(177 days)
K043466 Stryker Pain Pump2
No
The provided text describes a catheter kit for pain management and mentions an antimicrobial agent. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections.
Yes
The device delivers medication for pain management, which is a therapeutic intervention.
No
The device is intended for the delivery of medication for pain management and contains an antimicrobial agent to prevent microbial growth on the catheter, not for diagnostic purposes.
No
The device description clearly describes a physical catheter and its intended use with a pain pump system, indicating it is a hardware device, not software-only.
Based on the provided information, the Stryker AntiMic Catheter Kit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to deliver medication for pain management at surgical wound sites. This is a therapeutic and drug delivery function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics of the catheter and its function in delivering medication. While it contains an antimicrobial agent, this agent is intended to prevent microbial growth on the catheter itself, not to diagnose or test for the presence of microorganisms in a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Stryker AntiMic Catheter Kit does not fit this definition.
N/A
Intended Use / Indications for Use
The Stryker AntiMic Catheter is intended to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative, perioperative, and postoperative pain management. The Stryker AntiMic Catheter is contraindicated for the epidural space and in neonatal populations.
The Stryker AntiMic Catheter contains an antimicrobial 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 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.
Product codes (comma separated list FDA assigned to the subject device)
BSO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical wound sites
Indicated Patient Age Range
Not in neonatal populations.
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.
K051401 I-Flow: On-Q SilverSoaker Catheter, K061250 Vygon: MultiCath Expert
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.
K043466 Stryker Pain Pump2
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
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 Instruments
4100 E. Milham Avenue
Kalamazoo, 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 Catheter
K061250 Vygon: MultiCath Expert
K043466 Stryker Pain Pump2 |
| Device Description: | 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. |
| Indications for Use: | The Stryker AntiMic Catheter is intended to provide continuous or
intermittent delivery of medication (such as local anesthetics or
narcotics) to or around surgical wound sites for preoperative,
perioperative, and postoperative pain management. The Stryker
AntiMic Catheter is contraindicated for the epidural space and in
neonatal populations.
The Stryker AntiMic Catheter contains an antimicrobial agent which
may destroy or inhibit the growth of microorganisms on both the |
1
| 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:
2
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.
3
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
4
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