(252 days)
Fahl Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.
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.
The provided text describes the performance data for Fahl Tracheostomy Tubes (Duravent, Laryngotec, Duracuff, Silvervent, Duratwix, Tracheotec, Spiraflex). The study described is a series of tests against established international standards rather than a clinical trial with human subjects/patients. Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information) are not applicable or cannot be extracted from this type of regulatory document.
Here's a breakdown of the acceptance criteria and performance as reported:
1. Table of Acceptance Criteria and Reported Device Performance:
| Requirement/Tested Specification | Acceptance Criteria (Implied by "Passed") | Reported Device Performance (All Fahl Tracheostomy Tubes included in the test unless otherwise specified) |
|---|---|---|
| Measurements of T. Tubes according to ISO 5366-1 | Conformance to ISO 5366-1 | Passed |
| Leak-Tightness of Tracheostomy tube with cuff according to ISO 5366-1 | Conformance to ISO 5366-1 | Passed (for Duracuff, Duratwix, Tracheotec, Spiraflex; n.a. for others as they are uncuffed or not applicable) |
| Diameter of air filled Cuff according to ISO 5366-1 | Conformance to ISO 5366-1 | Passed (for Duracuff, Duratwix, Tracheotec, Spiraflex; n.a. for others) |
| Tensile Strength to the neck flange according 5366-1 | Conformance to ISO 5366-1 | Passed (for Duravent, Duracuff, Duratwix, Tracheotec, Spiraflex; n.a. for others) |
| Tensile Strength of attachments of the tube to the neck flange 5366-1 | Conformance to ISO 5366-1 | Passed (for Duravent, Duracuff, Tracheotec, Spiraflex; n.a. for Silvervent; Not tested for Duratwix) |
| Measurements of connectors According to ISO 5356-1 | Conformance to ISO 5356-1 | Passed |
| Surface Strength of connectors according to ISO 5356-1 | Conformance to ISO 5356-1 | Passed (n.a. for Silvervent) |
| Leak-Tighteness of Connectors according to 5356-1 | Conformance to ISO 5356-1 | Passed (n.a. for Laryngotec, Silvervent) |
| Biocompatibility according to ISO 10993-1 | Conformance to ISO 10993-1 | Passed (n.a. for Silvervent) |
| Biocompatibility - Ethylene Oxide sterilization residuals according to ISO 100993-7 | Conformance to ISO 100993-7 | Passed (n.a. for Duravent, Silvervent, Tracheotec, Spiraflex; "passed" for all others mentioned explicitly) |
| Validation of Sterilisation according to ISO 11135 | Conformance to ISO 11135 | Passed (Not tested for Laryngotec; "passed" for all others mentioned explicitly) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of units or samples tested for each specification. It generally states that "Test results provide reasonable assurance that the tubes are safe for their intended use."
- Data Provenance: The tests were conducted according to international standards (ISO 5356-1, ISO 5366-1, ISO 10993-1, and ISO 10993-7). The manufacturer is Andreas Fahl Medizintechnik-Vertrieb GmbH in Koeln, Germany, suggesting the testing was performed in a controlled laboratory environment, likely in Germany or a location complying with these international standards. This is prospective testing related to regulatory approval, not retrospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This study involves laboratory testing against established engineering and material standards, not expert clinical review or ground truth derived from expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set:
- Not Applicable. As this is laboratory testing against physical specifications and standards, there is no expert adjudication method as would be typical for clinical studies or AI-driven diagnostic tools.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a regulatory filing for a medical device (tracheostomy tubes), not an AI/software as a medical device (SaMD) or diagnostic imaging study. Therefore, no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This premarket notification is for physical medical devices and does not involve an algorithm or AI.
7. The type of ground truth used:
- Standard Specifications: The "ground truth" for this study is defined by the technical requirements and acceptance criteria outlined in the referenced ISO standards (ISO 5356-1, ISO 5366-1, ISO 10993-1, ISO 10993-7, ISO 11135). The devices either "Passed" or met "n.a." (not applicable) for these standards.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning or AI study, so there is no training set.
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set for this type of device performance testing.
