Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on physical filtration and moisture exchange mechanisms, with no mention of AI or ML technologies.

Therapeutic

No.

Explanation: The devices described (Besmed HME Filter and Besmed Bacterial Filter) are designed to decrease the transmission of bacteria and viruses and maintain moisture levels in the respiratory tract. While they assist in the delivery of other therapies (anesthesia, artificial respiration, ventilation), their primary function is filtration and humidification within the breathing circuit, not direct treatment or alleviation of a disease or condition itself. They are supportive devices rather than therapeutic ones.

Diagnostic

No

The device, a Heat and Moisture Exchange (HME) filter and a Bacterial Filter, is intended to decrease the transmission of bacteria and viruses, maintain moisture levels, and filter gases in the respiratory tract during ventilation or anesthesia. Its function is to modify the air provided to the patient, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical filter made of materials like electrostatic cotton and paper roll, designed to absorb heat and moisture and filter contaminants. 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:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The Besmed HME Filter and Besmed Bacterial Filter are designed to filter gases within a patient's respiratory system during ventilation or anesthesia. They are placed in the breathing circuit and interact with the air/gas being inhaled and exhaled, not with specimens taken from the body.
Intended Use: The intended use clearly states their purpose is to decrease the transmission of bacteria and viruses and maintain moisture levels in the respiratory tract, not to analyze biological samples for diagnostic purposes.

Therefore, these devices fall under the category of respiratory support devices or filters used in medical breathing circuits, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Besmed HMEF

Besmed HME Filter (Heat and Moisture Exchange) is intended to decrease the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract while administering anesthesia gas, providing artificial respiration, or assisting with ventilation.

The Besmed HME Filter is typically placed at the patient's end of the breathing system, specifically between the circuits Y - piece and either the catheter mount or patient airway device. It is essential to note that the Besmed HME Filter is intended for single-use only and should be used on a single patient for up to 24 hours.

Besmed HME Filter is intended to be used within critical care and hospital/ institutional environments by qualified personnel.

Besmed Bacterial Filter

The purpose of the Besmed Bacterial Filter is to diminish the passage of bacteria and viruses to patients receiving anesthesia gas. Besmed Bacterial Filter is designed for utilization with ventilators, anesthesia machines, and open flow systems where there is a need for filtration of inhaled gases.

The Besmed Bacterial Filter is a disposable device intended for the exclusive use of a single patient within a 24-hour timeframe. Bacterial Filter is designed for utilization in hospital environments by medical professionals who possess adequate training in the operation of mechanical ventilators, respiratory systems, and humidification systems.

Product codes (comma separated list FDA assigned to the subject device)

CAH

Device Description

The Besmed HME Filter absorbs the heat and moisture exhaled by the patients. Upon inhalation, it releases the previously retained heat and humidity to the dry inhalation gases. The HME filter is designed with electrostatic cotton for filtration, as well as a heat-preserved and moisture-absorbed paper roll for maintaining the warmth and humidity of the airway in a respiratory system. Additionally, it eliminates bacterial and viral contaminants from the breathing circuit gas. To ensure passive humidification treatment, it is recommended to install the Heat and Moisture Exchanger Filter (HMEF) on the patient's end. Besmed HME Filter is intended for adult and child patients with the tidal volume between 150ml-1000ml.
Besmed Bacterial Filter is for single-use purpose. The intended use is achieved through the implementation of an electrostatic filtration mechanism. Transparent and compact housing material makes it easy to check the surface of the filter media for a foreign substance.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's respiratory tract

Indicated Patient Age Range

Child and Adult

Intended User / Care Setting

Besmed HME Filter is intended to be used within critical care and hospital/institutional environments by qualified personnel.

Bacterial Filter is designed for utilization in hospital environments by medical professionals who possess adequate training in the operation of mechanical ventilators, respiratory systems, and humidification systems.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Summary of Nonclinical Testing was performed. Key results are listed under "Summary of Nonclinical Testing" section. No clinical test study was included or required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Bacterial filter and HMEF efficiency shall be > 99.9% @15 LPM and 30 LPM under 0 hour and 24 hour conditioning.
Bacterial / Virus Filtration Efficiency test (ASTM F2101-19): Evaluate BFE/VFE filter efficiency shall be greater than 90%.
HME moisture output: Greater than 30 mg/L

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K163300

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K191909

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.

November 14, 2024

Besmed Health Business Corp. Steven Wong Manager, Regulatory Affairs No. 5, Lane 116 Wu-Kong 2nd Rd Wu-Ku District New Taipei City, Taiwan 24888

Re: K241339

Trade/Device Name: Besmed Bacterial Filter and HMEF Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH Dated: April 23, 2024 Received: October 15, 2024

Dear Steven Wong:

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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn

2

(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Katharine Segars -S

Katharine Segars, Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K241339

Device Name Besmed Bacterial Filter and HMEF

Indications for Use (Describe)

Besmed HMEF

Besmed HME Filter (Heat and Moisture Exchange) is intended to decrease the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract while administering anesthesia gas, providing artificial respiration, or assisting with ventilation.

