(47 days)
The Catalyst wheelchair is a manually operated device intended to be used as a means of mobility for persons restricted to a sitting position.
The Catalyst is a traditional folding cross-brace wheelchair. It is made of lightweight aluminum tubing similar to what is used on existing products. The frame utilizes two cross tube sets and, when opened, nestles inside of the frame onto 4 hooks to create a box like rigid assembly. Upon the outside of this framework, and to the rear, are assembled 2 machined aluminum axle plates. Stainless steel receivers are mounted within the axle plates. Wheels of varying size and type are connected to the receivers via stainless steel axles. On the front end of the frame are assembled 2 aluminum housings. Caster forks are mounted to these housings via stainless steel axles. A variety of caster wheels and tires are then connected to the forks. Upon the top of the frame is attached a seat sling. Into the rear of the frame assembly 2 backtubes are inserted to the desired height. Backrest upholstery is affixed to the backtubes. Armrests receivers bolt onto the rear of each side frame. Individual Swing Away tubular arms are then inserted into the receivers. If flipback armrests are chosen a receiver is mounted onto the from of each side frame to catch the forward most section of the arm and the rear mounting is pivoting to allow the arm to rotate backward. Height Adjustable arms fit into a receiver that mounts onto the outside of the frame. Wheel locks mount onto the upper side frame and are adjusted so that the brake arm engages with the tire and when in the locked position prevents to the wheel from rotating. Swing Away footrests with footplates and heel loops attach at the front of the chair. There is a plug at the top of the footrest hanger that inserts into an opening at the top front of the wheelchair frame. The footrest hanger is turned 90 degrees away from the frame. Hold the latch, which is midway down the hanger, tightly against the front of the frame and rotate the footrest back towards center. The latch will engage once the footrest hanger is centered.
The provided document is a 510(k) Summary of Safety and Effectiveness for the Catalyst manual wheelchair. It outlines the device description, intended use, comparison to a predicate device, and performance testing results.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI-RESNA WC - Vol 1 - 1998 Section 1: Determination of static stability | Complies with the standard. |
| ANSI-RESNA WC - Vol 1 - 1998 Section 8: Static, impact, and fatigue strengths | Complies with the standard. |
| ANSI-RESNA WC - Vol 1 - 1998 Section 16: Determination of Flammability | Complies with the standard. |
| ANSI-RESNA WC - Volume 1 - 1998 Section 5: Determination of Overall Dimensions, Mass and Turning Space | Complies with the standard. |
| ANSI-RESNA WC - Volume 1 - 1998 Section 7: Measurement of seating and wheel dimensions | Complies with the standard. |
| ANSI-RESNA WC - Volume 1 - 1998 Section 93: Maximum Overall Dimension | Complies with the standard. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It states that the "Catalyst has been tested," implying a physical testing of the device itself rather than a data-driven study on a set of cases.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in the document. The "ground truth" for a medical device like a wheelchair is established through adherence to engineering and safety standards, not through expert consensus on diagnostic interpretations. The device's performance is measured against these established standards.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided in the document. Adjudication methods are typically associated with studies involving human interpretation or subjective assessments, which is not the case for the physical testing of a wheelchair against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance:
This information is not applicable and not provided in the document. The device is a manual wheelchair, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study or assessment of AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable and not provided in the document. The device is a physical mechanical wheelchair, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for this device's acceptance is based on adherence to recognized international engineering and safety standards, specifically:
- ANSI/RESNA WC Volume 1 - 1998 Standards - Sections 1, 5, 7, 8, 16 & 93.
- Section 1: Determination of static stability
- Section 5: Determination of Overall Dimensions, Mass and Turning Space
- Section 7: Measurement of seating and wheel dimensions
- Section 8: Static, impact, and fatigue strengths
- Section 16: Determination of Flammability
- Section 93: Maximum Overall Dimension
These standards themselves define the "ground truth" for what constitutes a safe and effective manual wheelchair.
8. The Sample Size for the Training Set:
This information is not applicable and not provided in the document. As a physical product, there is no "training set" in the context of an algorithm or AI model development. The design and manufacturing processes are likely informed by engineering principles, material science, and previous product development, rather than a formal data training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided in the document for the reasons explained in point 8. The "ground truth" for manufacturing a wheelchair is established through engineering specifications, material properties, and quality control processes to ensure the final product meets the defined safety and performance standards.
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K06260
Image /page/0/Picture/1 description: The image shows the logo for KI, a company that provides furniture and architectural wall systems. The logo consists of the letters "Ki" in a bold, sans-serif font. The letters are black and are surrounded by an oval shape. The oval shape is also black and is slightly tilted to the right.
