(225 days)
Not Found
No
The device description and summary of performance studies do not mention any AI or ML components or capabilities. The device is described as a mechanical vibratory vest.
Yes
The device is intended for promoting airway clearance and improving bronchial drainage to mobilize secretions, which are therapeutic actions. It is also described as a "HFCWO Vibratory Vest" (High-Frequency Chest Wall Oscillation), a known therapeutic modality.
No
The device description states its purpose is to promote airway clearance and improve bronchial drainage by enhancing mobilization of secretions, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is comprised of a vest with installed oscillating vibratory motors, buckles, straps, a charger, and a wired remote, all of which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- AffloVest Function: The AffloVest is a physical therapy device that uses mechanical vibration to help clear airways. It works externally on the body and does not involve testing or analyzing samples taken from the patient.
- Intended Use: The intended use clearly states it's 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." This describes a physical intervention, not a diagnostic test.
- Device Description: The description details a wearable vest with motors, buckles, and a remote. This is consistent with a physical therapy device, not an IVD.
- Lack of IVD-related information: The document lacks any mention of samples, reagents, assays, or any other elements typically associated with IVD devices.
Therefore, based on the provided information, the International Biophysics Corporation AffloVest is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
BYI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thorax
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician's choice of treatment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Nonclinical Performance Data: None required
Clinical Performance Data: None required
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 |
| Austin, Texas 78744 | |
| Contact Person: | H. David Shockley, Jr., CEO & President |
| Telephone: | (512) 326-3244 |
| Fax: | (512) 326-3299 |
| Email: | hdavid@ibcbio.com |
| Preparation Date: | July 15, 2012 |
| Device Trade Name: | International Biophysics Corporation AffloVest |
| Common Name: | IBC HFCWO Vibratory Vest |
| Classification Name: | Therapeutic Device, Powered Percussor |
| 73-BYI | |
| 21 CFR 868.5665 | |
| Legally Marketed Predicate Device | K965192 -- Hill-Rom |
| The Vest® Airway Clearance System by Hill-Rom is | |
| manufactured by Hill-Rom at 1020 West County Road F, St. | |
| Paul, MN 55126. The vest is intended to use HFCWO to | |
| dislodge mucus from the bronchial walls, increase | |
| mobilization, and move it along toward central airways. | |
| The action also works to thin thick secretions, making | |
| them easier to clear. Once the mucus has moved from the |
1
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
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
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.
3
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 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
4
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 | X 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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". ・・・・.