The Besmed HME Filter is typically placed at the patient's end of the breathing system, specifically between the circuits Y - piece and either the catheter mount or patient airway device. It is essential to note that the Besmed HME Filter is intended for single-use only and should be used on a single patient for up to 24 hours.

Besmed HME Filter is intended to be used within critical care and hospital/ institutional environments by qualified personnel.

Besmed Bacterial Filter

The purpose of the Besmed Bacterial Filter is to diminish the passage of bacteria and viruses to patients receiving anesthesia gas. Besmed Bacterial Filter is designed for utilization with ventilators, anesthesia machines, and open flow systems where there is a need for filtration of inhaled gases.

The Besmed Bacterial Filter is a disposable device intended for the exclusive use of a single patient within a 24-hour timeframe. Bacterial Filter is designed for utilization in hospital environments by medical professionals who possess adequate training in the operation of mechanical ventilators, respiratory systems, and humidification systems.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the text "BESMED HEALTH BUSINESS CORP." in bold, sans-serif font. The text is arranged on a single line and is the only element in the image. The background is plain white.

No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888

☎:+886-2-2290-3959 幅:+886-2-2299-9076

: info@besmed.com & : www.besmed.com

510(k) Summary - K241339

Date Prepared:	14-November-2024
Company Name and Address:	Besmed Health Business Corp.
No. 5, Lane 116, Wu-Kong 2nd Road,
Wu-Ku District, New Taipei City, Taiwan 24888
Tel: +886-2-2290-3959
Fax: +886-2-2299-9076
www.besmed.com
Prepared and Submitted by:	Steven Wong
Manager, Regulatory Affairs & Quality Affairs
Tel: +886-2-2290-3959 ext 211
Email: research6@besmed.com
Official Contact:	Sarah Lu (Ms.)
Vice President
Tel: +886-2-2290-3959
Email: sarah.lu@besmed.com
Proprietary or Trade Name:
Common Name:	Besmed Bacterial Filter and HMEF
Filter, Bacterial, Breathing-Circuit
Classification Regulation Name:	21 CFR § 868.5260, Breathing circuit bacterial filter
FDA Product Code:	CAH
Regulatory Class:	Class II
Type of Submission:	Traditional
Predicate Device
Trade Name:	ThermoShield HME Filter
510(k) Number:	K163300
Manufacturer Name:	Flexicare Medical Limited
Reference Device
Trade Name:	HepaShield Bacterial Viral Breathing System Filter
510(k) Number:	K191909

Image /page/4/Picture/7 description: The image contains the word "Besmed" in a dark brown, sans-serif font. To the right of the word is a green symbol that resembles a plus sign inside of a letter "D". The plus sign is white, and the "D" is green.

5

Image /page/5/Picture/0 description: The image shows the text "BESMED HEALTH BUSINESS CORP." in bold, sans-serif font. The text is arranged on a single line and appears to be a company name. The letters are uniformly sized and spaced, creating a clear and legible presentation.

Image /page/5/Picture/1 description: The image shows the logo for Besmed. The word "Besmed" is written in black font on the left side of the image. To the right of the word is a green symbol that looks like the letter "B" with a white medical cross in the middle.

1.1 Indications for Use Besmed HMEF

. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District,

6-2-2290-3959

Besmed HME Filter (Heat and Moisture Exchange) is intended to decrease the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract while administering anesthesia gas, providing artificial respiration, or assisting with ventilation.

The Besmed HME Filter is typically placed at the patient's end of the breathing system, specifically between the circuits Y-piece and either the catheter mount or patient airway device. It is essential to note that the Besmed HME Filter is intended for single-use only and should be used on a single patient for up to 24 hours.

Besmed HME Filter is intended to be used within critical care and hospital/institutional environments by qualified personnel.

Besmed Bacterial Filter

The purpose of the Besmed Bacterial Filter is to diminish the passage of bacteria and viruses to patients receiving anesthesia gas. Besmed Bacterial Filter is designed for utilization in conjunction with ventilators, anesthesia machines, and open flow systems where there is a need for filtration of inhaled gases.

The Besmed Bacterial Filter is a disposable device intended for the exclusive use of a single patient within a 24-hour timeframe. Bacterial Filter is designed for utilization in hospital environments by medical professionals who possess adequate training in the operation of mechanical ventilators, respiratory systems, and humidification systems.

6

Image /page/6/Picture/0 description: The image shows the logo for Besmed, a medical device company. The logo features the company name in a bold, sans-serif font, with a green plus sign incorporated into the "B". Below the logo, the text "1.2 Device Description Besmed HMEF" is displayed in a smaller, bold font. The text indicates that the image is related to a device description for a Besmed HMEF product.

