K Number
K013122
Device Name
EMS ELECTROSTATIC FLITER AND HME COMBINATION
Date Cleared
2002-04-19

(212 days)

Product Code
Regulation Number
868.5260
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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. Model with tidal volumes ranging from 20-70 cc for neonate, 70-250 cc for pediatric and >150 cc for adults. Use up to 24 hours.
Device Description
The EMS Filter and combined Filter / HME are available in multiple sizes and shapes, rectangular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. The depth filter uses electrostatic media for filtration and a foam media for the HME media.
More Information

No
The summary describes a passive filter and HME device with no mention of computational or adaptive capabilities.

No.
The device's primary functions are filtration and humidification of gases for patients on ventilators or anesthesia machines. While these functions support a patient's physiological needs, they are not directly therapeutic in the sense of treating a disease or condition but rather supporting ventilation.

No

The device is described as a filter and HME (Heat and Moisture Exchanger) used with ventilators and anesthesia machines for gas filtration and moisture retention. Its performance metrics relate to filtration efficiency and humidification output, not to diagnosing a medical condition.

No

The device description clearly describes a physical filter and HME with specific materials and connectors, indicating it is a hardware device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes a device used with ventilators, anesthesia machines, and open flow systems to filter and humidify inspired and expired gases. This is a function related to respiratory support and gas management, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
  • Device Description: The device description details a filter and filter/HME with specific connectors and media for filtration and humidification. This aligns with a respiratory accessory, not an IVD.
  • Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), reagents, or diagnostic procedures.

Therefore, this device falls under the category of a medical device used in respiratory care, not 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. Model with tidal volumes ranging from 20-70 cc for neonate, 70-250 cc for pediatric and >150 cc for adults. Use up to 24 hours.

Product codes

CAH

Device Description

The EMS Filter and combined Filter / HME are available in multiple sizes and shapes, rectangular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. The depth filter uses electrostatic media for filtration and a foam media for the HME media.

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

neonate, pediatric, adult

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

Not Found

Key Metrics

Bacterial filtration - BFE - Nelson Lab.: 99.999+%
Viral filtration - VFE - Nelson Lab.: 99.99+%
Humidification output:
32 mg H2O/L at TV of 1000 cc - adult
32 mg H2O/L at TV of 250 cc - pediatric
30 mg H2O/L at TV of 50 cc - neonate

Predicate Device(s)

Mallinckrodt - Barrierbac "S" – K941536, Mallinckrodt - Hygrobac "S", Hygroboy, Hygrobaby – K941381, 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

APR 1 9 2002

EMS Electra

513122

Section 2 - Certifications and Summaries

Premarket Notification 510(k)

Engineered Medical Systems, Inc. 2055 Exceutive Dr. Indianapolis, IN 46241

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 April 2, 2002

Engineered Medical SystemsTel (317) 246-5500
2055 Executive Dr.Fax (317) 246-5501
Indianapolis, IN 46241
Official Contact:Bonnie Holly - Quality Manager
Proprietary or Trade Name:EMS Electra Filter and Filter / HME
Common/Usual Name:Bacterial / Viral Filter and Heat and Moisture Exchanger
Classification Name:Filter, Bacterial, Breathing Circuit, CAH
Predicate Devices:Mallinckrodt - Barrierbac "S" – K941536
Mallinckrodt - Hygrobac "S", Hygroboy, Hygrobaby – K941381
SIMS Filter – K002201

Device Description:

The EMS Filter and combined Filter / HME are available in multiple sizes and shapes, rectangular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. The depth filter uses electrostatic media for filtration and a foam media for the HME media.

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. Model with tidal volumes ranging from
20-70 cc for neonate, 70-250 cc for pediatric and >150 cc for
adults. Use up to 24 hours.
Environment of Use --Home, Hospital, Sub-acute Institutions, Emergency services

1

Premarket Notification 510(k)

EMS Electra

Section 2 - Certifications and Summaries

Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2 April 2, 2002

General Technical Characteristics

AttributeEMS - Proposed devices
Indications for use - To filter inspired and / or
expired gases.Same
Intended for single patient, up to 24 hoursYes
PrescriptionYes
Intended populationAny patient
Intended Environment of UseHome, Hospital, sub-acute, Emergency services
Placement in various locations in circuitYes
Design
Gas sampling portYes
Standard 15/22 mm connectorsYes
Dead Space (ml)10 to 65 ml
Resistance to flow≤3 cm H2O @ 60 lpm - Adult
1.0 cm H2O @ 20 lpm - Pediatric
0.5 cm H2O @ 5 lpm Neonate
Bacterial filtration - BFE - Nelson Lab.99.999+%
Viral filtration - VFE - Nelson Lab.99.99+%
Weight (gm)10 to 35 gm
Humidification output (mg H2O/l)32 mg H2O/L at TV of 1000 cc - adult
32 mg H2O/L at TV of 250 cc - pediatric
30 mg H2O/L at TV of 50 cc - neonate
Tidal volume ranges20-70 cc - neonate
70-250 cc - pediatric

150 cc - adult |
| Materials | |
| Housing polystyrene | Yes |
| Filter media | Electrostatic polypropylene |
| Performance Standards | |
| None under Section 514 | Yes |
| ISO 5356-1 Conical 15/22 | Yes |
| ISO 594-2 Luer Fittings | Yes |
| ISO 9360 - HME moisture output | Yes |

Differences between Other Legally Marketed Predicate Devices

The data within the submission demonstrates that the proposed devices when compared to the I he uata within the submission conference and are substantially equivalent to the predicate devices.

.

2

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol in the center. The symbol appears to be a stylized representation of a human figure or figures, possibly suggesting care or support. The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" clearly visible.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2002

Mr. Paul Dryden Engineered Medical Systems c/o ProMedic, Inc. 6329 W. Waterview Court McCordsville, IN 46055-9501

Re: K013122

EMS Filter and Filter / HME (Model Numbers 5801, 5806, 5807, and 5810) Regulation Number: 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II (two) Product Code: CAH Dated: March 14, 2002 Received: March 15, 2002

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

3

Page 2 – Mr. Paul Dryden

Please be advised that FDA's issuance of a substantial equivalence determination does not mean f that FDA has made a determination that your device complies with other requirements of the Act that 1 Dr Hosal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of R Part 877) its enstems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and my of substantial equivalence of your device of your device to a legally premaince noticated device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the O invi genefit Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dale Tillman, Ph.D.

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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EMS Electra

ndications for Use ಿಂದ ಸಾಮಾನ್ಯ 2017-08-2 ::

Page 1 of 1

510(k) Number:

K013122 (To be assigned)

EMS Filter and Filter / HME

Device Name:

Intended 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.

Various model range with tidal volumes of -20-70 ml for neonate, 70-250 ml for pediatric, and >150 ml for adult

Single patient use for a duration up to 24 hours.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K01322

Prescription Use _XX
(Per CFR 801.109)

Or

Over-the-counter use