Arrow Epidural Catheter Kit

• K Number: K143581
• Device Name: Arrow Epidural Catheter Kit
• Manufacturer: Teleflex Medical, Inc.
• Date Cleared: 2015-06-26 ( 190 days)
• Product Code: CAZ
• Regulation Number: 868.5140

Intended Use

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.

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.

Predicate Devices

K083451, K103658

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical medical device (catheter kit) and its performance testing, with no mention of software, algorithms, or AI/ML terms.

Therapeutic

Yes
The device is used to administer epidural anesthetic, which is a therapeutic intervention for pain relief.

Diagnostic

No

Explanation: The device, an epidural catheter kit, is intended for the administration of epidural anesthetic. Its primary function is to deliver a substance (anesthetic) for therapeutic purposes, not to diagnose a condition or disease. The description of performance studies also focuses on the physical and material integrity of the device components rather than diagnostic accuracy.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "catheter kit" consisting of a "catheter" and "accessory components," which are physical hardware. The performance studies also describe tests on physical components like luers, housing, and filters.

IVD (In Vitro Diagnostic)

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 administration of epidural anesthetic." This describes a device used in vivo (within the body) for delivering medication.
• Device Description: The description details a catheter and accessory components for insertion into the epidural space. This is consistent with an in vivo medical device.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. The tests described are related to the physical and biological properties of the device itself, not the analysis of patient samples.

Therefore, the Arrow Epidural Catheter kit is an in vivo medical device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes (comma separated list FDA assigned to the subject device)

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

Patients that require administration of local anesthetics.

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)

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.
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.
Packaging	ISO 11607-1 ASTM D4169	Packaging stability Distribution simulation testing

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.

K083451, K103658

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

Regulation Number and Section

§ 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).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 26, 2015

Teleflex Medical, Inc. Ms. Angela Bouse Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd. Morrisville, NC 27560

Re: K143581

Trade/Device Name: Arrow Epidural Catheter Kit Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: May 22, 2015 Received: May 26, 2015

Dear Ms. 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.

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Page 2 - Ms. Bouse

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 device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division 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) K143581

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.

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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510(k) SUMMARY

A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: [phone] Fax:

B. Contact Person

Angela Bouse Senior Regulatory Affairs Specialist

C. Date Prepared

June 26, 2015

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 Portex Epidural Filter - K083451 Flextip Plus Closed Tip Epidural Catheter - K103658

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.

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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:
Smiths Medical, Portex
Epidural Filter
K083451 | Predicate Device:
Flextip Plus Closed Tip
Epidural Catheter
K103658 | Proposed Device:
Arrow Epidural
Catheter Kit with 0.2
Micron In-Line Flat
Anesthesia Conduction
Filter |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Classification
Name | Anesthesia Conduction
Filter | Anesthesia Conduction Kit | Same |
| Product Code /
CFR | BSN, 868.5130 | CAZ, 868.5140 | Same |
| Intended Use/
Indications for
Use | An anesthesia
conduction filter is used
while administering to a
patient injections of local
anesthetics to minimize
particulate (foreign
material) contamination
of the injected fluid. | The Arrow Epidural
Catheter permits access to
the epidural space for the
administration of epidural
anesthetic. The epidural
catheter is intended for use
up to 72 hours. | Similar |
| Patient
Population | Patients that require
administration of local
anesthetics. | Patients that require
administration of local
anesthetics. | Same |
| Design | Round flat filter | Filter Kit Component:
Round flat filter | Same |
| Inlet
Connection | Female luer lock | Filter Kit Component:
Female luer lock | Same |
| Outlet
Connection | Male Luer with a
rotating Locking Hub | Filter Kit Component:
Male Luer | Same |
| Membrane Pore
Size | 0.2 micron | Filter Kit Component:
0.2 micron | Same |
| Filtration Area | 5.25 cm $^{2}$ | Filter Kit Component:
4.3 cm $^{2}$ | 3.8 cm $^{2}$ |
| Bubble Point
Pressure | $\geq$ 46 psi | Filter Kit Component:
$\geq$ 46 psi | Same |
| Bacterial
Retention | 100% bacterial retention | Filter Kit Component:
100% bacterial retention | Same |
| Comparative
Characteristic | Predicate Device:
Smiths Medical, Portex
Epidural Filter
K083451 | Predicate Device:
Flextip Plus Closed Tip
Epidural Catheter
K103658 | Proposed Device:
Arrow Epidural
Catheter Kit with 0.2
Micron In-Line Flat
Anesthesia Conduction
Filter |
| Housing
Material | Modified acrylic | Filter Kit Component:
Modified acrylic | Cyrolite G20 Hiflo,
Modified Acrylic |
| Filter Material | Not stated | Filter Kit Component:
Polyethersulfone | Sterlitech,
Polyethersulfone |
| Membrane
Filtration | Hydrophilic | Filter Kit Component:
Hydrophilic | Same |
| Rotating
Locking Hub
Material | Not stated | N/A – filter design does
not include a rotating collar | Titanpro 6331,
Polypropylene with
Unicolour UYL0845 PP
Yellow |
| Shelf Life | Not stated | Two years | One year |
| Method of
Sterilization | Not stated | Ethylene Oxide | Ethylene Oxide |
| Single Use | Yes | Yes | Same |
| Kit
Components | Not Applicable | 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
replacement of the 0.2
Micron Anesthesia
Conduction Filter |
| IFU | Not stated | Arrow Epidural Catheter
IFU | Similar |

Table 1 - Differences Between the Proposed and Predicate Devices

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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.
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.
Packaging	ISO 11607-1
ASTM D4169	Packaging stability
Distribution simulation testing

Performance Testing Summary Table 2 –

J. Conclusion

The Arrow Epidural Catheter kit has similar 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.