(178 days)
No
The device description focuses on physical filtration and humidification components, and there is no mention of AI, ML, or related concepts in the provided text.
Yes
The device is described as adding, maintaining, and retaining moisture for the patient's exhaled breath, and it connects to ventilators and anesthesia machines, indicating a direct therapeutic benefit for the patient's respiratory function.
No
The device description indicates it is a filter (HEPA filter, HME) for use with ventilators and anesthesia machines to filter gases and maintain moisture. There is no mention of it being used to diagnose any condition or disease.
No
The device description clearly states it is a physical filter with specific materials and connectors, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes filtration of inspired and expired gases and adding/retaining moisture for the patient's breath. This is a function related to respiratory support and patient care, not the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or screening.
- Device Description: The description details the physical components (filters, connectors, media) and performance characteristics related to filtration and humidification of gases. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD-specific information: There is no mention of analyzing biological specimens, reagents, calibrators, controls, or any other elements typically associated with IVD devices.
The device is clearly intended for use in respiratory support systems (ventilators, anesthesia machines) to manage the air/gas being delivered to and exhaled by the patient. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired and to add maintain and retain moisture for the exhaled breathe of the patient. For adults patients with Tidal Volumes > 150 ml. Intended for use up to 24 hours.
Product codes
73 CAH
Device Description
The EMS HEPA Filter and combined HEPA filter / HME are available in multiple sizes and shapes, recogular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. recoalignar and round, and morporativer for filtration and a foam media for the HME media. Each filter is individually tested for rating performance according to BS 3928 Sodium Flame for Air filters. The "HEPA" performance was in accordance to DOE 3202-97 and ASTM D2986 – DOP.
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
Adults patients with Tidal Volumes > 150 ml.
Intended User / Care Setting
Home, Hospital, Sub-acute Institutions, Emergency services
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial filtration - BFE - Nelson Lab. 99.9999%
Viral filtration - VFE - Nelson Lab. 99.9999%
Humidification output (mg H2O/l) 27 mg H₂O /L at TV of 500 cc, where applicable
DOE 3202-97 and ASTM D2986 - DOP 99.97%
Predicate Device(s)
Mallinckrodt Sterivent and Sterivent "S"- K941676, Mallinckrodt - Hygroster - K941585, Mallinckrodt Hygrobac "S" - K941381, ARC Medical Filter - K011212, Allegiance Two Way HEPA - K011132, SIMS Filter - K002201
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).
0
| MAR 1 4 2002 | |
|---|---|
| -- | -------------- |
Engineered Medical Systems, Inc. 2055 Executive Dr. Indianapolis, IN 46241
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 March 13, 2002
| Engineered Medical Systems
2055 Executive Dr.
Indianapolis, IN 46241 | Tel (317) 246-5500
Fax (317) 246-5501 | | | |
|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Official Contact: | Bonnie Holly - Quality Manager | | | |
| Proprietary or Trade Name: | EMS HEPA Filter and HEPA Filter / HME | | | |
| Common/Usual Name: | Bacterial / Viral Filter and Heat and Moisture Exchanger | | | |
| Classification Name: | Filter, Bacterial, Breathing Circuit, CAH | | | |
| Predicate Devices: | Mallinckrodt Sterivent and Sterivent "S"- K941676
Mallinckrodt - Hygroster - K941585
Mallinckrodt Hygrobac "S" - K941381
ARC Medical Filter - K011212
Allegiance Two Way HEPA - K011132
SIMS Filter - K002201 | | | |
Device Description
The EMS HEPA Filter and combined HEPA filter / HME are available in multiple sizes and shapes, recogular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. recoalignar and round, and morporativer for filtration and a foam media for the HME media. Each filter is individually tested for rating performance according to BS 3928 Sodium Flame for Air filters. The "HEPA" performance was in accordance to DOE 3202-97 and ASTM D2986 – DOP.
| Intended Use | |
|---|---|
| Indicated Use -- | For use with ventilators, anesthesia machines, and open flow |
| systems where filtration of inspired and / or expired gases is | |
| desired and to add maintain and retain moisture for the exhaled | |
| breathe of the patient. For adults patients with Tidal Volumes |
150 ml. Intended for use up to 24 hours. |
| Environment of Use -- | Home, Hospital, Sub-acute Institutions, Emergency services |
| | Non-Confidential Summary of Safety and Effectiveness |
1
Page 2 of 2 March 13, 2002
General Technical Characteristics
| Attribute | EMS - Proposed devices |
|---|---|
| Indications for use - To filter inspired and / or expired gases. | Same |
| Intended for single patient, up to 24 hours | Yes |
| Prescription | Yes |
| Intended population | Any patient |
| Intended Environment of Use | Home, Hospital, sub-acute, Emergency services |
| Placement in various locations in circuit | Yes |
| Design | |
| Gas sampling port | Yes |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | 45 to 80 ml |
| Resistance to flow |