Image /page/6/Picture/1 description: The image shows the contact information for BESMED HEALTH BUSINESS CORP. The address is No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888. The phone number is +886-2-2290-3959 and the fax number is +886-2-2299-9076. The email address is info@besmed.com and the website is www.besmed.com.

The Besmed HME Filter absorbs the heat and moisture exhaled by the patients. Upon ■ inhalation, it releases the previously retained heat and humidity to the dry inhalation gases. The HME filter is designed with electrostatic cotton for filtration, as well as a heat-preserved and moisture-absorbed paper roll for maintaining the warmth and humidity of the airway in a respiratory system. Additionally, it eliminates bacterial and viral contaminants from the breathing circuit gas. To ensure passive humidification treatment, it is recommended to install the Heat and Moisture Exchanger Filter (HMEF) on the patient's end. Besmed HME Filter is intended for adult and child patients with the tidal volume between 150ml-1000ml.

Besmed Bacterial Filter

. Besmed Bacterial Filter is for single-use purpose. The intended use is achieved through the implementation of an electrostatic filtration mechanism. Transparent and compact housing material makes it easy to check the surface of the filter media for a foreign substance.

7

Image /page/7/Picture/0 description: The image shows the text "BESMED HEALTH BUSINESS CORP." in bold, sans-serif font. The text is arranged on a single line and appears to be the name of a company. The background is plain and white, which makes the text stand out.

Image /page/7/Picture/1 description: The image contains the word "Besmed" in a dark brown, sans-serif font. To the right of the word is a large, green letter "B" with a white plus sign in the middle. The plus sign is formed by the negative space within the "B" shape.

5 Lane 116 Wil-Kong 2nd

☎ : +886-2-2290-3959 📠 : +886-2-229
✉ : info@bosmed.com 🌐 : www.bosm

besmed.com : www.besmed.com

1.3 Comparison of Technological Characteristic with the Predicate Device

The subject and predicate devices have technical characteristics in terms of the intended use, principle of operation, design specification, consisting of the filter media and housing. Additionally, both the subject and predicate devices utilize an electrostatic filtration mechanism, which employs electric charges to enhance particle capture.

The tables below show the similarities and differences between the subject and predicate/reference device.

| Device feature | Subject Device
(K241339) | Predicate Device
(K163300) | Comparison | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Manufacturer | Besmed Health Business Corp. | Flexicare Medical
Limited | N/A | |
| Proprietary Name | Besmed HMEF with Luer Lock
Port
Besmed HMEF | ThermoShield HME
Filter | N/A | |
| Device models | Sterile
models
FL-70311
FL-70312
FL-70313 | Non-sterile
models
FL-70301
FL-70302
FL-70303 | Not stated in the 510(k)
summary | N/A |
| Intended Patient
Population | Child and Adult | Adult and Mini
(Pediatric) | Similar | |
| Color | Transparent and Green | Clear/ colorless, Blue | Different | |
| Emergency use | Yes | Yes | Same | |
| Primary components | Luer port cap | Tethered luer port cap | Similar | |
| | Filter housing top | Filter housing top | | |
| | Filter paper | Filter pad | | |
| | HME paper medium | HME paper | | |
| | Filter housing bottom | HME paper medium | | |
| | Outer stickers | Outer shrink sleeve | | |
| Assembly Method | Ultrasonic welded housing | Snap Fit casing | Different | |
| Port diameter | 22M/15F | 22M/15F | Same | |
| Configurations | Straight
with luer
port
Straight without
luer port | Straight with luer port | Same | |
| Filtration Method | Electrostatic | Electrostatic | Same | |
| Placement within circuit | Patient side | Patient side | Same | |
| Weight (g) | Straight with luer port 34.50g | Straight with luer port 38g | Different | |
| Indications for Use | Besmed HME Filter (Heat and Moisture Exchange) is intended to decrease the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract while administering anesthesia gas, providing artificial respiration, or assisting with ventilation. The Besmed HME Filter is typically placed at the patient's end of the breathing system, specifically between the circuits Y-piece and either the catheter mount or patient airway device. It is essential to note that the Besmed HME Filter is intended for single-use only and should be used on a single patient for up to 24 hours. Besmed HME Filter is intended to be used within critical care and hospital/ institutional environments by qualified personnel. | Flexicare's ThermoShield HME (Heat and Moisture Exchange) Filters are intended to reduce the transmission of bacteria and viruses. to/from a patient, and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. An HMEF is normally positioned at the patient end of the breathing system between the circuit Y- piece and the catheter mount or patient airway device. Flexicare's ThermoShield HME Filters are single use devices for use on a single patient for up to 24hrs and are available in Adult and Mini (pediatric) sizes. Flexicare's ThermoShield HME Filters are designed to be used in pre-hospital, hospital and homecare environments by trained personnel. Expert clinical judgment must be used in assessing patient humidification requirements | Similar. Both devices are intended to minimize the transfer of bacteria and viruses to/from a patient. It also aids in maintaining moisture levels in the patient's respiratory tract while administering anesthesia gas, providing artificial respiration, or assisting with ventilation. Both devices are single use devices for use on a single patient for up to 24hrs, there is a difference in the intended use environment in which both devices are operated. It will not alter the device's intended purpose. | |
| Environment of Use | Critical care and Hospital/ Institutional Environment | Pre-hospital, Hospital & Homecare Environment | Similar | |
| Device Type | Disposable | Disposable | Same | |

