(344 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML terms or functionalities.
No.
The device is a manual wheelchair intended for mobility, not to cure, treat, or prevent a disease or condition.
No
This device is a mechanical wheelchair, which is a mobility aid, not a diagnostic tool. Its intended use is to provide mobility.
No
The device description clearly outlines a physical, mechanical wheelchair constructed from materials like chrome-molly steel, carbon fiber, rubber, and polymer. The performance studies also focus on physical and mechanical testing of the wheelchair's components and overall performance. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide mobility to persons that have the capability of operating a mechanical wheelchair." This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details the physical components of a wheelchair (frame, wheels, seat, etc.). There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The information provided clearly describes a mechanical mobility aid, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Panthera mechanical wheelchairs are manually operated multifunctional wheelchairs designed for indoor / outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
Panthera mechanical wheelchairs are of a spoke and hub design and made of chrome-molly steel to construct the chassis (frame and back rest), except for the X model which uses carbon fiber reinforced composite (CFRC) instead of chrome-molly steel. All Panthera mechanical wheelchairs have rubber tires, while the casters are of a semi-solid polymer-based design. The seat cushions and backs are made from flame retardant polyurethane coated polyester fabric, over a foam core. The primary differences in the models of wheelchairs are in their dimensions, gross weight carrying capacities, adjustability features, wheels, accessories and hardware options.
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)
To demonstrate substantial equivalence of the subject Bambino 3, S3, S3 Swing, U3, U3 Light and X model wheelchairs to the predicate Bambino, S2, S2 Swing, U2 and U2 wheelchairs, Panthera submitted their devices for the following non-clinical tests. Results confirm that the design inputs and performance specifications for the modified subject devices have been met.
- Biocompatibility testing per: ISO 10993-1
- Cytotoxicity testing per: ISO 10993-5
- Chemical Characterization testing per: ISO 10993-18
- Toxicological Risk Assessment per: ISO 10993-17
- Wheelchair Performance Testing per:
- ISO 7176-16, Resistance to Ignition of Postural Support Devices
- EN 12183, Manual Wheelchairs. Requirements and Test Methods (equivalent to):
- ISO 7176-1 (static stability)
- ISO 7176-3 (brakes)
- ISO 7176-8 (static, impact and fatigue strengths)
- ISO 7176-11 (test dummies)
- ISO 7176-15 (information, documentation and labeling)
- ISO 7176-19 (crash)
- ISO 7176-22 (Set-up procedures)
Panthera also performed the following internal quality control measures during the design, development and manufacturing of their Bambino 3, S3, S3 Swing, U3, U3 Light and X wheelchairs:
- Compliance with the following FDA guidance document: Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles
- Compliance with 21 CFR Part 820 Quality System Regulation (including Design Controls)
- Compliance with 21 CFR Part 801 Labeling
- Compliance with 21 CFR Part 830 Unique Device Identification
- Dimensional Verification per: Panther internal specifications
- Risk Analysis (FMEA) per: ISO 14971, Medical Devices Application of Risk Management to Medical Devices
In conclusion, the performance of the subject devices met the non-clinical bench testing and demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate devices, and therefore support substantial equivalence to them.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
February 16, 2023
Panthera AB % Stuart Goldman Sr. Consultant RA/QA Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K220698
Trade/Device Name: Bambino 3, S3 and S3 Swing, U3 and U3 Light, X Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: July 7, 2022 Received: July 11, 2022
Dear Stuart Goldman:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Julia E. Slocomb -S Julia E. 2023.02.16 15:08:16 Slocomb -S -05'00'
for Tushar Bansal, PhD
Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220698
Device Name Bambino 3, S3, S3 Swing, U3, U3 Light and X
Indications for Use (Describe)
Panthera mechanical wheelchairs are manually operated multifunctional wheelchairs designed for indoor / outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary Panthera Mechanical Wheelchairs (Bambino 3, S3, S3 Swing, U3, U3 Light and X)
1. Submission Sponsor
Panthera AB Gunnebogatan 26 SE-163 53 Spanga Stockholm, Sweden +46-8-7615040-73869 Fredrik Skantz, VP/General Manager
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746, USA +1.512.327.9997 Stuart R. Goldman, Sr. Consultant, RA/QA
3. Date Prepared
February 15, 2023
4. Device Identification
| Trade/Proprietary Name: | Bambino 3, S3, S3 Swing, U3, U3 Light and X |
|---|---|
| Common/Usual Name: | Wheelchair |
| Classification Name: | Mechanical wheelchair |
| Regulation Number: | 890.3850 |
| Product Code: | IOR |
| Class: | 1 |
| Classification Panel: | Physical Medicine |
5. Legally Marketed Predicate Device
| Device name: | Bambino, S2, S2 Swing, U2, U2 Light |
|---|---|
| 510(k) number: | K083231 |
| Manufacturer: | Panthera AB |
The subject devices are modified versions of the predicate devices have not been subject to a design related recall. The following reference device is also included in this submission:
4
| Trade Name: | APEX Manual Wheelchair |
|---|---|
| 510(k) No.: | K161425 |
| Manufacturer: | Motion Composites |
6. Indication for Use
Panthera mechanical wheelchairs are manually operated multifunctional wheelchairs designed for indoor / outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair.
