(151 days)
Not Found
No
The device description focuses on the physical components and materials of the catheter and kit, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies listed are standard for medical devices and do not suggest AI/ML validation.
Yes
The device is indicated for "delivery of medication for regional anesthesia and pain management" and for "patients undergoing continuous regional anesthesia and pain management procedures," which are therapeutic applications.
No
The device is described as a catheter used for the delivery of medication for regional anesthesia and pain management, not for diagnosing a condition.
No
The device description clearly details physical components like catheters, stylets, and packaging, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of medication for regional anesthesia and pain management." This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details a catheter and kit designed for delivering medication, not for examining specimens from the human body to provide diagnostic information.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health.
IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for delivering medication.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
BSO, CAZ
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.
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 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 catheter sleeve composed of Tyvek and polyester.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Performance Testing Data:
ISO:10555-1:2013
ASTM F 1980-07
EN-13868:2002
ISO:10555-5:2013
All applicable performance standards are the same. ISO 10555-5:2013 does not apply because this is not an over the needle catheter.
Biocompatibility:
ISO:10993-1:2009 Compliant
ISO:10993-3:2003 No statistically significant increase in the number of revertant colonies compared to negative control
ISO:10993-4:2002 No statistically significant difference compared to negative control
ISO:10993-5:2009 Acceptance Criteria $≤$ Grade 2
ISO:10993-6:2007 No significant difference compared to the controls.
ISO:10993-10:2010 Acceptance Criteria: Sensitization Index
§ 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).
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 | |
| ON-Q* Echogenic Catheter | |
| Date Prepared: | September 29, 2016 |
| 510(k) Submitter: | Gwendolyn George |
| Halyard Health® | |
| 5405 Windward Parkway | |
| Alpharetta, GA 30004 | |
| 520-204-6442 | |
| gwendolyn.george@hyh.com | |
| Establishment Registration Number: 3011270181 | |
| PRIMARY CONTACT | |
| FOR THIS 510(k) | |
| SUBMISSION: | Gwendolyn George |
| Technical Leader, Regulatory Affairs | |
| 520-204-6442 (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.
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
QuikBloc* Over-the-Needle
Catheter Set
(K143164) | Subject Device
ON-Q* Echogenic Catheter |
|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Product Code | BSO | Same |
| Manufacturer | Halyard Health | Same |
| Indications for Use | The ON-Q* QuikBloc* Over-the-Needle
Catheter Set is indicated for delivery of
medication (such as local anesthetics) for
regional anesthesia and pain management.
Route of administration may be
intraoperative, percutaneous, or perineural.
The ON-Q* QuikBloc* Over-the-Needle
Catheter Set is contraindicated for the
epidural space. | 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. |
| Sterilization
Method | Ethylene Oxide | Same |
| Catheter
Tubing
composition | Pebax | Same |
| Echogenic screw
tip | N/A | Stainless Steel |
| Echogenic | N/A | Yes |
| Depth Markings | Graduated depth markings every 10 mm | Same |
| Radiopaque
Stripes | Barium sulfate stripes | Same |
| Labeling | Case and sterile pack with identification
label of catheter type, size etc. and IFU | Same |
| MRI
Compatibility | MR Safe | MR UnSafe |
| Single Use Device | Yes | Same |
| Packaging
Chevron Style Sterile Tyvek Pouch
ASTM F1980-07
ASTM D4169-09
ASTM F 2096-11
ASTM F 1886-09
ISO 15223:2012
ISO 11607-1:2006 | | |
| Characteristic | Predicate Device
QuikBloc* Over-the-Needle
Catheter Set
(K143164) | Subject Device
ON-Q* Echogenic Catheter |
| Performance
Testing Data | ISO:10555-1:2013
ASTM F 1980-07
EN-13868:2002
ISO:10555-5:2013 | All applicable performance standards
are the same. ISO 10555-5:2013 does
not apply because this is not an over
the needle catheter. |
| Biocompatibility | ISO:10993-1:2009
Compliant
ISO:10993-3:2003
No statistically significant increase
in the number of revertant colonies
compared to negative control
ISO:10993-4:2002
No statistically significant difference
compared to negative control
ISO:10993-5:2009
Acceptance Criteria $≤$ Grade 2
ISO:10993-6:2007
No significant difference compared
to the controls.
ISO:10993-10:2010
Acceptance Criteria: Sensitization
Index