(212 days)
The Hard Shell Vented Nasal Mask is intended to provide an interface for application of positive airway pressure therapy, such as CPAP or bi-level.
The mask is intended for:
- Single use, disposable .
- . Single patient, multi-use in the home setting
- . Multi-patient, multi- use in the hospital or institutional settings
- Single patient, short-term use (up to 7 days) in the hospital or institutional settings ●
The masks are to be used on adult patients (>66 lbs. />30 kg) for whom CPAP or bi-level therapy has been prescribed.
The SleepNet Innova Nasal Vented Mask is similar to other CPAP mask. The Innova Nasal Vented mask is nearly identical to our iQ Nasal mask, K102317, except for the following changes:
- Slightly different indications for use, but the predicate is Respironics ComfortGel Blue . Nasal mask, K092835.
- . A range of durations of use for marketing purposes only
- o single use, disposable
- single patient, multi-use up to 7 days o
- single patient, multi-use in home setting o
- o multi-patent, multi-use in institutional settings
- . material for shell, hard vs. soft
- a new exhaust elbow design .
Here's an analysis of the provided 510(k) summary for the SleepNet Innova Nasal Vented Mask, addressing your specific questions:
Device Name: Innova Nasal Vented Mask (also referred to as Hard Shell Vented Nasal Mask)
510(k) Number: K121321
Predicate Device: Respironics ComfortGel Blue Nasal Mask (K092835)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Innova Nasal Vented Mask are based on demonstrating equivalence or being "well within" the established limits of the predicate device (Respironics ComfortGel Blue Nasal Mask, K092835) or relevant ISO standards.
| Acceptance Criteria / Performance Aspect | Acceptance Criteria | Reported Device Performance (Innova Nasal Vented Mask) | Discussion/Conclusion |
|---|---|---|---|
| CO2 Washout | Per ISO 17510-2: changes in CO2 at various pressures to be < 20% and < 60% from baseline. | 4 cm H2O: 6.0 (15%) 5 cm H2O: 5.9 (14%) 10 cm H2O: 5.8 (11%) Occluded: 6.7 (30%) | "The performance of the proposed device is well within the pass/fail criteria as stated in ISO 17510-2." (The predicate device's measured CO2 washout was: 4 cm H2O: 5.6 (6%), 5 cm H2O: 5.5 (3%), 10 cm H2O: 5.4 (2%), Occluded: 6.3 (19%)) |
| Exhaust Flow (Pressure vs. Flow) | Comparable to the predicate device (no specific pass/fail criteria, reportable values only). | 4 cm H2O: 18.2 lpm 10 cm H2O: 30.4 lpm 20 cm H2O: 43.8 lpm | "The proposed device has equivalent 'Leak or Flow' rate at all pressure vs. the predicate. The differences do not have any clinical significance." (Predicate device: 4 cm H2O: 17.3 lpm, 10 cm H2O: 27.0 lpm, 20 cm H2O: 38.7 lpm) |
| Pressure Drop (Resistance to Flow) | Equivalent to the predicate device (no specific pass/fail criteria, reportable values only). | 30 lpm: 0.04 cm H2O 50 lpm: 0.16 cm H2O 60 lpm: 0.24 cm H2O 100 lpm: 0.82 cm H2O | "The proposed device is equivalent to the predicate." (Predicate device: 30 lpm: 0.04 cm H2O, 50 lpm: 0.15 cm H2O, 60 lpm: 0.22 cm H2O, 100 lpm: 0.74 cm H2O) |
| Internal Volume / Deadspace | Comparable to the predicate device (no specific pass/fail criteria, reportable values only). "Key performance features for CPAP mask performance." | Small: 82 ml Medium: 100 ml Large: 108 ml | "The proposed device is equivalent and CO2 washout and Pressure vs. Flow are the key performance features for CPAP mask performance. The difference4s are not clinically significant and do not raise any new safety or effectiveness concerns." (Predicate device: Small: 97 ml, Medium: 99 ml, Large: 118 ml) |
| Cleaning Validation | Visual and performance testing post-cleaning found to be similar to pre-cleaning. Meeting performance specifications. | Repeated cleaning performed per recommended instructions. Visual and performance testing post-cleaning confirmed similarity to pre-cleaning. | "The proposed mask can be cleaned as intended and meet its performance specifications." |
| Environmental/Mechanical Testing | Meet performance specifications after conditioning (high/low temperatures, drop test). | Samples subjected to high/low temperatures and a drop test. Met performance specifications after conditioning and cleaning. | "The proposed device met the performance specifications after conditioning and cleaning." |
| Biocompatibility (Materials) | Materials in patient contact are identical to previously cleared predicate devices (Minime K090935 or iQ Nasal K102317). | Gel Bladder, Bladder film, Shell, Elbow assembly, Headgear materials are "Identical" to materials used in Sleepnet MiniMe Pediatric mask (K090935) or Sleepnet iQ Ventilation mask (K102317). | "The materials are identical to the cited predicates." This implies that prior biocompatibility assessments for those predicate devices are leveraged for the Innova mask. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices tested) for the performance tests (Exhaust Flow, Pressure Drop, Internal Volume/Deadspace, CO2 Washout, Cleaning validation, Environmental/Mechanical testing). It generally refers to "samples" or "largest size tested" for CO2 washout.
