SUMMIT STAIRWAY LIFT

K032880 · Summit Lifts, Inc. · ILK · Nov 10, 2003 · Physical Medicine

Device Facts

• Record ID: K032880
• Device Name: SUMMIT STAIRWAY LIFT
• Applicant: Summit Lifts, Inc.
• Product Code: ILK · Physical Medicine
• Decision Date: Nov 10, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This 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. This design offers easy installation. 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.

Device Story

Summit™ Stairway Lift is a residential chairlift for navigating stairs; rated load 300 lbs; max travel 20 feet; speed 22 feet/minute. System uses aircraft-grade lifting cable on grooved aluminum drum; powered by 110 VAC. Operation via constant pressure controls; includes footrest safety sensors, swivel safety switch, and limit switches for automatic stops. Chair swivels 180 degrees at landings for safe access; seat folds up when not in use. Installed on staircase treads; user-operated. Benefits include improved mobility and quality of life for patients with physical limitations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered patient transport; cable-driven lifting system using aircraft-grade cable on grooved aluminum drum; 110 VAC power source; includes mechanical limit switches, footrest safety sensors, and swivel safety actuators; foldable seat and footrest; 300 lb weight capacity.

Indications for Use

Indicated for patients with limited function of knees, hips, or ankles, or difficulty bending joints; includes stroke recovery, MS, arthritis, heart disease, or general inability to exert effort required for stair climbing. Requires ability to transfer for wheelchair-bound users.

Regulatory Classification

Identification

Powered patient stairway chair lifts: 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. All other powered patient transport: 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.

Special Controls

(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.

Predicate Devices

• Silver-Glide®-HD

Submission Summary (Full Text)

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K032880 1/2

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## Summit Lifts, Inc.

23615 S. 291 Highway Harrisonville, Mo 64701 PH: 816-887-9919 Fax: [phone] "TAKING YOU TO NEW HEIGHTS"

NOV 1 0 2003

## 510(k) SUMMARY

- Submitted by: Summit Lifts, Inc. 23615 South 291 Highway Harrisonville, MO 64701
- Contact:
- Telephone: [phone] Facsimile [phone]

Kent T. Perry

- Date Prepared: August 29, 2003
- Summit™Stairway Lift Subject Device:
- Predicate Devices: Silver-Glide®
- Subject Product

Description:

The Summit™Stairway Lift is a stairway chairlift designed to carry a rated load of 300 lbs. directly up and down a set of stairs in a residence. The Summit™Stairway Lift is designed to travel a maximum 20 feet at a rated speed of 22 feet per minute. Foot rest safety sensors stop the lift in either direction should it strike anything on the stairs. The chair can be swivelled at the top and bottom landing for easy and safe access to the seat. A swivel safety switch makes sure the seat is in the proper position before allowing the unit to run. The Summit™Stainway Lift can be transformed from a left hand to a right hand side on the site of installation within minutes. The chairlift can also be folded in the up position as to facilitate access to the staircase. Seat belt is standard. The lifting system is aircraft grade lifting cable on a grooved aluminum drum. The lifting system has safeties to stop the lift if the cable is not properly tensioned. Limit switches shut the unit off in the same place at the top and bottom of the stairs automatically. Constant pressure controls are designed to stop the lift immediately if and when controls are released. Features include:

- Cable driven
- . 180 degree swivel at both landings
- Adjustable seat height .
- . Seat belt

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- Padded seat folds up when not in use
- Fold up footrest adjusts to two different heights
- Obstacle sensor
- . Swivel seat actuator
- . Arm control switch
- . 110 VAC grounded outlet
- . Magazine rack

Intended Use:

This 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. This design offers easy installation. 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 stainway 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.

## Product Comparison:

The Summit™Stairway Lift is substantially equivalent to the the Silver-Glide ®-HD Both products are used by the patient to assist in navigating a specific set of stairs.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2003

Summit Lifts, Inc. C/o Mr. Kent T. Perry Kent T. Perry & Co., LC 7300 W. 110th St. Overland Park. Kansas 66210

Re: K032880

Trade/Device Name: Summit™ Stairway Lift Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: II Product Code: ILK Dated: September 11, 2003 Received: September 15, 2003

Dear Mr. Perry:

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. Kent T. Perry

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

6 Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS OF USE STATEMENT

This 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. This design offers easy installation. 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.

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K032880