(168 days)
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, 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.
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.
The provided text describes the Dymedso Frequencer™ v2x, an airway clearance device, and its performance testing to demonstrate substantial equivalence to a predicate device. However, the document does NOT contain details about acceptance criteria directly in a clear, tabulated format with specific performance metrics and their corresponding reported values for the Frequencer™ v2x itself.
Instead, the document focuses on:
- Comparison to a predicate device: Frequencer™ 1001.
- Bench testing results: demonstrating "similar, though slightly lower maximum applied force" compared to the predicate. This comparison is not a direct measure against specific acceptance criteria for the Frequencer™ v2x's therapeutic effect.
- Reference to prior clinical testing on the original Frequencer: which showed "comparable sputum weights" and "higher flow rates of mucus in vitro." These are findings from the predicate device's studies, not new studies for the v2x.
- Compliance with safety and electromagnetic standards: IEC 60601-1 and IEC 60601-1-2. These are general safety standards, not performance criteria for its therapeutic indication.
Therefore, many of the requested items (sample sizes, expert qualifications, adjudication methods, MRMC studies, ground truth details for training/test sets) for the Frequencer™ v2x are not explicitly stated in this 510(k) summary. The summary focuses on showing that the Frequencer™ v2x is substantially equivalent to the Frequencer™ 1001 due to identical indications, operating principles, electronics, and similar basic performance (force applied).
Given the limitations of the provided text, here's an attempt to answer the questions based only on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
As specific therapeutic acceptance criteria for the Frequencer™ v2x (e.g., minimum sputum weight, minimum mucus flow rate) are not explicitly stated or quantified in this 510(k) summary, and the performance testing primarily focused on comparison to a predicate device and compliance with general safety standards, a direct table of acceptance criteria vs. specific reported values for the v2x's therapeutic efficacy cannot be fully constructed from the provided text.
The closest we can infer for "acceptance" is substantial equivalence to the predicate device.
| Acceptance Criterion (Inferred from Text) | Reported Device Performance (Frequencer™ v2x) |
|---|---|
| Mechanical Performance: Maximum force applied (comparison to predicate) | "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)." |
| Electrical Safety: Compliance with IEC 60601-1 | Tested in accordance with IEC 60601-1 (Implicitly, it met the standard for a Type A device). |
| Electromagnetic Compatibility: Compliance with IEC 60601-1-2 | Tested in accordance with IEC 60601-1-2 (Implicitly, it met the standard for a Type A device). |
| Software Validation: Functionality and safety | "Software verification and validation testing has also been performed on the device." (Implicitly, it met validation criteria). |
| Overall Equivalence: Identical to predicate in key aspects | "The proposed Frequencer™ v2x has the identical indications, operating principle and electronics as the predicate device Frequencer™ 1001." |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" with a defined sample size for the Frequencer™ v2x. The clinical data referenced pertains to the original Frequencer™ (the predicate device). The performance testing for the v2x appears to be bench testing for mechanical force comparison and compliance testing for safety standards.
- Sample Size for Frequencer™ v2x performance testing: Not specified. It refers to "Performance bench testing" but not specific numbers of tests or devices.
- Data Provenance for Frequencer™ v2x: Not explicitly stated, implied to be laboratory bench testing undertaken by the manufacturer (DYMEDSO, Inc.) in Canada.
- Clinical data provenance (for predicate device results): Not detailed (e.g., country of origin, retrospective/prospective). It only mentions "Clinical testing conducted on the original Frequencer™."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a clinical "test set" and ground truth establishment involving human experts for the Frequencer™ v2x performance evaluation. The clinical claims for efficacy are based on the predicate device's studies, for which expert involvement is not described in this summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication by experts is described for the Frequencer™ v2x.
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. The Frequencer™ v2x is an airway clearance device, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Frequencer™ v2x is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the Frequencer™ v2x performance, the "ground truth" was its mechanical performance measured against the predicate device and compliance with safety standards. For the predicate device's efficacy data, the "ground truth" appears to be:
- "comparable sputum weights produced after treatment" (clinical outcome).
- "higher flow rates of mucus through a capillary tube" (in vitro laboratory measurement).
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. This device does not involve a "training set."
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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:Submitter:Address: | August 31, 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™ 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 (800) 638-2041 or (301) 796-7100 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
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
§ 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).