(202 days)
K973673 Zippy TS / TS SE
Not Found
No
The device description and performance studies focus on the mechanical and structural aspects of a pediatric wheelchair, with no mention of AI or ML technologies.
No
The device is a wheelchair intended for mobility, not to treat or prevent a medical condition.
No
Explanation: The device is a pediatric wheelchair designed to provide mobility and positioning assistance for children. It is a mobility aid, not a diagnostic tool.
No
The device description clearly outlines physical components like a frame, wheels, seat, restraints, and footrests, indicating it is a hardware device. The performance studies also focus on physical characteristics and standards related to wheelchair construction and safety.
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 movement and support, not the examination of specimens derived from the human body.
- Device Description: The description details the physical components of a wheelchair (frame, wheels, seat, restraints, etc.) and its adjustability for user comfort and growth. It does not mention any components or processes related to analyzing biological samples.
- Principle of Operation: The principle of operation is described as providing a "stable seat and wheel chassis designed to provide mobility." This is a mechanical principle, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on biological analysis.
In summary, the Element pediatric wheelchair is a medical device designed for mobility and support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Element pediatric 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 Element Pediatric Wheelchair is designed for children who are limited to a seated position and require mobility and positioning assistance. It is intended for individuals less than 21 years old, who weigh less than 185 pounds.
The Element Pediatric Wheelchair consists of a frame and wheels (part number 3101-0000). The frame is powder-coated aluminum and the non-inflatable wheels are polyurethane plastic. The seat back, seat bottom, restraints and armrests are covered in flame retardant nylon fabric. The footrests are powder-coated aluminum. The seat back, seat bottom, armrests, footrests, and restraints are specified by a professional wheelchair fitter. Parameters such as seat width (18-28") and depth (10-22") are changeable over the course of use. This adds adjustability to the wheelchair to meet the needs of growth, postural changes, and level of disability.
Parameters adjustable by manufacturer or distributor include: seat width, seat depth, seat to floor height, wheel size, wheel base distance. Parameters adjustable by user include: back cane height, tilt of chair, foot rest height, and seat back angle (recline).
The Element has a "Transit Option" that is compliant with RESNA WC-19. The Element is foldable for storage or transport.
The Element was designed for firm and smooth surfaces, both indoors and outdoors. It is intended for surfaces with less than 5° slope. A back cane hand grip is provided for an attendant to push.
Principle of Operation: The Leggero Element Pediatric Wheelchair provides a stable seat and wheel chassis designed to provide mobility to persons restricted to a sitting 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
individuals less than 21 years old
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)
Specifically performance tests for the Element followed the standards:
ANSI/RESNA Section 1: Determination of static stability.
ANSI/RESNA Section 5: Determination of dimensions, mass, and maneuvering space
ANSI/RESNA Section 7: Method of measurement of seating and wheel dimensions. ANSI/RESNA Section 8: Requirements and test methods for static, impact and fatigue strengths.
ANSI/RESNA Section 11: Test dummies.
ANSI/RESNA Section 13: Determination of coefficient of friction of test surfaces. ANSI/RESNA Section 22: Set-up procedures.
ANSI/RESNA Section 26: Vocabulary
RESNA WC-2 Section 3: Determination of the effectiveness of brakes
RESNA WC-1 Section 15: Requirements for information disclosure, documentation and labeling
ISO 7176-19 Wheeled mobility devices for use as seats in motor vehicles.
ISO 7176-16 Resistance to ignition of postural support devices
ISO 10993-1 (4th Edition 2009) guided the biocompatibility assessments of the patient and operator contact surfaces.
Comparison of Functional Testing results for the Element compared to the predicate Zippie: Both Element and Zippie were tested to ANSI/RESNA and ISO standards.
Test Results:
Determination of static stability: PASS
Static Impact and fatigue strength: PASS
Determination of Dimensions, mass, turning space: PASS
Determination of safety when used as seat in motor vehicle: PASS
Biocompatibility of contact surfaces: PASS
Both the Element and Zippie were tested to ISO 10993 for biocompatibility. Nonclinical tests demonstrate that the Element is safe, effective and performs as well as the legally marketed device predicate.
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.
K973673 Zippy TS / TS SE
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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April 29, 2019
Leggero LLC % Mike Johnson Consultant Philosopher's River LLC P.O. Box 106 Willow Creek, Montana 59760
Re: K182840
Trade/Device Name: Element Pediatric Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: January 9, 2019 Received: January 29, 2019
Dear Mike Johnson:
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.
