(244 days)
Not Found
No
The document describes a mechanical patient interface accessory and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a "patient interface accessory intended for use with devices that administer CPAP (continuous positive airway pressure) and bi-level airway pressure in treating adult patients," indicating its role in delivering a therapeutic treatment (PAP).
No.
The device is described as a "patient interface accessory" for administering positive airway pressure, not for diagnosing a condition. It facilitates treatment delivery rather than identifying or monitoring a medical condition.
No
The device description explicitly states it is a "patient interface accessory" comprising physical components like a nasal/tubing assembly and headgear, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "patient interface accessory intended for use with devices that administer CPAP and bi-level airway pressure in treating adult patients." This describes a device used on a patient to deliver therapy, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description details a physical interface (nasal cannula, tubing, headgear) that connects a patient to a therapy device. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing diagnostic information about a patient's health status
The device is a medical device used for delivering respiratory therapy, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Spiritus™ Respiratory System is a patient interface accessory intended for use with devices that administer CPAP (continuous positive airway pressure) and bi-level airway pressure in treating adult patients.
The Spiritus™ Respiratory System is a single-patient interface accessory intended for use by patients who have been prescribed positive airway pressure treatment (PAP) including CPAP and BiPAP.
Product codes
BZD
Device Description
The device is a single-patient-use, patient interface accessory for patients receiving positive airway pressure treatment including CPAP and BiPAP and comprises the nasal/tubing assembly and associated headgear.
The nasal cannula protuberances fit into the patient's nares effecting a substantially artight seal, facilitating the delivery of the positive airway pressure. Tubing is fitted to the nasal cannula via elbow connectors which may be used to secure the detachable headgear. The tubing fits to a "Y" connector to effect connection to the flow generator output tube.
The nasal cannula, tubing and connectors may be cleaned with mild soap and water for use by the same patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nares
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
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
Performance was confirmed through the execution of flow resistance, enclosed volume, and intentional leak rate tests.
Key Metrics
Not Found
Predicate Device(s)
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
K02 06 41
OCT 2 9 2002
Non-confidential 510(k) Summary of Safety and Effectiveness
1. Applicant Name & Address
Worldwide Medical Technologies Inc. 3178 Keen Drive Waycross, Georgia 31503.
2. Trade Name of Device
Spiritus™ Respiratory System
3. Common Name(s) of Device
Patient Interface Accessory
4. Classification Name
Accessory to the CPAP/BiPAP device [VENTILATOR, NON-CONTINUOUS (RESPIRATOR)]
5. Classification & Classification Code
21 CFR 868.5905,73 BZD Class II.
6. Device Description
The device is a single-patient-use, patient interface accessory for patients receiving positive airway pressure treatment including CPAP and BiPAP and comprises the nasal/tubing assembly and associated headgear.
The nasal cannula protuberances fit into the patient's nares effecting a substantially artight seal, facilitating the delivery of the positive airway pressure. Tubing is fitted to the nasal cannula via elbow connectors which may be used to secure the detachable headgear. The tubing fits to a "Y" connector to effect connection to the flow generator output tube.
The nasal cannula, tubing and connectors may be cleaned with mild soap and water for use by the same patient.
7. Intended Use
The Spiritus™ Respiratory System is a patient interface accessory intended for use with devices that administer CPAP (continuous positive airway pressure) and bi-level airway pressure in treating adult patients.
8. Predicate Device
Substantial equivalence is claimed to the Puritan-Bennett Airway Delivery & Management (ADAM) Nasal Ventilation, subject of 510(k) K900164.
9. Summary of Performance Testing
Performance was confirmed through the execution of flow resistance, enclosed volume, and intentional leak rate tests.
Conclusion 10.
Based on the above, we conclude the Spiritus™ Respiratory System is substantially equivalent to predicate device, and is safe and effective for its intended use.
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a human figure with three overlapping profiles. The profiles are facing to the right and are connected by a series of curved lines.
OCT 2 9 2002
od and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Worldwide Medical Technologies, Incorporated C/O Mr. Jonathan Lee JSL Consulting Incorporated 138 Spartina Avenue St. Augustine, Florida 32080
Re: K020641
Trade/Device Name: Spiritus™ Respiratory System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator, Accessory Regulatory Class: II Product Code: BZD Dated: October 7, 2002 Received: October 9, 2002
Dear Mr. Lee:
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.
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.
2
Page 2 - Mr. Lee
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
- U.S. Food and Drug Administration - Center for Devices and Radiological Health و
Page 1 of 1
510(k) Number (if known): Ho2064)
Device Name: SpiritusTM Respiratory System
Indications for Use:
The Spiritus™ Respiratory System is a single-patient interface accessory intended for use by patients who have been prescribed positive airway pressure treatment (PAP) including CPAP and BiPAP.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use ✓
le7Wutshamn
(Optional Format 3-10-98)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K02064