(85 days)
Not Found
No
The document describes a physical mask and headgear for delivering positive airway pressure. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI/ML. The performance studies focus on physical characteristics like CO2 performance, not algorithmic performance.
No
The device is a mask that channels airflow from a positive airway pressure device to the patient, rather than being a therapeutic device itself. Its function is to provide an interface for a prescribed therapy.
No
The device, Swift LT, is described as an interface for channeling airflow from a positive airway pressure device to a patient. Its function is to deliver therapy, not to diagnose a condition.
No
The device description clearly indicates a physical mask and headgear, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Swift LT is a mask that channels airflow from a positive airway pressure device to a patient's nose. It is a physical interface for delivering therapy.
- Intended Use: The intended use is to provide positive airway pressure to treat conditions like sleep apnea. It does not involve testing biological samples.
- Device Description: The description focuses on the physical components and how it connects to a positive pressure source.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity associated with in vitro diagnostics.
Therefore, the Swift LT is a medical device used for respiratory therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Swift LT channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system. The Swift LT is: to be used by adult patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed. intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Swift LT provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face. Swift LT is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Swift LT is a prescription device supplied nonsterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's nose
Indicated Patient Age Range
adult patients (> 66 lb/30 kg)
Intended User / Care Setting
single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Use of vented nasal masks with CPAP or Bilevel therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the Swift LT, as was the case with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
073638
MAR 2 0 2008
RESMED
.
Swift LT Traditional 510k
| 510(k) SUMMARY
| [As required by 21 CFR 807.92(c)] | ||
|---|---|---|
| Date Prepared | December 18th, 2007 | |
| Official Contact | Mr. David Thomson, | |
| Senior Regulatory Affairs Manager | ||
| Device Trade Name | Swift™ LT | |
| Device Common Name/ | ||
| Classification Name | Vented Nasal Mask; | |
| Accessory to Noncontinuous Ventilator (IPPB) | ||
| Classification | 21 CFR 868.5905, 73 BZD (Class II) | |
| Predicate Devices | Mirage Swift (K042403) | |
| Ultra Mirage II Mask (K050359) | ||
| Description | The Swift LT provides an interface such that airflow from a | |
| positive pressure source is directed to the patient's nose. The | ||
| mask is held in place with adjustable headgear that straps the | ||
| mask to the face. | ||
| Swift LT is safe when used under the conditions and purposes | ||
| intended as indicated in the labeling provided with the product. | ||
| Swift LT is a prescription device supplied nonsterile. | ||
| Intended Use | The Swift LT channels airflow noninvasively to a patient from a | |
| positive airway pressure device such as a continuous positive | ||
| airway pressure (CPAP) or bilevel system. | ||
| The Swift LT is: | ||
| to be used by adult patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed. intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment. | ||
| Technological | ||
| Characteristics | ||
| comparison | Comparison with predicate Mirage Swift | |
| The new device and the predicate mask, provide a seal via silicone interface. Both masks are offered in various sizes to ensure adequate fit over the extended patient population. | ||
| Both the masks incorporate vent holes to provide continuous air leak to flush out and minimize the amount of CO2 rebreathed by the patient. The design of the mask components is such that the incorporation of these vent-holes does not interfere with the intended performance of the masks. | ||
| Both the masks connect to a conventional air delivery hose between the mask and the positive airway-pressure source via standard conical connectors (ref: ISO 5356-1:2004) | ||
| Both the masks are constructed using molded plastic and silicone components and fabric / nylon headgear. All the | ||
| December 18, 2007 | 17 | |
| components of both the masks are fabricated using materials | ||
| deemed safe. (ref: ISO 10993-1). | ||
| Both the new device and the predicate are designed to operate | ||
| on the same Mirage or Swift ResMed flow generator settings. | ||
| The pressure-flow characteristics and flow impedance of both | ||
| the new device and the predicate device are substantially | ||
| equivalent. | ||
| Both the new device and the predicate device can be reused in | ||
| the home and hospital / institution environment. | ||
| The main differences between Swift LT and Mirage Swift is in | ||
| the number of components, their design/geometry and how | ||
| individual components interface with each other. Both the | ||
| masks are designed and constructed under ResMed's 21 CFR | ||
| Part 820 compliant Quality Management System. | ||
| Clinical Data | Use of vented nasal masks with CPAP or Bilevel therapy is | |
| proven technology and is well accepted by the medical | ||
| community. Bench testing is sufficient to demonstrate safety | ||
| and efficacy of the Swift LT, as was the case with the predicate | ||
| device. | ||
| Performance Data | Comparison with predicate Ultra Mirage II | |
| The CO2 performance of the new device and the predicate | ||
| device are substantially equivalent. | ||
| Substantial Equivalence | ||
| Conclusion | Swift LT is substantially equivalent to the predicate devices: |
- it has the same though reworded intended use;
- it has similar technological characteristics to both
predicates: - it does not raise new questions of safety and
effectiveness; - it is at least as safe and effective as the predicate
devices Mirage Swift and Ultra Mirage II | |
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
MAR 2 @ 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ResMed Limited C/O Mr. David D' Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K073638
Trade/Device Name: Swift™ LT Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 6, 2008 Received: March 10, 2008
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.
3
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 (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.
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
Syutte Y. Michie Dats
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
4
RESMED
Swift LT Traditional 510k
Indication for Use
510(k) Number (if known): Swift™ LT Device Name: Indication for Use
The Swift LT channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Swift LT is:
- to be used by adult patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed. .
- intended for single-patient re-use in the home environment and multipatient re-use in the . hospital/institutional environment.
Min Thul
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
07363 510(k) Number: J
Prescription Use X AND/OR Over-The-Counter Use_ (Part 21 CFR 801 Subpart D) (Part 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)
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December 18, 2007
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