K Number

Device Name

WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]

Manufacturer

Westmed, Inc.

Date Cleared

2012-12-06

(212 days)

Product Code

CAH

Regulation Number

868.5260

Intended Use

The Westmed, Inc. BlockAide™ Filter is designed as a disposable and single-use, bi-directional filter for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary function testing instruments, associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. The device is indicated for diagnostic applications.

Device Description

The BlockAide™ Filter, manufactured by Westmed, Inc., is a disposable, single-use barrier type, bi-directional filter fabricated from a plastic resin that is supplied to the customer packaged and non-sterile. Fabricated with a filtering medium that is highly effective in reducing the numbers of both bacterial and viral contaminates that may be present in a patient's exhaled gas, the device's design also minimizes the resistance to air flow. The product is intended to protect both the patient and pulmonary function instruments from potential transmission of pathogens by droplets and aerosols. The device consists of two molded plastic housings enclosing a disk of filter media. To avoid confusion, the patient housing side is made from an opaque plastic and the machine housings are fabricated from the same plastic but with different number molded into the housing to identify machine end. The numbered end fits the machine and the opaque end is for the patient side; therefore making clear definition as to which end is used for the patient and the machine.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K043148, K973314, K934475, K934272, K951410

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical filter with no mention of software, algorithms, or data processing capabilities that would indicate the use of AI/ML.

Therapeutic

No
The device is described as a bi-directional filter for use in reducing bacterial and/or viral cross contamination of spirometers and pulmonary function testing instruments, indicated for diagnostic applications, not for treating a disease or condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "The device is indicated for diagnostic applications."

SaMD (Software as a Medical Device)

The device description clearly states it is a physical filter fabricated from plastic resin and filter media, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The primary intended use is to reduce cross-contamination of spirometers and pulmonary function testing instruments. While it's used in a diagnostic application (pulmonary function testing), the device itself is a physical barrier filter, not a test or reagent used to examine specimens from the human body to provide information for diagnosis.
Device Description: The description clearly states it's a "barrier type, bi-directional filter." It physically filters air, it doesn't analyze biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other components typically associated with IVD devices.
Performance Studies: The performance studies focus on filtration efficiency (bacterial and viral), airflow resistance, and biocompatibility – metrics relevant to a physical filter, not an IVD.

While the device is used in a diagnostic setting, its function is to protect the equipment and patient from contamination, not to perform a diagnostic test on a biological sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

73 CAH

Device Description

The device consists of two molded plastic housings enclosing a disk of filter media. To avoid confusion, the patient housing side is made from an opaque plastic and the machine housings are fabricated from the same plastic but with different number molded into the housing to identify machine end. The numbered end fits the machine and the opaque end is for the patient side; therefore making clear definition as to which end is used for the patient and the machine.

Because spirometers can have different sensor diameters, the BlockAide™ Filter is available in six different sizes with a number that correlates with their respective part numbers.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-Clinical Tests:

Bacterial Filtration Efficiency (BFE) testing demonstrated the BlockAide™ Filter, at an increased challenge, to be %BFE = > 99.9%. Viral Filtration Efficiency (VFE) testing demonstrated the BlockAide™ filter, at an increased challenge, to be %VFE = > 99.9%.
Airflow resistance testing demonstrated the device to an average of 5.028 cm H2O/SLPM at 720 L. (Ref. 760 mm HGA 70 degrees F), which is approximately 0.419 cm H2O/L/sec.
Filter dead space was demonstrated to be approximately 54 mL.
The BlockAide™ Filter meets the recommendations of the American Thoracic Society's Standardization of Spirometry (1994 update) for minimal recommendations for Diagnostic Spirometry Equipment with in-line filters i.e., that the measuring equipment as attached to the filter have air flow resistance of less than 1.5cm H2O/L/s.
The device was categorized as a surface device with skin and mucosal membrane and as an external communicating device with tissue contact both for limited 99.9%
Viral Filtration Efficiency (VFE): > 99.9%
Airflow resistance: average of 5.028 cm H2O/SLPM at 720 L (approx. 0.419 cm H2O/L/sec)
Filter dead space: approx. 54 mL

Predicate Device(s)

K043148, K973314, K934475, K934272, K951410

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).

Summary

4.0 510(k) Summary

In accordance with 21 CFR sections 807.92, Westmed, Inc. is submitting the following 510(k) summary:

K1773

DEC

ﮯ ۔

Date of Preparation 4.1

May 18, 2012

Submitter Information: 4.2

Westmed, Inc. Company Representative: R. Jon McKinnon, President 5580 S. Nogales Highway Tucson, AZ 85706 United States USA FDA Registration No .: 2028807 Owner / Operator No .: 9006543

Preparer of Submission and Contact for Information: 4.2

Westmed, Inc 5580 S. Nogales Highway Tucson, AZ 85706 United States Telephone: (800) 724-2328 / Fax: (520) 294-2780

R. Jon McKinnon (contact for correspondence and information) Telephone: (800) 724-2328 / Fax (520) 294-2780

4.3 Name of Device:

Proprietary Name:	BlockAide™ Filter.
Common Name:	Disposable bacterial/viral filter.
Classification Name:	Breathing circuit bacterial filter, [21 CFR 868.5260(a)].
Regulation Number:	21 CFR 868.5260(a) for Breathing circuit bacterial
filters.
Product Code:	73 CAH
Class:	Class II (performance standards)

