(79 days)
The Nasal Jacks Mask is an accessory to a non-continuous ventilator (respirator), intended for single-patient multiple use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinical, and home environments.
The Nasal Jacks Mask is designed for adult patients for the delivery of non-invasive ventilatory support using continuous positive airway pressure or bi-level therapy. It is intended for singlepatient, multi-use and is minimally obtrusive to the user providing a high level of comfort, ease-ofuse and seal. The Nasal Jacks Mask is supported by headgear to allow a seal with the patients nostrils via the nasal cushions, then connected via tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is thus applied to the lungs in a non-invasive manner. The Nasal Jacks Mask comes in one frame size and has three nasal cushion sizes.
The provided text describes the 510(k) summary for the Nasal Jacks Mask, a device intended for non-invasive ventilatory support. Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device was tested for) | Reported Device Performance (Summary of results) |
|---|---|
| Pressure-flow characteristic | The results of the performance data show that the mask is substantially equivalent to the predicate mask. |
| Functional dead space (CO2 re-breathing) | The results of the performance data show that the mask is substantially equivalent to the predicate mask. |
| Physical dead space | The results of the performance data show that the mask is substantially equivalent to the predicate mask. |
| Flow impedance | The results of the performance data show that the mask is substantially equivalent to the predicate mask. |
| Materials Biocompatibility | Materials either predicate materials or tested to ISO 10993 standards by an independent certified laboratory. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the test set or the data provenance (country of origin, retrospective/prospective). It generally states that "Performance testing has been carried out to verify and validate the safety and effectiveness."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information about the number of experts used to establish ground truth or their qualifications. The testing appears to be primarily engineering/objective performance testing rather than human expert assessment of outcomes.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method as the studies described are performance tests and biocompatibility tests, not clinical studies requiring human adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size.
No, an MRMC comparative effectiveness study was not done. The study described focuses on the physical and material characteristics of the device compared to predicate devices.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.
Not applicable. This device is a medical mask, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the performance tests (pressure-flow, dead space, flow impedance), the ground truth was based on objective measurements and comparison to established predicate device performance. For material biocompatibility, the ground truth was based on ISO 10993 standards or the existing approval of predicate materials.
8. The Sample Size for the Training Set
Not applicable. This device is a physical mask and does not involve a "training set" in the context of machine learning or algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an algorithm-based device.
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510(K) SUMMARY 3
510(k) SUMMARY-Nasal Jacks Mask
| Submitter Name: | ResMed Corp. |
|---|---|
| Submitter Address: | 14040 Danielson Street, Poway CA 92064-6857USA |
| Contact Person: | David D'Cruz, VP US Clinical & Regulatory Affairs |
| Phone Number: | (858) 746 2238 |
| Fax Number: | (858) 746 2900 |
| Date Prepared: | August 1, 2003 |
| Device Trade Name: | Not available at time of submission |
| Device Common Name/Classification Name: | Nasal Jacks Mask |
| Predicate Devices: | Primary predicate: ADAM™ Interface System. K900164Secondary predicate: Mirage Nasal Mask (clearedinSULLIVAN® AUTOSET® Nasal CPAP System K980721) |
Device Description:
The Nasal Jacks Mask is designed for adult patients for the delivery of non-invasive ventilatory support using continuous positive airway pressure or bi-level therapy. It is intended for singlepatient, multi-use and is minimally obtrusive to the user providing a high level of comfort, ease-ofuse and seal.
Intended Use:
The Nasal Jacks Mask is an accessory to a non-continuous ventilator (respirator), intended for single-patient multi-use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinical, and home environments.
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Device Technological Characteristics and Comparison to Predicate Device(s):
Overview:
The Nasal Jacks Mask is supported by headgear to allow a seal with the patients nostrils via the nasal cushions, then connected via tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is thus applied to the lungs in a non-invasive manner.
The Nasal Jacks Mask comes in one frame size and has three nasal cushion sizes.
The Nasal Jacks Mask design is substantially equivalent to predicate device(s) (ADAM™ Interface System and Mirage Nasal Mask). The Nasal Jacks Mask design has the same intended use and has the same fundamental scientific technology as its predicates.
Performance Data:
Performance testing has been carried out to verify and validate the safety and effectiveness of the Nasal Jacks Mask. The Nasal Jacks Mask was tested to determine the pressure-flow characteristic, functional dead space (CO2 re-breathing), physical dead space and flow impedance. The results of the performance data show that the mask is substantially equivalent to the predicate mask (refer section 5.2.1)
Materials Biocompatibility
Materials have been carefully selected to ensure patient safety and efficacy of the product. The materials used to create components of the Nasal Jacks Mask, which contact the skin, mucosal membrane and/or the air-path, are either predicate materials (i.e., cleared previously for the same intended use), or have been tested to the ISO 10993 standards by an independent certified laboratory. The details are referenced in section 5.4.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
OCT 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ResMed Limited C/O Mr. David D'Cruz Vice President US Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K032433
Trade/Device Name: Nasal Jacks Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: August 1, 2003 Received: August 11, 2003
Dear Mr. D'Cruz:
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 such 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. D'Cruz
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
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Chiu Lin, Ph.D. 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 4
510(k) Number (if known):
| 1 | { | t | far |
|---|---|---|---|
| C | 1 | ||
Device Name:
Nasal Jacks Mask
Indications for Use:
The Nasal Jacks Mask is an accessory to a non-continuous ventilator (respirator), intended for single-patient multiple use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinical, and home environments.
Selma M. Quinto
(Division Sign Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: الكم 32433
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
| Prescription | |
|---|---|
| Use | |
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).