(52 days)
The intended use of the Pride Mobility Products Corporation Kids ROCK 3 Chair is to provide mobility to persons limited to a seated position.
The Kids ROCK 3 Chair is a Mechanical Wheelchair that offers adjustable and customizable seating and positioning to meet the needs of a growing client. The Reaction Dynamic Seating System allows a user the freedom to move into flexion or extension in the chair while maintaining proper positioning and support.
This document is a 510(k) premarket notification for a mechanical wheelchair, specifically the Pride Mobility Products Corporation Kids ROCK 3 Chair. It demonstrates the device's substantial equivalence to a predicate device through non-clinical testing. It does not describe a study to prove the device meets acceptance criteria using performance metrics like sensitivity, specificity, or AUC, as would be common for AI/ML-based medical devices.
Therefore, many of the requested items (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC study, standalone performance, ground truth types) are not applicable to the provided document.
Here's a summary of the information that is available in the document, formatted to address your request where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/RESNA WC19 (Wheelchairs Used as Seats in Motor Vehicles) | Compliant |
| ISO 7176-19 (Wheeled Mobility Devices for Use in Motor Vehicles) | Compliant |
| ISO 7176-15 (Requirements for information disclosure, documentation, and labeling) | Compliant |
| ISO 7176-8 (Requirements and test methods for static, impact, and fatigue strengths) | Compliant |
| ISO 7176-1 (Determination of static stability) | Compliant |
| ISO 7176-7 (Measurement of seating and wheel dimensions) | Compliant |
| ISO 7176-5 (Determination of overall dimensions, mass, and turning space) | Compliant |
| ISO 7176-3 (Determination of efficiency of brake) | Compliant |
| Fabric and Foam Testing | Compliant |
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical product subjected to engineering and material tests according to international standards. The document doesn't provide specific sample sizes (e.g., number of wheelchairs tested) for these non-clinical tests, nor does it refer to "data provenance" in the context of medical imaging or AI/ML data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document pertains to the physical and mechanical testing of a medical device, not a diagnostic or AI algorithm requiring expert ground truth for interpretation. Compliance with standards is typically determined by testing against predefined physical criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons mentioned above.
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: No. This document describes a mechanical wheelchair, not an AI/ML device, so no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This document describes a mechanical wheelchair.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's safety and effectiveness is its compliance with established engineering and safety standards (e.g., ISO, ANSI/RESNA) through non-clinical physical testing.
8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable for the reasons mentioned above. The "ground truth" for the device's design and manufacturing is established by adherence to recognized engineering standards and good manufacturing practices.
Summary:
This document is a 510(k) summary for a mechanical wheelchair, which is a traditional medical device. The "acceptance criteria" discussed are compliance with established international and national standards for wheelchair safety, performance, and durability. The "study that proves the device meets the acceptance criteria" refers to non-clinical testing performed against these standards. It does not involve clinical studies or the type of performance evaluation (e.g., sensitivity, specificity, AUC) typically associated with AI/ML devices, and hence, many of the requested details are not relevant to this submission. The device was deemed substantially equivalent to a predicate device (Litestream 500E, K042444) based on similar intended use and technological characteristics, and compliance with the relevant standards.
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KIII739
AUG 1 2 2011
Exhibit 1 510(k) Summary Pride Mobility Products Corporation Kids ROCK 3 Chair
Submitter's Name & Address:
Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, Pa. 18643 Phone: (570) 655-5574 Facsimile: (570) 655-2990
Contact Person:
Kimberly Blake Assistant Manager, Regulatory
Date Prepared:
6/17/2011
Name of Device and Proprietary Name:
Kids ROCK 3 Chair / Pride Mobility Products Corporation
Common or Usual Name:
Mechanical Wheelchair
Classification Name:
Physical Medicine / Mechanical Wheelchair
Product Code:
IOR
Comparison to Predicate Devices:
The Kids ROCK 3 Chair is substantially equivalent to the Pride Mobility Litestream 500E (K042444) when comparing performance, maneuverability, stability, and structure. The performance characteristics are similar to achieve the same intended use functions that enable the device to maintain optimum stability without hindering performance.
The major differences between the Kids ROCK 3 Chair and the Litestream 500E (K042444) are in the seating. The Kids ROCK 3 Chair seating is adjustable to allow for growth as the user moves through various stages of life and offers a manual tilting feature.
Please refer to Exhibit 4 for specific product descriptions and comparison of the Kids ROCK 3 Chair to the cleared Litestream 500E (K042444).
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Device Description:
The Kids ROCK 3 Chair is a Mechanical Wheelchair that offers adjustable and customizable seating and positioning to meet the needs of a growing client. The Reaction Dynamic Seating System allows a user the freedom to move into flexion or extension in the chair while maintaining proper positioning and support.
Intended Use:
The intended use of the Pride Mobility Products Corporation Kids ROCK 3 Chair is to provide mobility to persons limited to a seated position.
Non-Clinical Testing:
ANSI/RESNA WC19 Wheelchairs Used as Seats in Motor Vehicles ISO 7176-19 Wheeled Mobility Devices for Use in Motor Vehicles ISO 7176-15 Requirements for information disclosure, documentation, and labeling ISO 7176-8 Requirements and test methods for static, impact, and fatigue strengths ISO 7176-1 Determination of static stability ISO 7176-7 Measurement of seating and wheel dimensions ISO 7176-5 Determination of overall dimensions, mass, and turning space ISO 7176-3 Determination of efficiency of brake Manually propelled wheelchairs Technical Aids for Disabled Persons Fabric and Foam Testing
Discussion of Clinical Testing Performed:
N/A
Conclusions:
The Kids ROCK 3 Chair has the same intended use and similar technological characteristics as the Litestream 500E (K042444). Moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Kids ROCK 3 Chair is substantially equivalent to the Litestream 500E (K042444).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MI) 20993-0002
Pride Mobility Products Corporation % Ms. Kimberly Blake Assistant Manager, Regulatory 182 Susquehanna Avenue Exeter, PA 18643
Re: K111739
Trade/Device Name: Kids ROCK 3 Chair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: July 11, 2011 Received: July 14, 2011
AUG 12 2011
Dear Ms. Blake:
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 device-related adverse events) (21 CFR 803); good nianufacturing practice requirements as set
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Page 2 - Ms. Kimberly Blake
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), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millhiser
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exhibit 3
Indications for Use
510(k) Number (if known): K
Kids ROCK 3 Chair Device Name:
Indications for Use: The intended use of the Kids ROCK 3 Chair is to provide mobility to persons limited to a seated position.
Prescription Use × (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use _ X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thurman L. Gray
(Division Sign-Off) (Division Sign of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111739
§ 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).