(217 days)
The CLINITRON® RITE®HITE™ Air Fluidized Therapy is intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid in circulation. This bed will be an ideal support for patients who have advanced pressure ulcers, flaps, grafts, or burns, and require frequent transfers or variable head elevation and any other conditions appropriate for air-fluidized therapy. The bed also can be used for intractable pain, extensive epidermal detachment, Stevens-Johnson Syndrome, purpura fulminans, aid in infection control, induce relaxation which may reduce need for sedative and pain medication, improve patient outcome, and reduce wound healing time. The bed will permit easy positioning and egress, thereby enhancing the independence of residents.
The CLINITRON® RITE®HITE™ Air Fluidized Therapy Unit combines the best features of the predicate devices, CLINITRON ELEXIS® (K943385)and the CLINITRON AT+HOME® (K942184), in order to meet the design objectives. The intent of the design is to provide an economical combinational therapeutic support surface on a mobile articulating frame specifically for use in the Long Term Care setting. Another design objective was to provide this type of surface on a frame that would go as low as possible. The CLINITRON® RITE®HITE™ tank edge is at 21.5 inches in its lowest position. This will permit easier positioning and egress. The combinational support surface includes both low airloss and air fluidized therapies. The upper half delivers low air loss therapy through low-friction support cushions which supports the upper half of the body (above the waist) and the lower half consists of air fluidized therapy which supports the lower half of the body (below the waist). This type of sleep surface is common to both the CLINITRON ELEXIS and the CLINITRON AT.HOME®
The provided text describes a 510(k) premarket notification for the CLINITRON® RITE•HITE™ Air Fluidized Therapy unit. The core of this submission is to demonstrate substantial equivalence to predicate devices, rather than establishing new safety and efficacy through a detailed clinical study with acceptance criteria and a detailed study design as typically seen for novel devices.
Therefore, the document does not provide the specific information requested about acceptance criteria, a standalone study to prove performance against those criteria, sample sizes, expert qualifications, or adjudication methods for a novel device. Instead, it focuses on comparing the new device's features and intended use to existing, legally marketed devices.
Here's how the provided information relates to your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission, not a de novo clearance requiring novel performance criteria. The "acceptance criteria" are effectively that the device is "substantially equivalent" in safety and efficacy to the predicate devices.
- Reported Device Performance: The document states, "The safety characteristics of this product compare to those of the predicate devices. No significant changes have been made which impact the safety and efficacy of the CLINITRON® RITE. HITE™ Air Fluidized Therapy Unit as compared to the predicate devices." No specific quantitative performance metrics are provided beyond this qualitative statement.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: No "test set" in the context of a performance study is described. The demonstration of substantial equivalence relies on comparative analysis with predicate devices, not on a new clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: No "test set" requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No "test set" requiring adjudication is described.
5. 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 an air-fluidized therapy unit, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader improvement with AI is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable: No "ground truth" data from a performance study is mentioned. The "truth" in this submission is the established safety and efficacy of the predicate devices.
8. The sample size for the training set
- Not Applicable: This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable: As above, no training set is relevant here.
Summary of Device and Evidence for Substantial Equivalence:
The CLINITRON® RITE•HITE™ Air Fluidized Therapy unit is intended for medical purposes to treat or prevent bedsores, severe burns, or to aid circulation. It combines features of two predicate devices: CLINITRON ELEXIS® (K943385) and CLINITRON AT•HOME® (K942184).
Key arguments for substantial equivalence (which serve as the "proof" the device meets the regulatory requirements for market clearance):
- Intended Use: The CLINITRON® RITE•HITE™ has the same intended uses as the predicate devices: providing a pressure-relieving sleep surface for patients with pressure ulcers, burns, flaps, grafts, and other conditions suitable for air-fluidized therapy.
- Technological Characteristics:
- Uses the same air fluidization medium (silicon-coated glass microspheres).
- Employs the same principle of passing pressurized air through a diffuser board to fluidize microspheres and through a filter sheet to the patient.
- Uses the same microspheres, filter sheet fabric, and similar closure systems.
- Incorporates similar cushion sections for pressure relief and articulable head sections.
- Has air cushions organized into zones continuously monitored by a microprocessor to adjust pressures.
- Uses identical cushion material and construction to predicate devices.
- Operated and controlled by a microprocessor.
- Safety and Efficacy: The submission explicitly states: "The safety characteristics of this product compare to those of the predicate devices. No significant changes have been made which impact the safety and efficacy of the CLINITRON® RITE. HITE™ Air Fluidized Therapy Unit as compared to the predicate devices."
- Differences and Justification: While there are differences (e.g., design for long-term care vs. acute care, specific features like CPR function, X-ray plates, built-in scales, remote control design, siderail mechanisms, specific alarm behaviors), the manufacturer argues that "Although these differences provide servicing and user benefits, none of the differences adversely affects the safety or efficacy of the device."
In conclusion, this 510(k) submission successfully demonstrated substantial equivalence by highlighting the similarities in intended use and technological characteristics to already-approved predicate devices, and by arguing that differences did not compromise safety or efficacy. It did not involve performance testing against specific acceptance criteria in the manner of a clinical trial for a novel device.
§ 890.5160 Air-fluidized bed.
(a)
Identification. An air-fluidized bed is a device employing the circulation of filtered air through ceramic spherules (small, round ceramic objects) that is intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid circulation.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.