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); 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.htm); 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,
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) K182840
Device Name Element Pediatric Wheelchair
Indications for Use (Describe)
The Element pediatric 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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K182840
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 04-24-2019 [21 CFR 807.92(a)(1)].
A. Applicant Name and Address [21 CFR 807.92(a)(1)]
Leggero Ilc
P O Box 485
Burnet, Texas 78611
Tel: 406-551-9443
Fax: 406-551-9370
B. Contact Information
Philosopher's River llc
P O Box 106
Willow Creek, MT 59760
Tel: 406-209-3039
Fax: 406 209-3039
Contact person: Mike Johnson M.D.
mike(@philosophersriver.com
C. Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade Name: Element Pediatric Wheelchair Device Common Name: Wheelchair Classification Name: Wheelchair, Mechanical 21 CFR 890.3850 Product Code: IOR Device Classification: Class I
4
D. Predicate Devices [21 CFR 807.92(a)(3)]
The Element Pediatric Wheelchair uses similar technology and has a similar indication for use as the following predicate devices: Primary predicate K973673 Zippy TS / TS SE
E. Device Description [21 CFR 807.92(a)(4)]
The Element Pediatric Wheelchair is designed for children who are limited to a seated position and require mobility and positioning assistance. It is intended for individuals less than 21 years old, who weigh less than 185 pounds.
The Element Pediatric Wheelchair consists of a frame and wheels (part number 3101-0000). The frame is powder-coated aluminum and the non-inflatable wheels are polyurethane plastic. The seat back, seat bottom, restraints and armrests are covered in flame retardant nylon fabric. The footrests are powder-coated aluminum. The seat back, seat bottom, armrests, footrests, and restraints are specified by a professional wheelchair fitter. Parameters such as seat width (18-28") and depth (10-22") are changeable over the course of use. This adds adjustability to the wheelchair to meet the needs of growth, postural changes, and level of disability.
Parameters adjustable by manufacturer or distributor include: seat width, seat depth, seat to floor height, wheel size, wheel base distance. Parameters adjustable by user include: back cane height, tilt of chair, foot rest height, and seat back angle (recline).
The Element has a "Transit Option" that is compliant with RESNA WC-19. The Element is foldable for storage or transport.
The Element was designed for firm and smooth surfaces, both indoors and outdoors. It is intended for surfaces with less than 5° slope. A back cane hand grip is provided for an attendant to push.
Principle of Operation: The Leggero Element Pediatric Wheelchair provides a stable seat and wheel chassis designed to provide mobility to persons restricted to a sitting position.
F. Device Specifications and Comparison to Predicates [21 CFR 807.92(a)(6)]
The Leggero Element Pediatric Wheelchair is compared to the predicate
- · Primary predicate K973673 Zippy TS / TS SE
The indications for use and classification for the Leggero Element Wheelchair are equivalent to the predicate. Below is a comparison table.
5
| Characteristic | Leggero Element Pediatric
Wheelchair | Sunrise Medical Zippie TS/TS SE |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | "Element" | "Zippie" |
| Applicable
510(k)s | NA | Primary predicate K973673 Zippie TS/TS SE |
| Panel/ | Physical Medicine | Physical Medicine |
| Product Code/
Regulation
Number | IOR
21 CFR 890.3850 | IOR
21 CFR 890.3850 |
| Indications for
Use Statement | The Element pediatric wheelchair is
intended for medical purposes to
provide mobility to persons restricted
to a sitting position. | From K973673 (substantial equivalence is
claimed for only first sentence): Quickie
manual wheelchairs empower physically
challenged persons by providing a means of
mobility. This includes temporary and
permanent conditions in all ages such as:
Arthritis, Amputee, Paraplegic, Cerebral Palsy,
Hemiplegic, Tetraplegic, Quadriplegic, Spina
Bifida, Head Injury or Trauma, Muscular
Dystrophy, Multiple Sclerosis, Polio, Geriatric
Conditions and other Immobilizing or
debilitating condition. |
| Risk
Classification | Class I | Class I |
| Common Name | Wheelchair, Mechanical | Wheelchair, Mechanical |
| Mechanism of
Action | Adjustable seat on wheels, propelled
by attendant. | Adjustable seat on wheels, propelled by
attendant. |
The specifications for the Leggero Element Wheelchair are equivalent to the predicate. Below is a comparison table.
