(281 days)
K110269 - Well Lead Endotracheal Tube with Evacuation Lumen
No
The device description and performance studies focus on the physical characteristics and standard testing of an endotracheal tube, with no mention of AI or ML capabilities.
No.
A therapeutic device is one that treats a disease or condition. This device is used for airway management and suctioning, which are supportive functions, not direct treatments of a disease.
No
This device, an endotracheal tube, is used for airway management, including mechanical ventilation and suctioning of secretions, which are therapeutic and management functions, not diagnostic ones. It does not identify or detect a disease or condition.
No
The device description clearly details a physical, cuffed endotracheal tube made of materials like polyvinylchloride and polyurethane, with lumens, connectors, and a radiopaque line. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Salter Labs Trach-Vac endotracheal tube is a medical device used for airway management, specifically for intubation, ventilation, and suctioning within the trachea. It is a physical device inserted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a procedure involving direct interaction with the patient's airway, not the analysis of biological samples.
- Device Description: The description details the physical components and function of the tube for airway management, not for diagnostic testing.
Therefore, the Salter Labs Trach-Vac endotracheal tube falls under the category of a medical device used for treatment and management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Salter Labs Trach-Vac endotracheal tubes are indicated for nasal or oral intubation of the trachea for anesthesia and airway management, including mechanical ventilation and suctioning of accumulated subglottic secretions in the trachea of adult patients.
Product codes
BTR
Device Description
The Salter Labs Trach-Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyurethane).
The Salter Labs Trach-Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff™ (6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 mm ID) are cuffed, sterile, single-use devices supplied with a standard 15mm conical connector. It is made of primarily of polyvinylchloride with a polyurethane (PU) cuff. In addition to the main lumen, the tube has a separate cuff inflation line and Evac lumen which has a dorsal opening above the cuff. A capped luer-style connection tube allows access to the separate lumen, enabling the health care professional to apply the suction to remove patient secretions. The tube incorporates a Magill curve, a hooded tip with two Murphy Eyes and a radiopaque line over the full length of the tube to assist in radiographic visualization.
The Salter Labs Trach-Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyvinylchloride).
The Salter Labs Trach-Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff™ (6.0, 6.5, 7.0. 7.5, 8.0. 8.5, 9.0 mm ID) are cuffed, sterile, single-use devices supplied with a standard 15mm conical connector. The tubing is made of primarily of polyvinylchloride (PVC) with a PVC cuff. In addition to the main lumen, the tube has a separate cuff inflation line and Evac lumen which has a dorsal opening above the cuff. A capped luer-style connection tube allows access to the separate lumen, enabling the health care professional to apply the suction to remove patient secretions. The tube incorporates a Magill curve, a hooded tip with two Murphy Eyes and a radiopaque line over the full length of the tube to assist in radiographic visualization in the trachea after they pass through the vocal cords.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic visualization
Anatomical Site
Trachea
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Professional use only: Intubation in the field (emergency medical services) or hospital environment, including ER, OR, and ICU.
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)
Non-clinical Testing Summary -
Bench testing -
- Bench testing specific to
- ISO 5361-1 (2016) ET Tubes o
- o ISO 80369-7 (2016) Luer fitting
- o ISO 5356-1 (2016) = Conical Connectors = 15/22 mm
- Age testing ●
Clinical Testing Summary -
There was no clinical testing performed.
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.
K110269 - Well Lead Endotracheal Tube with Evacuation Lumen
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.
K100546 - Parker ET Tube with Flex Tip
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
§ 868.5730 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
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Salter Labs, Inc. % Paul Dryden Consultant Salter Labs 2365 Camino Vida Roble Carlsbad, California 92011
Re: K190878
Trade/Device Name: Salter Labs Trach-Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter Thin Cuff Salter Labs Trach-Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff Regulation Number: 21 CFR 868.5730
Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: December 10, 2019 Received: December 12, 2019
Dear Paul Dryden:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K190878
Device Name
Salter Labs Trach-Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM and Salter Labs Trach-Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuffTM
Indications for Use (Describe)
The Salter Labs Trach-Vac endotracheal tubes are indicated for nasal or oral intubation of the trachea for anesthesia and airway management, including mechanical ventilation and suctioning of accumulated subglottic secretions in the trachea of adult patients.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary January 7, 2020
| Official Contact: | | Salter Labs
2365 Camino Vida Roble
Carlsbad, CA 92011
Mara Caler – Regulatory Affairs |
|----------------------------|-----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Correspondent: | | Tel: 760-795-7094
Paul Dryden, Consultant
ProMedic, LLC
E - paul.dryden@promedic.cc
T - 239-307-6061 |
| Proprietary or Trade Name: | and | Salter Labs Trach- Vac Endotracheal Tube (SFTVPU) Subglottic
Suction Tube with Salter Flex-Tip™ and Salter ThinCuff ™
Salter Labs Trach- Vac Endotracheal Tube (SFTVVC) Subglottic
Suction Tube with Salter Flex-Tip™ and Salter ThinCuff ™ |
| Common/Usual Name: | | Tracheal Tube (w and w/o connector) |
| Classification Name: | | BTR - tube, tracheal (w/wo connector)
21CFR 868.5730, Class II |
| Predicate Device: | | K110269 - Well Lead Endotracheal Tube with Evacuation Lumen |
| Reference Device: | | K100546 - Parker ET Tube with Flex Tip |
Device Description:
The Salter Labs Trach-Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyurethane).
The Salter Labs Trach-Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff™ (6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 mm ID) are cuffed, sterile, single-use devices supplied with a standard 15mm conical connector. It is made of primarily of polyvinylchloride with a polyurethane (PU) cuff. In addition to the main lumen, the tube has a separate cuff inflation line and Evac lumen which has a dorsal opening above the cuff. A capped luer-style connection tube allows access to the separate lumen, enabling the health care professional to apply the suction to remove patient secretions. The tube incorporates a Magill curve, a hooded tip with two Murphy Eyes and a radiopaque line over the full length of the tube to assist in radiographic visualization.
