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.

AI/ML Overview

The provided document describes the acceptance criteria and a study to demonstrate substantial equivalence for the NOP Demand Nasal Oxygen Cannula and NOP Modified Demand Nasal Oxygen Cannula.

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Criteria	Reported Device Performance
Shall not have a back pressure that exceeds 3 psi at a maximum flow rate in ambient of 5°C, 20°C, and 40°C.	The NOP Demand/Modified Demand Nasal Oxygen Cannula met the objective back pressure requirements. Maximum back pressure was found to be less than 2 psi.
The bonded components of the set will have a bond strength that is ≥ 2 lbs. when pulled at a rate of 5 inches per minute.	The NOP Demand/Modified Demand Nasal Oxygen Cannula passed all bond strength requirements. All test samples measured above the bond interface tensile load limit. The worst case cannula sample was able to achieve over 2 times the minimum allowable value.
The cannula shall withstand storage and transport temperatures. A high temperature limit of 50°C and a low temperature limit of -29°C.	The NOP Demand/Modified Demand Nasal Oxygen Cannula met the above performance criteria after storage and transport environmental conditioning.

2. Sample size used for the test set and the data provenance

Sample Size: A minimum required sample size of 29 was used for the performance testing.
Data Provenance: The document does not specify the country of origin of the data. It is a retrospective study conducted by the manufacturer (Salter Labs) to demonstrate substantial equivalence for a material change.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The study focuses on direct physical and performance testing of the device, not on expert evaluation or consensus for a "ground truth" as might be relevant for diagnostic or AI-based devices.

4. Adjudication method for the test set

This information is not applicable/provided as the study did not involve expert adjudication for establishing ground truth. The testing involved objective measurements against predefined criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a nasal oxygen cannula, not an AI-based diagnostic tool, so an MRMC study is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically defined for diagnostic or AI studies is not directly applicable here. Instead, the study establishes "truth" through direct physical performance measurements (e.g., back pressure, bond strength, temperature resistance) against specified engineering and product design criteria.

8. The sample size for the training set

This information is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable. As there is no training set, there is no ground truth for it. The study established performance data through direct physical testing.

Summary

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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

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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

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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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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 Cannulamodels: 4804, 4805, 4807, 4824, & 4827.	NOP Demand Nasal Oxygen Cannula
NOP Modified Demand Nasal OxygenCannula 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

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D. Device Descriptions

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 DemandNasal OxygenCannula	NOP Demand OxygenCannula	PerformanceTesting
MaterialFormulation	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.

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The tests performed are summarized below:

Criteria	Results	Comments
Shall not have a backpressure that exceeds 3 psi ata maximum flow rate inambient of 5°C, 20°C, and40°C	The NOP Demand/ModifiedDemand Nasal OxygenCannula met the objective backpressure requirements	Maximum backpressure wasfound to be lessthan 2 psi.
The bonded components ofthe set will have a bondstrength that is $≥$ 2 lbs. whenpulled at a rate of 5 inchesper minute.	The NOP Demand/ModifiedDemand Nasal OxygenCannula passed all bond strengthrequirements. All test samplesmeasured above the bond interfacetensile load limit.	The worst casecannula samplewas ableto achieve over2 times theminimumallowablevalue.
The cannula shall withstandstorage and transporttemperatures. A hightemperature limit of 50°Cand a low temperature limitof -29°C.	The NOP Demand/ModifiedDemand Nasal OxygenCannula met the aboveperformance criteria after storageand transport environmentalconditioning.	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

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).