(203 days)
Not Found
No
The device description and performance studies indicate a purely mechanical wheelchair with no mention of AI or ML capabilities.
No.
The device's intended use is to provide mobility, not to treat or prevent a disease or condition.
No
Explanation: The device is a manual wheelchair intended for mobility, not for diagnosing medical conditions or diseases.
No
The device description clearly states it is a "mechanical wheelchair" and describes physical components like a "solid seating surface (seat pan)". This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to adults limited to a sitting position. This is a mechanical function related to physical support and movement, not the examination of specimens derived from the human body.
- Device Description: The description clearly states it's a "mechanical wheelchair" and describes its physical characteristics and function (providing mobility).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases or conditions. This wheelchair does not perform any such function.
N/A
Intended Use / Indications for Use
The Invacare® Solara® 3G Manual Wheelchair and Invacare® Solara® 3G Spree Manual Wheelchair are intended to provide mobility to adults limited to a sitting position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The Invacare® Solara® 3G Manual Wheelchair is an attendant operated and self-propelled, mechanical wheelchair for adults. The indication for use of the Invacare® Solara® 3G Manual Wheelchair is to provide mobility to adults limited to a sitting position. The indication for use of the Invacare® Solara® 3G Spree Manual Wheelchair is to provide mobility to person limited to a sitting position. These devices are rigid, "non-folding" type wheelchairs that incorporate a solid seating surface (seat pan).
Below is the subject devices weight capacity:
- Invacare® Solara® 3G Manual Wheelchair weight capacity is 300 lbs. .
- Invacare® Solara® 3G Manual Wheelchair with Heavy Duty weight capacity is 400 . lbs.
Invacare® Solara® 3G Spree Manual Wheelchair weight capacity is 200 lbs. . Invacare® Solara® 3G and Invacare® Solara® 3G Spree Manual Wheelchair include a "Tilt in Space" feature which allows the seat and back of the wheelchair to be tilted backward. This feature is used for those patients who require a tilt feature for stability, comfort or head control. It also serves as an attendant aid in those situations where the patient needs to be fed or receive care. Both predicate devices include the "Tilt in Space" feature.
Both subject devices include a Low Shear Recline which was developed to reduce the amount of shear experienced by the user versus the single-pivot recline system incorporated into the predicate devices.
The associated model and accessories include:
- . Invacare® Solara® 3G Manual Wheelchair o weight capacity is 300 lbs.
- . Invacare® Solara® 3G Manual Wheelchair with Heavy Duty
- o weight capacity is 400 lbs.
- Invacare® Solara® 3G Spree Manual Wheelchair ●
- o weight capacity is 200 lbs.
- . Stealth™ Headrest
- . Matrx™ Cushions
- Straps (seat, hook and loop, airline buckle)
- . Loops (Heal, Toe)
- . Anti-Tippers
- . Telescoping Rod
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
Adults
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 Test per 21 CFR 807.92(b)(1)
Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) testing was performed to demonstrate that the subject device meets the performance requirements and is substantially equivalent to the predicate devices identified throughout this submission.
The following testing was performed:
- . ANSI/RESNA WC-1:2009 Section 1: Determination of Static Stability
- ANSI/RESNA WC-1:2009 Section 3: Determination of Effectiveness of Brakes
- ANSI/RESNA WC-1:2009 Section 5: Determination of Dimensions, Mass . and Maneuvering Space
- ANSI/RESNA WC-1:2009 Section 7: Method of Measurement of Seating and . Wheel Dimensions
- ANSI/RESNA WC-1:2009 Section 8: Requirements and Test Methods for Static, . Impact and Fatigue Strengths
- ANSI/RESNA WC-1 :2009 Section 15: Requirements for Information . Disclosure, Documentation and Labeling
- ANSI/RESNA WC-1:2009 Section 13: Determination of Coefficient of . Friction of Test Surfaces
- ANSI/RESNA WC-1:2009 Section 11: Test Dummies .
