(151 days)
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.
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.
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.
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.
Here's a breakdown of the acceptance criteria and study information, based on the provided document. It's important to note that this document is a 510(k) summary for medical devices, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with explicit acceptance criteria for performance metrics like sensitivity/specificity.
The provided documents describe two devices:
- ON-Q EchoSpark Echogenic Catheter** (K161232)
- ON-Q T-bloc Echogenic Continuous Nerve Block Kit** (K161232)
Both devices reuse part of the same summary. The information provided heavily emphasizes comparison to predicate devices and adherence to standards, rather than defining specific performance metrics against clinical ground truth.
For the ON-Q EchoSpark Echogenic Catheter (K161232):**
The acceptance criteria here are primarily about demonstrating substantial equivalence to the predicate device (ON-Q* Pain Relief System, QuikBloc* Over-the-Needle Catheter Set, K143164) and compliance with relevant performance standards and biocompatibility requirements. There are no explicit quantitative performance metrics like sensitivity/specificity for the echogenic catheter's visibility that are stated as acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Equivalent / Standard Compliant) | Reported Device Performance (Subject Device) |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate: delivery of medication for regional anesthesia and pain management. Predicate contraindicates epidural space 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." Subject device does not have the epidural contraindication (as it is not an over-the-needle catheter). Stated to be "not critical to the intended therapeutic or surgical use... and do not affect the safety and efficacy." |
| Regulation/Product Code | BSO (same as predicate) | BSO (Same) |
| Manufacturer | Halyard Health (same as predicate) | Halyard Health (Same) |
| Sterilization Method | Ethylene Oxide (same as predicate) | Same |
| Catheter Tubing Composition | Pebax (same as predicate) | Same |
| Depth Markings | Graduated depth markings every 10 mm (same as predicate) | Same |
| Radiopaque Stripes | Barium sulfate stripes (same as predicate) | Same |
| Labeling | Case and sterile pack with identification label of catheter type, size etc. and IFU (same as predicate) | Same |
| Single Use Device | Yes (same as predicate) | Yes (Same) |
| Packaging Standards | ASTM F1980-07, ASTM D4169-09, ASTM F 2096-11, ASTM F 1886-09, ISO 15223:2012, ISO 11607-1:2006 (same as predicate) | Same |
| Performance Testing Standards | ISO:10555-1:2013, ASTM F 1980-07, EN-13868:2002, ISO:10555-5:2013 (for predicate) | "All applicable performance standards are the same. ISO 10555-5:2013 does not apply because this is not an over the needle catheter." |
| Biocompatibility Standards | ISO:10993 series (1, 3, 4, 5, 6, 10, 11) compliant (with specific criteria like Grade ≤ 2 for cytotoxicity, Sensitization Index <3, etc., as detailed for predicate) | Same (implied full compliance to the listed ISO 10993 standards and their acceptance criteria). |
| Sterilization Standards | ISO 10993-7:2008, ISO 11135-1:2007 (same as predicate) | Same |
| Echogenic Screw Tip | N/A (predicate lacked this feature) | Stainless Steel (present) |
| Echogenic Property | N/A (predicate lacked this feature) | Yes (present) |
| MRI Compatibility | MR Safe (predicate) | MR UnSafe (subject device, noted as a difference but not framed as a failure to meet acceptance, likely due to a change in material for echogenicity). |
2. Sample Size for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the sense of patient data for evaluating diagnostic performance. The testing described is primarily engineering performance testing (e.g., against ISO standards, biocompatibility).
- Sample Size: Not specified for any clinical or image-based test set, as such a study is not detailed. For engineering tests, the sample sizes would be described within the individual test protocols (e.g., number of catheters tested for tensile strength, number of animals in biocompatibility).
- Data Provenance: Not applicable for a clinical test set from this document. The engineering tests likely originate from the manufacturer's labs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. No clinical test set with human-established ground truth is described.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set with expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study is not mentioned. The device is a physical medical device (catheter) for drug delivery, not an AI diagnostic algorithm. The primary "improvement" is the echogenic tip for better visibility under ultrasound, which is a design feature rather than an AI-driven enhancement.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical catheter, not a standalone algorithm.
