GGM Breathing Circuit Bacterial Filter

K210352 · Great Group Medical Co, Ltd. · CAH · Mar 27, 2022 · Anesthesiology

Device Facts

• Record ID: K210352
• Device Name: GGM Breathing Circuit Bacterial Filter
• Applicant: Great Group Medical Co, Ltd.
• Product Code: CAH · Anesthesiology
• Decision Date: Mar 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

The Bacterial Filter is intended to reduce the transmission of bacteria and viruses to a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired gases is desired. The Bacterial Filter is single use device for use on a single patient for up to 24hrs. The Bacterial Filter is designed to be used in hospital environments by trained personnel. HME (Heat and Moisture Exchange) Filter is 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. HME Filter is normally positioned at the patient end of the breathing system between the circuits Y-piece and the catheter mount or patient airway device. HME Filter is a single use device for use on a single patient for up to 24hrs. HME Filter is designed to be used in hospital environments by trained personnel.

Device Story

GGM Breathing Circuit Bacterial Filter comprises two variants: Bacterial Filter (filtering only) and HME Filter (filtering plus heat/moisture exchange). Input: respiratory gases from ventilators/anesthesia machines. Operation: Bacterial Filter uses electrostatic cotton to trap pathogens; HME Filter uses electrostatic cotton for filtration and paper roll for passive humidification/heat preservation. Output: filtered, conditioned gas delivered to patient airway. Used in hospital settings by trained clinicians. Device placed between breathing circuit Y-piece and patient airway interface (ET tube/LMA). Benefits: reduces pathogen transmission to/from patient; maintains airway moisture during ventilation. Single-use, disposable (max 24 hours).

Clinical Evidence

No clinical data. Bench testing only. Performance validated via ISO 9360-1 (moisture loss, pressure drop, leakage, compliance), ASTM F2101 (BFE/VFE), and ISO 18562 (particulate/VOC emissions). Biocompatibility confirmed via ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation).

Technological Characteristics

Materials: Polypropylene/K-Resin housing, electrostatic polypropylene cotton, paper HME roll. Connectivity: Standard 22/15mm connections (ISO 5356-1) and luer ports (ISO 594-2/ISO 80369-7). Form factor: In-line breathing circuit filter. Sterilization: Ethylene Oxide (EO). Single-use, disposable.

Indications for Use

Indicated for adult patients requiring anesthesia or assisted ventilation. Bacterial filters (VF-2160, VF-2160-1) for patients with tidal volumes 250ml-1500ml. HME filters (VH-3110) for patients with tidal volumes 250ml-1500ml; (VH-3210) for patients with tidal volumes 250ml-1000ml. Designed for hospital use by trained personnel.

Regulatory Classification

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.

Predicate Devices

• HepaShield Bacterial Viral Breathing System Filter (K191909)
• ThermoShield HME Filter (K163300)

Submission Summary (Full Text)

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March 27, 2022

Great Group Medical Co., Ltd. Kiki Hung Regulatory Affairs No. 168, Xingong 2nd Rd., Tianzhong Township Changhua County, 520 Taiwan

Re: K210352

Trade/Device Name: GGM Breathing Circuit Bacterial Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH Dated: March 18, 2022 Received: March 23, 2022

Dear Kiki Hung:

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

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K210352

#### Device Name

GGM Breathing Circuit Bacterial Filter

## Indications for Use (Describe)

GGM Breathing Circuit Bacterial Filter contains two types of bacterial Filters, namely "Bacterial Filter" with only filtering function and "HME Filter" with heat and moisture exchanger function.

Intended patient population: VF-2160, VF-2160-1 and VH-3110 are intended for adult patients with the tidal volume between 250ml-1500ml; VH-3210 is intended for adult patients with the tidal volume between 250ml-1000ml.

## Bacterial Filter (VF-2160, VF-2160-1) -

The Bacterial Filter is intended to reduce the transmission of bacteria and viruses to a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired gases is desired. The Bacterial Filter is single use device for use on a single patient for up to 24hrs. The Bacterial Filter is designed to be used in hospital environments by trained personnel.

## HME Filter (VH-3110, VH-3210) -

HME (Heat and Moisture Exchange) Filter is 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.

HME Filter is normally positioned at the patient end of the breathing system between the circuits Y-piece and the catheter mount or patient airway device. HME Filter is a single use device for use on a single patient for up to 24hrs. HME Filter is designed to be used in hospital environments by trained personnel.