- CAL 117:2013, Section 1: Flammability Test
- · ISO 8191-1:1987 & 8191-2:1988: Flammability Testing
Design Verification Testing demonstrated that the subject Invacare® Solara® 3G Manual Wheelchair with weight capacities of 300 and 400 lbs. and Invacare® Solara® 3G Spree Manual Wheelchair with capacity of 200 lbs. are substantially equivalent to the marketed predicate devices.
Biocompatibility Testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95 – 1 "Use of International Standard ISO – 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993 – 1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- . AAMI / ANSI / ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 5: Tests for in vitro Cytotoxicity
- AAMI / ANSI / ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: . Tests for Skin Irritation
Risk Management
Risk Management has been conducted in accordance with ISO 14971:2012 - Medical Devices -Application of Risk Management to Medical Devices" for the subject Invacare® Solara® 3G Manual Wheelchair with weight capacities of 300 and 400 lbs. and Invacare® Solara® 3G Spree Manual Wheelchair with capacity of 200 lbs. The Category Hazard Analysis (CHA) provides guidance on the principal factors to consider in conducting a risk-based assessment to determine the Device Hazard Analysis (DHA) of the subject device's risk profile. The risk assessment Device Hazard Analysis (DHA)involves describing the relationships between a hazard (a potential source of harm) and the ultimate consequences in terms of physical injury or damage. Based on the risk-based assessment Device Hazard Analysis (DHA) performed, the subject device's risk profile remained unchanged and there is no significant impact on the safety or effectiveness of the subject 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
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November 14, 2018
Invacare Corporation Elijah Wreh Regulatory Affairs Manager One Invacare Way Elyria, Ohio 44035
Re: K181090
Trade/Device Name: Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: August 13, 2018 Received: August 16, 2018
Dear Elijah Wreh:
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. 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.
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
1
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); 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 L. 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) K181090
Device Name
Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs
Indications for Use (Describe)
The Invacare® Solara® 3G Manual Wheelchair and Invacare® Solara® 3G Spree Manual Wheelchair are intended to provide mobility to adults 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
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Yes, you can:
510(k) Summary - K181090
SUBMITTER per 21 CFR 807.92(a)(1)
Invacare Corporation One Invacare Way Elyria, OH 44035
| PRIMARY CONTACT
PERSON: | Elijah Wreh
Regulatory Affairs Manager
Phone: (440) 329-6840
Email: ewreh@invacare.com |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| SECONDARY CONTACT
PERSON: | Kevin Malinowski
Senior Quality Engineer
Phone: (440) 329-6179
Email: kmalinowski@invacare.com |
| MANUFACTURER: | INVAMEX S.DE R.L. DE C.V.
Avenida El Puente S/N
Parque Industrial El Puente Manimex
Reynosa Tamaulipas, Mexico C.P. 88783 |
Date Prepared per 21 CFR 807.92(a)(1)
November 14, 2018
DEVICE INFORMATION per 21 CFR 807.92(a)(2)
Name of Device: Common or Usual Name: Regulation Description: Regulation Number: Review Panel: Device Class: Product Code:
Solara® 3G and Solara® 3G Spree Manual Wheelchairs Wheelchair, Mechanical Mechanical Wheelchair 21 CFR §890.3850 Physical Medicine 1 IOR
4
PRIMARY PREDICATE Invacare® Solara® Manual Wheelchairs (K984447) DEVICE:
SECONDARY PREDICATE Invacare® Solara® Jr. Manual Wheelchairs (K012370) DEVICE:
DEVICE DESCRIPTION per 21 CFR 808.92(a)(4)
The Invacare® Solara® 3G Manual Wheelchair is an attendant operated and self-propelled, mechanical wheelchair for adults. The indication for use of the Invacare® Solara® 3G Manual Wheelchair is to provide mobility to adults limited to a sitting position. The indication for use of the Invacare® Solara® 3G Spree Manual Wheelchair is to provide mobility to person limited to a sitting position. These devices are rigid, "non-folding" type wheelchairs that incorporate a solid seating surface (seat pan).