4925 Coye Drive Suite D Stevens Point, WI 54481 715-254-0991 715-254-0996 (fax) dhmunsey@kimobility.com
0C1 2 4 2006
October 13, 2006
510(k) Summary of Safety and Effectiveness
Submitter
Ki Mobility 4925 Coye Drive Suite D Stevens Point, WI 54481 USA
Telephone: (715) 254-0991 Fax: (715) 254-0996
Contact: Douglas H. Munsey
510(k) Number: K062660
Trade Name: Catalyst
Common Name: Folding Ultra-Lightweight Manual Wheelchair
Classification Name: Mechanical wheelchair
Classification: Class I
Predicate Device
The predicate device is the Quickie 2 wheelchair. K850536
Device Description
The Catalyst is a traditional folding cross-brace wheelchair. It is made of lightweight aluminum tubing similar to what is used on existing products. The frame utilizes two cross tube sets and, when opened, nestles inside of the frame onto 4 hooks to create a box like rigid assembly. Upon the outside of this framework, and to the rear, are assembled 2 machined aluminum axle plates. Stainless steel receivers are mounted within the axle plates. Wheels of varying size and type are connected to the receivers via stainless steel axles.
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On the front end of the frame are assembled 2 aluminum housings. Caster forks are mounted to these housings via stainless steel axles. A variety of caster wheels and tires are then connected to the forks.
Upon the top of the frame is attached a seat sling. Into the rear of the frame assembly 2 backtubes are inserted to the desired height. Backrest upholstery is affixed to the backtubes.
Armrests receivers bolt onto the rear of each side frame. Individual Swing Away tubular arms are then inserted into the receivers. If flipback armrests are chosen a receiver is mounted onto the from of each side frame to catch the forward most section of the arm and the rear mounting is pivoting to allow the arm to rotate backward. Height Adjustable arms fit into a receiver that mounts onto the outside of the frame.
Wheel locks mount onto the upper side frame and are adjusted so that the brake arm engages with the tire and when in the locked position prevents to the wheel from rotating.
Swing Away footrests with footplates and heel loops attach at the front of the chair. There is a plug at the top of the footrest hanger that inserts into an opening at the top front of the wheelchair frame. The footrest hanger is turned 90 degrees away from the frame. Hold the latch, which is midway down the hanger, tightly against the front of the frame and rotate the footrest back towards center. The latch will engage once the footrest hanger is centered.
| Feature | Description | Materials |
|---|---|---|
| Intended Use | The Catalyst wheelchair is a manually operated device intended to be used as a means of mobility for persons restricted to a sitting position. | |
| Primary Frame Materials | 6061-T6 Aluminum | 6061-T6 Aluminum |
| Folding Method | Collapsible Cross-brace | 6061-T6 Aluminum |
| Frame Widths | 14" to 20" | |
| Overall Width | 20.5" to 26.5" | |
| Seat Depths | 14" to 20" | |
| Back Heights | 8.5" to 19" | |
| Weight Limit | 220 lbs | |
| Seat Height | 15" to 21" | |
| Chair Weight | 23 lbs (w/o footrests) | |
| Warranty | Lifetime on frame | |
| Armrests | 1. Flip Back Height Adjustable -- Desk & Full Length Arm pads2. Flip Back Desk & Full Length Arm pads3. Height Adjustable- Desk & Full Length Arm pads4. Tubular Swing-Away | 1,2,3 - 6061-T6 Aluminum tubing, ERW 1020 Steel upper, plastic side guard, 303 stainless steel pin, Plastic armrest pad4. - 6061-T6 Aluminum |
| Front End Type | Swing-Away, Non-Swing Away | Welded 6061-T6 Aluminum |
| Back Type | Straight with push handles, 8 degree bend with push handles, no push handles | 6061-T6 Aluminum |
| Footrests Hangers | 70°, Elevating legrest | Welded 6061-T6 Aluminum |
| Footplates | Composite, Foam, Angle Adjustable | Composite - Nylon 66 with 15% short glass.Foam - 6061-T6 Aluminum with PU foam coverAngle Adj - 6061-T6 Aluminum plate |
| Extension Tubes | Ex. Short, Short, Medium, Long | 6061-T6 Aluminum |
| Back Heights | 8.5" to 19" in 3 adjustable sections |
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| Back Upholstery | Sewn Nylon Parapak 420D w/ ¼" polyurethane foam batting | Sewn Nylon Parapak 420D w/ ¼" polyurethane foam batting |
