(130 days)
Not Found
No
The device description and intended use focus on the physical components and function of a tracheal tube, with no mention of AI or ML capabilities. The performance studies are bench tests comparing it to a predicate device, not evaluating algorithmic performance.
No.
The device is used for airway management and secretion removal, which are supportive functions, not direct therapeutic treatments for a disease or condition. Its purpose is to facilitate other medical procedures (mechanical ventilation, anesthesia) and manage a common complication (secretions), rather than providing a direct cure or treatment.
No
Explanation: The device is a tracheal tube used for airway management, mechanical ventilation, and removal of subglottic secretions. Its intended use is therapeutic and supportive, not for diagnosing medical conditions.
No
The device description clearly outlines a physical medical device (tracheal tube) made of materials like polyvinyl chloride, with physical components like a cuff, inflation line, pilot balloon, and suction port. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Description and Intended Use: The description and intended use clearly state that this is a tracheal tube used for airway management during mechanical ventilation and anesthesia, and for removing subglottic secretions. This is a device that is inserted into the body and directly interacts with the patient's airway.
- No Mention of Specimens or In Vitro Testing: There is no mention of examining specimens (like blood, urine, tissue, etc.) or performing any tests outside of the body.
Therefore, the Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Port is a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TELEFLEX ISIS™ HVTTM Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is indicated for airway management by oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.
Product codes
BTR
Device Description
The Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is a single-use, sterile tracheal tube made of a polyvinyl chloride tube body, cuff inflation line and a compatible pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the tracheal tube. Each tracheal tube is supplied with an appropriately sized 15mm connector. The Teleflex ISIS™ HVTTM Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is sold in Murphy eye style. Each tube has a dorsal lumen with an opening above the cuff and a male suction connector port attached to the tube, which is close to the machine end of the tube. Access to the suction lumen is accomplished via a connection of the suction accessory pack (P/N 5-23000) directly to the male suction connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
locations where endotracheal intubation may be performed.
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)
Bench testing has been performed to verify that the performance of the proposed Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is substantially equivalent to the predicate device, and that the Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port will perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 24,2014
Teleflex Medical, Inc. James Cochie Sr. Regulatory Affairs Specialist 2917 Weck Dr. Research Triangle Park, NC 27709
Re: K141939
Trade/Device Name: Teleflex ISIS HVT Tracheal Tube, Cuffed With Subglottic Secretion Suction Port Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: October 28, 2014 Received: October 29, 2014
Dear Mr. Cochie,
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.
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 (reporting of medical device
1
related 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Susan Runne DDS, mA
Erin Keith Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141939
Device Name
TELEFLEX ISIS™ HVTM Tracheal Tube, Cuffed with Subglottic Secretion Suction Port
Indications for Use (Describe)
The TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Port is indicated for airway management by oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port
510(k) Summary
510(k) SUMMARY
TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8083 Fax: 919-433-4996
B. Contact Person
James Cochie Sr. Regulatory Affairs Specialist
C. Date Prepared
November 24, 2014
D. Device Name
Trade Name: Teleflex ISIS™ HVTTM Tracheal Tube, Cuffed with Subglottic Secretion Suction Port
Common Name: Tracheal Tube
Classification Name: Tracheal Tube (W/Wo Connector) (21 CFR 868.5730, Product Code BTR)
E. Device Description
The Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is a single-use, sterile tracheal tube made of a polyvinyl chloride tube body, cuff inflation line and a compatible pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the tracheal tube. Each tracheal tube is supplied with an appropriately sized 15mm connector. The Teleflex ISIS™ HVTTM Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is sold in Murphy eye style. Each tube has a dorsal lumen with an opening above the cuff and a male suction connector port attached to the tube, which is close to the machine end of the tube. Access to the suction lumen is accomplished via a connection of the suction accessory pack (P/N 5-23000) directly to the male suction connector.
4
Section 29 - 510(k) Summary
F. Indications for Use
The Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is indicated for airway management by oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.
G. Target Population
This device is intended for use on adult patients
H. Intended Environment of use
This device is intended for locations where endotracheal intubation may be performed.
This product is single use only.
