(151 days)
No
The description focuses on the physical characteristics and performance of a nasal mask, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The MiniMe 2 Nasal mask is an accessory to CPAP or Bi-level positive pressure systems, which are therapeutic devices, but the mask itself is not providing the therapy. It is a patient interface.
No
This device is a nasal mask intended to deliver positive pressure therapy, not diagnose a condition.
No
The device description clearly states it is a "Nasal mask," which is a physical hardware component used as a patient interface for positive pressure therapy. The performance studies also describe testing of physical properties like exhaust flow, pressure drop, and mechanical testing.
Based on the provided information, the MiniMe 2 Nasal mask is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide a patient interface for applying positive pressure therapy (CPAP or Bi-level). This is a therapeutic application, not a diagnostic one.
- Device Description: The description reinforces its function as a mask for delivering therapy.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the physical and functional aspects of the mask (flow, pressure, CO2 washout, cleaning, mechanical testing), not on diagnostic accuracy or performance related to analyzing biological samples.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. The MiniMe 2 Nasal mask is a medical device used for delivering therapy.
N/A
Intended Use / Indications for Use
The MiniMe 2 Nasal mask is intended to provide a patient interface for application of positive pressure therapy. The mask is to be used as an accessory to CPAP or Bi-level positive pressure systems. It is intended for patients >2 years old and 2 years old and 2 years old and
§ 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).
0
KI21692
NOV
510(k) Summary Page 1 of 6
| SleepNet Corporation
5 Merrill Industrial Drive
Hampton, NH 03842 | Tel - 603-758-6625
Fax - 603-758-6699 |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Official Contact: | Jennifer Kennedy – Director of Quality |
| Proprietary or Trade Name: | MiniMe 2 Nasal Mask |
| Common/Usual Name: | Patient interface |
| Classification Code/Name: | BZD – non-continuous ventilator (IPPB)
21CFR 868.5905
Class 2 |
| Device: | MiniMe 2 Nasal Mask |
| Predicate Devices: | K090935 – SleepNet MiniMe pediatric nasal mask
K060105 – ResMed Kidsta Pediatric Mask |
Device Description:
.
The MiniMe 2 Nasal mask is intended to provide a patient interface for application of positive pressure therapy. The mask is to be used as an accessory to CPAP or Bi-level positive pressure systems. It is intended for patients >2 years old and 2 years old and 2 years old and 2 yo and 2 yo to 2 yo to 7 yo and up |
| Environment of Use | The masks are intended for use in the
home or hospital/institutional
environment. | The masks are intended for use in the
home or hospital/institutional
environment. | The masks are intended for use in the
home or hospital/institutional
environment. |
| Duration of Use | Single patient, disposable (hospital or
institutional settings) | Single patient, multi-use (home setting) | Single patient, multi-use (home setting) |
| | | Single patient, short-term use up to 7
days (hospital or institutional settings) | Single patient, short-term use up to 7
days (hospital or institutional settings) |
| Prescriptive | Yes | Yes | Yes |
| Cleaning | Soap and water | Soap and water | Soap and water |
| Incorporates Exhalation port
with multiple holes | Yes | Yes | Yes |
| Non-vented elbow
configuration used with circuit
with integrated exhalation valve | Yes | Yes | N/A |
