(51 days)
The product will be used by the patient to assist in navigating a specific set of stairs. This is a self-contained product that is mounted to the tread of a staircase. A trained dealer will install the unit, test it and teach the end user how to operate it. The typical user is someone who has limited function of their knees, hips or ankles and/or has trouble bending these joints. Other users include rehabilitated stroke victims, those inflicted with MS, arthritis, heart disease, and those who cannot handle the exertion of walking up and down the stairs. The unit may be recommended by doctors or physical therapists, for those who are recuperating but a large number of users acquire a stairway elevator just because to eases the burden of climbing stairs, improving their quality of life. For those who are wheelchair bound, it requires that they be able to transfer and is usually an option only if the physical limitations of the residence prohibits a vertical elevator.
The Stepsaver is a stairway chairlift designed to carry a rated load of 300 lb. directly up and down a set of stairs in a residence. The Step-saver is designed to travel a maximum 32 feet at a rated speed of 18 feet per minute. Safety switches installed on the Step-saver stop the carriage when it reaches the top or bottom of the stairway. The footrest incorporates obstruction sensors, which will stop the carriage if an obstacle is encountered on the stairs. Features include: Rack and pinion drive 60 and 90 degree swivel at top Adjustable seat height Seat belt with positive locking mechanism Flip-up padded armrests Constant pressure control switch on armrest (reversible side) Obstacle sensor Swivel seat actuator Electronic controller with soft start
This document is a 510(k) summary for the "Step-saver (B2002)" Stairway Chairlift. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Based on the provided text, the device is not an AI/ML powered medical device, but rather a physical stairway chairlift. Therefore, the questions regarding acceptance criteria, study details, and AI/ML specific metrics (like MRMC studies, standalone performance, training sets, etc.) are not applicable in the context of typical AI/ML device submissions.
The submission focuses on demonstrating substantial equivalence to a predicate device (Bruno Electra-Ride K921648) by meeting established safety standards for such equipment.
Here's an attempt to extract relevant information, acknowledging that many fields will be N/A due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards Compliance (Substantial Equivalence) | Both the Step-saver and the predicate device (Bruno Electra-Ride) "have been designed and engineered to meet and exceed the safety standards CSA-B355 - 'Lifts for persons with physical disabilities' and ASME A17.1 part XX and part XXI 'Safety Code for Elevators and Escalators'." |
| Rated Load Capacity | 300 lb. (Step-saver) |
| Maximum Travel Distance | 32 feet (Step-saver) |
| Rated Speed | 18 feet per minute (Step-saver) |
| Safety Features | Safety switches (top/bottom stops), obstruction sensors on footrest (stops carriage), rack and pinion drive, 60/90 degree swivel at top, adjustable seat height, seat belt with positive locking mechanism, flip-up padded armrests, constant pressure control switch on armrest, swivel seat actuator, electronic controller with soft start. (Step-saver) |
| Intended Use Equivalence | Both products "are used by the patient to assist in navigating a specific set of stairs. They are both self-contained product that are mounted to the tread of a staircase." (Step-saver and Bruno Electra-Ride) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This is a physical device submission demonstrating compliance with engineering standards, not a data-driven AI/ML model for which a test set of data would be used. The "study" here refers to the engineering and design process to meet established safety standards.
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)
- N/A. Ground truth in the context of an AI/ML model is not applicable here. Compliance with safety standards would be assessed by engineering experts, testing bodies, and regulatory agencies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are specific to human review of data, typically for AI/ML or clinical trial endpoints.
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
- N/A. This device does not involve human readers interpreting medical images or data. It is a mechanical assistant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a mechanical system, not an algorithm. Its "standalone" performance would be its functional operation in isolation, which is implicitly covered by its design specifications and compliance with safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's safety and effectiveness lies in its compliance with established engineering and safety standards (CSA-B355 and ASME A17.1 parts XX and XXI), as well as its functional specifications (load capacity, speed, safety features).
8. The sample size for the training set
- N/A. There is no "training set" in the context of an AI/ML model. The design and engineering process for this mechanical device would involve iterative design, prototyping, and testing.
9. How the ground truth for the training set was established
- N/A. There is no "training set" or "ground truth for training" as understood in AI/ML development. The "ground truth" for its design and manufacturing is adherence to engineering principles, materials science, and established safety regulations for medical/accessibility devices.