Below is the subject devices weight capacity:
- Invacare® Solara® 3G Manual Wheelchair weight capacity is 300 lbs. .
- Invacare® Solara® 3G Manual Wheelchair with Heavy Duty weight capacity is 400 . lbs.
Invacare® Solara® 3G Spree Manual Wheelchair weight capacity is 200 lbs. . Invacare® Solara® 3G and Invacare® Solara® 3G Spree Manual Wheelchair include a "Tilt in Space" feature which allows the seat and back of the wheelchair to be tilted backward. This feature is used for those patients who require a tilt feature for stability, comfort or head control. It also serves as an attendant aid in those situations where the patient needs to be fed or receive care. Both predicate devices include the "Tilt in Space" feature.
Both subject devices include a Low Shear Recline which was developed to reduce the amount of shear experienced by the user versus the single-pivot recline system incorporated into the predicate devices.
The associated model and accessories include:
- . Invacare® Solara® 3G Manual Wheelchair o weight capacity is 300 lbs.
- . Invacare® Solara® 3G Manual Wheelchair with Heavy Duty
- o weight capacity is 400 lbs.
- Invacare® Solara® 3G Spree Manual Wheelchair ●
- o weight capacity is 200 lbs.
5
- . Stealth™ Headrest
- . Matrx™ Cushions
- Straps (seat, hook and loop, airline buckle)
- . Loops (Heal, Toe)
- . Anti-Tippers
- . Telescoping Rod
INTENDED USE per 21 CFR 807.92(A)(5)
The Invacare® Solara® 3G Manual Wheelchair is intended to provide mobility to persons limited to a sitting position.
INDICATIONS FOR USE per FORM FDA 3881
The Invacare® Solara® 3G Manual Wheelchair and Invacare® Solara® 3G Spree Manual Wheelchair are intended to provide mobility to adults limited to a sitting position.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES per 21 CFR 807.92(a)(6)
The device comparison showed that the subject device is substantially equivalent in intended use, design and operational principles to the previously Invacare® Solara® Jr. Manual Wheelchairs (K012370) and Invacare® Solara® Manual Wheelchairs (K984447). The subject device is substantially equivalent to the predicate devices regarding intended use, design, materials, and operational principles to provide mobility to persons limited to a sitting position.
BASIS OF SUBSTANTIAL EQUIVALENCE per 21 CFR 807.100(b)(2)(ii)(A)
The substantial equivalence of the subject device was determined as per the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" and the technological characteristics which include materials, design, energy source, and other device features, as defined in section 513(i)(1)(B) of the FD&C Act and 21 CFR 807.100(b)(2)(ii)(A).
The subject device components are as safe and effective as the predicate devices and do not raise different questions of safety and effectiveness.
The major frame components for the subject Invacare® Solara® 3G and Invacare® Solara® 3G Spree Manual Wheelchair and the previously cleared Invacare® Solara® Jr. Manual
6
Wheelchairs (K012370) and Invacare® Solara® Manual Wheelchairs (K984447) are the same. The data generated from the subject device test report supports a finding of substantial equivalence regarding the device comparison, dimensional analysis, device specifications, design characteristics and to provide mobility to persons limited to a sitting position. The difference in weight capacity between the subject Invacare® Solara® 3G and Invacare® Solara® 3G Spree Manual Wheelchair and the previously cleared Invacare® Solara® Jr. Manual Wheelchairs (K012370) and Invacare® Solara® Manual Wheelchairs (K984447) do not raise new issues of safety or effectiveness.
