(226 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a needle, with no mention of AI or ML.
Yes
The device is intended to inject local anesthetic for regional anesthesia or facilitate the placement of an epidural catheter for continuous infusion of local anesthetics, which are therapeutic interventions aimed at pain relief or allowing further medical procedures.
No
Explanation: The device is intended for injecting local anesthetic and facilitating epidural catheter placement for regional anesthesia, not for diagnosing a condition.
No
The device description clearly outlines physical components (plastic cannula hub, stainless steel cannula, plastic stylet, guard) and the performance studies focus on physical properties and testing of these hardware components. There is no mention of software.
Based on the provided information, the Arrow Epidural Needles are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "inject local anesthetic into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter." This is a direct medical intervention on a patient's body.
- Device Description: The description details a needle, hub, stylet, and connectors, all designed for physical insertion into the body and delivery of a substance.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro) to obtain diagnostic information. IVD devices are typically used for tests on blood, urine, tissue samples, etc.
The device is clearly intended for direct clinical use on a patient for therapeutic or procedural purposes, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Arrow Epidural Needles are intended to inject local anesthetic into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter.
Product codes
BSP
Device Description
The Arrow Epidural Needles are sterile, single use, disposable devices. They are used for the injection of anesthetic agents into a patient for regional anesthesia administration or to facilitate the placement of an epidural catheter for continuous infusion of local anesthetics.
The Arrow Epidural Needles consist of a plastic cannula hub with integrated wings that come with either Luer Connector and NRFit Connector, stainless steel cannula, and plastic stylet. The purpose of the stylet is to prevent tissue coring during needle insertion. The needle assembly is protected with a guard to prevent damage to the needle.
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
Not Found
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
A summary of tests relied upon to demonstrate substantial equivalence to the predicate can be found in the Table below
| Test | Standard (if applicable) | Principle of Test |
|---|---|---|
| Joint Between the Needle Hub and Needle Cannula Joint Between the Stylet Hub and Stylet Cannula | BS 6196 | A tensile force is applied for a specified time to the union being tested, and the union observed to determine if it parts. |
| Stiffness | ISO 9626 | A specified force is applied to the centre of the specified length of tubing, which is supported at both ends, and the amount of deflection measured. |
| Resistance to breakage | ISO 9626 | One end of the tubing is firmly fixed, and a force applied to the tubing at a specified distance from the point of fixation, so as to bend the tubing through a specified angle, first in one direction and then in the opposite direction, for a specified number of cycles. |
| Resistance to corrosion | ISO 9626 | The tubing is partially immersed in sodium chloride solution for a specified time and afterwards the immersed portion compared visually with the un immersed portion for signs of corrosion. |
| Luer Connector | ISO 594-1 ISO 594-2 | To test unscrewing gauging, liquid leakage, air leakage, separation force. |
| NRFit Connector | ISO 80369-6 | To test unscrewing gauging, liquid leakage, air leakage, separation force. |
| Biocompatibility | ISO 10993 | Testing included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity and Material Mediated Pyrogenicity |
| LAL Bacterial Endotoxin | AAMI ST72 | LAL Bacterial Endotoxin testing of medical devices that have contact with CSF |
| Packaging | ISO 11607-1 ASTM D4169 | Stability and Distribution simulation testing |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
August 21, 2019
Teleflex Medical Lakshmi Kanuri Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
Re: K190026
Trade/Device Name: Arrow Epidural Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: July 19, 2019 Received: July 22, 2019
Dear Lakshmi Kanuri:
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.
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
1
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 (OS) 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 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. 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190026
Device Name Arrow Epidural Needles
Indications for Use (Describe)
The Arrow Epidural Needles are intended to inject local anesthetic into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter.
| 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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3
510(k) SUMMARY
K190026
1. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919-361-4087 Fax: 919-433-4996
2. Contact Person
Lakshmi Kanuri Regulatory Affairs Specialist
3. Date Prepared
August 21, 2019
4. Device Name
| Trade Name: | Arrow Epidural Needles |
|---|---|
| Classification Name: | Anesthesia conduction needle (w/wo introducer) |
| FDA Product Code: | BSP |
| CFR Number: | 868.5150 |
| Regulatory Class: | II |
5. Predicate Device
K131006 - AN-E Epidural Needle
6. Device Description
The Arrow Epidural Needles are sterile, single use, disposable devices. They are used for the injection of anesthetic agents into a patient for regional anesthesia administration or to facilitate the placement of an epidural catheter for continuous infusion of local anesthetics.
The Arrow Epidural Needles consist of a plastic cannula hub with integrated wings that come with either Luer Connector and NRFit Connector, stainless steel cannula, and plastic stylet. The purpose of the stylet is to prevent tissue coring during needle insertion. The needle assembly is protected with a guard to prevent damage to the needle.