|---|---|---|
| Seat Upholstery | Sewn Dacron Polyester Sailcloth - No filling | Sewn Dacron Polyester Sailcloth - No filling |
| Cushion | 2' foam cushion | Manufactured and distributed by Hudson Industries. Model - PressureEez 2 General Seat Cushion |
| Axle Plates | Standard, Curved, Amputee, Offset | Machined 6061-T6 Aluminum |
| Axle | Quick Release or Fixed | Machined 303 Stainless steel |
| Wheel Sizes | 22,24,26 | |
| Wheel Types | Spoke, Composite Mag, Octopus (performance spoke) | Spoke & Octopus- Machined 6061-T6 Aluminum rims, Stainless steel spokes, Machined 6061 - T6 Aluminum hubMag - Nylon 66 with 15% short Glass |
| Tire Types | Pneumatic, Pneumatic w/ airless insert, Full profile Polyurethane, Low Profile Polyurethane, Iron Cap (puncture resistant), High Pressure | Synthetic rubber and Urethane |
| Handrims | Aluminum, Plastic Coated, Projections | 6061-T6 Aluminum, anodized or covered with PVC coating |
| Caster Sizes | 4", 5", 6", 7", 8" | |
| Caster Types | Poly, Pneumatic, Pneumatic w/ airless insert | Nylon 66 with 15-30% short glassSynthetic rubber and Urethane tires |
| Forks Sizes | 4", 5", 6", 7" | Machined 6061-T6 Aluminum |
| Fork Stem Sizes | Std, +3/4", +1 ½" | Machined 303 Stainless steel |
| Wheel Locks | Push to Lock, Pull To Lock, Scissor Lock | Machined 6061-T6 Aluminum |
| Anti Tips Tubes | Locate off of the axle to insure safety at all seat heights | Cast aluminum housing with 6061-T6 tubes and plastic wheels |
| Where used | Solid surface | |
| Target Population | Persons restricted to a sitting position. | |
| Standards | Static Stability and Fatigue Strength: ANSI/RESNAWheelchair Std. Vol. 1Sections 1, 5, 7, 8, 16 & 93 | |
| Tubing thicknesses | .070" on frame except front vertical tube, which is .1". X-tube is .070. | |
| Tube properties | 6061-T4 prior to welding. After welding the |
Indications for Use
The Catalyst wheelchair is a manually operated device intended to be used as a means of mobility for persons restricted to a sitting position.
| Feature | Quickie 2 | Catalyst |
|---|---|---|
| Intended Use | The Quickie wheelchair is a manuallyoperated device intended to be used as ameans of mobility for persons restrict to asitting position. | The Catalyst wheelchair is a manuallyoperated device intended to be used as ameans of mobility for persons restrict to asitting position. |
| Primary Materials | 6061-T6 Aluminum | 6061-T6 Aluminum |
| Folding Method | Collapsible Cross-brace | Collapsible Cross-brace |
| Frame Widths | 11" to 22" | 14" to 20" |
| Overall Width | 20.5" to 28.5" | 20.5" to 26.5" |
| Seat Depths | 10" to 20" | 14" to 20" |
| Back Heights | 8.5" to 19" | 8.5" to 19" |
| Weight Limit | 250 lbs (350lbs. Heavy Duty ) | 220 lbs |
| Seat Height | 16.75" to 22.75" | 15" to 21" |
| Chair Weight | 27 lbs (w/o footrests) | 23 lbs (w/o footrests) |
| Warranty | Lifetime on frame | Lifetime on frame |
| Armrests | 1. Flip Back Height Adjustable - Desk & Full Length Arm pads2. Flip Back3. Height Adjustable- Desk & Full Length Arm pads4. Tubular Swing-Away5. Adjustable Locking Flip-up6. Length Adjustable Locking Flip-up | 5. Flip Back Height Adjustable - Desk & Full Length Arm pads6. Flip Back Desk & Full Length Arm pads7. Height Adjustable- Desk & Full Length Arm pads8. Tubular Swing-Away |
| Front End Type | Swing-Away, Non-Swing Away | Swing-Away, Non-Swing Away |
| Back Type | Std, Angle Adjustable, Depth Adjustable | Std |
| Footrests Hangers | 60°, 70°, 70°V, 90°, Articulating Legrest, Elevating legrest, 90° Elevating, 1-Piece | 70°, Elevating legrest |
| Footplates | Composite, Foam, Aluminum, Angle Adjustable, Platform Flip-up, Locking Angle Adjustable | Composite, Foam, Angle Adjustable |
| Extension Tubes | Ex Short, Short, Medium, Long | Ex Short, Short, Medium, Long |
| Back Upholstery | Low, Medium, Tall, Adjustable, Reinforced | Low, Medium, Tall, Adjustable |
| Axle Plates | Standard, Curved, Amputee, Offset | Standard, Curved, Amputee, Offset |
| Wheel Sizes | 20,22,24,26 | 22,24,26 |
| Wheel Types | Spoke, Composite Mag, Spinergy (performance spoke), One Arm Drive | Spoke, Composite Mag, Octopus (performance spoke) |
