(183 days)
The Intended Use of the Pride Mobility T3 Lift Chair is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
The Pride Mobility T3 Lift Chair is an upholstered chair having welded steel frame construction. The chair upholstery (foam and fabric) are compliant to Cal 117 and BS5852 Flammability requirements. The upholstered chair is assembled to a weldedsteel lifting frame mechanism, and a Hand Control Switch Device engages motor / actuators to position the chair to recline, sitting, or standing positions. The system is a low voltage DC motor system that reduces the standard household alternating current of 110V AC / 240V AC to direct current (24 / 39V DC). The electrical components include the external transformer with battery backup, two motor / actuators, and the Hand Control.
The provided text describes a 510(k) submission for the Pride Mobility T3 Lift Chair. This is a medical device that assists individuals with mobility challenges in transitioning from a seated to a standing position.
Here's an analysis of the provided information, specifically addressing the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
For the Pride Mobility T3 Lift Chair, the "acceptance criteria" are based on its compliance with specific safety and flammability standards, and its substantial equivalence to a predicate device. The device's performance is demonstrated by passing tests related to these standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Compliance Status) |
|---|---|
| Flammability Testing: | |
| CAL 117 Sections A, D, & E | Compliant |
| BS5852 | Compliant |
| Electromagnetic Compatibility: | |
| EN 61000-6-3 (Emissions) | Compliant |
| EN 61000-6-1 (Immunity) | Compliant |
| Medical Electrical Equipment Safety: | |
| EN60601-1 / A2: 1995 | Compliant |
| Mechanical Integrity/Durability: | |
| Fatigue Testing - Cycle Tests | Passed |
| Fatigue Testing - Impact Tests | Passed |
| Fatigue Testing - Downward Force Tests | Passed |
| Substantial Equivalence: | |
| Comparison to Pride Mobility C5 (K070950) | Deemed Substantially Equivalent (same intended use, similar technological characteristics, differences do not raise new safety/effectiveness questions) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a "test set" in the context of clinical data. The testing performed was non-clinical testing of the device itself (flammability, electrical safety, mechanical fatigue). Therefore, "data provenance" in terms of subject data is not applicable. The tests were likely conducted in a controlled laboratory environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable to this device. The "ground truth" for the non-clinical tests (flammability, electrical, mechanical) is typically the standard itself (e.g., "does the material ignite within X seconds under Y conditions?"). Expert consensus in the medical or diagnostic sense is not relevant for these types of engineering and safety tests. The reports from the testing labs would serve as the attestations to compliance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as there was no clinical test set requiring adjudication of findings. The tests were objective assessments against established engineering and safety standards.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology), not for a mechanical lift chair. The device's function is to directly provide lift assistance, not to assist humans in making a diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device is a mechanical chair, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests was the objective pass/fail criteria defined by the respective safety and performance standards. For example, for flammability, the ground truth is whether the material meets the specified burn rates or self-extinguishing properties outlined in CAL 117 or BS5852. For fatigue testing, the ground truth is whether the components withstand the prescribed number of cycles or impact forces without failure. For substantial equivalence, the "ground truth" is whether the technical characteristics and intended use align sufficiently with the predicate device.
8. The sample size for the training set
This is not applicable as there is no "training set" in the context of an algorithm or AI model for this mechanical device.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
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Research & Development 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990 www.pridemobility.com
Exhibit 1
510(k) Summary Pride Mobility Products Corporation T3 Lift 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:
Thomas Schappert Official Correspondent
Date Prepared:
05-08-09
Name of Device and Proprietary Name:
T3 Lift Chair / Pride Mobility Products Corporation
Common or Usual Name:
Electric Lift Chair
Classification Name:
Electric Positioning Chair per 21 CFR, 890.3110
Product Code:
INO
Comparison to Predicate Devices:
The T3 Lift Chair is substantially equivalent to the Pride Mobility C5 (K070950) when comparing construction and performance. The performance characteristics and positioning of components are similar to achieve the same Intended Use. The T3 offers a dual actuator system vrs. one actuator on the C5; the dual actuator system enables the chair components to move independently to create additional comfort positioning.
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Image /page/1/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, sans-serif font, with the letters slightly overlapping. Below the word "Pride", the words "Mobility Products Corp." are written in a smaller, sans-serif font. The logo is black and white.
Research & Development 182 Susquehanna Ave Exeter, PA 18643 570-655-5574 FAX 655-2990 www.pridemobility.com
Device Description:
The Pride Mobility T3 Lift Chair is an upholstered chair having welded steel frame construction. The chair upholstery (foam and fabric) are compliant to Cal 117 and BS5852 Flammability requirements. The upholstered chair is assembled to a weldedsteel lifting frame mechanism, and a Hand Control Switch Device engages motor / actuators to position the chair to recline, sitting, or standing positions. The system is a low voltage DC motor system that reduces the standard household alternating current of 110V AC / 240V AC to direct current (24 / 39V DC). The electrical components include the external transformer with battery backup, two motor / actuators, and the Hand Control.
Intended Use:
The Intended Use of the Pride Mobility T3 Lift Chair is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
Non-Clinical Testing:
The Pride Mobility T3 Lift Chair was tested to the following Safety Standards: CAL 117 Sections A. D. & E - Flammability Testing for Upholstered Furniture BS5852 - Flammability (foam and fabric)
EN 61000-6-3, and EN 61000-6-1 - Electromagnetic Emissions & Immunity Tests EN60601-1 / A2: 1995 / EN60601-1 / A2: 1995 -- Medical Electrical Equipment -General Requirements for Safety
Fatigue Testing - Cycle Tests, Impact Tests, and Downward Force Tests
Discussion of Clinical Testing Performed:
N/A
Conclusions:
The Pride Mobility T3 Lift Chair has the same intended use and similar technological I characteristics as the C5 (K070950), 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 T3 Lift Chair is substantially equivalent to the predicate device, has passed all the necessary testing, and is considered to be safe for user operation.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Pride Mobility Products Corporation % Mr. Thomas Schappert 182 Susquehanna Avenue Exeter, Pennsylvania 18643-2694
DEC - 2 2009
Re: K091578
Trade/Device Name: T3/Electric Positioning Chair Regulation Number: 21 CFR 890.3110 Regulation Name: Electric positioning chair Regulatory Class: Class II Product Code: INO Dated: October 21, 2009 Received: November 2, 2009
Dear Mr. Schappert:
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.
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 manufacturing practice requirements as set
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Page 2 - Mr. Thomas Schappert
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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Millman
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
Device Name: T3 / Electric Positioning Cliair
Indications for Use:
The Intended Use of the Pride Mobility T3 I...ift Chair is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
Prescription Use x AND / OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use × (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of GDRH, Office of Device Evaluation (ODE)
FOR M. MELKERSON
(Division Sign-Off)
Division of Surgical. Orthopedic. and Restes alive Devices
Page 1 of 1
510(k) Number: K011578
§ 890.3110 Electric positioning chair.
(a)
Identification. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.(b)
Classification. Class II. The electric positioning chair is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(1) Appropriate analysis and non-clinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;
(2) Appropriate analysis and non-clinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;
(3) Appropriate analysis and non-clinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;
(4) Appropriate analysis and non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-1, “Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance,” and ANSI/AAMI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Disturbances—Requirements and Tests”) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, “Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process,” ANSI/AAMI/ISO 10993-5, “Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity,” and ANSI/AAMI/ISO 10993-10, “Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization”) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, “Medical Device Software—Software Life Cycle Processes”) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable;
(9) Appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and
(10) Adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment.