(87 days)
Not Found
No
The device description and performance studies focus on mechanical and pneumatic principles (vibration/pulsation generator, air pressure piston system, HFCWO) and standard electrical/mechanical safety testing. There is no mention of AI, ML, data analysis, or learning algorithms in the provided text.
Yes
The device is described as providing "airway clearance therapy" and "external manipulation of the thorax to promote airway clearance or improve bronchial drainage," which are therapeutic actions. It also describes a mechanism of action (HFCWO) to remove mucus, indicating a direct therapeutic effect.
Yes
The "Intended Use / Indications for Use" section states: "In addition, the RespIn11 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation." The collection of mucus for diagnostic evaluation indicates a diagnostic purpose.
No
The device description explicitly states it is made up of a jacket connected to a vibration/pulsation generator and a multistage blower, which are hardware components. The performance studies also include testing of hardware aspects like frequency, pressure, pneumatic, and electrical safety.
Based on the provided information, the RespIn11 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use of the RespIn11 is to provide airway clearance therapy through external manipulation of the thorax (High Frequency Chest Wall Oscillation - HFCWO). While it mentions being indicated for collecting mucus for diagnostic evaluation, this is a secondary function and the device itself is not performing a diagnostic test on the mucus. It's facilitating the collection of a sample.
- Device Description: The device description clearly outlines a mechanical system that applies pressure and vibration to the chest wall to loosen and move mucus. This is a physical therapy, not a diagnostic process that analyzes biological samples.
- Lack of IVD Characteristics: IVD devices typically involve the examination of specimens derived from the human body (like blood, urine, tissue, or mucus) to provide information for diagnostic purposes. The RespIn11 does not perform this type of analysis.
In summary, the RespIn11 is a therapeutic device used to assist in clearing airways and collecting samples, but it does not perform the diagnostic analysis itself.
N/A
Intended Use / Indications for Use
The RespIn11 is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy' (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the RespIn11 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.
Product codes
BYI
Device Description
RespIn11 is a medical device developed for an effective therapy of airway obstruction conditions. The device is made up of a jacket connected to a vibration/pulsation generator where the pulsations are obtained by the pressure differences of a multistage blower. These pulsations are transmitted to the subject's chest through an air pressure piston system specially designed and inserted into the front and rear cavities of the vest provided. The compression then release cycle on the chest wall generates a differential air speed in the bronchial airway in the lungs. This produces a shearing effect which pulls the mucus off the bronchial airway walls and to then be moved through mucociliary action into the larger upper airways to then be eliminated naturally through coughing or if necessary by external suction. This respiratory therapy is called HFCWO (High Frequency Chest Wall Oscillation).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thorax
Indicated Patient Age Range
Not explicitly limited
Intended User / Care Setting
Hospital, sub-intensive, clinical offices, home
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)
Performance Testing
We have performed performance testing and the results demonstrated that the device performs as intended and is substantially equivalent to the performance of the predicate.
The tests included:
- Frequency Testing ●
- Pressure Testing .
- . Pneumatic Testing
- Fault condition testing .
- IEC 60601-1 Safety .
- IEC 60601-1-2 Electromagnetic Compatibility ●
The results of the testing demonstrate that the RespIn11 performs equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 868.5665 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
| 510(k) Summary | ||
|---|---|---|
| Page 1 of 6 | ||
| 4/15/2012 | K 121170 |
| RespInnovation SAS
611 Chemin de l'Adrech
SEILLANS, 83440 France | Tel - +33 6 17 81 08 01
Fax - +33 6 17 81 08 01 | JUL 13 2012 |
|------------------------------------------------------------------------|------------------------------------------------------|-------------|
| Official Contact: | Barrett R. Mitchell- President | |
| Proprietary or Trade Name: | RespIn11 Model | |
| Common/Usual Name: | Powered Percussor | |
| Classification Name/Code: | BYI - Powered Percussor
CFR 868.5 665
Class II | |
| Device: | RespIn11 | |
| Predicate Device: | Advanced Respiratory - The Vest K024309 | |
Device Description:
RespIn11 is a medical device developed for an effective therapy of airway obstruction conditions. The device is made up of a jacket connected to a vibration/pulsation generator where the pulsations are obtained by the pressure differences of a multistage blower. These pulsations are transmitted to the subject's chest through an air pressure piston system specially designed and inserted into the front and rear cavities of the vest provided. The compression then release cycle on the chest wall generates a differential air speed in the bronchial airway in the lungs. This produces a shearing effect which pulls the mucus off the bronchial airway walls and to then be moved through mucociliary action into the larger upper airways to then be eliminated naturally through coughing or if necessary by external suction. This respiratory therapy is called HFCWO (High Frequency Chest Wall Oscillation).
