(119 days)
For use in injecting local anesthetics into a patient to provide regional anesthesia.
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.
This document is a 510(k) premarket notification for a medical device called the Entellus Medical Reinforced Anesthesia Needle. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria with respect to a clinical outcome.
Therefore, much of the requested information cannot be extracted from this document, as it pertains to a different type of device evaluation (a clinical trial or a standalone performance study of an AI/diagnostic device).
However, I can provide what is present in the document about the performance data and the comparison to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria with numerical targets for clinical performance (e.g., sensitivity, specificity, accuracy). Instead, it states that the device "meets design specifications and performed as intended" based on various engineering and biocompatibility tests. The "performance" here refers to meeting technical specifications rather than clinical efficacy metrics.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Meets ISO 10993-1 standards; included cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, and pyrogen testing. |
| Sterilization Validation | Meets ISO 11137-1 standards. |
| Design Verification | Included dimensional, strength, and Human Factors Engineering & Usability Engineering (HFE/UE) testing. Meets design specifications. |
| Design Validation | Included HFE/UE testing. Performed as intended. |
| Packaging | Performance testing completed. |
| Shelf Life | Performance testing completed per ISO 594-2, ISO 9626, and ISO 7864. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The "test set" in this context refers to the samples used for the engineering, biocompatibility, and sterilization tests, not a clinical data set. The document does not specify the number of devices or units tested for each performance criterion.
- Data Provenance: Not applicable for clinical data. The tests are laboratory-based engineering and biocompatibility tests of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for these types of tests is typically established by laboratory standards and protocols (e.g., ISO standards), rather than expert medical consensus on patient cases.
4. Adjudication method for the test set
Not applicable. This is not a clinical study involving human judgment or adjudication of patient cases.
5. 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
Not applicable. This is not an AI/CAD device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/CAD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests conducted (biocompatibility, sterilization, dimensional accuracy, strength, HFE/UE) would be established by the relevant engineering and medical device standards (e.g., ISO, internal design specifications) rather than clinical outcomes or expert consensus on patient data.
8. The sample size for the training set
Not applicable. This is not an AI/CAD device, and therefore no "training set" in the context of machine learning was used.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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.
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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 (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,
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
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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)
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510(k) Summary
| Date Prepared:Submitter Information: | March 13, 2017Entellus Medical, Inc.3600 Holly lane North, Suite 40Plymouth, MN 55447 |
|---|---|
| Establishment Registration: | 3006345872 |
| Contact Information: | Karen E. PetersonVice President Clinical, Regulatory and Quality(763) 463-7066kpeterson@entellusmedical.com |
| 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 andCompany [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
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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.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).