ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit
Device Facts
| Record ID | K161232 |
|---|---|
| Device Name | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit |
| Applicant | Halyard Health |
| Product Code | BSO · Anesthesiology |
| Decision Date | Sep 30, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5120 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The ON-Q* EchoSpark* Echogenic Catheter is indicated for delivery of medication for regional anesthesia and pain management. Routes of administration may be perineural, intraoperative, or percutaneous. The ON-Q* EchoSpark* Echogenic Catheter is indicated for patients undergoing continuous regional anesthesia and pain management procedures.
Device Story
ON-Q* EchoSpark/T-bloc devices are catheters for regional anesthesia and pain management; used in clinical settings for continuous medication delivery. Catheter features stainless steel echogenic screw tip for ultrasound visualization; polyamide nylon (Pebax) tubing with barium sulfate radiopaque stripes; depth markings. Includes Nitinol stylet and polypropylene thread assist guide. Operated by clinicians; ultrasound guidance allows precise placement. Output is medication delivery to target site; benefits include improved visualization during placement and effective pain management. Not for intravascular use.
Clinical Evidence
Bench testing only. Compliance with ISO 10555-1:2013, ISO 10993 (biocompatibility), and sterilization standards (ISO 11135-1:2007). No clinical data presented.
Technological Characteristics
Catheter: Polyamide nylon (Pebax) tubing, barium sulfate radiopaque stripes, stainless steel echogenic screw tip. Stylet: Nitinol wire. Holder: ABS. Guide: Polypropylene. Sterilization: Ethylene Oxide. Packaging: Tyvek/polyester pouch (ASTM F1980-07, F2096-11, F1886-09, D4169-09). Connectivity: None. Energy: None.
Indications for Use
Indicated for patients undergoing continuous regional anesthesia and pain management procedures via perineural, intraoperative, or percutaneous routes. Contraindicated for intravascular delivery.
Regulatory Classification
Identification
An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.
Predicate Devices
- ON-Q* Pain Relief System, QuikBloc* Over-the-Needle Catheter Set (K143164)
- Peripheral Nerve Block Tray (K073187)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three parallel lines extending from the heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2016
Halyard Health Gwendolyn George Technical Leader, Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K161232
Trade/Device Name: ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO. CAZ Dated: August 29, 2016 Received: August 30, 2016
Dear Gwendolyn George:
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.
{1}------------------------------------------------
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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
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) K161232
Device Name
ON-Q* EchoSpark* Echogeneic Catheter
Indications for Use (Describe)
The ON-Q* EchoSpark* Echogenic Catheter is indicated for delivery of medication for regional anesthesia and pain management. Routes of administration may be perineural, intraoperative, or percutaneous.
The ON-Q* EchoSpark*Echogenic Catheter is indicated for patients undergoing continuous regional anesthesia and pain management procedures.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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}------------------------------------------------
#### Indications for Use
510(k) Number (if known) K161232
Device Name
ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit
#### Indications for Use (Describe)
The ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is indicated for delivery of medication for regional anesthesia and pain management. Routes of administration may be perineural, intraoperative, or percutaneous.
The ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is indicated for patients undergoing continuous regional anesthesia and pain management procedures.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the Halyard logo. The logo consists of a circular emblem on the left and the word "HALYARD" in bold, dark blue letters on the right. The emblem features two stylized shapes, one white and one green, within a dark blue circle.
