(51 days)
Not Found
No
The summary describes a physical needle with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a needle used to administer anesthetics, which are therapeutic agents, but the needle itself is an instrument for delivery, not a therapeutic device.
No
The device is described as an injection needle for administering anesthetic solutions, not for diagnosis.
No
The device description clearly describes a physical needle, which is a hardware component, not a software-only device. The performance studies also focus on physical properties and biocompatibility of the needle.
Based on the provided information, the Reach Needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for in injecting local anesthetics into a patient to provide regional anesthesia." This is a therapeutic procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a needle used for administering substances into the body. This aligns with a medical device used for treatment or diagnosis in vivo, not in vitro.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Reach Needle's function is to deliver medication, which is a therapeutic action.
N/A
Intended Use / Indications for Use
The Reach Needle is used for in injecting local anesthetics into a patient to provide regional anesthesia.
Product codes (comma separated list FDA assigned to the subject device)
BSP
Device Description
The Reach Needle is a sterile, single use, 4-inch-long needle used for administering anesthetic solutions for regional anesthesia. The Reach Needle is 27-gauge needle that is reinforced to reduce needle flex during administration of anesthesia solutions. The needle tip is a short bevel quincke style tip that extends approximately 2mm past the reinforcing shaft, providing a distal stop for consistent injection depth. The distal end of the needle has a slight bend to help access difficult to reach areas such as nasal anatomy. The needle hub is compatible with luer lock connectors. The Reach Needle is intended for use in adults (>= 22 years).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults (>= 22 years)
Intended User / Care Setting
Not Found
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)
Summary of non-clinical test:
Device Performance was tested to comply to:
- ISO 80369-7
- ISO 9626
- ISO 7864
Package Integrity per ISO 11607-1 and 11607-2.
Reach needle is an externally communicating device with direct tissue contact for limited duration; biocompatibility testing is in compliance with ISO 10993-1 and included: - Cytotoxicity
- Irritation
- Sensitivity
- Systemic toxicity
- Pyrogenicity
Summary of clinical test:
Clinical testing was not necessary for this device.
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.
Entellus Reinforced Anesthesia Needle (K163435)
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.
Not Found
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
§ 868.5150 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 21, 2024
Aerin Medical Inc. Teri Feeley Regulatory Affairs Manager 2565 Leghorn St. Mountain View, California 94043
Re: K240253
Trade/Device Name: Reach Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: January 26, 2024 Received: January 30, 2024
Dear Teri Feeley:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.
2
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,
Image /page/2/Picture/3 description: The image shows the text "Bradley Q. Quinn -S" in a large, sans-serif font. The text is black and is set against a white background. The letters are evenly spaced and the text is easy to read.
Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Reach Needle
Indications for Use (Describe)
The Reach Needle is used for in injecting local anesthetics into a patient to provide regional anesthesia.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/4/Picture/0 description: The image shows the logo for Aerin Medical. The word "Aerin" is in a large, blue, sans-serif font. Below "Aerin" is the word "MEDICAL" in a smaller, sans-serif font. To the right of "Aerin" are several green circles of varying sizes.
510(k) Summary
General Information
| Submitter Information | |
|---|---|
| Company: | Aerin Medical Inc. |
| Submitter address: | 2565 Leghorn St. |
| Mountain View, CA 94043 | |
| Contact Person: | Teri Feeley |
| Regulatory Affairs Manger | |
| Phone: 210-827-1618 | |
| Establishment Registration Number: | 3011625895 |
| Date Prepared: | 15 Mar 2024 |
| Name of Device | |
| Brand Name: | Reach Needle |
| Common Name: | Needle, Conduction, Anesthetic (w/wo introducer) |
| Classification Name: | Anesthesia conduction needle |
| Device Class: | Class II |
| Product Code: | BSP |
| CFR Regulation: | 21 CFR 868.5150 |
| Predicate Device: | Entellus Reinforced Anesthesia Needle (K163435) |
| Device Description |
The Reach Needle is a sterile, single use, 4-inch-long needle used for administering anesthetic solutions for regional anesthesia. The Reach Needle is 27-qauge needle that is reinforced to reduce needle flex during administration of anesthesia solutions. The needle tip is a short bevel quincke style tip that extends approximately 2mm past the reinforcing shaft, providing a distal stop for consistent injection depth. The distal end of the needle has a slight bend to help access difficult to reach areas such as nasal anatomy. The needle hub is compatible with luer lock connectors. The Reach Needle is intended for use in adults (≥ 22 years).
Indications for Use
The Reach Needle is used for injecting local anesthetics into a patient to provide regional anesthesia.
Summary of Technological characteristics compared to the predicate device
The subject device has the same technological characteristics as the predicate including the principle of operation, performance, and design features. The subject device and predicate device both have a stainless-steel cannula that is reinforced with a plastic hub to deliver local anesthetic solutions for regional anesthesia. Both devices are 27-gauge needles with a reinforced sleeve, a quincke style tip, 2mm distal stop, and a bend incorporated at the distal end of the reinforced cannula. The subject device cannula is 4 inches long with a 30° bend and a Short Bevel tip; whereas the predicate device cannula is 3.5 inches long with an 18° bend and long, beveled tip.
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Image /page/5/Picture/0 description: The image shows the logo for Aerin Medical. The word "Aerin" is in a large, blue, sans-serif font. Below "Aerin" is the word "MEDICAL" in a smaller, sans-serif font. To the right of "Aerin" are several green circles of varying sizes, arranged in a pattern.
510(k) Summary
| Subject Device | Predicate Device | |
|---|---|---|
| Intended Use | Same | For use in injecting local |
| anesthetics into a patient to | ||
| provide regional anesthesia. | ||
| Use | Same | Single use |
| Materials | Same | Stainless steel needle and |
| plastic hub | ||
| Hub design | Same | Standard luer lock connector |
| Needle gauge | Same | 27G |
| Needle length | 4 inches | 3.5 inches |
| Device reinforcement | Same | Reinforced sleeve |
| Needle bend | 30 degree bend | 18 degree bend |
| Insertion stop (distal stop) | Same | 2mm insertion depth stop |
| Needle tip | Same | Quincke style |
| Short bevel | Long bevel |
Summary of non-clinical test
Device Performance was tested to comply to:
- ISO 80369-7 ●
- ISO 9626 ●
- ISO 7864 ●
Package Integrity per ISO 11607-1 and 11607-2.
Reach needle is an externally communicating device with direct tissue contact for limited duration; biocompatibility testing is in compliance with ISO 10993-1 and included:
- Cytotoxicity .
- . Irritation
- Sensitivity ●
- Systemic toxicity ●
- . Pyrogenicity
Summary of clinical test
Clinical testing was not necessary for this device.
Conclusion
The subject device is substantially equivalent to the predicate device based on a comparison of the intended use, indications for use, and technological characteristics and the minor differences do not raise new questions of safety or effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.