The Electro Flo® 6 Airway Clearance System is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.

The device is intended for home or institutional use by patients weighing at least 23 Kg.

Device Description

The Electro Flo® 6 Airway Clearance System is a High Frequency Chest Wall Oscillation System (HFCWO), including all accessories and supplies.

Electro Flo® 6 Airway Clearance System comprises:

An electrically powered Control Box with a power switch on the back and two knobs on the front: one knob provides five intensity settings, and the other provides six frequency settings,
The Power Head, connected by a cable to the Control Box, ●
The Carrying Case,
The Information Manual, ●
The Optional Self-Administrator® Strap that can hold the Electro Flo® 6 system Power Head and enable a patient to apply therapy to the back, unassisted.

The Electro Flo® 6 Airway Clearance System's operating mechanism is an electromechanical "hammer and anvil"; the hammer is the handheld body of the Power Head, and the anvil is the surface of the Power Head that is held in contact with the chest. Repeated electrical pulses from the Control Box separate the hammer and anvil. The Frequency knob of the Control Box controls the repetition rate, and the Power knob controls the pulse duration; there are 30 combinations.

When each electrical pulse ends, the force applied by the therapist's hand forces the hammer through the gap until it strikes the anvil and delivers a mechanical impulse to the chest. The resulting pressure wave radiates into the chest cavity to shake mucus loose. Because the energy transmitted to the chest vibrations is a multiple of the force applied by hand, the Electro Flo® 6 system acts as a "force multiplier" that provides the therapist with additional control.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Electro Flo® 6 Airway Clearance System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies or extensive standalone testing.

Therefore, many of the requested details, such as a table of acceptance criteria with reported performance, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, and detailed standalone algorithm performance, are not applicable or not present in this type of FDA submission document.

Here's a breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain a table of specific performance acceptance criteria for clinical outcomes or diagnostic accuracy per se. Instead, it focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of indications for use, intended use, and technological characteristics.

The "performance data" section (Section XI) refers to bench testing to characterize mechanical performance and verify its nature as a high-frequency chest wall oscillator.

Performance Metric (Bench Data)	Reported Performance (Qualitative)
Mechanism Category	At all settings, most of the power generated was in the acoustic frequency range of 16 - 127 Hz, consistent with High Frequency Chest Wall Oscillation (HFCWO).
Control of Power Output	Varying the static load could control the power output, as predicted by the force multiplier design principle.

2. Sample Size for the Test Set and Data Provenance:

Test Set Sample Size: Not applicable. The "test set" here refers to bench testing of the device itself, not a clinical patient cohort. The testing involved various settings (frequency, power, static loads) on a single physical device within a controlled laboratory setup.
Data Provenance: The bench testing was conducted by Aeromethod Precision Engineering and Manufacturing, San Diego, CA, and analysis was performed by BioMedical Strategies, White River Junction, VT. This is laboratory-generated data, not from patient populations. It is inherently "prospective" in the sense of being planned testing, but not clinical.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. For this type of mechanical device and 510(k) submission, "ground truth" is established through engineering and physics principles, and measured physical parameters, not expert human interpretation of complex data (like radiology images). The objective measurements from the bench test served as the data.

4. Adjudication Method for the Test Set:

Not applicable. There was no "adjudication" necessary as the test involved objective mechanical measurements.

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

Not applicable. This device is a therapeutic/clearance system, not a diagnostic AI tool, so a MRMC study is not relevant to its performance demonstration. The submission focuses on comparison to predicate mechanical devices.

6. Standalone (i.e., algorithm only without human-in-the-loop performance):

Yes, in the context of mechanical performance. The "bench data" section describes the standalone mechanical characterization of the device itself.
The study demonstrated that the device, on its own when operated, functions as a high-frequency chest wall oscillator and its power output can be controlled.

7. Type of Ground Truth Used:

Engineering/Physics Measurements: The ground truth for the bench testing was objective, quantitative measurements of mechanical output (vibration data, power spectra) collected from the device under controlled laboratory conditions, analyzed based on established engineering and physics principles.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set" of data in the computational sense. Its design and development would have involved engineering principles and iterative testing, but not "training data" in the AI context.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" in the AI/ML sense for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 12, 2021

Med Systems, Inc. % Frederick Cahn Principal BioMedical Strategies 133 Colonial Dr. White River Junction, Vermont 05001

Re: K201490

Trade/Device Name: Electro Flo® 6 Airway Clearance System Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: Class II Product Code: BYI Dated: August 26, 2020 Received: September 8, 2020

Dear Frederick Cahn:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brandon L. Blakely, Ph.D. Acting Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K201490

Device Name

Electro Flo® 6 Airway Clearance

Indications for Use (Describe)

