Who is the manufacturer of FAHL TRACHEOSTOMY TUBES (MULTIPLE)?

Andreas Fahl Medizintechnik-Vertrieb GmbH filed the 510(k) submission for FAHL TRACHEOSTOMY TUBES (MULTIPLE) (K123699).

What is the FDA product code for FAHL TRACHEOSTOMY TUBES (MULTIPLE)?

JOH. It is classified under 21 CFR 868.5800 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for FAHL TRACHEOSTOMY TUBES (MULTIPLE)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for FAHL TRACHEOSTOMY TUBES (MULTIPLE)?

Primed Tracheostomy Tubes (Multiple) (K120079); Tracoe Twist Tracheostomy Tubes (K961449); Tracheostomy Tube and Cuff by Portex (K912124).

Who can help prepare an FDA 510(k) submission like FAHL TRACHEOSTOMY TUBES (MULTIPLE)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FAHL TRACHEOSTOMY TUBES (MULTIPLE)

K123699 · Andreas Fahl Medizintechnik-Vertrieb GmbH · JOH · Aug 12, 2013 · Anesthesiology

Device Facts

Record ID	K123699
Device Name	FAHL TRACHEOSTOMY TUBES (MULTIPLE)
Applicant	Andreas Fahl Medizintechnik-Vertrieb GmbH
Product Code	JOH · Anesthesiology
Decision Date	Aug 12, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5800
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

Fahl Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.

Device Story

Fahl Tracheostomy Tubes provide tracheal access for airway management in tracheostomized patients. Available in multiple models (Duravent, Duracuff, Laryngotec, Duratwix, Silvervent, Spiraflex, Tracheotec), the devices are manufactured from medical-grade polymers or sterling silver. They are provided in various sizes, lengths, and configurations (cuffed/uncuffed, sieved/unsieved, with/without inner cannulas). Accessories include HME filters, decannulation plugs, neck holders, and stoma buttons. The tubes are inserted into the trachea to maintain an open airway; physicians select the specific model and size based on individual patient anatomy and clinical needs. The devices are intended for adult use only and are available by prescription. They facilitate ventilation or airway maintenance, potentially improving patient respiratory status.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included measurements per ISO 5366-1, leak-tightness of cuffs and connectors per ISO 5356-1, tensile strength of neck flange attachments, and biocompatibility per ISO 10993-1/7. All tested specifications passed.

Technological Characteristics

Materials: medical-grade polymers (radiolucent) or sterling silver. Features: 15mm/22mm connectors, low-pressure cuffs, integrated pilot lines, adjustable neck flanges, and metal spiral reinforcement. Standards: ISO 5356-1 (connectors), ISO 5366-1 (tracheostomy tubes), ISO 10993-1/7 (biocompatibility/sterilization residuals). Sterilization: Ethylene Oxide (ISO 11135).

Indications for Use

Indicated for airway management in adult tracheostomized patients requiring tracheal access.

Regulatory Classification

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.

Predicate Devices

Primed Tracheostomy Tubes (Multiple) (K120079)
Tracoe Twist Tracheostomy Tubes (K961449)
Tracheostomy Tube and Cuff by Portex (K912124)

Submission Summary (Full Text)

{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

FAHL TRACHEOSTOMY TUBES (MULTIPLE)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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FAHL TRACHEOSTOMY TUBES (MULTIPLE)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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