KARMA POWER WHEELCHAIR, MODEL KP-25 by KARMA MEDICAL PRODUCTS CO., LTD.

The KARMA Power Wheelchair, KP-25 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the KARMA Power Wheelchair, KP-25, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full de novo clinical study with extensive acceptance criteria and detailed performance statistics. Therefore, the information available is limited to what's typically required for a 510(k) submission.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., speed, range, turning radius, battery life) with corresponding target values. Instead, the "acceptance criteria" are implicitly met by demonstrating compliance with recognized standards and substantial equivalence to a legally marketed predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety and Performance Standards Compliance:
ANSI / RESNA WC/Vol.2-1998 (Electrically Powered Wheelchairs)	The device underwent "Performance Testing" including this standard. The implication is that it passed the requirements.
CISPR 11: 1990 (EMC)	The device underwent "Performance Testing" including this standard. The implication is that it passed the requirements. Additionally, the electronic systems are stated as "all passed by the UL certificated."
EN61000-3-2: 1995 (EMC - Harmonics)	The device underwent "Performance Testing" including this standard. The implication is that it passed the requirements.
IEC61000-3-3: 1995 (EMC - Flicker)	The device underwent "Performance Testing" including this standard. The implication is that it passed the requirements.
Substantial Equivalence to Predicate Device:
Electronic systems (controller, batteries, charger, switches)	"The electronic systems between two devices are the same and all passed by the UL certificated... Thus the same safety level for the two devices is assured."
Foldable frame	"the two devices are the same foldable frame..."
Maximum speed	"...same maximum speed..."
Removable arm type	"...same removable arm type..."
Warranty on component and frame	"...same warranty on component and frame..."
Back upholstery material (resistance ignition test)	"...back upholstery are the same material that also be passed the resistance ignition test by SGS."
Differences (overall dimension and weight) are not safety-related	"The major differences existing of the two Powered Wheelchairs are the different overall dimension and weight between the two devices. The overall appearance and weight differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect."

Study Details

The provided document describes a bench and engineering testing approach to demonstrate substantial equivalence, rather than a clinical study with a test set of data, human readers, or ground truth developed by experts.

Sample size used for the test set and the data provenance:
- No "test set" of patient data is mentioned in the context of a clinical study.
- The "test set" for performance testing refers to the physical device itself. The tests were performed on the KARMA Power Wheelchair, KP-25.
- Data Provenance: The testing appears to be conducted in a laboratory/engineering setting, likely by KARMA Medical Products Co., Ltd. or contracted testing facilities (e.g., UL, SGS). The manufacturer is in Taiwan, R.O.C., so the testing likely occurred there or by international certification bodies. The document does not specify whether the data is retrospective or prospective, but in the context of device performance testing against standards, it would be prospective data generated specifically for the submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There's no "ground truth" established by clinical experts for a test set in this type of submission. Ground truth for engineering tests is typically defined by the specified parameters and methodologies within the adopted standards (e.g., a certain current, a specific speed measurement, a strength test).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There's no adjudication process as described for clinical interpretation. The performance testing against standards involves objective measurements and pass/fail criteria as defined by the standards.
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. This is a medical device (power wheelchair), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI are not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not feature an algorithm that would be tested in a standalone capacity.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is objective measurements against engineering standards (e.g., EMC compliance, structural integrity, speed). This is determined by the test methodologies of standards like ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, and IEC61000-3-3, and independent certification bodies like UL and SGS.
The sample size for the training set:
- Not applicable. There is no machine learning or AI component requiring a training set mentioned in this submission.
How the ground truth for the training set was established:
- Not applicable (as above).

Summary

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Image /page/0/Picture/20 description: The image shows the logo for Karma Home & Health Care. The word "Karma" is written in a bold, sans-serif font, with a heart shape replacing the letter "A". Above the heart is a small, stylized wing. Below the word "Karma" is the phrase "home & health care" in a smaller, thinner font.

