(84 days)
The Nasal Pillow Mask is intended for patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in home, hospital, or institutional environments. This device is intended to be use under the direction of a physician.
The Nasal Pillow Mask is patient interface device intended for use with CPAP/VPAP therapy systems. The device provides non-invasive means of delivering positive airway pressure to the user by creating a sealed interface using nasal pillows that fit directly into the patients' nostrils. The Nasal Pillow Mask is made of silicone material and comes in 3 different sizes (S, M & L). The nasal mask comes with standard hose fitting intended to be used with standard CPAP/VPAP system. It is intended to be use on patients (> 30 kg) who have been prescribed CPAP/VPAP therapy at home, hospital, or institutional environments. The complete mask set incudes headgear, frame, tube, and nasal pillows (S, M, & L sizes).
This document is a 510(k) summary for a Nasal Pillow Mask, indicating that the device is substantially equivalent to a previously cleared predicate device. As such, it highlights the lack of a new study to demonstrate acceptance criteria because the device is deemed identical to its predicate in all relevant aspects.
Here's the breakdown of why the requested information cannot be fully provided based solely on the input, and what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "The subject device is identical to predicate device except for manufacturer name, brand name, and resulting labeling updates. The indications for use, design, principles of operation, and materials are all identical to the predicate device already cleared by FDA. Therefore, no new non-clinical testing is required."
This means that for the current 510(k) submission (K243225), no new acceptance criteria or reported device performance data was generated or provided for the subject device. The acceptance criteria and performance data would have been established and demonstrated for the predicate device (K120920) in its original submission.
The table in the document provides specifications for Deadspace Volume, Resistance, Therapy pressure, Noise level, Environmental Conditions, Weight, and Size Flow, which are common technical specifications for such devices. These are not explicitly stated as "acceptance criteria" but rather as "Specifications" that are "Same" as the predicate.
| Specification Item | Subject Device Performance (Reported as "Same" as Predicate) |
|---|---|
| Deadspace Volume | S size: 90.8M size: 94.3L size: 95 |
| Resistance 50 L/m | (Value not numerically given, stated as "Same") |
| Resistance 100 L/m | S size: 6.87M size: 5.93L size: 5.3 |
| Therapy pressure | 5~20cmH2O (Reported as 10cmH2O) |
| Noise level | S size: 35.0 |
| Environmental Conditions | Storage and Transportation: 15°C ~ 25°C, up to 95% non-condensing Storage relative humidity: <85% |
| Weight | 69.9g |
| Size Flow (l/min) @ 5 cmH2O | S: 24.94, M: 24.85, L: 25.28 |
| Size Flow (l/min) @ 10 cmH2O | S: 35.66, M: 35.61, L: 35.79 |
| Size Flow (l/min) @ 15 cmH2O | S: 44.76, M: 45.07, L: 44.71 |
| Size Flow (l/min) @ 20 cmH2O | S: 52.46, M: 52.21, L: 51.99 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No new sample size or test set was used for the subject device as "no new non-clinical testing is required." Testing relevant to these specifications would have been performed for the predicate device.
- Data provenance: Not applicable for the subject device's 510(k) as no new studies were conducted. The origin of the predicate device's data is not provided in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No expert ground truth establishment was conducted for the subject device's 510(k), as it leveraged the equivalence to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new test set or expert adjudication was performed for the subject device.
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
- No. This device is a physical medical device (nasal pillow mask), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or assessment of AI assistance is irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical medical device and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for the subject device's 510(k). The substantial equivalence determination is based on the device being identical to the predicate in design, materials, and intended use, not on new clinical performance data or ground truth establishment for the subject device. The specifications listed are objective physical measurements.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set was used.
In summary of the provided document:
The 510(k) submission for the Nasal Pillow Mask (K243225) is based on the premise of substantial equivalence to a predicate device (Hsiner Nasal Pillow Mask, K120920). The manufacturer asserts that the subject device is identical to the predicate device in terms of indications for use, design, principles of operation, and materials. Therefore, no new performance studies, acceptance criteria demonstration, or clinical data were generated for the subject device. The FDA's clearance is based on the established safety and effectiveness of the predicate device, which the subject device is claimed to replicate.
