(57 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The KARMA Manual Wheelchair, Budget 800 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. Back upholstery material is also the same resistance-ignitability fabric.
Here's an analysis of the provided text regarding the KARMA Manual Wheelchair, Budget 800, focusing on acceptance criteria and supporting studies:
Acceptance Criteria and Study for KARMA Manual Wheelchair, Budget 800
Based on the provided document, the KARMA Manual Wheelchair, Budget 800 demonstrates compliance by meeting established performance standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria / Standard | Reported Device Performance |
|---|---|
| Performance Requirements (General) | Meets applicable requirements as specified in ANSI/RESNA WC Vol. 1 and ISO 7176 Wheelchair Standards. |
| Weight Capacity | 115 kgs (same as predicate device) |
| Frame Warranty | 5 years |
| Overall Dimensions (e.g., Frame Width, Depth) | Similar to predicate device, with minor differences noted as not impacting safety. |
| Tire Sizes | Differences noted from predicate device, but not impacting safety. |
| Back Upholstery Material | Resistance-ignitability fabric (same as predicate device) |
| Light and Portable Weight | Similar to predicate device, offering convenient transport. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "Performance Testing" indicating a device or devices were tested, but does not specify the number of units or the specific test protocols followed beyond citing the standards.
- Data Provenance: Not explicitly stated beyond the fact that the testing was performed, presumably by or for the manufacturer, KARMA Medical Products Co., Ltd., based in Taiwan, R.O.C. The document does not specify if the tests were conducted retrospectively or prospectively.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This type of information is not applicable to this device and its regulatory submission. The "ground truth" for a mechanical device like a wheelchair is established by standardized performance tests (e.g., durability, stability, strength, static loads) against international and national engineering standards (ANSI/RESNA WC Vol. 1, ISO 7176). There is no "expert consensus" on diagnostic images or clinical outcomes required to determine if a wheelchair meets mechanical safety and performance criteria.
4. Adjudication Method for the Test Set:
- This concept is not applicable to this device. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or evaluations of subjective interpretations (e.g., reading medical images) where multiple experts might disagree on an outcome and a method is needed to reach a definitive "ground truth." For mechanical performance testing, the results are typically quantitative and objective measurements against defined pass/fail criteria in a standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was performed or is relevant for this device. An MRMC study is used to assess the change in diagnostic performance of human readers (e.g., radiologists) when assisted by an AI algorithm, compared to reading without AI. This is a mechanical device, not a diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
- No standalone algorithm performance study was performed or is relevant for this device. This is a mechanical wheelchair; there is no embedded algorithm requiring standalone performance evaluation.
7. Type of Ground Truth Used:
- The "ground truth" for this device's performance is established by objective measurements and observations against the pass/fail criteria defined in the referenced standards: ANSI/RESNA WC Vol. 1 and ISO 7176 Wheelchair Standards. These standards quantify safety, durability, static strength, impact resistance, stability, and other mechanical aspects.
8. Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
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KCX623//
OCT - 4 2006
August 4, 2006
46 510(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:
Classification Name:
Common or Usual Name:
KARMA Manual Wheelchair, Budget 800 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:
The KARMA Manual Wheelchair, Budget 800 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for Back upholstery material is also the same transport and it is foldable easily. resistance-ignitability fabric.
Performance Testing:
The KARMA Manual Wheelchair, Budget 800 is Foldable Wheelchair meet the applicable performance requirements as specified in ANSVRESNA 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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Comparison Table_
: 参考:
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| ITEMS | SUBJECT DEVICE | PREDICATE DEVICE |
|---|---|---|
| BRAND NAME | KARMA | WH |
| MANUFACTURER | KARMA Medical ProductsCo., Ltd. | Well Home Health Products Co. |
| MODEL NO | Budget 800 | WML100 |
| 510K NO | K062311 | K060251 |
| INTENDED USE | SAME | The device is intended formedical purposes to providemobility to persons restrictedto a sitting position. |
| FRAMEWidthCross braceDepthSeatBackrest heightReclining backrestSeat sling | 610 mmSAME1080 mmwidth: 407mm / 458 mmlength: 432mmSAMESAMESAME | 21" (534mm)YES15.7"(400mm)width: 18" (458mm)depth: 16" (406mm)adjustablefixedpadded nylonblue, black |
| Frame colorsARMRESTArm padFlip backHeight-adjustable | SAMESAME | PaddedYES, non-detachableNO |
| HANGERSSwing-awayElevating leg restArticulating leg restFootplate styleHeel loopFootrest angle | SAMESAMESAMEStainlessSAME30° | NONONONylon fiber(one-piece style)NO70° |
| REAR AXLEOffset axle | SAME | YESYES |
| ITEMS | SUBJECT DEVICE | PREDICATE DEVICE |
| MODEL NO | Budget 800 | WML100 |
| REAR WHEELSizeTire typeHandrim material | 24" | convert12" or 24" |
| CASTERSSizeTire type | 8"Solid | 7"Solid |
| WHEEL LOCK | SAME | Pull-to-Lock |
| WEIGHT CAPACITY | SAME | 250 lbs / 115 kg |
| WEIGHT OF CHAIR | 14.44 kg or 14.65 kg | 15 kg (33 lb) |
| WARRANTY | 5 years on frame | 6 years on frame |
| OPTIONALACCESSORIESAnti-tipperRear stepperFold down push handle | YESYESYES | YESYESYES |
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and the comments of
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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. 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.
D4
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Image /page/4/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 4 2006
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
Re: K062311
Trade/Device Name: KARMA Manual Wheelchair, Budget 800 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 we nave reviewed your betermined 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 r ou may, mercere, mains of the Act include requirements for annual registration, listing of genoral oonlives provisive, 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 i least be advised that i Dri of issuality over device complies with other requirements of the Act that I Dr has Intact a and regulations administered by other Federal agencies. You must or any I cacal statutes and regarments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quany of trol 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) This letter will anow you to begin maketing your ufrice as valence of your device to a legally
premarket notification. The FDA finding of substantial equipal this permits vo premarket notification. The I DA Intuing of bassanal on 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
rs the regulation of the 10-10-10-10-10-10-10-10-10-19 regulation entitled If you desire specific advice for your do noo on our of on one note the regulation entitled, the legit contact the Office of Compliance at (240) 210 - 1240 Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain " Misbranding by relefence to pic.narket notifiedated. < < trom the Division of Small
other general information on your responsibilities under the tall, from worker (800) 638 other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free humber ind Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehrig
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 ):____K 062 3) |
Device Name: KARMA Manual Wheelchair, Budget 800
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)
Chaulena Aniem MD
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 _of 1
510(k) Number K062160
- ,
§ 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).