(82 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects and safety standards of a manual wheelchair, with no mention of AI or ML technologies.
Yes
The device is a rehab wheelchair intended to provide mobility to persons limited to a sitting position, which qualifies it as a therapeutic device.
No
The device is described as a "Rehab Wheelchair" and its intended use is to "provide mobility to persons limited to a sitting position," which are functions of a mobility aid, not a diagnostic device.
No
The device description clearly outlines physical components like wheels, armrests, and a shear reduction system, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide mobility to persons limited to a sitting position." This is a mechanical function for physical support and movement.
- Device Description: The description details the physical components of a wheelchair (wheels, armrests, frame, upholstery).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed for testing biological samples outside of the body. This device is a mobility aid.
N/A
Intended Use / Indications for Use
The AST Model MA012 and MS019 Rehab Wheelchairs are to provide mobility to persons limited to a sitting position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The AST Model MA012 and MS019 Rehab Wheelchair are manual wheelchairs. They have adjustable armrests, and multiple axle position. The casters are 6"/7"/8" PU wheels with height adjustable forks and the rear wheels are 20"/22"/24″*1-3/8″ polyurethane(MA012 and MS019). The wheelchair also has a shear reduction system: by carefully aligning the pivot points of the user, to minimize the sliding down of the user and also minimize the shear force and pressure against the back. The armrest height can be adjusted from 8" to 12" and it is detachable.
The wheel for MA012 is quick release rear wheel. The AST MS019 Rehab Wheelchair has NO quick release rear wheel;
The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices.
The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed based on the following ISO standards:
- ISO 7176-1:2014 Determination of Static Stability
- ISO 7176-3:2012 Determination of effectiveness of brakes
- ISO 7176-5:2008 Determination of overall dimensions, mass and maneuvering space
- ISO 7176-7:1998 Method of Measurement of Seating and Wheel Dimensions
- ISO 7176-8:2014 Requirements and test methods for static, impact and fatigue strengths
- ISO 7176-11:2012 Test dummies
- ISO 7176-13:1989 Determination of coefficient of friction of test surfaces
- ISO 7176-15:1996 Requirements for Information Disclosure, Documentation and Labeling
- ISO 7176-16:2012 Resistance to ignition of postural support devices
- ISO 14971:2007 Medical devices -- Application of risk management to medical devices
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Key results: The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 25, 2018
Sichuan AST Medical Equipment Co., Ltd. Johnson Van Technical Sales Associate No.58, Jin-Peng Road, C Area, Luxian Industrial Park Luzhou City, Sichuan 646100 China
Re: K181795
Trade/Device Name: AST Model MA012 and MS019 Rehab Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: July 3, 2018 Received: July 5, 2018
Dear Johnson Van:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
for Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181795
Device Name
AST Model MA012 and MS019 Rehab Wheelchair
Indications for Use (Describe)
The AST Model MA012 and MS019 Rehab Wheelchairs are to provide mobility to persons limited to a sitting position.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
Sichuan AST medical Equipment Co., Ltd. 510(k) Premarket Notification
Submitter:
Sichuan AST Medical Equipment Co., Ltd.
No.58, Jin-Peng Road, C Area, Luxian Industrial Park, Luzhou City, Sichuan, China, 646100
Contact Person:
Johnson Van
Sichuan AST Medical Equipment Co., Ltd. No.58, Jin-Peng Road, C Area, Luxian Industrial Park, Luzhou City, Sichuan, China, 646100 Phone: +86-830-8130286 Fax: +86-830-8130262
Date Prepared:
June 2nd, 2018
Proprietary Name:
AST Model MA012 and MS019 Rehab Wheelchair
Common name:
Manual Wheelchair
Classification name:
Mechanical Wheelchair, Class 1
Product Code:
IOR
Regulation Number:
21 CFR 890.3850
Indications for Use
The AST Model MA012 and MS019 Rehab Wheelchairs are to provide mobility to persons limited to a sitting position.
4
The Predicate Device:
This submission indicates the Substantial Equivalence of the AST Model MA012 and MS019 Rehab Wheelchair, with the predicate Invacare Tracer SX5 Manual Wheelchair (Heavy Duty 450lbs) mechanical wheelchair (K162621). MA012 and MS019 have the same intended uses and similar indications, technological characteristics and principles of operation with predicate device.
Device Description
The AST Model MA012 and MS019 Rehab Wheelchair are manual wheelchairs. They have adjustable armrests, and multiple axle position. The casters are 6"/7"/8" PU wheels with height adjustable forks and the rear wheels are 20"/22"/24″*1-3/8″ polyurethane(MA012 and MS019). The wheelchair also has a shear reduction system: by carefully aligning the pivot points of the user, to minimize the sliding down of the user and also minimize the
shear force and pressure against the back. The armrest height can be adjusted from 8" to 12" and it is detachable.
The wheel for MA012 is quick release rear wheel. The AST MS019 Rehab Wheelchair has NO quick release rear wheel;
The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices.
