(287 days)
The CLINI-DYNE rotational/low air loss system is a patient rotation, pressure relieving support system used for the treatment and prevention of decubitus ulcers, urinary tract blockage, to aid circulation and for complications associated with immobility.
The CLINI-DYNE Rotational Therapy System consists of an electromechanical inflation pump control unit which is connected to a mattress with cells (air filled bladders) through hose assemblies connected to the inflation pump. The system affords programmed patient position changes by gently turning the patient from supine to left side or right side and back to supine position when staff is unable to do so or needs assistance.
The provided text describes a Premarket Notification [510(K)] Summary for the GAYMAR INDUSTRIES, INC. CLINI-DYNE Rotational Therapy System. This document focuses on demonstrating substantial equivalence to a predicate device (CLA 1400 System) rather than reporting on a study demonstrating the device meets pre-defined acceptance criteria in the way a clinical trial for a novel AI device would.
Therefore, the requested information elements related to AI device performance studies (like sample size for test sets, expert consensus, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document. This is a regulatory submission for a medical device that predates the common application of AI in medical imaging or diagnosis.
However, I can extract information related to the device's technical specifications and safety testing, which serve as a form of "acceptance criteria" for demonstrating substantial equivalence.
Here's the information that can be extracted from the provided text, adapted to the requested format where possible:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of 510(k) submission, "acceptance criteria" are typically defined by demonstrating that the new device is as safe and effective as the predicate device. The performance is compared feature-by-feature for substantial equivalence.
| Feature / Acceptance Criteria Category | Predicate Device (CLA-1400) Performance | CLINI-DYNE (CLD-1000) Performance | Acceptance (Substantial Equivalence) |
|---|---|---|---|
| Biocompatibility | |||
| Primary Skin Irritation | Pass | Pass | Met |
| Delayed Contact Sensitization | Pass | Pass | Met |
| Cytotoxicity | Pass | Pass | Met |
| Tissue Interface Testing | Pass | Pass | Met |
| Flammability | Pass | Pass | Met |
| UL Approvals | UL 544 | UL 2601-1 (pending) | Considered Met (with pending approval) |
| Alerts (Audible) | Yes | Yes | Met |
| Audible Alert Silence | 30 minutes | No | Difference (See Note 1) |
| Head of Bed Elevation Alert | Yes | No* | Difference (See Note 1) |
| Out of Rotation Alert | Yes | No* | Difference (See Note 1) |
| Siderail UP/Down Alert | Yes | No* | Difference (See Note 1) |
| Alerts (Visual) | Yes | Yes | Met |
| Alerts (Hi/low pressure) | Yes | Yes | Met |
| Alerts (Out of range) | Yes | Yes | Met |
| Rotation Angle | 0-45° | 0-40°** | Substantially Equivalent |
| CPR Deflate Mechanism | Quick-disconnect feature of hose from pump | Remove panel at mattress | Substantially Equivalent |
NOTE 1: The document notes "See Substantial Equivalence" for these differences, implying that despite the direct difference, the total package of features and safety data still allows for a claim of substantial equivalence for the intended use.
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes a Traditional 510(k) for a physical medical device (Rotational Therapy System). The "test set" and "data provenance" as understood in AI/ML performance studies (e.g., patient data, image sets) are not relevant here. The "testing" involved physical and electrical safety standards (e.g., biocompatibility on materials, flammability, UL standards).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in the context of expert consensus on data interpretation is not relevant for this device's regulatory submission. Safety and performance were assessed against established technical standards and by comparison to a predicate device.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple experts interpreting data, which is not applicable to the type of testing described here.
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. MRMC studies are used for evaluating diagnostic performance, often in conjunction with AI. This document is for a physical patient support system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used
- For Biocompatibility, Tissue Interface Testing, and Flammability: The "ground truth" was established by standardized laboratory testing procedures against pass/fail criteria for physical and chemical properties.
- For UL Approvals: "Ground truth" is compliance with Underwriters Laboratories (UL) standards.
- For comparative features: "Ground truth" is the demonstrated performance and characteristics of the predicate device (CLA-1400).
8. The sample size for the training set
- Not Applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- Not Applicable. This device does not involve a "training set."
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Image /page/0/Picture/1 description: The image shows the word "GAYMAR" in bold, black letters. The letters are sans-serif and appear to be a standard font. To the right of the word, there is a small circle with an R inside, indicating a registered trademark.
GAYMAR INDUSTRIES, INC.
APR 30 1997 K962788
Premarket Notification [510(K)] Summary
| Submitter: | Peter Scott |
|---|---|
| Phone: | 716/662-2551, ext. 676 |
| FAX: | 716/662-8763 |
| Date Summary | |
| Prepared: | January 30, 1997 |
| Device Name: | CLINI-DYNE Rotational Therapy System |
| Common Name: | Rotation/Low Air Loss System |
| Classification Name: | Alternating Pressure Air Flotation Mattress per |
| 21 CFR, Section 880.5550 | |
| Predicate Device: | CLA 1400 System |
Intended use of Device:
The CLINI-DYNE rotational/low air loss system is a patient rotation, pressure relieving support system used for the treatment and prevention of decubitus ulcers, urinary tract blockage, to aid circulation and for complications associated with immobility.