The device is intended for home or institutional use by patients weighing at least 23 Kg.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
--------------------------------------------------------------------------------------	-----------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

I. SUBMITTER: Med Systems, Inc. 2631 Ariane Drive San Diego, CA 92117
Contact: Susan B. Davis, CEO (858) 483-9671

II. Electro Flo® 6 Airway Clearance System (K201490) DEVICE: Classification Code: BYI, "Percussor, Powered-Electric" Regulation 21 CFR 868.5665, "Powered Percussor" Class II

III. PREDICATE DEVICES

Primary Predicate: Monarch Airway Clearance System (K173603) Classification Code: BYI, "Percussor, Powered-Electric" Regulation 21 CFR 868.5665, "Powered Percussor" Class II

Reference Predicate: Med Systems Electro Flo Percussor Model 5000 (K031876) Classification Code: BYI, "Percussor, Powered-Electric" Regulation 21 CFR 868.5665, "Powered Percussor" Class II

IV. DATE February 11, 2021

V. DESCRIPTION

Device Identification

The Electro Flo® 6 Airway Clearance System is a High Frequency Chest Wall Oscillation System (HFCWO), including all accessories and supplies.

Electro Flo® 6 Airway Clearance System comprises:

An electrically powered Control Box with a power switch on the back and two knobs on the front: one knob provides five intensity settings, and the other provides six frequency settings,
The Power Head, connected by a cable to the Control Box, ●
The Carrying Case,
The Information Manual, ●

{4}------------------------------------------------

The Optional Self-Administrator® Strap that can hold the Electro Flo® 6 system Power Head and enable a patient to apply therapy to the back, unassisted.

Device Characteristics and Environment of Use

The Electro Flo® 6 Airway Clearance System is durable medical equipment for home use. It is non-sterile and has no software or patient-contacting materials. Treatment sessions can last up to 20 minutes.

Device Description

VI. INTENDED USE

The Electro Flo® 6 System is designed for home or institutional use and provides HFCWO with controllable frequency and intensity similar to the hand percussion therapy provided by a therapist. The chest vibrations target and loosen thick, sticky mucus in the lungs so that the patient can clear it by huffing, coughing, or suction. The Electro Flo® 6 system has advantages over hand percussion because patients can administer therapy without assistance, because it does not suffer fatigue, and because it can operate at higher frequencies and force than a human therapist.

INDICATIONS FOR USE VII.

The Electro Flo® 6 Airway Clearance System is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging. The device is intended for home or institutional use for patients weighing at least 23 Kg.

VIII. CONTRAINDICATIONS

The Electro Flo® 6 system is not intended for the following classes of patients:

Infants or children weighing less than 50 pounds (23 Kg). ●
Patients with pacemakers or other implanted medical devices in or near the ● chest.

{5}------------------------------------------------

. Patients with brittle bones, broken ribs or severe osteoporosis, severe calcium deficiencies, or severe osteoporosis.
Patients with collapsed lungs, pulmonary embolism, lung abscess, or ● tuberculosis.
Patients with angina, arrhythmia, aneurism in the head, neck, chest, or abdomen. ●
Patients with severe asthma. ●
Patients with injuries to the chest wall, spine, head, or neck that could be ● exacerbated by strong vibrations.

WARNINGS AND PRECAUTIONS IX.

WARNING - To avoid the risk of electrocution, fire, or serious injuries:

Keep the Electro Flo® 6 system out of the reach of children. ●
Do not use the Electro Flo® 6 system with, near, or in water. ●
Do not use the Electro Flo® 6 system near flammable vapors or fire. ●
Do not insert any object into any opening on the Electro Flo® 6 system.
Inspect the Control Box and Power Head before use. Do not use the Electro ● Flo® 6 system if there is damage to the power cord or any other part of the device.

WARNING - Do not use the Electro Flo 6 while you are experiencing conditions such as:

Recent heart attack.
Recent surgery to the chest, abdomen, head, or neck. ●
Bleeding from the lungs or coughing up blood. ●
Open wounds or burns.
Vomiting.
. Pressure in the skull.
Intense pain. ●
Active hemorrhage.
Acute asthma.

CAUTION

The Electro Flo® 6 system is available by prescription only and is intended . solely for the person for whom it was prescribed and only for the prescribed use.
. Users should always observe all contraindications, warnings, and cautions listed in the Information Manual.
Do not use the Electro Flo® 6 system directly after eating. ●
Do not percuss over bare skin. ●
Do not percuss directly on the shoulder blade, collar bone, spine, breastbone (sternum), or breasts.
Percussion should not hurt. If it does, STOP. Reduce the hand pressure on the ● Power Head's rear cover or reduce the power setting on the Control Box.
Do not place Self-Administrator® strap over the head or around the neck.