| Tire Types | Pneumatic, Pneumatic w/ airless insert, Full profile Polyurethane, Low Profile Polyurethane, Kevlar (puncture resistant), High Pressure | Pneumatic, Pneumatic w/ airless insert, Full profile Polyurethane, Low Profile Polyurethane, Iron Cap (puncture resistant), High Pressure |
| Handrims | Aluminum, Plastic Coated, Projections | Aluminum, Plastic Coated, Projections |
| Caster Sizes | 4", 5", 6", 8", 8x2 | 4", 5", 6", 8" |
| Caster Types | Poly, Semi-Pneumatic, Soft Roll, Pneumatic, Pneumatic w/ airless insert | Poly, Pneumatic, Pneumatic w/ airless insert |
| Forks Sizes | 3", 4", 5 ¼", 6", 7", Frog Legs | 4", 5", 6", 7", Frog Legs |
| Fork Stem Sizes | Std, +3/4", +1 ½" | Std, +3/4", +1 ½" |
| Caster Options | Multi-Position Fork, Caster Pin Locks, Quick Release Caster Stems | NA |
| Wheel Locks | Push to Lock, Pull To Lock, Scissor Lock, Grade Aid | Push to Lock, Pull To Lock, Low Profile |
| Anti Tips Tubes | Yes | Yes |
| Power Adapter | Quickie Extender | NA |
| Where used | Solid surface. | Solid surface |
| Target Population | Persons restricted to a sitting position. | Persons restricted to a sitting position. |
| Standards | Unknown | Static Stability and Fatigue Strength ANSI/RESNA Wheelchair Std. Vol. 1 Sections 1, 5, 7, 8, 16 & 93 |
| Tubingthicknesses | .083" on frame except front vertical tube, which is .125". X-tube is variable in thickness from .083" to .125" as it is a custom extrusion | .070" on frame except front vertical tube which is .1". X-tube is .070. |
| Tube properties | 6061 - T6 prior to welding. Hardness | 6061-T4 prior to welding. After welding |
Technological Comparison to the Predicate Device
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|---|---|---|---|
| 11'welcing. |
It is Ki Mobility's conclusion that the Catalyst manual wheelchair is substantially equivalent to the Quickie 2 manual wheelchair currently marketed by Sunrise Medical.
Summary of Performance Testing
The Catalyst has been tested and found to comply with the ANSI-RESNA WC Volume 1 1998 standards sections 1, 5, 7, 8, 16 & 93.
Conclusions
As stated above, Ki Mobility's conclusion is that the Catalyst wheelchair is safe, effective, complies with the appropriate medical device standards, and is substantially equivalent to the Quickie 2 wheelchair.
This 510(k) Summary of Safety and Effectiveness may be copied and submitted to interested parties as required by 21CFR807.92.
| STANDARD | TITLE and COMMENTS |
|---|---|
| ANSI-RESNA WC - Vol 1-1998 Section 1 | Determination of static stability |
| ANSI-RESNA WC - Vol 1-1998 Section 8 | Static, impact, and fatigue strengths |
| ANSI-RESNA WC- Vol 1- 1998 Section 16 | Determination of Flammability |
| ANSI-RESNA WC -Volume 1-1998 Section 5 | Determination of Overall Dimensions, Mass and Turning Space |
| ANSI-RESNA WC -Volume 1-1998 Section 7 | Measurement of seating and wheel dimensions |
| ANSI-RESNA WC -Volume 1-1998 Section 93 | Maximum Overall Dimension |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ki Mobility LLC % Mr. Douglas H. Munsey 4925 Coye Drive, Suite D Stevens Point, Wisconsin 54481
OCT 2 4 2006
Re: K062660
Trade/Device Name: Catalyst Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: October 6. 2006 Received: October 10, 2006
Dear Mr. Munsey:
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. Douglas H. Munsey
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) 276-0120Also, 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,
Kavita Buelow
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
Applicant:
Ki Mobility 4925 Coye Drive Suite D Stevens Point, WI 54481 USA
Telephone: (715) 343-1280 Fax: (715) 343-1280 510(k) Number: K062660
Device Name: Catalyst
Indications for Use:
The Catalyst wheelchair is a manually operated device intended to be used as a means of mobility for persons restricted to a sitting position.
Prescription Use (Per 21 CFR 801.116)
Over-The-Counter OR X
(Please do not write below this line -- continue on another page if needed)
bashase-Puchand
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division of General, Restorative, and Neurological Devices
510(k) Number K062460
§ 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).