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) .

Device Description

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) .

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, the MiniMe 2 Nasal Mask, seeking substantial equivalence to predicate devices. It does not describe an AI/ML device or a study involving human readers or ground truth established by experts/pathology/outcomes data. Therefore, much of the requested information (like sample sizes for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, and how ground truth was established for training) is not applicable or cannot be extracted from this document.

The document primarily focuses on demonstrating that the MiniMe 2 Nasal Mask is substantially equivalent to existing predicate devices (SleepNet MiniMe pediatric nasal mask and ResMed Kidsta Pediatric Mask) through comparative performance testing and material biocompatibility.

Here's the information that can be extracted based on the provided text, adapted to the questions where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate devices in various performance aspects. The "reported device performance" are the actual measurements for the MiniMe 2 Nasal Mask, which are then compared to the predicates.

Acceptance Criteria (Implicitly, Equivalence to Predicate)	MiniMe 2 Nasal Mask Performance	SleepNet MiniMe Nasal Mask (K090935) Performance (Predicate 1)	ResMed Kidsta (K060105) Performance (Predicate 2)
Indications for Use: Provide patient interface for positive pressure therapy, accessory to CPAP/Bi-level, for patients >2 yo and <12 yo. Different durations of use: single use/disposable, single patient multi-use (home), single patient short-term use (up to 7 days).	Identical	Identical (Except for MiniMe 2 adding "Single use, disposable (hospital or institutional settings)" as a shorter duration which is also considered equivalent)	Intended to provide non-invasive ventilation with RI or OSA (Broader, but MiniMe 2 aligns with SleepNet MiniMe)
Patient Population: >2 yo to <12 yo	Identical	Identical	> 7 yo and up (MiniMe 2 aligns with SleepNet MiniMe)
Environment of Use: Home or hospital/institutional	Identical	Identical	Identical
Durations of Use: Single use, disposable; Single patient, multi-use (home); Single patient, short-term (up to 7 days).	Matched or represented as shorter duration which is acceptable.	Single patient, multi-use (home); Single patient, short-term (up to 7 days).	Single patient, multi-use (home); Single patient, short-term (up to 7 days).
Prescriptive: Yes	Yes	Yes	Yes
Cleaning: Soap and water	Soap and water	Soap and water	Soap and water
Exhalation Port: 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 cm H2O	3-20 cm H2O	>4 cm H2O
CO2 washout profile (ETCO2% at mask at various pressures): Should be comparable to predicates/not excessively high. Testing done per ISO 17510-2 (largest size tested, worst case).	4 cm H2O: 5.3 (6%) 5 cm H2O: 5.2 (4%) 10 cm H2O: 5.1 (3%) Occluded: 5.3 (7%)	4 cm H2O: 5.3 (6%) 5 cm H2O: 5.2 (4%) 10 cm H2O: 5.1 (3%) Occluded: 5.3 (7%)	4 cm H2O: 5.8 (14%) 5 cm H2O: 5.7 (12%) 10 cm H2O: 5.5 (7%) Occluded: 6.8 (34%)
Dead Space: Small volume.	Small 25 ml (Small size) 40 ml (Large size)	Small 21 ml (Small size)	Small 81 ml (Large size)
Exhaust - pressure / flow: Comparable flow rates at given pressures.	4 cmH2O: 17.1 lpm 12 cmH2O: 33.5 lpm 20 cmH2O: 43.6 lpm	4 cmH2O: 19.1 lpm 12 cmH2O: 34.8 lpm 20 cmH2O: 45.8 lpm	4 cmH2O: 19.5 lpm 12 cmH2O: 36.2 lpm 20 cmH2O: 48.7 lpm
Resistance to Flow: Acceptable resistance to flow values at various flow rates.	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
Biocompatibility: Materials in patient contact are identical to predicate or tested per ISO 10993.	Materials are either identical to predicate SleepNet masks or tested per ISO 10993 for specific contact types (e.g., skin and gas pathway, permanent duration) and passed respective ISO 10993 tests (e.g., Cytotoxicity, Sensitization, Genotoxicity, Implantation, Intracutaneous, Systemic Toxicity for tubing).	Defined by the predicate devices.	Not explicitly detailed for this predicate.
Mechanical Testing: Drop Test	Performed, but results not detailed in the summary.	Not detailed.	Not detailed.
Cleaning Validation:	Performed, but results not detailed in the summary.	Not detailed.	Not detailed.
Environmental Testing:	Performed, but results not detailed in the summary.	Not detailed.	Not detailed.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document does not specify a "test set" in terms of subject count. The testing performed is laboratory-based comparative performance testing (e.g., pressure-flow, CO2 washout, dead space, resistance to flow) comparing the device's physical properties to those of predicate devices.
Data Provenance: The data is generated from laboratory testing of the physical device, not from human subject data or retrospective/prospective clinical studies. The origin is stated implicitly as SleepNet Corporation facilities (Hampton, NH, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a physical device performance and biocompatibility study, not one requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No adjudication by experts is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable in the context of expert ground truth. The "ground truth" for the device's performance is established by standardized engineering tests and measurements (e.g., flow meters, pressure sensors for exhaust/resistance, CO2 sensors for washout) and adherence to material standards (ISO 10993). In terms of regulatory "ground truth" for substantial equivalence, it's defined by the performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