{6}------------------------------------------------

NOTICES

To avoid damage or excessive wear:

Do not unplug or switch off the unit until the cool-down is complete. ●
Do not block the fan vent with hand or fingers.
. Limit percussion to 20 minutes maximum per session to avoid overheating the system.
Avoid using the unit in a dusty environment or laying the device on a blanket or ● carpet as lint may be drawn in by the fan and damage the unit.
. Do not spray disinfectant on the Control Box and device; fluid could enter the device and damage the system.
If any interferences from a television, computer, cell phone, or other electronic ● device are experienced when using the Electro Flo® 6 system, move the Electro Flo® 6 system to another room or location or turn off the interfering device.

COMPARISONS WITH THE PREDICATE DEVICES X.

Comparison with Primary Predicate

We compare the Electro Flo® 6 Airway Clearance System to a legally marketed predicate device: The Monarch Airway Clearance System (K173603). The predicate Monarch Airway Clearance System is classified in product code BYI, "Percussor, Powered-Electric", classification 868.5665, "Powered Percussor." The devices have identical indication statements.

Comparison of Indication Statements

Electro Flo® 6 Airway	Monarch Airway	Commentary
Clearance System	Clearance System
The Electro Flo® 6 Airway ClearanceSystem is intended to provide AirwayClearance Therapy and promote bronchialdrainage where external manipulation of thethorax is the physician's choice oftreatment. It is indicated for patients havingdifficulty with secretion clearance, or thepresence of atelectasis caused by mucusplugging.	The Monarch product is intended toprovide Airway Clearance Therapyand promote bronchial drainage whereexternal manipulation of the thorax isthe physician's choice of treatment. Itis indicated for patients havingdifficulty with secretion clearance, orthe presence of atelectasis caused bymucus plugging.	The indicationsstatements areidentical.

The devices are both electromechanical devices intended for airway clearance and have substantially equivalent technology, as shown in the following table:

{7}------------------------------------------------

Characteristic	Electro Flo® 6 AirwayClearance System	Monarch AirwayClearance System	Commentary
Mechanism	Variable frequencyelectromechanicalactuators.	Variable frequencyelectromechanicalactuators.	Substantially equivalent:both vibrate the chest.
Anatomicpositions of theactuator(s) on thethorax	Determined by thetherapist or patientmanually or aided by arepositionable fabric self-administrator strap.	Determined by the eightpockets at fixed anatomiclocations in a fabric vest.	Substantially equivalent:The Electro Flo® 6 systemcan be positioned at thesame anatomic locations asthe Monarch System'sactuators, but it is notlimited to those positions.
Actuator motion	The electromechanicalactuator of the ElectroFlo® 6 system provides avibratory, shaking motionto the body.	The electromechanicalactuator of the Monarchsystem provides avibratory, shaking motionto the body.	Substantially equivalent:
Type of device	Durable medicalequipment for home use.	Durable medicalequipment for home use.	Substantially equivalent.
ControllerFrequency range	5 — 25 Hz	5-20 Hz	Substantially equivalent.
Power supply	120 V, 60 Hz AC	Rechargeable battery.	Substantially equivalent.Both devices are electricallypowered
Weight	1.5 Kg (Power Head)	6 Kg (vest)	The lighter weight of theElectro Flo® 6 systemenables it to be easilyhandheld. The Monarch vestsystem is worn on the body,making the higher weighteasily tolerated.

Comparison of Technical Characteristics

Comparison with Reference Predicate

We compare the Electro Flo® 6 Airway Clearance System our previously cleared device: The Electro Flo Percussor Model 5000 (K021876). The Electro Flo Percussor Model 5000 is also classified in product code BYI, "Percussor, Powered-Electric", classification 868.5665, "Powered Percussor."

{8}------------------------------------------------

Electro Flo® 6 AirwayClearance System	Electro Flo Percussor Model 5000	Commentary
The Electro Flo® 6 AirwayClearance System isintended to provide AirwayClearance Therapy andpromote bronchial drainagewhere external manipulationof the thorax is thephysician's choice oftreatment. It is indicated forpatients having difficultywith secretion clearance, orthe presence of atelectasiscaused by mucus plugging.	The intended use of the Med Systems Electro FloPercussor Model 5000 is the same as the predicate device,which is to provide airway clearance therapy whenexternal manipulation of the thorax is the physician'schoice of treatment. Indications for this form of therapyare described by the American Association forRespiratory Care (AARC) in the Clinical PracticesGuidelines for Postural Drainage Therapy (1991).According to AARC guidelines, specific indications forexternal manipulation of the thorax include evidence or asuggestion of retained secretions, evidence that the patientis having difficulty with the secretion clearance, orpresence of atelectasis caused by mucus plugging. Inaddition, the Med Systems Electro Flo Percussor Model5000 is also indicated for external manipulation of thethorax to promote airway clearance or improve bronchialdrainage for purposes of collecting mucus for diagnosticevaluation.	Substantiallyequivalent.

