(456 days)
Not Found
No
The device description clearly states it is a "passive device" and there is no mention of any computational or learning capabilities. The description focuses on mechanical components and their function.
Yes
The device is intended to add moisture to breathing gases for administration to patients requiring humidification of high flow supplemental breathing gases, which is a therapeutic intervention.
No
The device is a bubble humidifier intended to add moisture to breathing gases; its function is for humidification and not for diagnostic purposes.
No
The device description clearly outlines physical components such as a bottle, lid, pressure relief mechanism, and diffuser tube, indicating it is a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a bubble humidifier intended to add moisture to breathing gases for administration to patients. It is a passive device that humidifies air or oxygen before it is inhaled.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is purely related to the delivery of humidified breathing gas.
Therefore, the Salter Labs Bubble Humidifier is a medical device, but it falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BTT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
1 month
Intended User / Care Setting
homecare, hospital, extended care and hospice.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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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3
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 Bubble | |||
| Humidifier (6-15 LPM) with | |||
| 6 PSI (410mbars) safety | |||
| valve. | Respiratory gas | ||
| humidifier | Respiratory gas | ||
| humidifier | 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
4
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.
5
F. Substantial Equivalence:
| Comparison of Technological Characteristics with the Predicate Device |
|---|
| Specification | Predicate: Salter Labs
Bubble Humidifier (High
Flow) | Test device: Salter Labs
Bubble Humidifier (6-15
LPM) with 6 PSI
(410mbars) safety valve | Changes |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Device Use & General Characteristics | | | |
| Indications for
use | The bubble humidifier is a
device that is intended to
add moisture to breathing
gases for administration to a
patient. 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 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 patient
population
and the use
environment
has been
defined |
| Target Patient
Population | The device is indicated for
patients who require
humidification of high flow
supplemental breathing
gases. | The device is indicated for
patients >1 month who
require humidification of
high flow supplemental
breathing gases. | The patient
population
has been
defined |
| Intended use | To humidify breathing gases | To humidify breathing gases | Unchanged |
| Environment of
use | For use in homecare,
hospital, acute care facilities,
extended care facilities and
hospice environments. | For use in homecare,
hospital, acute care facilities,
extended care facilities and
hospice environments. | Unchanged |
| Use | Single patient use | Single patient use | Unchanged |
| Supplied as | Non-sterile | Non-sterile | Unchanged |
| Principal of
Operation/
Mechanisms of
Action | The bubble humidifier is
indicated for use with
oxygen concentrators or gas
sources to humidify (add
water to) the oxygen | The bubble humidifier is
indicated for use with
oxygen concentrators or gas
sources to humidify (add
water to) the oxygen | Unchanged |
| Technology | Air is channelled through a | Air is channelled through a | Unchanged |
| Specification | Predicate: Salter Labs
Bubble Humidifier (High
Flow) | Test device: Salter Labs
Bubble Humidifier (6-15
LPM) with 6 PSI
(410mbars) safety valve | Changes |
| Device Use & General Characteristics | | | |
| | water-containing bottle. The
air then becomes humidified
before exiting to the patient | water-containing bottle. The
air then becomes humidified
before exiting to the patient | |
| Flow rate | 6-15 liters per minute | 6-15 liters per minute | Unchanged |
| Pop-off safety
valve | At 6 PSI | At 6 PSI | Unchanged |
| Power Source | None - this is a passive
device | None - this is a passive
device | 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 |
| Required
preparations prior
to use | None | None | Unchanged |
| Manufacturing
Process of Device
from Material | Molded (bottle, lid)
Extruded (diffuser tube) | Molded (bottle, lid)
Extruded (diffuser tube) | Unchanged |
| Patient-Contact
Components | Device does not touch the
patient. | Device does not touch the
patient. | Unchanged |
| Labeling | Instructions for Use are
unchanged except for the
removal of the DEHP
symbol. | Instructions for Use are
unchanged except for the
removal of the DEHP
symbol. | SE |
| Environmental
Limitations | 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 |
6
7
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).
8
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 | Predicate
K113542 | Modified
device | Performance
Testing |
|----------------------------------------------------------------------------------------------------------|----------------------|--------------------|-------------------------------------|
| Material Formulation
of the diffusor tubing
and diffusor (all other
materials are
unchanged. | PVC, DEHP | PVC, DOTP | Biocompatibility
and Performance |
9
Standards
Standards used for this submission:
| Standard | Test | Results |
|---|---|---|
| ISO 10993-5 | Biological Evaluation of Medical Devices | |
| Part 5: Tests for in-vitro cytotoxicity | Acceptable | |
| ISO 10993-10 | Biological evaluation of medical devices - | |
| Part 10: Tests for irritation and skin | ||
| sensitization. | Acceptable | |
| ISO 10993-18 | Biological evaluation of medical devices - | |
| Part 18: Chemical characterization of | ||
| materials | 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.