(90 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
Yes.
The device is intended to provide an interface for the application of CPAP or bi-level therapy, which are forms of respiratory support used to treat medical conditions.
No
The device is described as an NIV (Non-Invasive Ventilation) elbow intended to provide an interface for CPAP or bi-level therapy and allow for respiratory care procedures, not to diagnose a condition.
No
The device description clearly describes a physical elbow component that replaces parts of existing masks and includes physical features like a duckbill valve and an anti-asphyxia valve. The performance studies also focus on bench testing of physical properties and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The ReddyPort Elbow is a mechanical device that provides an interface for delivering CPAP or bi-level therapy and allows for oral access during these therapies. It does not perform any tests on patient samples.
- Intended Use: The intended use is to facilitate respiratory therapy and allow for simultaneous procedures, not to diagnose or monitor a patient's condition through testing of biological samples.
The description clearly indicates it's a component used in the delivery of respiratory support, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The ReddyPort Elbow is intended to provide an interface for application of CPAP or bi-level therapy to the patient including while the patient is simultaneously undergoing another care procedure (e.g. oral care, suctioning, bronchoscopy) by hospital/institutional clinicians. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients (> 40 lbs/ 18.2 kg) for whom CPAP or bi-level therapy has been prescribed. The elbow can be used with Philips Respironics AF541 masks and AF531 masks with the clip-style connection.
Product codes
MNS
Device Description
The ReddyPort Elbow is an NIV elbow that replaces the elements AF541 style masks and AF531 masks with a clip-style comection and provides oral access for clinicians to the patient's airway during CPAP and bi-level therapy. The ReddyPort Elbow is compatible with both Over the Nose (OTN) cushion ((S, M, L, XL sizes) and an Under the Nose (UTN) cushion (A, B, C sizes) configurations of the AF541 EE Mask and AF531 mask with clip-style connection. ReddyPort permanently replaces the conventional elbow on the mask and maintains positive pressure. This elbow allows for respiratory care procedures (e.g. oral care, suctioning, bronchoscopy) to be performed on a patient while the patient is receiving non-invasive ventilation. The elbow contains a duckbill valve that allows the patient's airway and that seals with similar leak rates to conventional NIV elbows. In addition, the elbow includes an anti-asphysia valve to ensure safety of the patient.
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
patients (> 40 lbs/ 18.2 kg)
Intended User / Care Setting
hospital/institutional clinicians / hospital/institutional environment
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
The following bench testing was completed for the proposed device:
- ISO 17510:2015 Medical devices -- Sleep apnoea breathing therapy Masks and application accessories
- ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical conne
- Mask and Tubing Connection Force
- Dead Space
The ReddyPort Elbow met all applicable requirements and acceptance criteria.
Also, biocompatibility testing was conducted: - ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity and reproductive toxicity
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5:Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11:Tests for systemic toxicity
- ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-18:2020 Biological evaluation of medical devices Part 18: Chemical device materials within a risk management process
- ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process
- ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 2: Tests for emissions of particulate matter
- ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 2: Tests for emissions of particulate matter
- ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4: Tests for leachables in condensate
All biological testing conducted demonstrated passince criteria) and were conducted on test articles that are representative of the final, finished device in its final, finished form.
No clinical testing was conducted.
Key Metrics
Leak Rates (L/min) for Subject Device:
4 cmH2O: 0.6
10 cmH2O: 0.65
17 cmH2O: 0.89
24 cmH2O: 1.11
30 cmH2O: 1.34
Resistance to Flow During Regular Condition (cmH2O):
50 L/min flow: 0.23
100L/min flow: 0.13
Resistance Under Single Fault (cmH2O):
Added Inspiratory Resistance: 1.23
Added Expiratory Resistance: 0.43
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 13, 2023
SMD Manufacturing LLC % Tianna Benson RAOA Manager Lean RAQA, LLC 131 E Loch Lomond Dr. Oro Valley, Arizona 85737
Re: K231064
Trade/Device Name: ReddyPort Elbow Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: MNS Dated: April 13, 2023 Received: April 14, 2023
Dear Tianna Benson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231064
Device Name ReddyPort Elbow
Indications for Use (Describe)
The ReddyPort Elbow is intended to provide an interface for application of CPAP or bi-level therapy to the patient including while the patient is simultaneously undergoing another care procedure (e.g. oral care, suctioning, bronchoscopy) by hospital/institutional clinicians. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients (> 40 lbs/ 18.2 kg) for whom CPAP or bi-level therapy has been prescribed. The elbow can be used with Philips Respironics AF541 masks and AF531 masks with the clip-style connection.