Table 1. A Comparison between the Subject and Predicate Device

8

No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888

☎:+886-2-2290-3959 幅:+886-2-2299-9076 info@besmed.com

金:www.besmed.com

Image /page/8/Picture/6 description: The image shows the logo for Besmed. The word "Besmed" is written in a dark brown, bold font. To the right of the word is a green symbol that looks like a stylized letter "B" with a white cross in the middle.

9

No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District,
New Taipei City, Taiwan. 24888

Image /page/9/Picture/2 description: The image shows the logo for Besmed. The word "Besmed" is written in a dark brown font. To the right of the word is a green letter "B" with a white medical cross in the middle.

☎:+886-2-2290-3959 幅:+886-2-2299-9076

		:+886-2-2290-3959		:+886-2-2299-9076
	Patient Usage
Type	Single patient use		Single patient use		Same
	Duration of contact	Limited (≤ 24 h)		Limited (≤ 24 h)		Same
	Mode of
application	Non-invasive		Non-invasive		Same
Supplied sterile		Sterile and Non-Sterile
Variants		Non-Sterile		Differences in the device
sterility have no impact on
the indication for use and
HMEF's principle of
operation.
Technical	Material	Luer port cap:	PP	Tethered
luer port
cap:	PVC	Different
		Filter housing
top:	ABS	Filter
housing
top:	PP
		Filter paper:	Filter paper	Filter pad:	PP
		HME paper
medium:	Filter paper
impregnated
CaCl2	HME
paper:	Paper
		Filter housing
bottom:	ABS	Filter
housing
bottom:	PP
				Outer
shrink
sleeve:	LDPE
	Latex/ DEHP
content	No			No	Same
	Internal
Volume/dead
space as per
ISO 9360-1	19 ml
deadspace
model
FL-
70311/FL-
70301	Available for
children and
adult
population	47ml		Different
		45 ml
deadspace
model
FL-70312/ FL-
70302	Available for
adult
population
		60 ml
deadspace
model
FL-70313/ FL-
70303	Available for
adult
population

10

No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District,
New Taipei City, Taiwan. 24888

Image /page/10/Picture/2 description: The image shows the logo for Besmed. The word "Besmed" is written in a bold, dark brown font. To the right of the word is a green symbol that resembles a "B" with a white medical cross in the middle.

| Image: Besmed logo | | | New Taipei City, Taiwan. 24888
: +886-2-2290-3959 : +886-2-2299-9076
: info@besmed.com www.besmed.com | |
|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| HME
moisture output
(mg/L) | 19ml deadspace model rep
FL-70311
35.23 mg/L at TV 250ml
32.79 mg/L at TV 500ml
32.49 mg/L at TV 1000ml
45ml deadspace model rep
FL-70312
35.23 mg/L at TV 250ml
32.79 mg/L at TV 500ml
32.49 mg/L at TV 1000ml
60 ml deadspace model rep
FL-70313
35.23 mg/L at TV 250ml
32.79 mg/L at TV 500ml
32.49 mg/L at TV 1000ml | 30.4 mg/L at TV 500ml | Different.
The subject device's
moisture output
performance is above the
clinical acceptance criteria
of 30 mg/L, as well as that
of the predicate device,
under varying conditions
of tidal volume, respiratory
rate, and flow rate. | |
| HME moisture
loss (mg/L) | 19ml deadspace model rep
FL-70311
6.81 mg/L at TV 250ml
11.71 mg/L at TV 500ml
11.06 mg/L at TV 1000ml
45ml deadspace model rep
FL-70312
6.81 mg/L at TV 250ml
11.71 mg/L at TV 500ml
11.06 mg/L at TV 1000ml
60 ml deadspace model rep
FL-70313
6.81 mg/L at TV 250ml
11.71 mg/L at TV 500ml
11.06 mg/L at TV 1000ml | 6.8 mg/L at TV 500ml | Different.
The subject device's
moisture loss results are
generally higher than
those of the predicate
device under varying
conditions of tidal
volume, respiratory rate,
and flow rate. | |
| Tidal Volume
Range (ml) | 150 - 1000ml | 138~800ml | Different.
Tidal volume for both
devices varies. | |
| Pressure Drop/
Flow resistance | 19ml deadspace model rep
FL-70313
At 0 hour
0.15 hPa @30L/min
0.27 hPa @60L/min
1.34 hPa @90L/min
At 24 hour
0.17 hPa @30L/min
0.32 hPa @60L/min
1.41 hPa @90L/min
45ml deadspace model rep
FL-70312
At 0 hour
0.58 hPa @30L/min
1.58 hPa @60L/min | 1.71 hPa @30L/min
4.31 hPa @60L/min
7.82 hPa @90L/min | Different.
The pressure drop results of
the subject device, are lower
than those of the predicate
device under varying flow
rates. | |
| | 3.25 hPa @90L/min
At 24 hour
0.58 hPa @30L/min
1.60 hPa @60L/min
3.45 hPa @90L/min

