(10 days)
The Provox® NID™ Voice Rehabilitation System is intended for use in prosthetic voice rehabilitation after total laryngectomy only by patients who have been trained in the use of the device and, as assessed by the clinician who prescribes the device, have demonstrated the ability to understand and consistently follow the Instructions for Use without clinician supervision.
The Provox NID is intended for single patient use.
The Provox® NID™ Rehabilitation System is a non-indwelling (Standard) voice prosthesis equipped with a safety medallion, an insertion tool and some accessories.
The Provox NID voice prosthesis is available in two outer diameters (17 and 20 French) and six different lengths, (6, 8, 10, 12, 14 and 18 mm). Each prosthesis comes individually packed with a re-usable inserter. The design of the device is based on the indwelling voice prostheses Provox1, Provox2 and ActiValve.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are not explicitly detailed in a quantifiable manner (e.g., specific thresholds for success, failure rates, etc.). Instead, the study's goal was to demonstrate that the device's performance satisfies its "design intent" and that it is "substantially equivalent" to predicate devices. The study results are reported qualitatively as supporting this conclusion.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional equivalency to predicate devices in valve performance | "Functional equivalency test have been performed on the three prostheses, which demonstrate the equivalency of the valve performance with the three designs." |
| Device performance satisfies the design intent | "Test results support the conclusion that the actual device performance satisfies the design intent." |
| Substantial equivalence to predicate devices in design, intended use, and materials of manufacture | "The proposed device is substantially equivalent to the legally marketed predicate Technological Characteristics devices in design, intended use and materials of manufacturer." |
| Provides voicing after total laryngectomy | "The Provox® NID™ Rehabilitation System is provided for the same indications for use as its predicate devices... All three devices are designed to provide voicing after total laryngectomy." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 14 patients
- Data Provenance:
- Country of Origin: Brisbane, Australia (Performed by Princess Alexandra Hospital)
- Retrospective or Prospective: Prospective (implied by "participated in this clinical trail" and the approval by a Research Ethics Committee)
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the test set. It mentions the study was "Performed by Princess Alexandra Hospital," implying clinical oversight and assessment, but no specific number or roles of independent experts for ground truth establishment are provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes a clinical trial with patients using the device, but it does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The device itself is a physical voice prosthesis, not an AI diagnostic tool.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. The Provox® NID™ Voice Rehabilitation System is a medical device (voice prosthesis), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
The ground truth or evaluation standard implicitly revolves around clinical assessment of "voicing" effectiveness and the patient's ability to use the device as intended. The "functional equivalency test" for valve performance would likely involve objective measurements, but the specific type of ground truth for overall device performance is not detailed beyond demonstrating that it "satisfies the design intent" and is "substantially equivalent" to predicate devices. Prior to the study, patients were using the Blom-Singer Low Pressure Voice Prosthesis, suggesting a baseline for comparison in terms of patient experience or outcome.
8. Sample Size for the Training Set
Not applicable. As this is a medical device (voice prosthesis) and not an AI/machine learning algorithm, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of medical device.
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Image /page/0/Picture/1 description: The image shows the text "Premarket Notification 510(k) Provox® NID™ Voice Rehabilitation System". The text is left-aligned and appears to be the title or heading of a document. The text is written in a simple, sans-serif font and is easy to read.
Image /page/0/Picture/2 description: The image shows the logo for Atos Medical. The word "ATOS" is in large, bold, black letters. Below the word "ATOS" is a black line, and below the line is the word "MEDICAL" in a smaller font.
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6.4 510(k) Summary of Safety and Effectiveness
| Date | Monday, November 08, 2004 |
|---|---|
| 510(k) Number | K043138 (To be assigned) |
| Submitter's Name | Atos Medical ABP O Box 183Kraftgatan 8SE-242 22 HörbySweden |
| Telephone: Int+46-415-198 00Fax: Int+46-415-198 98E-mail: info@atosmedical.com | |
| Contact Person | Eddy ÅbergDirector of Quality & Regulatory Affairs |
| Trade or Proprietary Name | Provox® NID™ Voice Rehabilitation System |
| Common or Usual Name | Voice Prosthesis |
| Device Classification Name | Laryngeal prosthesis (Taub design) |
| Product Code | EWL |
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Image /page/1/Picture/1 description: The image shows the logo for Atos Medical. The word "ATOS" is in large, bold, sans-serif font. Below the word "ATOS" is a horizontal line, and below the line is the word "MEDICAL" in a smaller, sans-serif font.
