EMS PULMONARY FUNCTION TESTING FILTER

K013123 · Engineered Medical Systems · BZG · Mar 14, 2002 · Anesthesiology

Device Facts

• Record ID: K013123
• Device Name: EMS PULMONARY FUNCTION TESTING FILTER
• Applicant: Engineered Medical Systems
• Product Code: BZG · Anesthesiology
• Decision Date: Mar 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2

Intended Use

For use with pulmonary function testing. To filter air between the patient's exhaled air and the testing equipment. Single patient use.

Device Story

The EMS PFT Filter is a compact, single-patient-use electrostatic filter designed for integration into pulmonary function testing (PFT) circuits. It acts as a barrier between the patient's exhaled air and the testing equipment to prevent cross-contamination. The device features a polystyrene housing and electrostatic polypropylene filter media, with various end-fittings to ensure compatibility with multiple PFT machine models. It is intended for use in hospital and sub-acute institutional settings by healthcare professionals. By filtering exhaled air, the device protects the testing equipment and potentially reduces the risk of pathogen transmission between patients during respiratory diagnostic procedures.

Clinical Evidence

Bench testing only. Performance data provided includes bacterial filtration efficiency (99.9999%), viral filtration efficiency (99.999%), and resistance to flow (0.7 cm H2O at 720 lpm; 0.5 cm H2O at 60 lpm).

Technological Characteristics

Compact electrostatic filter. Materials: Polystyrene housing, electrostatic polypropylene filter media. Deadspace: 75 ml. Resistance: 0.7 cm H2O at 720 lpm; 0.5 cm H2O at 60 lpm. Single patient use. Various end-fittings for PFT equipment compatibility.

Indications for Use

Indicated for use with pulmonary function testing for any patient requiring such testing. Single patient use. Prescription use only.

Regulatory Classification

Identification

A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

Predicate Devices

• Pulmonary Data Services - KoKo (K934475)

Submission Summary (Full Text)

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Premarket Notification 510(k)

Section 2 - Certifications and Summaries

### MAR 1 4 2002

EMS PFT Filtcr

1013123

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

### Non-Confidential Summary of Safety and Effectiveness

Page i of 2 March 7, 2002

| EMS | Tel [phone] |
|----------------------------|------------------------------------------|
| 2055 Executive Dr. | Fax [phone] |
| Indianapolis, IN 46241 | |
| Official Contact: | Bonnic Holly - Quality Manager |
| Proprietary or Trade Name: | EMS Pulmonary Function Testing Filter |
| Common/Usual Name: | PFT filter |
| Classification Name: | Filter, Bacterial, Breathing Circuit |
| Predicate Devices: | Pulmonary Data Services - KoKo – K934475 |

#### Device Description:

The EMS PFT Filter is acompact, electrostatic filter with various end-fitting adaptable to various pulmonary function testing circuits. It has 75 ml deadspace and resistance of 07. cm H2O at 720 Ipm per ATS spirometry or 0.5 cm I-120 @ 60 lpm. There are various connectors to allow connection to various PFT equipment. Single patient use.

| Intended Use: | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Indicated Use -- | For use with pulmonary function testing. To filter<br>air between the patient's exhaled air and the testing<br>equipment. Single patient use. |
| Environment of Use -- | Hospital, Sub-acute Institutions |

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# Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2

March 7, 2002

### Comparison to Predicate Devices:

| | EMS Proposed device<br>Filter - Model # 5813 | Predicate PDS KoKo<br>K934475 |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Attribute | | |
| Intended use | For use with pulmonary function<br>testing. To filter<br>air between the patient's exhaled<br>air and the testing<br>equipment | Same |
| Intended for single patient | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population | Any patient | Same |
| Intended Environment of Use | Hospital, sub-acute | Same |
| Can be used with several<br>different PFT machines | Yes | Yes |
| Design Features | | |
| Compact housing | Yes | Yes |
| Various end-fittings | Yes | Yes |
| Dead Space (ml) | 75 ml | 60 ml |
| Resistance to flow at 720 lpm<br>per ATS standard for<br>spirometry | 0.7 cm H2O | <1.5 cm H2O |
| Resistance to flow at 60 lpm | 0.5 cm H2O | <1.5 cm H2O |
| Bacterial filtration | 99.9999% | 99.99+% |
| Viral filtration | 99.999+% | 99.99+% |
| Weight | 40 gm | N/A |
| Materials | | |
| Housing polystyrenc | Yes | Yes |
| Filter media | Electrostatic polypropylene | Electrostatic polypropylene |
| Performance | | |
| None under Section 514 | Yes | Yes |

# Differences between Other Legally Marketed Predicate Devices

There are no significant differences between the intended device and the predicates -- PDS -- Koko K934475.

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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 consists of a stylized eagle with its wings spread, and three horizontal bars below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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: K013123

Pulmonary Function Testing Filter Regulation Number: 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II (two) Product Code: BZG Dated: December 14, 2001 Received: December 17, 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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Premarket Notification 510(k) Section 2 - Certifications and Summaries

adications for Use

EMS Pulmonary Function Filter

Page 1 of 1

(To be assigned) K013123

Device Name:

510(k) Number:

Intended Use:

For use with pulmonary function testing. To filter air between the patient's cxhaled air and the testing equipment.

Single patient use.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013123

**Prescription Use - XX**
(Per CFR 801.109)

or

Over-the-counter use _________________________________________________________________________________________________________________________________________________________