11

No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888

Image /page/11/Picture/2 description: The image features the logo for "Besmed". The word "Besmed" is written in a bold, sans-serif font, with the letters in black. To the right of the word, there is a stylized green symbol that resembles a plus sign integrated into a letter "B". The plus sign is formed by the negative space within the green shape.

省:+886-2-2290-3959 昌:+886-2-2299-9076 info@b 1

12

No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District,

	New Taipei City, Taiwan. 24888
	+886-2-2290-3959
info@besmed.com	+886-2-2299-9076
www.besmed.com
99.98% @30
LPM
At 24 hour
99.99% @15
LPM
99.99% @30
LPM
FL-70313	98.90%	Different.
The filtration efficiency for
the subject device is higher
than the predicate device.
At 0 hour
99.98% @30
LPM
At 24 hour
99.98% @30
LPM
m Temperature	25+5℃ Room	Same

| | Available
for adult
population | FL-70313
At 0 hour
99.98% @30
LPM
At 24 hour
99.98% @30
LPM | | |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operation
temperature | 25±5 °C, Room Temperature | | 25±5 °C, Room
Temperature | Same |
| Storage condition | -20~60 °C,
30-70% RH | | -20 to 60 °C,
15-95% RH | Similar.
The storage humidity for the
subject device is
within the range of the
predicate device. |
| Packaging | RST 80/XPA film | | Non-Sterile
Primary - Polybag -
(LDPE)
Sterile
Primary - Top Web -
EO Permeable Paper
Blister Pack -(PVC) | Different |
| Sterilization
method | Ethylene oxide sterilization | | N/A | Different |
| Shelf life | 5 years | | 4 years | Different.
The stability of the
subject device was
verified by conducting a
5-year real time aging test
and 5-year accelerated
aging test. |
| Biocompatibility
test in compliance
with ISO 10993-1 | Cytotoxicity, Skin Irritation,
Sensitization, Acute Systemic
toxicity - All test Pass | | Cytotoxicity, Implant,
Sensitization,
Genotoxicity- All test
pass | Biocompatibility testing for
both devices was
conducted in accordance
with use of International
Standard ISO 10993-1,
"Biological evaluation of
medical devices - Part 1:
Evaluation and testing
within a risk management
process". |

Image /page/12/Picture/4 description: The image contains the word "Besmed" in a bold, dark font. To the right of the word is a green symbol that resembles a stylized letter "B" with a white cross in the center. The cross is formed by the negative space within the green shape, creating a medical or healthcare-related visual element.