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510(k) SUMMARY
| Submitted by: | Barnes, Richardson & Colburn1225 Eye Street, N.W.Washington, D.C. 20005 |
|---|---|
| Contact: | Stephen BrophyTel: (202) 457-0300 FEB 06 2003 |
| Date Prepared: | December 10, 2002 |
| Subject Device: | "Step-saver (B2002)" Stairway Chairlift |
| Predicate Device: | .Bruno Electra-Ride (510(k) number K921648) |
| Subject Product Description: | The Stepsaver is a stairway chairlift designed to carry a rated load of 300lb. directly up and down a set of stairs in a residence. The Step-saver isdesigned to travel a maximum 32 feet at a rated speed of 18 feet perminute. Safety switches installed on the Step-saver stop the carriage whenit reaches the top or bottom of the stairway. The footrest incorporatesobstruction sensors, which will stop the carriage if an obstacle isencountered on the stairs. Features include:Rack and pinion drive 60 and 90 degree swivel at top Adjustable seat height Seat belt with positive locking mechanism Flip-up padded armrests Constant pressure control switch on armrest (reversible side) Obstacle sensor Swivel seat actuator Electronic controller with soft start |
| Intended Use: | The product will be used by the patient to assist in navigating a specific setof stairs. This is a self-contained product that is mounted to the tread of astaircase. A trained dealer will install the unit, test it and teach the enduser how to operate it. The typical user is someone who has limitedfunction of their knees, hips or ankles and/or has trouble bending thesejoints. Other users include rehabilitated stroke victims, those inflicted withMS, arthritis, heart disease, and those who cannot handle the exertion ofwalking up and down the stairs. The unit may be recommended bydoctors or physical therapists, for those who are recuperating but a largenumber of users acquire a stairway elevator just because to eases theburden of climbing stairs, improving their quality of life. For those whoare wheelchair bound, it requires that they be able to transfer and is |
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usually an option only if the physical limitations of the residence prohibits a vertical elevator.
Product Comparison: The Step-saver in substantially equivalent to the Bruno Electra-Ride (K9721648). Both products are used by the patient to assist in navigating a specific set of stairs. They are both self-contained product that are mounted to the tread of a staircase. Both stairlifts, (Bruno and Savaria) have been designed and engineered to meet and exceed the safety standards CSA-B355 - "Lifts for persons with physical disabilities" and ASME A17.1 part XX and part XXI "Safety Code for Elevators and Escalators".
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with three curved lines above them, possibly representing movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 6 2003
Services Industriels Savaria, Inc. Barnes, Richardson & Colburn c/o Stephen Brophy 1225 Eye Street, N.W., Suite 1150 Washington, D.C. 20005
Re: K024167
Trade/Device Name: Step-Saver Stairway Chairlift Regulation Number: 890.5150 Regulation Name: Powered patient transport Regulatory Class: Class II Product Code: ILK Dated: January 24, 2003 Received: January 24, 2003
Dear Mr. Brophy:
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.
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Page 2 - Mr. Stephen Brophy
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 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
l Mark N. Milkena
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN) :
DEVICE NAME : "Step-saver" Stairway Chairlift
INDICATIONS FOR USE:
The product will be used by the patient to assist in navigating a specific set of stairs. This is a self-contained product that is mounted to the tread of a staircase. A trained dealer will install the unit, test it and teach the end user how to operate it. The typical user is someone who has limited function of their knees, hips or ankles and/or has trouble bending these joints. Other users include rehabilitated stroke victims, those inflicted with MS, arthritis, heart disease, and those who cannot handle the exertion of walking up and down the stairs. The unit may be recommended by doctors or physical therapists, for those who are recuperating but a large number of users acquire a stairway elevator just because to eases the burden of climbing stairs, improving their quality of life. For those who are wheelchair bound, it requires that they be able to transfer and is usually an option only if the physical limitations of the residence prohibits a vertical elevator.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109
OR
Over-The-Counter-Use
(Optional Format 1)
fo Mark N Milkman
sion Sign-Off vision of General, Restorative and Neurological Devices
510(k) Number K024167
§ 890.5150 Powered patient transport.
(a)
Powered patient stairway chair lifts —(1)Identification. A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.(2)
Classification. Class II. The stairway chair lift 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:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of American Society of Mechanical Engineers (ASME) A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the chair in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”);
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety; and
(v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.
(b)
All other powered patient transport —(1)Identification. A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.(2)
Classification. Class II.