(177 days)
The Stryker AntiMic Catheter Kit is intended to provide continuous or intermittent delivery of medication (such as local anesthetics) to or around surgical wound sites for preoperative, perioperative, and postoperative pain management. The Stryker AntiMic Catheter Kit is contraindicated for the epidural space and in neonatal populations.
The Stryker AntiMic Catheter Kit contains an anti-microbial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.
The Stryker AntiMic catheter is intended to be used with the Stryker Pain Pump Systems. Catheters are available in the following sizes: Standard; and 2.5", 5.0", and 10" Extended Fenestration. The Standard catheter has a closed tip with three holes arranged radially along the lateral surface at the distal end of the device. The Extended Fenestration catheters have a closed tip with multiple holes arranged radially along the lateral surface at the distal end of the device.
The catheter contains an antimicrobial agent that is intended to inhibit the growth of microorganisms and reduce the possibility of the catheter becoming microbially compromised.
The provided 510(k) summary for the Stryker AntiMic Catheter Kit does not contain the detailed information necessary to complete the requested table and study information.
This document focuses on establishing substantial equivalence to predicate devices rather than presenting performance data from a specific study against predefined acceptance criteria. Clinical trial or performance data, sample sizes, expert qualifications, and ground truth methodologies are typically found in more comprehensive study reports or regulatory submissions, which are not part of this 510(k) summary.
Therefore, I cannot provide the requested information from the given text.
Explanation of limitations based on the provided document:
- No acceptance criteria or reported device performance: The document declares substantial equivalence based on similar intended use and technological characteristics to predicate devices. It does not define specific acceptance criteria (e.g., a certain percentage reduction in infection, a specific tensile strength) or provide numerical performance data for the Stryker AntiMic Catheter.
- No sample sizes, data provenance, expert information, adjudication methods, or MRMC studies: These details are relevant for studies specifically designed to demonstrate safety and effectiveness or to compare performance, which are not presented in this 510(k) summary. The summary simply states that "performance characteristics" are similar to predicate devices, implying that any underlying data would have been part of the predicate device's approvals or internal testing by Stryker, but no such data is included here.
- No standalone algorithm performance or ground truth type: This device is a physical medical catheter, not an AI or algorithmic device. Therefore, the concepts of "standalone algorithm performance," "training set," and "ground truth" (in the context of clinical decision-making or diagnostic AI) do not apply to this submission.
- No training set information: As it's not an AI/algorithm-based device, there is no training set mentioned.
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MAR 1 9 2008
4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 800 965 6505
www.stryker.com
:
stryker
Instruments
510(k) Summary
| Device Sponsor: | Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(f) 269-324-5412 |
|---|---|
| Registration No.: | 1811755 |
| Trade Name: | Stryker AntiMic Catheter Kit |
| Common Name: | Antimicrobial Catheter |
| Classification Name: | Anesthesia, Conduction Catheters (BSO) |
| Equivalent to: | K051401 I-Flow: On-Q SilverSoaker CatheterK061250 Vygon: MultiCath ExpertK043466 Stryker Pain Pump2 |
| Device Description: | The Stryker AntiMic catheter is intended to be used with the StrykerPain Pump Systems. Catheters are available in the following sizes:Standard; and 2.5", 5.0", and 10" Extended Fenestration. TheStandard catheter has a closed tip with three holes arranged radiallyalong the lateral surface at the distal end of the device. The ExtendedFenestration catheters have a closed tip with multiple holes arrangedradially along the lateral surface at the distal end of the device.The catheter contains an antimicrobial agent that is intended toinhibit the growth of microorganisms and reduce the possibility of thecatheter becoming microbially compromised. |
| Indications for Use: | The Stryker AntiMic Catheter is intended to provide continuous orintermittent delivery of medication (such as local anesthetics ornarcotics) to or around surgical wound sites for preoperative,perioperative, and postoperative pain management. The StrykerAntiMic Catheter is contraindicated for the epidural space and inneonatal populations.The Stryker AntiMic Catheter contains an antimicrobial agent whichmay destroy or inhibit the growth of microorganisms on both the |
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| inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections. | |
|---|---|
| Substantial Equivalence (SE) Rational: | The Stryker AntiMic Catheter has the same intended use as the I- Flow On-Q Silver Soaker Catheter and the same technology of the antimicrobial process as the Vygon MultiCath Expert Catheter. This device and the predicate devices have the same technological characteristics, use the same patient contacting materials and have similar performance characteristics. |
| Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Stryker AntiMic Catheter is substantially equivalent to legally marketed devices. |
Submitted by:
Julie Pryor Regulatory Affairs Representative
Julie Riya
Signature
9/21/07
Date submitted:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Julie Pryor Regulatory Affairs Representative Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49001
MAR 1 9 2008
Re: K072702
Trade/Device Name: Stryker AntiMic Catheter Kit Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: February 15, 2008 Received: February 19, 2008
Dear Ms. Pryor:
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 - Ms. Pryor
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 yours,
Sudie J. Michie Omd.
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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Page 1 of 1
510(K) Number (if known):
Device Name: Stryker AntiMic Catheter Kit
Indications for Use
The Stryker AntiMic Catheter Kit is intended to provide continuous or intermittent delivery of medication (such as local anesthetics) to or around surgical wound sites for preoperative, perioperative, and postoperative pain management. The Stryker AntiMic Catheter Kit is contraindicated for the epidural space and in neonatal populations.
The Stryker AntiMic Catheter Kit contains an anti-microbial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.
Prescription Use X (Part 21 CFR 801 Subpart D) and/or
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)
Suor Runner fr MH
Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Intection Control, Dental Devices
510(k) Number: K072702
§ 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).