The KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105 are indoor / outdoor wheelchairs that have the base with four-wheeled with a seat. The devices can be disassembled for transport and it is foldable easily. Back upholstery material is also the same resistance-ignitability fabric.

AI/ML Overview

This 510(k) premarket notification for the KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria for a complex clinical outcome. The "acceptance criteria" here are the performance requirements of recognized standards, which the device is declared to meet.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Reference)	Reported Device Performance
ANSI/RESNA WC Vol. 1 Wheelchair Standard	Device meets applicable performance requirements.
ISO 7176 Wheelchair Standards	Device meets applicable performance requirements.

Note: The document does not provide specific numerical outcomes for each test within these standards. It simply states that the devices meet the applicable requirements. The core of this 510(k) is a comparison to a predicate device, not a novel clinical study for the subject device.

Study Details:

This submission is a premarket notification (510(k)) that relies on performance testing against recognized standards and comparison to a legally marketed predicate device to establish substantial equivalence. It is not a clinical study in the typical sense of evaluating a device's performance in a patient population to determine specific clinical acceptance criteria. Therefore, many of the requested study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set) are not applicable to this type of regulatory submission.

Specifically:

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "test set" in the context of human data. For mechanical performance testing, the sample size would typically refer to the number of wheelchairs tested to meet the ANSI/RESNA and ISO standards. This specific number is not provided in the summary.
- Data Provenance: Not applicable for a human data test set. The performance testing was conducted by KARMA Medical Products Co., Ltd. (Taiwan, R.O.C.) against international standards for mechanical wheelchairs.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The "ground truth" for this type of submission is the adherence to established engineering and performance standards (ANSI/RESNA, ISO 7176) for mechanical wheelchairs. There is no expert clinical review of "cases" to establish ground truth in this context.
Adjudication method for the test set:
- Not Applicable. There is no clinical test set requiring adjudication in this regulatory summary.
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. This is a mechanical wheelchair. MRMC studies, AI assistance, and "human readers" are not relevant to this device or its regulatory pathway.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or basis for acceptance) is the conformance to established international performance standards for wheelchairs (ANSI/RESNA WC Vol. 1 and ISO 7176) and the demonstration of substantial equivalence to a legally marketed predicate device (WH Convertible Lightweight Wheelchair, WHL100 - K060251) based on intended use, technology, and safety/effectiveness profiles.
The sample size for the training set:
- Not Applicable. There is no "training set" in the context of an algorithm or AI for this mechanical device.
How the ground truth for the training set was established:
- Not Applicable. As there is no training set mentioned or implied for this device, this question is not relevant.

Summary

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Ka62309

Image /page/0/Picture/1 description: The image shows the logo for Karma Mobility. The word "KARMA" is in large, bold, sans-serif font. The letter "M" is stylized with a heart shape. Above the heart is a small wing. Below the word "KARMA" is the word "mobility" in a smaller, sans-serif font.

KARMA MEDICAL PRODUCTS CO., LTD.

No.2363, Sec.2, Da-Shiue Rd., Min-Hsiung Shiang, Chia-Yi Hsien 62144, Taiwan, R.O.C. TEL:886-5-206-6688 FAX : 886-5-206-7788 E-mail:eukarma@ms29.hinet.net http://www.karmamedical.com.tw

OC7 1 0 2006

August 5, 2006

66 510(k) SUMMARY "

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

No. 2363, Sec.2, Da-Shiue Road, Min-Hsiung Shiang, Chia-Yi Hsien, 62144, Taiwan, R.O.C.

Date summary prepared:

Device Name:

Proprietary Name:

Common or Usual Name: Classification Name:

KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105 Mechanical Wheelchair Mechanical Wheelchair, Class I. 21 CFR 890.3850

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:

The KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105 are Foldable Wheelchair meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.

Legally marketed device for substantial equivalence comparison:

WH Convertible Lightweight Wheelchair, WHL100 ( K060251 )

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Image /page/1/Picture/0 description: The image shows the logo for Karma Mobility. The word "KARMA" is in large, bold, sans-serif font, with a heart shape above the "M". A wing-like design is above the heart. Below "KARMA" is the word "mobility" in a smaller, sans-serif font.

