MINIME 2 NASAL MASK

{0}------------------------------------------------ KI21692 NOV 510(k) Summary Page 1 of 6 | SleepNet Corporation<br>5 Merrill Industrial Drive<br>Hampton, NH 03842 | Tel - 603-758-6625<br>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)<br>21CFR 868.5905<br>Class 2 | | Device: | MiniMe 2 Nasal Mask | | Predicate Devices: | K090935 – SleepNet MiniMe pediatric nasal mask<br>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 <12 years old. The mask is designed and labeled for different durations of use: - Single use, disposable (hospital or institutional settings) . - Single patient, multi-use (home setting) . - Single patient, short-term use up to 7 days (hospital or institutional settings) . These indications for use are identical to the predicate SleepNet MiniMe Pediatric Nasal mask, K090935. The durations for use are identical to - SleepNet MiniMe Pediatric Nasal mask, K090935 for - Single patient, multi-use (home) o - Single patient, multi-use < 7 days is a subset of the single patient, multi-use o (hospital / institutional) - Single patient, disposable (hospital / institutional) is a shorter duration of use and a . labeling claim only. - The design, materials, and performance are identical to the predicates and would O not be considered a new indication that raises new safety or effectiveness concerns. 5 2012 {1}------------------------------------------------ #### 510(k) Summary Page 2 of 6 5-Nov-12 ### Indications for Use: The MiniMe 2 Nasal masks are 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 <12 years old. The mask is designed and labeled for different durations of use: - . Single use, disposable (hospital or institutional settings) - Single patient, multi-use (home setting) . - . Single patient, short-term use up to 7 days (hospital or institutional settings) Patient Population: Patients >2 years old and <12 years old Environment of Use: Home or hospital / institutional environments #### Predicate Device Comparison: The MiniMe 2 Nasal masks are viewed as substantially equivalent to the predicate device because: ### Indications - - . The MiniMe 2 Nasal masks are intended to provide a patient interface for application of positive pressure therapy. The mask is to be used as an accessory for use with CPAP or Bi-level positive pressure systems intended to provide an interface for application of CPAP or bi-level therapy. Identical to SleepNet MiniMe Pediatric Nasal mask (K090935). - . Discussion - The indications for use are identical to the predicate, SleepNet MiniMe Pediatric Nasal mask (K090935). #### Patient Population - - The masks are for patients > 2 yo and < 12 yo for whom positive airway pressure therapy . has been prescribed. Identical to SleepNet MiniMe (K090935). - Discussion The population is identical to the predicate, SleepNet MiniMe Pediatric . Nasal mask (K090935). #### Technology - - . Identical technology to - SleepNet MiniMe Pediatric Nasal mask - K090935 - Discussion The technology, shape, design, configuration of the mask, head strap as . well as the manufacturing methods are identical to the predicate, SleepNet MiniMe Pediatric Nasal mask - K090935. 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 CO2 washout testing vs. the predicate ResMed Kidsta (K060105). {2}------------------------------------------------ # 510(k) Summary Page 3 of 6 5-Nov-12 ### Materials – - The materials in patient contact are identical or have been tested per ISO 10993 to our . own predicate devices - . Discussion - The materials utilized in the MiniMe 2 are commonly used in medical devices and are either identical to the predicate or have been tested per ISO 10993 and found to be acceptable for the intended use. # Environment of Use - - The masks are intended for use in the home or hospital/institutional environment. . - Identical to predicate SleepNet MiniMe Pediatric Nasal mask (K090935) . - Discussion The environments of use are identical to the predicate. . See Table 1 for comparison. ### Non-Clinical Testing Summary: ### Comparative Performance - We have performed comparative performance testing that included: - Exhaust Flow (Pressure vs. Flow) . - Pressure Drop / Resistance to Flow . - Internal Volume / Dead space . - CO2 washout per ISO 17510-2 . - Cleaning validation . - Environmental testing . - Mechanical testing Drop Test . Discussion - The comparative performance and specifications demonstrate that the MiniMe 2 is equivalent in performance to the predicates. # Biocompatibility of Materials - Materials listed