NeumoFilt Ergo/Neumo Filt BiteOn

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other, resembling a stylized human figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 20, 2014 Medical Respiratory Devices S.L. Mr. Paul Dryden President, PreMedic, Inc. Avda. de las Americas 4, Nave A7 Coslada (Madrid) 28823 SPAIN Re: K142303 Trade/Device Name: NeumoFilt Ergo and NeumoFilt BiteOn Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: October 21, 2014 Received: October 22, 2014 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. 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. {1}------------------------------------------------ Page 2 - Mr. 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); 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K142303 Device Name NeumoFilt Ergo Indications for Use (Describe) 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, disposable. Duraton of use < 24 hours. Environment of use: Hospital, Sub-acute facilities, Clinics, Physician offices. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K142303 Device Name NeumoFilt BiteOn Indications for Use (Describe) 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, disposable. Duraton of use < 24 hours. Environment of use: Hospital, Sub-acute facilities, Clinics, Physician offices. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {4}------------------------------------------------ ### 510(k) Summary Page 1 of 4 8-Nov-14 | Medical Respiratory Devices S.L.<br>Avda. de las Americas 4, Nave A7<br>28823 Coslada (Madrid) SPAIN | Telephone: +34 91 6745003 | |------------------------------------------------------------------------------------------------------|--------------------------------------------| | Official Contact: | Jose Alberto Hernandez<br>General Manager | | Proprietary or Trade Name: | NeumoFilt Ergo<br>NeumoFilt BiteOn | | Common/Usual Name: | Diagnostic Spirometer (Accessory) | | Regulation description: | Diagnostic Spirometer | | Product code: | BZG | | Regulation number: | 21 CFR 868.1840 | | Device class: | Class II | | Predicate Device: | Air Safety Model 2800 PFT filter (K051712) | Device Description: The MRD NeumoFilt pulmonary function filter ("PFT filter") is a standard electrostatic filter that is placed between the patient and the pulmonary function testing equipment to keep a patient inhaled and exhaled breath from contaminating the equipment. There are 2 models with the only difference being the patient end piece which is either a biteblock shape (BiteOn) or the mouthpiece shape (Ergo). 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, disposable. Duration of use < 24 hours. Environment of use: Hospital, Sub-acute facilities, Clinics, Physician offices. ### Contraindications: None ## Substantial Equivalence Rationale: The MRD NeumoFilt is viewed as substantially equivalent to the predicate devices because: Indications - 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, disposable. Duration of use < 24 hours. Environment of use: Hospital, Sub-acute facilities, Clinics, Physician offices. Discussion - This is identical to the predicate - Air Safety Model 2800 PFT Filter - K051712, which is intended for use with pulmonary function testing equipment, to filter air between the patient's exhaled air and the testing equipment. {5}------------------------------------------------ ## 510(k) Summary Page 2 of 4 8-Nov-14 | Features | Proposed<br>NeumoFilt PFT Filter | Predicate<br>Air Safety Model 2800 PFT Filter<br>(K051712) | |---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | For use with pulmonary function testing<br>(PFT) equipment only, to filter air<br>between the patient's exhaled air and the<br>testing equipment. Single patient use,<br>disposable. Duration of use < 24 hours.