EMS ELECTROSTATIC FLITER AND HME COMBINATION

K013122 · Engineered Medical Systems · CAH · Apr 19, 2002 · Anesthesiology

Device Facts

• Record ID: K013122
• Device Name: EMS ELECTROSTATIC FLITER AND HME COMBINATION
• Applicant: Engineered Medical Systems
• Product Code: CAH · Anesthesiology
• Decision Date: Apr 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

EMS Electra Filter and Filter/HME are breathing circuit accessories; incorporate electrostatic polypropylene media for bacterial/viral filtration and foam media for heat and moisture exchange (HME). Devices feature standard 15/22 mm connectors and gas sampling luer ports. Used in hospitals, homes, sub-acute institutions, and emergency services; operated by clinicians or caregivers. Device placed in breathing circuit to filter inspired/expired gases and retain moisture for exhaled breath. Benefits include reduced risk of cross-contamination and maintenance of airway humidity. Output is filtered, humidified gas delivered to patient.

Clinical Evidence

Bench testing only. Performance validated via Nelson Laboratories for bacterial (BFE 99.999+%) and viral (VFE 99.99+%) filtration efficiency. Humidification output tested per ISO 9360 (32 mg H2O/L for adult/pediatric; 30 mg H2O/L for neonate). Resistance to flow verified at specified lpm for each patient population.

Technological Characteristics

Housing: Polystyrene. Filter media: Electrostatic polypropylene. Connectors: ISO 5356-1 (15/22 mm). Luer fittings: ISO 594-2. HME performance: ISO 9360. Dead space: 10-65 ml. Weight: 10-35 gm. Passive filtration/humidification; no energy source or software.

Indications for Use

Indicated for patients requiring mechanical ventilation, anesthesia, or open flow gas systems. Supports neonates (20-70 cc tidal volume), pediatric (70-250 cc), and adults (>150 cc). Intended for single-patient use up to 24 hours.

Regulatory Classification

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.

Predicate Devices

• Mallinckrodt - Barrierbac "S" (K941536)
• Mallinckrodt - Hygrobac "S", Hygroboy, Hygrobaby (K941381)
• SIMS Filter (K002201)

Submission Summary (Full Text)

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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 Systems | Tel [phone] |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| 2055 Executive Dr. | Fax [phone] |
| 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<br>Mallinckrodt - Hygrobac "S", Hygroboy, Hygrobaby – K941381<br>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<br>systems where filtration of inspired and / or expired gases is<br>desired and to add maintain and retain moisture for the exhaled<br>breathe of the patient. Model with tidal volumes ranging from<br>20-70 cc for neonate, 70-250 cc for pediatric and >150 cc for<br>adults. Use up to 24 hours. |
| Environment of Use -- | Home, Hospital, Sub-acute Institutions, Emergency services |

- - -

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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

| Attribute | EMS - Proposed devices |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Indications for use - To filter inspired and / or<br>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) | 10 to 65 ml |
| Resistance to flow | ≤3 cm H2O @ 60 lpm - Adult<br>1.0 cm H2O @ 20 lpm - Pediatric<br>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<br>32 mg H2O/L at TV of 250 cc - pediatric<br>30 mg H2O/L at TV of 50 cc - neonate |
| Tidal volume ranges | 20-70 cc - neonate<br>70-250 cc - pediatric<br>> 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.

.

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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