(169 days)
Not Found
No
The summary describes a physical medical device (epidural catheter kit) and its components. There is no mention of software, algorithms, image processing, AI, or ML. The performance studies focus on physical and biological properties of the device.
No.
The device administers anesthetic, which is a drug, and therefore it is a drug delivery device, not a therapeutic device.
No
Explanation: The "Intended Use / Indications for Use" states that the device "permits access to the epidural space for the administration of epidural anesthetic." This clearly indicates it is for therapeutic administration, not for diagnosis.
No
The device description explicitly states it is a "kit" consisting of a catheter and accessory components, which are physical hardware. The performance studies also focus on physical properties and tests of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "permit access to the epidural space for the administration of epidural anesthetic." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is a catheter kit used for insertion into the epidural space. This is a physical device used for a medical procedure, not a reagent, instrument, or system intended for the examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural – facilitating the delivery of medication into a specific anatomical location.
N/A
Intended Use / Indications for Use
The Arrow Epidural Catheter kit permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours. Patient Population: Adult
Product codes
CAZ
Device Description
The Arrow Epidural Catheter Kit consists of the epidural catheter packaged with various combinations of accessory components including 0.2 Micron In-Line Flat Anesthesia Conduction Filter necessary for the catheter insertion procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space
Indicated Patient Age Range
Adult
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 brief summary of tests relied upon to demonstrate substantial equivalence to the predicate can be found in Table 2 below.
Table 2 - Performance Testing Summary:
- Luer Strength Test: Reference to Standard: Internal Requirement; Principle of Test: Force is applied to the male and female luer tapers until failure.
- Housing Burst Pressure Test: Reference to Standard: Internal Requirement; Principle of Test: Hydrostatic pressure is applied until part bursts.
- Flow Rate Test: Reference to Standard: Internal Requirement; Principle of Test: Water is passed through the filter at a pressure of 10 psi and collected in a graduated cylinder for 60 seconds. The volume of water is recorded.
- Filter Luer Slip: Reference to Standard: ISO 594-1; Principle of Test: To test unscrewing gauging, liquid leakage, air leakage, separation force.
- Filter Luer-Lock: Reference to Standard: ISO 594-2; Principle of Test: To test unscrewing torque, ease of assembly, resistance to overriding, stress cracking.
- Bacterial Retention and Bubble Point Test: Reference to Standard: ASTM F838; Principle of Test: To test bacterial retention of membrane filter.
- Biocompatibility: Reference to Standard: ISO 10993; Principle of Test: Testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic systemic toxicity, genotoxicity, implantation, and extractables & leachables.
- EO Residuals: Reference to Standard: ISO 10993-7; Principle of Test: The EO residual testing for prolonged contact devices.
- LAL Bacterial Endotoxin: Reference to Standard: AAMI ST72; Principle of Test: LAL bacterial endotoxin testing for medical devices that have contact with CSF.
- Rabbit Pyrogen: Reference to Standard: ISO 10993-11; Principle of Test: Material Mediated Rabbit Pyrogen
- Packaging: Reference to Standard: ISO 11607-1, ASTM D4169; Principle of Test: Packaging stability; 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
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 4, 2016
Teleflex Medical, Inc. Angela Bouse Sr. Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, NC 27560
Re: K161075
Trade/Device Name: Arrow Epidural Catheter Kit Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: Class II Product Code: CAZ Dated: September 2, 2016 Received: September 6, 2016
Dear Angela Bouse:
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.
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 (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.
1
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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
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) K161075
Device Name Arrow Epidural Catheter Kit
Indications for Use (Describe)
The Arrow Epidural Catheter kit permits access to the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
Patient Population: Adult
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) SUMMARY
A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919-433-4904 Fax: 919-433-4989
B. Contact Person
Angela Bouse Senior Regulatory Affairs Specialist
C. Date Prepared
October 4, 2016
D. Device Name
| Trade Name: | Arrow Epidural Catheter Kit |
|---|---|
| Classification Name: | Anesthesia Conduction Kit |
| Product Code: | CAZ |
| Regulation Number: | 868.5140 |
| Classification: | II |
| Classification Panel: | Anesthesiology |
E. Predicate Device
This submission demonstrates substantial equivalence to the predicate device Arrow Epidural Catheter Kit - K143581
F. Device Description
The Arrow Epidural Catheter Kit consists of the epidural catheter packaged with various combinations of accessory components including 0.2 Micron In-Line Flat Anesthesia Conduction Filter necessary for the catheter insertion procedure.