The devices have the same intended use and are the identical technologically, as shown in the following table:

Characteristic	Electro Flo® 6 AirwayClearance System	Electro Flo PercussorModel 5000	Commentary
Mechanism	Variable frequencyelectromechanicalactuators.	Variable frequencyelectromechanicalactuators.	Identical
Anatomicpositions of theactuator(s) on thethorax	Determined by thetherapist or patientmanually or aided by arepositionable fabric self-administrator strap.	Determined by thetherapist or patientmanually or aided by arepositionable fabric self-administrator strap.	Identical
Actuator motion	The electromechanicalactuator provides avibratory, shaking motionto the body.	The electromechanicalactuator provides avibratory, shaking motionto the body.	Identical
Type of device	Durable medicalequipment for home use.	Durable medicalequipment for home use.	Identical
ControllerFrequency range	5 - 25 Hz	5 - 25 Hz	Identical
Power supply	120 V, 60 Hz AC	120 V, 60 Hz AC	Identical
Weight	1.5 Kg (Power Head)	1.5 Kg (Power Head)	Identical

Comparison of Technical Characteristics

XI. PERFORMANCE DATA

Safety and Electromagnetic Radiation

The Electro Flo® 6 system meets the following safety and electromagnetic radiation standards:

{9}------------------------------------------------

Standard Reference	Titles
UL 60601-1:2003Ed.1 +R:26Apr2006	Medical Electrical Equipment - Part 1: General Requirements forSafety
CSA C22.2 #601.1:1990Ed.1+G1;S1;A2;G2]	Medical Electrical Equipment - General RequirementsFor Safety (R2005)
EN60601-1-2	Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance
EN55011 Class A	Industrial, scientific and medical equipment- Radio-frequencydisturbance characteristics, limits, and methods of measurement
FCC Part 15 Subpart B	Unintentional radiators

Bench Data

Med Systems. Inc. contracted with Aeromethod Precision Engineering and Manufacturing, San Diego, CA, to conduct testing to characterize the Electro Flo® 6 system's mechanical performance. The test objectives were to verify and document that the Electro Flo® 6 system can be described as a high frequency chest wall oscillator (HFCWO) and to demonstrate that the output can be controlled by the force applied by the user to the device, as expected from its force multiplier design principle.

The test assembly was designed to collect one-dimensional vibration data along the axis of the Power Head. The Power Head body was rigidly attached to a linear bearing that could slide along a linear guide track. An elastic material pressed on the Power Head created a Static Load to simulate hand pressure. The Power Head's anvil end was attached to a plastic cvlinder in contact with a load cell that measured the waveforms at a sampling rate of 1000 Hz over a one-second interval. Waveforms were collected at a full factorial sampling with three frequency settings (1,3,6) on the Control Box, three power settings (1,3,5) on the Control Box, and three static loads of one, three, and five pounds of force applied to the Power Head. BioMedical Strategies, White River Junction, VT computed power spectra of the waveforms in arbitrary power units.

Results

At all settings, most of the power generated by the Electro Flo® 6 system was in the acoustic frequency range of 16 - 127 Hz. Varying the static load could control the power output, as predicted by the force multiplier design principle.

Comparison with Predicates

The Electro Flo and the Monarch primary predicate have variable frequency and power output. The Electro Flo has additional control over power output via hand pressure. They operate in overlapping frequency ranges.

The Electro Flo 6 and the reference predicate Electro Flo 5000 are the identical hardware, with the same frequency range, power, and controllability.

SUBSTANTIAL EQUIVALENCE CONCLUSION XII.

Substantial Equivalence between the Electro Flo® 6 Airway Clearance System and the primary predicate Monarch Airway Clearance System is demonstrated by:

Identical indications statements. ●
Identical intended use. ●

{10}------------------------------------------------

Substantially equivalent technological characteristics: .
- o Both employ electromechanical actuators;
- Both treat the same anatomic locations of the thorax; O
- Both provide a vibratory, shaking motion to the body; and o
- o Both operate over the same fundamental frequency range.

Substantial Equivalence between the Electro Flo® 6 Airway Clearance System and the reference predicate Electro Flo 5000 system is demonstrated by:

Substantially equivalent indications statements. ●
. Identical intended use.
Identical technological characteristics. ●

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).