(89 days)
Not Found
No
The description focuses on the mechanical function of a CPAP device and does not mention any AI/ML terms or capabilities.
Yes
The device is indicated for the "treatment" of obstructive sleep apnea (OSA), which explicitly states its therapeutic purpose.
No
The device is described as a CPAP device intended for the treatment of obstructive sleep apnea, not for diagnosis. Its function is to deliver airflow to maintain an "air splint" for effective treatment.
No
The device description explicitly states that the Tasman is a portable CPAP device with integrated blower, mask, and tubing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of obstructive sleep apnea (OSA) by delivering airflow noninvasively. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is described as a portable CPAP device that generates pressure to treat OSA. This aligns with a therapeutic device.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's function is to deliver therapy, not to perform diagnostic tests.
N/A
Intended Use / Indications for Use
The Tasman is indicated for the treatment of obstructive sleep apnea (OSA) in adult patients weighing more than 66 lb (>30 Kg). The Tasman mask system delivers airflow noninvasively to a user from the integrated Continuous Positive Airway (CPAP) device. The Tasman is intended for single-patient re-use in the home environment and while travelling.
Product codes
73 BZD
Device Description
The Tasman is a portable CPAP device where the blower, mask and tubing are integrated and mounted to the headgear. The blower generates the required CPAP pressure to maintain an "air splint" for effective treatment of OSA.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
single-patient re-use in the home environment and while travelling.
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)
Design and Verification activities were performed on the Tasman System as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria. This included pressure stability, jitter, swings, ISO 17510-1 pressure performance and functional dead space tests against the predicate devices using common protocols for both devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
S8 Prime (K033841), Ultra Mirage II Nasal Mask (K050359)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
, n° ﺮ ﻣﺮ
RESMED
Tasman Traditional 510(k)
| | K112393
Traditional 510(k) SUMMARY
[As required by 21 CFR 807.92(c)] | | |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Date Prepared | 16th Aug, 2011 | | |
| Submitter Name | Mr. Kim Kuan Lee | | |
| Official Contact | Mr. David D'Cruz | | |
| | V.P., Medical & Regulatory Affairs | | |
| | 9001 Spectrum Center Blvd | | |
| | San Diego CA 92123 USA | | |
| | Tel: (858) 836-5984 | | |
| Device Trade Name | Tasman | | |
| Device Common Name | Non continuous Ventilator (IPPB) | | |
| Classification | 21 CFR 868.5905 (Class II) | | |
| Product Code | 73 BZD | | |
| Predicate Device | S8 Prime (K033841) | | |
| | Ultra Mirage II Nasal Mask (K050359) | | |
| Reason for submission | New Device | | |
| Intended Use | The Tasman is indicated for the treatment of obstructive
sleep apnea (OSA) in adult patients weighing more than
66 lb (>30 Kg). The Tasman mask system delivers airflow
noninvasively to a user from the integrated Continuous
Positive Airway (CPAP) device. The Tasman is intended
for single-patient re-use in the home environment and
while travelling. | | |
| Substantial Equivalence | The new device has the following similarities to the
previously cleared predicate devices.
• Same intended use
• Similar operating principle
• Similar technologies
• Similar manufacturing process
Design and Verification activities were performed on the
Tasman System as a result of the risk analysis and
design requirements. All tests confirmed the product met | | |
1
the predetermined acceptance criteria. This included pressure stability, jitter, swings, ISO 17510-1 pressure performance and functional dead space tests against the predicate devices using common protocols for both devices. ResMed has determined that the new device has not altered the safety and effectiveness of CPAP treatment for adult patients with Obstructive Sleep Apnoea (OSA) who weigh more than 66 lb (>30 kg). The new device complies with the applicable requirements referenced in the FDA guidance documents:
-
FDA Draft Reviewer Guidance for Ventilators (July . 1995)
The Tasman is a portable CPAP device where the blower, Device Description mask and tubing are integrated and mounted to the headgear. The blower generates the required CPAP pressure to maintain an "air splint" for effective treatment of OSA. -
The Tasman is substantially equivalent to the Predicate Conclusion devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ResMed Limited C/O Mr. David D'Cruz Vice President, Medical & Regulatory Affairs Resmed Corporation 9001 Spectrum Center Boulevard San Diego, California 92123
NOV 1 6 2011
Re: K112393.
Trade/Device Name: Tasman Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: August 16, 2011 Received: August 19, 2011
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. 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.
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); 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 /ucm 115809.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/Safety/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.
hn for
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
4
RESMED
Tasman Traditional 510(k)
Indication for Use
1112393 510(k) Number (if known):
Device Name:
Tasman
Indication for Use
The Tasman is indicated for the treatment of obstructive sleep apnea (OSA) in adult patients weighing more than 66 lb (>30 Kg). The Tasman mask system delivers airflow noninvasively to a user from the integrated Continuous Positive Airway (CPAP) device. The Tasman is intended for single-patient re-use in the home environment and while travelling.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (Part 21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Copcurrence of CDRH; Office of Device Evaluation (ODE)
.
(Division Sign-Off Thurth
Page 1 of__1
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
16th Aug, 2011
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