(263 days)
For patients breathing spontaneously via a tracheostomy tube, the TrachVox provides heat and humidity for entrained air and incorporates a cough relief and suction port valve. The unit may be closed by the patient's finger, which directs the air through the vocal cords to facilitate speech.
For patients breathing spontaneously via an endotracheal tube (ET tube) the TrachVox provides heat and moisture for the inhaled air.
The TrachVox connects to a 15 mm tracheostomy or endotracheal tube connector of a spontaneously breathing patient. It incorporates four (4) key features:
- HME media for humidifying inhaled air
- Suction port
- Method for closing off exhalation to outside and divert the exhaled breathe around the tracheostomy tube and through the vocal cords for speech
- Connector for delivery of supplemental oxygen
The provided text describes a medical device called TrachVox, a Tracheal HME with speech valve and suction port. The submission is a 510(k) premarket notification and focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types for test/training sets, and training set details) are not directly applicable or available in this type of submission.
However, I can extract information related to the device's technical specifications and how its performance is compared to predicate devices, which implicitly serves as the "study" for establishing substantial equivalence.
Here's a breakdown of the available information structured to answer your request where possible, and indicating when information is not present:
Acceptance Criteria and Study Details for TrachVox
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission establishes substantial equivalence by comparing the TrachVox device's attributes and performance characteristics to those of legally marketed predicate devices. The "acceptance criteria" here are implicitly defined by the attributes and performance ranges of these predicate devices, which the TrachVox aims to match or perform comparably to.
| Attribute | Predicate Device Performance (Implicit Acceptance Criteria) | Reported TrachVox Device Performance |
|---|---|---|
| For spontaneously breathing tracheostomy patients | Yes | Yes |
| Incorporated speech valve | Yes | Yes |
| Provides heat and humidity | Yes | Yes |
| Can provide supplemental oxygen | Yes | Yes |
| Intended to connect to tracheostomy tube of spontaneously breathing patient | Yes | Yes |
| Can connect to an ET tube of spontaneously breathing patient | Yes | Yes |
| Intended for single patient up to 24 hours | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population | Any patient | Any patient |
| Intended Environment of Use | Home, Hospital, sub-acute, ICU | Home, Hospital, sub-acute, ICU |
| Placement in various locations in circuit | Yes | Yes |
| Supplemental oxygen connection | Yes | Yes |
| Standard 15/22 mm connectors | Yes | Yes |
| Dead Space (ml) | (Not explicitly stated for predicates, implied to be comparable) | 9.5 ml |
| Resistance to flow | (Not explicitly stated for predicates, implied to be comparable) | 0.23 cm H₂O @ 30 Lpm |
| 0.9 cm H₂O @ 60 Lpm | ||
| Weight | (Not explicitly stated for predicates, implied to be comparable) | 2.9 gm |
| Normally closed suction slit valve | Yes | Yes |
| Speech valve normally open for inhalation | Yes | Yes |
| Allows exhalation to atmosphere freely | Yes | Yes |
| Method for diverting exhaled air through vocal cord for facilitating speech (Speech valve) | Mechanically similar mechanisms on predicates | Cover suction valve with fingers, depress housing, compressing foam and closes off exhalation to atmosphere vents |
| Method for revert to normal exhalation after speaking | Mechanically similar mechanisms on predicates | Remove finger, foam spring-action raises housing, opening exhalation to atmosphere vents |
| Moisture output (mg H₂O/l) ISO 9360 | (Not explicitly stated for predicates, but implies compliance with ISO 9360 standards) | 20.1 mg H₂O /l @ 500 ml TV |
| Moisture output (mg H₂O/l) ISO 9360 with supplemental oxygen | (Not explicitly stated for predicates, but implies compliance with ISO 9360 standards) | 14.9 mg H₂O /l @ 10 Lpm |
| Housing components - polypropylene | Yes | Yes |
| HME media | Foam | Foam |
| Valve | Silicone | Silicone |
| None under Section 514 | Yes | Yes |
| ISO 5356-1 Conical 15/22 | Yes | Yes |
| ISO 9360 - HME moisture output | Yes | Yes |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (defined by substantial equivalence to predicate devices) is primarily a comparative analysis of specifications and functional features. For quantitative metrics like Dead Space, Resistance to Flow, Weight, and Moisture Output, it is implied that bench testing was conducted on the TrachVox device to obtain these performance values, and these values were deemed acceptable when compared to relevant predicate devices or industry standards (like ISO 9360).
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This submission relies on engineering specifications and bench testing of the single device model, not a patient-based "test set" in the context of clinical trials or AI/diagnostic studies.
- Data Provenance: The data primarily comes from engineering design specifications and bench testing of the TrachVox device itself, and comparison to publicly available specifications/regulatory submissions of predicate devices. The country of origin for the data generation would be the manufacturer, Engineered Medical Systems, in Indianapolis, IN, USA. The data is prospective in the sense that the new device's performance was measured.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study involving human interpretation of data where "ground truth" is established by experts.
4. Adjudication method for the test set:
- Not applicable. No expert adjudication was done for this type of submission.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical medical device, not an AI algorithm.