Page 9 of 115

Substantial Equivalence: 4.4

This submission establishes the substantial equivalence of the Westmed, Inc. BlockAide™ Filter to five predicate devices:

The All Flow Pulmonary Filter, (1)
K043148, SE letter: 12/13/04.
The SpiroSafe Disposable PF Filter, (2) (3)
K973314, SE letter: 11/21/97. K934475, SE letter: 10/21/93.
The KOKO Disposable PF Filter II, The MicroGard Disposable PF Filter,
- K934272, SE letter: 11/24/93.
The MultiSPIRO Disposable PF Filter, K951410, SE letter: 04/24/95. (5)

Description of the Device: 4.5

(4)

Figure I Example of Filter Part No. 6901-E with patient and machine housing components separated:

Image /page/1/Picture/14 description: The image shows three circular objects on a dark background. Two of the objects appear to be the lids of containers, with intricate designs and a hole in the center. The third object is a solid, round disc with a textured surface, and an arrow points towards it.

Opaque machine housing with number

Filter medium Page 10 of 115 Opaque patient housing with mp

Figure 2, Example of filter assembled:

Image /page/2/Picture/2 description: The image shows a dark, grainy photo of a vase. The vase is dark in color and has a rounded body with a cylindrical neck. The background is black, which makes it difficult to see the details of the vase. The image is low quality and has a lot of noise.

Because spirometers can have different sensor diameters, the BlockAide™ Filter is available in six different sizes with a number that correlates with their respective part numbers. The following chart lists the size and number of each model:

Filter Chart

| BlockAide™ Filter
Part No. | number combination
(patient housing / machine
housing) | I.D / O.D (mm) |
|-------------------------------|--------------------------------------------------------------|----------------|
| 6901-R/E | Opaque / Opaque 1 | 27.23 / 30.18 |
| 6902-R/E | Opaque / Opaque 2 | 34.48 / 33.15 |
| 6903-R/E | Opaque / Opaque 3 | 45.47 / 47.45 |
| 6904-R/E | Opaque / Opaque 4 | 26.26 / 28.73 |
| 6905-R/E | Opaque / Opaque 5 | 29.52 / 32.77 |
| 6906-R/E | Opaque / Opaque 6 | 37.39 / 33.63 |

Intended Use of the Device: 4.6

The BlockAide™ Filter is designed as a disposable and single-use bi-directional filter for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary function testing instruments, associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. The device is indicated for diagnostic purposes.

Technological Characteristics in Comparison to the Predicates: 4.7

The BlockAide™ Filter has no differences in Technological characteristics and is substantially equivalent to the five predicate devices with respect to the following design characteristics and functions:

The devices are intended for use in reducing the possible cross contamination 1. of spirometers and pulmonary function testing instruments from bacterial and/or viral pathogens by droplets, particulates, and/or aerosols.

The devices function as a barrier type, bi-directional filter, which is within a 2. sealed double port assembly, with one port contacting the patient's mouth and the other port to be attached to the spirometers or pulmonary function-testing instrument.
The device housing components are fabricated from the same or similar 3. The 'donoo noderials used in the predicate devices. The filter media is the same as or similar to that used in the predicate devices. These materials have long and extensive use in medical device applications.
The devices have been demonstrated to function effectively in reducing high 4. challenge numbers of bacterial and viral contaminates.
The devices provide air filtration while minimizing alrflow resistance through ട്. the filter assemblies to the pulmonary test equipment.
The BlockAide™ Filter met the recommendations of the American Thoracic 6. Society's Standardization of Spirometry (1994 update) for minimal Society S - Otandardization - of Spirometry Equipment with in-line filters; i.e., that the measuring equipment as attached to the filter have air flow resistance of less than 1.5 cm H₂O/L/s.

Conclusions drawn from the Non-Clinical Tests: 4.8

Data provided in this submission indicate that the basic functional characteristics of the BlockAide™ Filter are substantially equivalent to those of the predicate devices.

Bacterial Filtration Efficiency (BFE) testing demonstrated the BlockAide™ Filter, at an increased chailenge, to be %BFE = > 99.9%.
Viral Filtration Efficiency (VFE) testing demonstrated the BlockAide™ filter, at an increased challenge, to be %VFE = > 99.9%.
Airflow resistance testing demonstrated the device to an average of 5.028 cm ' 2. H2O/SLPM at 720 L. (Ref. 760 mm HGA 70 °F), which is approximately 0.419 cm H2O/L/sec.
Filter dead space was demonstrated to be approximately 54 mL. 3.
The BlockAide™ Filter meets the recommendations of the American Thoracic 4. Society's Standardization of Spirtometry (1994 update) for minimal recommendations for Diagnostic Spirometry Equipment with in-line filters i.e., that the measuring equipment as attached to the filter have air flow resistance of less than 1.5cm H2O/L/s.
The device was categorized as a surface device with skin and mucosal 5. membrane and as an external communicating device with tissue contact both for limited