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 K231064
Applicant/Submitter
| Company Name | : SMD MANUFACTURING LLC |
|---|---|
| Street Address | : 918 S 500 W, Ste A |
| City | : Salt Lake City |
| State | : UT |
| Zip Code | : 84101 |
Contact Person
| Full Name | : Jared Spendlove |
|---|---|
| Phone | : (801) 458-1959 |
Correspondent Information
| Full Name | : Laura Nygard |
|---|---|
| Phone | : 734-807-1282 |
Date of Preparation
Date of Preparation
: 07/06/2023
Device Information
Device Information Table
| Trade Name | ReddyPort Elbow |
|---|---|
| Common or Usual Name | Ventilator, Continuous, Non-Life-Supporting |
| Classification Name | 21 CFR 868.5895 Continuous ventilator. |
| Regulatory Class | 2 |
| Product Code | MNS |
Predicate Device(s)
4
Predicate Device(s) Table
| Predicate Type | 510(k) Number | Name Of Device | Name Of Manufacturer | Purpose of Reference
Device |
|------------------|---------------|-------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Device | K171827 | ReddyPort NIV Access
Elbow | SMD Manufacturing, LLC | N/A - Primary Predicate
Device |
| Reference Device | K150639 | AF541 EE Full Face Mask | RESPIRONICS, INC. | The ReddyPort Elbow
interfaces with this
mask, replacing the
AF541 EE elbow, in
order to allow patients
under CPAP or bi-level
therapy to also undergo
another care procedure. |
| Reference Device | K132168 | BRONCHOSCOPY
ELBOW | RESPIRONICS, INC. | Demonstrate substantial
equivalence for the
ReddyPort Elbow's use
during bronchoscopy
indication. |
Device Description
The ReddyPort Elbow is an NIV elbow that replaces the elements AF541 style masks and AF531 masks with a clip-style comection and provides oral access for clinicians to the patient's airway during CPAP and bi-level therapy. The ReddyPort Elbow is compatible with both Over the Nose (OTN) cushion ((S, M, L, XL sizes) and an Under the Nose (UTN) cushion (A, B, C sizes) configurations of the AF541 EE Mask and AF531 mask with clip-style connection. ReddyPort permanently replaces the conventional elbow on the mask and maintains positive pressure. This elbow allows for respiratory care procedures (e.g. oral care, suctioning, bronchoscopy) to be performed on a patient while the patient is receiving non-invasive ventilation. The elbow contains a duckbill valve that allows the patient's airway and that seals with similar leak rates to conventional NIV elbows. In addition, the elbow includes an anti-asphysia valve to ensure safety of the patient.
Intended Use/Indications for Use
The ReddyPort Elbow is intended to provide an interface for application of CPAP or bi-level therapy to the patient is simultaneously undergoing another care procedure (e.g. oral care, suctioning, bronchoscopy) by hospital/institutional clinicians. The elbow is for single patient use in the hospital'institutional environment. The elbow is to be used on patients (> 40 lbs/ 18.2 kg) for whom CPAP or bi-level therapy has been prescribed. The elbow can be used with Philips Respironics AF541 masks with the clip-style connection.