The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
5
Discussions of Non-clinical Tests Performed for Determinations of Substantial equivalence are as follows:
| ISO 7176-1:2014 | Determination of Static Stability |
|---|---|
| ISO 7176-3:2012 | Determination of effectiveness of brakes |
| ISO 7176-5:2008 | Determination of overall dimensions, mass and maneuvering |
| space | |
| ISO 7176-7:1998 | Method of Measurement of Seating and Wheel Dimensions |
| ISO 7176-8:2014 | Requirements and test methods for static, impact and fatigue |
| strengths | |
| ISO 7176-11:2012 | Test dummies |
| ISO 7176-13:1989 | Determination of coefficient of friction of test surfaces |
| ISO 7176-15:1996 | Requirements for Information Disclosure, Documentation and |
| Labeling | |
| ISO 7176-16:2012 | Resistance to ignition of postural support devices |
| ISO 14971:2007 | Medical devices -- Application of risk management to medical |
| devices | |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in |
| vitro cytotoxicity | |
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests for |
| irritation and skin sensitization |
The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
6
Comparison of the Technological Characteristics:
The AST Model MA012 and MS019 Rehab Wheelchair, is substantially equivalent to the Invacare Tracer SX5 Manual Wheelchair (Heavy Duty 350lbs) mechanical wheelchair (K162621). Both products are mechanical designed for use as personal manual mobility aids. Performance characteristics and drive mechanisms are similar and all have the same intended function and use which is to provide mobility to persons limited to a sitting position. Additional, they are all constructed from the same basic materials, have the same basic operational principles or operated by others. The comparison table is as follow:
| Characteristics | | The AST Model
MS019 Rehab
Wheelchair(K18179
5) | The AST Model
MA012 Rehab
Wheelchair(K18179
5) | Invacare Tracer SX5
Manual Wheelchair
mechanical
wheelchair (K162621) |
|------------------------------|--------|------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Indications for Use | | To provide mobility to
persons limited to a
sitting position. | To provide mobility to
persons limited to a
sitting position. | To provide mobility to
persons limited to a
sitting position. |
| Dimension | Length | 1196mm(±1mm) | 1173mm(±1mm) | 828mm(±1mm) |
| | Width | 775mm (±1mm) | 645mm (±1mm) | 762mm(±1mm) |
| | Height | 894mm (±1mm) | 892mm (±1mm) | 889mm(±1mm) |
| Weight | Total | 46 lbs | 38 lbs | 40 lbs |
| Weight Capacity | | 450 lbs | 300 lbs | 250/300 lbs |
| Seat width | | 18"/20"/22"/24" | 16"/18"/20" | 14"-22" |
| Seat height | | 19.8" | 19.7" | 17.5"-19.5" |
| Seat depth | | 18"-20" | 16"-20" | 18"-20" |
| Frame type | | foldable | foldable | foldable |
| Cross-brace
configuration | | 14 · , 16 · , 18 · , 20 · or
22 · | 14 · , 16 · , 18 · , 20 · or
22 · | 14 · , 16 · , 18 · , 20 · or
22 · |
| Back Style | | Fixed | Adjustable | Fixed |
| Anti-tippers | | Optional | Optional | Optional |
| Wheel
construction | | Fixed | Quick release | Fixed |
| Tires | | Front: 6",7",8"
Rear: 20",22",24" | Front: 6",7",8"
Rear: 20",22",24" | Front: 6",7",8"
Rear: 20",22",24" |
| Armrest | | Fixed or
adjustable
height; desk
or full length;
removable | Height Adjustable
desk length
armrest | Fixed or
adjustable
height; desk or
full length;
removable |
| Foot rest | | Optional/ swing away | Optional/ swing away | Optional/ swing away |
| Rear Axle Position | | Multiple | Multiple | Multiple |
| Frame Construction | | Foldable
frame | Foldable
frame | Fixed Frame
(Or foldable) |
| Frame Material | | Steel | Auminum | Steel |
| Safety Feature | | Manual Wheel Lock | Manual Wheel Lock | Manual Wheel Lock |
7
The comparison of the technical details between MA012 and MS019 and its predicate device are summarized in the following:
- a. Dimension: The dimensions of our device and the predicate are similar. And our device conforms to the specific ISO test and that the results are disclosed to the user appropriately, as documented in the ISO standards for disclosure. So there is no deleterious affection of safety and effectiveness about the differences from the dimensions with the predicate device.
- b. Weight: Although the total weight bearing capacity of MA012 and MS019 is heavier than Invacare Tracer SX5 Manual Wheelchair (Heavy Duty 350lbs) mechanical wheelchair (K162621). The device conforms to the specific ISO test and that the results are disclosed to the user appropriately, as documented in the ISO standards for disclosure (Requirements and test methods for static, impact and fatique strengths) test. So there is no deleterious affection of safety and effectiveness about the difference on weight bearing capacity with predicate device.
- ﻥ Both of our devices and the predicate are equipped with PU foam Seat/Backrest Pad, adjustable Headrest and Armrest. Our MA012 AND MS019 is supplied with a standard Elevating Legrest/Footrest, while the predicate device is provided it as an option. The Elevating Legrest/Footrest can provide better strain-relief for legs.
- d. Multiple Rear Axle Position: Both our MA012 AND MS019 and the predicate device are provided with Multiple Rear Axle Positions to allow users to change its seat height to a best fitting position.
- Frame Construction and material: Our MS019 and MA012 devices and the e. predicated device are the same foldable frames.
- Safety Feature: Both of our devices and the predicated device are equipped f. with Manual Wheel Locks to prevent unexpected movement while parking.
The minor differences between MA012 and MS019 and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the MA012 and MS019 is substantially equivalent to the predicate device.
8
Conclusions
According to comparison table, the differences on weight capacity, adjustable back angle and dimensions do not deleteriously affect the safety and effectiveness of the device.
The non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do no raise any new questions of safety or effectiveness.
So based on the design, performance specifications and testing and intended use, The AST Model MA012 and MS019 Rehab Wheelchair, is substantially equivalent to the Invacare Tracer SX5 Manual Wheelchair (Heavy Duty 450lbs) mechanical wheelchair (K162621).