(456 days)
The bubble humidifier is intended to add moisture to breathing gases for administration to patients >1 month in homecare, hospital, extended care and hospice.
The bubble humidifier is a non-sterile device indicated for single-patient usage. The device is indicated for patients who require humidification of high flow supplemental breathing gases.
The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410 mbars) safety valve is an empty, disposable, non-sterile, not made with natural rubber latex, device intended to humidify breathing gas prior to delivery to a patient. The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve is provided with a 6 pounds per square inch (PSI) safety valve and can operate within flow rates of 6 to 15 liters per minute (LPM). The device is used with various breathing gas sources (i.e., oxygen concentrators, gas cylinders and wall outlets) and provides connection for delivery of humidified breathing gas via face masks or cannulas, and use of optional oxygen tubing and water traps (face masks, 21 CFR 868.5580: nasal cannulas, 21 CFR 868.5340; oxygen tubing, 21 CFR 868.5860 and water traps, 21 CFR 868.5995 are 510(k) exempt).
This device is a passive device and is not a cascade humidifier, is not heated and is not prefilled.
The device is made of a humidifier bottle which is used to hold water during use, a lid which seals the humidifier bottle, an audible pressure relief mechanism to notify the user of a downstream occlusion and a diffuser located at the end of a PVC diffuser tube inside the humidifier bottle. The diffusor is designed to uniformly disperse the gas throughout the water. Both the bottle and lid are constructed to be easy to grip and reduce the chance of cross threading. The bottle is permanently marked with "minimum/maximum" water levels. The lid is marked with minimum source pressure, flow ranges and pressure value of the safety valve.
The provided document describes a 510(k) premarket notification for a medical device, specifically a "Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the device acceptance criteria and study information provided are tailored to this regulatory pathway, primarily involving performance testing and biocompatibility assessments related to a material change.
The document does not describe the development or evaluation of an Artificial Intelligence (AI) device. Consequently, several of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, training set size, and ground truth for training set) are not applicable to this submission.
Here's an analysis of the provided information, addressing the relevant points:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the performance specifications of the predicate device and relevant international standards. The "Performance Data" section indicates that the focus was on verifying that the material change did not adversely affect performance.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Biocompatibility Standards Compliance: | |
| ISO 10993-5 (in-vitro cytotoxicity) | Acceptable |
| ISO 10993-10 (irritation and skin sensitization) | Acceptable |
| ISO 10993-18 (chemical characterization) | Acceptable |
| Material Performance: | |
| Bond strength of new diffuser material | Met pre-defined performance specifications |
| Cleaning Durability: | |
| Performance after cleaning per Instructions for Use | Verified |
| Useful Life: | |
| Performance up to 120 cleaning cycles | Verified |
| Flow Rate: | 6-15 LPM (Unchanged from predicate) |
| Pop-off Safety Valve Pressure: | 6 PSI (410 mbars) (Unchanged from predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the performance tests conducted on the modified device (e.g., bond strength, cleaning, useful life studies). However, such tests would typically involve a statistically relevant number of units.
- Data Provenance: The tests were conducted internally by Salter Labs, the manufacturer. No country of origin for test data is specified beyond the manufacturer's location in Carlsbad, California, USA. The studies are prospective in the sense that they were designed and executed to evaluate the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. The studies involved physical and chemical testing of the device, not the establishment of ground truth by human experts, as would be the case for diagnostic AI.
4. Adjudication Method for the Test Set
This question is not applicable. The tests involved objective physical and chemical measurements against predetermined specifications, not subjective interpretation requiring adjudication.
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 question is not applicable. This is not an AI device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. This is not an AI device.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on:
- Established Performance Specifications: For parameters like flow rate, pop-off pressure, and mechanical integrity (bond strength), the "ground truth" refers to the pre-defined engineering and performance specifications that the device must meet, often derived from the predicate device's performance or relevant industry standards.
- International Standards (Biocompatibility): For biocompatibility, compliance with ISO 10993 standards (e.g., negative cytotoxicity, no irritation/sensitization) serves as the "ground truth."
8. The Sample Size for the Training Set
This question is not applicable. This is not an AI device; therefore, there is no AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. There is no training set for an AI model.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2017
Salter Labs Mara Caler Regulatory Affairs 2365 Camino Vida Roble Carlsbad, California 92011
Re: K161719
Trade/Device Name: Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: September 14, 2017 Received: September 18, 2017
Dear Mara 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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,
Tara A. Ryan -S
for Tina Kiang, Ph.D. Acting 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) K161719
Device Name
Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve
Indications for Use (Describe)
The bubble humidifier is intended to add moisture to breathing gases for administration to patients >1 month in homecare, hospital, extended care and hospice.
