(254 days)
No
The device description details a manual wheelchair with mechanical features. There is no mention of AI, ML, or any computational processing that would suggest the use of such technologies.
No.
The device description and intended use indicate it is for mobility for persons restricted to a sitting position, which is a supportive rather than a therapeutic function.
No
Explanation: The device description and intended use clearly state that this is a manual wheelchair providing mobility, not a device designed to identify or diagnose medical conditions.
No
The device description clearly outlines a physical wheelchair with mechanical components, not a software-only 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 restricted 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 details the physical components of a wheelchair (frame, wheels, seat, etc.) and its mechanical features (tilting, adjusting, braking). There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document explicitly states "Not Found" for mentions of image processing, AI/DNN/ML, input imaging modality, anatomical site, patient age range, intended user/care setting, training/test set descriptions, and key metrics like sensitivity, specificity, etc. These are common elements found in descriptions of IVD devices.
- Performance Studies: The performance studies focus on physical properties like ignitability, stability, brake effectiveness, dimensions, strength, and information disclosure – all relevant to a mechanical mobility device, not an IVD.
- Predicate/Reference Devices: The listed predicate and reference devices are also wheelchairs, further confirming the device's classification as a mobility aid.
In summary, the Pure Tilt™ wheelchair is a medical device, but it falls under the category of a mobility aid, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pure Tilt™ wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The Proactive Comfort Pure Tilt™ wheelchair is an indoor / outdoor manual wheelchair composed of two (2) main components (assemblies): a lower frame assembly and a tilting seat assembly. The lower frame contains two rear wheels, two front casters, two anti-tippers, one pair of brakes and two armrest assemblies. The Seat assembly contains four sub-assemblies; a tilting seat, a leg rest, a backrest and a headrest. The Proactive Comfort Pure Tilt™ possesses the following features:
- A tilting seat with adjusting capability up to 45°; ●
- User-operated seat tilt adjusting mechanism, which is assisted by a mechanical spring piston;
- Hinged, non-detachable armrests that swing upward and toward the back to facilitate ● transfer of a subject into or out of the wheelchair;
- Built-in housing for compatible transfer board;
- Mechanical armrest locks that secure the armrests to be used safely as handles for lifting ● the wheelchair with the user in it;
- Two 21" diameter rear wheels with aluminum hand-rims for self-propelling;
- Two 6" diameter front casters that swivel for easy maneuvering;
- Adjustable seat-to-floor height (2 Settings: 19" and 17"); ●
- Angle-adjustable leg-rest assembly with the following features:
- Foot platform that swings upward to facilitate stowage .
- Telescoping adjustable height .
- User-operated mechanism to adjust leg-position angle, which is assisted by mechanical spring piston;
- Backrest that has adjustable vertical position and that folds 90° forward to facilitate storage and transport; and
- Headrest with adjustable vertical position.
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)
Nonclinical performance data was provided based on the following standards, with all tests passed:
- ISO 8191-1:1987 Attachment 18.1: Assessment of Ignitability of Upholstered Furniture - Smoldering Cigarette
- ISO 8191-2: 1988 Attachment 18.2: Assessment of Ignitability of Upholstered Furniture – Match-Flame Equivalent
- Resna standards: 2009 Version Attachment 18.3:
- Section 1: Determination of Static Stability
- Section 3: Determination of Effectiveness of Brakes
- Section 5: Determination of Dimensions, Mass, and Maneuvering Space
- Section 7: Method of Measurement of Seating and Wheel Dimensions
- Section 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths
- Section 15: Requirements for Information Disclosure, Documentation and Labeling
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.