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Fahl Tracheostomy Tubes
| 1 GENERAL INFORMATION | |
|---|---|
| • Manufacturer: | Andreas Fahl Medizintechnik-Vertrieb GmbHAugust-Horch-Str. 4a51149 Koeln / Germany |
| • Establishment Registration Number: | 3007913402 |
| • Contact Person: | Claudia WinterschladenRegulatory Affairs ManagerAndreas Fahl Medizintechnik-Vertrieb GmbHAugust-Horch-Str. 4a51149 Koeln / GermanyPhone: +49 2203 2980-520Fax: +49 2203 2980-517Email: 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-
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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/TestedSpecification | SubjectDevice:Duravent | SubjectDevice:Laryngotec | SubjectDevice:Duracuff | SubjectDevice:Silvervent | SubjectDevice:Duratwix | SubjectDevice:Tracheotec | SubjectDevice:Spiraflex |
|---|---|---|---|---|---|---|---|
| Measurements ofT. Tubes accordingto ISO 5366-1 | Passed | Passed | Passed | Passed | Passed | Passed | Passed |
| Leak-Tightness ofTracheostomy tubewith cuff accordingto ISO5366-1 | n.a. | n.a. | Passed | n.a. | Passed | passed | passed |
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510(k) Summary
Fahl Tracheostomy Tubes
| Requirement/TestedSpecification | SubjectDevice:Duravent | SubjectDevice:Laryngotec | SubjectDevice:Duracuff | SubjectDevice:Silvervent | SubjectDevice:Duratwix | SubjectDevice:Tracheotec | SubjectDevice:Spiraflex |
|---|---|---|---|---|---|---|---|
| Diameter of airfilled Cuffaccording to ISO5366-1 | n.a. | n.a. | Passed | n.a. | Passed | Passed | passed |
| Tensile Strength tothe neck flangeaccording5366-1 | Passed | n.a. | Passed | n.a. | Passed | Passed | passed |
| Tensile Strength ofattachments of thetube to the neckflange 5366-1 | Passed | n.a. | Passed | n.a. | Not tested | Passed | passed |
| Measurementsof connectorsAccording to ISO5356-1 | Passed | Passed | Passed | Passed | Passed | Passed | passed |
| Surface Strengthof connectorsaccording to ISO5356-1 | Passed | Passed | Passed | n.a. | Passed | Passed | passed |
| Leak-Tighteness ofConnectorsaccording to 5356-1 | Passed | n.a. | Passed | n.a. | Passed | Passed | passed |
| Biocompatibilityaccording to ISO10993-1 | Passed | Passed | Passed | n.a. | Passed | Passed | passed |
| Biocompatibility -Ethylene Oxidesterilizationresidualsaccording to ISO100993-7 | n.a. | passed | Passed | n.a. | passed | Passed | passed |
| Validation ofSterilisationaccording to ISO11135 | passed | Not tested | Passed | n.a. | passed | passed | passed |
8 SUBSTANTIAL EQUIVALENCE TABLE
| Feature | SubjectDevice | Predicate | SubjectDevice | Predicate | SubjectDevice | Predicate |
|---|---|---|---|---|---|---|
| Duravent | PrimedistomK120079 | Duracuff | Primedistomw cuffK120079 | Silvervent | PrimediSilverK120079 | |
| Intended Use | Intended toprovidetrachealaccess forairwaymanagementof tracheo-stomizedpatients. | Intended toprovidetrachealaccess forairwaymanagementof tracheo-stomizedpatients. | Intended toprovidetrachealaccess forairwaymanagementof tracheo-stomizedpatients. | Intended toprovidetrachealaccess forairwaymanagementof tracheo-stomizedpatients. | Intended toprovidetrachealaccess forairwaymanagementof tracheo-stomizedpatients. | Intended toprovidetrachealaccess forairwaymanagementof tracheo-stomizedpatients. |
| 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 |
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510(k) Summary
| Feature | SubjectDevice | Predicate | SubjectDevice | Predicate | SubjectDevice | Predicate |
|---|---|---|---|---|---|---|
| Sterile packed | yes | yes | yes | yes | no | no |
| Material | Medicalgrade plastic | Medicalgrade plastic | Medicalgrade plastic | Medicalgrade plastic | Sterlingsilver | Sterlingsilver |
| Prescriptionuse | yes | yes | yes | yes | yes | yes |
| Patientpopulation | adult | adult | adult | adult | adult | adult |
| * These cannulas are also available in shorter and/or extra long. |
| Fahl Tracheostomy Tubes | |
|---|---|
| -- | ------------------------- |
| Feature | SubjectDevice | Predicate | SubjectDevice | Predicate | SubjectDevice | Predicate |
|---|---|---|---|---|---|---|
| Duravent | PrimedistomK120079 | Duracuff | Primedistomw cuffK120079 | Silvervent | PrimediSilverK120079 | |
| Intended Use | Intended toprovidetrachealaccess forairwaymanagementof tracheo-stomizedpatients. | Intended toprovidetrachealaccess forairwaymanagementof tracheo-stomizedpatients. | Intended toprovidetrachealaccess forairwaymanagementof tracheo-stomizedpatients. | Intended toprovidetrachealaccess forairwaymanagementof tracheo-stomizedpatients. | Intended toprovidetrachealaccess forairwaymanagementof tracheo-stomizedpatients. | Intended toprovidetrachealaccess forairwaymanagementof tracheo-stomizedpatients. |
| 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 | Medicalgrade plastic | Medicalgrade plastic | Medicalgrade plastic | Medicalgrade plastic | Sterlingsilver | Sterlingsilver |
| Prescriptionuse | yes | yes | yes | yes | yes | yes |
| Patientpopulation* These cannulas are also available in shorter and/or extra long. | adult | adult | adult | adult | adult | adult |
| Feature | Subject Device | Predicate |
|---|---|---|
| Tracheotec | Portex Blue lineK912124 | |
| Intended Use | Intended to provide tracheal access forairway management of tracheo-stomizedpatients. | Intended to provide tracheal access forairway management of tracheo-stomizedpatients. |
| 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.
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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.
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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
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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
§ 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.