(412 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the GGM Breathing Circuit Bacterial Filter, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document lists "Methodology only, no acceptance criteria" for some tests but then states "Meet the requirements of the clinical application" or "Meet the requirements of the standard" for their results. For such cases, I've used the general "Meets standards" or "Clinical application met" as the "Reported Performance" to reflect this. For metrics where specific criteria are given, those are included.
| Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 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) | > 0.1 kg/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 (Security of Engagement, 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 < 2.9) | PASS |
| ISO 18562-2 (Emissions of Particulate Matter) | PM2.5 ≤ 12 µg/m3; PM10 ≤ 150 µg/m3 | PASS |
| ISO 18562-3 (Emissions of VOCs and Aldehydes) | Risk Assessment | PASS |
| ISO 18562-4 (Leachable in Condensate) | Risk Assessment | PASS |
| Performance Test | ||
| ASTM F2101 (Bacterial / Virus Filtration Efficiency test) | Methodology only, no acceptance criteria | Meet the requirements of the standard |
| ISO 9360-1 (Moisture Loss, Pressure Drop) | Methodology only, no acceptance criteria | Meet the requirements of the clinical application |
| Life Time test | Not explicitly stated but implied by "PASS" | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each of the non-clinical tests (e.g., number of filters tested for filtration efficiency, number of animals for biocompatibility tests). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective, beyond stating they were "non-clinical testing."
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable. The device is a breathing circuit bacterial filter, and the evaluations are based on laboratory, physical, and chemical tests against established standards and methodologies, not on expert interpretation of medical images or patient data to establish a "ground truth."
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation (e.g., radiologists reviewing images). This document describes non-clinical, laboratory-based testing against defined standards and measurement parameters. Therefore, an adjudication method in this sense is not applicable. The results are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical test data was used not needed for this submission" and focuses entirely on non-clinical, laboratory-based testing to demonstrate substantial equivalence to predicate devices. Therefore, there's no information on how human readers improve with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, this question does not apply, as the device is a physical medical device (breathing circuit bacterial filter) and not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for evaluating the device performance is based on established international and national standards, test methodologies, and predefined acceptance criteria. This includes:
- ISO standards (e.g., ISO 10993 series for biocompatibility, ISO 9360-1 for HME performance, ISO 5356-1 for connections, ISO 11737-2 for sterility, ISO 18562 series for emissions).
- ASTM standards (e.g., ASTM F1608 for microbial ranking, ASTM F1929 for dye penetration, ASTM F1140 for burst/creep, ASTM F88 for seal peel strength, ASTM F2101 for filtration efficiency).
- Specific quantitative limits (e.g., cell viability > 70%, PM2.5 ≤ 12 µg/m3).
8. The Sample Size for the Training Set
This question does not apply, as the device is a physical medical device and does not involve AI model training sets.
9. How the Ground Truth for the Training Set was Established
This question does not apply, as the device is a physical medical device and does not involve AI model training sets or associated ground truth establishment.
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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
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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 (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
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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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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: | +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 BreathingSystem 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
{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.
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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).
| ItemFeature | Subject device | Predicate device | Comparison | ||