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)

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# 510(k) SUMMARY

## K210352

- 5.1 Type of Submission: Traditional
- 5.2 Date of Summary: 03/18/2022

| 5.3 | Submitter: | Great Group Medical Co., Ltd. |
|-----|------------|-----------------------------------------------|
| | Address: | No. 168, Xingong 2nd Rd., Tianzhong Township, |
| | | Changhua County 520, Taiwan (R.O.C.) |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | Contact: | Kiki Hung |
| | | ([e-mail]) |

#### 5.4 Identification of the Device:

| Proprietary/Trade name: | GGM Breathing Circuit Bacterial Filter |
|------------------------------|----------------------------------------|
| Classification Product Code: | CAH |
| Regulation Number: | 868.5260 |
| Regulation Description: | Breathing circuit bacterial filter |
| Review Panel: | General Hospital |
| Device Class: | II |

#### 5.5 Identification of the Predicate Device I:

| Predicate Device Name: | HepaShield Bacterial Viral Breathing<br>System Filter | |
|------------------------------|-------------------------------------------------------|--|
| Manufacturer: | Flexicare Medical Limited | |
| Classification Product Code: | CAH | |
| Regulation number: | 868.5260 | |
| Device Class: | II | |
| 510(k) Number: | K191909 | |

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ર્ડ.(

| Identification of the Predicate Device II: | |
|--------------------------------------------|---------------------------|
| Predicate Device Name: | ThermoShield HME Filter |
| Manufacturer: | Flexicare Medical Limited |
| Classification Product Code: | CAH |
| Regulation number: | 868.5260 |
| Device Class: | II |
| 510(k) Number: | K163300 |

# 5.7 Indications for Use of the Device

GGM Breathing Circuit Bacterial Filter contains two types of bacterial filters, namely "Bacterial Filter" with only filtering function and "HME Filter" with heat and moisture exchanger function.

Intended patient population: VF-2160, VF-2160-1 and VH-3110 are intended for adult patients with the tidal volume between 250ml-1500ml; VH-3210 is intended for adult patients with the tidal volume between 250ml-1000ml.

Bacterial Filter (VF-2160, VF-2160-1) -

The Bacterial Filter is intended to reduce the transmission of bacteria and viruses to a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired gases is desired.

The Bacterial Filter is single use device for use on a single patient for up to 24hrs. The Bacterial Filter is designed to be used in hospital environments by trained personnel.

HME Filter (VH-3110, VH-3210) -

HME (Heat and Moisture Exchange) Filter is 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.

HME Filter is normally positioned at the patient end of the breathing system between

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the circuits Y-piece and the catheter mount or patient airway device. HME Filter is a single use device for use on a single patient for up to 24hrs.

HME Filter is designed to be used in hospital environments by trained personnel.

# 5.8 Device Description

GGM Breathing Circuit Bacterial Filter contains two types of bacterial filters, namely "Bacterial Filter" with only filtering function and "HME Filter" with heat and moisture exchanger function.

Bacterial Filter (models VF-2160, VF-2160-1):

Bacterial Filter is a single-used medical device, which is used for filtering the bacteria and virus in the respiratory gas to the patient during the respiratory therapy. VF-2160 and VF-2160-1 are all intended for adult patients with the tidal volume between 250ml-1500ml.

HME Filter (models VH-3110, VH-3210):

HME Filter is a kind of breathing circuit bacterial filter with the function of passive heat and moisture exchanger (artificial nose). It is a breathing circuit bacterial filter that contains electrostatic cotton for filtration and contains heat preserved and moisture absorbed paper roll for airway heat preservation and humidification. The Heat and Moisture Exchanger Filter (HMEF) should be installed on the patient's end based on the principle of passive humidification treatment. VH-3110 is intended for adult patients with the tidal volume between 250ml-1500ml, and VH-3210 is intended for adult patients with the tidal volume between 250ml-1000ml.

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#### 5.9 Technological Characteristic Comparison Table

The GGM Breathing Circuit Bacterial Filter, including Bacterial Filters and HME Filters, submitted in this 510(k) file is substantially equivalent in intended use, has similar technology/principles of operation, and similar performance to the cleared HepaShield Bacterial Viral Breathing System Filter (K191909) and ThermoShield HME Filter (K163300).

