INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST

K122480 · International Biophysics Corporation · BYI · Mar 27, 2013 · Anesthesiology

Device Facts

• Record ID: K122480
• Device Name: INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST
• Applicant: International Biophysics Corporation
• Product Code: BYI · Anesthesiology
• Decision Date: Mar 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5665
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The International Biophysics Corporation AffloVest is intended for promoting airway clearance and improvement of bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment.

Device Story

The AffloVest is a wearable HFCWO (high-frequency chest wall oscillation) device designed to mobilize bronchial secretions. It consists of a synthetic polymer fabric vest containing oscillating vibratory motors arranged in six zones. The device is powered by batteries and includes a wired remote control for the patient to adjust oscillation intensity as prescribed. The vest is secured using three front buckles and shoulder straps to ensure a snug, even fit. By delivering high-frequency vibrations to the chest wall, the device thins and dislodges mucus from bronchial walls, moving it toward larger airways for easier removal via coughing or suctioning. It is intended for use where external thoracic manipulation is the physician's chosen treatment to improve bronchial drainage.

Clinical Evidence

No clinical data or nonclinical performance testing data were required for this submission.

Technological Characteristics

Synthetic polymer fabric vest; six-zone oscillating vibratory motor array; battery-powered with external charger; wired remote control interface; adjustable intensity settings; non-invasive external thoracic application.

Indications for Use

Indicated for patients requiring airway clearance and bronchial drainage via external thoracic manipulation, as prescribed by a physician.

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

• The Vest® Airway Clearance System by Hill-Rom (K965192)
• SmartVest® Airway Clearance System, Model TL (K053248)

Submission Summary (Full Text)

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122480/5001

# Attachment I

MAR 2 7 2013

### · 510(k) Summary

International Biophysics Corporation HFCWO Vibratory Vest

This 510(k) Summary of Safety and Effectiveness for the IBC HFCWO Vibratory Vest is submitted in accordance with the requirements of SMDA 1990 and following guidance concerning the organization and content of a 510(k) summary.

| Applicant: | International Biophysics Corporation |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 2101 E. St. Elmo Road, Suite 275<br>Austin, Texas 78744 |
| Contact Person: | H. David Shockley, Jr., CEO & President |
| Telephone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| Preparation Date: | July 15, 2012 |
| Device Trade Name: | International Biophysics Corporation AffloVest |
| Common Name: | IBC HFCWO Vibratory Vest |
| Classification Name: | Therapeutic Device, Powered Percussor<br>73-BYI<br>21 CFR 868.5665 |
| Legally Marketed Predicate Device | K965192 -- Hill-Rom<br>The Vest® Airway Clearance System by Hill-Rom is<br>manufactured by Hill-Rom at 1020 West County Road F, St.<br>Paul, MN 55126. The vest is intended to use HFCWO to<br>dislodge mucus from the bronchial walls, increase<br>mobilization, and move it along toward central airways.<br>The action also works to thin thick secretions, making<br>them easier to clear. Once the mucus has moved from the |

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smaller to larger airways, it can be easily removed by coughing or suctioning.

K053248 - Electromed Inc.

The SmartVest®' Airway Clearance System, Model TL is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.

The International Biophysics Corporation HFCWO Vibratory Vest is comprised of a vest of synthetic polymer fabric with installed oscillating vibratory motors organized into six zones. It has three buckles and straps on the front and one over each shoulder that are used to provide the wearer with a snug and evenly-distributed fit. Additionally, there is an included charger for the batteries and a remote that is wired into the vest to adjust the intensity of the oscillation on the patient as necessary and as prescribed by a physician.

The International Biophysics Corporation AffloVest is intended for promoting airway clearance and improvement of bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment.

Nonclinical Performance Data:

Clinical Performance Data:

Intended Use of the Device

Conclusion:

None required

None required

The International Biophysics Corporation AffloVest is substantially equivalent to other existing legally marketed HFCWO vests that are currently in commercial distribution.

Additional Information:

None requested at this time.

Description of the Device

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Public Health Service

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

### March 27, 2013

Mr. H. David Shockley, Jr. Chief Executive Officer & President International Biophysics Corporation 2101 East Elmo Road, Suite 275 AUSTIN TX 78744

Re: K122480

Trade/Device Name: International Biophysics Corporation HFCWO Vibratory Vest Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: II Product Code: BYI Dated: February 19, 2013 Received: February 1, 2013

Dear Mr. Shockley:

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. Isting 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.

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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,

Image /page/3/Picture/7 description: The image shows the name "Kwame Ulmer" in a stylized font. The letters are bold and sans-serif. The letters are arranged in two rows, with "Kwame" on the top row and "Ulmer" on the bottom row. The letters are partially obscured by a geometric design that includes a circle, a triangle, and a series of lines.

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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# INDICATION FOR USE STATEMENT

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: International Biophysics Corporation HFCWO Vibratory Vest

Indications for Use:

The International Biophysics Corporation AffloVest is intended for promoting airway clearance and improvement of bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment.

(Please do not write below this line – continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">X</span> OR Over-the-Counter Use ________ (per 21 CFR 801.109) |
|------------------|---------------------------------------------------------------------------------------------------------|
|------------------|---------------------------------------------------------------------------------------------------------|

Digitally signed by Lester W. Schultheis Jr

DN: c=US, o=U.S. Government, ou=HHS,

ou=FDA, ou=People,

0.9.2342.19200300.100.1.1=1300188833,

cn=Lester W. Schultheis Jr

Date: 2013.03.26 14:00:36 -04'00'

Lester W.

Schultheis Jr

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | K122480 |
|----------------|---------|
|----------------|---------|

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