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/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2016
Proactive Comfort, LLC % EJ Smith President Smith Associates 1468 Harwell Avenue Crofton, MD 21114
Re: K152021
Trade/Device Name: Pure Tilt Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: February 29, 2016 Received: March 1, 2016
Dear Mr. Smith:
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. 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 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 (reporting of
1
medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael J. Hoffmann -A
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) K152021
Device Name Pure Tilt™ wheelchair
Indications for Use (Describe) The Pure Tilt™ wheelchair is intended for medical purposes to provide mobility to persons restricted 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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510(k) Summary
SPONSOR
| Company Name: | Proactive Comfort, LLC |
|---|---|
| Company Address: | 3901 Centerview Drive, Suite L |
| Chantilly, VA 20151 | |
| USA | |
| Telephone: | 703-995-7104 |
| Fax: | 703-834-0039 |
| Contact Person: | Tracy Augustine |
Summary Preparation Date: February 23, 2016
DEVICE NAME
| Trade Name: | Pure Tilt™ |
|---|---|
| Common/Usual Name: | Mechanical Wheelchair |
| Classification Name: | Physical Medicine |
| Regulation Number: | 890.3850 |
| Product Code: | IOR |
| Device Class: | Class I |
PREDICATE DEVICE
| Legally Marketed Equivalent Device | ||
|---|---|---|
| Company | Product | 510(k) # |
| BRODA | 587 Manual Wheelchair | K032133 |
DEVICE DESCRIPTION
The Proactive Comfort Pure Tilt™ wheelchair is an indoor / outdoor manual wheelchair composed of two (2) main components (assemblies): a lower frame assembly and a tilting seat assembly. The lower frame contains two rear wheels, two front casters, two anti-tippers, one pair of brakes and two armrest assemblies. The Seat assembly contains four sub-assemblies; a tilting seat, a leg rest, a backrest and a headrest. The Proactive Comfort Pure Tilt™ possesses the following features:
- A tilting seat with adjusting capability up to 45°; ●
- User-operated seat tilt adjusting mechanism, which is assisted by a mechanical spring ● piston;
- Hinged, non-detachable armrests that swing upward and toward the back to facilitate ● transfer of a subject into or out of the wheelchair;
- Built-in housing for compatible transfer board;
- Mechanical armrest locks that secure the armrests to be used safely as handles for lifting ● the wheelchair with the user in it;
- Two 21" diameter rear wheels with aluminum hand-rims for self-propelling;
- Two 6" diameter front casters that swivel for easy maneuvering;
- Adjustable seat-to-floor height (2 Settings: 19" and 17"); ●
- Angle-adjustable leg-rest assembly with the following features:
- Foot platform that swings upward to facilitate stowage .
- Telescoping adjustable height .
5
- User-operated mechanism to adjust leg-position angle, which is assisted by mechanical . spring piston;
- . Backrest that has adjustable vertical position and that folds 90° forward to facilitate storage and transport; and
- . Headrest with adjustable vertical position.
DEVICE INDICATIONS FOR USE
The Pure Tilt™ wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.
| ITEMS | PROACTIVE
WHEELCHAIR | PREDICATE DEVICE |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| BRAND NAME | Pure Tilt™ | Valentine |
| K number | | K130017 |
| Product Code | IOR | IOR |
| MANUFACTURER | Proactive Comfort, LLC
129 N. West Street,
Easton, MD 21601 | Valentine International Ltd |
| MODEL | Proactive - Pure Tilt™ | Steel Wheelchair model 1000 |
| 510K NO. | | K130017 |
| Indications for Use | The device is intended to
provide mobility to persons that
