(90 days)
The MiniMe™ Pediatric Mask is intended to provide an interface for application of CPAP or bi-level therapy. It is intended for patients > 2 years old and < 12 years old. The MiniMe Pediatric Mask is intended for single patient, multi-use in the home environment and multiple patients, multi-use in the hospital/ institutional environment.
The SleepNet MiniMe™ Pediatric Mask with vent holes for a fixed leak during use and without vent holes when used with a patient circuit that incorporates its own anti-asphyxia valve, It is single patient, multi-use or multi-patient, reusable.
Here's an analysis of the provided text regarding the MiniMe™ Pediatric Mask, structured to address your specific points about acceptance criteria and the supporting study:
This 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices for a pediatric mask, which is a fairly low-risk device. Therefore, the "acceptance criteria" and "study" described are focused on comparative performance to established devices rather than demonstrating novel efficacy or specific clinical outcomes. The provided text doesn't contain a detailed clinical trial with a traditional "test set" or specific "ground truth" as one might expect for a diagnostic AI. Instead, it relies on engineering testing and comparison to predicates.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly from predicates) | Reported Device Performance (MiniMe™ Pediatric Mask) |
|---|---|---|
| Indications for Use | Provide an interface for CPAP or bi-level therapy; patients > 2 and < 12 years old; single patient/multi-use (home), multi-patient/multi-use (hospital/institutional). | Identical to predicates K954207, K053352 for interface application. Patient population similar to K032922 and K060105, fitting between them with no new risks. |
| Technology | Function as a patient interface for CPAP/bi-level therapy. | Identical technology to SleepNet MiniMe™ K013306 (its own predicate, implying similar design and function). |
| Materials | Biocompatible materials in patient contact, suitable for medical use. | Identical to predicate devices for materials in patient contact. |
| Environment of Use | Home or hospital/institutional settings. | Identical to predicates SleepNet K013306, Respironics K954207 and K053352. |
| Performance (Functional) | Maintain appropriate pressure-flow characteristics, manage leaks, and have acceptable internal volume/dead space. | Substantially equivalent to predicates in Pressure vs. Flow / leak and Internal volume / dead space testing. |
| Safety | No new risks introduced compared to predicate devices. | Claimed no new risks due to similar patient population fit. |
The primary "acceptance criterion" for this 510(k) was substantial equivalence to the identified predicate devices in terms of indications for use, technology, materials, environment of use, and functional performance. The reported device performance met this criterion by demonstrating identity or similarity across these aspects and showing comparable engineering test results.
Study Information
Given the nature of the device (a mask accessory) and the 510(k) pathway, the "study" described is not a clinical trial but rather comparative performance testing against predicate devices.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The type of testing (Pressure vs. Flow / leak, Internal volume / dead space) typically involves testing multiple units of the device and comparing them to multiple units of predicate devices. However, the exact number of units or data points is not provided.
- Data Provenance: Not explicitly stated, but assumed to be from internal testing conducted by SleepNet Corporation, likely in a laboratory setting. There is no mention of country of origin for data or whether it's retrospective or prospective, as it's not a clinical study on patients.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground Truth Experts: Not applicable in the context of this engineering-focused comparative study. The "ground truth" for pressure, flow, leak, and dead space metrics would be established by validated measurement equipment and engineering standards, not human expert consensus for a "test set." The predicates themselves serve as the "ground truth" standard to be met.
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Adjudication method for the test set:
- Adjudication Method: Not applicable. This was engineering testing, not a subjective assessment requiring human adjudication. The results would be quantitative measurements.
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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:
- MRMC Study: No, an MRMC study was not done. This device is a physical medical accessory (a mask), not an AI-powered diagnostic tool or image analysis system. Therefore, the concept of "human readers" and "AI assistance" is not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a physical medical accessory, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" relied upon here is the established performance characteristics of the predicate devices as measured by engineering specifications (e.g., pressure-flow curves, leak rates, dead space volumes). The goal was to demonstrate that the new device's engineering performance for these metrics was "substantially equivalent" to these known and accepted predicates.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is not an AI algorithm requiring a training set. The "design" of the device would be based on engineering principles and potentially prior product experience, not a "training set" in the machine learning sense.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
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510(k) Summary Page 1 of 2 18-Jun-09
JUL - 1 2009
| SleepNet Corporation | |
|---|---|
| 5 Merrill Industrial Drive | Tel - 603-758-6625 |
| Hampton, NH 03842 | Fax - 603-758-6699 |
| Official Contact: | Jennifer Kennedy - Director of Quality |
| Proprietary or Trade Name: | MiniMe™ Pediatric Mask |
| Common/Usual Name: | Patient interface |
| Classification Code/Name: | BZD - accessory for ventilator, non-continuous (respirator)CFR 868.5905 |
| Device: | MiniMe™ Pediatric Mask |
| Predicate Devices: | K073600 / K954207 - Respironics ComfortGel |
| K053352 - Respironics ComfortLite2 | |
| K032922 -- Airway Development Clarissa | |
| K060105 - ResMed Kidsta | |
| K013306 - SleepNet MiniMe |
Device Description:
The SleepNet MiniMe™ Pediatric Mask with vent holes for a fixed leak during use and without vent holes when used with a patient circuit that incorporates its own anti-asphyxia valve,
It is single patient, multi-use or multi-patient, reusable.
Indications for Use:
The MiniMe™ Pediatric Mask is intended to provide an interface for application of CPAP or bilevel therapy. It is intended for patients > 2 years old and < 12 years old. The MiniMe Pediatric Mask is intended for single patient, multi-use in the home environment and multiple patients, multi-use in the hospital/ institutional environment.
Patient Population: For patients aged > 2 years and < 12 years old
Environment of Use: Home or hospital / institutional environments.
The MiniMeTM is viewed as substantially equivalent to the predicate devices because:
Indications -
Patient Population -
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510(k) Summary Page 2 of 2 18-Jun-09
Technology -
- Identical technology to SleepNet MiniMeTM K013306 ◆
Materials -
- The materials in patient contact identical to predicate devices .
Environment of Use -
Differences -
There are no differences between the predicates and the proposed device. We are only changing the indications for use.
Comparative Performance
We have performed comparative performance testing including -- Pressure vs. Flow / leak and Internal volume / dead space testing.
The results demonstrated that the devices were substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
JUL - 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ProMedicm, Incorporated C/O Paul E. Dryden President SleepNet Corporation 24301 Woodsage Drive Bonita Springs, Florida 34134-2958
Re: K090935
Trade/Device Name: MiniMeTM Pediatric Mask Regulation Number: 21 CFR 868 5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 18, 2009 Received: June 19, 2009
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.
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 (OS) 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runner, D.D.S., M.A.
Acting 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:
Device Name:
MiniMe™ Pediatric Mask
Indications for Use:
The MiniMe™ Pediatric Mask is intended to provide an interface for application of CPAP or bi-level therapy. It is intended for patients > 2 years old and < 12 years old.
The MiniMe Pediatric Mask is intended for single patient, multi-use in the home environment and multiple patients, multi-use in the hospital/ institutional environment.
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)
Susan Ginse
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090935
§ 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).