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.

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).

AI/ML Overview

RespInnovation SAS's RespIn11 device, a powered percussor for High-Frequency Chest Wall Oscillation (HFCWO) therapy, was deemed substantially equivalent to a predicate device, The Vest (K024309), based on its performance testing and comparison of characteristics. The information provided outlines the acceptance criteria and the study that demonstrated the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for RespIn11 were established by demonstrating substantial equivalence to the predicate device, The Vest (K024309). The performance of RespIn11 was compared directly to The Vest in various specifications.

Feature / Acceptance Criteria	RespInnovation RespIn11 Performance	Predicate Device (The Vest, K024309) Performance	Comparison Outcome
Indications for Use	Intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment, following AARC guidelines for retained secretions, secretion clearance difficulty, or atelectasis caused by mucus plugging. Also indicated for collecting mucus for diagnostic evaluation.	Same intended use, following AARC guidelines for retained secretions, secretion clearance difficulty, or atelectasis caused by mucus plugging. Also indicated for collecting mucus for diagnostic evaluation.	Equivalent
Prescriptive Nature	Yes	Yes	Identical
Technology	Pneumatic percussor, electronic control	Pneumatic percussor, electronic control	Identical
Environment of Use	Hospital, sub-intensive, clinical offices, home	Hospital, sub-intensive, clinical offices, home	Identical
Power	100-240 VAC, 50-60 Hz, 4.7 A MAX	100 V AC to 230 V AC, 50 Hz to 60 Hz, 3.4 A @ 100 VAC, 2.0 A @ 230 VAC	Equivalent
Standards Compliance	IEC 60601-1, IEC 60601-1-2	IEC 60601-1, IEC 60601-1-2	Identical
Alarms	None	None	Identical
Control Unit Interface	Alphanumeric	Alphanumeric	Identical
Performance (Frequency)	Frequencies between 5 - 20 Hz	Frequencies between 5 - 20 Hz	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 (common prescription specifies treatment between 10 and 30 minutes)	Equivalent
Patient Interface (Jacket Sizes)	2 jacket sizes: S/M, L/XXL	4 "vest" styles	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	Equivalent
Patient Population	Intended for patients whose clinician has determined this treatment is appropriate.	Similar to the predicate, for patients whose clinician has determined this treatment is appropriate.	Similar
User Interface	Alphanumeric control unit	Alphanumeric control unit	Identical
Safety and EMC	Compliance with IEC 60601-1 (Safety) and IEC 60601-1-2 (Electromagnetic Compatibility)	Compliance with IEC 60601-1 (Safety) and IEC 60601-1-2 (Electromagnetic Compatibility)	Identical

2. Sample Size and Data Provenance for Test Set

The device's performance was evaluated through various engineering and regulatory compliance tests. The document does not specify a separate "test set" sample size in terms of patient data or clinical trials, as the primary method of proving substantial equivalence was through a comparison of technical specifications and performance characteristics against a legally marketed predicate device.

The study presented here is a premarket notification (510(k)) summary, which typically relies on comparisons to predicate devices and engineering bench testing rather than extensive clinical studies with human subjects. Thus, there is no specified sample size for a test set based on patient data, nor information on data provenance (country of origin, retrospective/prospective).

The performance testing mentioned ("Frequency Testing," "Pressure Testing," "Pneumatic Testing," "Fault condition testing," "IEC 60601-1 Safety," "IEC 60601-1-2 Electromagnetic Compatibility") would have been conducted on the device itself, likely in a laboratory setting.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This type of submission (510(k) for a powered percussor) does not typically involve human expert adjudication for image analysis or diagnostic tasks to establish ground truth in the way AI/CADe devices do. The "ground truth" here is based on engineering specifications, regulatory standards compliance, and the established performance of the predicate device.

4. Adjudication Method for Test Set

Not applicable. As there was no test set involving human interpretation where ground truth needed to be established through expert consensus, no adjudication method was used or described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted or described in this 510(k) summary. This type of study focuses on the impact of AI on human reader performance, which is not relevant for a powered percussor device that primarily performs a physical therapy.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Yes, in a sense, a "standalone performance" was assessed. The engineering and compliance tests (Frequency, Pressure, Pneumatic, Fault, Safety, EMC testing) evaluate the device's inherent functional capabilities and adherence to standards independently. The device itself (RespIn11) is the "algorithm" in this context, performing its intended function without requiring human interpretation or decision-making as part of its core therapeutic mechanism. The summary states: "The results of the testing demonstrate that the RespIn11 performs equivalent to the predicate."

7. Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence was based on:

Predicate Device Specifications: The established performance parameters and technical specifications of the legally marketed predicate device, The Vest (K024309).
Engineering Standards: Compliance with recognized international standards such as IEC 60601-1 (Safety) and IEC 60601-1-2 (Electromagnetic Compatibility).
Functional Testing: The results of direct performance tests (frequency, pressure, pneumatic, fault conditions) demonstrating the device's physical output met established operating ranges and safety requirements.

8. Sample Size for the Training Set

Not applicable. As this device is a physical therapy device and not an AI/machine learning algorithm that requires training data, there is no "training set" in the context of machine learning.

9. How Ground Truth for Training Set Was Established

Not applicable, for the same reasons as point 8.

Summary

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510(k) Summary
Page 1 of 64/15/2012		K 121170

RespInnovation SAS611 Chemin de l'AdrechSEILLANS, 83440 France	Tel - +33 6 17 81 08 01Fax - +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 PercussorCFR 868.5 665Class II
Device:	RespIn11
Predicate Device:	Advanced Respiratory - The Vest K024309

Device Description:

Indications for Use:

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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.

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remarket Notification 510(
ection 5 -- 510(k) Summary

espInnovation RespIn1

510(k) Summary

able of Compar

Table of ComparisonFeature	Respinnovation RespIn11510(k)	Advanced Respiratory (Hill-Rom) -The Vest510(k) K024309	Comment
Indications	The Respln11 is intended to provideairway clearance therapy when externalmanipulation of the thorax is thephysician's choice of treatment.Indications for this form of therapy aredescribed by the American Associationfor Respiratory Care (AARC) in theClinical Practices Guidelines forPostural Drainage Therapy' (1991).According to AARC guidelines, specificindications for external manipulation ofthe thorax include evidence or asuggestion of retained secretions,evidence that the patient is havingdifficulty with the secretion clearance,or presence of atelectasis caused bymucus plugging. In addition, theRespIn11 is also indicated for externalmanipulation of the thorax to promoteairway clearance or improve bronchialdrainage for purposes of collectingmucus for diagnostic evaluation.	The intended use of the ModifiedVest™ Airway Clearance System is thesame as the predicate device, which is toprovide airway clearance therapy whenexternal manipulation of the thorax isthe physician's choice of treatment.Indications for this form of therapy aredescribed by the American Associationfor Respiratory Care (AARC) in theClinical Practices Guidelines forPostural Drainage Therapy' (1991).According to AARC guidelines, specificindications for external manipulation ofthe thorax include evidence or asuggestion of retained secretions,evidence that the patient is havingdifficulty with the secretion clearance,or presence of atelectasis caused bymucus plugging. In addition, theVest™ Airway Clearance System isalso indicated for external manipulationof the thorax to promote airwayclearance or improve bronchial drainagefor purposes of collecting mucus fordiagnostic evaluation.	Equivalent
Prescriptive	Yes	Yes	Identical

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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
PerformanceFrequency	Frequencies between 5 - 20 Hz	Frequencies between 5 - 20	Equivalent
PerformancePressure	Pressure applied in 0-10 steps(*max pressure = 50 mbar)	Pressure applied in 0-10 steps(*max pressure = 50 mbar)	Identical
PerformanceTherapy Times	Session therapy from 5 to 30 minutesdepending upon Dr.'s recommendationsper patient	From 0 to 60 minutes (* from the VestUser Manual: common prescriptionspecify a treatment session time to bebetween 10 and 30 minutes)	Equivalent
Patient InterfacePatientPopulation	2 jacket sizes: S/M, L/XXLNot explicitly limited	4 "vest" stylesNot explicitly limited	Equivalent
OperatingTemperature	10°C to 34°C (50°F to 95 °F)	50°F to 93°F (10°C to 34°C)ambient temperature (* from Vest UserManual)	Equivalent

PDF Page 18 of 258

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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 -

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.

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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.

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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

Regulation Number and Section

§ 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).