(189 days)
Quickie® and Zippie® power wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. The Zippie power wheelchairs are specifically for people who are slightly smaller in stature—including children.
Quickie and Zippie wheelchairs are battery-powered, user-controlled, electric wheelchairs. All models of these wheelchairs will be offered with an optional wireless pointer control feature. This option entails adding a Bluetooth Mouse Module (BMM)—a small Bluetooth transmitter—mounted to the chair and wired into its control bus. With BMM in place, the wheelchair's controller can then use the pointer-control feature built into the BMM hardware and software. Pointer control can only be activated when the wheelchair is stationary and not actively performing wheelchair functions. The BMM lets users use the chair's joystick, or other input device, to control the pointer functions of Bluetooth-enabled devices (such as personal or tablet computers) while the chair is not in operation. The wireless pointer control feature will be offered on all models of the Quickie Pulse and Zippie ZM-310 series chairs. Technologically, all of these chair designs are identical. Model designations relate to widths and heights of their seats and various components: such as seating, wheels, and other options available. Quickie Pulse chairs are sized to fit medium to large size individuals Zippie ZM-310 chairs fit individuals of smaller stature—including children. These chairs, along with the BMM, are meant for use in healthcare facilities, in the home, outdoors, and other places of individual activity for the disabled.
The provided text is a 510(k) summary for the Quickie Pulse and Zippie ZM-310 power wheelchairs with an optional wireless pointer control feature (Bluetooth Mouse Module - BMM). It describes the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.
Regarding your request for "acceptance criteria and the study that proves the device meets the acceptance criteria," it's important to note that this document is for a medical device (powered wheelchair) and not an AI/ML-driven diagnostic tool. Therefore, the questions related to AI/ML performance metrics (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training set) are not applicable in this context.
The "acceptance criteria" for this device are implicitly tied to safety and functional performance, particularly regarding the added Bluetooth Mouse Module (BMM) and its impact on the wheelchair's operation and electromagnetic compatibility. The "study" that proves the device meets these criteria is the non-clinical performance testing.
Here's a breakdown of the relevant information from the document, tailored as much as possible to your request, while acknowledging that it's not an AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implicit from Testing) | Reported Device Performance |
|---|---|---|
| Operational Performance | Wireless pointer function operates without detriment to wheelchair function or features. | "Operational performance of wireless pointer function without detriment to wheelchair function or features" was achieved. |
| Wheelchair's electrical braking holds on maximum slope during BMM operation. | "Chair's electrical braking continued to hold on a maximum slope during BMM operation." | |
| Wireless pointer function properly executes on typical external Bluetooth-enabled electronic devices from wheelchair inputs. | "Wireless pointer function properly executed on typical external Bluetooth-enabled electronic device from wheelchair inputs." | |
| Electromagnetic Compatibility (EMC) | Immunity of the total chair system with BMM mounted and connected. | "Immunity of total chair system with BMM mounted and connected" was demonstrated during EMC testing. |
| No effect on chair operation during BMM activation. | "No effect on chair during BMM activation" was demonstrated during EMC testing. | |
| Software Qualification | Wireless pointer function demonstrated while the chair is not in operation. | "Wireless pointer function demonstrated while chair not in operation, qualifying the BMM and its software by successful device performance." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a numerical sample size for the test set. The performance data section describes types of tests conducted on the device itself (e.g., "chair's electrical braking," "BMM operation," "EMC testing"). This implies testing was done on the physical device, likely prototypes or production samples, rather than a "data set" in the AI/ML sense.
- Data Provenance: Not explicitly stated, but standard practice for medical device testing like this would be in a controlled laboratory or testing facility within the manufacturer's operational region. It is not "retrospective or prospective" data in the clinical study sense; it's non-clinical engineering and functional testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the physical reality of the device's function (e.g., brakes holding, wireless signal working without interference). This is typically established by engineers, technicians, and potentially regulatory compliance specialists following established test protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for interpreting medical images or diagnoses where inter-reader variability exists. This document describes non-clinical performance and safety testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. An MRMC study is relevant for comparing diagnostic performance, often with AI assistance in clinical settings. This device is a powered wheelchair with an added Bluetooth feature; it is not a diagnostic tool requiring human reader performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This refers to AI/ML algorithm performance. The "BMM" has software, but its "performance" is evaluated as part of the overall wheelchair system's function and electromagnetic compatibility, not as a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on engineering standards and physical measurements of performance. For example:
- Brake holding capability is verified against a specific angle/load (engineering spec).
- EMC is verified against international standards (e.g., ANSI/RESNA WC2, extended frequency ranges) using proper measurement equipment.
- Wireless pointer function is verified by observing its actual function with compatible external devices.
8. The sample size for the training set
- Not Applicable. This device does not use machine learning, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for machine learning, this question is not relevant.