G. Indications for Use
The Arrow Epidural Catheter kit permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
Patient Population: Adult
4
H. Technological Characteristics Comparison to the predicate
The proposed Arrow Epidural Catheter Kit with 0.2 Micron In-Line Flat Anesthesia Conduction Filter is substantially equivalent to the predicate device with respect to indications for use, technology and construction. The differences between the predicate and the proposed devices are minor and any risks have been mitigated through testing. Table 1 summarizes the differences between the proposed and predicate devices.
| Comparative
Characteristic | Predicate Device:
Arrow Epidural Catheter Kit
K143581 | Proposed Device:
Arrow Epidural Catheter
Kit |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Classification Name | Anesthesia Conduction Kit | Same |
| Product Code / CFR | CAZ, 868.5140 | Same |
| Intended Use/
Indications for Use | The Arrow Epidural Catheter kit
permits access to the epidural space
for the administration of epidural
anesthetic. The epidural catheter kit is
intended for use up to 72 hours. | Same |
| Patient Population | Patients that require administration of
local anesthetics. | Same |
| Design | Filter Component of the Kit: Round
flat filter | Same |
| Inlet Connection | Filter Component of the Kit:
Female luer lock | Same |
| Outlet Connection | Filter Component of the Kit:
Male Luer | Same |
| Membrane Pore Size | Filter Component of the Kit:
0.2 micron | Same |
| Filtration Area | Filter Component of the Kit:
$3.8 cm^2$ | Filter Component of the Kit:
$5.25 cm^2$ |
| Bubble Point Pressure | Filter Component of the Kit:
$\geq$ 46 psi | Same |
| Bacterial Retention | Filter Component of the Kit:
100% bacterial retention | Same |
| Housing Material | Filter Component of the Kit:
Modified acrylic | Filter Component of the Kit:
Modified Acrylic |
| Filter Material | Filter Component of the Kit:
Polyethersulfone | Filter Component of the Kit:
Supor Polyethersulfone |
| Membrane Filtration | Filter Component of the Kit:
Hydrophilic | Same |
| Rotating Locking Hub | Filter Component of the Kit: | Filter Component of the Kit: |
| Comparative
Characteristic | Predicate Device:
Arrow Epidural Catheter Kit
K143581 | Proposed Device:
Arrow Epidural Catheter
Kit |
| Material | Polypropylene | Polypropylene |
| Shelf Life | One year | Same |
| Method of Sterilization | Ethylene Oxide | Same |
| Packaging | Thermoformed Tray sealed with
Tyvek Lidstock | Same |
| Single Use | Yes | Same |
| Kit Components | List of the main kit components:
Epidural Catheter
Catheter Syringe Adapter
0.2 Micron Anesthesia Conduction
Filter
SnapLockTM
Epidural Needle
Injection Needle
Standard Syringe
LOR Syringe
SharpsAway IITM Locking Disposal
Cup
Clear Fenestrated Drape with adhesive
Towel
5 Micron Straw Filter
Gauze Pads
Prep Sponge Swabs
Medicine Cup
Tray: Prep | Same, except for the 0.2
Micron Anesthesia
Conduction Filter |
| IFU | Arrow Epidural Catheter IFU | Same |
Table 1 - Differences Between the Proposed and Predicate Devices
5
I. Performance Data
A brief summary of tests relied upon to demonstrate substantial equivalence to the predicate can be found in Table 2 below.
| Table 2 - Performance Testing Summary | ||
|---|---|---|
| --------------------------------------- | -- | -- |
| Test | Reference to
Standard
(if applicable) | Principle of Test |
|--------------------|---------------------------------------------|-----------------------------------------------------------------------|
| Luer Strength Test | Internal Requirement | Force is applied to the male and female luer
tapers until failure. |
6
| Housing Burst
Pressure Test | Internal Requirement | Hydrostatic pressure is applied until part
bursts. |
|-------------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Flow Rate Test | Internal Requirement | Water is passed through the filter at a pressure
of 10 psi and collected in a graduated cylinder
for 60 seconds. The volume of water is
recorded. |
| Filter Luer Slip | ISO 594-1 | To test unscrewing gauging, liquid leakage,
air leakage, separation force. |
| Filter Luer-Lock | ISO 594-2 | To test unscrewing torque, ease of assembly,
resistance to overriding, stress cracking. |
| Bacterial Retention
and Bubble Point
Test | ASTM F838 | To test bacterial retention of membrane filter. |
| Biocompatibility | ISO 10993 | Testing included cytotoxicity, sensitization,
irritation, acute systemic toxicity, subchronic
systemic toxicity, genotoxicity, implantation,
and extractables & leachables. |
| EO Residuals | ISO 10993-7 | The EO residual testing for prolonged contact
devices. |
| LAL Bacterial
Endotoxin | AAMI ST72 | LAL bacterial endotoxin testing for medical
devices that have contact with CSF. |
| Rabbit Pyrogen | ISO 10993-11 | Material Mediated Rabbit Pyrogen |
| Packaging | ISO 11607-1
ASTM D4169 | Packaging stability
Distribution simulation testing |
J. Conclusion
The Arrow Epidural Catheter kit has the same indications for use and technology of construction as the predicate devices. Performance test results demonstrate that the proposed device meets its intended use. It is for these reasons that the proposed device can be found substantially equivalent.