7. Type of Ground Truth Used
The "ground truth" used for this device's acceptance is based on adherence to recognized international and national standards for medical devices (ISO, ASTM, EN), biocompatibility testing results, and the safety and performance characteristics of its predicate device. For the "echogenic" attribute, the ground truth would be the physical property of being visible under ultrasound, demonstrated through product design and potentially in vitro/in vivo bench testing.
8. Sample Size for the Training Set
Not applicable. There is no AI algorithm being trained.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
For the ON-Q T-bloc Echogenic Continuous Nerve Block Kit (K161232):**
Similar to the individual catheter, the acceptance criteria are predominantly about demonstrating substantial equivalence to its predicate device (Peripheral Nerve Block Tray, K073187) and compliance with relevant standards. The key distinguishing feature is the inclusion of the new Echogenic Catheter.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Equivalent / Standard Compliant) | Reported Device Performance (Subject Device) |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate: "administration of regional or local anesthesia to a patient." | "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." The document notes expansion to identify routes and patient population, but states these are "not critical to the intended therapeutic or surgical use... and do not affect the safety and efficacy." |
| Regulation/Product Code | CAZ (same as predicate) | CAZ (Same) |
| Sterilization Method | Ethylene Oxide (same as predicate) | SAME |
| Single Use Device | Yes (same as predicate) | SAME |
| Packaging | Sterile Tyvek Pouch, Sterile .035" HDPE tray with Tyvek Lid (same as predicate) | SAME |
| Catheter Component (Key Difference) | 20 GA x 24 in (61 cm) Spirol® Catheter, with Inner Stylet and Thread Assist Guide (predicate) | 20 GA x 24 in (61 cm) Echogenic Catheter, with Inner Stylet and Thread Assist Guide (subject device - includes the previously described echogenic catheter) |
| Stylet Material (Key Difference) | Stainless Steel (predicate) | Nitinol (subject device) |
2. Sample Size for the Test Set and Data Provenance
Not applicable for a clinical "test set" in the AI sense. Primarily engineering and component-level testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study is not mentioned.
6. Standalone (Algorithm Only) Performance
Not applicable.
7. Type of Ground Truth Used
The "ground truth" for this kit's acceptance is based on adherence to recognized standards, biocompatibility, and the safety and performance of its predicate device, incorporating the design and testing of the Echogenic Catheter component.
8. Sample Size for the Training Set
Not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Overall Summary regarding AI/Software Performance:
The provided documents are for physical medical devices (an anesthesia catheter and a nerve block kit). They do not describe an AI or software device, nor do they detail clinical studies with human readers or AI algorithms for diagnostic performance. Therefore, many of the requested points related to AI performance metrics, training/test sets, expert ground truth, and reader studies are not applicable to this submission. The focus is on demonstrating substantial equivalence in terms of intended use, technology, materials, and compliance with general device safety and performance standards.
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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.
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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
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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."
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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."
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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) SummaryON-Q* Echogenic Catheter | |
| Date Prepared: | September 29, 2016 |
| 510(k) Submitter: | Gwendolyn GeorgeHalyard Health®5405 Windward ParkwayAlpharetta, GA 30004520-204-6442gwendolyn.george@hyh.comEstablishment Registration Number: 3011270181 |
| PRIMARY CONTACTFOR THIS 510(k)SUBMISSION: | Gwendolyn GeorgeTechnical Leader, Regulatory Affairs520-204-6442 (Phone)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-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.