7
Design Comparison – Invacare® Solara® 3G Manual Wheelchair with 300 lbs Weight Capacity
| Device | Invacare® Solara® 3G Manual Wheelchair | Invacare® Solara® Manual Wheelchairs |
|---|---|---|
| 510(k) Number | Subject Device | |
| Pending Submission | Predicate Device | |
| (K984447) | ||
| Intended Use | The Invacare® Solara® 3G Manual Wheelchair is intended to provide | |
| mobility to persons limited to a sitting position. | Intended to provide mobility to persons limited to a sitting position. | |
| Indications for Use | The Invacare® Solara® 3G Manual Wheelchair and Invacare® Solara® 3G | |
| Spree Manual Wheelchair are intended to provide mobility to adults limited | ||
| to a sitting position. | To provide mobility to adults limited to a sitting position | |
| Design | ||
| Weight Limit | 300 lbs. | 250 lbs. |
| 300 lbs. (With Heavy Duty Package) | ||
| Seat Width | 12"-24" | 14"-20" |
| Seat Depth | 12"-22" | 14"-18" |
| Back Style | Standard Back Cane | |
| 1Low Sheer Recline (not available on 400 lbs. weight limit wheelchair) | Standard Back Cane | |
| Back Height | 17"-20" Adjustable: 20" or 24" fixed. | 20" and 24" |
| Anti-Tippers | Standard | Standard |
| Arm Types | Full Adjustable Height, Desk Cantilever | Full Adjustable Height, Desk Cantilever |
| Wheel Locks | Push-to-Lock (Standard) or Pull-to-Lock, Foot lock | Push-to-Lock (Standard) |
| Turning Radius | 25" | 25" |
| Rear Wheel Sizes | 12"-24" | 12"-22" |
| Front riggings | Swing away | Swing away |
| Product Weight | 34.5 lbs. without accessories | 50 lbs. |
| Tilt Range (Tilt in Space Feature) | -5° to 50° | -5° to 50° |
| Tilt-in-Space | Dual Cable Trigger Mechanism or Foot Pedal Mechanism (Standard) | Dual Cable Trigger Mechanism |
1 Note: The Low Shear Recline is designed to reace the anom of shear experienced by the user versus the system incorporated into the predicate device. The Low Sheur Recline for similar construction as the single point recline design incorporated into both predicate devices, brase, bras, locking gas cylinders and nutbolt feature is operated by two triggers that enggedissenge the locking cylinders wa adjustable ables. This is the same operating neckanism as wed in the predicate devices. Design Verfication testing demonstrates that the fective ind found to be substantially equivalent to the predicate devices throughout this 510(k) submission.
8
Design Comparison - Invacare® Solara® 3G Manual Wheelchair 400 lbs Weight Capacity
| Device | Invacare® Solara® 3G Manual Wheelchair | Invacare® Solara® Manual Wheelchairs |
|---|---|---|
| 510(k) Number | Subject Device | |
| Pending Submission | Predicate Device | |
| (K984447) | ||
| Intended Use | The Invacare® Solara® 3G Manual Wheelchair is intended to provide | |
| mobility to persons limited to a sitting position. | Intended to provide mobility to persons limited to a sitting position. | |
| Indications for Use | The Invacare® Solara® 3G Manual Wheelchair and Invacare® Solara® 3G | |
| Spree Manual Wheelchair are intended to provide mobility to adults limited | ||
| to a sitting position. | To provide mobility to adults limited to a sitting position | |
| Design | ||
| Weight Limit | 1400 lbs. (With Heavy Duty Package) | 250 lbs. |
| 300 lbs. (With Heavy Duty Package) | ||
| Seat Width | 12"-24" | 14"-20" |
| Seat Depth | 12"-22" | 14"-18" |
| Back Style | Standard Back Cane | |
| 2Low Sheer Recline (not available on 400 lbs. weight limit wheelchair) | Standard Back Cane | |
| Back Height | 17"-20" Adjustable: 20" or 24" fixed. | 20" and 24" |
| Anti-Tippers | Standard | Standard |
| Arm Types | Full Adjustable Height, Desk Cantilever | Full Adjustable Height, Desk Cantilever |
| Wheel Locks | Push-to-Lock (Standard) or Pull-to-Lock, Foot lock | Push-to-Lock (Standard) |
| Turning Radius | 25" | 25" |
| Rear Wheel Sizes | 12"-24" | 12"-22" |
| Front riggings | Swing away | Swing away |
| Product Weight | 34.5 lbs. without accessories | 50 lbs. |
| Tilt Range (Tilt in Space Feature) | -5° to 50° | -5° to 50° |
| Tilt-in-Space | Dual Cable Trigger Mechanism or Foot Pedal Mechanism (Standard) | Dual Cable Trigger Mechanism |
' Note: Invacare® Solara® 3G Manual Wheelcht copacity components and accessories are substantially equivalent to the predicate device itentified throughout this submission based on the technological che includes materials, design, operational principles, and neckanical properties per 21 CFR 807.100(b)(2)(ii).). The basic opentional principe device as well as the is to provide mobility to persons linited to a sitting position. Design Verfication testing according to ANSINESNA device components and accessories are substantially equivalent to the predicated over regarding static stubility, effectiveness of brakes, dimensivering space, neasurement of secting and wheel dimensions, static inpact and fairger strences of ficion, information and abeling. The subject device's risk profile remains unchanged and the ligher weight appacity as and raise different questions of safety and effectiveness.
