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.

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).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the NeumoFilt Ergo and NeumoFilt BiteOn devices, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Predicate: Air Safety Model 2800 PFT filter (K051712))	Reported Device Performance (NeumoFilt PFT Filter)
Resistance to flow @ 1 l/sec	0.5 cm H2O	0.56 cmH2O
Resistance to flow @ 5 or 12 l/sec	0.7 cm H2O @ 12 l/sec	0.74 cmH2O @ 5 l/sec
Resistance to flow @ 14 l/sec	Not reported	1.47 cmH2O
Bacterial Filtration Efficiency (BFE)	99.9999%	99.9998%
Viral Filtration Efficiency (VFE)	99.999+%	99.9939%
Weight (gm)	40 grams	30 grams
Internal volume / Dead space	75 ml	70 ml (Ergo), 68 ml (BiteOn)
Housing Burst Pressure	Not reported	> 120 cm H2O
Biocompatibility	Not reported (implied to be acceptable)	Tested per ISO 10993 (Cytotoxicity, Sensitization, Irritation)

Notes on the Table:

Acceptance Criteria for Resistance to Flow: The document primarily uses the predicate's reported values as the basis for substantial equivalence, with an additional measurement for the NeumoFilt at 14 l/sec which wasn't reported for the predicate. The ATS standard for spirometry is mentioned for flow rates, implying these values are compared against that standard.
"Not Reported" for Acceptance Criteria: For some items (like Housing Burst Pressure and Biocompatibility), the predicate's values are not explicitly stated as "acceptance criteria" but rather as "not reported." The NeumoFilt's performance in these areas is presented as additional testing to demonstrate safety and efficacy.
Small Differences: The document explicitly states that "The slight differences in BFE / VFE, weight, and Dead Space do not raise any new safety concern and thus can be considered substantially equivalent."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not explicitly state the sample size (number of filters) used for the performance testing (Resistance to flow, BFE, VFE, Dead space, Housing burst strength, Age testing). It refers to "a number of non-clinical tests" and "performance data and testing."
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It only states that the tests were performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the device is a physical medical filter, not an AI/software device that requires expert review for ground truth establishment. The performance is measured through laboratory tests against established standards (e.g., MIL-M-36954C for BFE/VFE, ATS standard for spirometry for resistance to flow, ISO 10993 for biocompatibility).

4. Adjudication Method for the Test Set

This section is not applicable as the performance is measured through objective laboratory tests, not through subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable as the device is a physical medical filter and not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable as the device is a physical medical filter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of this device is established through:

Objective Laboratory Measurements: For resistance to flow, BFE, VFE, dead space, weight, and housing burst strength. These are quantifiable physical properties.
Standardized Biocompatibility Testing: According to ISO 10993.

8. The Sample Size for the Training Set

This section is not applicable as the device is a physical medical filter and does not involve a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable as the device is a physical medical filter and does not involve a training set for an algorithm.

Summary

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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.

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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

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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)

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)

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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)

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)

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510(k) Summary Page 1 of 4 8-Nov-14

Medical Respiratory Devices S.L.Avda. de las Americas 4, Nave A728823 Coslada (Madrid) SPAIN	Telephone: +34 91 6745003
Official Contact:	Jose Alberto HernandezGeneral Manager
Proprietary or Trade Name:	NeumoFilt ErgoNeumoFilt 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.

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510(k) Summary Page 2 of 4 8-Nov-14

Features	ProposedNeumoFilt PFT Filter	PredicateAir Safety Model 2800 PFT Filter(K051712)
Indications for use	For use with pulmonary function testing(PFT) equipment only, to filter airbetween the patient's exhaled air and thetesting equipment. Single patient use,disposable. Duration of use < 24 hours.Environment of use: Hospital, Sub-acutefacilities, Clinics, Physician offices.	Model 2800 is indicated for use withpulmonary function testing equipment,to filter air between the patient'sexhaled air and the testing equipment.
Patient Use / Duration ifuse	Single patient use, disposable,< 24 hours	Single patient use, disposable,< 24 hours
Environment of Use	Hospital, Sub-acute facilities, Clinics,Physician offices	Hospital, Sub-acute facilities,Physician offices
Patient Population	No specific limitations	No specific limitations
Contraindications	None	None
Features, Specifications and Performance
Can be used with severaldifferent PFT machines	Yes	Yes
Various sizes of machineside end fittings – 30, 33,35, 36, 48 mm	Yes	Yes
Patient uses amouthpiece or biteblock	Yes	Yes
Filtration method	Electrostatic	Electrostatic
Resistance to flow @ 1,5, 14 l/sec per ATSstandard for spirometry	0.56 cmH2O @ 1 l/sec0.74 cmH2O @ 5 l/sec1.47 cmH2O @ 14 l/sec	0.5 cm H2O @ 1 l/sec0.7 cm H2O @ 12 l/sec
Bacterial FiltrationEfficiency (BFE)	99.9998%	99.9999%
Viral FiltrationEfficiency (VFE)	99.9939%	99.999+%
Weight (gm)	30 grams	40 grams
Internal volume/Dead space	70 ml – Ergo68 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 10993CytotoxicitySensitizationIrritation	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.

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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

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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.

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
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.(b)
Classification. Class II (performance standards).