(252 days)
Not Found
No
The summary describes a mechanical medical device (tracheostomy tubes and accessories) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on physical properties and biocompatibility.
No
The device provides mechanical access and support for airflow, but it does not directly treat a disease or condition; it facilitates management for tracheostomized patients.
No
The device is a tracheostomy tube, which is used for providing tracheal access and airway management. It does not identify or detect medical conditions or diseases.
No
The device description clearly outlines physical components like tubes, cuffs, and accessories, and the performance studies detail physical testing of these components. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide tracheal access for airway management of tracheostomized patients." This is a direct intervention on the patient's airway, not a test performed on a sample taken from the body.
- Device Description: The description details physical tubes and accessories used for airway management. There is no mention of reagents, analyzers, or any components used for testing biological samples.
- Lack of IVD Characteristics: The provided information does not include any of the typical characteristics of an IVD, such as:
- Measuring or detecting substances in a sample (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening based on sample analysis
- Mentioning any laboratory procedures or sample handling
This device is a medical device used for direct patient care and airway management, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Fahl Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.
Product codes (comma separated list FDA assigned to the subject device)
BTO, JOH, BTR, BYD
Device Description
The Fahl Tracheostomy Tubes (Duravent, Duracuff, Laryngotec, Duratwix, Silvervent, Spiraflex, and Tracheotec) are available cuffed or uncuffed. They can be obtained sieved or unsieved, with or without speaking valve, cuffed or uncuffed, with or without inner cannulas. The accessories comprise different Humid Moist Exchangers (HME), decannulation plugs, neck holders, and stoma buttons. Fahl offers the tubes in varying sizes and length so that the physician can select a tracheostomy tube, which best fits the individual needs of the patient. All Fahl Tracheostomy Tubes are for adults only and available on prescription.
Duravent (with or without inner cannula), made of soft transparent polymer (radiolucent) with lateral xray contrast strip, sizes 3 to 13, different lengths, with 15 mm connector and/or 22 mm adapter.
Duracuff (with or without inner cannula) made of soft transparent polymer (radiolucent) with lateral xray contrast strip, sizes 7 to 12, different lengths, with 15 mm connector and/or 22 mm adapter, with a low-pressure cuff made of medical grade polymer.
Duratwix (with or without inner cannula), sizes 7 to 10, different lengths, with 15 mm swivel connector, with or without low-pressure cuff, pilot line of cuff is integrated into the outer cannula making the outer shape flush and smooth, available sieved or unsieved.
Silvervent (with inner cannula), made of seamless sterling silver, sizes 0 to 14, with or without 15 mm connector, default bent is 1/4 radius, conical tube (diameter of the tube decreases from neck flange to the cannula tip).
Spiraflex (with 1 inner cannula), with integrated metal spiral, which acts as X-ray contrast; sizes 7 to 11, with 15 mm connector; with an adjustable neck flange
Laryngotec (without inner cannula), made of soft and flexible silicone; size 7 to 13, with 22 mm adapter, neck flange tailored to the neck anatomy.
Tracheotec (without inner cannula), made from soft transparent medical-grade polymer, sizes 3 to 10. with 15 mm connector, with or without low-pressure cuff, pilot line is integrated into the outer cannula making the outer shape flush and smooth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tracheal access
Indicated Patient Age Range
adults only
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Fahl Tracheostomy Tubes conform to applicable parts of the standards ISO 5356-1, ISO 5366-1, ISO 10993-1, and ISO 10993-7. Surface tension, tensile strength of wire-enforced tracheostomy tubes and attachment of the tubes to the neck flange were tested. Test results provide reasonable assurance that the tubes are safe for their intended use.
Summary of results:
- Measurements of T. Tubes according to ISO 5366-1: All subject devices passed.
- Leak-Tightness of Tracheostomy tube with cuff according to ISO 5366-1: Duracuff, Duratwix, Tracheotec, Spiraflex passed. Duravent, Laryngotec, Silvervent (n.a.).