The data provenance is laboratory testing conducted by SleepNet Corporation ("We have performed comparative performance testing..."). There is no mention of country of origin for data or whether it was retrospective or prospective in a clinical sense, as these are physical performance tests of the device rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this 510(k) summary. This document describes the testing of a medical device (CPAP mask) for its physical and functional performance characteristics against established engineering standards (e.g., ISO 17510-2) and comparison to a predicate device. It does not involve human expert interpretation of images or diagnostic data where "ground truth" would be established by experts. The "ground truth" here is the measured physical properties and performance against validated methods and a predicate.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used in studies where human readers are making subjective judgments (e.g., classifying medical images), and a consensus is needed to establish ground truth. The tests described are objective, quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This 510(k) pertains to a physical medical device (a CPAP mask), not an AI algorithm or a diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone (algorithm only) performance study was not done. This 510(k) relates to a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests described is based on:
- International Standards: Specifically, ISO 17510-2 for CO2 washout.
- Comparison to a Predicate Device: Many performance metrics (Exhaust Flow, Pressure Drop, Deadspace) were deemed acceptable by demonstrating "equivalence" or "comparability" to the Respironics ComfortGel Blue Nasal Mask (K092835).
- Internal Specifications/Validated Test Methods: Cleaning validation and Environmental/Mechanical testing adhered to internal performance specifications and standard test methods.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" mentioned or implied, as this is a physical device going through performance and comparability testing, not a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth to establish for it in this context.
{0}------------------------------------------------
K121321
510(k) Summary Page 1 of 6 19-Nov-12
| SleepNet Corporation5 Merrill Industrial DriveHampton, NH 03842 | Tel - 603-758-6625Fax - 603-758-6699 |
|---|---|
| Official Contact: | Jennifer Kennedy – Director of Quality |
| Proprietary or Trade Name: | Innova Nasal Vented Mask |
| Common/Usual Name: | Patient interface |
| Classification Code/Name: | BZD – non-continuous ventilator (IPPB)21CFR 868.5905, Class 2 |
| Predicate Device: | K092835 - Respironics ComfortGel Blue nasal mask |
Device Description:
The SleepNet Innova Nasal Vented Mask is similar to other CPAP mask. The Innova Nasal Vented mask is nearly identical to our iQ Nasal mask, K102317, except for the following changes:
- Slightly different indications for use, but the predicate is Respironics ComfortGel Blue . Nasal mask, K092835.
- . A range of durations of use for marketing purposes only
- o single use, disposable
- single patient, multi-use up to 7 days o
- single patient, multi-use in home setting o
- o multi-patent, multi-use in institutional settings
- . material for shell, hard vs. soft
- a new exhaust elbow design .
Indications for Use:
The Innova Nasal Vented Mask is intended to provide an interface for application of positive airway pressure therapy, such as CPAP or bi-level.
- . The mask is intended for:
- Single use, disposable .
- Single patient, multi-use in the home setting .
- Multi-patient, multi- use in the hospital or institutional settings. �
- o Single patient, short-term use (up to 7 days) in the hospital or institutional settings
· The masks are to be used on adult patients (>66 lbs. />30 kg) for whom CPAP or bi-level therapy has been prescribed.
Patient Population: For adults (> 66 lbs. / >30 kg)
NOV 3 0 2012
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510(k) Summary Page 2 of 6 19-Nov-12
Environment of Use: Home or hospital or institutional environments
Predicate Device Comparison:
The Innova Nasal Vented Mask as compared to the predicate is viewed as substantially equivalent to the predicate device because:
Indications -
- The Innova Nasal Vented Mask is intended to provide a patient interface for application . of positive airway pressure therapy with CPAP or bi-level devices.
The masks are to be used on adult patients (>66)bs. />30 kg) for whom positive airway pressure therapy has been prescribed. Identical to Respironics ComfortGel Blue Nasal (K092835)
Discussion - The indications for use are identical to the predicate Respironics ComfortGel Blue Nasal (K092835)
Patient Population -
- The masks are to be used on adult patients (>66 lbs. />30 kg) for whom positive airway . pressure therapy has been prescribed. Identical to Respironics ComfortGel Blue Nasal (K092835)
Discussion - The patient population is identical to the predicate Respironics ComfortGel Blue Nasal (K092835).