The bubble humidifier is a non-sterile device indicated for single-patient usage. The device is indicated for patients who require humidification of high flow supplemental breathing gases.
| 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
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), and in particular §807.92, the following summary of substantial equivalence information is provided:
510 (k) Summary
A. Submitter:
Salter Labs 2365 Camino Vida Robles Carlsbad, CA 92011 Telephone: 760-795-7100 760-683-6797 Fax:
Contact Person: Mara Caler Regulatory Affairs
Date Prepared: 14 Sept 2017
Device Names: B.
| Trade Name | Common Name | Classification Name | Product Code |
|---|---|---|---|
| Salter Labs BubbleHumidifier (6-15 LPM) with6 PSI (410mbars) safetyvalve. | Respiratory gashumidifier | Respiratory gashumidifier | BTT |
| Regulation Number: | 868.5450 |
|---|---|
| Classification: | II |
| Classification Panel: | Anaesthesiology (73) |
C. Predicate Devices:
This submission demonstrates substantial equivalence to the predicate device: K113542, Salter Labs Bubble Humidifier
D. Device Descriptions
The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410 mbars) safety valve is an empty, disposable, non-sterile, not made with natural rubber latex, device intended to
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humidify breathing gas prior to delivery to a patient. The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve is provided with a 6 pounds per square inch (PSI) safety valve and can operate within flow rates of 6 to 15 liters per minute (LPM). The device is used with various breathing gas sources (i.e., oxygen concentrators, gas cylinders and wall outlets) and provides connection for delivery of humidified breathing gas via face masks or cannulas, and use of optional oxygen tubing and water traps (face masks, 21 CFR 868.5580: nasal cannulas, 21 CFR 868.5340; oxygen tubing, 21 CFR 868.5860 and water traps, 21 CFR 868.5995 are 510(k) exempt).
This device is a passive device and is not a cascade humidifier, is not heated and is not prefilled.
The device is made of a humidifier bottle which is used to hold water during use, a lid which seals the humidifier bottle, an audible pressure relief mechanism to notify the user of a downstream occlusion and a diffuser located at the end of a PVC diffuser tube inside the humidifier bottle. The diffusor is designed to uniformly disperse the gas throughout the water. Both the bottle and lid are constructed to be easy to grip and reduce the chance of cross threading. The bottle is permanently marked with "minimum/maximum" water levels. The lid is marked with minimum source pressure, flow ranges and pressure value of the safety valve.
E. Indications for Use:
The bubble humidifier is intended to add moisture to breathing gases for administration to patients >1 month in homecare, hospital, extended care and hospice.
The bubble humidifier is a non-sterile device indicated for single-patient usage. The device is indicated for patients who require humidification of high flow supplemental breathing gases.
E.1: Usage
The bubble humidifier is indicated for use with oxygen concentrators or gas sources in homecare, hospital, extended care facilities and hospice environments. The bubble humidifier is a non-sterile device indicated for single-patient usage. The device is indicated for patients who require humidification of high flow supplemental breathing gases.
E.2: Comparison of intended use to the predicate device and separate it from the Indications for Use Statement.
The predicate device is indicated for any patient population requiring humidification of high flow supplemental breathing gases. There are no excluded patient populations. For clarity, a more detailed description of the patient population is defined in the indications for use statement. This device is intended for the same intended population, including patients >1 month in homecare, hospital, extended care and hospice environments.
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F. Substantial Equivalence:
| Comparison of Technological Characteristics with the Predicate Device |
|---|
| Specification | Predicate: Salter LabsBubble Humidifier (HighFlow) | Test device: Salter LabsBubble Humidifier (6-15LPM) with 6 PSI(410mbars) safety valve | Changes |
|---|---|---|---|
| Device Use & General Characteristics | |||
| Indications foruse | The bubble humidifier is adevice that is intended toadd moisture to breathinggases for administration to apatient. The bubblehumidifier is a non-steriledevice indicated for single-patient usage. The device isindicated for patients whorequire humidification ofhigh flow supplementalbreathing gases. | The bubble humidifier isintended to add moisture tobreathing gases foradministration topatients >1 month inhomecare, hospital, extendedcare and hospice.The bubble humidifier is anon-sterile device indicatedfor single-patient usage. Thedevice is indicated forpatients who requirehumidification of high flowsupplemental breathinggases. | The patientpopulationand the useenvironmenthas beendefined |
| Target PatientPopulation | The device is indicated forpatients who requirehumidification of high flowsupplemental breathinggases. | The device is indicated forpatients >1 month whorequire humidification ofhigh flow supplementalbreathing gases. | The patientpopulationhas beendefined |
| Intended use | To humidify breathing gases | To humidify breathing gases | Unchanged |
| Environment ofuse | For use in homecare,hospital, acute care facilities,extended care facilities andhospice environments. | For use in homecare,hospital, acute care facilities,extended care facilities andhospice environments. | Unchanged |
| Use | Single patient use | Single patient use | Unchanged |
| Supplied as | Non-sterile | Non-sterile | Unchanged |