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December 31, 2024
Genadyne Biotechnologies, Inc. Chien Ming Goh Vice President 16 Midland Ave Hicksville, New York 11801
Re: K243225
Trade/Device Name: Nasal Pillow Mask - Small (NNPM-01/ Nefes S): Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) Regulation Number: 21 CFR 868.5905 Regulation Name: Non-continuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 17, 2024 Received: December 17, 2024
Dear Chien Ming Goh:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rachana Visaria -S
Rachana Visaria, PhD Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K243225
Device Name
Nasal Pillow Mask – Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)
Indications for Use (Describe)
The Nasal Pillow Mask is intended for patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in home, hospital, or institutional environments. This device is intended to be use under the direction of a physician.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510k Summary
Date Prepared
December 20, 2024
Company Name/Owner
Genadyne Biotechnologies, Inc. 16 Midland Ave, Hicksville, NY 11801
Official Contact
Mr. Chien Ming (Andrew), GOH chiengoh(@genadyne.com (t) 516.487.8787 (f) 516.977.8974
Device Name/ Trade Name
Nasal Pillow Mask – Small (NNPM-01/ Nefes S); Nasal Pillow Mask – Medium (NNPM-02/ Nefes M); Nasal Pillow Mask – Large (NNPM-03/ Nefes L) Common/Usual Name Patient interface for CPAP
Regulation Name and Product Code
21 CFR 868.5905 - Non-continuous ventilator (IPPB), BZD
Classification
Class II
Predicate Device
Hsiner Nasal Pillow Mask (K120920)
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Device Description
The Nasal Pillow Mask is patient interface device intended for use with CPAP/VPAP therapy systems. The device provides non-invasive means of delivering positive airway pressure to the user by creating a sealed interface using nasal pillows that fit directly into the patients' nostrils. The Nasal Pillow Mask is made of silicone material and comes in 3 different sizes (S, M & L). The nasal mask comes with standard hose fitting intended to be used with standard CPAP/VPAP system. It is intended to be use on patients (> 30 kg) who have been prescribed CPAP/VPAP therapy at home, hospital, or institutional environments. The complete mask set incudes headgear, frame, tube, and nasal pillows (S, M, & L sizes).
Intended Use / Indications for Use
The Nasal Pillow Mask is intended for patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in home, hospital, or institutional environments. This device is intended to be use under the direction of a physician.
Comparison to Predicate Device
The goal of this 510(k) is to re-introduce the predicate device under a different manufacturer and brand name as a result of an acquisition. The indications for use, design, principles of operation, and materials are all identical to the predicate device already cleared by FDA.
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K243225 | K120920 |
| Company | Genadyne BiotechnologiesInc. | HSINER Co. LTD. |
| Device Name | Nasal Pillow Mask | Hsiner Nasal Pillow Mask |
| Indications forUse | The Nasal Pillow Maskis intended for patients(> 30 kg) who havebeen prescribedCPAP/VPAP therapy inhome, hospital, orinstitutionalenvironments. Thisdevice is intended to beuse under the directionof a physician. | The Hsiner Nasal Pillow Mask is intended to be usepatients (> 30 kg) who have been prescribedCPAP/VPAP therapy in a home, hospital orinstitutional environments.This device is intended to be use under the specificdirection of a physician. |
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| Patient Population | Same | Adults | ||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Use Environment | Same | Hospital, Home environment | ||||||||||||||||||||||||||||||||||||||||
| StructureandMaterials | Same | Nasal Plug: SiliconeFrame: PolycarbonateL Connector: PolycarbonateTube: Hytrel®Connector: PolycarbonateHeadgear: PC + Nylon Fabric | ||||||||||||||||||||||||||||||||||||||||
| Specification | Same | Items Specifications Deadspace Volume S size: 90.8M size: 94.3L size: 95 Resistance 50 L/m 100 L/mS size: 6.87M size: 5.93L size: 5.3 Therapy pressure 5 |
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Non-Clinical Performance Evaluation
The subject device is identical to predicate device except for manufacturer name, brand name, and resulting labeling updates. The indications for use, design, principles of operation, and materials are all identical to the predicate device already cleared by FDA. Therefore, no new non-clinical testing is required.
Conclusion
The subject device is identical to predicate device except for manufacturer name, brand name, and resulting labeling updates. The indications for use, design, principles of operation, and materials are all identical to the predicate device already cleared by FDA. Based on this comparison of intended use and technological characteristics of the subject device compared with the predicate device, we can conclude that the subject device is substantially equivalent to the predicate device.
§ 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).