Device Description 7.
Panthera mechanical wheelchairs are of a spoke and hub design and made of chrome-molly steel to construct the chassis (frame and back rest), except for the X model which uses carbon fiber reinforced composite (CFRC) instead of chrome-molly steel. All Panthera mechanical wheelchairs have rubber tires, while the casters are of a semi-solid polymer-based design. The seat cushions and backs are made from flame retardant polyurethane coated polyester fabric, over a foam core. The primary differences in the models of wheelchairs are in their dimensions, gross weight carrying capacities, adjustability features, wheels, accessories and hardware options.
8. Device Modifications
The minor modifications made to the predicate Bambino, S2, S2 Swing, U2 and U2 Light model wheelchairs to create the subject Bambino 3, S3, S3 Swing, U3 and U3 Light model wheelchairs are primarily related to dimensional changes, as well as minor modifications to some of the components and accessories used on the wheelchairs. These modifications were undertaken in order to make these devices more modular in their design, construction and features than the predicate devices. In addition, the X model wheelchair was added as a product line extension of the U2 Light model, as the X model uses CFRC instead of chrome-molly steel to construct the frame chassis.
g. Substantial Equivalence Discussion
The following tables compare the modified subject devices to the unmodified predicate devices with respect to their intended uses, indications for use and technological characteristics and forms the basis for the determination of substantial equivalence. The subject devices do not raise any new questions of safety or effectiveness compared to the predicate devices.
| Attributes | Predicate Devices
(K083231) | Subject Devices | Comparison |
|--------------|----------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------|
| Manufacturer | Panthera AB | Panthera AB | Same |
| Models | Bambino, S2, S2 Swing, U2, U2
Light | Bambino 3, S3, S3 Swing, U3, U3
Light and X | Equivalent. Model X is
a product line
extension of the U2
light model. |
| Table 5-1 - Comparison of Characteristics of Panthera Subject and Predicate Devices | |
|---|---|
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| Attributes | Predicate Devices
(K083231) | Subject Devices | Comparison |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Provide mobility to persons
restricted to a sitting position. | Provide mobility to persons
restricted to a sitting position. | Same |
| Indications for
Use | Panthera mechanical wheelchairs
are manually operated
multifunctional wheelchairs
designed for indoor / outdoor use
and intended to provide mobility
to persons that have the capability
of operating a mechanical
wheelchair. | Panthera mechanical wheelchairs
are manually operated
multifunctional wheelchairs
designed for indoor / outdoor use
and intended to provide mobility
to persons that have the capability
of operating a mechanical
wheelchair. | Same |
| Mode of
Operation | User propelled, manual,
mechanical wheelchair. | User propelled, manual,
mechanical wheelchair. | Same |
| Models
Bambino (G356) vs. Bambino 3 (G517) | | | |
| Frame Width
(cm) | 52-61 | 55-64 | Similar |
| Seat Depth
(cm) | 23-30 | 25-30 | Similar |
| Back Rest
Angle (°) | 12-(-7.7) | 11.5-(-7.5) | Similar |
| Back Rest
Height (cm) | 17-25 (standard)
27-35 (optional) | 20-28 (standard)
27-35 (optional) | Similar
Same |
| Footrest Angle
(°) | 103 | 100 | Similar |
| Footrest Width
(cm) | 29.5-38.5 | 32.5-38.5 | Similar |
| Total Weight
(kg) | 8.1-8.8 | 9.8-10.4 | Similar |
| Castors
(inches) | 5 | 4.73 | Similar |
| Models
S2 (G348) vs. S3 (G548) | | | |
| Back Rest
Angle (°) | 11.5-(-7.3) | 17.3-(-5) | Similar |
| Footrest Width
(cm) | 46-64 | 46-63 | Similar |
| Total Weight
(kg) | 8.3-8.8 | 8.2-8.8 | Similar |
| Attributes | Predicate Devices
(K083231) | Subject Devices | Comparison |
| Castors
(inches) | 5 | 4.73 | Similar |
| Models
S2 Swing (G347) vs. S3 Swing (G547) | | | |
| Total Height
(cm) | 64-84 | 93 | Similar |
| Back Rest
