ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50

K050424 · Fim Medical · BZG · Jun 23, 2005 · Anesthesiology

Device Facts

• Record ID: K050424
• Device Name: ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50
• Applicant: Fim Medical
• Product Code: BZG · Anesthesiology
• Decision Date: Jun 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Intended to perform spirometry and may be used in hospitals and medical offices or at other locations including homes. The accessory is a Bacterial/Viral Filter designed for single patient use. For use on both adult and pediatric patients.

Device Story

Ergofilter™ SP1 is a single-use, non-sterile bacterial/viral filter accessory for spirometers. It features an anatomical mouthpiece and utilizes 3M™ Filtrete™ electrostatic filtration medium to capture small particles while maintaining low airflow resistance. Used in hospitals, clinics, and home settings by clinicians or patients during spirometry examinations. The device acts as a barrier to reduce cross-contamination between the patient and the spirometry instrument. It is a passive mechanical accessory; it does not process data or provide clinical outputs.

Clinical Evidence

Bench and clinical testing performed. Bench testing confirmed bacterial removal efficiency >99.9% and airflow resistance of 0.60 cmH2O/L/s at 12 L/Sec. Clinical testing results indicated the device is as safe and effective as the predicate.

Technological Characteristics

Bacterial/viral filter with anatomical mouthpiece. Filtration medium: 3M™ Filtrete™ electrostatic polypropylene. Enclosure material: Food contact grade plastic (meets 21CFR177.1520). Non-sterile, single-use. Airflow resistance: 0.60 cmH2O/L/s at 12 L/Sec. Dead volume: 65 ml. Passive mechanical device.

Indications for Use

Indicated for adult and pediatric patients requiring spirometry testing in hospitals, medical offices, or home settings to reduce cross-contamination.

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

• PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER (K934509)

Submission Summary (Full Text)

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KOSOYZY

### JUN 2 3 2005

## EXHIBIT 2 510(k) Summary

FIM Medical

30, rue Camille 69003 Lyon, France Fim(@fim-medical.com Tel + 33 (0)4 72 34 89 89 Fax + 33 (0)4 72 33 43 51

February 10, 2005 Contact: Eric Derei, President

- 1. Identification of the Device: Proprietary-Trade Name: Ergofilter™ SP1 Accessory to Spirolyser SPL-50 Classification Names: Spirometer, diagnostic BZG or Filter, Bacterial, Breathing Circuit, Product Code CAH Common/Usual Name: Filter (accessory to spirometer)
- 2. Equivalent legally marketed devices PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER, K934509
- 3. Indications for Use (intended use) The accessory is a Bacterial/Viral Filter designed for single patient use. For use on both adult and pediatric patients.
- 4. Description of the Device: The Ergofilter™ SP1 filter is a bacterial and viral filter with an anatomical mouthpiece, for spirometers. The filter is a single use, non-sterile filter. A new filter must be used for each new patient and for each new spirometry examination. Operating principle of Filtrete™ 3M™ filtration medium: The filtering medium is manufactured by the 3M company in a clean room; it uses an electrostatic process which attracts small mass particles, while having a very small resistance to arr flow; the density and thickness of the filtration medium itself provides an increased filtration capacity.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices.

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# 6. Comparison to predicate:

| Characteristic | PULMOGUARD<br>DISPOSABLE<br>BATERIAL/VIRAL<br>FILTER K934509 | Ergofilter™ SP1 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Indications for Use | Intended to reduce cross-contamination between the patient and the spirometers and pulmonary function testing instruments. Single patient use. | SAME |
| Intended population | Any patient | SAME |
| Intended environment | Hospital, outpatient, home | SAME |
| Design features | | |
| Compact housing | Yes | SAME |
| Various end fittings | Yes | SAME |
| Filter medium | 3 M electrostatic filtration medium, polypropylene | SAME |
| Enclosure material | Plastic | Food contact grade, meets 21CFR177.1520. |
| Single patient, non-sterile | Yes | SAME |
| Prescription device | Yes | SAME |
| Airflow resistance | $0.862cm H_20/L/Sec$ at 14L/Sec | $0.60cmH_2O/L/s$ at 12 L/Sec |
| Dead volume | 60 ml | 65 ml |
| % of bacterial removal efficiency | >99.7% | >99.9 % |
| Compatibility | Fits Most Adult Spirometers without an Adapter. Adapters Available | SAME |
| Performance standard | NONE | NONE |

#### 7. Conclusion

After analyzing bench, filter effectiveness, and clinical testing data, it is the conclusion of FIM Medical that the Ergofilter™ SP1 Accessory to Spirolyser SPL-50 as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of human figures or silhouettes arranged in a flowing, abstract design. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged around the image.

Public Health Service

JUN 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FIM Medical C/O Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K050424

Trade/Device Name: Ergofilter™ SP1 (Accessory to Spirolyser SPL-50) Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: May 2, 2005 Received: May 10, 2005

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becatermined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendina, or to arrivand Cosmetic Act (Act) that do not require approval of a premarket the Fourth I out, Drag, and ( You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of 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 (1 WI (), It may be bacyoo in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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### Page 2 -- Mr. Kamm

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualites of a substitions with other requirements
mean that FDA has made a determination that your casinos with other peoples mean that FDA has made a decemination had your and inistered by other Federal agencies.
of the Act or any Federal statutes and regulations and mot limited to: registration of the Act or any rederal statues and regirements, including, but not limited to: registration
You must comply with all the Act starts of a 1901) and manufacturing practice You must comply with an the Act 3 requirements and 301); good manufacturing practice and listing (21 CFR Part 807), idocinig (21 CFR Party Books) (21 CFR Pat 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Pat 820); and i requirements as set form in the quality systems (Sections (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)
the success of the color of the color and chargest of your device to a This letter will anow you to begin maineting your and equivalence of your device to a
premarket notification. The FDA finding of substantial equivalers and thus, per premarket notification. The PDA miding of basicines of 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), a If you desire specific advice for your device en a last and the regulation prease contact the Other or Companies and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miormational and Consumer Assistance at its toll-free Division [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sudie Y. Michael MD

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Ergofilter™ SP1 (Accessory to Spirolyser SPL-50) Device Name:

Indications For Use:

Intended to perform spirometry and may be used in hospitals and medical offices or at other locations including homes. The accessory is a Bacterial/Viral Filter designed for single patient use. For use on both adult and pediatric patients.

.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ihm Sulcom

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(Division Sigh-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number _