<br>Environment of use: Hospital, Sub-acute<br>facilities, Clinics, Physician offices. | Model 2800 is indicated for use with<br>pulmonary function testing equipment,<br>to filter air between the patient's<br>exhaled air and the testing equipment. | | Patient Use / Duration if<br>use | Single patient use, disposable,<br>< 24 hours | Single patient use, disposable,<br>< 24 hours | | Environment of Use | Hospital, Sub-acute facilities, Clinics,<br>Physician offices | Hospital, Sub-acute facilities,<br>Physician offices | | Patient Population | No specific limitations | No specific limitations | | Contraindications | None | None | | Features, Specifications and Performance | | | | Can be used with several<br>different PFT machines | Yes | Yes | | Various sizes of machine<br>side end fittings – 30, 33,<br>35, 36, 48 mm | Yes | Yes | | Patient uses a<br>mouthpiece or biteblock | Yes | Yes | | Filtration method | Electrostatic | Electrostatic | | Resistance to flow @ 1,<br>5, 14 l/sec per ATS<br>standard for spirometry | 0.56 cmH2O @ 1 l/sec<br>0.74 cmH2O @ 5 l/sec<br>1.47 cmH2O @ 14 l/sec | 0.5 cm H2O @ 1 l/sec<br>0.7 cm H2O @ 12 l/sec | | Bacterial Filtration<br>Efficiency (BFE) | 99.9998% | 99.9999% | | Viral Filtration<br>Efficiency (VFE) | 99.9939% | 99.999+% | | Weight (gm) | 30 grams | 40 grams | | Internal volume/<br>Dead space | 70 ml – Ergo<br>68 ml - BiteOn | 75 ml | | Housing Burst Pressure | > 120 cm H2O | Not reported | | Performance | None under section 514 | None under section 514 | | Biocompatibility | Tested per ISO 10993<br>Cytotoxicity<br>Sensitization<br>Irritation | Not reported | Technology – The MRD NeumoFilt is an electrostatic media that is equivalent in performance and the fundamental principle of operation as the predicate. Discussion - There are no differences in technology between the proposed device and the predicate Air Safety Model 2800 PFT filter - K051712. {6}------------------------------------------------ ## 510(k) Summary Page 3 of 4 8-Nov-14 Environment of Use - Hospitals, Sub-acute facilities, clinics and physician offices. Discussion - The environment of use is substantially equivalent to the predicate Air Safety Model 2800 PFT filter – K051712. Patient Population - There are no patient specific limitations. Discussion - This is identical to the predicate Air Safety Model 2800 PFT filter - K051712. Performance Specifications - The performance specifications are substantially equivalent to the predicates - Air Safety Model 2800 PFT filter - K051712. Non-clinical Testing - We performed a number of non-clinical tests to demonstrate the safety and efficacy of the MRD NeumoFilt. These tests included: Materials – The materials have been evaluated and tested in accordance with ISO 10993-1 and G95-1. Based upon ISO 10993-1 and G95-1 the NeumoFilt filter would be considered as: - Externally communicating (indirect gas pathway) ● - Tissue contact ● - Limited duration (< 24 hours) . And the housing: - Surface Contact ● - Mucosa contact - Limited duration (< 24 hours) ● We have performed the following tests: - Cytotoxicity ● - Sensitization - Intracutaneous reactivity or Irritation ● Performance Testing - We have performed the following performance data and testing: - Resistance to flow at 1, 5, 14 1/second ● - Bacterial / Viral filtration efficiency per Nelson Laboratories ● - o Pre - and Post - conditioning - Bacterial Filtration Efficiency (BFE) 99.9998% per MIL-M-36954C, S. aureus o ATCC# 6538 of approximately 3.0 micron size, > 107 challenge. - Viral Filtration efficiency (VFE) 99.9939% per MIL-M-36954C. X174 о bacteriophage of approximately 2.9 micron size, > 106 challenge. - Dead space ● - Housing burst strength ● - Age testing ### Discussion of Differences and Similarities - As the above table and rationale present there are no major differences between the proposed NeumoFilt and the predicate. Each filter is operates on the same filtration technology that is placed between two houses. They each connect to PFT testing equipment. The predicate may be used with a separate mouthpiece to make it easier for the user whereas the proposed Ergo design the patient end-fitting is shaped like a mouthpiece thus not requiring a separate piece. Their physical {7}------------------------------------------------ ### 510(k) Summary Page 4 of 4 8-Nov-14 size, design, dimensions are very similar and not considered significantly different as demonstrated by the comparative performance testing. The slight differences in BFE / VFE, weight, and Dead Space do not raise any new safety concern and thus can be considered substantially equivalent. Substantial Equivalence Conclusion - The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.