Indications for Use:
The RespIn11 is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy' (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the RespIn11 is also indicated for external manipulation of the
1
510(k) Summary Page 2 of 6 4/15/2012
thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.
Environment of Use:
Hospital, sub-intensive, clinical offices, home
Contraindications
- Intracranial pressure (ICP) greater than 20 mm Hg .
- Recent spinal surgery or acute spinal injury .
- Bronchopleural fistula �
- Pulmonary edema associated with congestive heart failure .
- Large pleural effusions or empyema .
- Pulmonary embolism .
- Head and/or neck injury that has not yet been stabilized ●
- Active hemorrhage with hemodynamic instability .
- . Distended abdomen
- Active or recent gross hemoptysis ●
- Uncontrolled airway at risk for aspiration such as tube feeding or a recent meal .
- . Subcutaneous emphysema
- Recent epidural spinal infusion or spinal anesthesia .
- Suspected pulmonary tuberculosis .
- Lung contusion .
- Bronchospasm ●
- Coagulopathy .
- Complaint of chest wall pain ●
- Rib fractures, with or without flail chest (within 30 days after this may help . splint/stabilize)
- Surgical wound or healing tissue or recent skin grafts or flaps on the thorax .
- Recent esophageal surgery .
- Burns, open wounds, and skin infections on the thorax .
- Recent placement of transvenous or subcutaneous pacemaker (within 30 days) ●
Summary of substantial equivalence
The RespIn11 was compared to the predicate The Vest (K024309) and is presented in the following comparison table.
2
remarket Notification 510(
ection 5 -- 510(k) Summary
·
espInnovation RespIn1
510(k) Summary
able of Compar
| Table of Comparison
Feature | Respinnovation RespIn11
510(k) | Advanced Respiratory (Hill-Rom) -
The Vest
510(k) K024309 | Comment |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications | The Respln11 is intended to provide
airway clearance therapy when external
manipulation of the thorax is the
physician's choice of treatment.
Indications for this form of therapy are
described by the American Association
for Respiratory Care (AARC) in the
Clinical Practices Guidelines for
Postural Drainage Therapy' (1991).
According to AARC guidelines, specific
indications for external manipulation of
the thorax include evidence or a
suggestion of retained secretions,
evidence that the patient is having
difficulty with the secretion clearance,
or presence of atelectasis caused by
mucus plugging. In addition, the
RespIn11 is also indicated for external
manipulation of the thorax to promote
airway clearance or improve bronchial
drainage for purposes of collecting
mucus for diagnostic evaluation. | The intended use of the Modified
Vest™ Airway Clearance System is the
same as the predicate device, which is to
provide airway clearance therapy when
external manipulation of the thorax is
the physician's choice of treatment.
Indications for this form of therapy are
described by the American Association
for Respiratory Care (AARC) in the
Clinical Practices Guidelines for
Postural Drainage Therapy' (1991).
