(21 days)
K24309
Not Found
No
The description focuses on mechanical components and HFCWO technology, with no mention of AI or ML.
Yes.
The device is used for treating pulmonary disorders by clearing mucus, indicating a therapeutic purpose.
No
The device is described as a treatment system (promoting airway clearance and improving bronchial drainage) and its function is to assist in the loosening and elimination of mucus, not to diagnose a condition.
No
The device description clearly outlines hardware components such as a blower, motor-driven valve, power supply, control board, inflatable jacket, and hoses, which are essential for its function. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the inCourage™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The inCourage™ System is a therapeutic device. Its purpose is to physically manipulate the chest wall to help clear mucus from the lungs. It does not analyze any biological samples.
The description clearly states its function is to promote airway clearance and improve bronchial drainage through mechanical means (High Frequency Chest Wall Oscillation). This is a physical therapy/treatment method, not a diagnostic test.
N/A
Intended Use / Indications for Use
The inCourage™ System is indicated when external manipulation of the chest is the physician's treatment of choice to increase the clearance of mucus. It is intended for use in the treatment of a variety of Chronic Obstructive Pulmonary Diseases (COPD'S). The system promotes airway clearance and improves bronchial drainage utilizing High Frequency Chest Wall Oscillation (HFCWO).
Product codes
BYI
Device Description
The inCourage™ System is designed to assist in the loosening & eliminating of mucus from the lungs, utilizing high-frequency chest wall oscillation (HFCWO), when external manipulation of the chest is the physician's treatment of choice to increase the clearance of mucus. The primary components of The inCourage™ System include a blower, a motordriven valve, a power supply, and a control board that are connected to an inflatable iacket through interconnecting hoses. The blower-valve combination creates oscillating air that is delivered to the jacket via the interconnecting hoses. The result is a mythmic inflation and deflation of the jacket against the user's chest creating high-frequency chest wall oscillation, mobilization, and clearance of bronchial secretions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician's treatment of choice
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)
Functional and performance comparisons of the inCourage™ System's triangular waveform were made to the predicate device. Comparisons of the pressure, rate and volume of airflow were completed. It was concluded that the subject of this 510/k) is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K24309
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5665 Powered percussor.
(a)
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.(b)
Classification. Class II (performance standards).
0
JUN 17 2005
Tech®
Advancements in Respiratory Health.
510(k) SUMMARY -- SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
| Date of Submission: | April 19, 2005 | 17 MAY 2005 |
|---|---|---|
| Submitter: | ||
| Address: | Respiratory Technologies Inc., D.B.A. RespirTech | |
| 8095 215th Street West | ||
| Lakeville, MN 55044 | ||
| Establishment Registration #: | 3004961434 | |
| Owner/Operator Number: | 9068715 | |
| Contact: | Mario Nozzarella, CEO | |
| Phone: | (952) 469-0461 | |
| Fax: | (952) 469-3903 | |
| Common Name of Device: | ||
| Proprietary Device Name: | ||
| Classification Name: | ||
| Device Class: | ||
| Product Code: | POWERED PERCUSSOR | |
| The inCourage™ System | ||
| PERCUSSOR, POWERED-ELECTRIC | ||
| 2 | ||
| BYI | ||
| Predicate Device: | The Vest™ Airway Clearance System | |
| Model 104 | ||
| 510(k) Number: K24309 | ||
| Product Code: BYI |
Description of Device:
The inCourage™ System is designed to assist in the loosening & eliminating of mucus from the lungs, utilizing high-frequency chest wall oscillation (HFCWO), when external manipulation of the chest is the physician's treatment of choice to increase the clearance of mucus. The primary components of The inCourage™ System include a blower, a motordriven valve, a power supply, and a control board that are connected to an inflatable iacket through interconnecting hoses. The blower-valve combination creates oscillating air that is delivered to the jacket via the interconnecting hoses. The result is a mythmic inflation and deflation of the jacket against the user's chest creating high-frequency chest wall oscillation, mobilization, and clearance of bronchial secretions.
Intended Use:
The inCourage™ System is indicated when external manipulation of the chest is the physician's treatment of choice to increase the clearance of mucus. It is intended for use in the treatment of a variety of Chronic Obstructive Pulmonary Diseases (COPD'S). The system promotes airway clearance and improves bronchial drainage utilizing High Frequency Chest Wall Oscillation (HFCWO).
8095 215th Street West · Lakeville, MN 55044 Phone 612.325.3600 • Fax 952.469.3903 www.respirtech.com
1
Comparison of Technological Characteristics:
The inCourage™ System is equivalent to The Vest™ Airway Clearance System, Model 104 (K024309) in that it has the same indications for use, the same target population, the jacket and vest materials are both made of similar materials and are worn by the patient in similar fasion. The inCourage™ System utilizes ambient air regeneration, while the predicate uses reciprocating bellows. Both systems transport air pulses to the patient through interconnecting hoses. The pulses are delivered at similar rates and similar pressures. Both systems have the following features:
-
- Main Unit creates pulses of air
-
- Interconnecting Hoses delivers the air pulses from the Main Unit to the Jacket
-
- Jacket transfers the pulses of air as a percussive therapy to the patients chest area
-
- Electronic User Interface used to set and administer the therapy
-
- Varying Jacket Sizes to fit a variety of patients
The administration of therapy is essentially the same between the The inCourage™ System and the predicate device.
Performance Testing:
Functional and performance comparisons of the inCourage™ System's triangular waveform were made to the predicate device. Comparisons of the pressure, rate and volume of airflow were completed. It was concluded that the subject of this 510/k) is substantially equivalent to the predicate device.
Conclusion/Substantial Equivalence:
Respiratory Technologies Inc., D.B.A. RespirTech believes that The inCourage™ System is substantially equivalent to The Vest™ Airway Clearance System - Model 104 (K024309) with regard to form, fit, function and intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight, arranged in a layered formation.
Public Health Service
JUN 17 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Respiratory Technologies, Incorporated C/O Mr. Robert Mosenkis Responsible Third Party Official CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298
Re: K051383
Trade/Device Name: The InCourage™ System Regulation Number: 868.5665 Regulation Name: Powered Percussor Regulatory Class: BYI Product Code: II Dated: June 10, 2005 Received: June 13, 2005
Dear Mr. Mosenkis
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. Mosenkis
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) 276-0120. 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,
Jenette f. Michaud m.D.
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
Indications for Use
510(k) Number (if known):
O\u02c62/383
Device Name:
The inCourage™ System
Indications For Use:
The inCourage™ System is indicated when external manipulation of the chest is the physician's treatment of choice for increasing the clearance of mucus in patients with pulmonary disorders. The system promotes airway clearance and improves bronchial drainage utilizing High Frequency Chest Wall Oscillation (HFCWO).
Mahal Mahal
Division of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number: K051383
Prescription Use _ X_ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(Please Do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)