Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with a stylized design that suggests flowing hair or water beneath the profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 11, 2016 Salter Labs Margaret Caler Regulatory Associate 2365 Camino Vida Robles Carlsbad, California 92011 Re: K151506 Trade/Device Name: NOP Demand Nasal Oxygen Cannula, Models 4804, 4805, 4807, 4824. & 4827 and NOP Modified Demand Nasal Oxygen Cannula, Models 4904, 4905, & 4907 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: NFB Dated: February 5, 2016 Received: February 11, 2016 Dear Ms. Caler: 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. 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 {1}------------------------------------------------ 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 Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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) K151506 ### Device Name NOP Demand Nasal Oxygen Cannula, Models 4804, 4807, 4824, & 4827 and NOP Modified Demand Nasal Oxygen Cannula, Models 4904, 4905, & 4907. Indications for Use (Describe) The intended use is to deliver oxygen to the patient nasally, controlled by a demand system | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | 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}------------------------------------------------ ## Section 9.0: 510 (k) Summary In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR §807), a the following summary information is provided: ### 510 (k) Summary #### A. Submitter: Salter Labs 2365 Camino Vida Robles Carlsbad, CA 92011 Telephone: 760-795-7100 Fax: 760-683-6797 Contact Person: Mara Caler Director, Regulatory Affairs Date Prepared: 11 March 2016 #### B. Device Names: | Trade Name | Common Name | |----------------------------------------------------------------------------|------------------------------------------| | NOP Demand Nasal Oxygen Cannula<br>models: 4804, 4805, 4807, 4824, & 4827. | NOP Demand Nasal Oxygen Cannula | | NOP Modified Demand Nasal Oxygen<br>Cannula models: 4904, 4905, & 4907. | NOP Modified Demand Nasal Oxygen Cannula | | Classification Name: | Conserver, Oxygen | |-----------------------|-------------------| | Product Code: | NFB | | Regulation Number: | 868.5905 | | Classification: | II | | Classification Panel: | Anaesthesiology | #### Predicate Devices: C. This submission demonstrates substantial equivalence to the predicate devices: K890298, Demand Nasal Oxygen Cannula K892407, Modified Demand Nasal Oxygen Cannula {4}------------------------------------------------ #### D. Device Descriptions The demand cannula is a special cannula designed to give adult and pediatric users of dual port oxygen conservation delivery system all the comfort and conveniences of a Salter-Style® cannula. Unique dual tubing delivers oxygen on demand through one tube while inspiratory / expiratory effort is also sensed through the other tube. Meets dual port device manufacturers' specifications. #### Indications for Use E. The intended use is to delivery oxygen to patient nasally, controlled by a demand system. #### Comparison of Technological Characteristics with the Predicate Device F. The proposed NOP Demand Nasal Oxygen Cannula and Modified NOP Demand Nasal Oxygen Cannula is substantially equivalent to the predicate device listed above in that the the indications for use, the intended use, and fundamental scientific technology remain unchanged. The differences between the NOP Demand Nasal Oxygen Cannula and Modified NOP Demand Nasal Oxygen Cannula and the predicate device are: | Features | Predicate Demand<br>Nasal Oxygen<br>Cannula | NOP Demand Oxygen<br>Cannula | Performance<br>Testing | |-------------------------|---------------------------------------------|------------------------------|------------------------| | Material<br>Formulation | PVC, DIDP | PVC, DINCH | Biocompatibility | | | PVC, DEHP | PVC, DOTP | and Performance | #### ﻦ Performance Data The NOP Demand Nasal Oxygen Cannula and Modified NOP Demand Nasal Oxygen Cannula were tested to verify that the new material bond and performance characteristics of flow rate, back pressure, and tubing bond strength did not impact the strength or performa nce of the modified demand devices after the material change. Statistical methods were used to determine, the minimum required sample size was 29 to support a 95% confidence level at 91% reliability. The test results demonstrate that the NOP Demand Nasal Oxygen Cannula and Modified NOP Demand Nasal Oxygen Cannula is substantially equivalent to the predicate devices. {5}------------------------------------------------ The tests performed are summarized below: | Criteria | Results | Comments | |-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | Shall not have a back<br>pressure that exceeds 3 psi at<br>a maximum flow rate in<br>ambient of 5°C, 20°C, and<br>40°C | The NOP Demand/Modified<br>Demand Nasal Oxygen<br>Cannula met the objective back<br>pressure requirements | Maximum back<br>pressure was<br>found to be less<br>than 2 psi. | | The bonded components of<br>the set will have a bond<br>strength that is $≥$ 2 lbs. when<br>pulled at a rate of 5 inches<br>per minute. | The NOP Demand/Modified<br>Demand Nasal Oxygen<br>Cannula passed all bond strength<br>requirements. All test samples<br>measured above the bond interface<br>tensile load limit. | The worst case<br>cannula sample<br>was able<br>to achieve over<br>2 times the<br>minimum<br>allowable<br>value. | | The cannula shall withstand<br>storage and transport<br>temperatures. A high<br>temperature limit of 50°C<br>and a low temperature limit<br>of -29°C. | The NOP Demand/Modified<br>Demand Nasal Oxygen<br>Cannula met the above<br>performance criteria after storage<br>and transport environmental<br>conditioning. | N/A | The NOP Demand Nasal Oxygen Cannula and Modified NOP Demand Nasal Oxygen Cannula meet established Salter Labs performance specifications. #### Clinical / Non-Clinical H. The following biocompatibility testing was performed. The materials passed all parameters: - Irritation - · Sensitization · - · Cytotoxicity - Particulate - Volatile organic compounds #### I. Conclusions The NOP Modified Demand and NOP Demand Nasal Oxygen Cannula data and test results demonstrate that the devices are substantially equivalent to the predicate devices