- Diameter of air filled Cuff according to ISO 5366-1: Duracuff, Duratwix, Tracheotec, Spiraflex passed. Duravent, Laryngotec, Silvervent (n.a.).
- Tensile Strength to the neck flange according 5366-1: Duravent, Duracuff, Duratwix, Tracheotec, Spiraflex passed. Laryngotec, Silvervent (n.a.).
- Tensile Strength of attachments of the tube to the neck flange 5366-1: Duravent, Duracuff, Tracheotec, Spiraflex passed. Laryngotec, Silvervent (n.a.). Duratwix (Not tested).
- Measurements of connectors According to ISO 5356-1: All subject devices passed.
- Surface Strength of connectors according to ISO 5356-1: Duravent, Laryngotec, Duracuff, Duratwix, Tracheotec, Spiraflex passed. Silvervent (n.a.).
- Leak-Tighteness of Connectors according to 5356-1: Duravent, Duracuff, Duratwix, Tracheotec, Spiraflex passed. Laryngotec, Silvervent (n.a.).
- Biocompatibility according to ISO 10993-1: Duravent, Laryngotec, Duracuff, Duratwix, Tracheotec, Spiraflex passed. Silvervent (n.a.).
- Biocompatibility - Ethylene Oxide sterilization residuals according to ISO 100993-7: Laryngotec, Duracuff, Duratwix, Tracheotec, Spiraflex passed. Duravent, Silvervent (n.a.).
- Validation of Sterilisation according to ISO 11135: Duravent, Duracuff, Duratwix, Tracheotec, Spiraflex passed. Laryngotec (Not tested), Silvervent (n.a.).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K120079 Primed Tracheostomy Tubes (Multiple) by Primed, K961449 Tracoe Twist Tracheostomy Tubes by Tracoe, K912124 Tracheostomy Tube and Cuff by Portex
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.
Not Found
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).
Not Found
§ 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.
0
Fahl Tracheostomy Tubes
| 1 GENERAL INFORMATION | |
|---|---|
| • Manufacturer: | Andreas Fahl Medizintechnik-Vertrieb GmbH |
| August-Horch-Str. 4a | |
| 51149 Koeln / Germany | |
| • Establishment Registration Number: | 3007913402 |
| • Contact Person: | Claudia Winterschladen |
| Regulatory Affairs Manager | |
| Andreas Fahl Medizintechnik-Vertrieb GmbH | |
| August-Horch-Str. 4a | |
| 51149 Koeln / Germany | |
| Phone: +49 2203 2980-520 | |
| Fax: +49 2203 2980-517 | |
| Email: Winterschladen@fahl.de | |
| • Date summary was prepared: | August 12, 2013 |
| 2 DEVICE IDENTIFICATION | |
| • Proprietary/Trade Name: | Fahl Tracheostomy Tubes: |
- Duravent,
- Duracuff,
- Laryngotec,
- Duratwix,
- Silvervent,
- Spiraflex,
- Tracheotec |
| • Common/Usual Name: | Tracheostomy Tube |
| • Classification Name: | Tracheostomy Tube and Tube Cuff |
| • Regulations Number: | 21 CFR 868.5800 (Product Codes BTO and JOH) together with - 21 CFR 868.5730 (Tube, Tracheal (W/Wo Connector / BTR), and
- 21 CFR 868.5375 (Condenser, Heat and Moisture (Artificial Nose);
BYD; exempt) |
| • Regulatory Class: | Class II |
| • Product Code: | BTO together with - JOH
- BTR
- BYD (Class I; exempt) |
| • Device Panel: | Anesthesiology |
AUG 1 2 2013### 3 PREDICATE DEVICES
There are several predicate devices marketed in the US, which have the same intended use and similar design and technological characteristics. Substantially equivalence of the Fahl Tracheostomy Tubes is claimed to the following predicate devices:
- . K120079 Primed Tracheostomy Tubes (Multiple) by Primed
- . K961449 Tracoe Twist Tracheostomy Tubes by Tracoe
- . K912124 Tracheostomy Tube and Cuff by Portex
4 DEVICE DESCRIPTION
The Fahl Tracheostomy Tubes (Duravent, Duracuff, Laryngotec, Duratwix, Silvervent, Spiraflex, and Tracheotec) are available cuffed or uncuffed. They can be obtained sieved or unsieved, with or without speaking valve, cuffed or uncuffed, with or without inner cannulas. The accessories comprise different Humid Moist Exchangers (HME), decannulation plugs, neck holders, and stoma buttons. Fahl offers the tubes in varying sizes and length so that the physician can select a tracheostomy tube, which best fits the individual needs of the patient. All Fahl Tracheostomy Tubes are for adults only and available on prescription.