5405 Windward Parkway Alpharetta, GA 30004
| Section 5 | |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) Summary<br>ON-Q* Echogenic Catheter |
| Date Prepared: | September 29, 2016 |
| 510(k) Submitter: | Gwendolyn George<br>Halyard Health®<br>5405 Windward Parkway<br>Alpharetta, GA 30004<br>520-204-6442<br>gwendolyn.george@hyh.com<br>Establishment Registration Number: 3011270181 |
| PRIMARY CONTACT<br>FOR THIS 510(k)<br>SUBMISSION: | Gwendolyn George<br>Technical Leader, Regulatory Affairs<br>520-204-6442 (Phone)<br>gwendolyn.george@hyh.com |
| TRADE NAME: | ON-Q* EchoSpark Echogenic Catheter |
| CLASSIFICATION NAME: | Anesthesia Conduction Catheter |
| DEVICE CLASSIFICATION: | Class II |
| REGULATION NUMBER: | 21 CFR 868.5120 |
| PRODUCT CODE: | BSO |
| PREDICATE DEVICE: | ON-Q* Pain Relief System, QuikBloc* Over-the-<br>Needle Catheter Set (K143164) |
SUBJECT DEVICE DESCRIPTION: The ON-Q* Echogenic Catheter is a closed tip catheter composed of polyamide nylon (Pebax) tubing that contains two radiopaque barium sulfate stripes, black pad printed depth markings, and a stainless steel echogenic screw tip that is visible under ultrasound. The catheter assembly will also include a stylet composed of Nitinol wire with an ABS Finger holder and a polypropylene thread assist guide in a sterile Tyvek and polyester pouch.
INDICATIONS FOR USE: The ON-Q* EchoSpark Echogenic Catheter is indicated for delivery of medication for regional anesthesia and pain management. Routes of administration may be perineural, intraoperative, or percutaneous.
The ON-Q* EchoSpark* Echogenic Catheter is indicated for patients undergoing continuous regional anesthesia and pain management procedures.
CONTRAINDICATIONS: The ON-Q* Echogenic Catheter is not indicated for intravascular delivery.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the Halyard logo. The logo consists of a circular icon on the left and the word "HALYARD" in capital letters on the right. The icon contains a white shape and a green shape inside a blue circle. The word "HALYARD" is written in a bold, blue font.
SUMMARY OF SUBSTANTIAL EQUIVALENCE: The technological characteristics, indications for use, and construction material of the ON-Q* Echogenic Catheter are substantially equivalent to the currently-marketed predicate device, ON-Q* Pain Relief System, QuikBloc* Over-the-Needle Catheter Set cleared under K143164. The same fundamental technology, assembly, labeling, packaging, and sterilization method, will be used. The distinguishing feature of the Echogenic Catheter is the stainless steel echogenic screw tip; which makes the catheter visible under ultrasound.
The ON-Q* Echogenic Catheter like the predicate device can be sold stand alone or in a kit.
| Characteristic | Predicate Device<br>QuikBloc* Over-the-Needle<br>Catheter Set<br>(K143164) | Subject Device<br>ON-Q* Echogenic Catheter |
|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation<br>Product Code | BSO | Same |
| Manufacturer | Halyard Health | Same |
| Indications for Use | The ON-Q* QuikBloc* Over-the-Needle<br>Catheter Set is indicated for delivery of<br>medication (such as local anesthetics) for<br>regional anesthesia and pain management.<br>Route of administration may be<br>intraoperative, percutaneous, or perineural.<br>The ON-Q* QuikBloc* Over-the-Needle<br>Catheter Set is contraindicated for the<br>epidural space. | The ON-Q* EchoSpark* Echogenic Catheter is<br>indicated for delivery of medication for<br>regional anesthesia and pain management.<br>Routes of administration may be perineural,<br>intraoperative, or percutaneous.<br>The ON-Q* EchoSpark* Echogenic Catheter<br>is indicated for patients undergoing<br>continuous regional anesthesia and pain<br>management procedures. |
| Sterilization<br>Method | Ethylene Oxide | Same |
| Catheter<br>Tubing<br>composition | Pebax | Same |
| Echogenic screw<br>tip | N/A | Stainless Steel |
| Echogenic | N/A | Yes |
| Depth Markings | Graduated depth markings every 10 mm | Same |
| Radiopaque<br>Stripes | Barium sulfate stripes | Same |
| Labeling | Case and sterile pack with identification<br>label of catheter type, size etc. and IFU | Same |
| MRI<br>Compatibility | MR Safe | MR UnSafe |
| Single Use Device | Yes | Same |
| Packaging<br>Chevron Style Sterile Tyvek Pouch<br>ASTM F1980-07<br>ASTM D4169-09<br>ASTM F 2096-11<br>ASTM F 1886-09<br>ISO 15223:2012<br>ISO 11607-1:2006 | | |
| Characteristic | Predicate Device<br>QuikBloc* Over-the-Needle<br>Catheter Set<br>(K143164) | Subject Device<br>ON-Q* Echogenic Catheter |