4 Note: The Low Shear Recline for anount of thear experienced by the user versus the single-pivot recline system incorporated into the predicate device. The Low Shear Recline is of sinilar construction as the signing recined into both predicate devices (seel uling, steel plant, locking as cylinders and nutbolt feature is operated by two triggers that enggeddissenges the locking cylinders wa adjustable. This is the same operating mechanism as wed in the single of the predicate devices. Design Verfication testing demonstrates that the fective in 1 found to be substantially equivalent to the predicate devices throughout this 510(k) submission.
9
| Device | Invacare® Solara® 3G Spree Manual Wheelchair | Invacare® Solara® Jr. Manual Wheelchairs |
|---|---|---|
| 510(k) Number | Subject Device | |
| Pending Submission | Predicate Device | |
| (K012370) | ||
| Intended Use | The Invacare® Solara® 3G Manual Wheelchair is intended to provide | |
| mobility to persons limited to a sitting position. | To provide mobility to adults limited to a sitting position. | |
| Indications for Use | The Invacare® Solara® 3G Manual Wheelchair and Invacare® Solara® 3G | |
| Spree Manual Wheelchair are intended to provide mobility to adults limited | ||
| to a sitting position. | Persons who may be restricted to a sitting position. | |
| Design | ||
| Weight Limit | 1200 lbs. | 150 lbs. |
| Seat Width | 12"-18" | 10"-16" |
| Seat Depth | 12"-19" | 12"-18" |
| Back Style | Standard Back Cane | |
| 2Low Sheer Recline | Standard Back Cane | |
| Recliner and Adjustable Angle | ||
| Back Height | 17"-20" Adjustable | |
| 20" and 24" 3Fixed | 20" or 24" | |
| Adjustable | ||
| Arm Types | Full Adjustable Height, Desk Cantilever | Full Adjustable Height, Desk Cantilever |
| Rear Wheel Sizes | 12"-24" | 12"-22" |
| Front Riggings | Swing away | Swing away |
| Product Weight | 32 lbs. without accessories | 27.5 lbs. |
| Tilt Range (Tilt in Space Feature) | -5° to 50° | -5° to 50° |
Design Comparison - Invacare® Solara® 3G Spree Manual Wheelchair with 200 lbs Weight Capacity
- Note: Imacare® Solara® 3G Manual Wheelchar 2001 s weight components and accessories are substantially equivalent o the predicate device itentified throughout this submission based on the technistics which includes naterials, design, qperational principles, and nechanical proveties per CFR 807.100(b)(2)(ii).A). The basic overtional prices as vell as the subject devices is to provide no a sitting position. Design Verfication testing according to ANSIPESMA demonstrates that the components and accessories are substantially equivalent to the prearling static stability, effectivenes of brakes, and manewering space, neasurement of secting and wheel dimensions, static inpact and fairger strences of cofficient of ficion, information and abeling. The subject device's risk profile remains underged and the higher weight appear one not not not not not not not not not not not not not not n of safety and effectiveness.
