(412 days)
Not Found
No
The device description and performance studies focus on the physical filtration and heat/moisture exchange properties of the filters. There is no mention of any computational or analytical functions that would typically involve AI/ML.
Yes.
The device is intended to reduce the transmission of bacteria and viruses to patients, and the HME Filter also maintains moisture levels in the respiratory tract, which are therapeutic actions.
No
Explanation: The device is a filter intended to reduce the transmission of bacteria and viruses and to maintain moisture levels in the respiratory tract. Its function is prophylactic and supportive, not diagnostic, as it does not identify, monitor, or detect health conditions or diseases.
No
The device description clearly indicates it is a physical filter made of materials like electrostatic cotton and paper roll, designed to be installed in a breathing system. It is not software.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The GGM Breathing Circuit Bacterial Filter and HME Filter are designed to filter bacteria and viruses from the air being breathed by a patient during respiratory support. They also have a function related to heat and moisture exchange in the respiratory tract.
- Intended Use: The intended use is to reduce the transmission of bacteria and viruses and maintain moisture levels in the respiratory tract during procedures like anesthesia and ventilation. This is a direct interaction with the patient's respiratory system, not the analysis of a specimen taken from the body.
The device is a medical device used in the respiratory circuit, but it does not perform any diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CAH
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.
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
Adult
Intended User / Care Setting
hospital environments by trained personnel.
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)
A series of safety and performance tests were conducted on the subject device,
GGM Breathing Circuit Bacterial Filter.
- Sterilization validation test
- EO/ ECH/ EG residual test
- Biological Indicator (BI) validation test
- Bioburden test
- Sterility test
- Shelf life test
- Moisture Loss Test
- Pressure Drop Test
- Leakage Test
- Compliance Test
- Test for Security of Engagement of Latching Sockets to Cones
- Housing Burst Strength
- Drop Test
- Filtration Efficiency Test
- Biocompatibility test
- In Vitro Cytotoxicity test
- Skin Sensitization Study (Maximization Test)
- White Rabbit Intracutaneous Reactivity Test
- Acute Systemic Toxicity Study
- Repeat- Dose Subchronic Systemic Toxicity Study
- In Vitro Mammalian Cell Gene Mutation Test
- Salmonella Reverse Mutation Test
- Mice Erythrocyte Micronucleus Test
- Muscle Implant Study
- ISO 18562 Biocompatibility Evaluation
- Emissions of Particulate Matter
- Emissions of VOCs and Aldehydes
- ISO 18562-4 Leachable in Condensate Study
- ISO 18562-4 Biocompatibility Evaluation
- Performance test
- Bacterial Filtration Efficiency test
- Virus Filtration Efficiency test
- Moisture Loss and Pressure Drop test
- Life Time test
All the test results demonstrate GGM Breathing Circuit Bacterial Filter meets the requirements of its pre-defined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial Filter (VF-2160, VF-2160-1):
- Bacterial/Viral Filtration Efficiency/Filter Integrity (Fresh): BFE - 99.9%, VFE - 99.9%
- Salt Method Filtration Efficiency: 99.61%
- Pressure Drop/Flow resistance: 0.47 hPa @30L/min, 0.98 hPa @60L/min, 1.47 hPa @90L/min
- Leakage per BS EN ISO 23328-2/ BS EN ISO 9360-1: 101kPa
- Leakage per ISO 9360-1: No leak at 101kPa
- Compliance per ISO 9360-1: 0.9 ml/kPa (VH-3110), 0.4 ml/kPa (VH-3210)
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.
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.
Not Found
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
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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: | +886-4-875-8181 | |
| Fax: | +886-4-875-6161 | |
| Contact: | Kiki Hung | |
| (liting@greatgroup.com.tw) |
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
System Filter | |
|------------------------------|-------------------------------------------------------|--|
| Manufacturer: | Flexicare Medical Limited | |
| Classification Product Code: | CAH | |
| Regulation number: | 868.5260 | |
| Device Class: | II | |
| 510(k) Number: | K191909 | |
4
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
5
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.
