(68 days)
The STAIR-LIFT is intended to mechanically transport one person in a wheelchair or in a fold-down seat up and down stairs in a private or public facility either indoors or outdoors.
The STAIR-LIFT is an unenclosed inclined platform lift designed to carry a wheelchair and its occupant or a mobility-impaired person seated on a folding seat between floors in a public or private facility. There are currently three different models designed to address the nature of the stairway involved in its use. The GSL-1 model is designed for straight and turning stairways. It follows the inside radius of a stairwell. The GSL-2 model is designed strictly for straight stairways, and the GSL-3 model is designed for complex turning stairways that follow either the inside or outside radius of the stairwell. Each of the three models is accessible via one of three types of platform/ramp units. These platform/ramps are raised either manually or electrically. The GSL-1 and GSL-3 (turning) models use two parallel steel tubes, custom built for the stairway, to support their platforms. The tubes contain a continuous loop of wire haul rope that attaches to the platform through a slot in the upper tube. An electrical motor at the top of the system turns a drive cog, which moves the wire haul rope, carrying the wheelchair platform up and down the stairway. Delrin spheres and knuckles are affixed to the rope to keep it in the center of the tubes. The GSL-2 (straight) model uses three square structural steel rails to support the platform. The top two rails contain a roller chain which is held in a continuous loop by aircraft cable. The chains are attached to the platform through a slot in the upper rail. The bottom rail guides the platform, while an electrical drive motor at the top of the system propels the chains.
This K981486 document is a K510(k) premarket notification for a medical device called the STAIR-LIFT. It details the device's description, intended use, and a comparison to a predicate device (SAVARIA ES-125). However, this document does not contain any information about acceptance criteria for performance, a study proving it meets those criteria, or any details related to sample sizes, ground truth, or expert involvement as typically found in clinical validation studies for AI/ML devices.
The K510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through new clinical studies, especially for devices without AI/ML components.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance based on the provided text. The document is about a physical stair lift device, not a diagnostic or AI/ML-driven device that would typically involve such performance metrics and studies.
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JUL - 1 1998
510(k) SUMMARY
(In accordance with 21 C.F.R. §807.92)
Submitted by:
Barnes, Richardson & Colburn 1225 Eye Street, N.W. #1150 Washington, D.C. 20005
(202) 457-0300 Tel: (202) 331-8746 Fax:
Contact: Alyssa Chumnanvech
Savaria ES-125 STAIR PLATFORM LIFT
Date Prepared:
Inclined Platform Lift Common Device Name:
Trade Name:
STAIR-LIFT
April 23, 1998
Predicate Device:
Subject Product Description:
The STAIR-LIFT is an unenclosed inclined platform lift designed to carry a wheelchair and its occupant or a mobility-impaired person seated on a folding seat between floors in a public or private facility. There are currently three different models designed to address the nature of the stairway involved in its use. The GSL-1 model is designed for straight and turning stairways. It follows the inside radius of a stairwell. The GSL-2 model is designed strictly for straight stairways, and the GSL-3 model is designed for complex turning stairways that follow either the inside or outside radius of the stairwell. Each of the three models is accessible via one of three types of platform/ramp units. These platform/ramps are raised either manually or electrically.
The GSL-1 and GSL-3 (turning) models use two parallel steel tubes, custom built for the stairway, to support their platforms. The tubes contain a continuous loop of wire haul rope that attaches to the platform through a slot in the upper tube. An electrical motor at the top of the system turns a drive cog, which moves the wire haul rope, carrying
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the wheelchair platform up and down the stairway. Delrin spheres and knuckles are affixed to the rope to keep it in the center of the tubes.
The GSL-2 (straight) model uses three square structural steel rails to support the platform. The top two rails contain a roller chain which is held in a continuous loop by aircraft cable. The chains are attached to the platform through a slot in the upper rail. The bottom rail guides the platform, while an electrical drive motor at the top of the system propels the chains.
Garaventa's STAIR-LIFT is intended to mechanically Intended Use: transport one person in a wheelchair or in a fold-down seat up and down stairs in a private or public facility either indoors or outdoors.
Product Comparison Table:
| SAVARIA ES-125 | STAIR-LIFT GSL | |
|---|---|---|
| Intended Use | to mechanically transport one mobility-impaired person up and down stairs in a private or public facility | to mechanically transport one mobility-impaired person up and down stairs in a private or public facility |
| Indoor or Outdoor Use | yes | yes |
| ANSI A17.1 Compliant | yes | yes |
| Electric Motor | yes | yes |
| Type of Drive Unit | chain drive sprocket (standard on ES-125 Plus model) | chain drive sprocket (GSL 2) wire rope sprocket (GSL 1 and 3) |
| Drive Unit Power | 0.373 kW (1/2 HP) | 0.75 kW (1 HP) or 1.12 kW (1.5 HP) |
| Mains Power | 208-230 volts AC | 208-240 volts AC |
| Electric Control Board | yes | yes |
| Optional Manual Operation | yes | yes |
| Key-Operated Station Controls | yes | yes |
| On-Board | yes | yes |
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| SAVARIA ES-125 | STAIR-LIFT GSL | |
|---|---|---|
| Control withKey Switch | ||
| ContinuousPressureDirectionalControls | yes | yes |
| UnderPlatformSensing toStop LiftUpon Contactwith Obstacle | optional only | standard on all three models;STAIR-LIFT also equipped with:(1) under hanger sensing to stopmovement upon contact withobstacle upon being called to/fromlanding areas, (2) multi-directionalramp sensing to detect pressurefrom inside the platform ramps toensure passenger positioned safelybefore lift begins movement, and(3) overspeed safety device |
| Optional Fold-Down Seat forNon-WheelchairPassengers | yes | yes |
| FoldablePlatform | yes | yes |
| AutomaticAccess Ramp | yes | yes |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are black and are connected by a flowing, ribbon-like shape at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1998
Ms. Alyssa Chumnanvech ·Barnes, Richardson & Colburn Representing Garaventa (Canada) Limited 1225 Eye Street, N.W. Suite 1150 Washington, DC 20005
Re: K981486 STAIR-LIFT Trade Name: Regulatory Class: II Product Code: ING Dated: April 24, 1998 Received: April 24, 1998
Dear Ms. Chumnanvech:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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· Page 2 - Ms. Alyssa Chumnanvech
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celi a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Stairway Elevator
Indications for Use:
The STAIR-LIFT is intended to mechanically transport one person in a wheelchair or in a fold-down seat up and down stairs in a private or public facility either indoors or outdoors.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Device Evaluation (ODE)
(Division Sign-Um)
Division of General Restorative Devices K991444
510(k) Number
Prescription Use (Per 21 C.F.R. § 801.109)
OR
Over-the Counter Use
§ 890.3930 Wheelchair elevator.
(a)
Permanently mounted wheelchair platform lift —(1)Identification. A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a guided platform to move a person from one level to another, with or without a wheelchair.(2)
Classification. Class II. The permanently mounted wheelchair platform 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 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 platform in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the enclosures to prevent the user from falling from the device; and
(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.
(b)
Portable wheelchair elevators —(1)Identification. A portable wheelchair elevator is a motorized lift device that is not permanently mounted in one location and that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a means to move a person, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).(2)
Classification. Class II.