4 Note: The Low Shear Recline for anount of thear experienced by the user versus the single-pivot recline system incorporated into the predicate device. The Low Shear Recline is of sinilar construction as the sign incryporated into both predicate clevices (steel tubing, steel plans, locking gas cylinders and nutbolt feature is operated by two triggers that enggeddissnage the locking cylinders via adjustable. This is the same operating mechanism as used in the predicate devices. Design Verfication testing demonstrates that the feature is safe and effective and found to be substantially equivalent to the predicate devices throughout these 510(k) submissions.
1 Note: The subject device fixed back height is similate back height because the fixed back height was the norst-case seencrio used for the testing. The Design Verification testing device fixed back height met the requirements acceptance criteria and do not raise diferent questions of safet and effectiveness. The only difference between the fixed back height is that the adjustable back height has the ability to increase the leight of the back cane.
10
PERFORMANCE DATA
Non-Clinical Test per 21 CFR 807.92(b)(1)
Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) testing was performed to demonstrate that the subject device meets the performance requirements and is substantially equivalent to the predicate devices identified throughout this submission.
The following testing was performed:
- . ANSI/RESNA WC-1:2009 Section 1: Determination of Static Stability
- ANSI/RESNA WC-1:2009 Section 3: Determination of Effectiveness of Brakes
- ANSI/RESNA WC-1:2009 Section 5: Determination of Dimensions, Mass . and Maneuvering Space
- ANSI/RESNA WC-1:2009 Section 7: Method of Measurement of Seating and . Wheel Dimensions
- ANSI/RESNA WC-1:2009 Section 8: Requirements and Test Methods for Static, . Impact and Fatigue Strengths
- ANSI/RESNA WC-1 :2009 Section 15: Requirements for Information . Disclosure, Documentation and Labeling
- ANSI/RESNA WC-1:2009 Section 13: Determination of Coefficient of . Friction of Test Surfaces
- ANSI/RESNA WC-1:2009 Section 11: Test Dummies .
- CAL 117:2013, Section 1: Flammability Test
- · ISO 8191-1:1987 & 8191-2:1988: Flammability Testing
Design Verification Testing demonstrated that the subject Invacare® Solara® 3G Manual Wheelchair with weight capacities of 300 and 400 lbs. and Invacare® Solara® 3G Spree Manual Wheelchair with capacity of 200 lbs. are substantially equivalent to the marketed predicate devices.
Biocompatibility Testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95 – 1 "Use of International Standard ISO – 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993 – 1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
11
- . AAMI / ANSI / ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 5: Tests for in vitro Cytotoxicity
- AAMI / ANSI / ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: . Tests for Skin Irritation
Risk Management
Risk Management has been conducted in accordance with ISO 14971:2012 - Medical Devices -Application of Risk Management to Medical Devices" for the subject Invacare® Solara® 3G Manual Wheelchair with weight capacities of 300 and 400 lbs. and Invacare® Solara® 3G Spree Manual Wheelchair with capacity of 200 lbs. The Category Hazard Analysis (CHA) provides guidance on the principal factors to consider in conducting a risk-based assessment to determine the Device Hazard Analysis (DHA) of the subject device's risk profile. The risk assessment Device Hazard Analysis (DHA)involves describing the relationships between a hazard (a potential source of harm) and the ultimate consequences in terms of physical injury or damage. Based on the risk-based assessment Device Hazard Analysis (DHA) performed, the subject device's risk profile remained unchanged and there is no significant impact on the safety or effectiveness of the subject device.
Animal Study
Animal testing was not required for this submission.
Clinical Testing
Clinical testing was not required for this submission.
CONCLUSIONS per 21 CFR 807.92(b)(3)
The subject device has the same intended use and similar technological characteristics as the predicate devices. The performance testing, device comparison, and dimensional analysis demonstrates that the subject device components are substantially equivalent to the predicate devices regarding static stability, effectiveness of brakes, dimensions, mass and maneuvering space, measurement of seating and wheel dimensions, static impact and fatigue strength, coefficient of friction, information disclosures, documentation and labeling. The non-clinical laboratory data support the safety and performance of the subject device and demonstrate that the subject device should perform as intended in the specified use conditions.