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| PredicateDevices | Provox®2 Voice Prosthesis System |
|---|---|
| 510(k) Number : K971244 | |
| Atos Medical AB, Sweden | |
| Blom-Singer Low Pressure Voice Prosthesis | |
| 510(k) Number: K821568 | |
| Inhealth Technologies, USA |
- The Provox NID voice rehabilitation system is intended for use in prosthetic voice Intended Use rehabilitation after total laryngectomy only by patients who have been trained in the use of the device and, as assessed by the clinician who prescribes the device, have demonstrated the ability to understand and consistently follow the Instructions for Use without clinician supervision.
The Provox NID is intended for single patient use.
The Provox® NID™ Rehabilitation System is a non-indwelling (Standard) voice Description of prosthesis equipped with a safety medallion, an insertion tool and some the Device accessories.
Image /page/1/Picture/7 description: The image shows two medical instruments. The first instrument is a laryngoscope, which is used to view the larynx. It has a handle and a blade with a light at the end. The second instrument is a tracheostomy tube holder, which is used to secure a tracheostomy tube in place. The holder has a strap that goes around the neck and a clamp that attaches to the tube.
The Provox NID voice prosthesis is available in two outer diameters (17 and 20 French) and six different lengths, (6, 8, 10, 12, 14 and 18 mm). Each prosthesis
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Image /page/2/Picture/0 description: The image shows the logo for Atos Medical. The word "ATOS" is in large, bold, sans-serif font, with a thick line underneath. Below the line, the word "MEDICAL" is printed in a smaller, sans-serif font.
Page 3 of 3 comes individually packed with a re-usable inserter. The design of the device is based on the indwelling voice prostheses Provox1, Provox2 and ActiValve. Performed by Princess Alexandra Hospital, Brisbane, Australia. The Human Clinical Test Research Ethics Committee of the hospital approved the study. All of the patients were using the Blom-Singer Low Pressure Voice Prosthesis prior to this study. In total, 14 patients participated in this clinical trail. Test results support the conclusion that the actual device performance satisfies the design intent. The proposed device is substantially equivalent to the legally marketed predicate Technological Characteristics devices in design, intended use and materials of manufacturer. The Provox® NID™ Rehabilitation System is provided for the same indications for use as its predicate devices, the Provox®2 Voice Prosthesis System and the Blom-Singer Low Pressure Voice Prosthesis. All three devices are designed to provide voicing after total laryngectomy. The devices are placed in a surgically created fistula between the trachea and esophagus in order to divert air through the
prosthesis valve to created voicing.
Functional equivalency test have been performed on the three prostheses, which demonstrate the equivalency of the valve performance with the three designs.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2004
Atos Medical AB Attn: Eddy Åberg P O Box 183 Kraftgatan 8 SE-242 22 Hörby Sweden
Re: K043138
: 11015150
Trade/Device Name: Provox® NID™ Voice Rehabilitation System Regulation Number: 21 CFR 874.3730 Regulation Name: Laryngeal Prosthesis (Taub design) Regulatory Class: II Product Code: EWL Dated: November 8, 2004 Received: November 12, 2004
Dear Ms. Åberg:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rothered your because in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass baced in 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 mat (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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be fray of 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); 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.
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Page 2 - Ms. Åberg
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A kalpi korenthal
A. Ralph Rosenthal, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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6.3 Indications for Use
| Applicant: | Atos Medical AB, Sweden | ||
|---|---|---|---|
| 510(k) Number: | K043138 | (To be assigned) | |
| Device Name: | Provox® NID™ Voice Rehabilitation System |
Intended Use:
The Provox® NID™ Voice Rehabilitation System is intended for use in prosthetic voice rehabilitation after total laryngectomy only by patients who have been trained in the use of the device and, as assessed by the clinician who prescribes the device, have demonstrated the ability to understand and consistently follow the Instructions for Use without clinician supervision.
The Provox NID is intended for single patient use.
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation
Prescription Use √
or
(Per 21 CFR 801.109)
Over-the-counter
(Division Sign-Off) Division of Onhthalmic Ear, Nose and Throat Davises
510(k) Number: K043138
6-13
Phone +46 415 198 00 Fax +46 415 198 98 E-mail info@atosmedical.com Web www.atosmedical.com
Org. nr. 556268-7607 Vat No. SE556268760701
§ 874.3730 Laryngeal prosthesis (Taub design).
(a)
Identification. A laryngeal prosthesis (Taub design) is a device intended to direct pulmonary air flow to the pharynx in the absence of the larynx, thereby permitting esophageal speech. The device is interposed between openings in the trachea and the esophagus and may be removed and replaced each day by the patient. During phonation, air from the lungs is directed to flow through the device and over the esophageal mucosa to provide a sound source that is articulated as speech.(b)
Classification. Class II (special controls). The device, when it is a voice amplification device, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.