The Salter Labs Trach-Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyvinylchloride).
The Salter Labs Trach-Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff™ (6.0, 6.5, 7.0. 7.5, 8.0. 8.5, 9.0 mm ID) are cuffed, sterile, single-use devices supplied with a standard 15mm conical connector. The tubing is made of primarily of polyvinylchloride (PVC) with a PVC cuff. In addition to the main lumen, the tube has a separate cuff inflation line and Evac lumen which has a dorsal opening above the cuff. A capped luer-style connection tube allows access to the separate lumen, enabling the health care professional to apply the suction to remove patient secretions. The tube incorporates
4
510(k) Summary
January 7, 2020
a Magill curve, a hooded tip with two Murphy Eyes and a radiopaque line over the full length of the tube to assist in radiographic visualization in the trachea after they pass through the vocal cords.
Indications for Use:
The Salter Labs Trach-Vac Endotracheal Tubes are indicated for nasal or oral intubation of the trachea for anesthesia and airway management, including mechanical ventilation and suctioning of accumulated subglottic secretions in the trachea of adult patients.
Device Comparison
Table 1 compares the subject device to the predicate
5
510(k) Summary January 7, 2020
Table 1 - Comparison of Proposed vs. Predicate Device
| Specifications | Predicate K110269
Well Lead Endotracheal Tube with Evacuation Lumen | Subject device
Salter Labs Cuffed Trach-Vac Flex Tip ET Tube | Changes |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| | Device Use & General Characteristics | | |
| Regulation | 21 CFR 868.5730 | 21 CFR 868.5730 | Same |
| Class name | Tube, Tracheal (w/wo connector) | Tube, Tracheal (w/wo connector) | Same |
| Product code | 73 BTR | 73 BTR | Same |
| Intended Use | The Well Lead Endotracheal Tube with Evacuation Lumen
is intended for Oral intubation and drainage of the
subglottic space for airway management. | The Salter Labs Trach-Vac Endotracheal Tube
Subglottic Suction Tube with Salter Flex-Tip™ and
Salter ThinCuff™ is indicated for airway management
by oral intubation during mechanical ventilation and
anesthesia including the capability to aid in the
removal of Subglottic secretions. | Similar with
details related to
the tip design |
| Target Patient
Population | The device is indicated for patients who require airway
management via an endotracheal tube with subglottic
suctioning. | The device is indicated for adult patients who require
airway management via an endotracheal tube with
subglottic suctioning. | Both devices are
intended for adults.
however the
predicate wording
did not include the
specifics |
| Indications for use | The device is intended for oral intubation and drainage of
the subglottic space for airway management. | The Salter Labs Trach-Vac Endotracheal Tubes are
indicated for nasal or oral intubation of the trachea for
anesthesia and airway management, including
mechanical ventilation and suctioning of accumulated
subglottic secretions in the trachea of adult patients. | Similar anatomical
locations and
population |
| Environment of
use | Hospital, ICU | Professional use only: Intubation in the field
(emergency medical services) or hospital environment,
including ER, OR, and ICU. | The environments
of use are similar.
Use in the pre-
hospital
environment is
also by trained
providers |
| Principal of
Operation and | a. The device is packaged individually and supplied sterile
with a standard 15mm connector. | a. The device is packaged individually and supplied
sterile with a standard 15mm connector. | Same |
6
510(k) Summary
January 7, 2020
| January
| ) | 2020 | |
|---|---|---|
| -------------- | -- | ------ |
| Specifications | Predicate K110269
Well Lead Endotracheal Tube with Evacuation Lumen | Subject device
Salter Labs Cuffed Trach-Vac Flex Tip ET Tube | Changes |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | Device Use & General Characteristics | | |
| Mechanisms of
Action | b. The endotracheal tube has a curved construction with
primary lumen for patient ventilation. Two (2) narrower
lumens within the primary wall are used for cuff
inflation and subglottic evacuation (vacuum). | b. The endotracheal tube has a curved construction
with primary lumen for patient ventilation. Two (2)
narrower lumens within the primary wall are used
for cuff inflation and subglottic evacuation
(vacuum). | Same |
| | c. A low pressure, conformable cuff is inflated through the
inflation line with pilot balloon using a standard 10cc
syringe (air only) through a one-way check valve. | c. A low pressure, conformable cuff is inflated through
the inflation line with pilot balloon using a standard
10cc syringe (air only) through a one-way check
valve. | Same |
| | d. For evacuation of subglottic secretions, a separate
suction line connects to standard hospital vacuum
receptacles. Once properly intubated, subglottic
secretions are evacuated through the suction line just
superior to the cuff. | d. For evacuation of subglottic secretions, a separate
suction line connects to standard hospital vacuum
receptacles. Once properly intubated, subglottic
secretions are evacuated through the suction line just
superior to the cuff. | Same |
| | e. To facilitate proper positioning, the suction appendage
and lumen line marker are radiopaque. | e. To facilitate proper positioning, the suction
appendage and lumen line marker are radiopaque. | Same |
| Sterile or
Non-Sterile | Sterile | Sterile | Same |
| Sterilization | Ethylene oxide | Ethylene oxide | Same |
| Use | Single patient/ single use only | Single patient / single use only | Same |
| | Biocompatibility of Patient Contacting Materials | | |
| ISO 10993-1 | Externally Communicating / Tissue and
Surface Contact / Mucosal
Prolonged Duration of Use (> 24 hr, 24 hr, 24 hours and