Technology -
- . Technology, method of manufacture and construction of a gel cushion, hard or soft shell and elbow with exhalation holes are identical to the predicate SleepNet iQ Nasal mask -K 102317 and similar to the predicate Respironics ComfortGel Blue Nasal (K092835).
Discussion - The technology, shape, design, configuration of the mask, head strap as well as the manufacturing methods are identical to the predicate, SleepNet iQ Nasal mask (K102317).
The use of multiple ports in the elbow for exhalation and CO2 washout is substantially equivalent as demonstrated by the comparative Pressure vs. Flow curves and the CO- washout testing vs. the predicate Respironics ComfortGel Blue Nasal (K092835) and the differences are not clinically significant and do not affect safety and effectiveness.
Environment of Use -
- The masks are intended for use in the home or hospital or institutional environment. . Identical to predicate - Respironics ComfortGel Blue Nasal (K092835)
Discussion - The environments of use are identical to the predicate.
{2}------------------------------------------------
510(k) Summary Page 3 of 6 19-Nov-12
Environment of Use -
- The masks are intended for use in the home or hospital or institutional environment. . Identical to predicate - Respironics ComfortGel Blue Nasal (K092835)
Discussion - The environments of use are identical to the predicate.
| Table of Comparison to Predicate | ||
|---|---|---|
| will which beliefler under first and the below | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Attributes | Innova Nasal vented mask | Respironics ComfortGel BlueK092835 |
|---|---|---|
| Indications for Use | The Innova Nasal Vented Mask isintended to provide an interface forapplication of positive airwaypressure therapy, such as CPAP orbi-level.The mask is intended for:• Single use, disposable• Single patient, multi-use in thehome setting• Multi-patient, multi- use in thehospital or institutional settings• Single patient, short-term use (up to7 days) in the hospital or institutionalsettingsThe masks are to be used on adultpatients (>66 lbs. / >30 kg) for whomCPAP or bi-level therapy has beenprescribed. | The ComfortGel Blue Nasal Mask isintended to provide an interface ofCPAP or bi-level therapy to patients.The mask is for single patient use inthe home or multi-patient use in thehospital / institutional environment.The mask is to be used on adultpatients (>66 lbs. / >30 kg) for whomCPAP or bi-level therapy has beenprescribed. |
| Patient Population | Adult (>66 lbs. / >30 kg) | Adult (>66 lbs. / >30 kg) |
| Environment of Use | The masks are intended for use in thehome or hospital or institutionalenvironment. | The masks are intended for use in thehome or hospital/institutionalenvironment. |
| Prescriptive | Yes | Yes |
| Duration of Use | Single use, disposableSingle patient, multi-useMulti-patient, multi- useSingle patient, short-term use (up to7 days) | Single patient, multi-useMulti-patient, multi-use |
| Cleaning methods | Soap and waterOPA | Soap and water |
| Incorporates an Exhaust portelbow | Yes | Yes |
| Delivered Pressure range | $4 - 20 cm H_2O$ | $4 - 30 cm H_2O$ |
| Available sizes | 3 | 4 |
| Shape | Similar | Similar |
| Shell | Rigid | Rigid |
| Materials | Identical to Minime K090935 oriQ Nasal K102317 | |
| Attributes | Innova Nasal vented mask | Respironics ComfortGel BlueK092835 |
| CO2 washout profile | Pressure | ETCO2% at |
| Tested per ISO 17510-2(largest size tested, which isworst case) | mask (% increase) | |
| 4 cm H2O6.0 (15%) | 4 cm H2O5.6 (6%) | |
| 5 cm H2O5.9 (14%) | 5 cm H2O5.5 (3%) | |
| 10 cm H2O5.8 (11%) | 10 cm H2O5.4 (2%) | |
| Occluded6.7 (30%) | Occluded6.3 (19%) | |
| Deadspace | ||
| Small | 82 ml | 97 ml |
| Medium | 100 ml | 99 ml |
| Large | 108 ml | 118 ml |
| Exhaust - pressure / flow | Pressure (cmH2O) Flow (lpm) | Pressure (cmH2O)Flow (lpm) |
| 418.2 | 417.3 | |
| 1030.4 | 1027.0 | |
| 2043.8 | 2038.7 | |
| Pressure Drop | 30 lpm - 0.04 cm H2O | 30 lpm - 0.04 cm H2O |
| 50 lpm - 0.16 cm H2O | 50 lpm - 0.15 cm H2O | |
| 60 lpm - 0.24 cm H2O | 60 lpm - 0.22 cm H2O | |
| 100 lpm - 0.82 cm H2O | 100 lpm - 0.74 cm H2O | |
| Components | Headgear | Headgear |
| Shell / Cushion | Shell / Cushion | |
| Swivel elbow | Swivel elbow |
{3}------------------------------------------------
510(k) Summary Page 4 of 6 19-Nov-12
Non-clinical Testing Summary
Comparative Performance -
We have performed comparative performance testing pre- and post-conditioning that included:
Exhaust Flow (Pressure vs. Flow)
- Standard test method using CPAP unit at various flow rates and measuring the leak at the . patient interface
- No pass / fail criteria, reportable values only. It should be comparable to the predicate. .
