(27 days)
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.
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.
The provided document (K063234) is a 510(k) summary for the ON-Q Introducers, a medical device. It does not contain information about studies conducted to meet specific acceptance criteria through performance metrics like sensitivity, specificity, or AUC, as would be common for diagnostic AI/ML devices.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices by meeting recognized consensus standards for device design and performance requirements. The concept of "acceptance criteria" here refers to compliance with these established standards and the safety and effectiveness profile similar to already marketed devices.
Therefore, for this particular device (ON-Q Introducers), the request for details on acceptance criteria and a study proving the device meets them needs to be interpreted within the context of a 510(k) submission for a non-AI/ML device.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance (Claim of Substantial Equivalence) |
|---|---|
| ISO 10555-5:1996: Sterile, Single-Use Intravascular Catheters - Over Needle Peripheral Catheters | Device meets the requirements of this standard. |
| ISO 10555-1:1995: Sterile, Single-Use Intravascular Catheters - General Requirements | Device meets the requirements of this standard. |
| ISO 594-1:1986: Conical Fittings with 6% (Luer) Taper - Part 1 | Device meets the requirements of this standard. |
| ISO 594-2:1998: Conical Fittings with 6% (Luer) Taper - Part 2 | Device meets the requirements of this standard. |
| ISO 9626:1991: Stainless Steel Needle Tubing | Device meets the requirements of this standard. |
| Overall Safety and Effectiveness: Device is safe and effective for its intended use. | The ON-Q Introducers are substantially equivalent to existing introducers that are currently marketed. |
| Intended Use: 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. | Device performs as intended and is equivalent to predicate devices for these indications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document primarily focuses on compliance with international standards and comparison to predicate devices, rather than a clinical study with a "test set" in the context of diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided and is not applicable to this type of device submission. Ground truth, in the sense of expert consensus for diagnostic interpretation, is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable to this type of device submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication of an MRMC study being performed. This is not an AI/ML device, and the submission is not focused on improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI/ML device, so a standalone algorithm performance study is not applicable and not mentioned.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of device, ground truth relates to the physical and functional properties of the device meeting established engineering standards (e.g., sterility, material properties, luer taper dimensions, needle tubing specifications). This is assessed through laboratory testing and manufacturing controls, rather than diagnostic "ground truth." The document does not detail specific testing protocols or results in full.
8. The sample size for the training set
This information is not provided and is not applicable. The device is not an AI/ML product that would require a "training set."
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no "training set" for this device.
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ON-Q Introducers Section 5 - Summary of Safety and Effectiveness NOW 2 1 2006
510(K) - SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter: | I-Flow Corporation20202 Windrow DriveLake Forest, CA. 962630 |
|---|---|
| Contact: | Shane NoehreDirector, Regulatory AffairsI-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 |
| TechnologyComparison: | The ON-Q Introducers use the same technology as legally marketedpredicate devices. |
| Conclusion: | The ON-Q Introducers are substantially equivalent to existing introducersthat are currently marketed. |
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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.
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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
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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
Page 1 of 1
§ 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).