(61 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 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 it 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 B.07 is a stairway chairlift designed to carry a rated load of 300 lb. directly up and down a set of stairs in a residence or public setting. The B.07 is designed to travel a maximum 32 feet at a rated speed of 18 feet per minute. Safety switches installed on the B.07 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. The B.07's simple design allows for easy operation, quick installation and reliability. Its rail is made of extruded aluminum and hides the drive components and the traveling cable. It is a vertical mount rail that attaches to the tread so wear marks cannot develop on its outer surface due to the internal rolling system. The angle is fully adjustable for staircases of 25 to 45 degrees. The seat and footrest height are adjustable for both short and tall people. The chair can be swiveled at the top and bottom landing for easy and safe access to the seat. The stairlift can be transformed from a left hand to a right hand side on the site of installation within minutes. The device uses a roller chain drive system with an aluminum rail that allows for modifying the length of travel without having a weld. For safety, the B.07 is equipped with a safety brake, an obstruction sensor, a swiveled seat detector and a final limit switch. The chair lift can also be folded in the up position as to facilitate access to the staircase.
The provided 510(k) summary for the B.07 Stairway Chairlift does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of medical efficacy or diagnostic performance.
This document describes a stairway chairlift, which is a mechanical device for patient transport, not a diagnostic or AI-powered medical device that would have performance metrics like sensitivity, specificity, or agreement with expert readers. The 510(k) process for such a device focuses on demonstrating substantial equivalence to a predicate device, primarily concerning its design, intended use, and safety features.
Therefore, I cannot provide answers to the requested points, as they are not applicable to the type of device and the information presented in this 510(k) summary. The document focuses on:
- Subject Device Description: Mechanical features, load capacity, speed, safety mechanisms (obstruction sensors, safety brake, limit switch).
- Intended Use: Assisting patients with limited mobility to navigate stairs.
- Product Comparison: Substantial equivalence to another stairway chairlift (Bruno Electra-Ride K921648).
There is no mention of an algorithm, AI, human readers, ground truth consensus, or effect sizes related to diagnostic improvement.
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FEB 2 6 2003
510(k) SUMMARY
| Submitted by: | Barnes, Richardson & Colburn1225 Eye Street, N.W.Washington, D.C. 20005 |
|---|---|
| Contact: | Stephen BrophyTel: (202) 457-0300 |
| Date Prepared: | December 16, 2002 |
| Subject Device: | B-07 Stairway Chairlift |
| Predicate Device: | Bruno Electra-Ride (510(k) number K921648) |
| Subject ProductDescription: | The B.07 is a stairway chairlift designed to carry a rated load of 300 lb.directly up and down a set of stairs in a residence or public setting. TheB.07 is designed to travel a maximum 32 feet at a rated speed of 18 feetper minute. Safety switches installed on the B.07 stop the carriage when itreaches the top or bottom of the stairway. The footrest incorporatesobstruction sensors, which will stop the carriage if an obstacle isencountered on the stairs.The B.07's simple design allows for easy operation, quick installation andreliability. Its rail is made of extruded aluminum and hides the drivecomponents and the traveling cable. It is a vertical mount rail that attachesto the tread so wear marks cannot develop on its outer surface due to theinternal rolling system. The angle is fully adjustable for staircases of 25 to45 degrees. The seat and footrest height are adjustable for both short andtall people. The chair can be swiveled at the top and bottom landing foreasy and safe access to the seat. The stairlift can be transformed from aleft hand to a right hand side on the site of installation within minutes.The device uses a roller chain drive system with an aluminum rail thatallows for modifying the length of travel without having a weld. Forsafety, the B.07 is equipped with a safety brake, an obstruction sensor, aswiveled seat detector and a final limit switch. The chair lift can also befolded in the up position as to facilitate access to the staircase. |
| 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 of |
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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.
Product Comparison:
The B.07 is substantially equivalent to the Bruno Electra-Ride (K9721648). Both products are used by the patient to assist in navigating a specific set of stairs.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three human profiles facing right. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2003
Services Industriels Savaria, Inc. c/o Mr. Stephen W. Brophy Barnes, Richardson & Colburn 1225 Eye Street, N.W., Suite 1150 Washington, DC 20005
Re: K024345
Trade/Device Name: B.07 Stairway Chairlift Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: II Product Code: ILK Dated: February 5, 2003 Received: February 5, 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 f 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 W. 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). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely, yours,
O Mark N Milliman
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 : B.07 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 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 it 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.
(?LEASE 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)
Mark A. Milliken
vision Sion-Off ivision of General, Restorative and Neurological Devices
:10(k) Number K024345
§ 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.