FREQUENCER MODEL V2X

K100749 · Dymedso, Inc. · BYI · Aug 31, 2010 · Anesthesiology

Device Facts

• Record ID: K100749
• Device Name: FREQUENCER MODEL V2X
• Applicant: Dymedso, Inc.
• Product Code: BYI · Anesthesiology
• Decision Date: Aug 31, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5665
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Frequencer™ v2x provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of chest physiotherapy by providing a convenient method of external thorax manipulation. It is indicated for patients having respiratory ailments which involve defective mucociliary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchitis, bronchiectasis, ciliary dyskinesia syndromes, asthma, muscular dystrophy, neuromuscular degenerative disorders, post-operative atelectasis and thoracic wall defects. Indications for this form of therapy are described in the Clinical Practice Guidelines for Postural Drainage Therapy of the American Association for Respiratory Care (AARC) published in 1991. This particular device provides a gentler, less painful form of therapy than the traditional "clapping" method of postural drainage therapy, allowing it to be used on patients who cannot be treated by clapping. The Frequencer™ v2x is only intended for use in hospitals and clinics.

Device Story

Frequencer™ v2x is a powered percussor for airway clearance therapy. Device uses electro-acoustical transducer (Power Head) placed on patient's chest to induce oscillatory sound waves (20-65 Hz) via frequency generator. Vibrations loosen mucus deposits to promote bronchial drainage. Used in hospital/clinic settings by healthcare providers. Provides gentler alternative to manual 'clapping' (postural drainage). Output is mechanical vibration; provider monitors patient response to therapy. Benefits include improved mucus clearance for patients with respiratory conditions.

Clinical Evidence

No new clinical data provided for v2x. Relies on clinical data from original Frequencer™ demonstrating comparable sputum weights to Conventional Chest Physiotherapy (CCPT) in cystic fibrosis subjects. Bench testing showed v2x produces slightly lower maximum force than predicate, both lower than CCPT. In vitro capillary tube testing showed increased mucus flow rates compared to no treatment.

Technological Characteristics

Powered percussor; electro-acoustical transducer; 20-65 Hz frequency range. Housing/adapters: polycarbonate/ABS blend. User interface: touch screen. Electrical safety: IEC 60601-1; EMC: IEC 60601-1-2. Multi-patient use supported by disposable filters.

Indications for Use

Indicated for patients with respiratory ailments involving defective mucociliary clearance, including cystic fibrosis, chronic bronchitis, bronchiectasis, ciliary dyskinesia, asthma, muscular dystrophy, neuromuscular degenerative disorders, postoperative atelectasis, and thoracic wall defects.

Regulatory Classification

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.

Predicate Devices

• Frequencer™ 1001 (K063645)

Submission Summary (Full Text)

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KY00749

## l.510(k) Summary

This summary of safety and effectiveness is being submitted in accordance AUG 3 1 2010 with the requirements of SMDA 1990 and 21 CFR Part 807.92.

| Date of Submission:<br>Submitter:<br>Address: | August 31, 2010<br>DYMEDSO, Inc.<br>901A, Boul. Du Curé Boivin<br>Boisbriand, Québec J7G 2S8<br>CANADA |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Establishment Registration #: | 3004365906 |
| Contact: | Yvon Robert, President |
| Phone: [phone] | Fax: [phone] |
| Proprietary Device Name: | Frequencer™ v2x |
| Common Name of Device: | Airway Clearance Device |
| Classification Name: | Percussor, Powered-Electric |
| Device Class: | 2 |
| Product Code: | BYI |

Predicate Device: K063645 - Frequencer™ 1001

### Description:

The Frequencer™ v2x provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. It induces oscillatory sound waves in the chest by means of an electro-acoustical transducer (hereafter referred to as the "Power Head") which is placed externally on the patient's chest. The Power Head is connected to a frequency generator which is capable of producing frequencies between 20 and 65 Hz. The Power Head induces sound waves in the patient's chest which are effective in loosening mucus deposits. This model is intended for use in hospital and clinic settings only and disposable filters are available for multi-patient use.

### Indications for Use:

The Frequencer™ v2x provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of chest physiotherapy by providing a convenient method of external thorax manipulation.