| Performance<br>Testing Data | ISO:10555-1:2013<br>ASTM F 1980-07<br>EN-13868:2002<br>ISO:10555-5:2013 | All applicable performance standards<br>are the same. ISO 10555-5:2013 does<br>not apply because this is not an over<br>the needle catheter. |
| Biocompatibility | ISO:10993-1:2009<br>Compliant<br>ISO:10993-3:2003<br>No statistically significant increase<br>in the number of revertant colonies<br>compared to negative control<br>ISO:10993-4:2002<br>No statistically significant difference<br>compared to negative control<br>ISO:10993-5:2009<br>Acceptance Criteria $≤$ Grade 2<br>ISO:10993-6:2007<br>No significant difference compared<br>to the controls.<br>ISO:10993-10:2010<br>Acceptance Criteria: Sensitization<br>Index <3<br>Acceptance Criteria: Test article<br>mean score- control article mean<br>score <1<br>ISO:10993-11:2012<br>None of the test animals show<br>greater biological reaction than<br>control animals. | Same |
| Sterilization | ISO 10993-7:2008<br>ISO 11135-1:2007 | Same |
The ON-Q* Echogenic Catheter Substantial Equivalence Table is provided below.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the Halyard logo. The logo consists of a circular emblem on the left and the word "HALYARD" on the right. The emblem contains two stylized shapes, one white and one green, set against a dark blue background. The word "HALYARD" is written in a bold, sans-serif font, with each letter in dark blue.
The Indications for Use statements of the subject and predicate devices are the same (i.e., both are intended for regional anesthesia and pain management) except for the order in which the routes of administration are listed, additional specificity regarding indicated patient population, and the predicate includes a contraindication for use of the epidural space. The subject device does not contain a needle; therefore, the predicate contraindication is not applicable to this device. The listed order of routes of administration, additional specificity regarding indicated patient population, and removal of the non-applicable contraindication are not critical to the intended therapeutic or surgical use of the device and do not affect the safety and efficacy of the device when used as labeled.
Based on the design, labeling, and results of testing, the proposed new CONCLUSION: Echogenic Catheter does not raise any different questions of safety or effectiveness. The device is as safe, as effective and performs as well as or better than the predicate. The Echogenic Catheter is substantially equivalent to the predicate ON-Q* QuikBloc* Over-the-Needle Catheter Set.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the Halyard logo. The logo consists of a circular icon on the left and the word "HALYARD" in bold, dark blue letters on the right. The icon features a dark blue circle with two shapes inside: a white shape on the left and a green shape on the right.
5405 Windward Parkway Alpharetta, GA 30004
# Section 5
# 510(k) Summary
ON-Q* T-bloc*Echogenic Continuous Nerve Block Kit
| Date Prepared: | September 29, 2016 |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | Gwendolyn George<br>Halyard Health®<br>5405 Windward Parkway<br>Alpharetta, GA 30004<br>520-204-6442<br>gwendolyn.george@hyh.com<br>Establishment Registration Number: 3011270181 |
| PRIMARY CONTACT<br>FOR THIS 510(k)<br>SUBMISSION: | Gwendolyn George<br>Technical Leader, Regulatory Affairs<br>520-204-6442 (Phone)<br>gwendolyn.george@hyh.com |
| TRADE NAME: | ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit |
| CLASSIFICATION NAME: | |
| DEVICE CLASSIFICATION: | Class II |
| REGULATION NUMBER: | |
| PRODUCT CODE: | CAZ |
| PREDICATE DEVICE: | Peripheral Nerve Block Tray (K073187) |
SUBJECT DEVICE DESCRIPTION: ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is designed for the Regional Anesthesia market to deliver medication for regional anesthesia and pain management. The Kit contains multiple components; one being Halyard Health's new Echogenic Catheter. The Echogenic Catheter is a closed tip catheter composed of polvamide nylon (Pebax) tubing that contains two radiopaque barium sulfate stripes, black pad printed depth markings, and a stainless steel echogenic screw tip that is visible under ultrasound. The catheter assembly will also include a stylet composed of Nitinol wire with an ABS Finger holder and a polypropylene thread assist quide in a sterile catheter sleeve composed of Tyvek and polyester.
