Entellus Medical Reinforced Anesthesia Needle

K163435 · Entellus Medical, Inc. · BSP · Apr 5, 2017 · Anesthesiology

Device Facts

• Record ID: K163435
• Device Name: Entellus Medical Reinforced Anesthesia Needle
• Applicant: Entellus Medical, Inc.
• Product Code: BSP · Anesthesiology
• Decision Date: Apr 5, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in injecting local anesthetics into a patient to provide regional anesthesia.

Device Story

The Entellus Medical Reinforced Anesthesia Needle is a 3.5-inch, 27-gauge disposable needle designed for transnasal administration of local anesthetics. It features a reinforcing sleeve to minimize needle flex and a distal bend to facilitate access to nasal anatomy. The device includes a standard luer-lock hub and a Quincke tip that extends 2 mm beyond the sleeve, acting as a distal stop. It is intended for use by clinicians to provide regional anesthesia. The device functions by manual injection of anesthetic solutions. It provides a stable, reinforced delivery mechanism compared to standard needles, potentially improving procedural access and control during nasal interventions.

Clinical Evidence

No clinical or animal testing was performed. Evidence consists of bench testing, including biocompatibility (ISO 10993-1: cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity), sterilization validation (ISO 11137-1), and design verification/validation (dimensional, strength, HFE/UE testing per ISO 594-2, ISO 9626, ISO 7864). Results confirmed the device meets design specifications.

Technological Characteristics

Stainless steel cannula, plastic luer-lock hub. 27-gauge, 3.5-inch length. Features a reinforcing sleeve and 18-degree distal bend. Quincke tip style. Sterile, single-use. Biocompatible per ISO 10993-1. Standards: ISO 594-2 (luer), ISO 9626 (needle tubing), ISO 7864 (sterile needles), ISO 11137-1 (sterilization).

Indications for Use

Indicated for patients requiring regional anesthesia via injection of local anesthetics. No specific contraindications noted.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Predicate Devices

• BD Spinal Needle (K091758)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, often associated with healthcare. The symbol is composed of three interconnected profiles facing to the right, suggesting a sense of unity and collaboration.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002

April 5, 2017

Entellus Medical Inc. Karen Peterson VP Clinical, Regulatory & Quality 3600 Holly Lane North, Suite 40 Plymouth, Minnesota 55447

Re: K163435

Trade/Device Name: Entellus Medical Reinforced Anesthesia Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: February 24, 2017 Received: February 27, 2017

Dear Karen Peterson:

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.

{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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tina Kiang -
s

Tina Kiang, Ph.D. Acting 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) K163435

Device Name

Entellus Medical Reinforced Anesthesia Needle

Indications for Use (Describe) For use in injecting local anesthetics into a patient to provide regional anesthesia.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X | 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 [e-mail]

"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."

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

Image /page/3/Picture/2 description: The image contains the logo for "entellus MEDICAL". To the left of the company name is a circular graphic with blue and black curved lines. The company name is in black, with the word "MEDICAL" in smaller letters below the first word.

#### 510(k) Summary

| Date Prepared:<br>Submitter Information: | March 13, 2017<br>Entellus Medical, Inc.<br>3600 Holly lane North, Suite 40<br>Plymouth, MN 55447 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration: | 3006345872 |
| Contact Information: | Karen E. Peterson<br>Vice President Clinical, Regulatory and Quality<br>[phone]<br>[e-mail] |
| Device Information: | |
| Trade Name: | Entellus Medical Reinforced Anesthesia Needle |
| Common Name: | Needle, Conduction, Anesthetic (w/wo introducer) |
| Classification Regulation: | 21 CFR 868.5150 |
| Classification Name: | Anesthesia conduction needle |
| Classification Panel: | Anesthesiology |
| Device Classification: | Class II |
| Product Code: | BSP |
| Predicate Device | BD Spinal Needle; Becton, Dickinson and<br>Company [K091758] |

#### Device Description:

The Entellus Medical Reinforced Anesthesia Needle is a 3.5" long disposable medical device that allows the user to transnasally administer anesthetic solutions. The Reinforced Anesthesia Needle device is a 27 gauge needle with a reinforcing sleeve which supports the needle to reduce needle flex during administration of anesthetic solutions. A slight bend at the distal end of the needle is designed to improve access to nasal anatomy. The Quincke tip extends approximately 2 mm past the reinforcing sleeve creating a distal stop. The needle hub features a standard luerlock connector.

Image /page/3/Figure/7 description: This image shows a needle with several labels. The first label points to the left side of the needle and says "Needle Hub". The next label is above the needle and says "Needle Reinforcing Sleeve". On the right side of the image, there is a close up of the needle tip with two labels: "Needle Distal Tip (27 ga.)" and "Needle Distal Stop".

Reinforced Anesthesia Needle

{4}------------------------------------------------

# Indications for Use/ Intended Use

For use in injecting local anesthetics into a patient to provide regional anesthesia

### Contraindications:

None known.

### Technological Characteristics:

The technological characteristics of the subject device are very similar to the predicate device [K091758], including: principle of operation, design, function, materials, biocompatibility and sterility.

Both the subject device and predicate device [K091758] are needles comprised of stainless steel cannulae attached to needle luer hubs comprised of plastic. They both provide a means to administer local anesthetic solutions to provide regional anesthesia. Both devices are provided sterile, single use only and are biocompatible per ISO 10993-1. Both device designs incorporate the same Quincke tip style, length, gauge, and luer hub. The subject device reinforcement is provided by a needle reinforcing sleeve whereas the predicate device [K091758] is reinforced by a stylet. The subject device has an 18 degree bend on the distal end whereas the predicate device [K091758] is provided straight.

### Substantial Equivalence:

The indication for use and intended use of the subject device is similar to the predicate device [K091758]; the differences are semantic. The technological characteristics of the subject device are very similar to the predicate device [K091758], including: principle of operation, design, function, materials, biocompatibility, and sterility.

#### Performance Data:

Performance testing for the Reinforced Anesthesia Needle consisted of biocompatibility testing per ISO 10993-1, sterilization validation per ISO 11137-1, design verification, design validation, packaging, and shelf life per ISO 594-2, ISO 9626 and ISO 7864. Biocompatibility testing included cytoxicity, sensitization, intracutaneous reactivity, systemic toxicity, and pyrogen testing. Design verification included dimensional, strength, and Human Factors Engineering & Usability Engineering (HFE/UE) testing. Design validation included HFE/UE testing. Animal and clinical testing were not performed. Performance testing showed that the device meets design specifications and performed as intended.

## Conclusion

In conclusion, the subject device is substantially equivalent to the predicate device based on a comparison of intended use, indications for use, and technological characteristics. The subject device is as safe, as effective, and performs as well as or better than the predicate.