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# Dymedso Frequencer v2x™ Powered Percussor

It is indicated for patients having respiratory ailments which involve defective mucociliary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchitis, bronchiectasis, ciliary dyskinesia syndromes, asthma, muscular dystrophy, neuromuscular degenerative disorders, postoperative atelectasis and thoracic wall defects. Indications for this form of therapy are described in the Clinical Practice Guidelines for Postural Drainage Therapy of the American Association for Respiratory Care (AARC) published in 1991. This particular device provides a gentler, less painful form of therapy than the traditional "clapping" method of postural drainage therapy, allowing it to be used on patients who cannot be treated by clapping.

The Frequencer™ v2x is only intended for use in hospitals and clinics.

### Comparison of Technological Characteristics:

The Frequencer™ v2x is identical to the predicate device in terms of indications for use, contra-indications, acoustic operating principle and basic electronics. The polymer material used for the housing and adapters has been changed from a polyurethane to a polycarbonate/ABS blend. In addition, the user interface no longer consists of touch pad buttons and an LCD display but is now a touch screen. The device is only intended for use in hospitals or clinics as opposed to the predicate, which was intended for home or residential environments.

### Performance Testing

The device was tested in accordance with IEC 60601-1 for electrical safety and tested in accordance with IEC 60601-1-2 for electromagnetic radiation. with acceptance criteria consistent with a Type A device for non-domestic environments such as hospitals or clinics. Software verification and validation testing has also been performed on the device.

Performance bench testing was conducted to determine the maximum force applied by the device in comparison to the predicate device. The testing demonstrated a similar, though slightly lower maximum applied force in comparison to the predicate. Both devices still provide considerably lower forces than applied during Conventional Chest Physiotherapy (CCPT). The lower forces produced by the Frequencer™ may be able to provide a gentler treatment compared to CCPT. Clinical testing conducted on the original Frequencer™ have demonstrated comparable sputum weights produced after treatment with the Frequencer™ in comparison to Conventional Chest Physiotherapy (CCPT) in subjects with Cystic Fibrosis (CF). In vitro flow rate measurements of mucus through a capillary tube also demonstrated higher flow rates of mucus when using the Frequencer compared to no treatment.

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# Dymedso Frequencer v2x™ Powered Percussor

## Conclusions:

The proposed Frequencer™ v2x has the identical indications, operating principle and electronics as the predicate device Frequencer™ 1001. The only differences are the polymer housing material, user interface, and intended environments. In addition, disposable filters are available for use in multi-patient settings. The performance testing provides validation of new features of this device and demonstrates similar performance characteristics to the predicate device. Thus, the proposed Frequencer™ v2x is substantially equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human figures connected at the shoulders, with their arms raised in a gesture of support or unity. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dymedso, Incorporated C/O Ms. Jean Bigoney Springfield Metallurgical Services, Incorporated 127 Main Street Springfield, Vermont 05156-0826

AUG 3 1 2010

Re: K100749

Trade/Device Name: Frenquencer" v2x Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: II Product Code: BYI Dated: August 2, 2010 Received: August 5, 2010

Dear Ms. Bigoney:

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 Eederal Register.

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### Page 2- Ms. Bigoney

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

hh 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

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## Indications for Use

K100749

510(k) Number (if known):

Device Name:

Frequencer™ v2x

Indications for Use:

The Frequencer™ v2x provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of chest physiotherapy by providing a convenient method of external thorax manipulation.

lt is indicated for patients having respiratory ailments which involve defective mucociliary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchitis, bronchiectasis, ciliary dyskinesia syndromes, asthma, muscular dystrophy, neuromuscular degenerative disorders, post-operative atelectasis and thoracic wall defects. Indications for this form of therapy are described in the Clinical Practice Guidelines for Postural Drainage Therapy of the American Association for Respiratory Care (AARC) published in 1991. This particular device provides a gentler, less painful form of therapy than the traditional "clapping" method of postural drainage therapy, allowing it to be used on patients who cannot be treated by clapping.

The Frequencer™ v2x is only intended for use in hospitals and clinics.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-theCounter Use (Part 21 CFR 801 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device EvaJuation (ODE)

f Device Evaluation (ODE)

L. Schultheis

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K/00749 Page 1 of 1