Arrow Epidural Catheter Kit

K161075 · Teleflexmedical, Inc. · CAZ · Oct 4, 2016 · Anesthesiology

Device Facts

• Record ID: K161075
• Device Name: Arrow Epidural Catheter Kit
• Applicant: Teleflexmedical, Inc.
• Product Code: CAZ · Anesthesiology
• Decision Date: Oct 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Arrow Epidural Catheter Kit provides access to epidural space for anesthetic administration; used in clinical settings by healthcare professionals. Kit includes epidural catheter, needles, syringes, and 0.2-micron in-line flat anesthesia conduction filter. Filter acts as mechanical barrier to prevent particulate/bacterial contamination during infusion. Device is single-use, sterile, and disposable. Healthcare provider inserts catheter into epidural space; connects filter to catheter and anesthetic source. Filter ensures delivery of filtered anesthetic to patient. Benefits include reduced risk of contamination during prolonged (up to 72-hour) epidural anesthesia.

Clinical Evidence

Bench testing only. No clinical data. Testing included luer strength, housing burst pressure, flow rate, luer slip/lock (ISO 594-1/2), bacterial retention/bubble point (ASTM F838), biocompatibility (ISO 10993), EO residuals (ISO 10993-7), bacterial endotoxin (AAMI ST72), rabbit pyrogen (ISO 10993-11), and packaging/distribution (ISO 11607-1/ASTM D4169).

Technological Characteristics

Kit includes epidural catheter and 0.2-micron in-line flat filter. Filter housing: modified acrylic; filter membrane: Supor polyethersulfone; catheter/components: polypropylene. Filtration area: 5.25 cm². Sterilization: Ethylene Oxide. Single-use. Mechanical filtration principle. No software or electronic components.

Indications for Use

Indicated for adult patients requiring administration of local anesthetics via the epidural space. Intended for use up to 72 hours.

Regulatory Classification

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.

Predicate Devices

• Arrow Epidural Catheter Kit (K143581)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [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

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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: [phone] Fax: [phone]

### 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<br>Characteristic | Predicate Device:<br>Arrow Epidural Catheter Kit<br>K143581 | Proposed Device:<br>Arrow Epidural Catheter<br>Kit |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Classification Name | Anesthesia Conduction Kit | Same |
| Product Code / CFR | CAZ, 868.5140 | Same |
| Intended Use/<br>Indications for Use | The Arrow Epidural Catheter kit<br>permits access to the epidural space<br>for the administration of epidural<br>anesthetic. The epidural catheter kit is<br>intended for use up to 72 hours. | Same |
| Patient Population | Patients that require administration of<br>local anesthetics. | Same |
| Design | Filter Component of the Kit: Round<br>flat filter | Same |
| Inlet Connection | Filter Component of the Kit:<br>Female luer lock | Same |
| Outlet Connection | Filter Component of the Kit:<br>Male Luer | Same |
| Membrane Pore Size | Filter Component of the Kit:<br>0.2 micron | Same |
| Filtration Area | Filter Component of the Kit:<br>$3.8 cm^2$ | Filter Component of the Kit:<br>$5.25 cm^2$ |
| Bubble Point Pressure | Filter Component of the Kit:<br>$\geq$ 46 psi | Same |
| Bacterial Retention | Filter Component of the Kit:<br>100% bacterial retention | Same |
| Housing Material | Filter Component of the Kit:<br>Modified acrylic | Filter Component of the Kit:<br>Modified Acrylic |
| Filter Material | Filter Component of the Kit:<br>Polyethersulfone | Filter Component of the Kit:<br>Supor Polyethersulfone |
| Membrane Filtration | Filter Component of the Kit:<br>Hydrophilic | Same |
| Rotating Locking Hub | Filter Component of the Kit: | Filter Component of the Kit: |
| Comparative<br>Characteristic | Predicate Device:<br>Arrow Epidural Catheter Kit<br>K143581 | Proposed Device:<br>Arrow Epidural Catheter<br>Kit |
| Material | Polypropylene | Polypropylene |
| Shelf Life | One year | Same |
| Method of Sterilization | Ethylene Oxide | Same |
| Packaging | Thermoformed Tray sealed with<br>Tyvek Lidstock | Same |
| Single Use | Yes | Same |
| Kit Components | List of the main kit components:<br>Epidural Catheter<br>Catheter Syringe Adapter<br>0.2 Micron Anesthesia Conduction<br>Filter<br>SnapLockTM<br>Epidural Needle<br>Injection Needle<br>Standard Syringe<br>LOR Syringe<br>SharpsAway IITM Locking Disposal<br>Cup<br>Clear Fenestrated Drape with adhesive<br>Towel<br>5 Micron Straw Filter<br>Gauze Pads<br>Prep Sponge Swabs<br>Medicine Cup<br>Tray: Prep | Same, except for the 0.2<br>Micron Anesthesia<br>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<br>Standard<br>(if applicable) | Principle of Test |
|--------------------|---------------------------------------------|-----------------------------------------------------------------------|
| Luer Strength Test | Internal Requirement | Force is applied to the male and female luer<br>tapers until failure. |

{6}------------------------------------------------

| Housing Burst<br>Pressure Test | Internal Requirement | Hydrostatic pressure is applied until part<br>bursts. |
|-------------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Flow Rate Test | Internal Requirement | Water is passed through the filter at a pressure<br>of 10 psi and collected in a graduated cylinder<br>for 60 seconds. The volume of water is<br>recorded. |
| Filter Luer Slip | ISO 594-1 | To test unscrewing gauging, liquid leakage,<br>air leakage, separation force. |
| Filter Luer-Lock | ISO 594-2 | To test unscrewing torque, ease of assembly,<br>resistance to overriding, stress cracking. |
| Bacterial Retention<br>and Bubble Point<br>Test | ASTM F838 | To test bacterial retention of membrane filter. |
| Biocompatibility | ISO 10993 | Testing included cytotoxicity, sensitization,<br>irritation, acute systemic toxicity, subchronic<br>systemic toxicity, genotoxicity, implantation,<br>and extractables & leachables. |
| EO Residuals | ISO 10993-7 | The EO residual testing for prolonged contact<br>devices. |
| LAL Bacterial<br>Endotoxin | AAMI ST72 | LAL bacterial endotoxin testing for medical<br>devices that have contact with CSF. |
| Rabbit Pyrogen | ISO 10993-11 | Material Mediated Rabbit Pyrogen |
| Packaging | ISO 11607-1<br>ASTM D4169 | Packaging stability<br>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.