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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 DeviceQuikBloc* Over-the-NeedleCatheter Set(K143164) | Subject DeviceON-Q* Echogenic Catheter |
|---|---|---|
| RegulationProduct Code | BSO | Same |
| Manufacturer | Halyard Health | Same |
| Indications for Use | The ON-Q* QuikBloc* Over-the-NeedleCatheter Set is indicated for delivery ofmedication (such as local anesthetics) forregional anesthesia and pain management.Route of administration may beintraoperative, percutaneous, or perineural.The ON-Q* QuikBloc* Over-the-NeedleCatheter Set is contraindicated for theepidural space. | The ON-Q* EchoSpark* Echogenic Catheter isindicated for delivery of medication forregional anesthesia and pain management.Routes of administration may be perineural,intraoperative, or percutaneous.The ON-Q* EchoSpark* Echogenic Catheteris indicated for patients undergoingcontinuous regional anesthesia and painmanagement procedures. |
| SterilizationMethod | Ethylene Oxide | Same |
| CatheterTubingcomposition | Pebax | Same |
| Echogenic screwtip | N/A | Stainless Steel |
| Echogenic | N/A | Yes |
| Depth Markings | Graduated depth markings every 10 mm | Same |
| RadiopaqueStripes | Barium sulfate stripes | Same |
| Labeling | Case and sterile pack with identificationlabel of catheter type, size etc. and IFU | Same |
| MRICompatibility | MR Safe | MR UnSafe |
| Single Use Device | Yes | Same |
| PackagingChevron Style Sterile Tyvek PouchASTM F1980-07ASTM D4169-09ASTM F 2096-11ASTM F 1886-09ISO 15223:2012ISO 11607-1:2006 | ||
| Characteristic | Predicate DeviceQuikBloc* Over-the-NeedleCatheter Set(K143164) | Subject DeviceON-Q* Echogenic Catheter |
| PerformanceTesting Data | ISO:10555-1:2013ASTM F 1980-07EN-13868:2002ISO:10555-5:2013 | All applicable performance standardsare the same. ISO 10555-5:2013 doesnot apply because this is not an overthe needle catheter. |
| Biocompatibility | ISO:10993-1:2009CompliantISO:10993-3:2003No statistically significant increasein the number of revertant coloniescompared to negative controlISO:10993-4:2002No statistically significant differencecompared to negative controlISO:10993-5:2009Acceptance Criteria $≤$ Grade 2ISO:10993-6:2007No significant difference comparedto the controls.ISO:10993-10:2010Acceptance Criteria: SensitizationIndex <3Acceptance Criteria: Test articlemean score- control article meanscore <1ISO:10993-11:2012None of the test animals showgreater biological reaction thancontrol animals. | Same |
| Sterilization | ISO 10993-7:2008ISO 11135-1:2007 | Same |
The ON-Q* Echogenic Catheter Substantial Equivalence Table is provided below.
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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.
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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 GeorgeHalyard Health®5405 Windward ParkwayAlpharetta, GA 30004520-204-6442gwendolyn.george@hyh.comEstablishment Registration Number: 3011270181 |
| PRIMARY CONTACTFOR THIS 510(k)SUBMISSION: | Gwendolyn GeorgeTechnical Leader, Regulatory Affairs520-204-6442 (Phone)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.
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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 DevicePeripheral Nerve Block Tray(K073187) | Subject DeviceON-Q* T-bloc* Echogenic ContinuousNerve Block Kit |
|---|---|---|
| RegulationProduct Code | CAZ | CAZ |
| Indications foruse | The Peripheral Nerve Block Tray is usedfor administration of regional or localanesthesia to a patient. | The ON-Q* T-bloc* Echogenic ContinuousNerve Block Kit is indicated for delivery ofmedication for regional anesthesia andpain management. Routes ofadministration may be perineural,intraoperative, or percutaneous.The ON-Q* T-bloc* Echogenic ContinuousNerve Block Kit is indicated for patientsundergoing continuous regionalanesthesia and pain managementprocedures. |
| SterilizationMethod | Ethylene Oxide | SAME |
| Single UseDevice | Yes | SAME |
| Packaging | Sterile Tyvek PouchSterile .035" HDPE tray with Tyvek Lid | SAME |
| CatheterComponent | 20 GA x 24 in (61 cm) Spirol® Catheter,with Inner Stylet and Thread AssistGuide | 20 GA x 24 in (61 cm) EchogenicCatheter, with Inner Stylet and ThreadAssist 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.
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).