JUL 2 3 2004

KARMA MEDICAL PRODUCTS CO., LTD. 康揚股份有限公司 U.K. U.S.A. TAIWAN THAI. Tel:886-(0)5-2066688 Fax:886-(0)5-2067788 Http://www.KarmaMedical.com K041678 E-mail:eukarma@ms29.hinet.net

June 13, 2004

દ્ધ 510(k) SUMMARY "

Submitter's Name: KARMA Medical Products Co., Ltd.

No. 2363, Sec. 2, Da-Shiue Road, Min-Hsiung Shiang, Chia-Yi Hsien, 621, Taiwan, R.O.C.

Date summary prepared:

Device Name:

Proprietary Name:

KARMA Power Wheelchair, KP-25

Common or Usual Name: Classification Name:

Powered Wheelchair Powered Wheelchair, Class II, 21 CFR 890.3860

Indications for Use:

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Description of the device:

Performance Testing:

EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods)

Legally marketed device for substantial equivalence comparison: SINON Power Wheelchair, SN-W401 (K040319)

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Image /page/1/Picture/0 description: The image shows the logo for Karma Home & Health Care. The word "Karma" is written in large, bold letters, with a heart shape replacing the letter "M". A small wing is attached to the top right of the heart. Below the word "Karma", the words "home & health care" are written in a smaller font.

KARMA MEDICAL PRODUCTS CO., LTD. 康揚股份有限公司 U.K. U.S.A. TAIWAN THAI. Tel:886-(0)5-2066688 Fax:886-(0)5-2067788 Http://www.KarmaMedical.com

E-mail:eukarma@ms29.hinet.net

Summary for substantial equivalence comparison:

The electronic systems between two devices are the same and all passed by the UL certificated, for instance the electronic controller, batteries and recharge, switches & switching power supplies. Thus the same safety level for the two devices is assured. Besides, the two devices are the same foldable frame, maximum speed, removable arm type, same warranty on component and frame, and back upholstery are the same material that also be passed the resistance ignition test by SGS. The major differences existing of the two Powered Wheelchairs are the different overall dimension and weight between the two devices. The overall appearance and weight differences are not safety aspect. TThus the new device is substantially equivalent to the predicate devices in this aspect.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

'JUL 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KARMA Medical Products Co., Ltd. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K041678

Trade/Device Name: KARMA Power Wheelchair, KP-25 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: June 13, 2004 Received: June 21, 2004

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarely be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated 976, the enactment date of the Medical Device Amendments, or to conniner of Price to Frid) 20, 2017, in accordance with the provisions of the Federal Food, Drug, de rices that have been that do not require approval of a premarket approval application (PMA). and Cosmetic For (11er) that as nevice, subject to the general controls provisions of the Act. The I va may, diereleve, mains of the Act include requirements for annual registration, listing of general bonurols profiseving 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 may or defect to deal 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 or uny I 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 orth 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 - Dr. Ke-Min Jen

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to ogin maneting of substantial equivalence of your device to a legally premarket notification: "The 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 If you desire specific arroliance at (301) 594-4659. Also, please note the regulation entitled, oonlaet the Office of Court Court Cation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Karma Home & Health Care. The word "Karma" is written in large, bold, sans-serif font. Below the word "Karma" is the phrase "home & health care" in a smaller, lighter font. To the right of the word "Karma" is a heart with a wing attached to it.

KARMA MEDICAL PRODUCTS CO., LTD. 康揚股份有限公司 U.K. U.S.A. TAIWAN THAI. Tel:886-10)5-2066688 Fax:886-(0)5-2067788

Http://www.KarmaMedical.com E-rnail:eukarma@ms29.hinet.net

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510 (K) NUMBER ( IF KNOW ): _ TBA DEVICE NAME: KARMA Power Wheelchair, KP-25

INDICATIONS FOR USE:

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Mark A Milkers

Division of General, Restorative, and Neurological Devices

510(k) Number K041678

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

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).