Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff

K190878 · Salter Labs, Inc. · BTR · Jan 10, 2020 · Anesthesiology

Device Facts

• Record ID: K190878
• Device Name: Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff
• Applicant: Salter Labs, Inc.
• Product Code: BTR · Anesthesiology
• Decision Date: Jan 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 Story

The Salter Labs Trach-Vac is a sterile, single-use cuffed endotracheal tube designed for airway management and subglottic secretion removal. It features a primary ventilation lumen, a cuff inflation line, and a dedicated subglottic suction lumen with a dorsal opening above the cuff. The device incorporates a Magill curve, a flexible 'Flex-Tip' distal end, two Murphy eyes, and a radiopaque line for visualization. It is operated by trained medical professionals in hospital (ICU, OR, ER) or field settings. The clinician connects the suction lumen's luer-style port to a hospital vacuum source to evacuate secretions pooling above the cuff, potentially reducing the risk of ventilator-associated complications. The device is supplied with a standard 15mm conical connector for integration with ventilation equipment.

Clinical Evidence

No clinical testing performed. Evidence consists of bench testing and biocompatibility evaluations per ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-18, alongside performance testing per ISO 5361-1, ISO 80369-7, and ISO 5356-1.

Technological Characteristics

Materials: Polyvinylchloride (PVC) tube, PVC or Polyurethane (PU) cuff. Design: Magill curve, 6.0-9.0 mm ID, 15mm conical connector, 6% male luer suction port. Features: Flex-Tip, two Murphy eyes, radiopaque line. Sterilization: Ethylene oxide. Connectivity: None (mechanical).

Indications for Use

Indicated for adult patients requiring nasal or oral tracheal intubation for anesthesia, airway management, mechanical ventilation, and suctioning of accumulated subglottic secretions.

Regulatory Classification

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.

Predicate Devices

• Well Lead Endotracheal Tube with Evacuation Lumen (K110269)

Reference Devices

• Parker ET Tube with Flex Tip (K100546)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

EF PSC Publishing Services [phone]

{3}------------------------------------------------

#### 510(k) Summary January 7, 2020

| Official Contact: | | Salter Labs<br>2365 Camino Vida Roble<br>Carlsbad, CA 92011<br>Mara Caler – Regulatory Affairs |
|----------------------------|-----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Correspondent: | | Tel: [phone]<br>Paul Dryden, Consultant<br>ProMedic, LLC<br>E - [e-mail]<br>T - 239-307-6061 |
| Proprietary or Trade Name: | and | Salter Labs Trach- Vac Endotracheal Tube (SFTVPU) Subglottic<br>Suction Tube with Salter Flex-Tip™ and Salter ThinCuff ™<br>Salter Labs Trach- Vac Endotracheal Tube (SFTVVC) Subglottic<br>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)<br>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<br>Well Lead Endotracheal Tube with Evacuation Lumen | Subject device<br>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<br>is intended for Oral intubation and drainage of the<br>subglottic space for airway management. | The Salter Labs Trach-Vac Endotracheal Tube<br>Subglottic Suction Tube with Salter Flex-Tip™ and<br>Salter ThinCuff™ is indicated for airway management<br>by oral intubation during mechanical ventilation and<br>anesthesia including the capability to aid in the<br>removal of Subglottic secretions. | Similar with<br>details related to<br>the tip design |
| Target Patient<br>Population | The device is indicated for patients who require airway<br>management via an endotracheal tube with subglottic<br>suctioning. | The device is indicated for adult patients who require<br>airway management via an endotracheal tube with<br>subglottic suctioning. | Both devices are<br>intended for adults.<br>however the<br>predicate wording<br>did not include the<br>specifics |
| Indications for use | The device is intended for oral intubation and drainage of<br>the subglottic space for airway management. | The Salter Labs Trach-Vac Endotracheal Tubes are<br>indicated for nasal or oral intubation of the trachea for<br>anesthesia and airway management, including<br>mechanical ventilation and suctioning of accumulated<br>subglottic secretions in the trachea of adult patients. | Similar anatomical<br>locations and<br>population |
| Environment of<br>use | Hospital, ICU | Professional use only: Intubation in the field<br>(emergency medical services) or hospital environment,<br>including ER, OR, and ICU. | The environments<br>of use are similar.<br>Use in the pre-<br>hospital<br>environment is<br>also by trained<br>providers |
| Principal of<br>Operation and | a. The device is packaged individually and supplied sterile<br>with a standard 15mm connector. | a. The device is packaged individually and supplied<br>sterile with a standard 15mm connector. | Same |

