(95 days)
The Tracoe Phon Assist I (Ref Models 650-S/SO and 650-T/TO) are one way valves with a supplemental oxygen port designed to allow tracheostomy patients with an intact larynx to vocalize without the need for finger occlusion. The single patient use valves are attached to the tracheostomy tube with a 15mm standard connector (Phon Assist I Ref Models 650-T/TO) or a Tracoe Stoma Button (Phon Assist I Ref Model 650-S/SO). Both valves consist of an identical cylindrical housing with a silicone membrane whereby the airflow is redirected up to the larynx and through the mouth. Air is allowed to enter in a unidirectional fashion upon inspiration and close upon expiration whereby the airflow is redirected up to the larynx and through the mouth. Tracoe Phon Assist I (Ref Models 650-T/TO) Speaking Valves are indicated for uncuffed tracheostomy tubes or cuffed tubes that have been fenestrated or deflated and Tracoe Stoma Buttons(Ref Model 650-S/SO) in the cases of:
- Mild Tracheal Stenosis
- Laryngeal Tumors
- Bilateral Vocal Cord Paralysis
- Trachealmalacia
- Head Trauma
- Broncheopulmonary Dysplasia
- Amyotrophic Lateral Scierosis
- Chronic Obstructive Pulmonary Disease
The Tracoe Phon Assist I (Ref Models 650-S/SO and 650-T/TO) are one way valves with a supplemental oxygen port designed to allow tracheostomy patients with an intact larynx to vocalize without the need for finger occlusion. The single patient use valves are attached to the tracheostomy tube with a 15mm standard connector (Phon Assist I Ref Models 650-T/TO) or a Tracoe Stoma Button (Phon Assist I Ref Model 650-S/SO). Both valves consist of an identical cylindrical housing with a silicone membrane whereby the airflow is redirected up to the larynx and through the mouth. Air is allowed to enter in a unidirectional fashion upon inspiration and close upon expiration whereby the airflow is redirected up to the larynx and through the mouth.
The provided document is a 510(k) premarket notification letter from the FDA regarding the Tracoe Phon Assist I. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive new performance studies with specific acceptance criteria like those often seen for novel or high-risk devices. For devices deemed substantially equivalent, the performance is generally considered acceptable if it is comparable to the predicate device.
Therefore, I cannot provide the requested information based solely on the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample size or data provenance for a test set.
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Whether an MRMC comparative effectiveness study was done or its effect size.
- Whether standalone algorithm performance was done.
- The type of ground truth used.
- Sample size for the training set or how its ground truth was established.
This information would typically be found in detailed performance studies submitted as part of the 510(k) application, but it is not summarized in the FDA's decision letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health. The caduceus is depicted with a staff and two snakes winding around it.
Public Health Service
FEB 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tracoe Medical GmbH C/O Mr. Michael A. Warren Boston Medical Products, Incorporated 117 Flanders Road Westborough, Massachusetts 01581
Re: K043160
Trade/Device Name: Tracoe Phon Assist I Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: January 24, 2005 Received: January 25, 2005
Dear Mr. Warren:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your becatermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to devises and Cosmetic Act (Act) that do not require approval of a premarket the Federal 1 000; Drag, and Coou may, therefore, market the device, subject to the general approval upplieation (she Act. The general controls provisions of the Act include controls provisions of an 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 (1 Wry, it may of bacyott is the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear oe roundsh further announcements concerning your device in the Federal Register
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Page 2 - Mr. Warren
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA 3 issualled of a basetainments with other requirements mean that FDA has made a decommans. In a ministered by other Federal agencies. of the Act of any receial statutes and regulations, but not limited to: registration You must comply with an the Fice brequility, which 801); good manufacturing practice and listing (21 CFR Part 607), labeling (21 cres (QS) regulation (21 CFR Part 820); and if requirements as sectionin the quality byocally (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to objacting of substantial equivalence of your device to a premarket notification. The PDF minating or 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), IT you desire specific advice for your de at (240) 276-0120. 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 may obtain other generalational 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/industry/support/index.html.
Sincerely yours,
Sinette Michie O
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4- Statement of Indications for Use
INDICATIONS FOR USE
Not Issued 510(k) Number:
Tracoe Phon Assist I Device Name:
Indications for Use:
The Tracoe Phon Assist I (Ref Models 650-S/SO and 650-T/TO) are one way valves with The Tracoc I hon I Loster (Tree Insees port designed to allow tracheostomy patients with and without a supplemental your portygen pered for finger occlusion. The single patient use all intact laryin' to voombo withiout to fa tracheostomy tube with a 15mm standard valves are attached to the Such 12650-T/TO) or a Tracoe Stoma Button (Phon Assist Icombelor (I hour Assist I "House cosist of an identical cylindrical housing with a silicone Model 050-67507. Bour var to enter in a unidirectional fashion upon inspiration and close menorano whereby the airflow is redirected up to the larynx and through the mouth. upon expiration whice of the a 650-T/TO) Speaking Valves are indicated for uncuffed I hon I hon I uses I (x 2 suffed tubes that have been fennestrated or deflated and Tracoe Stoma Buttons(Ref Model 650-S/SO) in the cases of:
- Mild Tracheal Stenosis u
- Laryngeal Tumors 1
- Bilateral Vocal Cord Paralysis .
- Trachealmalacia r
- . Head Trauma
- Broncheopulmonary Dysplasia .
- Amyotrophic Lateral Scierosis .
- Chronic Obstructive Pulmonary Disease .
X Prescription Use: (Part 21 CFR 801 Subpart D) Over-The-Counter-Use: (Part 21 CFR 807 Subpart C)
DO NOT WRITE BELOW THIS LINE
AND/OR
Concurrence of CDRH, Office of Device Evaluation
510(K) NOTIFICATION- TRACOE PHON ASSIST I TRACHEOSTOMY SPEAKING VALVF.S
Anne Sullivan
Genaral Hosnital .. Accord
Section 510(k) for Dental Devices
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.