| Principal ofOperation/Mechanisms ofAction | The bubble humidifier isindicated for use withoxygen concentrators or gassources to humidify (addwater to) the oxygen | The bubble humidifier isindicated for use withoxygen concentrators or gassources to humidify (addwater to) the oxygen | Unchanged |
| Technology | Air is channelled through a | Air is channelled through a | Unchanged |
| Specification | Predicate: Salter LabsBubble Humidifier (HighFlow) | Test device: Salter LabsBubble Humidifier (6-15LPM) with 6 PSI(410mbars) safety valve | Changes |
| Device Use & General Characteristics | |||
| water-containing bottle. Theair then becomes humidifiedbefore exiting to the patient | water-containing bottle. Theair then becomes humidifiedbefore exiting to the patient | ||
| Flow rate | 6-15 liters per minute | 6-15 liters per minute | Unchanged |
| Pop-off safetyvalve | At 6 PSI | At 6 PSI | Unchanged |
| Power Source | None - this is a passivedevice | None - this is a passivedevice | Unchanged |
| Prescription Use /Over-The-Counter Use | Prescription Devices | Prescription Devices | Unchanged |
| Sterile / Non-Sterile | Non-Sterile | Non-Sterile | Unchanged |
| Use | Single patient use | Single patient use | Unchanged |
| Requiredpreparations priorto use | None | None | Unchanged |
| ManufacturingProcess of Devicefrom Material | Molded (bottle, lid)Extruded (diffuser tube) | Molded (bottle, lid)Extruded (diffuser tube) | Unchanged |
| Patient-ContactComponents | Device does not touch thepatient. | Device does not touch thepatient. | Unchanged |
| Labeling | Instructions for Use areunchanged except for theremoval of the DEHPsymbol. | Instructions for Use areunchanged except for theremoval of the DEHPsymbol. | SE |
| EnvironmentalLimitations | Storage temperature:-40°C (-40°F) to +60°C(140 °F) | Storage temperature:-40°C (-40°F) to +60°C(140 °F) | Unchanged |
| Materials | |||
| K113542 | PVC (DEHP) | PVC (DOTP) | SE |
| Biocompatibility | ISO 10993 compliant | ISO 10993 compliant | Unchanged |
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Similarities and Differences:
Similarities:
The similarities between the Salter Labs Bubble Humidifier and the modified Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve are:
Design: The exact same design is used; there are no changes to the Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve except the materials used in the line/diffusor.
- Both are passive, non-heated, non-powered humidifier bottles. There is no external ● energy source.
- Both are in-line between the air source and patient circuit (nasal cannula) ●
- Both are intended for single-patient use. ●
- Both are supplied non-sterile
- Both use identical pop-off safety valve (6 PSI) made from identical material (brass) ●
- Both have identical dimensions. ●
| Parameter (inch) | Comparison to predicate | |
|---|---|---|
| Bottle | ||
| • Length | 5.12 | No change |
| • Diameter (base) | 2.75 | No change |
| • Diameter (top) | 2.84 | No change |
| Lid | ||
| • Height | 2.26 | No change |
| • Diameter | 3.08 | No change |
| Tubing | ||
| • Length | 5.50 | No change |
| • Diameter | 0.29 | No change |
| Diffusor | ||
| • Length | 0.51 | No change |
| • Diameter (Base) | 0.40 | No change |
| • Diameter (Top) | 0.33 | No change |
- Both have identical performance characteristics ●
- o Flow rate: 6-15 LPM
- o 6 PSA (410 mbars) for pop-off safety valve
Materials
- . Both use identical materials: polyethylene bottle with a polystyrene lid (except as identified in the "differences" table below).
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Energy source
- Both use are non-heated, non-powered in-line humidifier bottles. There is no . external energy source.
Differences
The differences between the Salter Labs Bubble Humidifier and the modified Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve is a material modification from PVC (DEHP) to PVC (DOTP). The materials used in the remainder of the device are unchanged.
| Features | PredicateK113542 | Modifieddevice | PerformanceTesting |
|---|---|---|---|
| Material Formulationof the diffusor tubingand diffusor (all othermaterials areunchanged. | PVC, DEHP | PVC, DOTP | Biocompatibilityand Performance |
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Standards
Standards used for this submission:
| Standard | Test | Results |
|---|---|---|
| ISO 10993-5 | Biological Evaluation of Medical DevicesPart 5: Tests for in-vitro cytotoxicity | Acceptable |
| ISO 10993-10 | Biological evaluation of medical devices -Part 10: Tests for irritation and skinsensitization. | Acceptable |
| ISO 10993-18 | Biological evaluation of medical devices -Part 18: Chemical characterization ofmaterials | Acceptable |
Performance Data G.
The modified Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve was tested to verify that the bond strength of the new material used for the different tube and diffusor met the pre-defined performance specifications.
The test results demonstrate that the modified Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve is substantially equivalent to the predicate devices. No clinical testing was required for this submission. A cleaning study was performed which verified the cleaning outlined in the instructions for use. A useful life study was performed which verified performance up to 120 cleaning cycles.
H. Conclusions
The Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) safety valve data and test results (bond strength testing) demonstrate that the devices are substantially equivalent to the predicate devices. Based on the performance testing performed on the modified device safety valve and bond strength, Salter Labs Bubble Humidifier (6-15 LPM) with 6 PSI (410mbars) we have demonstrated that the modified device continue to perform substantially equivalent to the predicate devices.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).