(114 days)
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Not Found
No
The device description and intended use describe a mechanical voice prosthesis, and there are no mentions of AI, ML, or related concepts in the provided text.
Yes
The device is intended to restore vocal abilities in patients after a Laryngectomy, which is a therapeutic purpose.
No
The device is described as an "indwelling voice prosthesis" used to restore vocal abilities after a laryngectomy, indicating a therapeutic or restorative function rather than a diagnostic one.
No
The device description explicitly states it is an "indwelling voice prosthesis, with a one-way ball valve," which are physical hardware components.
Based on the provided information, the VoiceMaster device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- VoiceMaster Function: The VoiceMaster is a physical prosthesis designed to be surgically implanted into a patient's body (specifically, a tracheo-esophageal fistula) to restore vocal abilities. It does not analyze biological samples.
Therefore, the VoiceMaster falls under the category of a medical device, specifically an implantable prosthesis, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VoiceMaster is to be used in patients after a Laryngectomy who would like to restore their vocal abilities.
Product codes
77 EWL
Device Description
This device is an indwelling voice prosthesis, with a one-way ball valve, designed to fit into a tracheo-esophageal fistula.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
tracheo-esophageal fistula
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Groningen Voice Prosthesis, Panje Voice Prosthesis, Provox Voice Prosthesis
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
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)
1
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
2
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