6
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
| Feature | Subject device | Predicate device | Comparison | ||
|---|---|---|---|---|---|
| Submitter | Great Group Medical Co., Ltd. | Flexicare Medical Limited | |||
| Proprietary Name | GGM Breathing Circuit Bacterial | ||||
| Filter - Bacterial Filters | HepaShield Bacterial Viral Breathing | ||||
| System Filter | |||||
| 510(k) No. | K210352 | K191909 | |||
| Models | VF-2160 | ||||
| VF-2160-1 | N/A | N/A | |||
| 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. | 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 | Same | | |
| Item
Feature | Subject device | Predicate device | | | |
| Submitter | Great Group Medical Co., Ltd. | Flexicare Medical Limited | Comparison | | |
| Proprietary Name | GGM Breathing Circuit Bacterial
Filter - Bacterial Filters | HepaShield Bacterial Viral Breathing
System Filter | | | |
| 510(k) No. | K210352 | K191909 | | | |
| Models | VF-2160
VF-2160-1 | N/A | N/A | | |
| Intended patient
population | For Adult patients with the tidal
volume between 250ml-1500ml | System Filters are designed to be
used in hospital environments by
trained personnel. | | | |
| Type of use | Prescription Use | Adult | Same | | |
| | | Prescription Use | Same | | |
| Components | Filter housing top
Filter housing bottom
Filter cotton (electrostatic cotton)
Luer port cap | Filter housing top
Filter housing bottom
Filter Media pack
Tethered luer port cap
Outer shrink sleeve | Similar | | |
| Assembly Method | Ultrasonic welded housing | Ultrasonic welded housing | Same | | |
| Emergency Use | Yes | Yes | Same | | |
| Environment of
Use | Hospital | Hospital | Same | | |
| Patient use/
Duration of use | Single use, disposable, 101kPa | >101kPa | Same | |
| Leakage
per ISO 9360-1 | No leak at 101kPa | No leak at 101kPa | Same | |
| Compliance per
ISO 9360-1 | 0.9 ml/kPa | 0.4 ml/kPa | 14 ml/kPa | Different |
| Reuse, Cleaning &
Disinfection | N/A- Single use (max 24hrs) | N/A- Single use (max 24hrs) | Same | |
| Shelf Life | 3 years | 4 years | Different | |
| Packaging | Sterile paper film | Non- sterile Polybag | Different | |
16
17
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Packaging for Terminally Sterilized Medical Devices | |||
| ISO 10993-7 | EO/ ECH/ EG residual | ||
| test | Non-Detected | PASS | |
| ISO 11737-2 | Sterility test | Negative | PASS |
| ASTM F1608 | Microbial Ranking Test | LRV>3.0 (99.9%) | PASS |
| ASTM F1929 | Dye Penetration Test | No Penetration | PASS |
| ASTM F1140 | Burst and Creep Test | Package successfully held | |
| for creep duration | PASS | ||
| ASTM F88 | Seal Peel Strength Test | >0.1kg/cm | PASS |
| Shelf Life Test | |||
| ISO 9360-1 | Moisture Loss, Pressure | ||
| Drop, Leakage, | |||
| Compliance | Methodology only, no | ||
| acceptance criteria | Meet the | ||
| requirements of the clinical application | |||
| ISO 5356-1 | Test for Security of | ||
| Engagement of Latching | |||
| Sockets to Cones, | |||
| Housing Burst Strength, | |||
| Drop Test | Does not fall off and crack | PASS | |
| ASTM F2101 | Filtration Efficiency Test | Methodology only, no acceptance criteria | Meet the requirements of the standard |
| Biocompatibility Test | |||
| ISO 10993-5 | In Vitro Cytotoxicity test | Cell viability is greater than 70% | PASS |
| ISO 10993-10 | Skin Sensitization Study | ||
| (Maximization Test) | Did not produce skin sensitization | PASS | |
| ISO 10993-10 | White Rabbit | ||
| Intracutaneous Reactivity | |||
| Test | Did not cause intracutaneous irritation | PASS | |
| ISO 10993-11 | Acute Systemic Toxicity | ||
| Study | Did not cause systemic toxicity reaction or death | PASS | |
| ISO 10993-11 | Repeat- Dose Subchronic | ||
| Systemic Toxicity Study | No significant adverse effects. | PASS | |
| ISO 10993-3 | In Vitro Mammalian Cell | ||
| Gene Mutation Test | No genotoxic effects | PASS | |
| ISO 10993-3 | Salmonella Reverse | ||
| Mutation Test | Did not cause mutagenic | PASS | |
| ISO 10993-3 | Mice Erythrocyte | ||
| Micronucleus Test | Does not produce micronuclei | PASS | |
| ISO 10993-6 | Muscle Implant Study | Nonirritant (Score |