(88 days)
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Not Found
No
The summary describes a mechanical infusion pump with programmable flow rates and patient-controlled boluses. There is no mention of AI, ML, or any adaptive or learning algorithms.
Yes.
The device is intended to deliver medication for pain management, antibiotic administration, and regional anesthesia, all of which are therapeutic interventions.
No
The device is used for delivering medication for pain management and antibiotic administration, not for diagnosing conditions.
No
The device description explicitly states that the device is a "kit that is comprised of an infusion set(s), introducer needle(s), syringe, and catheter securement accessories," which are physical hardware components.
Based on the provided text, the PainPump2 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- PainPump2 Function: The description clearly states that the PainPump2 delivers medication directly to the intraoperative site or in close proximity to nerves for pain management and antibiotic administration. This is a therapeutic function, not a diagnostic one.
- Routes of Administration: The specified routes (intramuscular, subcutaneous, intraoperative, perineural, percutaneous) involve delivering substances into the body, not analyzing samples from the body.
Therefore, the PainPump2 is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker PainPump2 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications are infused through intramuscular or subcutaneous routes. The Stryker PainPump2 is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.
PainPump2 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications are infused through intramuscular or subcutaneous routes. PainPump2 is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.
Product codes
MEA
Device Description
The Stryker PainPump2 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications are infused through intramuscular or subcutaneous routes. The Stryker PainPainPump2 is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous. The Stryker PainPum2 is a kit that is comprised of an infusion set(s), introducer needle(s), syringe, and catheter securement accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoperative site, in 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
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Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
KA30661
MAY 3 0 2003
stryker
INSTRUMENTS
4100 East Milham Avenue,
Kalamazoo, MI 49001
Phone (616) 323-7766,
800-383-8217
Device Name:
| Trade Name: | Stryker PainPump2 |
|---|---|
| Common Name: | Electromechanical Ambulatory Infusion Pump |
| Classification Name: | Pump, Infusion, PCA : 21 CFR 880.5725, Class II |
Device Sponsor:
| Manufacturer: | Stryker Instruments |
|---|---|
| 4100 E. Milham Avenue | |
| Kalamazoo, MI 49001 | |
| Registration No.: 1811755 |
Regulatory Class: Class II
Summary of Safety and Effectiveness:
The Stryker PainPump2 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications are infused through intramuscular or subcutaneous routes.
The Stryker PainPump2 is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.
The Stryker PainPum2 is a kit that is comprised of an infusion set(s), introducer needle(s), syringe, and catheter securement accessories.
The Stryker PainPump2 infusion pump is equivalent in intended use, safety, and effectiveness to existing infusion pump systems being marketed by I-Flow Corporation.
The Stryker PainPump2 catheters are equivalent in intended use, safety, and effectiveness to existing catheters being marketed by companies such as I-Flow and Sims Portex.
The Stryker PainPump2 does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker PainPump2 is substantially equivalent to these existing devices.
By: Nicole Petty
Nicole Petty Regulatory Analyst
Dated: 5-8-03
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle. The text is in all caps and evenly spaced.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2003
Ms. Nicole Petty Regulatory Affairs Analyst Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K030661
Trade/Device Name: Stryker PainPump2 Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA Dated: February 27, 2003 Received: March 3, 2003
Dear Ms. Petty:
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. Petty
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely vours.
Susan Runner
Susan Runner, DDS, MA Interim 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: Device Name: Stryker PainPump2 Indications For Use: PainPump2 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications are infused through intramuscular or subcutaneous routes. PainPump2 is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The- Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Pulver Crescent
510(k) Number: K030661