(51 days)
Not Found
No
The device description and intended use focus on mechanical and electronic controls for a chairlift, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
While the device assists individuals with medical conditions, its primary function is mobility assistance, not the diagnosis, treatment, or prevention of disease.
No
The device description clearly states it is a "stairway chairlift designed to carry a rated load... directly up and down a set of stairs." Its purpose is to assist in mobility, not to diagnose any medical condition.
No
The device description clearly outlines a physical chairlift with mechanical and electronic components (rack and pinion drive, safety switches, obstruction sensors, electronic controller, etc.), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device, the "Stepsaver," is a stairway chairlift. Its function is to physically transport a person up and down stairs. It does not involve the analysis of any biological specimens.
- Intended Use: The intended use is to assist patients with mobility issues in navigating stairs, improving their quality of life and independence. This is a physical assistance device, not a diagnostic tool.
Therefore, the Stepsaver clearly falls outside the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ILK
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) SUMMARY
| Submitted by: | Barnes, Richardson & Colburn
1225 Eye Street, N.W.
Washington, D.C. 20005 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Stephen Brophy
Tel: (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 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 |
| Intended 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 |
1
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".
2
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.
3
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
4
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