EMS HEPA FILTER AND HME COMBINATIONS

K013089 · Engineered Medical Systems · CAH · Mar 14, 2002 · Anesthesiology

Device Facts

• Record ID: K013089
• Device Name: EMS HEPA FILTER AND HME COMBINATIONS
• Applicant: Engineered Medical Systems
• Product Code: CAH · Anesthesiology
• Decision Date: Mar 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

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. For adults patients with Tidal Volumes > 150 ml. Intended for use up to 24 hours.

Device Story

Device is a breathing circuit filter and heat/moisture exchanger (HME) used in ventilators, anesthesia machines, and open flow systems. It incorporates standard 15/22 mm connectors and a gas sampling luer port. The device filters inspired/expired gases and retains moisture from exhaled breath using paper fiber filter media and foam HME media. Used in hospitals, homes, sub-acute institutions, and emergency services; operated by clinicians or caregivers. Output is filtered, humidified gas delivered to the patient. Benefits include protection against bacterial/viral contamination and maintenance of airway moisture for patients with tidal volumes > 150 ml.

Clinical Evidence

Bench testing only. Performance validated via Nelson Lab testing for bacterial and viral filtration efficiency (99.9999%). Moisture output tested per ISO 9360 (27 mg H2O/L at 500 cc tidal volume). Air filtration performance tested per BS 3928 and ASTM D2986 (99.97% DOP).

Technological Characteristics

Polystyrene housing; paper fiber filter media; foam HME media. Standard 15/22 mm conical connectors (ISO 5356-1); luer gas sampling port (ISO 594-2). Dead space 45-80 ml; weight 27-35 gm. Passive filtration/humidification; no energy source. Complies with ISO 9360 for moisture output.

Indications for Use

Indicated for adult patients with tidal volumes > 150 ml requiring filtration of inspired/expired gases and moisture retention during ventilation, anesthesia, or open flow system use. 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 Sterivent and Sterivent "S" (K941676)
• Mallinckrodt Hygroster (K941585)
• Mallinckrodt Hygrobac "S" (K941381)
• ARC Medical Filter (K011212)
• Allegiance Two Way HEPA (K011132)
• SIMS Filter (K002201)

Submission Summary (Full Text)

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| | MAR 1 4 2002 |
|--|--------------|
|--|--------------|

### Engineered Medical Systems, Inc. 2055 Executive Dr. Indianapolis, IN 46241

K013089

# Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 March 13, 2002

| Engineered Medical Systems<br>2055 Executive Dr.<br>Indianapolis, IN 46241 | Tel [phone]<br>Fax [phone] | | | |
|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| 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<br>Mallinckrodt - Hygroster - K941585<br>Mallinckrodt Hygrobac "S" - K941381<br>ARC Medical Filter - K011212<br>Allegiance Two Way HEPA - K011132<br>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<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. For adults patients with Tidal Volumes<br>> 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 |

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### 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 | < 3.4 cm H2O @ 60 lpm |
| Bacterial filtration - BFE - Nelson Lab. | 99.9999% |
| Viral filtration - VFE - Nelson Lab. | 99.9999% |
| Weight (gm) | 27 to 35 gm |
| Humidification output (mg H2O/l) | 27 mg H₂O /L at TV of 500 cc, where applicable |
| Materials | |
| Housing polystyrene | Yes |
| Filter media | Paper fiber |
| 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 |
| DOE 3202-97 and ASTM D2986 - DOP | 99.97% |

# Differences between Other Legally Marketed Predicate Devices

The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2002

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

Re: K013089

EMS HEPA Filter and HME Combinations (model # 5804, 5805 and 5814) Regulation Number: 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II (two) Product Code: 73 CAH Dated: December 13, 2001 Received: December 14, 2001

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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 forth in the quality systems (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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 Division of 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,

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 2.3 | Indications for Use | | |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-------------|
| | | | Page 1 of 1 |
| 510(k) Number: | K013089 | (To be assigned) | |
| Device Name: | EMS HEPA and HEPA / HME | | |
| Intended Use: | For use with ventilators, anesthesia machines and<br>open flow systems where filtration of inspired and / or<br>expired gases is desired and to add maintain and retain<br>moisture for the exhaled breathe of the patient | | |

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013084

**Prescription Use**
(Per CFR 801.109)

or

Over-the-counter use ___