(197 days)
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to add, maintain, retain moisture for the exhaled breathe of the patient. Use up to 24 hours.
The Models of the filters are A501-1, A501-2, A501-3, and A501-4. The filters are intended for patient population that weighs greater than 10Kgs.
Breathing circuit bacterial/viral filter has into two models: - 1) Bacterial/ viral filters; 2) Bacterial/viral filters HME. Breathing circuit bacterial/viral filters are available in multiple sizes and shapes, rectangular and round, and incorporate standard 15/22 mm connectors with a gas sampling luer port. The depth filter use electrostatic media for filtration and a foam media for the HME media.
The provided document is a 510(k) premarket notification for a medical device: a Breathing Circuit Bacterial/Viral Filter manufactured by Zhejiang Haisheng Medical Device Co., Ltd. The document asserts that the device is substantially equivalent to a legally marketed predicate device (EMS Electra Filter and Filter/HME, K013122).
Based on the provided text, here's information regarding the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is compared directly to the predicate device, implying that the predicate's performance metrics serve as the acceptance criteria for achieving substantial equivalence.
| Acceptance Criteria (from Predicate) | Reported Device Performance (Zhejiang Haisheng Breathing Circuit Bacterial/Viral Filter) | Met/Not Met |
|---|---|---|
| Resistance to Flow: | ||
| <3cm H2O@60Lpm - Adult | <3cm H2O@60Lpm - Adult | Met |
| <1cm H2O@20Lpm - Pediatric | 1cm H2O@20Lpm - Pediatric | Met |
| Humidification Output (mg H2O/L): | ||
| 32mg H2O/L at TV of 1000cc - Adult | 32mg H2O/L at TV of 1000cc - Adult | Met |
| 32mg H2O/L at TV of 250cc - Pediatric | 32mg H2O/L at TV of 250cc - Pediatric | Met |
| Bacterial Filtration Test: | 99.999% | Met |
| 99.999% | 99.99% | Met |
| Viral Filtration Test: | 99.99% | Met |
| Ethylene Oxide (EO) Residual: | <10µg/g | Met |
| <10µg/g | 3 years | Met |
| Shelf Life: | 3 years | Met |
| Standards Conformance: | ||
| ISO 5356-1 | Yes | Met |
| ISO 594-2 | Yes | Met |
| ISO 9360 | Yes | Met |
Additionally, other characteristics are compared for substantial equivalence:
- Indications For Use: Same
- Product Structure: Same (top cover, filter media, lower cover, sampling port)
- Materials (Top Cover, Filter Media, Lower Cover, Gas Sampling Port, Package): Same (polystyrene, electrostatic polypropylene, PE, dialyzing paper and PE film)
- Color Additive: None (Same)
- Sterilization: EO (Same)
2. Sample Size Used for the Test Set and Data Provenance
The document mentions that "Test data and reports were provided as part of the 510(k) submission," but does not specify the sample sizes of devices tested for each performance metric (e.g., how many filters were tested for bacterial filtration efficiency).
The data provenance is not explicitly stated in terms of country of origin for the testing, nor is it classified as retrospective or prospective. It is implied that the testing was conducted specifically for this 510(k) submission, suggesting it was prospective testing on the Zhejiang Haisheng device. The document states that some tests were performed by "Nelson Lab," which is a known independent laboratory (likely Nelson Laboratories, LLC in the USA), but this is not explicitly stated as the sole source of all test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of information (number and qualifications of experts) is not applicable to this device and submission. The device is a physical breathing circuit filter, and its performance (e.g., filtration efficiency, resistance) is measured objectively through standardized laboratory tests, not through expert interpretation or clinical judgment that would require establishing a "ground truth" by experts.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the performance is determined by objective laboratory measurements and does not involve human interpretation or adjudication in the context of, for example, image analysis or diagnostic tasks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance
This is not applicable as the device is a physical medical device (a filter) and not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and effects of AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a physical filter, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for verifying the device's performance is established through objective laboratory testing against recognized international standards and specific performance thresholds. For example:
- Bacterial/Viral Filtration: Determined by laboratory tests (e.g., Nelson Lab) measuring the percentage removal of specific microorganisms.