| Characteristic | Leggero Element Pediatric
Wheelchair
"Element" | Sunrise Medical Zippie TS/TS SE
"Zippie" |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Applicable
510(k)s | NA | Primary predicate K973673 Zippie TS/TS SE |
| Transit Option | Yes | Yes |
| Tilt | 45° | 45° |
| Chair Weight | 20, 22 24 lbs for the three models | 29 lbs w/o footrests |
| Weight Capacity
(w/o Seating) | 185 lbs | 165 lbs |
| Overall Width | 18 to 28 inches | 18.25 to 24.25 inches |
| Tubing Diameter | 1 inch | Frame 1 inch
Seat rail 1 inch |
| Frame Seat
Width | 10-20 inches | 10 to 18 inches |
| Seat Depth | 10-22 inches in one inch increments | 13 to 20 inches |
| Seat to Back
Angle Adjustment
(recline) | 90° to 115° | 85° to 120° |
| Seat to Floor
Height | 13 to 20 inches | 15.5 to 20 inches |
| Footrest / Frame
Angle | 70°, 80°, 90° Swing Away | 60°, 70°, 80° Swing Away |
| Back Type | Fixed Height and Height Adjustable | Fixed Height and Height Adjustable |
| Back Cane
(Handle) Height | Fixed Stroller Handles 21-25 inches, 23-27 inches, and 25-29 inches.
Each is adjustable in 1inch increments. | Fixed Stroller Handles 19, 22, 25 inches
Height Adjustable 16 to 22, 19 to 25 inches |
| Center of Gravity
Adjust (Varies
depending on
configuration) | No | No |
| Rear Wheel Sizes
(radius) | 12, 16, 18, 20, 22, 24 inches | 12, 16, 18, 20, 22, 24 inches |
| Caster Sizes | 3 to 8 inches | 3 to 8 inches |
| Warranty | Frame lifetime
Parts 1 year | Frame lifetime
Parts 1 year |
| Maximum Safe
Slope | 5° | 5° |
6
The Leggero Element has similar technological characteristics (design, materials) and indications for use as the predicate Sunrise Medical Zippie.
7
G. Indications for Use [21 CFR 807.92(a)(5)]
The Element pediatric wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.
H. Performance Data [21 CFR 807.92(b)(2)]
Specifically performance tests for the Element followed the standards:
ANSI/RESNA Section 1: Determination of static stability.
ANSI/RESNA Section 5: Determination of dimensions, mass, and maneuvering space
ANSI/RESNA Section 7: Method of measurement of seating and wheel dimensions. ANSI/RESNA Section 8: Requirements and test methods for static, impact and fatigue strengths.
ANSI/RESNA Section 11: Test dummies.
ANSI/RESNA Section 13: Determination of coefficient of friction of test surfaces. ANSI/RESNA Section 22: Set-up procedures.
ANSI/RESNA Section 26: Vocabulary
RESNA WC-2 Section 3: Determination of the effectiveness of brakes
RESNA WC-1 Section 15: Requirements for information disclosure, documentation and labeling
ISO 7176-19 Wheeled mobility devices for use as seats in motor vehicles.
ISO 7176-16 Resistance to ignition of postural support devices
ISO 10993-1 (4th Edition 2009) guided the biocompatibility assessments of the patient and operator contact surfaces.
Comparison of Functional Testing results for the Element compared to the predicate Zippie: Both Element and Zippie were tested to ANSI/RESNA and ISO standards.
| Test | Element |
|---|---|
| Determination of static | |
| stability | PASS |
| Static Impact and fatigue | |
| strength | PASS |
| Determination of | |
| Dimensions, mass, turning | |
| space | PASS |
| Determination of safety | |
| when used as seat in motor | |
| vehicle | PASS |
| Biocompatibility of contact | |
| surfaces | PASS |
Both the Element and Zippie were tested to ISO 10993 for biocompatibility. Nonclinical tests demonstrate that the Element is safe, effective and performs as well as the legally marketed device predicate.
8
I. Conclusion [21 CFR 807.92(b)(3)]
The Leggero Element Pediatric Wheelchair is substantially equivalent to the predicate devices, the Sunrise Medical Zippie; in terms of technology, function and indications for use. There are no new questions of safety or efficacy raised by the introduction of the Leggero Element Pediatric Wheelchair.