| Item<br>Feature | Subject device | Predicate device | Comparison | | |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|------------|------------|
| Submitter | Great Group Medical Co., Ltd. | Flexicare Medical Limited | | | |
| Proprietary Name | GGM Breathing Circuit Bacterial<br>Filter - Bacterial Filters | HepaShield Bacterial Viral Breathing<br>System Filter | | | |
| 510(k) No. | K210352 | K191909 | | | |
| Models | VF-2160<br>VF-2160-1 | N/A | N/A | | |
| Intended Use | The Bacterial Filter is intended to<br>reduce the transmission of bacteria<br>and viruses to a patient during<br>anesthesia. For use with ventilators,<br>anesthesia machines and open flow<br>systems where filtration of inspired<br>gases is desired.<br><br>The Bacterial Filter is single use<br>device for use on a single patient for<br>up to 24hrs. The Bacterial Filter is<br>designed to be used in hospital<br>environments by trained personnel. | Flexicare's HepaShield Bacterial<br>Viral Breathing System Filters are<br>intended to reduce the transmission<br>of bacteria and viruses to/from a<br>patient during anesthesia. For use<br>with ventilators, anesthesia machines<br>and open flow systems where<br>filtration of inspired and/or expired<br>gases is desired.<br><br>Flexicare's HepaShield Bacterial<br>Viral Breathing System Filters are<br>single use devices for use on a single<br>patient for up to 24hrs and are<br>available in Adult size. Flexicare's<br>HepaShield Bacterial Viral Breathing | Same | | |
| Item<br>Feature | Subject device | Predicate device | | | |
| Submitter | Great Group Medical Co., Ltd. | Flexicare Medical Limited | Comparison | | |
| Proprietary Name | GGM Breathing Circuit Bacterial<br>Filter - Bacterial Filters | HepaShield Bacterial Viral Breathing<br>System Filter | | | |
| 510(k) No. | K210352 | K191909 | | | |
| Models | VF-2160<br>VF-2160-1 | N/A | N/A | | |
| Intended patient<br>population | For Adult patients with the tidal<br>volume between 250ml-1500ml | System Filters are designed to be<br>used in hospital environments by<br>trained personnel. | | | |
| Type of use | Prescription Use | Adult | Same | | |
| | | Prescription Use | Same | | |
| Components | Filter housing top<br>Filter housing bottom<br>Filter cotton (electrostatic cotton)<br>Luer port cap | Filter housing top<br>Filter housing bottom<br>Filter Media pack<br>Tethered luer port cap<br>Outer shrink sleeve | Similar | | |
| Assembly Method | Ultrasonic welded housing | Ultrasonic welded housing | Same | | |
| Emergency Use | Yes | Yes | Same | | |
| Environment of<br>Use | Hospital | Hospital | Same | | |
| Patient use/<br>Duration of use | Single use, disposable, <24hrs | Single use, disposable, <24hrs | Same | | |
| Supplied sterile | Sterile | Both Non-sterile & sterile variants | Similar | | |
| Patient Connection | ET tube, Laryngeal Mask Airway,<br>Catheter mount, Breathing circuit | ET tube, Laryngeal Mask Airway,<br>Catheter mount, Breathing circuit | Same | | |
| Colors | Clear/ colorless, Green | Clear/ colorless, Blue | Different | | |
| Item<br>Feature | Subject device | | Predicate device | Comparison | |
| Submitter | Great Group Medical Co., Ltd. | | Flexicare Medical Limited | | |
| Proprietary Name | GGM Breathing Circuit Bacterial<br>Filter - Bacterial Filters | | HepaShield Bacterial Viral Breathing<br>System Filter | | |
| 510(k) No. | K210352 | | K191909 | | |
| Models | VF-2160 | VF-2160-1 | N/A | N/A | |
| Standard 22/15mm<br>connections in<br>compliance with<br>ISO 5356-1 | Yes | | Yes | Same | |
| Luer port for gas<br>sampling in<br>compliance with<br>ISO 594-2/ISO<br>80369-7 | Yes | | Yes | Same | |
| Configurations | Straight without<br>luer port | Straight with luer<br>port | Straight with luer port | Similar | |
| Filtration | Electrostatic | | Mechanical | Different | |
| Placement with<br>Circuit | Machine side | | Patient side<br>Machine side | Similar | |
| Item<br>Feature | Subject device | | Predicate device | | |
| Submitter | Great Group Medical Co., Ltd. | | Flexicare Medical Limited | Comparison | |
| Proprietary Name | GGM Breathing Circuit Bacterial<br>Filter - Bacterial Filters | | HepaShield Bacterial Viral Breathing<br>System Filter | | |
| 510(k) No. | K210352 | | K191909 | | |
| Models | VF-2160 | VF-2160-1 | N/A | N/A | |
| Weight | 21g | 23g | 42g | Different | |
| Internal Volume/<br>Dead space as per<br>ISO 9360-1 | 30ml | | 47ml | Similar | |
| Bacterial/ Viral<br>Filtration<br>Efficiency/ Filter<br>Integrity (Fresh) | BFE - 99.9%<br>VFE - 99.9% | | BFE- 99.99999%<br>VFE- 99.9999% | Similar | |
| Salt Method<br>Filtration<br>Efficiency | 99.61% |…