(64 days)
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No
The summary describes a mechanical voice prosthesis and its insertion tools, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is intended for prosthetic voice restoration after total laryngectomy, which directly addresses a health condition and helps restore function.
No
The text explicitly states the device's purpose is "prosthetic voice restoration" and "replacement" of a prosthesis, indicating a therapeutic or rehabilitative function, not diagnosis.
No
The device description explicitly mentions physical components like the prosthesis, insertion tool, guide wire, trocar and cannula, and pharynx protector, indicating it is a system with hardware components, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The PROVOX Voice Rehabilitation System is a prosthesis intended for surgical implantation to restore voice after laryngectomy. It is a physical device used within the body, not for analyzing samples outside the body.
- Intended Use: The intended use is for "prosthetic voice restoration after total laryngectomy," which is a surgical and rehabilitative procedure, not a diagnostic test.
Therefore, the PROVOX Voice Rehabilitation System falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
77 EWL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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.
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human figures, possibly representing health, family, and community. The figures are depicted in a flowing, interconnected manner.
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
1
Image /page/1/Picture/0 description: The image shows the logo for Atos Medical. The logo consists of the word "ATOS" in large, bold, sans-serif font, with a thick line underneath. Below the line is the word "MEDICAL" in a smaller, sans-serif font. The logo is black and white.
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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