Comparison of Technological Characteristics with Predicate
Substantial Equivalence Comparison Table
| Characteristics | Subject Device | Predicate Device | Reference Device | Reference Device | Substantial
Equivalence
Remarks |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Device | ReddyPort Elbow | ReddyPort NIV
Access Elbow | AF541 Leak 1 EE Elbow | BRONCHOSCOPY
ELBOW | N/A |
| Manufacturer | SMD
Manufacturing, LLC | SMD
Manufacturing,
LLC. | Respironics, Inc | RESPIRONICS,
INC. | N/A |
| Model | RP-541-L1 | RP531 | Unknown | Unknown | N/A |
| 510(k) Number | K231064 | K171827 | K150639 | K132168 | N/A |
| Characteristics | Subject Device | Predicate Device | Reference Device | Reference Device | Substantial
Equivalence
Remarks |
| Indications for
Use | The ReddyPort
Elbow is intended to
provide an interface
for application of
CPAP or bi-level
therapy to the patient
including while the
patient is
simultaneously
undergoing another
care procedure (e.g.
oral care, suctioning,
bronchoscopy) by
hospital/institutional
clinicians. The
elbow is for single
patient use in the
hospital/institutional
environment. The
elbow is to be used
on patients (> 40 lbs/
18.2 kg) for whom
CPAP or bi-level
therapy has been
prescribed. The
elbow can be used
with Philips
Respironics AF541
masks and AF531
masks with the clip-
style connection. | The ReddyPort NIV
Access Elbow is
intended to provide
an interface for
application of CPAP
or bi-level
therapy. The elbow is
for single patient use
in the
hospital/institutional
environment.The
elbow is to be used
on patients 7 years
or older
(>40lbs/18.2kg) for
whom CPAP or bi-
level therapy has
been prescribed. | This Mask is intended to provide
an interface for application of
CPAP or bilevel therapy to
patients. The mask is for single
use in the hospital/institutional
environment only.The mask is to
be used on patients (>40lbs/20kg)
for whom CPAP or bilevel
therapy has been prescribed. | The Bronchoscopy
Elbow can be used
with Respironics
Masks that
incorporate the
mating elbow hub
design. Use of this
elbow with these
masks allows CPAP
and bi-level therapy
to be delivered to the
patient during a
bronchoscopy
procedure. The
elbow is for single
use in the
hospital/institutional
environment only | Similar |
| PatientPopulation | Patients
(>40lbs/18.2kg) | Patients 7 years or
older
(>40lbs/18.2kg) | Patients (>40lbs/20kg) | Pediatrics and adults
(age >7 years and
40 lbs) | Similar |
| Environment of
Use | Hospital/Institutional
Environment Only | Hospital/Institutional
Environment Only | Hospital/InstitutionalEnvironment
only | Hospital/Institutional
Environment Only | Same |
| Product Code | MNS | MNS | BZD | BZD | Same as predicate |
| Provided Sterile
or Non-Sterile | Provided Non-
Sterile (Clean) | Provided Non-
Sterile (Clean) | Provided Non-Sterile (Clean) | Provided Non-
Sterile (Clean) | Same |
| Patient Usage
Type | Single patient use in
the
hospital/institutional
environment | Single patient use in
the
hospital/institutional
environment | Single patient use in the
hospital/institutional
environment | Single patient use in
the
hospital/institutional
environment | Same |
| Design | Permanent
replacement elbow
with duckbill and
anti-asphyxia
valve.The RP-541-
L1 style has a clip
style connection to
the mask. | Permanent
replacement elbow
with duckbill and
anti-asphyxia
valve.The
connection style is a
press fit design. | EE Leak 1 Elbow with anti-
asphyxia valve. | The Bronchoscopy
Elbow is a Leak 1
elbow that attaches
to an AF541 mask.It
contains an S-slit
valve through which
a bronchoscopy
scope may be
inserted to perform a
bronchoscopy
procedure while a
patient is on non-
invasive ventilation.