filtration

23328-1

performance ISO population

and adult

13

No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888

☎:+886-2-2290-3959 幅:+886-2-2299-9076

: info@besmed.com & : www.besmed.com

Table 2. A Comparison between the Subject and Reference Device

| Device feature | Subject Device
(K241339) | Reference Device
(K191909) | Comparison | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Manufacturer | Besmed Health Business Corp. | Flexicare Medical
Limited | N/A | |
| Proprietary Name | Besmed Bacterial Filter with Luer
Lock Port
Besmed Bacterial Filter | HepaShield Bacterial
Viral Breathing System
Filter | N/A | |
| Device models | Sterile models
FL-70210
FL-70220
FL-70226 | Non-sterile
models
FL-70211
FL-70221
FL-70223 | Not stated in the 510(k)
summary | N/A |
| Intended Patient
Population | Child and Adult | Adult | Different | |
| | Transparent and Green | | Different | |
| Emergency use | Yes | Yes | Same | |
| Port diameter | 22M/15F | 22M/15F | Same | |
| Assembly Method | Ultrasonic welded housing | Ultrasonic welded
housing | Same | |
| Type of use | Prescription Use | Prescription Use | Same | |
| Primary components | Luer port cap | Tethered luer port cap | | |
| | Filter housing top | Filter housing top | Same | |
| | Filter | Filter Media pack | | |
| | Filter housing bottom | Filter housing bottom | | |
| Configurations | Straight with
luer port | Straight
without luer port | Straight with luer port | Same |
| Filtration Method | Electrostatic | Mechanical | Different. | |
| | | | In both devices filtration
mechanism are used to
trap particles, including
bacteria and virus, as air
or liquid
passes through a filter
medium. | |
| Patient connection | Breathing circuit, manual
resuscitator, Air cushion mask,
resuscitation | ET tube, Laryngeal Mask
Airway, Catheter mount,
Breathing circuit | Different | |
| Placement within Circuit | Patient side | Patient side Machine
side | Different.
The predicate device
includes an additional
machine side placement. | |
| Weight (g) | Straight with luer port 23.60g | Straight with luer port 42g | Different | |
| Indications for Use | ■ The purpose of the Besmed
Bacterial Filter is to diminish
the passage of bacteria and
viruses to patients receiving
anesthesia gas. Besmed
Bacterial Filter is designed
for utilization in conjunction
with ventilators, anesthesia
machines, and open flow
systems where there is a need
for filtration of inhaled gases.
■ The Besmed Bacterial Filter is
a disposable device intended
for the exclusive use of a single
patient within a 24-hour
timeframe. Bacterial Filter is
designed for utilization in
hospital environments by
medical professionals who
possess adequate training in the
operation of mechanical
ventilators, respiratory systems,
and humidification systems. | Flexicare's HepaShield
Bacterial Viral Breathing
System Filters are intended to
reduce the transmission of
bacteria and viruses to/from a
patient during anesthesia. For
use with ventilators.
anesthesia machines and open
flow systems where filtration
of inspired and/or expired
gases is desired. Flexicare's
HepaShield Bacterial Viral
Breathing System Filters are
single use devices for use on
a single patient for up to 24hrs
and are available in Adult
size. Flexicare's HepaShield
Bacterial Viral Breathing
System Filters are designed to
be used in hospital
environments by trained
personnel. | Similar.
There is no distinction
in the intended purpose.
clinical usage, and
intended use
environment of both
devices. | |

Image /page/13/Picture/6 description: The image shows the logo for Besmed. The word "Besmed" is written in a dark brown, bold, italicized font. To the right of the word is a green letter "D" with a white plus sign in the middle. The plus sign is formed by the negative space within the "D".

14

No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888

☎:+886-2-2290-3959 幅:+886-2-2299-9076 : info@besmed.com & : www.besmed.com

Besmed ■

15

No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888

☎:+886-2-2290-3959 冒:+886-2-2299-9076
▽ : info@besmed.com Q:www.besmed.com

	0-0000 2000 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
	ed.com & : www.besmed.com

| Contraindications | | ■ Avoid positioning the Besmed
Bacterial filter between a
humidification device or
nebulizing device and the
patient end.
■ This device is strictly
restricted to single patient use,
do not attempt to re- sterilize
or reuse the device.
■ Do not try to cleanse or
decontaminate this device
using any method, such as
rinsing, washing, or subjecting
it to gas, heat, steam, or
boiling water. | | ■ DO NOT place the
HepaShield Bacterial
Viral Breathing System
Filter between a
humidification device or
nebulizing device and the
patient.
■ Single Use. Do not reuse.
■ DO NOT attempt to
decontaminate this
product in any way. This
includes rinsing, washing
or decontamination using
gas, heat, steam, or
boiling water.
■ When used in
conjunction with a
humidified breathing
system, the HepaShield
Bacterial Viral Breathing
System Filter is
contraindicated for use at
the patient end. | | Similar |
|---------------------|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------|
| Environment of Use | | Hospital Environments | | Hospital | | Similar |
| Device Type | | Disposable | | Disposable | | Same |
| Patient Usage Type | | Single patient use | | Single patient use | | Same |
| Duration of contact | | Limited (≤ 24 h) | | Limited (≤ 24 h) | | Same |
| Mode of application | | Non-invasive | | Non-invasive | | Same |
| Supplied sterile | | Both Non-sterile & sterile
variants | | Both Non-sterile & sterile
variants | | Same |
| | | Luer port cap: | PP | Tethered luer
port cap: | PVC | |
| | | Filter housing
top: | ABS | Filter housing
top: | ABS | Different |
| Technical | Materials | Filter : | Filter Paper | Filter Media
pack: | Hydro-
phobic
pleated
paper | |
| | | Filter housing
bottom | ABS | Filter housing
bottom: | ABS | |