5 INDICATIONS OF USE
The Fah! Tracheostomy Tubes are intended to provide tracheal access for airway management of tra-
1
510(k) Summary
Fahl Tracheostomy Tubes
cheostomized patients.
6 TECHNOLOGIC CHARACTERISTICS
The Fahl Tracheostomy Tubes ( Duracuff, Laryngotec, Duratwix, Silvervent, Spiraflex, and Tracheotec) equal the respective predicate devices in materials and sizes. The adoption of the key features of the predicate devices was made intentionally in order to provide efficient and safe products. All Fahl Tracheostomy Tubes are manufactured under clean room conditions and thereby fulfill high requirements with respect to cleanliness.
Duravent (with or without inner cannula), made of soft transparent polymer (radiolucent) with lateral xray contrast strip, sizes 3 to 13, different lengths, with 15 mm connector and/or 22 mm adapter.
Duracuff (with or without inner cannula) made of soft transparent polymer (radiolucent) with lateral xray contrast strip, sizes 7 to 12, different lengths, with 15 mm connector and/or 22 mm adapter, with a low-pressure cuff made of medical grade polymer.
Duratwix (with or without inner cannula), sizes 7 to 10, different lengths, with 15 mm swivel connector, with or without low-pressure cuff, pilot line of cuff is integrated into the outer cannula making the outer shape flush and smooth, available sieved or unsieved.
Silvervent (with inner cannula), made of seamless sterling silver, sizes 0 to 14, with or without 15 mm connector, default bent is 1/4 radius, conical tube (diameter of the tube decreases from neck flange to the cannula tip).
Spiraflex (with 1 inner cannula), with integrated metal spiral, which acts as X-ray contrast; sizes 7 to 11, with 15 mm connector; with an adjustable neck flange
Laryngotec (without inner cannula), made of soft and flexible silicone; size 7 to 13, with 22 mm adapter, neck flange tailored to the neck anatomy.
Tracheotec (without inner cannula), made from soft transparent medical-grade polymer, sizes 3 to 10. with 15 mm connector, with or without low-pressure cuff, pilot line is integrated into the outer cannula making the outer shape flush and smooth.
