(12 days)
The Intended Use of the Pride Mobility C5 Lift Chair is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
The Pride Mobility C5 Lift Chair is an upholstered chair assembly constructed of a welded steel frame, and foam and fabric compliant to Cal 117 Flammability requirements. The chair is assembled to a welded steel lifting frame mechanism having a 24 VDC motor / actuator powered by standard 110 volt AC power from a wall outlet. A Hand Held Switch Control Device engages the actuators to position the chair to a recline, sitting, or standing position.
Based on the provided text, the Acceptance Criteria and Study information for the Pride Mobility C5 Lift Chair is as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard Tested To) | Reported Device Performance (Compliance) |
|---|---|
| CAL 117 Sections A, D, & E - Flammability Testing for Upholstered Furniture | Compliant |
| EN 61000-6-3 - Electromagnetic Emissions | Compliant |
| EN 61000-6-1 - Electromagnetic Immunity | Compliant |
| EN60601-1 / A2: 1995 / EN60601-1 / A2: 1995 - Medical Electrical Equipment - General Requirements for Safety | Compliant |
2. Sample size used for the test set and the data provenance:
- The document states "The Pride Mobility C5 Lift Chair was tested to the following Safety Standards". This implies that one or more C5 Lift Chair units were tested. The exact number of units or the "sample size" is not explicitly stated.
- Data Provenance: The testing was conducted by Pride Mobility Products Corporation as a "Non-Clinical Testing" phase during the development and submission of the 510(k) application. This is internal testing data. The country of origin is implicitly the United States (where Pride Mobility is located). The testing is prospective in nature, as it's part of the development and validation of a new product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a mechanical lift chair, and the testing outlined is non-clinical safety standard compliance. It does not involve interpretation of medical images or patient data that would require "experts to establish ground truth" in the way a diagnostic AI would. The "ground truth" here is compliance with established engineering and safety standards, which is determined through laboratory testing and measurement.
4. Adjudication method for the test set:
- Not Applicable. As mentioned above, the testing is for compliance with engineering and safety standards. There is no concept of "adjudication" in the sense of resolving disagreements between human expert interpretations. The results are objective measurements against predefined thresholds of the 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. This document explicitly states "Discussion of Clinical Testing Performed: N/A". This device is a physical product (a lift chair), not a diagnostic AI or an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a mechanical lift chair, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable.
7. The type of ground truth used:
- The "ground truth" for this device's performance is compliance with established safety and performance standards (CAL 117, EN 61000-6-3, EN 61000-6-1, EN60601-1/A2:1995). These are objective, measurable criteria defined by regulatory bodies and industry associations.
8. The sample size for the training set:
- Not Applicable. This is a mechanical device, not a machine learning model. There is no "training set" in the context of AI.
9. How the ground truth for the training set was established:
- Not Applicable. As stated in point 8, there is no training set for this type of device.
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Image /page/0/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 a horizontal line running through the middle of the letters. 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
Exhibit 1
510(k) Summary Pride Mobility Products Corporation C5 Lift Chair
Submitter's Name & Address:
APR 16 2007
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:
03-02-07
Name of Device and Proprietary Name: C5 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 C5 Lift Chair is substantially equivalent to the Pride Mobility TMR-48 (K953342) when comparing; Construction, Performance, and Stability. The performance characteristics and positioning of components are similar to achieve the same Intended Use. The differences between the C5 Lift Chair and the TMR-48 are in the construction materials and electronics.
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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" is the text "Mobility Products Corp." in a smaller font. The logo is black and white.
Device Description:
The Pride Mobility C5 Lift Chair is an upholstered chair assembly constructed of a welded steel frame, and foam and fabric compliant to Cal 117 Flammability requirements. The chair is assembled to a welded steel lifting frame mechanism having a 24 VDC motor / actuator powered by standard 110 volt AC power from a wall outlet. A Hand Held Switch Control Device engages the actuators to position the chair to a recline, sitting, or standing position.
Intended Use:
The Intended Use of the Pride Mobility C5 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 C5 Lift Chair was tested to the following Safety Standards: CAL 117 Sections A, D, & E - Flammability Testing for Upholstered Furniture 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
Discussion of Clinical Testing Performed:
N/A
Conclusions:
The Pride Mobility C5 Lift Chair has the same intended use and similar technological characteristics as the TMR-48 (K953342), 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 C5 Lift Chair is substantially equivalent to the predicate device, has passed all the necessary testing procedures, and is considered to be safe for user operation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pride Mobility Products Corporation % Mr. Thomas Schappert 182 Susquehanna Avenue Exeter, Pennsylvania 18643
APR 16 2007
Re: K070950
Trade/Device Name: C5/Electric Positioning Chair Regulation Number: 21 CFR 890.3110 Regulation Name: Electric positioning chair Regulatory Class: Class II Product Code: INO Dated: March 23, 2007 Received: April 4, 2007
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 such 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); good manufacturing practice requirements as set 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
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Page 2 – Mr. Thomas Schappert
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Por
Mark N. Melkerson
Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K
Device Name: C5 / Electric Positioning Chair
Indications for Use:
The Intended Use of the Pride Mobility C5 Lift Chair is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
Deh
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
1670 98 0 510(k) Number_
Prescription Use X AND / OR (Part 21 CFR 801 Subpart D)
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)
Page 1 of 1
§ 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.