- Resistance to Flow: Measured using flow meters and pressure transducers.
- Humidification Output: Measured in a laboratory setting under controlled conditions (e.g., per ISO 9360).
- Material Compatibility/Biocompatibility: Determined by standardized material testing.
- Sterilization: Verified by ethylene oxide residual testing.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not a machine learning model, so there is no "training set" in the context of artificial intelligence or algorithm development. Production samples are tested for performance.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000
December 18, 2015
Zheiiang Haisheng Medical Device Co., Ltd Mr. Hu Junbin, Quality Director 305 Tanggong Road, Paojiang Industrial Zone Shaoxing City, Zhejiang 312071 China
Re: K151498
Trade/Device Name: Breathing Circuit Bacterial/viral Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial/Viral filter Regulatory Class: II Product Code: CAH Dated: November 11, 2015 Received: November 17, 2015
Dear Mr. Junbin,
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. 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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151498
Device Name Breathing circuit bacterial/viral filter
Indications for Use (Describe)
For use with ventilators, anesthesia machines and open filtration of inspired and/or expired gases is desired and to add, maintain, retain moisture for the exhaled breathe of the patient. Use up to 24 hours.
The Models of the filters are A501-1. A501-2. A501-4. The filters are intended for patient population that weighs greater than 10Kgs.
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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510(k) Summary
[As required by 21 CFR 807.92]
K151498
1. Date Prepared [21 CFR807.92 (a) (1)]
December 16, 2015
2. Submitter's Information [21 CFR807.92 (a) (1)]
Name of Sponsor: ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. Address: 305#Tanggong Road, Paojiang Industrial Zone Shaoxing City, Zhejiang 312071, P.R.China Contact Name: Hu Junbin Telephone No.: 86-575-88158510 Fax No.: 86-575-88158559 Email Address: hujb@hisern.com Correspondent: Jonathan Hu (Shanghai Medwheat Consulting)
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Breathing circuit bacterial/viral filter |
|---|---|
| Common Name: | Bacterial/viral filters and Heat and Moisture Exchanger |
| Model Name: | A501-1, A501-2, A501-3, A501-4 |
| Regulation Classification | 21 CFR 868.5260, Breathing circuit bacterial filter |
| Product Code: | CAH |
| Classification Panel: | Anesthesiology |
| Device Class: | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
The identified predicate within this submission is as follows:
The EMS Electra Filter and Filter/HME have been cleared by FDA through 510(k) K013122 (Decision Date - April 19, 2002)
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5. Description of the Device [21 CFR 807.92(a)(4)]
Breathing circuit bacterial/viral filter has into two models: - 1) Bacterial/ viral filters; 2) Bacterial/viral filters HME. Breathing circuit bacterial/viral filters are available in multiple sizes and shapes, rectangular and round, and incorporate standard 15/22 mm connectors with a gas sampling luer port. The depth filter use electrostatic media for filtration and a foam media for the HME media.
6. Intended Use [21 CFR 807.92(a)(5)]
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to add, maintain, retain moisture for the exhaled breathe of the patient. Use up to 24 hours.
The Models of the filters are A501-1, A501-2, A501-3, and A501-4. The filters are intended for patient population that weighs greater than 10Kgs.
