name: K450 Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class Il Product Code: ITI Dated: July 10, 2008 Received: July 10, 2008

Dear Ms. Astrom:

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 - Ms. Jan Astrom

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 procced 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 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.

Sincerely yours,

Mark M. Millman

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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ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: K450

INDICATION FOR USE

510(k) number Not assigned at the writing of this submission.

K450 Device name:

Indication for Use

The intended use of the K450 series of the powered wheelchair is to provide indoor and outdoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.

Prescription use __

Over the counter use __

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Marta H. Melkerss

(Division Sign-C Division of General, Restorative, and Neurological Dev

510(k) Number K081

Page 1 of 1

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).