7. The type of ground truth used:
- The "ground truth" for the TrachVox's performance metrics (dead space, resistance, moisture output) would be derived from direct physical measurements and laboratory bench testing according to established engineering and ISO standards (e.g., ISO 9360 for HME moisture output, ISO 5356-1 for connectors). For functional features, the "ground truth" is its design and operational mechanism. For the comparison to predicate devices, the "ground truth" is the regulatory and published specifications of those predicate devices.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning study.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning study.
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JUL 3 0 2002
K0137∂X
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 April 30, 2002
| Engineered Medical Systems2055 Executive Dr.Indianapolis, IN 46241 | Tel (317) 246-5500Fax (317) 246-5501 |
|---|---|
| Official Contact: | Bonnie Holly - Quality Manager |
| Proprietary or Trade Name: | TrachVox |
| Common/Usual Name: | Tracheal HME with speech valve and suction port |
| Classification Name: | Laryngeal (Taub) Prosthesis - Accessory |
| Predicate Devices: | In Health - Blom-Singer Tracheostoma withHumidiFilter Cap - K821568Passy Muir Speaking Valves - K944451Gibeck, Inc. - Trach-Vent - K952845Vital Signs - Breathe Easy - K914336Intersurgical - Hydro-Trach T - exemptB&B Technologies - Bodai Suction Safe -- K811241 |
Device Description:
The TrachVox connects to a 15 mm tracheostomy or endotracheal tube connector of a spontaneously breathing patient. It incorporates four (4) key features:
- HME media for humidifying inhaled air �
- 0 Suction port
- Method for closing off exhalation to outside and divert the exhaled breathe around the 0 tracheostomy tube and through the vocal cords for speech
- Connector for delivery of supplemental oxygen 0
| Intended Use: | |
|---|---|
| Indicated Use -- | For patients breathing spontaneously via a tracheostomy tube, theTrachVox provides heat and humidity for entrained air andincorporates a cough relief and suction port valve. The unit may beclosed by the patient's finger, which directs the air through the vocalcords to facilitate speech. |
| For patients breathing spontaneously via an endotracheal tube theTrachVox provides heat and moisture for the inhaled air. For singlepatient use. | |
| Environment of Use -- | Home, Hospital, ICU, Sub-acute Institutions |
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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 April 30, 2002
Comparison to Predicate Devices:
11
| Attribute | Proposed TrachVox device |
|---|---|
| For spontaneously breathing tracheostomy patients | Yes |
| Incorporated speech valve | Yes |
| Provides heat and humidity | Yes |
| Can provide supplemental oxygen | Yes |
| Intended to connect to tracheostomy tube ofspontaneously breathing patient | Yes |
| Can connect to an ET tube of spontaneously breathingpatient | Yes |
| Intended for single patient up to 24 hours | Yes |
| Prescription | Yes |
| Intended population | Any patient |
| Intended Environment of Use | Home, Hospital, sub-acute, ICU |
| Placement in various locations in circuit | Yes |
| Supplemental oxygen connection | Yes |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | 9.5 ml |
| Resistance to flow | 0.23 cm H₂O @ 30 Lpm or 0.9 cm H₂O @ 60 Lpm |
| Weight | 2.9 gm |
| Normally closed suction slit valve | Yes |
| Speech valve normally open for inhalation | Yes |
| Allows exhalation to atmosphere freely | Yes |
| Method for diverting exhaled air through vocal cordfor facilitating speech (Speech valve) | Cover suction valve with fingers, depress housing,compressing foam and closes off exhalation toatmosphere vents |
| Method for revert to normal exhalation after speaking | Remove finger, foam spring-action raises housing,opening exhalation to atmosphere vents |
| Moisture output (mg H₂O/l) ISO 9360 | 20.1 mg H₂O /l @ 500 ml TV |
| Moisture output (mg H₂O/I) ISO 9360with supplemental oxygen | 14.9 mg H₂O /l @ 10 Lpm |
| Housing components - polypropylene | Yes |
| HME media | Foam |
| Valve | Silicone |
| None under Section 514 | Yes |
| ISO 5356-1 Conical 15/22 | Yes |
| ISO 9360 - HME moisture output | Yes |
Differences between Other Legally Marketed Predicate Devices
The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Public Health Service
JUL 3 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Engineered Medical Systems C/O Mr. Paul Dryden Promedic. Incorporated 6329 W. Waterview Court McCordsville, Indiana 46055-9501
Re: K013728
Trade/Device Name: Trach Vox Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: April 30, 2002 Received: May 1, 2002
Dear Mr. Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 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 your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (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) 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.html
Sincerely yours,
Ullatorst
Timo ry A. Ulatowski 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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| 2.3 Indications for Use | |
|---|---|
| ------------------------- | -- |
| Page 1 of 1 | |
|---|---|
| 510(k) Number: | K013728 (To be assigned) |
| Device Name: | TrachVox |
| Intended Use: | For patients breathing spontaneously via a tracheostomy tube, the TrachVox provides heat and humidity for entrained air and incorporates a cough relief and suction port valve. The unit may be closed by the patient's finger, which directs the air through the vocal cords to facilitate speech.For patients breathing spontaneously via an endotracheal tube (ET tube) the TrachVox provides heat and moisture for the inhaled air. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
le Aulutohn
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 11/01/3728
Prescription Use
(Per CFR 801.109)
or
Over-the-counter use__________________________________________________________________________________________________________________________________________________________
§ 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.