(27 days)
Not Found
Not Found
No
The device description details a purely mechanical introducer system (trocar and sheath) with no mention of software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is used for introducing and placing catheters, which is a procedural step, not a therapeutic action in itself. While the catheters placed might deliver therapy (like medication), the introducer device itself is not therapeutic.
No
The device is described as an introducer for placing catheters, and can be used to aspirate or inject fluids or medications. Its purpose is mechanical introduction and placement, not the diagnosis of a condition or disease.
No
The device description clearly outlines physical components made of stainless steel and plastic, indicating it is a hardware device, not software-only.
Based on the provided information, the ON-Q Introducers are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the percutaneous introduction and placement of catheters into or around surgical wound sites and/or close proximity to nerves. This is a direct intervention on the patient's body for the purpose of delivering or placing a medical device (catheter).
- Device Description: The device components (stainless steel shaft, plastic sheath) and their function (introducing and placing catheters) are consistent with a surgical or procedural device used in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be inserted into the body for therapeutic or procedural purposes like placing catheters.
N/A
Intended Use / Indications for Use
The ON-Q Introducers are intended for the percutaneous introduction and placement of catheters into or around surgical wound sites and/or close proximity to nerves. Introducers with a luer hub may be used to aspirate or inject a bolus of fluid or medication prior to placing the catheters.
Product codes (comma separated list FDA assigned to the subject device)
BSO
Device Description
The ON-Q Introducers consist of the following two components: The first component is a stainless steel shaft (trocar) with a handle or luer hub. The trocar diameter ranges from 11 to 17 GA and the length ranges from 3.25 to 12 inches. The trocar may have a sharp, beveled tip or a blunt, rounded tip. The second component is a peelable (split T-Handle) plastic sheath that is designed to fit over the trocar. The model configurations are designated as follows: Models with a blunt tip are called ON-Q Tunnelers. The sheaths may be sold separately and are single use only. Some versions of the ON-Q Tunnelers may be reusable. Models with a sharp tip are called ON-Q Introducers Needles which are single use only. The ON-Q Introducers are intended for the percutaneous introduction and placement of catheters into or around surgical wound sites and/or close proximity to nerves. Introducers with a luer hub may be used to aspirate or inject a bolus of fluid or medication prior to placing the catheters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical wound sites and/or close proximity to nerves
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
ON-Q Introducers Section 5 - Summary of Safety and Effectiveness NOW 2 1 2006
510(K) - SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter: | I-Flow Corporation
20202 Windrow Drive
Lake Forest, CA. 962630 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Shane Noehre
Director, Regulatory Affairs
I-Flow Corporation |
| Trade Names: | ON-Q Introducer, ON-Q Needle, ON-Q Tunneler, ON-Q Sheath |
| Common Name: | Catheter Introducer Needle |
| Device Description: | The ON-Q Introducers consist of the following two components:
The first component is a stainless steel shaft (trocar) with a handle or luer hub. The trocar diameter ranges from 11 to 17 GA and the length ranges from 3.25 to 12 inches. The trocar may have a sharp, beveled tip or a blunt, rounded tip. The second component is a peelable (split T-Handle) plastic sheath that is designed to fit over the trocar. The model configurations are designated as follows: Models with a blunt tip are called ON-Q Tunnelers. The sheaths may be sold separately and are single use only. Some versions of the ON-Q Tunnelers may be reusable. Models with a sharp tip are called ON-Q Introducers Needles which are single use only. The ON-Q Introducers are intended for the percutaneous introduction and placement of catheters into or around surgical wound sites and/or close proximity to nerves. Introducers with a luer hub may be used to aspirate or inject a bolus of fluid or medication prior to placing the catheters. |
| Standards: | The ON-Q Introducers meet the requirements of the following FDA recognized consensus standards for the device design and performance requirements: ISO 10555-5:1996, Sterile, Single-Use Intravascular Catheters - Over Needle Peripheral Catheters ISO 10555-1:1995, Sterile, Single-Use Intravascular Catheters - General Requirements ISO 594-1:1986, Conical Fittings with 6% (Luer) Taper - Part 1 ISO 594-2:1998, Conical Fittings with 6% (Luer) Taper - Part 2 ISO 9626:1991, Stainless Steel Needle Tubing |
| Technology
Comparison: | The ON-Q Introducers use the same technology as legally marketed
predicate devices. |
| Conclusion: | The ON-Q Introducers are substantially equivalent to existing introducers
that are currently marketed. |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Shane Noehre Director, Regulatory Affairs I-Flow Corporation 20202 Windrow Drive Lake Forest, California 92630
NOV 2 1 2006
Re: K063234
Trade/Device Name: On-Q Introducers Regulation Number: 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: October 24, 2006 Received: October 25, 2006
Dear Mr. Noehre:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 - Mr. Noehre
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Cuy Cholionn for
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K063234 510(k) Number (if known):
ON-Q Introducers Device Name:
Indications For Use:
-
- The ON-Q Introducers are intended for the percutaneous introduction and placement of catheters into or around surgical wound sites and/or close proximity to nerves. Introducers with a luer hub may be used to aspirate or inject a bolus of fluid or medication prior to placing the catheters.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
- The ON-Q Introducers are intended for the percutaneous introduction and placement of catheters into or around surgical wound sites and/or close proximity to nerves. Introducers with a luer hub may be used to aspirate or inject a bolus of fluid or medication prior to placing the catheters.
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Reds C. Alopez L. Amm 11/21/2006
for Anesthesiology, General Hospital,
Control, Dental Devices
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