7 PERFORMANCE DATA
The Fahl Tracheostomy Tubes conform to applicable parts of the standards ISO 5356-1, ISO 5366-1, ISO 10993-1, and ISO 10993-7. Surface tension, tensile strength of wire-enforced tracheostomy tubes and attachment of the tubes to the neck flange were tested. Test results provide reasonable assurance that the tubes are safe for their intended use. The result and data of physical performance are given in the table below:
| Requirement/
Tested
Specification | Subject
Device:
Duravent | Subject
Device:
Laryngotec | Subject
Device:
Duracuff | Subject
Device:
Silvervent | Subject
Device:
Duratwix | Subject
Device:
Tracheotec | Subject
Device:
Spiraflex |
|-----------------------------------------------------------------------------------|--------------------------------|----------------------------------|--------------------------------|----------------------------------|--------------------------------|----------------------------------|---------------------------------|
| Measurements of
T. Tubes according
to ISO 5366-1 | Passed | Passed | Passed | Passed | Passed | Passed | Passed |
| Leak-Tightness of
Tracheostomy tube
with cuff according
to ISO
5366-1 | n.a. | n.a. | Passed | n.a. | Passed | passed | passed |
2
510(k) Summary
Fahl Tracheostomy Tubes
| Requirement/
Tested
Specification | Subject
Device:
Duravent | Subject
Device:
Laryngotec | Subject
Device:
Duracuff | Subject
Device:
Silvervent | Subject
Device:
Duratwix | Subject
Device:
Tracheotec | Subject
Device:
Spiraflex |
|----------------------------------------------------------------------------------------------------|--------------------------------|----------------------------------|--------------------------------|----------------------------------|--------------------------------|----------------------------------|---------------------------------|
| Diameter of air
filled Cuff
according to ISO
5366-1 | n.a. | n.a. | Passed | n.a. | Passed | Passed | passed |
| Tensile Strength to
the neck flange
according
5366-1 | Passed | n.a. | Passed | n.a. | Passed | Passed | passed |
| Tensile Strength of
attachments of the
tube to the neck
flange 5366-1 | Passed | n.a. | Passed | n.a. | Not tested | Passed | passed |
| Measurements
of connectors
According to ISO
5356-1 | Passed | Passed | Passed | Passed | Passed | Passed | passed |
| Surface Strength
of connectors
according to ISO
5356-1 | Passed | Passed | Passed | n.a. | Passed | Passed | passed |
| Leak-Tighteness of
Connectors
according to 5356-
1 | Passed | n.a. | Passed | n.a. | Passed | Passed | passed |
| Biocompatibility
according to ISO
10993-1 | Passed | Passed | Passed | n.a. | Passed | Passed | passed |
| Biocompatibility -
Ethylene Oxide
sterilization
residuals
according to ISO
100993-7 | n.a. | passed | Passed | n.a. | passed | Passed | passed |
| Validation of
Sterilisation
according to ISO
11135 | passed | Not tested | Passed | n.a. | passed | passed | passed |
8 SUBSTANTIAL EQUIVALENCE TABLE
| Feature | Subject
Device | Predicate | Subject
Device | Predicate | Subject
Device | Predicate |
|---------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| | Duravent | Primedistom
K120079 | Duracuff | Primedistom
w cuff
K120079 | Silvervent | Primedi
Silver
K120079 |
| Intended Use | Intended to
provide
tracheal
access for
airway
management
of tracheo-
stomized
patients. | Intended to
provide
tracheal
access for
airway
management
of tracheo-
stomized
patients. | Intended to
provide
tracheal
access for
airway
management
of tracheo-
stomized
patients. | Intended to
provide
tracheal
access for
airway
management
of tracheo-
stomized
patients. | Intended to
provide
tracheal
access for
airway
management
of tracheo-
stomized
patients. | Intended to
provide
tracheal
access for
airway
management
of tracheo-
stomized
patients. |
| Size range | 3 to 13 | 3.5 to 13 | 7 to 12 | 8 to 11 | 0 to 14 | 0 to 14 |
| Length (mm) | 55 to 90* | 55 to 90 | 65 to 90* | 70 to 87 | 50 to 90 | 50 to 90 |
| Bending angle | 90° | 90° | 90° | 90° | 90° | 90° |
| w/wo cuff | wo cuff | wo cuff | Low-
pressure | Low-
pressure | wo cuff | wo cuff |
3
510(k) Summary
| Feature | Subject
Device | Predicate | Subject
Device | Predicate | Subject
Device | Predicate |
|-------------------------------------------------------------------|--------------------------|--------------------------|--------------------------|--------------------------|--------------------|--------------------|
