(90 days)
The Frequencer™ V2 or 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, 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™ V2 or 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 electroacoustical power head (hereafter referred to as the "transducer") which is " placed externally on the patient's chest. The transducer is connected to a frequency generator which is capable of producing frequencies between 20 and 65 Hz. The transducer induces sound waves in the patient's chest which are effective in loosening mucus deposits. The model V2x uses disposable adapters with filters and is intended for use in multi-patient settings. The model V2 uses a permanent non-filtering adapter and is intended for single patient use.
The Dymedso Frequencer V2™ and Frequencer V2x™ Airway Clearance Device is not an AI/ML device. The provided text describes a medical device for airway clearance therapy that induces vibrations in the chest walls. The performance testing conducted includes electrical safety, electromagnetic radiation, biocompatibility, and bench testing to compare applied force with a predicate device and conventional chest physiotherapy (CCPT). There is no mention of an algorithm, AI, or machine learning in the device's description or performance testing. Therefore, the specific criteria requested for AI/ML device evaluations (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable to this submission.
Here's a summary of the performance testing and acceptance criteria as described in the document, which pertains to the physical and electrical characteristics of the device, and its safety:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Electrical Safety | IEC 60601-1 | Compliant | Device tested in accordance with IEC 60601-1 and met requirements. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Consistent with Type B device for domestic environments | Device tested in accordance with IEC 60601-1-2 and met acceptance criteria for a Type B device for domestic environments. New ferrites added to allow home/residential use. |
| Biocompatibility | ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization & Irritation) | Passing all tests (Level 1 biocompatible, allows direct skin contact) | Base resin (Bayblend 301 FR) used for adapter heads passed all tests, considered Level 1 biocompatible. |
| Applied Force | Bench Testing | Comparability to predicate device (K100749) and lower forces than CCPT | Demonstrated similar, though slightly lower, maximum applied force compared to the predicate. Both provide considerably lower forces than CCPT. |
| Clinical Effectiveness (Historical Data for Predicate) | Clinical testing on original Frequencer™ (K100749) | Comparable sputum weights to CCPT in CF patients | Sputum weights produced after treatment with Frequencer™ were comparable to CCPT in subjects with Cystic Fibrosis (CF). |
| Mucus Flow Rate (In Vitro) | In vitro flow rate measurements | Higher flow rates using Frequencer™ compared to no treatment | Demonstrated higher flow rates of mucus through a capillary tube when using the Frequencer™ compared to no treatment. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document references "Clinical testing conducted on the original Frequencer™" for sputum weights and "In vitro flow rate measurements," but does not specify sample sizes or data provenance for these studies. The primary testing for the V2 and V2x models focuses on electrical safety, EMC, biocompatibility, and a bench test for applied force, which do not typically involve patient "test sets" in the AI/ML context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The device is not an AI/ML device that generates outputs requiring expert ground truth for evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. The "standalone" performance here refers to the device's physical and electrical operation, and its ability to induce vibrations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance assessment, the "ground truth" or reference points were:
- Safety and EMC Standards: IEC 60601-1 and IEC 60601-1-2.
- Biocompatibility Standards: ISO 10993-5 and ISO 10993-10.
- Predicate Device Performance: Comparison of applied force to the Frequencer™ v2x (K100749).
- Conventional Chest Physiotherapy (CCPT): Used as a clinical benchmark for sputum weights and a comparison for applied force.
- No Treatment: Used as a benchmark for in vitro mucus flow rates.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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Dymedso Frequencer V2™ and Frequencer V2x™ Airway Clearance Device
V.510(k) Summary
JAN 2 6 2011
.. . . . . .
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
| Date of Submission:Submitter:Address: | October 26, 2010DYMEDSO, Inc.901A, Boul. Du Curé BoivinBoisbriand, Québec J7G 2S8CANADA |
|---|---|
| Establishment Registration #: | 3004365906 |
| Contact: | Yvon Robert, President |
| Phone: (450) 437-9601 | Fax: (450) 437-2063 |
| Proprietary Device Name: | Frequencer™ V2, Frequencer™ V2x |
| Common Name of Device: | Airway Clearance Device |
| Classification Name: | Percussor, Powered-Electric |
| Device Class: | 2 |
| Product Code: | BYI |
Predicate Device: K100749 - Frequencer™ v2x
Description:
The Frequencer™ V2 or 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 electroacoustical power head (hereafter referred to as the "transducer") which is " placed externally on the patient's chest. The transducer is connected to a frequency generator which is capable of producing frequencies between 20 and 65 Hz. The transducer induces sound waves in the patient's chest which are effective in loosening mucus deposits. The model V2x uses disposable adapters with filters and is intended for use in multi-patient settings. The model V2 uses a permanent non-filtering adapter and is intended for single patient use.
Indications for Use:
The Frequencer™ V2 or 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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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.
Comparison of Technological Characteristics:
The Frequencer™ V2 and V2x are identical to the predicate device in terms of indications for use, contra-indications, acoustic operating principle and basic electronics. The electromagnetic compatibility of the predicate device only allowed for use in hospitals or clinics as opposed to a home or residential environment. Ferrites have been added to allow the current device to be used in a home or residence. The polymer material used for the adapters has been shown to be sufficiently biocompatible to allow skin contact. The Frequencer™ V2x is identical to the predicate device in that it uses disposable adapters with filters, and is intended for multi-patient use. The Frequencer™ V2 comes with permanent non-filtering adapters and is intended for single patient use. Both adapter types are available in the same sizes as for the predicate device, namely 1", 2", 3", and 4" diameter. A flexible hose is now offered which may be affixed to the smallest adapter (1"), if deemed necessary, to accommodate situations where the weight of the transducer might cause discomfort.
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 electromağnetic radiation, with acceptance criteria consistent with a Type B device for domestic environments.
The base resin used in Bayblend 301 FR used for the adapter heads was tested in accordance with ISO 10993-5 and ISO 10993-10 "Biological Evaluation of Medical Devices" for cytotoxicity, sensitization and irritation, passing all tests. The adapter heads can therefore be considered Level 1 biocompatible and allow direct skin contact.
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
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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.
Conclusions:
The proposed Frequencer™ V2 and V2x have the identical indications, operating principle and electronics as the predicate device Frequencer™ v2x. The only differences are the allowed environment, demonstration of biocompatibility of the polymer adapter, and availability of a model for home use with a permanent adapter. The performance testing provides validation of new features of this device. Thus, the proposed Frequencer™ V2 and V2x is substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
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, PO Box 826 Springfield, Vermont 05156-0826
JAN 26 201
Re: K103176
Trade/Device Name: Frequencer" V2. Frequencer™ V2x Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: II Product Code: BYI Dated: October 26, 2010 Received: October 28, 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 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 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
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Page 2- Ms. Bigoney
(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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
far
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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IV.Indications for Use Statement
510(k) Number (if known):
Device Name:
Frequencer™ V2x, Frequencer™ V2
Indications for Use:
The Frequencer™ V2x and Frequencer™ V2 provide airway clearance therapy and promote 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 syndromeo, 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-the Counter 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 Evaluation (ODE)
L. Schulte
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
$1000
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દિવેલું છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા
§ 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).