|---|---|---|---|---|---|
| Submitter | Great Group Medical Co., Ltd. | Flexicare Medical Limited | |||
| Proprietary Name | GGM Breathing Circuit BacterialFilter - Bacterial Filters | HepaShield Bacterial Viral BreathingSystem Filter | |||
| 510(k) No. | K210352 | K191909 | |||
| Models | VF-2160VF-2160-1 | N/A | N/A | ||
| Intended Use | The Bacterial Filter is intended toreduce the transmission of bacteriaand viruses to a patient duringanesthesia. For use with ventilators,anesthesia machines and open flowsystems where filtration of inspiredgases is desired.The Bacterial Filter is single usedevice for use on a single patient forup to 24hrs. The Bacterial Filter isdesigned to be used in hospitalenvironments by trained personnel. | Flexicare's HepaShield BacterialViral Breathing System Filters areintended to reduce the transmissionof bacteria and viruses to/from apatient during anesthesia. For usewith ventilators, anesthesia machinesand open flow systems wherefiltration of inspired and/or expiredgases is desired.Flexicare's HepaShield BacterialViral Breathing System Filters aresingle use devices for use on a singlepatient for up to 24hrs and areavailable in Adult size. Flexicare'sHepaShield Bacterial Viral Breathing | Same | ||
| ItemFeature | Subject device | Predicate device | |||
| Submitter | Great Group Medical Co., Ltd. | Flexicare Medical Limited | Comparison | ||
| Proprietary Name | GGM Breathing Circuit BacterialFilter - Bacterial Filters | HepaShield Bacterial Viral BreathingSystem Filter | |||
| 510(k) No. | K210352 | K191909 | |||
| Models | VF-2160VF-2160-1 | N/A | N/A | ||
| Intended patientpopulation | For Adult patients with the tidalvolume between 250ml-1500ml | System Filters are designed to beused in hospital environments bytrained personnel. | |||
| Type of use | Prescription Use | Adult | Same | ||
| Prescription Use | Same | ||||
| Components | Filter housing topFilter housing bottomFilter cotton (electrostatic cotton)Luer port cap | Filter housing topFilter housing bottomFilter Media packTethered luer port capOuter shrink sleeve | Similar | ||
| Assembly Method | Ultrasonic welded housing | Ultrasonic welded housing | Same | ||
| Emergency Use | Yes | Yes | Same | ||
| Environment ofUse | Hospital | Hospital | Same | ||
| Patient use/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,Catheter mount, Breathing circuit | ET tube, Laryngeal Mask Airway,Catheter mount, Breathing circuit | Same | ||
| Colors | Clear/ colorless, Green | Clear/ colorless, Blue | Different | ||
| ItemFeature | Subject device | Predicate device | Comparison | ||
| Submitter | Great Group Medical Co., Ltd. | Flexicare Medical Limited | |||
| Proprietary Name | GGM Breathing Circuit BacterialFilter - Bacterial Filters | HepaShield Bacterial Viral BreathingSystem Filter | |||
| 510(k) No. | K210352 | K191909 | |||
| Models | VF-2160 | VF-2160-1 | N/A | N/A | |
| Standard 22/15mmconnections incompliance withISO 5356-1 | Yes | Yes | Same | ||
| Luer port for gassampling incompliance withISO 594-2/ISO80369-7 | Yes | Yes | Same | ||
| Configurations | Straight withoutluer port | Straight with luerport | Straight with luer port | Similar | |
| Filtration | Electrostatic | Mechanical | Different | ||
| Placement withCircuit | Machine side | Patient sideMachine side | Similar | ||
| ItemFeature | Subject device | Predicate device | |||
| Submitter | Great Group Medical Co., Ltd. | Flexicare Medical Limited | Comparison | ||
| Proprietary Name | GGM Breathing Circuit BacterialFilter - Bacterial Filters | HepaShield Bacterial Viral BreathingSystem Filter | |||
| 510(k) No. | K210352 | K191909 | |||
| Models | VF-2160 | VF-2160-1 | N/A | N/A | |
| Weight | 21g | 23g | 42g | Different | |
| Internal Volume/Dead space as perISO 9360-1 | 30ml | 47ml | Similar | ||
| Bacterial/ ViralFiltrationEfficiency/ FilterIntegrity (Fresh) | BFE - 99.9%VFE - 99.9% | BFE- 99.99999%VFE- 99.9999% | Similar | ||
| Salt MethodFiltrationEfficiency | 99.61% | 99.89% | Similar | ||
| Tidal VolumeRange | 250~1500ml | 141~800ml | Different | ||
| ItemFeature | Subject device | Predicate device | |||
| Submitter | Great Group Medical Co., Ltd. | Flexicare Medical Limited | Comparison | ||
| Proprietary Name | GGM Breathing Circuit BacterialFilter - Bacterial Filters | HepaShield Bacterial Viral BreathingSystem Filter | |||
| 510(k) No. | K210352 | K191909 | |||
| Models | VF-2160VF-2160-1 | N/A | N/A | ||
| Pressure Drop/Flow resistance perBS EN ISO23328-2/ EN ISO9360-1 | 0.47 hPa @30L/min0.98 hPa @60L/min1.47 hPa @90L/min | 1.70 hPa @ 30LPM3.92 hPa @ 60LPM6.56 hPa @ 90LPM | Different | ||
| Leakage per BSEN ISO 23328-2/BS EN ISO 9360-1 | < 10 ml/min | < 2 ml/min | Different | ||
