(114 days)
The VoiceMaster is to be used in patients after a Laryngectomy who would like to restore their vocal abilities.
This device is an indwelling voice prosthesis, with a one-way ball valve, designed to fit into a tracheo-esophageal fistula.
The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a 510(k) summary for a medical device (VoiceMaster Prosthesis) and the FDA's clearance letter for it.
The 510(k) summary:
- Identifies the product (VoiceMaster Prosthesis) and its intended use (restoring vocal abilities after a laryngectomy).
- Compares it to predicate devices (Groningen Voice Prosthesis, Panje Voice Prosthesis, Provox Voice Prosthesis), highlighting similarities in body design and material, and a difference in valve design (ball valve vs. slit/flap valves).
The FDA clearance letter:
- Confirms the device is substantially equivalent to legally marketed predicate devices.
- States that the device can be marketed.
Therefore, I cannot provide the requested information in the table format or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as this information is not present in the provided text.
To answer your request, a different type of document (e.g., a clinical study report, a detailed performance testing protocol, or a more comprehensive premarket submission) would be required.
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FEB 2 5 1998
510 (K) Summary as required by section 807.92 (C)
Contact Information:
Anthony M. Sacchetti E. Benson Hood Laboratories 575 Washington St. Pembroke, MA 02359
Phone: 1-617-826-7573 1-617-826-3899 Fax:
Product Names:
VoiceMaster Prosthesis Trade name: VM-008 Catalog Code #: VM-010
Product Description:
This device is an indwelling voice prosthesis, with a one-way ball valve, designed to fit into a tracheo-esophageal fistula.
74132
Intended Use:
The VoiceMaster is to be used in patients after a Laryngectomy who would like to restore their vocal abilities.
Predicate Devices: Groningen Voice Prosthesis, Panje Voice Prosthesis, Provox Voice Prosthesis
Summary of Technological Similarities and Differences with the Predicate Device:
The body design and material used in the submitted device is similar to the Predicate Devices. The submitted device uses a ball valve design rather than slit or flap valves as a means to control airflow and direction.
(Signed)
Anthony M. Sacchetti
(Typed Name)
10/30/97
(Dated)
(Permanent Notification [510K] number)
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Image /page/1/Picture/17 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three overlapping lines that resemble an abstract human form.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 1998
Anthony Sacchetti Quality Manager E. Benson Hood Laboratories 575 Washington St. Pembroke, MA 02359
Re:
K974132 VoiceMaster Indwelling Voice Prosthesis Dated: February 9, 1998 Received: February 11, 1998 Regulatory class: II 21 CFR 874.3730/Procode: 77 EWL
Dear Mr. Sacchetti:
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 indications for use 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, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (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 Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/edrh/dsmamain.html":
Sincerely yours,
h. Tliau Yu.
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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510(k) Number (il known): K914132
Device Name: Voice Name: _ Voice Mass + 23 Pro ; thisis
Indications I-or Use:
The VoiceMaster is to be used in patients after a Laryngectomy who would like to restore
s and their vocal abilities.
Page
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
(Per 21 CFR 801.109)
();i
Uver-The-Counter Use_
Optional Format 1-2-96)
David C. Bryson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number K974113.2
SK=11
§ 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.