Besmed ■

16

No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888

☎ : +886-2-2290-395

: +886-2-2290-3959	: +886-2-2299-9076
: info@besmed.com	: www.besmed.com

| Latex/
DEHP

content	No		No	Same
Internal
Volume / dead
space as per
ISO
9360-1	32ml
deadspace
model
FL-70210/FL-
70211/FL-
70226/FL-
70223
73ml
deadspace
model
FL-70220/FL-
70221	Available for
children and
adult
population
Available for
adult
population	47ml	Different.
The subject device
offers lower limit for
the recommended
tidal volume range
use for the identified
patient population.
Tidal
Volume
Range (ml)	150 - 1000ml		141~800ml	Different
Pressure
Drop/ Flow
resistance	32ml deadspace model rep
FL-70210
At 0 hour
0.65 hPa @30L/min
1.57 hPa @60L/min
2.69 hPa @90L/min
At 24 hour
0.64 hPa @30L/min
1.57 hPa @60L/min
2.54 hPa @90L/min
73ml deadspace model rep
FL-70220
At 0 hour
0.70 hPa @30L/min
1.62 hPa @60L/min
2.79 hPa @90L/min
At 24 hour
0.75 hPa @30L/min
1.74 hPa @60L/min
2.89 hPa @90L/min		1.70 hPa @30L/min
3.92 hPa @60L/min
6.56 hPa @90L/min	Different.
The pressure drop
results for the subject
device, are lower
than those of the
predicate device
under varying flow
rates.
Gas leakage	1.49 ml/min @7kpa
2.24 ml/min @15kpa		1.61ml/min @7kpa
2.03 ml/min @15kpa	Different
Leakage by
pressure
decay per
ISO 80369 -
7:2021, 6.1.2	FL-70210
0.00051 Pa·m³/s	0.00059 Pa·m³/s	Different.
The subject device's
leakage rate did not
exceed 0.005 Pa·m³/s
as per ISO 80369-7
requirements.
Sub-
atmospheric
pressure air
leakage per
ISO 80369-
7:2021, 6.2	FL-70313
0.00051 Pa·m³/s
No leak at 101 kPa	0.00051 Pa·m³/s No
leak at 101 kPa	Same
Compliance
per ISO
9360-1
6.5	0.63 ml/kPa	0.06 ml/kPa	Different.
The subject device's
compliance results are
higher than the
predicate device, but
leakage performance
are similar to predicate
device.
Standard
22/15mm
connections
in
compliance
with ISO
5356-1	Yes	Yes	Same
Luer port
for gas
sampling in
compliance
with ISO
80369-7	Yes	Yes	Same
Bacterial
filtration
efficiency
ASTM
F2101	FL-70210
BFE – 99.999 %
VFE – 99.99 %	BFE – 99.99999%
VFE – 99.9999%	Same
Salt test
method -
filtration
performance ISO
23328-1	Available
for
children and
adult
population	FL-70210
At 0 hour
99.98% @15 LPM
99.98% @30 LPM
At 24 hour
99.98% @15 LPM
99.98% @30 LPM	Different.
The subject device's
filtration efficiency is

99.9%. | |
| | Available
for
adult
population | FL-70220
At 0 hour
99.97% @30 LPM
At 24 hour
99.98% @30 LPM | | |
| | | 99.89% | | |
| Operation
temperature | 25±5 °C, Room
Temperature | 25±5 °C, Room
Temperature | Same | |
| Storage condition | -20~60 °C, 30-70% RH | -20 to 60 °C,15-95% RH | Similar | |
| Packaging | RST 80/XPA film | Polybag | Different | |
| Sterilization
method | Ethylene oxide sterilization | Non-sterile | Different | |
| Shelf life | 5 years | 5 years | Same | |
| Biocompatibility
test in
compliance
with ISO
10993-1 | Cytotoxicity, Skin
Irritation,
Sensitization, Acute
Systemic toxicity -
All test Pass | Cytotoxicity,
Irritation,
Sensitization,
Systemic
toxicity,
Material
Mediated
Pyrogenicity-
All test pass | Testing was conducted
in accordance with use
of International Standard
ISO 10993- 1,
"Biological evaluation of
medical devices - Part 1:
Evaluation and testing
within a risk
management process". | |
| Biocompatibility
test in
compliance with
ISO 18562 | Compliant | Compliant | Same | |

Image /page/16/Picture/6 description: The image shows the logo for Besmed. The word "Besmed" is written in a dark brown, sans-serif font. To the right of the word is a green square with a white plus sign in the center, which is slightly tilted.

17

No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888

省:+886-2-2290-3959 昌:+886-2-2299-9076 : info@besmed.com & : www.besmed.com

Image /page/17/Picture/4 description: The image is a close-up, abstract shot of a white background with a single, thick black vertical line running along the left side of the frame. The line is straight and appears to be in sharp focus, contrasting with the bright, uniform white space that dominates the rest of the image. The composition is simple, emphasizing the stark contrast between the black line and the white background.

Besmed ■

18

No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888

☎:+886-2-2290-3959 幅:+886-2-2299-9076 : info@besmed.com & : www.besmed.com

Image /page/18/Picture/4 description: The image contains the word "Besmed" in a bold, dark brown font. To the right of the word is a green symbol that resembles a plus sign inside of a letter B. The plus sign is white, and the letter B is green.

19

Image /page/19/Picture/0 description: The image shows the text "BESMED HEALTH BUSINESS CORP." in bold, sans-serif font. The text is arranged on a single line and is the only element in the image. The background is plain white.