Angle (°) | 7-(8.5) | 13.3-(-12) | Similar |
| Frame Width
(cm) | 57/60/63/66 | 57/60/63/66/71 | Similar |
| Seat Width
(cm) | 36/39/42/45 | 36/39/42/45/50 | Similar |
| Footrest Width
(cm) | 49-59 | 49-63 | Similar |
| Total Weight
(kg) | 9.6-10.0 | 9.4-10.3 | Similar |
| Castors
(inches) | 5 | 4.73 | Similar |
| Models
U2 (G351) vs. U3 (G551) | | | |
| Total Length
(cm) | 84.5 | 84 | Similar |
| Back Rest
Angle (°) | 11.5-(-7.3) | 17.3-(-5) | Similar |
| Total Weight
(kg) | 8.2-8.7 | 8.0-8.5 | Similar |
| Castors
(inches) | 3 | 3.54 | Similar |
| Models
U2 Light (G346) vs. U3 Light (G557) | | | |
| Back Rest
Height (cm) | 22-35 | 25-35 | Similar |
| Footrest Angle
(°) | 100 | 100 | Same |
| Total Weight
(kg) | 6.8-7.2 | 6.0-6.2 | Similar |
| Castors
(inches) | 3 | 2.95 | Similar |
| Attributes | Predicate Devices
(K083231) | Subject Devices | Comparison |
| Models
U2 Light (G346) vs. X (G350) | | | |
| Frame
Material | Chrome-molly chassis | CFRC | Different. CFRC is also
used to construct the
frame of the reference
device (K161425). |
| Total Weight
(kg) | 6.8-7.2 | 4.4-4.6 | Different. The
reference device
(K161425) has a similar
weight (4.9 kg with
wheels and 4.2 kg
without wheels) to the
X model subject device
as a result of its CFRC
chassis. |
| Safety and
Performance
Testing | Biocompatibility per ISO 10993-1. Requirements and Test Methods of Manual Wheelchairs per EN 12183. Resistance to Ignition of Postural Support Devices per ISO 7176-16. | Biocompatibility per ISO 10993-1. Requirements and Test Methods of Manual Wheelchairs per EN 12183. Resistance to Ignition of Postural Support Devices per ISO 7176-16. | Same |
6
7
10. Non-Clinical Performance Data
To demonstrate substantial equivalence of the subject Bambino 3, S3, S3 Swing, U3, U3 Light and X model wheelchairs to the predicate Bambino, S2, S2 Swing, U2 and U2 wheelchairs, Panthera submitted their devices for the following non-clinical tests. Results confirm that the design inputs and performance specifications for the modified subject devices have been met.
-
Biocompatibility testing per: .
o ISO 10993-1 -
. Cytotoxicity testing per:
- o ISO 10993-5
-
. Chemical Characterization testing per:
- o ISO 10993-18
-
. Toxicological Risk Assessment per:
- o ISO 10993-17
-
. Wheelchair Performance Testing per:
8
- ISO 7176-16, Resistance to Ignition of Postural Support Devices O
- EN 12183, Manual Wheelchairs. Requirements and Test Methods (equivalent to): O
- l ISO 7176-1 (static stability)
- ISO 7176-3 (brakes)
- ISO 7176-8 (static, impact and fatigue strengths)
- ISO 7176-11 (test dummies)
- ISO 7176-15 (information, documentation and labeling)
- ISO 7176-19 (crash)
- l ISO 7176-22 (Set-up procedures)
Panthera also performed the following internal quality control measures during the design, development and manufacturing of their Bambino 3, S3, S3 Swing, U3, U3 Light and X wheelchairs:
- . Compliance with the following FDA guidance document:
- Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for O Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles
- Compliance with 21 CFR Part 820 Quality System Regulation
- (including Design Controls) O
- Compliance with 21 CFR Part 801 Labeling
- Compliance with 21 CFR Part 830 Unique Device Identification
- . Dimensional Verification per:
- Panther internal specifications O
- . Risk Analysis (FMEA) per:
- o ISO 14971, Medical Devices Application of Risk Management to Medical Devices
In conclusion, the performance of the subject devices met the non-clinical bench testing and demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate devices, and therefore support substantial equivalence to them.
11. Clinical Performance Data
Clinical testing on the subject devices have not been performed.
12. Substantial Equivalence Conclusion
The Bambino 3, S3, S3 Swing, U3, U3 Light and X wheelchairs have the same intended use and indications for use as the Bambino, S2, S2 Swing, U2 and U2 wheelchairs, and the same or similar technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated that the subject devices are as safe and effective as the predicate devices and substantially equivalent to them.