| Attribute | Breathing circuit bacterial/viral filter |
|---|---|
| Indications for use – To filter inspired and /or expired gases. | Same |
| Intended for extended or single patient up to 24 hrs | Yes |
| Prescription Use | Yes |
| Intended Population | Any patient |
| Intended environment of use | Home, hospital, sub-acute, emergency services |
| Placement in various locations in circuit | Yes |
| Design | |
| Gas sampling port | Yes |
| Standard 15/22 mm connectors | Yes |
| Dead space (ml) | 10 to 65(ml) |
| Resistance to flow | ≤3cm H2O@ 60lpm-adult1cm H2O@ 20lpm-pediatric |
| Bacterial filtration-BFE-Nelson Lab | 99.999+% |
| Viral filtration-VFE-Nelson Lab | 99.99+% |
| Weight(g) | 10-32 (g) |
| Humidification output(mg H2O/L) | 32 mg H2O/L at TV of 1000cc-adult32 mg H2O/L at TV of 250cc-pediatric |
| Tidal volume ranges | >150cc-adult70-250cc-pediatric |
| Materials | |
| Housing polystyrene | Yes |
7. Technological Characteristics [21 CFR 807.92(a)(6)]
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| Filter media | Electrostatic polypropylene |
|---|---|
| Performance Standards | |
| None under Section 514 | Yes |
| ISO 5356-1 Conical 15/22 | Yes |
| ISO 594-2 Luer fittings | Yes |
| ISO 9360-HME moisture output | Yes |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
The breathing circuit bacterial/viral filter of Haisheng has been tested for biocompatibility, sterility and performance testing in accordance to conformance standards, FDA guidance and international standards. Test data and reports were provided as part of the 510(k) submission. A comparison between the subject device and predicate is provided below:
| Item | Subject Device | Predicate Device | Justification&Comments |
|---|---|---|---|
| Indications For Use | |||
| Description | For use with ventilators,anesthesia machines andopen flow systems wherefiltration of inspired and / orexpired gases is desired andadd maintain retain moisturefor the exhaled breathe of thepatient. Use up to 24 hours. | For use with ventilators,anesthesia machines andopen flow systems wherefiltration of inspired and / orexpired gases is desired andadd maintain retain moisturefor the exhaled breathe of thepatient. Use up to 24 hours. | same |
| Technology | |||
| Product Structure | The product can be divided intofour main sections, which is topcover, filter media and lowercover, sampling port. | The product can be dividedinto four main sections, whichis top cover, filter media, andlower cover, and samplingport. | same |
| Top Cover Material | Housing polystyrene | Housing polystyrene | same |
| Filter Media | Electrostatic polypropylene | Electrostatic polypropylene | same |
| Lower Cover Material | Housing polystyrene | Housing polystyrene | same |
| Gas Sampling PortMaterial | PE | PE | same |
| Package Material | Dialyzing paper and PE film | Dialyzing paper and PE film | same |
| Color Additive | None | None | same |
| Sterilization | EO | EO | same |
| Standards | ISO 5356-1ISO 594-2ISO 9360 | ISO 5356-1ISO 594-2ISO 9360 | same |
Table: Comparison to Predicate Device (K013122)
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| Performance Testing | |||
|---|---|---|---|
| Device BiocompatibilityTest | See section 016 -PatientContact Materials andCompatibility | ||
| EO Residual | <10µg/g | <10µg/g | same |
| Shelf Life | 3 years | 3 years | same |
| Accelerated Aging test | See section 019 – BreathingFilter validity validationReport | ||
| Resistance to Flow | <3cm H20@60L pm - Adult1cm H2O@20Lpm -pediatric | <3cm H20@60L pm - Adult1 cm H2O@20Lpm - pediatric | same |
| Humidification Output(mg H2O/L) | 32mg H2O/L at TV of1000cc - Adult32mg H2O/L at TV of 250cc- Pediatric | 32mg H2O/L at TV of 1000cc -Adult32mg H2O/L at TV of 250cc -Pediatric | same |
| Bacterial Filtration Test | 99.999% | 99.999% | same |
| Viral Filtration Test | 99.99% | 99.99% | same |
9. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act 21, CFR Part 807 and based on the Intended Use, Technological Characteristics, Performance data and non-clinical tests performed, the subject Breathing Circuit Bacterial/Viral Filter is substantially equivalent and is as safe and as effective as the legally marketed predicate 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).