Image /page/19/Picture/1 description: The image contains the word "Besmed" in a dark brown, bolded font. To the right of the word is a green symbol that resembles a plus sign inside of a letter "D". The plus sign is white, and the "D" is green.

No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888

☎:+886-2-2290-3959 幅:+886-2-2299-9076

: info@besmed.com & : www.besmed.com

1.4 Summary of Nonclinical Testing

Table 3. Summary of non-clinical Testing

Test Standards	Test Performed	Acceptance Criteria	Results
Packaging for Terminally Sterilized Medical Devices
ISO 11737-2:2020	Sterility test	Negative	Pass
ISO 10993-7:2008	EO/ ECH/ EG residual
test	Non-Detected	Pass
ASTM F1929-23	Dye Penetration Test	No Penetration	Pass
ASTM F1140/F1140M-
13(2020)e1	Burst test	Package successfully held
for creep duration	Pass
	Creep test	It should maintain the
specified pressure for 30
seconds	Pass
ASTM F88/F88M-23	Seal strength of flexible
barrier materials test	Seal strength shall not greater
than ± 2SD compare to pre
transit package	Pass
ASTM F1608-21	Microbial Ranking Test	LRV>3.0 (99.9%)	Pass
ISTA 2A:2011	Packaged products test	No visible damage	Pass
Shelf Life Test
ASTM F1980-21	Accelerated aging test	No visible damage after aging
simulation	Device meets its
performance
specification
Performance Test
	Measurement of
moisture loss	99.9%
@15 LPM and 30 LPM under 0
hour and 24 hour conditioning	Pass

ISO 80369-7:2021	Leakage by pressure decay	Leakage rate should not exceed
0.005 Pa·m³/s @ 330
kPa for 20 s	Pass
	Sub-atmospheric pressure
air leakage	Leakage rate should not exceed
0.005 Pa·m³/s @
101kPa for 20 s	Pass
	Stress cracking	No signs of seal break and
leakage @101 kPa after being
stress	Pass
	Resistance to separation
from axial load	No disconnections observed at
an axial force of 35 N	Pass
	Resistance to separation
from unscrewing	No disconnections observed at
unscrewing torque of
0.020Nm	Pass
	Resistance to overriding	No override the threads
observed at torque of 0.17 Nm	Pass
ISO 5356-1:2015	Security of engagement	No disconnections observed at
axial separation force of (50
± 5) N for 10 s	Pass
	Leakage from 22 mm
latching sockets	No signs of leakage at (8 ±
0.5) kPa	Pass
	Drop procedure for 22 mm
latching sockets	No signs of damage during the
test	Pass
ASTM F2101-19	Bacterial / Virus Filtration
Efficiency test	Evaluate BFE/VFE filter
efficiency shall be greater than
90%	Pass
Biocompatibility Test
ISO 10993-5:2009	In Vitro Cytotoxicity test	Not more than 50 % of the
cells are round	Pass
ISO 10993-10:2021	Skin sensitization tests
(Maximization Test)	Did not produce skin
sensitization on Guinea pig	Pass
ISO 10993-23:2021	Tests for irritation	Did not cause intracutaneous
irritation	Pass
ISO 10993-11:2017	Acute systemic toxicity
study	Did not cause systemic
toxicity reaction or death	Pass
USP 151	Pyrogenicity Test	Did not induce pyrogenic
response	Pass
ISO 18562-2:2024	Emissions of particulate
matter	Measured concentrations of
particulate matter PM2.5 ≤
35µg/m³
PM10 ≤ 150µg/m³	Pass
ISO 18562-3:2024	Emissions of VOCs	The MOS (Margin Of Safety)
value shall be higher than 1 for
identified substances.	Pass

20

Image /page/20/Picture/0 description: The image shows the word "Besmed" in a bold, dark font. To the right of the word is a green symbol that resembles a stylized letter "B" with a white cross in the middle. The cross is formed by two intersecting bars, and the green "B" shape has a checkered pattern on its edges.

No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District, New Taipei City, Taiwan. 24888

☎:+886-2-2290-3959 幅:+886-2-2299-9076

3935
: 1-800-2-223-9016
d.com : www.besmed.com

21

Image /page/21/Picture/0 description: The image contains the word "Besmed" in a dark brown, sans-serif font. To the right of the word is a green symbol that resembles a stylized letter "B" with a white cross in the middle. The symbol is likely a logo or trademark associated with the brand name "Besmed."

BESMED HEALTH BUSINESS CORP. No. 5, Lane 116, Wu-Kong 2nd Rd, Wu-Ku District,

New Taipei City, Taiwan. 24888 : +886-2-2290-3959 물 : +886-2-2299-9076

i : info@besmed.com 6 : www.besmed.com

1.5 Summary of Clinical Testing

Clinical test study was neither included nor required for this submission.

2. Conclusion

Based on the intended use, technological characteristics and the non-clinical performance tests, the subject device is as safe, as effective, and performs at least as safely and effectively as the predicate device.