I. Contraindications
There are no known contraindications.
J. Substantial Equivalence
The modified Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is substantially equivalent to the predicate device:
| Comparative
Characteristics | Proposed Device,
Teleflex ISIS™ HVT™
Tracheal Tube, Cuffed with
Subglottic Secretion
Suction Port | Predicate Device,
Teleflex ISIS™ HVT™
Tracheal Tube, Cuffed with
Subglottic Secretion
Suction Port |
|--------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Teleflex Medical, Inc. | Teleflex Medical, Inc. |
| 510(k) Number | N/A | K091761 |
| Indications for Use | Identical | The Teleflex ISIS™ HVT™
Tracheal Tube, Cuffed with
Subglottic Secretion Suction
Port is indicated for airway
management by oral
intubation during mechanical
ventilation and anesthesia
including the capability to aid
in the removal of subglottic
secretions. |
| Main Tube | Identical | Yes |
| Inflation Line | Identical | Yes |
5
Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port
| Pilot Balloon | Identical | Yes |
|---|---|---|
| Bi-directional Valve | Identical | Yes |
| Cuff Balloon | Identical | Yes |
| 15mm Connector | Identical | Yes |
| Male Suction Lumen | ||
| Connector | Identical | Yes |
| Black Ink | Printing Ink – 2405 Black Ink, Markem-Imaja Solvent – Medical Ink Reducer, Colorcon | Black Ink, Nazdar Thinner, Nazdar Retarder, Nazdar |
| Descriptive Size (ID) | Identical | 6.0mm, 6.5mm, 7.0mm, |
| 7.5mm, 8.0mm, 8.5mm, | ||
| 9.0mm | ||
| Biocompatibility | Identical | Meets ISO 10993-1 |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Single Use | Yes | Yes |
| Shelf Life | 12 Months (extending to 60 | |
| months as data becomes | ||
| available) | 12 Months (extending to 60 | |
| months as data becomes | ||
| available) | ||
| Packaging | Identical | 10 individually packaged in |
| either banana pack or Tyvek | ||
| pouches per dispenser box |
Section 29 – 510(k) Summary
K. Non-clinical Comparative Performance Testing
Bench testing has been performed to verify that the performance of the proposed Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is substantially equivalent to the predicate device, and that the Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port will perform as intended.
| Test | Reference to Standard (if | Principle of Test |
|---|---|---|
| Performed | applicable) | |
| Ink adherence | ISO 5361, Section 5.3.2 (check | Ink adherence is tested by application |
| compliance by inspection, as | and removal of tape to the inked surface | |
| indicated in 6.4.1 of ASTM | according to the test parameters and | |
| D3002. | inspected to a rating scale. | |
| Cytotoxicity | ISO 10993-5, Biological | Tests the potential biological reactivity of |
| Evaluation of Medical Devices - | a mammalian cell culture in response to | |
| Part 5: Tests for In Vitro | exposure to the extract of the test article. | |
| Cytotoxicity | ||
| Irritation | ISO 10993-10, Biological | Test the potential of the test article to |
| Evaluation of Medical Devices - | produce primary skin irritation after | |
| Part 10: Tests for Irritation and | topical application when extracted in | |
| Skin Sensitization | sodium chloride for injections and | |
| cottonseed oil. |
6
Teleflex ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port
| Sensitization | ISO 10993-10, Biological
Evaluation of Medical Devices –
Part 10: Tests for Irritation and
Skin Sensitization | Test the potential of the test article to
produce allergenic reaction when
extracted in sodium chloride and
cottonseed oil. |
|------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Extractables
& Leachables | N/A | Assesses the ET tube relative to
leachable/extractable profiles with
GC/MS, LC/MS, LC/UV, ICP and FTIR
under clinical use conditions |
Section 29 – 510(k) Summary
L. Substantial Equivalence
The modified Teleflex ISIS™ HVTTM Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is substantially equivalent in intended use, design, performance and principles of operation to the identified predicate device cleared under 510(k) K091761. The differences between the ISIS Tube and the predicated device are minor and raise no new issues of safety and efficacy. The ISIS Tube is substantially equivalent to the currently marketed predicate device.