(64 days)
The PROVOX Voice Rehabilitation System has exactly the same indications for use as the original PROVOX and is intended for use in prosthetic voice restoration after total laryngectomy. The prosthesis can be inserted at the time of laryngectomy (primary puncture), or at a later date (secondary puncture), or to replace another similar prosthesis.
The PROVOX Voice Rehabilitation System. Replacement is performed in an anterograde way, using the components accompanying the PROVOX2 device (Insertion tool). The development of an anterograde replacement method (through the tracheostoma) was a logical development since the retrograde replacement method (using a guide wire) is often discomfortable for the patient. The PROVOX2 can be used in primary or secondary TE-puncture procedures if it is used with the PROVOX GuideWire, the Trocar and Cannula, and the Pharynx Protector components of the PROVOX Voice Rehabilitation System.
The provided text is a 510(k) premarket notification letter from the FDA to Atos Medical regarding the Provox 2 Voice Prosthesis System. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter confirms that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the regulatory class and procode, and discusses general controls and regulations. The second page contains the "Indications for Use" for the Provox Voice Rehabilitation System.
Therefore, I cannot extract the requested information to fill in the table or answer the questions. The document you provided is a regulatory approval letter, not a clinical study report or a document detailing performance criteria and test results.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eddy Åberg Technical Manager Atos Medical P.O. Box 183 Kraftgaten 8 S242-22 Hörby Sweden
Dear Mr. Åberg:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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
JUN - 6 1997
Re: K971244
Provox 2 Voice Prosthesis System
21 CFR 874.3730/Procode: 77 EWL
Dated: March 18, 1997
Regulatory class: II
Received: April 3, 1997
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Pracice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. This response to your premarket notification does not affect any obligation you might have under sections 531 through 542
registration, listing of devices, good manufacturing practice, labeling, and prohibitions egainst misbranding and adulteration.
This letter will allow you to begin marketing your device as described in your 510(t) 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.
of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,
If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
hillian
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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June 4, 1997
14
20.2 INDICATIONS FOR USE, PROVOX® PROSTHESIS SYSTEM
Premarket Notification 510 (k) Number: K 971244
The PROVOX Voice Rehabilitation System has exactly the same indications for use as the original PROVOX and is intended for use in prosthetic voice restoration after total laryngectomy. The prosthesis can be inserted at the time of laryngectomy (primary puncture), or at a later date (secondary puncture), or to replace another similar prosthesis. Replacement is performed in an anterograde way, using the components accompanying the PROVOX2 device (Insertion tool). The development of an anterograde replacement method (through the tracheostoma) was a logical development since the retrograde replacement method (using a guide wire) is often discomfortable for the patient. The PROVOX2 can be used in primary or secondary TE-puncture procedures if it is used with the PROVOX GuideWire, the Trocar and Cannula, and the Pharynx Protector components of the PROVOX Voice Rehabilitation System.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | V |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| -- | ---------------------- |
| David A. Seegman | |
|---|---|
| (Optional Format 1-2-96) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K971244 |
P.O.Box 183 Kraitgatan 8 S-242 22 Hörbv Succlen
י ישותרויו +46 415 176 ()() F.I. -46-415-176-10 F-mail info@ alosmeche al.com Web Site: http://www.alosmedication.n
। भट्ट मिल 556268-56(17 :八】 ········································································································································································· SF554208-60-01
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§ 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.