(127 days)
The LIFTKAR PT™-S Is a method of transporting disabled persons, up and downstairs while seated on the stairclimber, and not in a wheelchair. This is done with a lifting mechanism. It is a battery on the bailed in the been and on a certified attendant and can be used on any stairs indoors or outside.
The LIFTKAR PT™ S is an attendant operated, battery powered lifting device that transports a disabled person in an integrated chair up or down stairs, not in a wheelchair. The LIFTKAR PT-S is designed for indoor and outdoor use allowing mobility for the person needing assistance.
Here's an analysis of the provided text regarding the LIFTKAR PT™-S device, focusing on acceptance criteria and study details:
This submission is for a K111858, a 510(k) premarket notification. In a 510(k), manufacturers demonstrate substantial equivalence to a legally marketed predicate device. This typically involves showing that their new device is as safe and effective as the predicate device, often through performance testing and comparison of technical specifications. It's important to understand that a 510(k) does not usually involve extensive clinical trials like a PMA (Premarket Approval) application, nor does it typically detail acceptance criteria in the same way one might for a novel, high-risk device. The "acceptance criteria" here are largely implied by demonstrating compliance with recognized standards and equivalence to the predicate.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the LIFTKAR PT™-S are not explicitly stated in a quantitative table with pass/fail thresholds. Instead, acceptance is demonstrated by conforming to relevant international standards and showing substantial equivalence in performance to its predicate device, the C-Max-U2 (K103122).
The following table summarizes the device performance of the LIFTKAR PT™-S and its comparison to the predicate, which implies the performance criteria were met if the LIFTKAR PT™-S's performance is similar to or better than the predicate and complies with the standards.
| Feature / Performance Metric | Predicate Device (C-Max-U2) Performance | LIFTKAR PT™-S Performance | Implied Acceptance Criterion / Conformance |
|---|---|---|---|
| Intended Use | Transport disabled person up/down stairs | Transport disabled person up/down stairs | Functionality match |
| Weight (total) | 78.7 lbs | 67 lbs | Similar/Improved (lighter) |
| Safe Workload (incl. chair) | 352 lbs | 352 lbs persons wt. | Equivalent |
| Overall height | 44.4 inches | 44.49 inches | Equivalent |
| Overall width (w/o armrests) | 16.9 inches | 19.88 inches | Similar |
| Depth (footrest out) | 30.9 inches | 29.3 inches | Similar/Improved (less deep) |
| Stair Landing minimum | 31.5 x 35.4 inches | 31.5 x 35.4 inches | Equivalent |
| Maximum Stair Height | 8.26 inches | 8.25 inches | Equivalent |
| Stair Type Depth | Not specified but implied comparable | 6 inches (includes winding) | Compliance with ISO 7176-23:2002 |
| Straight stair width | Not specified but implied comparable | 23.81 inches (Liftkar plus 3.93 inches) | Compliance with ISO 7176-23:2002 |
| Winding Stair Width | Not specified but implied comparable | 23.81 inches from point of stair depth of 6 inches | Compliance with ISO 7176-23:2002 |
| Battery Type | Sealed lead acid | Sealed lead gel | Acceptable battery technology |
| Capacity (fully charged battery) | 300 steps | 300-500 steps | Similar/Improved |
| Speeds | 8-23 steps/min (continually adjustable) | 10-18 steps/min (multiple modes) | Similar operational range |
| Battery capacity | 2x 12V 5 ah | 2x 12V5 ah | Equivalent |
| Nominal output voltage of charge | 24V | 24V | Equivalent |
| Main components | Handle, lifting device, battery | Handle, lifting device, battery | Equivalent |
| Biocompatibility | Not explicitly stated for predicate | Conforms to DIN EN ISO 10993-5 | Compliance with standard for safety |
| Stair Climbing Device Requirements | Not explicitly stated for predicate | Conforms to ISO 7176-23:2002 | Compliance with standard for performance |
The "acceptance criteria" are intrinsically tied to demonstrating that the LIFTKAR PT™-S meets the requirements of the listed international standards (ISO 7176-23:2002 and DIN EN ISO 10993-5) and performs comparably to or better than the predicate device in key functional areas.
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "sample size" in terms of number of devices tested for performance. It states that "The LIFTKAR PT™-S was tested by BERLIN CERT Pruf und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin." This implies that the device (likely one or a few units representative of the production model) was subjected to performance tests. The testing focuses on mechanical, electrical, and safety aspects according to standards, rather than statistical sampling from a large test set.
- Data Provenance: The testing was conducted by BERLIN CERT Pruf und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin (a German testing and certification body). This is in Europe (Germany/Austria). The study is prospective in the sense that the device was manufactured and then tested according to defined protocols to assess its conformance to standards and specifications. It is not a retrospective analysis of existing data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information (number and qualifications of experts for ground truth) is not applicable to this 510(k) submission. For a device like a powered patient transport, "ground truth" is established by direct physical measurement, engineering analysis, and evaluation against technical standards (e.g., measuring weight capacity, step height, battery life, and confirming compliance with ISO 7176-23). The "experts" involved would be the technical engineers and certifiers at BERLIN CERT, whose qualifications are implicit in the accreditation of the certification body, but not explicitly stated here (e.g., "radiologist with 10 years of experience" is for diagnostic devices).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic device evaluations where subjective interpretation plays a role and consensus among experts is needed for ground truth. For a mechanical device tested against engineering standards, the results are objective measurements and pass/fail determinations based on those standards.
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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:
- No. An MRMC study is not applicable to this device. This is a powered patient transport device, not a diagnostic imaging device with AI assistance for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical mechanical/electrical apparatus, not an algorithm. Its operation inherently involves a "human-in-the-loop" (the certified attendant).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" used for this device's performance evaluation is based on objective physical measurements and engineering assessments against recognized international standards (ISO 7176-23:2002 for requirements and test methods for attendant-operated stair climbing devices, and DIN EN ISO 10993-5 for biocompatibility/cytotoxicity testing). The device's specifications (e.g., weight capacity, maximum stair height, battery life) are the defined parameters that the tests verified.
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The sample size for the training set:
- Not applicable. This device does not use an AI algorithm that requires a "training set." The training relates to the attendant who uses the device, not an algorithm.
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How the ground truth for the training set was established:
- Not applicable. As there is no AI algorithm training set, this question is irrelevant. Any "training" mentioned refers to the certification of the human attendant who operates the device.
§ 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.