The intended use of the Med Systems Electro Flo Percussor Model 5000 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 (1) (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 Med Systems Electro Flo Percussor Model 5000 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

The Model 5000 "Electro Flo" Percussor is just an electrically cycled hammer. It has the exact same function and operation as the Model 2500 "Fluid Flo" percussor that our company has manufactured for hospitals since 10-23-82 under 510(k) number K802399. The "Fluid Flo" percussor is cycled by an oscillating pneumatic valve whereas the "Electro Flo" percussor is cycled electronically.

AI/ML Overview

This document describes the Med Systems Electro Flo Percussor Model 5000, a powered chest percussor. The submission focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance metrics in the way a diagnostic AI device submission would.

Therefore, many of the requested categories for AI device evaluation are not applicable or cannot be extracted from this document, as this is a 510(k) for a physical medical device, not an AI/software device.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

This submission does not contain specific performance acceptance criteria or reported device performance data in the traditional sense (e.g., sensitivity, specificity, AUC) because it's a submission for a physical medical device demonstrating substantial equivalence. The "performance" is implicitly tied to its functional similarity to predicate devices.

The table below summarizes the comparison to predicate devices, which serves as the basis for demonstrating substantial equivalence. The new device is accepted if it performs "as safe and effective as the predicate devices," primarily by matching their indications for use and having comparable technical specifications.

Feature	Predicate Device Performance / Acceptance Criteria (implied based on predicate)	Reported Device Performance (Med Systems 5000 Electro Flo)
INDICATION for USE	Same as predicate (respiratory secretion clearance for COPD, cystic fibrosis, emphysema, atelectasis and other obstructive lung conditions)	SAME
Power and Control	Pneumatic Solenoid, Electric Solenoid, or Electric Motor (from predicates)	Electronic Solenoid
Speed	5 to 60 Hz (range from predicates)	5 to 25 Hz
Weight	1.5 to 5 pounds (range from predicates)	1.5 pounds
Energy source	Pneumatic or 120 v 60 Hz AC (from predicates)	120 v 60 Hz AC

Note: The "acceptance criteria" here are implicit in the comparison to the predicate devices. The new device is considered acceptable if its features and indications for use are equivalent to or fall within the established safe and effective parameters of the predicate devices.

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

Not applicable. This is not a study involving a "test set" of patient data for an AI/diagnostic device. The submission relies on "bench and electrical safety testing data" and comparison of technical specifications to predicate devices.

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

Not applicable. No "ground truth" for a test set in the context of diagnostic performance was established for this device submission.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication was used.

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

Not applicable. This is not an AI device or a diagnostic device where human reader performance is evaluated.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm. Bench and electrical safety testing were performed, but these are not "standalone" performance evaluations in the AI context.

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence claim is primarily the established safety and effectiveness of the legally marketed predicate devices. The new device's performance is measured against the specifications and known clinical utility of these predicates through a comparison of technological characteristics and intended use.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. No training set was used.

Summary

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NOV 2 1 2003

K031876

EXHIBIT 2 510(k) Summary of Safety and Effectiveness

MED SYSTEMS 2631 Ariane Drive San Diego, CA 92117 Phone 800.345.9061 Fax 858.483.9827 medsystems.com

June 9, 2003 Contact: Jim Davis, President

1. Identification of the Device: Proprietary-Trade Name: Med Systems Electro Flo Percussor Model 5000 Classification Name: Powered Chest Percussor Product Code BYI Common/Usual Name: Powered Chest Percussor
1. Equivalent legally marketed devices: This product is similar in function to the Model 2500 "Fluid Flo" percussor that our company has manufactured for hospitals since 10-23-82 under 510(k) number K802399. (Company formerly known as Medical Equipment Development Co., Inc.) as well as PURITAN BENNETT McSHIRLEY | K801982 and SOUTHWEST MEDICAL MFG. INC (STROM) K821265, K821570 K813438
1. Indications for Use (intended use) : The intended use of the Med Systems Electro Flo Percussor Model 5000 is 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 Med Systems Electro Flo Percussor Model 5000is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.

(1). Bronchial Hygiene Guidelines Committee, American Association for Respiratory Care. AARC Clinical Practice Guideline: Postural Drainage Therapy. Respiratory Care 1991: 36: 1418 - 1426

1. Description of the Device:. The Model 5000 "Electro Flo" Percussor is just an electrically cycled hammer. It has the exact same function and operation as the Model 2500 "Fluid Flo" percussor that our company has manufactured for hospitals since 10-23-82 under 510(k) number K802399. The "Fluid Flo" percussor is cycled by an oscillating pneumatic valve whereas the "Electro Flo" percussor is cycled electronically.

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Feature	Med Systems2500 Fluid FloK802399	PURITANBENNETTMcSHIRLEYK801982	SOUTHWESTMEDICALMFG. INCSTROMK821265,K821570 K813438	Med Systems5000 Electro Flo(Thissubmission)
INDICATIONFor USE	For respiratorysecretionclearance forCOPD, cysticfibrosis,emphysema,atelectasis andother obstructivelung conditions	SAME	SAME	SAME
Power andControl	PneumaticSolenoid	Electric Solenoid	Electric Motor	ElectronicSolenoid
Speed	5 to 15 Hz	6 to 60 Hz	5 to 60 Hz	5 to 25 Hz
Weight	1.5 pounds	3 pounds	5 pounds	1.5 pounds
Energy source	Pneumatic	120 v 60 Hz AC	120 v 60 Hz AC	120 v 60 Hz AC

5. Substantial Equivalence Chart

1. Conclusion
  After analyzing bench and electrical safety testing data, it is the conclusion of MED Systems that the Med Systems Electro Flo Percussor Model 5000 is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and head. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2003

MED Systems C/O Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K031876

Trade/Device Name: Electro Flo Percussor, Model 5000 Regulation Number: 21 CFR 868.5665 Regulation Name: Percussor, Powered-Electric Regulation Class: II Product Code: BYI Dated: August 20, 2003 Received: August 25, 2003

Dear Mr. Kamm:

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.

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Page 2 - Mr. Daniel Kamm, P.E.

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 (OS) 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 (301) 594-4646. 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/dsma/dsmamain.html

Sincerely vours.

Chiu Lin, Ph.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

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j) Indications for Use

510(k) Number_ ماركا (13) 510

Device Name: Med Systems Electro Flo Percussor Model 5000

Indications for Use:

(1). Bronchial Hygiene Guidelines Committee, American Association for Respiratory Care. AARC clinical practice guideline: postural drainage therapy. Respiratory Care 1991; 36: 1418 - 1426.

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	X
OR	Over the Counter Use ______
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:	K031876

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).