| Compliance perBS EN ISO 9360-1 | 0.3ml/kPa | 0.057ml/kPa | Different | ||
| Reuse, Cleaning &Disinfection | N/A- Single use (max 24hrs) | N/A- Single use (max 24hrs) | Same | ||
| Shelf Life | 3 years | 5 years | Different | ||
| Packaging | Sterile paper film | Polybag | Different | ||
| ItemFeature | Subject device | Predicate device | Comparison | ||
| Submitter | Great Group Medical Co., Ltd. | Flexicare Medical Limited | |||
| Proprietary Name | GGM Breathing Circuit BacterialFilter – HME (Heat and MoistureExchange) Filters | ThermoShield HME Filter | |||
| 510(k) No. | K210352 | K163300 | |||
| Models | VH-3110VH-3210 | N/A | N/A | ||
| Intended Use | HME (Heat and Moisture Exchange)Filter is intended to reduce thetransmission of bacteria and virusesto/from a patient, and to maintainmoisture levels in the patient'srespiratory tract during anesthesia,artificial respiration and other typesof assisted ventilation.HME Filter is normally positioned atthe patient end of the breathingsystem between the circuits Y-pieceand the catheter mount or patientairway device. HME Filter is asingle use device for use on a singlepatient for up to 24hrs.HME Filter is designed to be used inhospital environments by trainedpersonnel. | Flexicare's ThermoShield HME(Heat and Moisture Exchange) Filtersare intended to reduce thetransmission of bacteria and virusesto/from a patient, and to maintainmoisture levels in the patient'srespiratory tract during anesthesia,artificial respiration and other typesof assisted ventilation.An HMEF is normally positioned atthe patient end of the breathingsystem between the circuit Y-pieceand the catheter mount or patientairway device.Flexicare's ThermoShield HME Filters are singleuse devices for use on a single patientfor up to 24hrs and are available inAdult and Mini (pediatric) sizes.Flexicare's ThermoShield HMEFilters are designed to be used in pre-hospital, hospital and homecare | Same | ||
| ItemFeature | Subject device | Predicate device | Comparison | ||
| Submitter | Great Group Medical Co., Ltd. | Flexicare Medical Limited | Comparison | ||
| Proprietary Name | GGM Breathing Circuit Bacterial Filter – HME (Heat and Moisture Exchange) Filters | ThermoShield HME Filter | |||
| 510(k) No. | K210352 | K163300 | N/A | ||
| Models | VH-3110 | N/A | N/A | ||
| VH-3210 | environments by trained personnel.Expert clinical judgment must be used in assessing patient humidification requirements. | ||||
| Intended PatientPopulation | For Adult patients with the tidal volume between 250ml-1500ml | Adult | Same for adult | ||
| For Adult patients with the tidal volume between 250ml-1000ml | |||||
| Type of use | Prescription Use | Same | |||
| Components | Filter housing topFilter housing bottomFilter cotton (electrostatic cotton)HME paper rollLuer port capOuter stickers | Similar | |||
| Filter housing topFilter housing bottomFilter padHME paperTethered luer port capOuter shrink sleeve | |||||
| Materials | Filter housing top | Filter housing top | Similar | ||
| Polypropylene/K-Resin | Polypropylene | ||||
| Filter housing bottom | Filter housing bottom | ||||
| Polypropylene/K-Resin | Polypropylene | ||||
| Filter cotton (electrostatic cotton) | Filter pad | ||||
| Polypropylene | Polypropylene | ||||
| HME paper roll | HME paper | ||||
| Paper | Paper | ||||
| Luer port cap | Tethered luer port | ||||
| PP | PVC | ||||
| ItemFeature | Subject device | Predicate device | Comparison | ||
| Submitter | Great Group Medical Co., Ltd. | Flexicare Medical Limited | |||
| Proprietary Name | GGM Breathing Circuit BacterialFilter – HME (Heat and MoistureExchange) Filters | ThermoShield HME Filter | |||
| 510(k) No. | K210352 | K163300 | |||
| Models | VH-3110 | VH-3210 | N/A | N/A | |
| Outer stickers | Paper | capOuter shrinksleeve | LDPE | ||
| Assembly Method | Ultrasonic welded housing | Snap Fit casing | Different | ||
| Emergency Use | Yes | Yes | Same | ||
| Environment ofUse | Hospital | Pre-hospital, Hospital & Homecare | Similar | ||
| Patient use/Duration of use | Single use, disposable, < 24hrs | Single use, disposable, < 24hrs | Same | ||
| Supplied sterile | Sterile | Non-sterile | Different | ||
| Patient Connection | connections in compliance with ISO5356-1 | connections in compliance with ISO5356-1 | Same | ||
| Colors | Clear/ colorless, White | Clear/ colorless, Blue | Different | ||
| ItemFeature | Subject device | Predicate device | Comparison | ||
| Submitter | Great Group Medical Co., Ltd. | Flexicare Medical Limited | |||
| Proprietary Name | GGM Breathing Circuit BacterialFilter – HME (Heat and MoistureExchange) Filters | ThermoShield HME Filter | |||
| 510(k) No. | K210352 | K163300 | |||