- . Discussion - The proposed device has equivalent "Leak or Flow" rate at all pressure vs. the predicate. The differences do not have any clinical significance
Pressure Drop (resistance to Flow)
- Standard test method of using a standard flow and measuring pressure drop .
- . No pass / fail criteria, reportable values only
- . Discussion - The proposed device is equivalent to the predicate.
{4}------------------------------------------------
510(k) Summary Page 5 of 6 19-Nov-12
Internal Volume / Deadspace
- Standard test method of measuring the volume of the parts near the patient. .
- . No pass / fail criteria, reportable values only. It should be comparable to the predicate.
- Discussion The proposed device is equivalent and CO2 washout and Pressure vs. Flow . are the key performance features for CPAP mask performance. The difference4s are not clinically significant and do not raise any new safety or effectiveness concerns.
CO2 washout
- Tested per ISO 17510-2 .
- Pass / fail criteria per ISO 17510-2 allow for changes in CO2 at various pressures to be < . 20% and < 60% from baseline).
- Discussion the performance of the proposed device is well within the pass / fail criteria . as stated in ISO 17510-2.
Cleaning validation
- Repeated cleaning was performed per the recommended cleaning instructions .
- Visual and performance testing was performed and compared pre and post- cleaning . and found to be similar
- . Discussion - The proposed mask can be cleaned as intended and meet its performance specifications
Environmental / Mechanical testing
- . Test method included subjecting samples to high and low temperatures and a drop test
- Pass / fail criteria was that they would meet the performance specifications which was . performed after the cleaning durability
- . Discussion - The proposed device met the performance specifications after conditioning and cleaning.
Materials -
- The materials in patient contact are identical to our own predicate devices SleepNet iQ . Nasal (K102317) and MiniMe mask (K090935).
- . Discussion - The materials are identical to the cited predicates.
{5}------------------------------------------------
510(k) Summary Page 6 of 6 19-Nov-12
Materials / Patient Coatact / Duration of Use (prolonged duration of use)
·
| Component | Patient Contact | Predicate for Biocompatibility |
|---|---|---|
| Gel Bladder | Surface contact SkinExternal communicating,Tissue / Gas Pathway | Identical - Sleepnet MiniMe Pediatric mask K090935 |
| Bladder film | Surface contact SkinExternal communicating,Tissue / Gas Pathway | Identical - Sleepnet IQ Ventilation mask K102317 |
| Shell | External communicating,Tissue / Gas Pathway | Identical - Sleepnet MiniMe Pediatric mask K090935 |
| Elbow assembly | External communicating,Tissue / Gas Pathway | Identical - Sleepnet MiniMe Pediatric mask K090935 |
| Headgear | Surface contact SkinExternal communicating,Tissue / Gas Pathway | Identical - Sleepnet IQ Ventilation mask K102317 |
Substantial Equivalence Conclusion -
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate can be found to be substantially equivalent.
.
.
{6}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 30, 2012
Sleepnet Corporation C/O Mr. Paul Dryden President Promedic. Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134
Re: K121321
Trade/Device Name: Hard Shell Vented Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 19, 2012 Received: November 20, 2012
Dear Mr. Dryden:
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.
{7}------------------------------------------------
Page 2 - Mr. Dryden
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-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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Kwame Ø. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital,
Respiratory, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
Indications for Use Statement
Page 1 of 1
510(k) Number:
K121321 (To be assigned)
Device Name:
Hard Shell Vented Nasal Mask
Indications for Use:
The Hard Shell Vented Nasal Mask is intended to provide an interface for application of positive airway pressure therapy, such as CPAP or bi-level.
The mask is intended for:
- Single use, disposable .
- . Single patient, multi-use in the home setting
- . Multi-patient, multi- use in the hospital or institutional settings
- Single patient, short-term use (up to 7 days) in the hospital or institutional settings ●
The masks are to be used on adult patients (>66 lbs. />30 kg) for whom CPAP or bi-level therapy has been prescribed.
Prescription Use XX (Part 21 CFR 801 Subpart D)
or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lester W. Schultheis Jr 2012.11.30 10:45:42 -05'00'
(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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).