INDICATIONS FOR USE: The ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is indicated for delivery of medication for regional anesthesia and pain management. Routes of administration may be perineural, intraoperative, or percutaneous.
The ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is indicated for patients undergoing continuous regional anesthesia and pain management procedures.
CONTRAINDICATIONS: The ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is not indicated for intravascular delivery.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the Halyard logo. The logo consists of a blue circle with two white and green shapes inside. To the right of the circle is the word "HALYARD" in blue, block letters.
SUMMARY OF TECHNOLOGIES: The technological characteristics, instructions for use, construction, and components of the ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit are substantially equivalent to the currently marketed predicate device, Peripheral Nerve Block Tray cleared under K073187. The same sterilization method, fundamental technology, packaging, assembly and labeling will be used. The distinguishing feature of the ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit is the Echogenic Catheter which will replace the existing Epimed Spirol® Catheter found in the predicate tray. The differences between the subject and predicate devices do not raise different questions of safety and effectiveness. Table 5.1 Tray comparison, outlines the differences in the predicate and subject devices.
| Characteristic | Predicate Device<br>Peripheral Nerve Block Tray<br>(K073187) | Subject Device<br>ON-Q* T-bloc* Echogenic Continuous<br>Nerve Block Kit |
|----------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation<br>Product Code | CAZ | CAZ |
| Indications for<br>use | The Peripheral Nerve Block Tray is used<br>for administration of regional or local<br>anesthesia to a patient. | The ON-Q* T-bloc* Echogenic Continuous<br>Nerve Block Kit is indicated for delivery of<br>medication for regional anesthesia and<br>pain management. Routes of<br>administration may be perineural,<br>intraoperative, or percutaneous.<br><br>The ON-Q* T-bloc* Echogenic Continuous<br>Nerve Block Kit is indicated for patients<br>undergoing continuous regional<br>anesthesia and pain management<br>procedures. |
| Sterilization<br>Method | Ethylene Oxide | SAME |
| Single Use<br>Device | Yes | SAME |
| Packaging | Sterile Tyvek Pouch<br>Sterile .035" HDPE tray with Tyvek Lid | SAME |
| Catheter<br>Component | 20 GA x 24 in (61 cm) Spirol® Catheter,<br>with Inner Stylet and Thread Assist<br>Guide | 20 GA x 24 in (61 cm) Echogenic<br>Catheter, with Inner Stylet and Thread<br>Assist Guide |
| Stylet | Stainless Steel | Nitinol |
## TABLE 5.1 Kit Comparison
The Indications for Use statements of the subject and predicate devices have the same intended use (i.e., both are intended for regional anesthesia and pain management); however, the subject device indications for use has been expanded to identify the routes of administration and inclusion of the indicated patient population. The identification of the routes of administration and inclusion of the indicated patient population are not critical to the intended therapeutic or surgical use of the device and do not affect the safety and efficacy of the device when used as labeled.
Conclusion: The ON-Q* T-bloc* Echogenic Continuous Nerve Block Sets & Tray have substantially equivalent Indications for use, sterilization methods, packaging, and kit components as the predicate device, Peripheral Nerve Block Tray (K073187). The design enhancements of the subject device catheter raises no different questions of safety and effectiveness. The device is as safe, as effective, and performs as well as or better than the predicate.