| Models | VH-3110 | VH-3210 | N/A | N/A | |
| Standard 22/15mmconnections incompliance withISO 5356-1 | Yes | Yes | Same | ||
| Luer port for gassampling incompliance withISO 594-2 | Yes | Yes | Same | ||
| Configurations | Straight with luer port | Straight with luer port | Same | ||
| Filtration | Electrostatic | Electrostatic | Same | ||
| Placement withCircuit | Patient side | Patient side | Same | ||
| Weight | 31g | 25g | 38g | Different | |
| Internal Volume/Dead space as perISO 9360-1 | 45ml | 29ml | 46ml | Similar |
5.9.1 For Bacterial Filters:
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5.9.2 For HME (Heat and Moisture Exchange) Filters:
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| ItemFeature | Subject device | Predicate device | Comparison | |
|---|---|---|---|---|
| Submitter | Great Group Medical Co., Ltd. | Flexicare Medical Limited | ||
| Proprietary Name | GGM Breathing Circuit BacterialFilter – HME (Heat and MoistureExchange) Filters | ThermoShield HME Filter | ||
| 510(k) No. | K210352 | K163300 | ||
| Models | VH-3110 | VH-3210 | N/A | N/A |
| Bacterial/ ViralFiltrationEfficiency/ FilterIntegrity (Fresh) | BFE - 99.9%VFE - 99.9% | BFE - 99.9%VFE - 99.7% | BFE- 99.999%VFE- 99.99% | Similar |
| Salt MethodFiltrationEfficiency | 99.05% | 98.34% | 98.90% | Similar |
| Moisture Output(mg/L) | 36.7 at Vt=500ml | 35.9 at Vt=500ml | 30.4, vt=500ml | Similar |
| Moisture Loss(mg/L) | 7.3 at Vt=500mL | 8.1 at Vt=500mL | 6.8, vt=500ml | Similar |
| Tidal VolumeRange | 250~1500ml | 250~1000ml | 138~800ml | Different |
| ItemFeature | Subject device | Predicate device | Comparison | |
| Submitter | Great Group Medical Co., Ltd. | Flexicare Medical Limited | ||
| Proprietary Name | GGM Breathing Circuit BacterialFilter – HME (Heat and MoistureExchange) Filters | ThermoShield HME Filter | ||
| 510(k) No. | K210352 | K163300 | N/A | |
| Models | VH-3110 | VH-3210 | N/A | |
| Pressure Drop/Flow resistance | 1.0 hPa@30L/min2.3 hPa@60L/min4.1 hPa@90L/min | 1.5 hPa@30L/min3.4 hPa@60L/min5.7 hPa@90L/min | 1.71 hPa @ 30LPM4.31 hPa @ 60LPM7.82 hPa @ 90LPM | Similar |
| Housing BurstStrength | >101kPa | >101kPa | Same | |
| Leakageper ISO 9360-1 | No leak at 101kPa | No leak at 101kPa | Same | |
| Compliance perISO 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 |
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| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Packaging for Terminally Sterilized Medical Devices | |||
| ISO 10993-7 | EO/ ECH/ EG residualtest | 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 heldfor creep duration | PASS |
| ASTM F88 | Seal Peel Strength Test | >0.1kg/cm | PASS |
| Shelf Life Test | |||
| ISO 9360-1 | Moisture Loss, PressureDrop, Leakage,Compliance | Methodology only, noacceptance criteria | Meet therequirements of the clinical application |
| ISO 5356-1 | Test for Security ofEngagement of LatchingSockets 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 RabbitIntracutaneous ReactivityTest | Did not cause intracutaneous irritation | PASS |
| ISO 10993-11 | Acute Systemic ToxicityStudy | Did not cause systemic toxicity reaction or death | PASS |
| ISO 10993-11 | Repeat- Dose SubchronicSystemic Toxicity Study | No significant adverse effects. | PASS |
| ISO 10993-3 | In Vitro Mammalian CellGene Mutation Test | No genotoxic effects | PASS |
| ISO 10993-3 | Salmonella ReverseMutation Test | Did not cause mutagenic | PASS |
| ISO 10993-3 | Mice ErythrocyteMicronucleus Test | Does not produce micronuclei | PASS |
| ISO 10993-6 | Muscle Implant Study | Nonirritant (Score < 2.9) | PASS |
| ISO 18562-2 | Emissions of ParticulateMatter | $PM2.5 ≤ 12 µg/m3$$PM10 ≤ 150 µg/m3$ | PASS |
| ISO 18562-3 | Emissions of VOCs andAldehydes | Risk Assessment | PASS |
| ISO 18562-4 | Leachable in Condensate | Risk Assessment | PASS |
| Performance Test | |||
| ASTM F2101 | Bacterial / VirusFiltration Efficiency test | Methodology only, no acceptance criteria | Meet the requirements of the standard |
| ISO 9360-1 | Moisture Loss, Pressure Drop | Methodology only, no acceptance criteria | Meet the requirements of the clinical application |
5.10 Non-clinical Testing
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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
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- 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.
5.11 Clinical and Usability Testing
No clinical test data was used not needed for this submission
5.12 Conclusion
The conclusions drawn from the nonclinical test demonstrate that the GGM Breathing Circuit Bacterial Filter is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 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).