ALERKAN SPIROMETRY FILTER

K111587 · Alerkan, Ltd. · BZG · Oct 20, 2011 · Anesthesiology

Device Facts

• Record ID: K111587
• Device Name: ALERKAN SPIROMETRY FILTER
• Applicant: Alerkan, Ltd.
• Product Code: BZG · Anesthesiology
• Decision Date: Oct 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2

Intended Use

For use with pulmonary function testing (PFT) equipment only. To filter air between the patient's exhaled air and the testing equipment. Single patient use, single session, and disposable. Maximum duration of use is 24 hrs.

Device Story

Alerkan Spirometry Filters (Models 9502, 9503, 9504, 9505) are disposable, single-patient, single-session filters designed for use with pulmonary function testing (PFT) equipment. The device acts as a physical barrier to filter air between the patient's exhaled breath and the PFT device. Used in hospitals, sub-acute institutions, doctor's offices, and laboratories. Operated by healthcare professionals during PFT procedures. The filter prevents cross-contamination between patients and protects the testing equipment. Maximum duration of use is 24 hours.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable, single-patient use filters. Available in four models (9502, 9503, 9504, 9505) with varying port sizes (ID/OD) to ensure compatibility with specific PFT equipment brands including Viasys, SensorMedics, Jaeger, MIR, Zan, nSpire, Micro Medical, Datospir, and KoKo series. Mechanical filtration principle. No software or electronic components.

Indications for Use

Indicated for adult patients undergoing pulmonary function testing (PFT) to filter exhaled air between the patient and the testing equipment.

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.

Submission Summary (Full Text)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service .

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 2 0 2011

Alerkan LTD C/O Mr. Glen Feye President Accurate Consultants, Incorporated 1340 West Pennsylvania Avenue San Diego, California 92013

Re: K111587

Trade/Device Name: Alerkan Spirometry Filters - Models 9502, 9503, 9504, and 9505 Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: October 11, 2011 Received: October 17, 2011

Dear Mr. Feye:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Feye

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Cim

Anthony D. Watson, B.S., M.S., M.B.A. 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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#### Section 4

#### INDICATIONS FOR USE

#### 510(k) Number (if known):

#### Alerkan Spirometry Filters- Models 9502, 9503, 9504, and 9505 Device Name:

Indications for Use: For use with pulmonary function testing (PFT) equipment only. To filter air between the patient's exhaled air and the testing equipment. Single patient use, single session, and disposable. Maximum duration of use is 24 hrs.

Adaptable for use with the following PFT equipment

| Model | Standard Port Sizes | PFT Device Compliance |
|-------|---------------------------------------------------------------|---------------------------------------------------------------------------------|
| 9502 | Approx. 30mm ID X 34 mm OD | Fits Viasys, SensorMedics, Jeager |
| 9503 | Approx. 26.5 mm ID X 30 mm OD | Fits MIR, Zan, nSpire, Micro Medical,<br>Datospir |
| 9504 | Approx. 45mm ID X 48.5 mm OD | Fits Koko Spirometer, KoKo Legend,<br>KoKoDigidoser and Koko Trek |
| 9505 | Approx. 30mm ID X 34 mm OD &<br>Approx. 26.5 mm ID X 30 mm OD | Fits Viasys, SensorMedics, Jeager, MIR,<br>Zan, nSpire, Micro Medical, Datospir |

Environment of Use -- Hospital, Sub-acute Institutions, Doctor's offices, Laboratories

Target Patient Populations: Adults

Prescription Use V. (Part 21 CFR 801 Subpart D AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Azhulthea

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

510(k) Number: K111587