(21 days)
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).
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for "The inCourage™ System":
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in the typical format of a target value or range for performance metrics. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (The Vest™ Airway Clearance System, Model 104) | Functional and performance comparisons of the inCourage™ System's triangular waveform (pressure, rate, and volume of airflow) concluded that it is substantially equivalent to the predicate device. The inCourage™ System has the same indications for use, target population, and similar jacket/vest materials and administration of therapy. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical data from patients. The performance testing described is focused on the functional characteristics of the device itself rather than its efficacy in a patient population. Therefore, there's no mention of sample size for a test set or data provenance from countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The study is a comparison of technological characteristics and functional performance against a predicate device, not a clinical study requiring expert assessment for ground truth on patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no clinical test set requiring adjudication. The "conclusion" of substantial equivalence was made by the submitter, Respiratory Technologies Inc., D.B.A. RespirTech.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was conducted. This device is a powered percussor for airway clearance, not an AI-assisted diagnostic or therapeutic tool with human reader involvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the device's functional performance without direct human intervention after initial setup, in comparison to the predicate device. The performance testing was a standalone comparison of the inCourage™ System's waveform characteristics (pressure, rate, volume) to the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established functional and performance characteristics of the predicate device, The Vest™ Airway Clearance System, Model 104. The inCourage™ System demonstrated that its own functional characteristics were comparable to this established baseline.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
{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. RespirTech8095 215th Street WestLakeville, 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 PERCUSSORThe inCourage™ SystemPERCUSSOR, POWERED-ELECTRIC2BYI | |
| Predicate Device: | The Vest™ Airway Clearance SystemModel 104510(k) Number: K24309Product 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)
§ 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).