are unable to ambulate safely or
are restricted to a sitting
position. | The device is intended for medical
purposes to provide mobility to
persons restricted to a sitting
position. |
| OPERATING | To be used on a level surface
Indoor or Outdoor | Indoor/Outdoor Wheelchair |
| TECHNOLOGICAL
CHARACTERISTICS | According to ANSI/RESNA
series standards (Sections 1, 3,
5,7,8 and 15) | According to ISO 7176-1/-3/-5/-7/-
8/-1 1/-13/ - 15/-16 series standards |
| FRAME | | |
| Primary Material | Tubular Aluminum | |
| Overall Height | 35" (889mm) | |
| Overall Width | 30" (762mm) | |
| Seat Width | 16.9" (430mm) | 18" |
| Seat Depth | 17.4" (442mm) | |
| Seat Height | Max: 19" (482mm) Min:
17" (431mm) | 20" |
| Seat Angle | Up to 45° | |
| Cross Brace | Built-in | Yes |
| Backrest Height | 17.6" (447mm) | Un-adjustable / Fixed |
| Backrest Width | 15.4" (391mm) | |
| Reclining Backrest | 13.2° - 52.7° | Fixed |
| Seat Sling | Padded cushion system | Padded nylon |
| Frame Colors | Black | Blue |
| ARMREST | | |
| Arm Pad | Padded | Padded |
| Flip Back | Yes, detachable padding | Yes, detachable |
| Height Adjustable | No | No |
| HANGERS | | |
| Swing-Away | Yes | Yes |
| Elevating Leg Rest | Yes | Yes |
| Articulating Leg Rest | Yes | Yes |
| Footplate Style | Flat, Non-Padded | Padded |
| Heel Loop | No | No |
| Footrest Angle | 18.9° - 90° | 10~15° |
| REAR AXLE | | |
| Offset Axle | Yes | Yes |
| Quick Release Axle | No | Yes |
| Whorl | No | No |
| REAR WHEEL | | |
| Size | 21" (533mm) x 1" (25.4mm) | 24" |
| Tire Type | PU Solid Material | PU Solid Material |
| Handrim Material | Aluminum | Steel Composite |
| CASTERS | | |
| Size | 6" (152mm) | 8" |
| Tire Type | Non-Marking Rubber Tires | PU Solid Material |
| WHEEL LOCK | Push-to-Lock / Manual | Pull-to-Lock / Manual |
| UPHOLSTERY MATERIAL | Vinyl | |
| WEIGHT CAPACITY | 275 lbs / 125 kgs | 250 lbs / 113.5 kgs |
| WEIGHT OF CHAIR | 59.8 lbs (31.7 kgs) w/o
cushions 69.8 lbs (31.7 kgs)
including all cushions | 40 lbs / 18.2 kgs |
| WARRANTY | 12 Months from date of
shipment | 12 Months for Main Parts (The
chair side frames are guaranteed
for 5 years from the date of
purchase) |
| ACCESSORIES | | |
| Anti-tipper | Yes | No |
| Rear Stepper | No | Yes |
| Fold Down Push Handle | No | Yes |
| Safety Belt | No | Optional |
COMPARISON OF TECHNICAL CHARACTERISTICS
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NONCLINICAL PERFORMANCE DATA
| Standard | Test Description | Results |
|---|---|---|
| ISO 8191-1:1987 | ||
| Attachment 18.1 | Assessment of Ignitability of Upholstered Furniture - Smoldering Cigarette | Passed |
| ISO 8191-2: 1988 | ||
| Attachment 18.2 | Assessment of Ignitability of Upholstered Furniture – Match-Flame Equivalent | Passed |
| Resna standards: 2009 Version | ||
| Attachment 18.3 | Section 1: Determination of Static Stability Section 3: Determination of Effectiveness of Brakes Section 5: Determination of Dimensions, Mass, and Maneuvering Space | Passed |
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| • | Section 7: Method of Measurement of
Seating and Wheel Dimensions |
|---|--------------------------------------------------------------------------------------|
| • | Section 8: Requirements and Test Methods
for Static, Impact and Fatigue Strengths |
| • | Section 15: Requirements for Information
Disclosure, Documentation and Labeling |
CONCLUSION
The data submitted in this 5 10(K) Premarket Notification supports the finding that this device (Proactive - Pure Tilt™) is substantially equivalent with respect to the intended use, technology, functionality, and safety features to the legally marketed Predicate Device (BRODA – 587 Manual Wheelchair). Therefore, we believe that this device meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(K) guidelines.