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510(k) Data Aggregation
(156 days)
Powered
April 24, 2012
HT-Wedge
Common Name:
Classification Name:
AC-powered patient lift (21 CFR 880.5500
Street
Bethlehem, Pennsylvania 18015
Re: K121287
Trade/Device Name: HT-Wedge Regulation Number: 21 CFR 880.5500
The purpose of the HT-Wedge is to pneumatically lift and position the head and chest of a patient who is lying in the supine position without manual lifting.
The HT-Wedge is an inflatable wedge with square headrest and two intake appendages, one for the head and one for the chest. An inflation/deflation valve is found in each appendage. There is also a tongue attached to the wedge that lies under the patient's buttocks. The inflatable portion of the product is 22" wide and 31 1/4" long. There are four attachment straps, two located on each side of the wedge in order for it to be secured to the OR table. The tongue adds an additional 20" in length. The wedge is constructed of polyurethane coated nylon with 2 one-way, inflation/deflation valves.
This document is a 510(k) summary for a medical device (HT-Wedge), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against specific quantitative acceptance criteria typically seen for diagnostic AI/ML devices.
Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text.
The document indicates that "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications," but it does not provide the specific specifications or the results of these tests. It relies on citing compliance with voluntary standards (ISO 10993) for biocompatibility rather than performance metrics related to lifting and positioning.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from 510(k) context) | Reported Device Performance (from document) |
|---|---|
| Functional Equivalence: Device must perform the same intended function as the predicate device. | "The purpose of the HT-Wedge is to pneumatically lift and position the head and chest of a patient who is lying in the supine position without manual lifting." "The HoverTech International® HT-Wedge is substantially equivalent to the HoverJack air patient lift... in function and intended use." "The basic technology is exact since they both require the same UL Listed air supply and make use of the same one-way inflation valve." "The basic technology and performance characteristics of these systems are the same." |
| Safety: Device must not raise new issues of safety compared to the predicate device. | "The differences described in the submission between the HoverTech International® HT-Wedge and that of the predicate devices do not raise any new issues of safety or effectiveness." "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications. These reports are maintained as required by 21 CFR 820, Quality Systems Regulations." "An assessment of known and reasonable hazards has been conducted to ensure that any risk associated with the device as of the date of product release is as low as reasonably possible." Compliance with ISO 10993 (biocompatibility) standards (Part 5: Cytotoxicity, Part 10: Irritation and Sensitization, Part 1: Evaluation & testing within a risk management process) is stated as voluntary standards adhered to. This addresses material safety from patient contact. |
| Effectiveness: Device must be as effective as the predicate device for its intended use. | "The differences described in the submission between the HoverTech International® HT-Wedge and that of the predicate devices do not raise any new issues of safety or effectiveness." The overall conclusion is "The HT-Wedge and its predicate device included in this submission are substantially equivalent." |
| Compliance with Regulations/Standards: Device must meet applicable regulatory requirements and voluntary standards. | "These reports [Safety Testing and performance characteristics] are maintained as required by 21 CFR 820, Quality Systems Regulations." "The device will comply with the following voluntary standards: ISO 10993-5, ISO 10993-10, ISO 10993-1." Compliance with regulations for medical devices (e.g., annual registration, listing, good manufacturing practice, labeling, medical device reporting) is mentioned in the FDA letter. |
| Mechanical Performance (e.g., lift capacity, inflation time, durability): (Implicit for a patient lift) | The document states "Safety Testing and performance characteristics have been conducted and successfully completed to ensure compliance with specifications," but does not detail these specifications or the results. It implies equivalence to the predicate in "basic technology and performance characteristics" but provides no quantitative data. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable / Not Provided. This summary is for a physical patient lift, not an AI/ML device relying on a test set of data (e.g., images). The "testing" referred to is likely engineering and safety testing on the device itself, not a dataset.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable / Not Provided. Ground truth establishment by experts is relevant for diagnostic AI/ML algorithms. For this physical device, "ground truth" would relate to its engineering specifications and safety, verified through manufacturing processes and compliance with standards. "Design review has been conducted by a cross-functional team, including but not limited to regulatory, quality, engineering and manufacturing," but detailed qualifications or number of individuals are not specified.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Provided. This applies to expert review of data, not physical device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is a physical patient lift, not a diagnostic AI assistance system. MRMC studies are used to evaluate human reader performance with and without AI assistance in diagnostic tasks.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not Applicable. This is not an algorithm. Performance relates to its mechanical and functional specifications.
7. The Type of Ground Truth Used:
- For this device, "ground truth" would be internal engineering specifications, safety standards (e.g., biocompatibility standards like ISO 10993), and the performance characteristics of the legally marketed predicate device. The document implies that the device performs as designed and meets safety standards, and that its performance is equivalent to the predicate.
- The document explicitly mentions "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications." These specifications are the "ground truth" the device was tested against, but the detailed specifications themselves are not provided in this 510(k) summary.
8. The Sample Size for the Training Set:
- Not Applicable / Not Provided. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable / Not Provided. (See point 8)
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(66 days)
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| Regulation Number | 21CFR 880.5500
Pennsylvania 18015
Re: K041503
Trade/Device Name: HoverJack™ Air Patient Lift Device Regulation Number: 880.5500
The HoverJack™ lifts a patient in a supine position, from the floor to the approximate height of a bed for a subsequent lateral patient transfer.
The HoverJack™ is made of four connected nylon air chambers, each measuring 32" x 70". When inflated, each chamber is 7" high. Each chamber has a dump valve for safety purposes. Each of these chambers has an air entry valve through which an external air supply is used to inflate the chamber against the floor is to be inflated first, then the other three chambers are inflated, in an upward succession, until the device is fully inflated. When fully inflated, the HoverJack™ feels hard and substantially supports the patient atop it, also providing a surface upon which emergency patient procedures can be performed, if necessary. Also in an emergency, dump valves are available to use for quick deflation. The HoverJack™ is constructed using 200 denier Nylon Oxford. Seams are RF welded (heat-sealed) to limit infection control issues. The bottom of the HoverJack™ has strips of a non-skid material attached for safety purposes. Fill-valves are self-sealing AND have caps that also screw on for additional closure. The HoverJack™ has two patient safety straps to buckle over the patient. The HoverJack™ does require the use of the Air Supply that is available as a separate unit. The Air Supply is CSA approved, meeting UL Standard #544. This Air Supply is also used to inflate other equipment such as the HoverMatt® which is an optional accessory to the HoverJack™.
While the provided text describes the HoverJack™ Air Patient Lift Device, its intended use, and a comparison to a predicate device, it does not contain the information needed to answer your specific questions regarding acceptance criteria and a study proving those criteria.
The document refers to "Non-Clinical, Volunteer, Safety Testing" and states that "Findings and feedback from all scenarios have resulted in safety and comfort improvements ultimately ending in the final design of the product." However, it does not provide details of this testing in a structured way that would allow for the extraction of acceptance criteria, reported performance against those criteria, or the methodology of a formal study.
Therefore, I cannot provide the requested information based on the input text. The information required for your questions (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not present in the provided document.
This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study reports or comprehensive performance data as you might find in an IDE or PMA submission.
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