(8 days)
The Pinnacle Stair Way Lift is intended to assist transfers of patients or mobility impaired persons up and down flights of stairs.
The Harmar Summit, LLC Pinnacle Stair Way Lift is a battery powered patient transport. It's intended function and use is to assist transfers of patients or mobility impaired persons up and down flights of stairs. It is intended for indoor use only. The system is designed to carry a single patient, up a single flight of stairs while seated, at angle of between 27-45 degrees. Maximum travel distance is 75' at the maximum patient weight is 350 lbs. Maximum travel speed at full rated load is 20' per minute.
The provided document describes the Harmar Summit Pinnacle Stair Way Lift, a battery-powered patient transport device. However, it does not contain information on the acceptance criteria and study design elements that would typically be found in a medical device clinical validation or performance study.
Here's a breakdown of what is available and what is missing based on your request:
Acceptance Criteria and Reported Device Performance (Missing/Not Applicable)
The document primarily focuses on regulatory approval (510(k)) and substantial equivalence to a predicate device, rather than detailed performance comparisons against quantitative acceptance criteria from a specific study.
- A table of acceptance criteria and the reported device performance: This information is not provided. The document states the device is "CSA and CUS listed under 226703" and "certified by CSA to the following standards; ASME A18.1 Safety Standards for Platform Lifts and Stairway Lifts, ASME A17.1 Safety Code for Elevators and Escalators." This implies the device meets the safety standards, but specific performance metrics and their corresponding acceptance criteria from a separate study are not detailed.
Study Details (Missing/Not Applicable for a medical device clinical validation)
The "Performance Data" section solely refers to certifications to standards, not a dedicated study to assess clinical performance or diagnostic accuracy. Therefore, most of the following information is not present:
- Sample size used for the test set and the data provenance: Not applicable. The document discusses regulatory certification to standards, not a test set of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Available Information Related to Performance:
The document mentions some physical specifications and operational limits, which could be interpreted as inherent performance characteristics, but not as part of a formal study with acceptance criteria:
- Maximum patient weight: 350 lbs.
- Maximum travel speed at full rated load: 20' per minute.
- Angle of stairs: between 27-45 degrees.
- Maximum travel distance: 75'.
- Intended for indoor use only.
Conclusion:
The provided 510(k) Premarket Notification focuses on demonstrating substantial equivalence to a predicate device and compliance with established safety standards (ASME A18.1 and A17.1) through CSA certification. It does not present a detailed study with acceptance criteria for device performance in the way one would expect for a diagnostic or AI-powered medical device. The "Performance Data" section simply states that the device is certified to existing safety standards, implying it meets the requirements of those standards rather than detailing a specific experimental validation study.
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510(k) Premarket Notification
Pinnacle Stair Way Lift
510(k) SUMMARY
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Summit Harmar, LLC 2075 47th Street Sarasota, Florida 34234 Phone: (941) 351-2776 Fax: (941) 684-1115
JUL - 1 2009
Kevin Kaminski Contact Person: Director, Global Sourcing and Logistics
June 19, 2009 Date Prepared:
Name of Device
Pinnacle Stair Way Lift
Common or Usual Name
Stair Way Lift
Classification Name
Transport, Patient, Powered
Predicate Device
Bruno Electra-Ride Stair Way Elevator (K033752)
Intended Use
The Pinnacle Stair Way Lift is intended to assist transfers of patients or mobility impaired persons up and down flights of stairs.
Device Description
The Harmar Summit, LLC Pinnacle Stair Way Lift is a battery powered patient transport The Thankar Junimit, the home. It's intended function and use is to assist transfers of patients or mobility impaired persons up and down flights of stairs. It is intended for indoor use only.
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Image /page/1/Picture/0 description: The image shows the logo for Harmar Summit. The logo is black and white and includes the words "Harmar Summit" in a bold font. Below the logo, the words "510(k) Premarket Notification" are written in a smaller font. The logo also includes a graphic of a mountain.
The system is designed to carry a single patient, up a single flight of stairs while seated, at angle of between 27-45 degrees. Maximum travel distance is 75' at the maximum patient weight is 350 lbs. Maximum travel speed at full rated load is 20' per minute.
Substantial Equivalence
The Summit Harmar Pinnacle Stair Way Lift is substantially equivalent to the Bruno Electra-Ride Stair Way Elevator (K033752).
Performance Data
The Pinnacle Stairway lift is CSA and CUS listed under 226703. It has been certified by CSA to the following standards;
ASME A18.1 Safety Standards for Platform Lifts and Stairway Lifts
ASME A17.1 Safety Code for Elevators and Escalators
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
JUL - 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Harmar Summit, LLC % Spectre Solutions, Inc. Mr. Edward Kroll 5905 Fawn Lane Cleveland, Ohio 44144
Re: K091858
Trade/Device Name: Harmar Summit Pinnacle Stair Way Lift Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: II Product Code: ILK Dated: June 22, 2009 Received: June 23, 2009
Dear Mr. Kroll:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Edward Kroll
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Mark N. Melkerson
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): TBD
Device Name: Harmar Summit Pinnacle Stair Way Lift
Indications for Use:
The intended use of the Pinnacle Stair Way Lift is to assist transfers of patients or mobility impaired persons up and down flights of stairs.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
vision Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K091858
§ 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.