(270 days)
Not Found
No
The summary describes a medical air compressor and does not mention any AI or ML capabilities.
No.
The Oricare C4500 Medical Air Compressor supplies compressed air to a medical ventilator, which is a therapeutic device. The compressor itself does not directly treat a patient; it provides critical support to a therapeutic device. Therefore, it is a component or accessory to a therapeutic device rather than a therapeutic device itself.
No
The device is an air compressor for medical ventilators, providing compressed air, not diagnosing medical conditions.
No
The device description explicitly states it is a "Medical Air Compressor" which is a hardware device that produces compressed air.
Based on the provided information, the Oricare C4500 Medical Air Compressor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to supply compressed air to a medical ventilator. This is a life support function, not a diagnostic test performed on samples taken from the body (in vitro).
- Device Description: The device description confirms it produces compressed air from the environment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Predicate Device: The predicate device is also a medical compressor, not an IVD.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Oricare C4500's function is purely mechanical and supportive for a medical device used in patient care.
N/A
Intended Use / Indications for Use
Intended Use:
This air compressor can be used as a gas supply for a critical care ventilat
Indications for Use:
Oricare C4500 Medical Air Compressor is indicated to supply dry filtered and compressed air to a Medical Ventilator France within the C4500 Compresses monufa perates within the C4500 Compressor manufacturer specification
Product codes
BTI
Device Description
The Oricare C4500 Medical Air Compressor operates from an AC Voltage source and produces air from the normal environment supply compressed air for nedical
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
Medical Care Facilities
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(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 the limitations in § 868.9.
0
8
3
3
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k
10(K) Summar
David Jamison, Executive Vice Presider
Oricare, Inc.
Thone: 215-538-2470 KOM DK50D Medical Compresso 500 Medical Air Compress Oricare, Inc.
1900 AM Drive, Suite 10
Quakertown, PA. 18951 mpressor, Air, Portab edical Air Compress ectober 19, 201 1CFR868.6256 060781 вті ame: Common / Usua evice Trade Name assification Nam egulation Numbe edicate 510(k) { Predicate Device ontact Persor Date Prepared Product Code Submitter
Substantial Equivalence Summary
stantial Equivalence Summary
C4500 Medical Compressor is substantially equivalent in intended use, physical characteristics, performance, and
acteristics to the EKOM DK50K, c
1
Intended Use
Intended Use:
This air compressor can be used as a gas supply for a critical care ventilat
cations for Use:
Oricare C4500 Medical Air Compressor is indicated to supply dry filtered and compressed air to a Medical Ventilator
France within the C4500 Compresses monufa perates within the C4500 Compressor manufacturer specification
Device Description:
The Oricare C4500 Medical Air Compressor operates from an AC Voltage source and produces air from the normal environment
supply compressed air for nedical
Device Testing
eners Four easing has been on case in accordance with vality ratous inh valier recognized
tandard, include tester 1999, 42:1995 and EC 6001-2-2.2007, Additionally, Air Esti
2
| # | Item of comparison | EKOM DK50 D Medical Compressor
(K060781) | Oricare C4500 Air Compressor | Discussion of the
differences |
|----|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Intended use of the
device | The DK50 D Medical Compressor is
indicated for supplying compressed
air for medical ventilators. | This air compressor can be used as a gas
supply for a critical care ventilator. | No differences |
| 2 | Indications for use | The EKOM DK50 D, DK50 DM is
indicated for use as medical air
compressor to supply a source of
clean, oil-free pressurized air for use
with medical ventilators. | The Oricare C4500 Medical Air
Compressor is indicated to supply dry
filtered and compressed air to a Medical
Ventilator that operates within the C4500
Compressor manufacturer specifications. | No differences |
| 3 | Environment of Use | Medical Care Facilities | Medical Care Facilities | No Differences |
| 4 | Principle of
operation | Compression, cooling, drying and
filtering of oil-free air | Compression, cooling, drying and filtering
of oil-free air | No Differences |
| 5 | Output flow/pressure | 40 l/min at 51 psig | 40 l/min at 50 psig | No Differences |
| 6 | Peak Flow | 200 pm for 2 sec | Peak Flow 180 Lpm for 0.6 sec | No Differences |
| 7 | Power | 120V/60 Hz | Power 115V/60 Hz | AC Mains line voltage
varies from 103VAC to
127VAC. Both systems
are within the range. |
| 8 | Power consumption | 5.6 A | Nominal current (amps) 80°C | Acoustic and optical if increase in internal
temperature > 80°C | No Difference |
| 19 | Automatic turn-on
pressure | When central distribution pressure