KARMA MEDICAL PRODUCTS CO., LTD. No.2363, Sec.2, Da-Shiue Rd., Min-Hsiung Shiang, Chia-Yi Hsien 62144, Taiwan, R.O.C. TEL:886-5-206-6688 FAX:886-5-206-7788 E-mail:eukarma@ms29.hinet.net

http://www.karmamedical.com.tw

Comparison Table

ITEMS	SUBJECT DEVICE	PREDICATE DEVICE
BRAND NAME	KARMA	WH
MANUFACTURER	KARMA Medical ProductsCo., Ltd.	Well Home Health Products Co
MODEL No.	S-Ergo 305	WML100
510K No.	K062309	K060251
INTENDED USE	SAME	The device is intended formedical purposes to providemobility to persons restrictedto a sitting position.
FRAME
Width	630 mm	21" (534mm)
Cross brace	SAME	YES
Depth	990 mm	15.7"(400mm)
Seat	width: 457mmlength: 432mm	width: 18" (458mm)depth: 16" (406mm)
Backrest height	SAME	adjustable
Reclining backrest	SAME	fixed
Seat sling	SAME	padded nylon
Frame colors	SAME	blue, black
ARMREST
Arm pad	Padded, adjustable	Padded
Flip back	YES, detachable	YES, non-detachable
Height-adjustable	adjustable	NO
HANGERS
Swing-away	SAME	NO
Elevating leg rest	SAME	NO
Articulating leg rest	SAME	NO
Footplate style	Stainless, adjustable	Nylon fiber(one-piece style)
Heel loop	SAME	NO
Footrest angle	30°	70°
REAR AXLE
Offset axle	SAME	YES
ITEMS	SUBJECT DEVICE	SUBJECT DEVICE
MODEL No.	S-Ergo 305	S-Ergo105
FOOTPLATE STYLE	Stainless, adjustable	Stainless, fixed
ARMREST	Padded, adjustable	Padded, fixed
SEAT HEIGHT	Adjustable	Fixed

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Image /page/2/Picture/0 description: The image shows the logo for Karma Mobility. The word "KARMA" is written in large, bold, black letters. Above the "M" is a heart with a wing coming out of the top right. Below the word "KARMA" is the word "mobility" in a smaller, less bold font.

KARMA MEDICAL PRODUCTS CO., LTD.

No.2363, Sec.2, Da-Shiue Rd., Min-Hsiung Shiang, Chia-Yi Hsien 62144, Taiwan, R.O.C. FAX:886-5-206-7788 TEL:886-5-206-6688 E-mail:eukarma@ms29.hinet.net http://www.karmamedical.com.tw

SUBJECT DEVICE PREDICATE DEVICE ITEMS MODEL No. S-Ergo 305 WML100 REAR WHEEL convert Size 24" 12" or 24" Tire type Handrim material CASTERS 8" 7" Size Solid Solid Tire type WHEEL LOCK SAME Pull-to-Lock 250 lbs / 115 kg SAME WEIGHT CAPACITY 15 kg (33 lb) 12.9 kg WEIGHT OF CHAIR 6 years on frame 5 years on frame WARRANTY OPTIONALACCESSORIES YES YES Anti-tipper YES Rear stepper YES Fold down push handle YES YES r l

Note: the subject device S-Ergo105 is same as S-Ergo 305 the difference as below:

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Image /page/3/Picture/0 description: The image shows the word "KARMA" in large, bold, sans-serif font. Above the letter "M" is a heart shape with a wing extending from the right side. Below the word "KARMA" is the word "mobility" in a smaller, sans-serif font. The image appears to be a logo or brand name.

KARMA MEDICAL PRODUCTS CO., LTD. No.2363, Sec.2, Da-Shiue Rd., Min-Hsiung Shiang, Chia-Yi Hsien 62144, Taiwan, R.O.C. TEL : 886-5-206-6688 FAX:886-5-206-7788 E-mail:eukarma@ms29.hinet.net http://www.karmamedical.com.tw

Summary for substantial equivalence comparison:

The intended use of the two devices is the same, and mainframes of two devices are the same foldable. The overall dimensions are similar. Back upholstery material is also the same resistance -ignitability fabric. The major differences existing are the overall dimension, and the size of tires are differences between the two devices. Especially, the subject device S-Ergo 305 has the adjustable armrest and footplate. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

The weight limit of the subject device and the predicate device are also 115 kgs, The seat heights between the new device and the predicate device have small difference, not leading to any safety hazard. The hanger and rear axle designs are The light and portable weight of the new device is similar to the predicate same. device and the user can feel more convenient transport it. At last the optional accessories for the two devices are same, and the users have the same status to choose the needed accessories to accommodate their needs.

Thus the new device is substantially equivalent to the predicate devices in this aspect.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Karma Medical Products Co., Ltd. % Dr. Jen Ke-Min No. 2363, Sec.2, Da-Shiue Road Min-Hsiung Shiang Chia-Yi Hsien 62144, Taiwan, R.O.C

OCT 1 0 2006

Re: K062309

Trade/Device Name: KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 23, 2006 Received: September 27, 2006

Dear Dr. Ke-Min:

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 -- Dr. Jen Ke-Min

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 Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

barbare Buelms

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: KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105

Indications for Use:

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

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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices	Page 1 of 1
510(k) Number	K06 2309

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).