{6}------------------------------------------------

# 510(k) Summary
January 7, 2020

| January<br>) | | 2020 |
|--------------|--|------|
|--------------|--|------|

| Specifications | Predicate K110269<br>Well Lead Endotracheal Tube with Evacuation Lumen | Subject device<br>Salter Labs Cuffed Trach-Vac Flex Tip ET Tube | Changes |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | Device Use & General Characteristics | | |
| Mechanisms of<br>Action | b. The endotracheal tube has a curved construction with<br>primary lumen for patient ventilation. Two (2) narrower<br>lumens within the primary wall are used for cuff<br>inflation and subglottic evacuation (vacuum). | b. The endotracheal tube has a curved construction<br>with primary lumen for patient ventilation. Two (2)<br>narrower lumens within the primary wall are used<br>for cuff inflation and subglottic evacuation<br>(vacuum). | Same |
| | c. A low pressure, conformable cuff is inflated through the<br>inflation line with pilot balloon using a standard 10cc<br>syringe (air only) through a one-way check valve. | c. A low pressure, conformable cuff is inflated through<br>the inflation line with pilot balloon using a standard<br>10cc syringe (air only) through a one-way check<br>valve. | Same |
| | d. For evacuation of subglottic secretions, a separate<br>suction line connects to standard hospital vacuum<br>receptacles. Once properly intubated, subglottic<br>secretions are evacuated through the suction line just<br>superior to the cuff. | d. For evacuation of subglottic secretions, a separate<br>suction line connects to standard hospital vacuum<br>receptacles. Once properly intubated, subglottic<br>secretions are evacuated through the suction line just<br>superior to the cuff. | Same |
| | e. To facilitate proper positioning, the suction appendage<br>and lumen line marker are radiopaque. | e. To facilitate proper positioning, the suction<br>appendage and lumen line marker are radiopaque. | Same |
| Sterile or<br>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<br>Surface Contact / Mucosal<br>Prolonged Duration of Use (> 24 hr, < 30 days) | Externally Communicating / Tissue and<br>Surface Contact / Mucosal<br>Prolonged Duration of Use (> 24 hr, < 30 days) | Same |
| Design | | | |
| Sizes (ID) | 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 mm | 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 mm | Same |
| Curve | Magill | Magill | Same |
| Murphy eye | Yes - 2 eyes | Yes - 2 eyes | Same |
| Connector<br>(size/type) | 15mm conical | 15mm conical | Same |
| Suction port for | 6% Male Luer connector | 6% Male Luer connector | Same |

{7}------------------------------------------------

# 510(k) Summary January 7, 2020

| Specifications | Predicate K110269<br>Well Lead Endotracheal Tube with Evacuation Lumen | Subject device<br>Salter Labs Cuffed Trach-Vac Flex Tip ET Tube | Changes |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Device Use & General Characteristics | | | |
| removal of<br>secretions that<br>accumulate above<br>the cuff | | | |
| Technological characteristics | | | |
| Technological<br>characteristics | The design is based upon the cuffed Tube with the addition<br>of a third lumen within the tube. It terminates above the<br>cuff via a 'notch' (evacuation port) which enables the<br>entrance (via suction) of secretions which have pooled<br>above the cuff. Half way along the tube length the suction<br>lumen is joined to a suction tube which is external to the<br>main tube. The suction tube is joined to the suction lumen<br>in a similar manner to that of the joint between the inflating<br>tube and the inflating lumen. The distal end of the suction<br>tube terminates in a capped Luer connector which can be<br>connected to either the suction tubing or a syringe. | The design is based upon the cuffed Tube with the<br>addition of a third lumen within the tube. It terminates<br>above the cuff via a 'notch' (evacuation port) which<br>enables the entrance (via suction) of secretions which<br>have pooled above the cuff. Half way along the tube<br>length the suction lumen is joined to a suction tube<br>which is external to the main tube. The suction tube is<br>joined to the suction lumen in a similar manner to that<br>of the joint between the inflating tube and the inflating<br>lumen. The distal end of the suction tube terminates in a<br>capped Luer connector which can be connected to<br>either the suction tubing or a syringe. | Same |
| Shelf life | 5 years | 5 years | Same |

# Differences

The differences between the Salter Labs Trach-Vac Endotracheal Tube with Salter Flex-Tig™ and Salter ThinCuff™ and the Well Lead Endotracheal Tube with Evacuation Lumen are below:

# Table 2 - Differences between Proposed and Predicate

| Features | K110269 | Subject device |
|------------|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tip design | Standard tip | The distal tip of the subject device includes a flexible tip, cleared in the reference device K100546,<br>Parker Medical FLEX-TIP TRACHEAL TUBE. This reference device refers specifically to the<br>design of the flexible tip at the distal end of the tube. |

{8}------------------------------------------------

# Substantial Equivalence Discussion

The proposed Salter Labs Trach-Vac Endotracheal Tube Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff ™ is viewed as substantially equivalent to the predicate device because:

# Indications -

- Both are indicated for airway management by tracheal or oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.
# Patient Population -

- Both are intended for adult patients requiring airway management and may require secretion . suctioning.
# Environment of Use -

- For use in clinical settings by trained medical personnel ●
# Technology and Principle Operation -

- Both are the same of a cuffed tube with a suctioning lumen. .
- The proposed device included the Flex-tip which is similar to the Parker Flex Tip cleared under . K100546.

#### Non-clinical Testing Summary -

We have performed tests appropriate for the proposed device. These tests include:

#### Biocompatibility of Materials -

The materials have been evaluated and tested in accordance with ISO 10993-1. Based upon ISO 10993-1 the subject device would be considered as having two types of patient contact.

- . Externally Communicating / Tissue and
- Surface Contact / Mucosal
- . Prolonged duration (> 24 hours and < 30 days)

The following testing was performed:

- . ISO 10993-5 (2009) - Cytotoxicity
- ISO 10993-10 (2013) Irritation / Intracutaneous Reactivity and Skin Sensitization ●
- ISO 10993-18 (2013) Chemical Characterization with Toxicological Risk Assessment ●

#### 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.

{9}------------------------------------------------

# Substantial Equivalence Conclusion

As established by description, data, and information contained within this 510(k), and as summarized in comparison table, the Salter Labs Trach-Vac Endotracheal Tube Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff ™ is substantially equivalent to the predicate distributed commercially in the U.S. and worldwide. The Salter Labs Trach-Vac Endotracheal Tube Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff ™ has the same Intended Use, Indications for Use nor does it alter the fundamental scientific technology, operation principles, design, or manufacturing process.