| Sterile packed | yes | yes | yes | yes | no | no |
| Material | Medical
grade plastic | Medical
grade plastic | Medical
grade plastic | Medical
grade plastic | Sterling
silver | Sterling
silver |
| Prescription
use | yes | yes | yes | yes | yes | yes |
| Patient
population | adult | adult | adult | adult | adult | adult |
| * These cannulas are also available in shorter and/or extra long. | | | | | | |
| Fahl Tracheostomy Tubes | |
|---|---|
| -- | ------------------------- |
| Feature | Subject
Device | Predicate | Subject
Device | Predicate | Subject
Device | Predicate |
|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| | Duravent | Primedistom
K120079 | Duracuff | Primedistom
w cuff
K120079 | Silvervent | Primedi
Silver
K120079 |
| Intended Use | Intended to
provide
tracheal
access for
airway
management
of tracheo-
stomized
patients. | Intended to
provide
tracheal
access for
airway
management
of tracheo-
stomized
patients. | Intended to
provide
tracheal
access for
airway
management
of tracheo-
stomized
patients. | Intended to
provide
tracheal
access for
airway
management
of tracheo-
stomized
patients. | Intended to
provide
tracheal
access for
airway
management
of tracheo-
stomized
patients. | Intended to
provide
tracheal
access for
airway
management
of tracheo-
stomized
patients. |
| Size range | 3 to 13 | 3.5 to 13 | 7 to 12 | 8 to 11 | 0 to 14 | 0 to 14 |
| Length (mm) | 55 to 90* | 55 to 90 | 65 to 90* | 70 to 87 | 50 to 90 | 50 to 90 |
| Bending angle | 90° | ರಿಂ | 90° | ಡಿಂ | ರಿಂ | 90° |
| w/wo cuff | wo cuff | wo cuff | Low-
pressure | Low-
pressure | wo cuff | wo cuff |
| Sterile packed | પહર | yes | yes | yes | no | no |
| Material | Medical
grade plastic | Medical
grade plastic | Medical
grade plastic | Medical
grade plastic | Sterling
silver | Sterling
silver |
| Prescription
use | yes | yes | yes | yes | yes | yes |
| Patient
population
- These cannulas are also available in shorter and/or extra long. | adult | adult | adult | adult | adult | adult |
| Feature | Subject Device | Predicate |
|---|---|---|
| Tracheotec | Portex Blue line | |
| K912124 | ||
| Intended Use | Intended to provide tracheal access for | |
| airway management of tracheo-stomized | ||
| patients. | Intended to provide tracheal access for | |
| airway management of tracheo-stomized | ||
| patients. | ||
| Size range | 3 to 10 | 5 to 10 |
| Length (mm) | 47.2 to 105.3 | Not available |
| Bending angle | 95° | 90° |
| w/wo cuff | w/wo low pressure cuff | w/wo low pressure cuff |
| Sterile packed | yes | yes |
| Material | Medical grade plastic | Medical grade plastic |
| Prescription use | yes | yes |
| Patient population | adult | adult |
9 CONCLUSION
Fahl Tracheostomy Tubes have intended use as the predicate devices. The basic design elements and their assemblies are identical to the predicate devices. Variations in size or length do not impose a new risk on the devices as they conform to applicable parts of the ISO 5356-1, ISO 5366-1, ISO 10993-1, and ISO 10993-7. Determination of substantial equivalence of the Fahl Tracheostomy Tubes was based on a comparison of device intended use and materials of composition.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2013
Andreas Fahl Medizintechnik-Vertrieb GmbH Ms. Claudia Winterschladen Regulatory Affairs Manager August-Horch-Str. 4a Koeln, Germany 51149
Re: K123699
Trade/Device Name: Fahl Tracheostomy Tubes (Multiple types: Duravent, Duracuff, Laryngotec, Duratwix, Silvervent, Spiraflex Tracheotec) Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH, BTO, BTR Dated: May 29, 2013 Received: May 31, 2013
Dear Ms. Winterschladen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
Page 2 - Ms. Winterschladen
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. 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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID
FOR Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K123699
Device Name: Fahl Tracheostomy Tubes (Duravent, Duracuff, Laryngotec, Duratwix, Silvervent, Spiraflex, Tracheotec )
Indications For Use: Fahl Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lester W. Schultheis Jr 2013.08.12 14:49:00 -04'00'
')ivision Sign-Off) ision of Anesthesiology, General Hospital :ection Control, Dental Devices
510(k) Number: K123699