According to AARC guidelines, specific
indications for external manipulation of
the thorax include evidence or a
suggestion of retained secretions,
evidence that the patient is having
difficulty with the secretion clearance,
or presence of atelectasis caused by
mucus plugging. In addition, the
Vest™ Airway Clearance System is
also indicated for external manipulation
of the thorax to promote airway
clearance or improve bronchial drainage
for purposes of collecting mucus for
diagnostic evaluation. | Equivalent |
| Prescriptive | Yes | Yes | Identical |
3
Premarket Notification 510(k)
Section 5 – 510(k) Summary
espInnovation RespIn1
| 510(k) Summary |
|---|
| Page 4 of 6 |
| 1/5/2012 |
| 0(k) Sunnial | |||
|---|---|---|---|
| Feature | espinnovation RespIn1 | dvanced Respiratory (Hill-Rom | Commen |
| 510(k) | |||
| The Vest | |||
| echnolog | neumatic percussor, electronic contro | Pneumatic percussor, electronic control | ldentica |
| nvironment | ospital, sub-intensive, clinical offices | ospital, sub-intensive, clinical offices | Identica |
| പ്രഭം: | nome | nome | |
| Power | 0-240 VAC, 50-60 Hz, 4.7 A MAX | Equivalen | |
| tandard | EC 60601-1, IEC 60601-1-2 | 100 V AC to 230 V AC, 50 Hz to 60 Hz 3.4 A @ 100 VAC, 2.0 A @ 230 VAC_ IEC 60601-1, IEC 60601-1-2 | dentica |
| Alarms | None | None | Identica |
| ontrol Unit | Iphanumeri | Alphanumeric | ldentica |
| nterface | |||
| erformance | equencies between 5 - 20 Hz | equencies between 5 – | Equivalen |
| requency | |||
| erformance | ressure applied in 0-10 steps | essure applied in 0-10 steps | dentica |
| Control Unit | Alphanumeric | Alphanumeric | Identical |
|---|---|---|---|
| Interface | |||
| Performance | |||
| Frequency | Frequencies between 5 - 20 Hz | Frequencies between 5 - 20 | Equivalent |
| Performance | |||
| Pressure | Pressure applied in 0-10 steps | ||
| (*max pressure = 50 mbar) | Pressure applied in 0-10 steps | ||
| (*max pressure = 50 mbar) | Identical | ||
| Performance | |||
| Therapy Times | Session therapy from 5 to 30 minutes | ||
| depending upon Dr.'s recommendations | |||
| per patient | From 0 to 60 minutes (* from the Vest | ||
| User Manual: common prescription | |||
| specify a treatment session time to be | |||
| between 10 and 30 minutes) | Equivalent | ||
| Patient Interface | |||
| Patient | |||
| Population | 2 jacket sizes: S/M, L/XXL | ||
| Not explicitly limited | 4 "vest" styles | ||
| Not explicitly limited | Equivalent | ||
| Operating | |||
| Temperature | 10°C to 34°C (50°F to 95 °F) | 50°F to 93°F (10°C to 34°C) | |
| ambient temperature (* from Vest User | |||
| Manual) | Equivalent |
PDF Page 18 of 258
4
510(k) Summary Page 5 of 6 4/15/2012
Differences Between Other Legally Marketed Predicate Devices
The RespIn! 1 is viewed as substantially equivalent to the predicate device because: The percussions provided by the RespIn11 is substantially equivalent to that commonly employed by other powered percussors.
Indications -
The RespIn11 is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy' (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the RespIn11 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.
Prescriptive - The RespIn11 is prescriptive as is the predicate.
Design and Technology - The RespIn11 has equivalent design and features as the predicate and has the identical technology to the predicate.
Performance and Specifications - The RespIn11 has equivalent specifications of performance as the predicate.
Compliance with standards - The RespIn11 and predicate device comply with IEC 60601-1 and IEC 60601-1-2.
Materials -No patient contact materials
Environment of Use -
RespIn11 is for Hospital, sub-intensive, clinical offices, home, which is similar for predicate.
Patient Population -
RespIn 1 is intended for patients that their clinician has determined that this treatment is appropriate. This is similar to the predicate.
5
510(k) Summary Page 6 of 6 4/15/2012
Performance Testing
We have performed performance testing and the results demonstrated that the device performs as intended and is substantially equivalent to the performance of the predicate.
The tests included:
- Frequency Testing ●
- Pressure Testing .
- . Pneumatic Testing
- Fault condition testing .
- IEC 60601-1 Safety .
- IEC 60601-1-2 Electromagnetic Compatibility ●
The results of the testing demonstrate that the RespIn11 performs equivalent to the predicate.
Conclusion
The RespIn11 has been demonstrated to be substantially equivalent to the predicate, The Vest (K024309), in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
RespInnovation SAS C/O Mr. Paul Dryden ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134
JUL 13 2012
Re: K121170
Trade/Device Name: RespIn11 Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: II Product Code: BYI Dated: April 15, 2012 Received: April 17, 2012
Dear Mr. Dryden:
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.
7
Page 2 - Mr. Dryden
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/ucm115809.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 vours.
Nh 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
8
Indications for Use Statement
Page 1 of 1
510(k) Number:
(To be assigned)
Device Name:
RespIn11
Indications for Use:
The RespIn11 is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy' (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the RespInl 1 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.
Prescription Use X (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) S
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schullstrom
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K121170