(23 days)
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No
The summary describes a motorized stairway chairlift with no mention of AI or ML capabilities.
No.
This device is described as a powered patient transport system (stairlift) intended to assist transfers, not to provide therapeutic treatment.
No
Explanation: The device is a 'Powered Patient Transport' (stairlift) used to assist in the physical transfer of patients, not to diagnose a medical condition.
No
The device description explicitly states it is a "motorized device" and a "Powered Patient Transport," indicating it is a hardware-based system with a motor and mechanical components, not solely software.
Based on the provided information, the Bruno Electra-Ride™ Elite Stairway Elevator System, Model SRE-2000, is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states its purpose is to "assist transfers of patients, or mobility-impaired persons, up and down flights of stairs." This is a physical assistance device, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description reinforces its function as a "motorized device intended for medical purposes to assist transfers."
- Lack of IVD Characteristics: The provided text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, the Bruno Electra-Ride™ Elite Stairway Elevator System is a medical device, but it falls under the category of a Powered Patient Transport or Stairlift, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Bruno Electra-Ride™ Elite Stairway Elevator System, Model SRE-2000, is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairlift. It is a motorized device intended for medical purposes to assist transfers of patients, or mobility-impaired persons, up and down flights of stairs.
Product codes
ILK
Device Description
Bruno Electra-Ride™ Elite Stairway Elevator System, Model SRE-2000
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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)
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§ 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
Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized symbol resembling an abstract caduceus or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2003
Mr. Richard A. Keller Product Development Manager Bruno Independent Living Aids, Inc. 1780 Executive Drive P.O. Box 84 Oconomowoc, Wisconsin 53066
Re: K033438
Trade/Device Name: Bruno Electra-Ride™ Elite Stairway Elevator System, Model SRE-2000 Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: II Product Code: ILK Dated: October 1, 2003 Received: October 28, 2003
Dear Mr. Keller:
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.
1
Page 2 - Mr. Richard A. Keller
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,
Celia M. Witten, Ph.D., MD
elia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Attachment 2 Indications for Use Statement
510(k) Number (if known):
Device Name: Bruno Electra-Ride™ Elite Stairway Elevator System, Model SRE-2000
Indications for Use:
The Bruno Electra-Ride™ Elite Stairway Elevator System, Model SRE-2000, is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairlift. It is a motorized device intended for medical purposes to assist transfers of patients, or mobility-impaired persons, up and down flights of stairs.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division
Division of General, Restorative and Neurological General, Rest
510(k) Number k 633436