In summary, the provided document describes a medical device in the context of a 510(k) submission, confirming its substantial equivalence to a predicate device. The "acceptance criteria" and "studies" are focused on engineering performance, safety, and electromagnetic compatibility for the physical device system, not on AI/ML diagnostic performance metrics.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2016
Sunrise Medical (US) LLC Laurie Roberts Director, Regulatory Affairs 2842 Business Park Av Fresno, California 93727
Re: K160031
Trade/Device Name: Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 9, 2016 Received: June 9, 2016
Dear Laurie Roberts:
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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), 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哥offmann -A
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160031
Device Name
Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)
Indications for Use (Describe)
Quickie® and Zippie® power wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. The Zippie power wheelchairs are specifically for people who are slightly smaller in stature-including children.
| 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
Submitter
| Company | Sunrise Medical (US) LLC2842 Business Park AvenueFresno, CA 93727Tel: 800-333-4000Fax: 559-294-2872 |
|---|---|
| Contact | Laurie Roberts, MS, RACDirector, Regulatory Affairs |
| Device | |
| Trade name | Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and ZippieZM-310 (Models BC, SC) |
| Class name | Wheelchair, powered (21 CFR 890.3860) |
| Product code | ITI |
| Class | 2 |
| Predicate | |
| Devices | Quickie Pulse: Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC and Zippie ZM-310: Models BC & SC; legally marketed per 510(k): K142457 |
| Recalls | These predicate devices have not been subject to a design-related recall. |
| Device Description | |
| Overview | Quickie and Zippie wheelchairs are battery-powered, user-controlled, electricwheelchairs. All models of these wheelchairs will be offered with an optionalwireless pointer control feature. |
| Wirelesspointercontrolfeature | This option entails adding a Bluetooth Mouse Module (BMM)-a smallBluetooth transmitter-mounted to the chair and wired into its control bus. |
| With BMM in place, the wheelchair's controller can then use the pointer-control feature built into the BMM hardware and software. | |
| Pointer control can only be activated when the wheelchair is stationary andnot actively performing wheelchair functions. | |
| Purpose offeature | The BMM lets users use the chair's joystick, or other input device, to controlthe pointer functions of Bluetooth-enabled devices (such as personal ortablet computers) while the chair is not in operation. |
| Modeldistinctions | The wireless pointer control feature will be offered on all models of theQuickie Pulse and Zippie ZM-310 series chairs.Technologically, all of these chair designs are identical. Model designationsrelate to widths and heights of their seats and various components: such asseating, wheels, and other options available. Quickie Pulse chairs are sized to fit medium to large size individuals Zippie ZM-310 chairs fit individuals of smaller stature—including children |
| Useenvironment | These chairs, along with the BMM, are meant for use in healthcare facilities,in the home, outdoors, and other places of individual activity for the disabled. |
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Device Description (continued)
Intended Use
| Indicationsfor Use | Quickie® and Zippie® power wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. The Zippie power wheelchairs are specifically for people who are slightly smaller in stature—including children. |
|---|---|
| Feature fact | The Indications for Use for the Quickie and Zippie power wheelchairs with wireless pointer control are identical to those for the chairs that do not have the feature. The feature is strictly an add-on for the convenience of the users. |
Technological Characteristics and Comparison
| Design | Technological characteristics—design, materials, motors, electronics, power source, etc.—are identical to the predicate devices with the exception of the addition of the BMM. |
|---|---|
| BMM option | By adding the BMM, wireless pointer control can be engaged.The BMM adds The ability to use the chair's joystick, or other input device, to control the pointer functions of Bluetooth-enabled electronic devices Some extra wiring to the electronic system raising the issue of continued electromagnetic compatibility for the chairs A low-power radio-frequency transmitter in the 2 to 2.5 GHz Bluetooth frequency range raising the issue of electromagnetic emissions interfering with chair brake function (chair is not in motion at the time of transmission but may be braking to hold chair on an incline) |
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Technological Characteristics and Comparison (continued)
| Parameters | K160031 (subject device) | K142457 (predicate device) |
|---|---|---|
| Models | Quickie Pulse® (Models: 6BC,6SC, 6CC, 5BC, 5CC, 6MPC)and Zippie® ZM-310 (Models:BC & SC) | Same |
| Intended Use | To provide mobility to personslimited to a seating positionthat have the capability ofoperating a poweredwheelchair | Same |
| Indications for Use | Quickie® and Zippie® powerwheelchairs are battery-operated devices with wheelsthat are intended for medicalpurposes to provide mobilityto persons restricted to asitting position. The Zippiepower wheelchairs arespecifically for people who areslightly smaller in stature-including children. | Same |
| Bluetooth feature available | YESBluetooth technology operatesin unlicensed industrial,scientific and medical (ISM)band at 2.4 to 2.485 GHz,using a spread-spectrum,frequency-hopping, full-duplexsignal at a nominal rate of1600 hops/sec.Class 1 output - usedprimarily in industrial usecases - 100 meters Power is100mW max for Class 1 | NO |
| Other technical features | Same | Same |
| Evaluation methods | Same | Same |
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Performance Data
The following non-clinical performance data were provided in support of the substantial equivalence determination.
| Performance | Operational performance of wireless pointer function without detriment towheelchair function or featuresChair's electrical braking continued to hold on a maximum slope duringBMM operation Wireless pointer function properly executed on typical external Bluetooth-enabled electronic device from wheelchair inputs |
|---|---|
| EMC | Electromagnetic compatibility testing carried out to cover functionalverification and device performance to ANSI/RESNA WC2 testing plus overextended frequency range through 3.0 GHz with BMM mounted in itsclosest proximity (worst-case) position to the wheelchair controllerdemonstrated Immunity of total chair system with BMM mounted and connected No effect on chair during BMM activation |
| Softwarequalification | Wireless pointer function demonstrated while chair not in operation,qualifying the BMM and its software by successful device performance. |
No animal or clinical data necessary to demonstrate the performance of this option.
Conclusion
The performance data support the electromagnetic compatibility of the BMM to the Quickie and Zippie power wheelchairs and their operation. The operational verification and validation of the wireless pointer control feature demonstrate that the feature performs as intended in the specified use conditions. Thus, the optional feature added to these chairs produce comparable results to the predicate devices for the same intended use. The devices are substantially equivalent to their predicates.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).