Description: The CLINI-DYNE Rotational Therapy System consists of an electromechanical inflation pump control unit which is connected to a mattress with cells (air filled bladders) through hose assemblies connected to the inflation pump. The system affords programmed patient position changes by gently turning the patient from supine to left side or right side and back to supine position when staff is 10 CENTRE DRIVE ORCHARD PARK, NY 14127 unable to do so or needs assistance.
(716) 662-2551 / (800) 828-7341 FAX #: (716) 662-6120
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Substantial Equivalence:
The following tables, CLINI-DYNE substantial equivalence matrix and the safety testing comparison table, summarize the technological characteristics and the nonclinical performance data upon which the substantial equivalence submission was made to the Food and Drug Administration.
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CLINI-DYNE SUBSTANTIAL EQUIVALENCE MATRIX
7/11/96
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| CLA-1400(Predicate) | CLD-1000 | |
|---|---|---|
| PERFORMANCE | ||
| Patient Support Surface | OverlayBlower | MattressElectro-mechanical reciprocatingpump |
| Air Source | ||
| Pressure controlmechanism | Microprocessor controlledpressure relief valve | Microprocessor controlledpressure relief valve |
| Voltage | 120v 60Hz Nominal | 120v 60Hz Nominal |
| Ambient | 60-90°F | 60-90°F |
| Tissue interface pressuremeasurements | Pressure relief | Pressure relief |
| Rotation angle | 0-45° | 0-40° ** |
| Safety | ||
| Maximum allowablepressure controlled by | Mechanical relief valve (55-60mmHg) | Mechanical relief valve (56 mmHg) |
| CPR Deflate mechanism | Quick-disconnect feature of hosefrom pump | Remove panel at mattress |
| Physicalcharacteristics | ||
| Construction (Patientsupport surface) | Air filled cells used as an overlay | Air filled cells contained in a foamcrib used as a mattress |
| Function &Intended uses | ||
| Type of therapy provided | Treatment of the diseases ofimmobility and treatment ofpressure ulcers | Treatment of the diseases ofimmobility and treatment ofpressure ulcers |
| (Primary) Targetpopulation | Acute care and alternate caresettings | Acute care and alternate caresettings |
| Life Expectancy (pump) | Reusable* | Reusable* |
| Life Expectancy (cell) | Resusable* | Reusable* |
| Product Labeling | Refer to TAB C - LABELING | Refer to TAB B - LABELING |
| Approvals | UI 544 | UL 2601-1 (submitted) |
- Cleanable using suggested disinfectants and cleaning agents.
** Dependent on physical characteristics of the patient. (40° minimum when set at maximum angle setting for each patient.)
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COMPARISON OF MAJOR CHARACTERISTICS
Characteristic
CLA-1400 (PREDICATE)
Cl
CLD-1000
| Alerts | ||
|---|---|---|
| Audible Alerts | yes | yes |
| Alert Silence (minutes) | 30 | no |
| Head of Bed Elevation Alert | yes | no* |
| Out of Rotation Alert | yes | no* |
| Siderail UP/Down Alert | yes | no* |
| Visual Alerts | yes | yes |
Rotation
| Automatic Left Only | yes | yes |
|---|---|---|
| Automatic Left to Right | yes | yes |
| Automatic Right Only | yes | yes |
| Center Only (no rotation) | yes | yes |
| Manual Left Only | yes | yes |
| Manual Right Only | yes | yes |
| Var.Angle, Min.range (degrees) | 0-45 | 0-45 |
| Variable Rate | yes | yes |
| Rotation Cycle Times (minutes) | 90, 30, 10, 2 | 60, 45, 30, 15 |
Cushion
| Placed onto Hospital Bed | yes | no (mattress replacement) |
|---|---|---|
| CPR Deflate | yes | yes |
| Low Air Loss | yes | yes |
| Pressure Relieving | yes | yes |
| Support Surface Inflation Control | yes | yes |
| Disposable Covers | yes | no** |
| Disposable Support Surface | yes | no** |
| Footboard/Foot Support Cushion | yes | yes |
Air Control Pump
| 120 Volt AC | yes | yes |
|---|---|---|
| 60 Hz | yes | yes |
| Amperage | 1-5 | 1 |
| Control Panel Lock-out | yes | yes |
| Microprocessor Control | yes | yes |
| U.L. Listed | yes | yes |
| Weight (lbs.) | 25 | 19 |
- See Substantial Equivalence
**Reusable mattress
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VI. SAFETY SUMMARY
Safety Testing Comparison Table
| CLA 1400 | CLD 1000 | ||
|---|---|---|---|
| Biocompatibility | |||
| a) primary skin irritation | pass | pass | |
| b) delayed contact sensitization | pass | pass | |
| c) cytotoxicity | pass | pass | |
| Tissue Interface Testing | pass | pass | |
| Flammability | pass | pass | |
| UL Approvals | UL 544 | UL 2601-1(pending) |
Alerts
ﺰ
| a) | hi/low pressure | yes | yes |
|---|---|---|---|
| b) | out of range | yes | yes |
§ 890.5225 Powered patient rotation bed.
(a)
Identification. A powered patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and 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.