Summary

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KI21692

NOV

510(k) Summary Page 1 of 6

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:	MiniMe 2 Nasal Mask
Common/Usual Name:	Patient interface
Classification Code/Name:	BZD – non-continuous ventilator (IPPB)21CFR 868.5905Class 2
Device:	MiniMe 2 Nasal Mask
Predicate Devices:	K090935 – SleepNet MiniMe pediatric nasal maskK060105 – ResMed Kidsta Pediatric Mask

Device Description:

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

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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).

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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.

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510(k) Summary

Table 1 Comparison to Predicates

	MiniMe 2 Nasal Mask	SleepNet MiniMe Nasal MaskK090935	ResMed KidstaK060105
Attributes
Indications for Use	Intended to provide a patient interfacefor application of positive pressuretherapy. The mask is to be used as anaccessory to CPAP or Bi-level positivepressure systems.	Intended to provide an interface ofCPAP or bi-level therapy to patients.	Intended to provide non-invasiveventilation 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 thehome or hospital/institutionalenvironment.	The masks are intended for use in thehome or hospital/institutionalenvironment.	The masks are intended for use in thehome or hospital/institutionalenvironment.
Duration of Use	Single patient, disposable (hospital orinstitutional settings)	Single patient, multi-use (home setting)	Single patient, multi-use (home setting)
		Single patient, short-term use up to 7days (hospital or institutional settings)	Single patient, short-term use up to 7days (hospital or institutional settings)
Prescriptive	Yes	Yes	Yes
Cleaning	Soap and water	Soap and water	Soap and water
Incorporates Exhalation portwith multiple holes	Yes	Yes	Yes
Non-vented elbowconfiguration used with circuitwith 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 MaskK090935	ResMed KidstaK060105
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 comparedto equivalent size of the Kidsta
CO2 washout profileTested per ISO 17510-2(largest size tested, which isworst case)	Identical to other SleepNet masks ortested per ISO 10993
ETCO2% at mask(% increase)	Pressure	Pressure	Pressure
	4 cm H2O5.3 (6%)	4 cm H2O5.3 (6%)	4 cm H2O5.8 (14%)
	5 cm H2O5.2 (4%)	5 cm H2O5.2 (4%)	5 cm H2O5.7 (12%)
	10 cm H2O5.1 (3%)Occluded5.3 (7%)	10 cm H2O5.1 (3%)Occluded5.3 (7%)	10 cm H2O5.5 (7%)Occluded6.8 (34%)
Dead space	Small25 ml	Small21 ml	Small81 ml
	Large40 ml	Large	Large81 ml
Exhaust - pressure / flow	Pressure (cmH2O) Flow (lpm)	Pressure (cmH2O) Flow (lpm)	Pressure (cmH2O) Flow (lpm)
	4 17.112 33.520 43.6	4 19.112 34.820 45.8	4 19.512 36.220 48.7
			With 15mm tubing
Resistance to Flow(Flow and pressure)	30 lpm - 0.22 cm H2O50 lpm - 0.72 cm H2O60 lpm - 1.03 cm H2O100 lpm - 3.09 cm H2O	30 lpm - 0.10 cm H2O50 lpm - 0.36 cm H2O60 lpm - 0.54 cm H2O100 lpm - 1.71 cm H2O	30 lpm - 0.12 cm H2O50 lpm - 0.44 cm H2O60 lpm - 0.67 cm H2O100 lpm - 2.10 cm H2O


Components	HeadgearShell / CushionSwivel elbowTubing	HeadgearShell / CushionSwivel elbowTubing	HeadgearShell / CushionSwivel elbowTubing
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

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510(k) Summary

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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.

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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.

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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

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Indications for Use Statement

Page 1 of 1

510(k) Number:

K121692

Device Name:

MiniMe 2 Nasal Mask

Indications for Use:

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_
(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)

(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices

510(k) Number;

Page 24 of 72

Regulation Number and Section

§ 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).