Arrow Epidural Catheter Kit

K143581 · Teleflexmedical, Inc. · CAZ · Jun 26, 2015 · Anesthesiology

Device Facts

• Record ID: K143581
• Device Name: Arrow Epidural Catheter Kit
• Applicant: Teleflexmedical, Inc.
• Product Code: CAZ · Anesthesiology
• Decision Date: Jun 26, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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; includes catheter and 0.2-micron in-line flat anesthesia conduction filter. Used by clinicians in clinical settings for catheter insertion and fluid delivery. Filter minimizes particulate contamination of injected fluid. Device components include catheter, needle, syringe, and filter. Output is delivery of anesthetic to patient. Benefits include controlled, filtered anesthetic administration for pain management. Device is single-use and sterile.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing: luer strength, housing burst pressure, flow rate, filter 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), and packaging/distribution (ISO 11607-1, ASTM D4169).

Technological Characteristics

Kit includes epidural catheter and 0.2-micron polyethersulfone membrane filter. Housing: Cyrolite G20 Hiflo (modified acrylic). Rotating locking hub: Titanpro 6331 (polypropylene). Filtration area: 3.8 cm2. Bubble point: ≥ 46 psi. Bacterial retention: 100%. Sterilization: Ethylene Oxide. Connectivity: None. Standards: ISO 594-1/2 (luer), ASTM F838 (filtration), ISO 10993 (biocompatibility), AAMI ST72 (endotoxin), ISO 11607-1/ASTM D4169 (packaging).

Indications for Use

Indicated for patients requiring administration of local anesthetics via the epidural space for 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

• Portex Epidural Filter (K083451)
• Flextip Plus Closed Tip Epidural Catheter (K103658)

Submission Summary (Full Text)

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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)

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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<br>Characteristic | Predicate Device:<br>Smiths Medical, Portex<br>Epidural Filter<br>K083451 | Predicate Device:<br>Flextip Plus Closed Tip<br>Epidural Catheter<br>K103658 | Proposed Device:<br>Arrow Epidural<br>Catheter Kit with 0.2<br>Micron In-Line Flat<br>Anesthesia Conduction<br>Filter |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Classification<br>Name | Anesthesia Conduction<br>Filter | Anesthesia Conduction Kit | Same |
| Product Code /<br>CFR | BSN, 868.5130 | CAZ, 868.5140 | Same |
| Intended Use/<br>Indications for<br>Use | An anesthesia<br>conduction filter is used<br>while administering to a<br>patient injections of local<br>anesthetics to minimize<br>particulate (foreign<br>material) contamination<br>of the injected fluid. | The Arrow Epidural<br>Catheter permits access to<br>the epidural space for the<br>administration of epidural<br>anesthetic. The epidural<br>catheter is intended for use<br>up to 72 hours. | Similar |
| Patient<br>Population | Patients that require<br>administration of local<br>anesthetics. | Patients that require<br>administration of local<br>anesthetics. | Same |
| Design | Round flat filter | Filter Kit Component:<br>Round flat filter | Same |
| Inlet<br>Connection | Female luer lock | Filter Kit Component:<br>Female luer lock | Same |
| Outlet<br>Connection | Male Luer with a<br>rotating Locking Hub | Filter Kit Component:<br>Male Luer | Same |
| Membrane Pore<br>Size | 0.2 micron | Filter Kit Component:<br>0.2 micron | Same |
| Filtration Area | 5.25 cm $^{2}$ | Filter Kit Component:<br>4.3 cm $^{2}$ | 3.8 cm $^{2}$ |
| Bubble Point<br>Pressure | $\geq$ 46 psi | Filter Kit Component:<br>$\geq$ 46 psi | Same |
| Bacterial<br>Retention | 100% bacterial retention | Filter Kit Component:<br>100% bacterial retention | Same |
| Comparative<br>Characteristic | Predicate Device:<br>Smiths Medical, Portex<br>Epidural Filter<br>K083451 | Predicate Device:<br>Flextip Plus Closed Tip<br>Epidural Catheter<br>K103658 | Proposed Device:<br>Arrow Epidural<br>Catheter Kit with 0.2<br>Micron In-Line Flat<br>Anesthesia Conduction<br>Filter |
| Housing<br>Material | Modified acrylic | Filter Kit Component:<br>Modified acrylic | Cyrolite G20 Hiflo,<br>Modified Acrylic |
| Filter Material | Not stated | Filter Kit Component:<br>Polyethersulfone | Sterlitech,<br>Polyethersulfone |
| Membrane<br>Filtration | Hydrophilic | Filter Kit Component:<br>Hydrophilic | Same |
| Rotating<br>Locking Hub<br>Material | Not stated | N/A – filter design does<br>not include a rotating collar | Titanpro 6331,<br>Polypropylene with<br>Unicolour UYL0845 PP<br>Yellow |
| Shelf Life | Not stated | Two years | One year |
| Method of<br>Sterilization | Not stated | Ethylene Oxide | Ethylene Oxide |
| Single Use | Yes | Yes | Same |
| Kit<br>Components | Not Applicable | List of the main kit components:<br>Epidural Catheter<br>Catheter Syringe Adapter<br>0.2 Micron Anesthesia<br>Conduction Filter<br>SnapLockTM<br>Epidural Needle<br>Injection Needle<br>Standard Syringe<br>LOR Syringe<br>SharpsAway IITM Locking<br>Disposal Cup<br>Clear Fenestrated Drape with<br>adhesive<br>Towel<br>5 Micron Straw Filter<br>Gauze Pads<br>Prep Sponge Swabs<br>Medicine Cup<br>Tray: Prep | Same, except for<br>replacement of the 0.2<br>Micron Anesthesia<br>Conduction Filter |
| IFU | Not stated | Arrow Epidural Catheter<br>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<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. |
| 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. |
| Packaging | ISO 11607-1<br>ASTM D4169 | Packaging stability<br>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.