The elbow does not
contain an anti-
asphyxia valve or
exhalation ports and
is only intended to
be used during a
bronchoscopy
procedure and
should be replaced
with an EE Elbow
after the procedure if
the patient is to
remain on non-
invasive ventilation. | Similar |
| Valve Type/Size | Duckbill Valve | Duckbill Valve | No access valve is incorporated | Valve for | Similar |
| Characteristics | Subject Device | Predicate Device | Reference Device | Reference Device | Substantial
Equivalence
Remarks |
| Body Material | Polypropylene | Polycarbonate | Polypropylene | Unknown | Similar |
| Access Valve
Material | Silicone Elastomer | Silicone Elastomer | Does not have an Access Valve
feature | Silicone Elastomer | Similar |
| Anti-Asphyxia
Valve Material | Silicone Elastomer | Silicone Elastomer | Silicone Elastomer | N/A | Same |
| Pick Off Port | N/A | Included | N/A | Included | N/A |
| Shape and Size | ReddyPort has a
streamlined, low
dead-space design
with a large duckbill
valve. | Has a larger overall
profile with higher
dead-space. | Traditional NIV elbow
streamlined, low dead space
design | Sizes small and large | Similar |
| Safety Valve | Includes anti-
asphyxia valve | Includes anti-
asphyxia valve | Includes anti-asphyxia valve | The bronchoscopy
elbow does not have
built in exhalation or
entrainment valve. | Same |
| Duration of
Replacement | In place for entirety
of NIV therapy | In place for entirety
of NIV therapy | In place for entirety of NIV
therapy | For temporary use
during a
bronchoscopy
procedure | Similar |
| Intentional vent
holes | No vent holes | No vent holes | No vent holes | No vent holes | Same |
| Pressure Range | 4 to 30 cmH2O | 4 to 30 cmH20 | 4 to 30 cmH2O | 4 to 30 cmH2O | Same |
| Patient Circuit
Connection | 22mm Connection | 22mm connection | 22mm Connection | 22mm Connection | Same |
| Elbow Deadspace | 37.59 mL | 50.9mL | Unknown* | Unknown* | Similar |
| Leak Rates | 4 cmH2O: 0.6 L/min
10 cmH2O: 0.65
L/min
17 cmH2O: 0.89
L/min
24 cmH2O: 1.11
L/min
30 cmH2O: 1.34
L/min | 4 cmH2O: 8.46
L/min
10 cmH2O: 7.26
L/min
17 cmH2O: 7.65
L/min
24 cmH2O: 7.56
L/min
30 cmH2O: 7.35
L/min | Unknown * | Unknown* | Similar |
| Resistance to
Flow During
Regular
Condition | Added resistance to
flow during:
50 L/min flow: 0.23
cmH2O
100L/min flow: 0.13
cmH2O | Added resistance to
flow during:
50 L/min flow:
0.223 cmH2O
100 L/min flow:
0.217 cmH2O | Unknown* | Unknown* | Similar |
| Resistance Under
Single Fault | Added Inspiratory
Resistance: 1.23
cmH2O
Added Expiratory
Resistance 0.43
cmH2O | Added Inspiratory
Resistance: 0.6
cmH20
Added Expiratory
Resistance 0.5
cmH2O | Unknown* | Unknown* | Similar |
5
6
*Data not publicly available.
Performance Testing
The following bench testing was completed for the proposed device:
- ISO 17510:2015 Medical devices -- Sleep apnoea breathing therapy Masks and application accessories
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical conne - Mask and Tubing Connection Force
- Dead Space
The ReddyPort Elbow met all applicable requirements and acceptance criteria.
7
Biocompatibility Testing
The biocompatibility impact of the changes was evaluated in accordance to ISO 18562-1:2017, and FDA Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" Document issued on September 4, 2020. The battery of testing included:
- ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity and reproductive toxicity
- · ISO 10993-5:2009 Biological evaluation of medical devices Part 5:Tests for in vitro cytotoxicity
- · ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- · ISO 10993-11:2017 Biological evaluation of medical devices Part 11:Tests for systemic toxicity
- · ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
- · ISO 10993-18:2020 Biological evaluation of medical devices Part 18: Chemical device materials within a risk management process
- · ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process
- · ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 2: Tests for emissions of particulate matter
- · ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 2: Tests for emissions of particulate matter
- ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4: Tests for leachables in condensate
The device is categorized as an External Communicating Device with Indirect Tissue contact for long-term duration contact (> 30 days).
All biological testing conducted demonstrated passince criteria) and were conducted on test articles that are representative of the final, finished device in its final, finished form.
Clinical Testing
No clinical testing was conducted as part of this 510(k) submission.
Conclusion
The conclusions drawn from the nonelinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.