in the following table are either identical to predict ate SleepNet mask or were evaluated per ISO 10993-1. Parts which are Externally communicating, Tissue - gas pathway contact, permanent duration. Pass / fail criteria was for the each respective ISO 10993 test Parts which are Surface communicating, Skin, permanent duration. Pass / fail criteria was for the each respective ISO 10993 test Discussion - The listed materials are either identical to predicate SleepNet mask which have the same patient contact and duration of use or were tested per ISO 10993-1. See Table 2 for a list of materials, patient contact and duration of use. {3}------------------------------------------------ 510(k) Summary Table 1 Comparison to Predicates | | MiniMe 2 Nasal Mask | SleepNet MiniMe Nasal Mask<br>K090935 | ResMed Kidsta<br>K060105 | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | Attributes | | | | | Indications for Use | Intended to provide a patient interface<br>for application of positive pressure<br>therapy. The mask is to be used as an<br>accessory to CPAP or Bi-level positive<br>pressure systems. | Intended to provide an interface of<br>CPAP or bi-level therapy to patients. | Intended to provide non-invasive<br>ventilation with RI or OSA | | Patient Population | >2 yo to <12 yo | >2 yo to <12 yo | > 7 yo and up | | Environment of Use | The masks are intended for use in the<br>home or hospital/institutional<br>environment. | The masks are intended for use in the<br>home or hospital/institutional<br>environment. | The masks are intended for use in the<br>home or hospital/institutional<br>environment. | | Duration of Use | Single patient, disposable (hospital or<br>institutional settings) | Single patient, multi-use (home setting) | Single patient, multi-use (home setting) | | | | Single patient, short-term use up to 7<br>days (hospital or institutional settings) | Single patient, short-term use up to 7<br>days (hospital or institutional settings) | | Prescriptive | Yes | Yes | Yes | | Cleaning | Soap and water | Soap and water | Soap and water | | Incorporates Exhalation port<br>with multiple holes | Yes | Yes | Yes | | Non-vented elbow<br>configuration used with circuit<br>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<br>K090935 | ResMed Kidsta<br>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<br>to equivalent size of the Kidsta | | | CO2 washout profile<br>Tested per ISO 17510-2<br>(largest size tested, which is<br>worst case) | Identical to other SleepNet masks or<br>tested per ISO 10993 | | | | ETCO2% at mask<br>(% increase) | Pressure | Pressure | Pressure | | | 4 cm H2O<br>5.3 (6%) | 4 cm H2O<br>5.3 (6%) | 4 cm H2O<br>5.8 (14%) | | | 5 cm H2O<br>5.2 (4%) | 5 cm H2O<br>5.2 (4%) | 5 cm H2O<br>5.7 (12%) | | | 10 cm H2O<br>5.1 (3%)<br>Occluded<br>5.3 (7%) | 10 cm H2O<br>5.1 (3%)<br>Occluded<br>5.3 (7%) | 10 cm H2O<br>5.5 (7%)<br>Occluded<br>6.8 (34%) | | Dead space | Small<br>25 ml | Small<br>21 ml | Small<br>81 ml | | | Large<br>40 ml | Large | Large<br>81 ml | | Exhaust - pressure / flow | Pressure (cmH2O) Flow (lpm) | Pressure (cmH2O) Flow (lpm) | Pressure (cmH2O) Flow (lpm) | | | 4 17.1<br>12 33.5<br>20 43.6 | 4 19.1<br>12 34.8<br>20 45.8 | 4 19.5<br>12 36.2<br>20 48.7 | | | | | With 15mm tubing | | Resistance to Flow<br>(Flow and pressure) | 30 lpm - 0.22 cm H2O<br>50 lpm - 0.72 cm H2O<br>60 lpm - 1.03 cm H2O<br>100 lpm - 3.09 cm H2O | 30 lpm - 0.10 cm H2O<br>50 lpm - 0.36 cm H2O<br>60 lpm - 0.54 cm H2O<br>100 lpm - 1.71 cm H2O | 30 lpm - 0.12 cm H2O<br>50 lpm - 0.44 cm H2O<br>60 lpm - 0.67 cm H2O<br>100 lpm - 2.10 cm H2O | | | | | | | | | | | | Components | Headgear<br>Shell / Cushion<br>Swivel elbow<br>Tubing | Headgear<br>Shell / Cushion<br>Swivel elbow<br>Tubing | Headgear<br>Shell / Cushion<br>Swivel elbow<br>Tubing | | Component | Patient Contact / Duration<br>(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: K121692 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 <12 years old. The mask is designed and labeled for different durations of use: - Single use, disposable (hospital or institutional settings) . - Single patient, multi-use (home setting) . - Single patient, short-term use up to 7 days (hospital or institutional settings) . | Prescription Use XX | or | Over-the-counter use<br>_ | |-----------------------------|----|---------------------------| | (Part 21 CFR 801 Subpart D) | | (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) hm (Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices 510(k) Number; Page 24 of 72