(135 days)
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.
The ISIS Tube is a single-use, sterile tracheal tube made of 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. ISIS Tube will be 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Teleflex ISIS HVT Tracheal Tube:
Summary of Acceptance Criteria and Device Performance:
The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining explicit performance acceptance criteria with numerical targets. The "Summary of Testing" section indicates that the device meets relevant international standards and that its suction/aspiration capability is equivalent to predicate devices.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Conformance to ISO 5361 (Anesthetic and Respiratory Equipment) | Tube meets ISO 5361 standards. |
| Conformance to ISO 5356-1 (Conical Connectors) | Tube meets ISO 5356-1 standards. |
| Conformance to ISO 10993 (Biological Evaluation of Medical Devices) | Tube meets ISO 10993 standards. |
| Conformance to ISO 14971 (Risk Management) | Tube meets ISO 14971 standards. |
| Conformance to ISO 11135 (Sterilization) | Tube meets ISO 11135 standards. |
| Equivalent suction/aspiration capability to predicate devices | Bench testing determined suction/aspiration capability is equivalent to K822082, K965132, and K081086. |
Study Information:
Based on the provided text, the study conducted is primarily bench testing for equivalence and conformance to international standards.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify the sample size for the test set used during the bench testing or compliance checks.
- The data provenance is not specified beyond "Bench testing determined...". It's likely in-house testing conducted by Teleflex Medical, Inc.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided as the study described is bench testing against standards and predicate devices, not studies involving human (e.g., clinical) interpretation or ground truth establishment by experts in that context.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided as the documentation describes bench testing for technical specifications and comparative performance, not a study requiring adjudication of human-derived data or expert consensus.
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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:
- No, an MRMC comparative effectiveness study was not done. This document describes a medical device (tracheal tube), not an AI-powered diagnostic system where human reader performance would be a relevant metric.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance evaluation was not done. This device is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the bench testing appears to be objective measurements and specifications defined by the referenced ISO standards and the measured performance of predicate devices. For example, the suction/aspiration capability was compared directly to that of other legally marketed devices.
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The sample size for the training set:
- This information is not applicable as the document describes the evaluation of a physical medical device, not an AI model that requires a training set.
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How the ground truth for the training set was established:
- This information is not applicable as the document describes the evaluation of a physical medical device, not an AI model.
In summary, the provided submission is an Abbreviated 510(k) for a medical device (tracheal tube). The "study" described is primarily bench testing and conformance to recognized standards, aiming to demonstrate substantial equivalence to existing predicate devices. It does not involve AI, human reader studies, or the methodologies typically associated with software-as-a-medical-device (SaMD) evaluations.
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091761
Abbreviated 510(k)
Teleflex ISISTM HVTTM Tracheal Tube, Cuffed with Subglottic Secretion Suction Port
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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 919-433-4996 Fax:
Section 5 - Summary of Safety and Effectiveness
B. Contact Person
OCT 2 9 2009
William Heard Regulatory Affairs Specialist
C. Date Prepared
May 15, 2009
D. Device Name
Trade Name: TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port (ISIS Tube) Common Name: Tracheal Tube
Classification Name: Tracheal Tube (W/Wo Connector) (21 CFR 868.5730, Product Code BTR)
E. Device Description
The ISIS Tube is a single-use, sterile tracheal tube made of 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. ISIS Tube will be 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.
Teleflex Medical, Inc.
CONFIDENTIAL
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F. Indications for Use
The ISIS Tube 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. Contraindications
There are no known contraindications.
H. Substantial Equivalence
The proposed ISIS Tube is substantially equivalent to the predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Sheridan HVT, Cuffed,Uncuffed Tracheal Tube | Teleflex Medical, Inc. | K822082 | 08/10/1982 |
| Hi-Lo Evac and Evac IIEndotracheal Tubes | Mallinckrodt Medical | K965132 | 03/20/1997 |
| Portex Blue Line Sacett SuctionAbove the Cuff Tracheal Tube | Smiths Medical ASD,Inc. | K081086 | 08/13/2008 |
I. Summary of Testing
The proposed ISIS Tube device meets the following standards: ISO 5361, ISO 5356-1, ISO 10993, ISO 14971, and ISO 11135. Bench testing determined that the suction/aspiration capability of the ISIS Tube is equivalent to the predicate devices.
J. Substantial Equivalence
The proposed ISIS Tube is substantially equivalent in intended use, design, performance and principles of operation to the identified predicate devices cleared under 510(k)s K822082, K965132 and K081086: The differences between the ISIS Tube and the predicated devices are minor and raise no new issues of safety and efficacy. The ISIS Tube is substantially equivalent to the currently marketed predicate devices.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three branches extending upwards.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mr. William Heard Regulatory Affairs Specialist Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, North Carolina 27709
OCT 2 9 2009
Re: K091761
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 15, 2009 Received: October 16, 2009
Dear Mr. Heard:
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 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 - Mr. Heard
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-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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Peanes
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
Page 1 of 1
510(k) Number:
Device Name:
TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port
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.
Prescription Use XX (Part 21 CFR 801 Subpart D)
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)
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091761
§ 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).