| Delivered Pressure range | $4-20 \text{ cm H}_2\text{O}$ | $3-20 \text{ cm H}_2\text{O}$ | $>4 \text{ cm H}_2\text{O}$ |
| Attributes | MiniMe 2 Nasal Mask | SleepNet MiniMe Nasal Mask
K090935 | ResMed Kidsta
K060105 |
| Features | | | |
| Available sizes | 2 | 1 | Multiple |
| Shape | Similar triangular shape | Similar triangular shape | Similar triangular shape |
| Shell | Hard | Soft | Hard |
| Materials | Soft | This is a small mask so we compared
to equivalent size of the Kidsta | |
| CO2 washout profile
Tested per ISO 17510-2
(largest size tested, which is
worst case) | Identical to other SleepNet masks or
tested per ISO 10993 | | |
| ETCO2% at mask
(% increase) | Pressure | Pressure | Pressure |
| | 4 cm H2O
5.3 (6%) | 4 cm H2O
5.3 (6%) | 4 cm H2O
5.8 (14%) |
| | 5 cm H2O
5.2 (4%) | 5 cm H2O
5.2 (4%) | 5 cm H2O
5.7 (12%) |
| | 10 cm H2O
5.1 (3%)
Occluded
5.3 (7%) | 10 cm H2O
5.1 (3%)
Occluded
5.3 (7%) | 10 cm H2O
5.5 (7%)
Occluded
6.8 (34%) |
| Dead space | Small
25 ml | Small
21 ml | Small
81 ml |
| | Large
40 ml | Large | Large
81 ml |
| Exhaust - pressure / flow | Pressure (cmH2O) Flow (lpm) | Pressure (cmH2O) Flow (lpm) | Pressure (cmH2O) Flow (lpm) |
| | 4 17.1
12 33.5
20 43.6 | 4 19.1
12 34.8
20 45.8 | 4 19.5
12 36.2
20 48.7 |
| | | | With 15mm tubing |
| Resistance to Flow
(Flow and pressure) | 30 lpm - 0.22 cm H2O
50 lpm - 0.72 cm H2O
60 lpm - 1.03 cm H2O
100 lpm - 3.09 cm H2O | 30 lpm - 0.10 cm H2O
50 lpm - 0.36 cm H2O
60 lpm - 0.54 cm H2O
100 lpm - 1.71 cm H2O | 30 lpm - 0.12 cm H2O
50 lpm - 0.44 cm H2O
60 lpm - 0.67 cm H2O
100 lpm - 2.10 cm H2O |
| | | | |
| | | | |
| Components | Headgear
Shell / Cushion
Swivel elbow
Tubing | Headgear
Shell / Cushion
Swivel elbow
Tubing | Headgear
Shell / Cushion
Swivel elbow
Tubing |
| Component | Patient Contact / Duration
(all are permanent) | Biocompatibility | |
| Gel Bladder | Skin and Gas Pathway | Identical Sleepnet MiniMe Pediatric mask K090935 | |
| Bladder film | Skin and Gas Pathway | Identical | |
| | | Sleepnet MiniMe Pediatric mask K090935 | |
| Shell | Gas Pathway | Identical Sleepnet IQ Ventilation mask K102317 | |
| | | Sleepnet MiniMe Pediatric mask K090935 | |
| Elbow assembly | Gas Pathway | Identical Sleepnet MiniMe Pediatric mask K090935 | |
| Headgear | Skin | Identical Sleepnet IQ Ventilation mask K102317 | |
| Tubing | Gas Pathway | Cytotoxicity | |
| | | Sensitization | |
| | | Genotoxicity | |
| | | Implantation | |
| | | Intracutaneous | |
| | | Systemic Toxicity | |
| Swivel Connector | Gas Pathway | Identical Sleepnet IQ Nasal mask K993269 | |
| Tubing Connector | Gas Pathway | Identical Sleepnet IQ Nasal mask K993269 | |
| 15 mm Connector | Gas Pathway | Identical Sleepnet IQ Nasal mask K021534 | |
4
510(k) Summary
5
510(k) Summary Page 6 of 6 5-Nov-12
Table 2
Materials in the Patient Contact
Substantial Equivalence Conclusion -
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 5, 2012
SleepNet Corporation C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134
Re: K121692
Trade/Device Name: MiniMe 2 Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 18, 2012 Received: September 19, 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/Safetv/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,
for Kwame O. Ulme
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, 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:
Device Name:
MiniMe 2 Nasal Mask
Indications for Use:
The MiniMe 2 Nasal mask is intended to provide a patient interface for application of positive pressure therapy. The mask is to be used as an accessory to CPAP or Bi-level positive pressure systems. It is intended for patients >2 years old and