7. Indications for Use
The Arrow Epidural Needles are intended to inject local anesthetic into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter.
4
| CHARACTERISTIC | PREDICATE DEVICE
K131006 | SUBJECT DEVICE |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Name | LCCS PRODUCTS
LIMITED | ARROW INTERNATIONAL
INC. |
| Device Classification Name | Anesthesia conduction
needle
(w/wo introducer) | Anesthesia conduction needle
(w/wo introducer) |
| FDA Product Code | BSP | BSP |
| CFR Number | 868.5150 | 868.5150 |
| Regulatory Class | II | II |
| Trade Name | AN-E Epidural Needle | Arrow Epidural Needle |
| Intended Use/Indications for
Use | Intended for the transient
delivery of anesthetics to
provide neuraxial
anesthetics or to facilitate
placement of an epidural
catheter. | The Arrow Epidural Needles
are intended to inject local
anesthetic into a patient to
provide regional anesthesia or
to facilitate the placement of an
epidural catheter. |
| Needle Guage Size | 15 GA - 20 GA | 17 GA |
| Needle Length | 50 mm - 150 mm | 88.9mm (8.89 cm) (3-1/2") |
| Tip Design | Tuohy, Quincke, Pencil
Point | Tuohy |
| Needle Cannula Material | 304 Stainless Steel | 304 Stainless Steel |
| Needle Hub Material | K-Resin KR03 | Clear Acrylic |
| Stylet Cannula Material | 304 STAINLESS STEEL | Clear Polypropylene |
| Stylet Hub Material | HDPE | Gray Polypropylene |
| Connector Type | ISO 594 Luer | ISO 594 Luer
ISO 80369-6 NRFit |
| Final Needle Assembly
Protection | Not stated | Guard |
| CHARACTERISTIC | PREDICATE DEVICE K131006 | SUBJECT DEVICE |
| Markings | Not stated | 1 cm (10 mm) |
| Performance | ISO 7864 Hub to Needle Bond Strength
ISO 9626 Stiffness
ISO 9626 Resistance to breakage
ISO 594-1 and ISO 594-2 Luer Connector | BS 6196 Joint Between the Needle Hub and Needle Cannula and Joint Between the Stylet Hub and Stylet Cannula
ISO 9626 Stiffness
ISO 9626 Resistance to breakage
ISO 9626 Resistance to corrosion
ISO 594-1 and ISO 594-2 Luer Connector
ISO 80369-6 NRFit Connector |
| Method of Sterilization | Not stated | Ethylene Oxide |
| Shelf Life | Not stated | One year |
| Packaging | Not stated | Tyvek Pouch |
8. Technological Characteristics Comparison to the predicate
5
6
9. Performance Data
A summary of tests relied upon to demonstrate substantial equivalence to the predicate can be found in the Table below
| Test | Standard (if applicable) | Principle of Test |
|---|---|---|
| Joint Between the Needle Hub and Needle Cannula | ||
| Joint Between the Stylet Hub and Stylet Cannula | BS 6196 | A tensile force is applied for a specified time to the union being tested, and the union observed to determine if it parts. |
| Stiffness | ISO 9626 | A specified force is applied to the centre of the specified length of tubing, which is supported at both ends, and the amount of deflection measured. |
| Resistance to breakage | ISO 9626 | One end of the tubing is firmly fixed, and a force applied to the tubing at a specified distance from the point of fixation, so as to bend the tubing through a specified angle, first in one direction and then in the opposite direction, for a specified number of cycles. |
| Resistance to corrosion | ISO 9626 | The tubing is partially immersed in sodium chloride solution for a specified time and afterwards the immersed portion compared visually with the un immersed portion for signs of corrosion. |
| Luer Connector | ISO 594-1 | |
| ISO 594-2 | To test unscrewing gauging, liquid leakage, air leakage, separation force. | |
| NRFit Connector | ISO 80369-6 | To test unscrewing gauging, liquid leakage, air leakage, separation force. |
| Biocompatibility | ISO 10993 | Testing included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity and Material Mediated Pyrogenicity |
| LAL Bacterial Endotoxin | AAMI ST72 | LAL Bacterial Endotoxin testing of medical devices that have contact with CSF |
| Packaging | ISO 11607-1 | |
| ASTM D4169 | Stability and Distribution simulation testing |
10. Conclusion
The Arrow Epidural Needle has similar indications for use and technology of construction as the predicate device. Performance test results demonstrate that the proposed device meets its intended use. It is for these reasons that the proposed device is substantially equivalent to the proposed predicate device and does not raise different questions of safety and effectiveness.