(287 days)
CLA 1400 System
Not Found
No
The description focuses on electromechanical control and programmed position changes, with no mention of AI/ML terms or data-driven learning.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "used for the treatment and prevention of decubitus ulcers, urinary tract blockage, to aid circulation and for complications associated with immobility." These are therapeutic purposes.
No
Explanation: The device description clearly states its purpose is for treatment and prevention of decubitus ulcers and other immobility complications by providing positional changes and pressure relief. There is no mention of it being used to diagnose any disease or condition.
No
The device description explicitly states it consists of an "electromechanical inflation pump control unit" and a "mattress with cells (air filled bladders)," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for patient rotation and pressure relief to treat and prevent conditions like decubitus ulcers and aid circulation. This is a therapeutic and preventative function applied directly to the patient's body.
- Device Description: The device description details an electromechanical system with an inflation pump and mattress cells that physically manipulate the patient's position. This is a mechanical device for patient support and movement.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any testing of biological samples.
Therefore, the CLINI-DYNE rotational/low air loss system is a therapeutic and supportive medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Acute care and alternate care settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety Testing Comparison Table:
Biocompatibility: a) primary skin irritation (pass), b) delayed contact sensitization (pass), c) cytotoxicity (pass)
Tissue Interface Testing (pass)
Flammability (pass)
UL Approvals: UL 544 (CLA 1400), UL 2601-1 (CLD 1000 - pending)
Alerts: a) hi/low pressure (yes), b) out of range (yes)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CLA 1400 System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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.
2
CLINI-DYNE SUBSTANTIAL EQUIVALENCE MATRIX
7/11/96
ి లేదా పెళ్ళి
మూలాలు
మూలాలు
మూలాలు
మూలాలు
| | CLA-1400
(Predicate) | CLD-1000 |
|---------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| PERFORMANCE | | |
| Patient Support Surface | Overlay
Blower | Mattress
Electro-mechanical reciprocating
pump |
| Air Source | | |
| Pressure control
mechanism | Microprocessor controlled
pressure relief valve | Microprocessor controlled
pressure relief valve |
| Voltage | 120v 60Hz Nominal | 120v 60Hz Nominal |
| Ambient | 60-90°F | 60-90°F |
| Tissue interface pressure
measurements | Pressure relief | Pressure relief |
| Rotation angle | 0-45° | 0-40° ** |
| Safety | | |
| Maximum allowable
pressure controlled by | Mechanical relief valve (55-60
mmHg) | Mechanical relief valve (56 mmHg) |
| CPR Deflate mechanism | Quick-disconnect feature of hose
from pump | Remove panel at mattress |
| Physical
characteristics | | |
| Construction (Patient
support surface) | Air filled cells used as an overlay | Air filled cells contained in a foam
crib used as a mattress |
| Function &
Intended uses | | |
| Type of therapy provided | Treatment of the diseases of
immobility and treatment of
pressure ulcers | Treatment of the diseases of
immobility and treatment of
pressure ulcers |
| (Primary) Target
population | Acute care and alternate care
settings | Acute care and alternate care
settings |
| 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.)
3
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
4
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 |