Breathing circuit bacterial/viral filter

{0}------------------------------------------------ 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. Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other. The faces are rendered in a simple, line-art style. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |---------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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) {4}------------------------------------------------ ### 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-adult<br>1cm 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-adult<br>32 mg H2O/L at TV of 250cc-pediatric | | Tidal volume ranges | >150cc-adult<br>70-250cc-pediatric | | Materials | | | Housing polystyrene | Yes | ### 7. Technological Characteristics [21 CFR 807.92(a)(6)] {5}------------------------------------------------ | 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<br>&<br>Comments | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | Indications For Use | | | | | Description | For use with ventilators,<br>anesthesia machines and<br>open flow systems where<br>filtration of inspired and / or<br>expired gases is desired and<br>add maintain retain moisture<br>for the exhaled breathe of the<br>patient. Use up to 24 hours. | For use with ventilators,<br>anesthesia machines and<br>open flow systems where<br>filtration of inspired and / or<br>expired gases is desired and<br>add maintain retain moisture<br>for the exhaled breathe of the<br>patient. Use up to 24 hours. | same | | Technology | | | | | Product Structure | The product can be divided into<br>four main sections, which is top<br>cover, filter media and lower<br>cover, sampling port. | The product can be divided<br>into four main sections, which<br>is top cover, filter media, and<br>lower cover, and sampling<br>port. | 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 Port<br>Material | 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 5356-1<br>ISO 594-2<br>ISO 9360 | ISO 5356-1<br>ISO 594-2<br>ISO 9360 | same | ### Table: Comparison to Predicate Device (K013122) {6}------------------------------------------------ | Performance Testing | | | | |-------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------| | Device Biocompatibility<br>Test | See section 016 -Patient<br>Contact Materials and<br>Compatibility | | | | EO Residual | <10µg/g | <10µg/g | same | | Shelf Life | 3 years | 3 years | same | | Accelerated Aging test | See section 019 – Breathing<br>Filter validity validation<br>Report | | | | Resistance to Flow | <3cm H20@60L pm - Adult<br>1cm H2O@20Lpm -<br>pediatric | <3cm H20@60L pm - Adult<br>1 cm H2O@20Lpm - pediatric | same | | Humidification Output<br>(mg H2O/L) | 32mg H2O/L at TV of<br>1000cc - Adult<br>32mg H2O/L at TV of 250cc<br>- Pediatric | 32mg H2O/L at TV of 1000cc -<br>Adult<br>32mg H2O/L at TV of 250cc -<br>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.