(146 days)
Not Found
No
The description focuses on the electromechanical nature of the pump and its controlled delivery based on pre-set flow rates and patient-controlled boluses, with no mention of adaptive learning, pattern recognition, or other AI/ML characteristics. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is described as delivering controlled amounts of medication and narcotics for pain management and/or antibiotic administration, which are therapeutic interventions.
No.
The PainPump2 is an electromechanical pump that delivers medication to the patient for pain management and antibiotic delivery, not for diagnosing medical conditions.
No
The device description explicitly states it is an "electromechanical pump," indicating it is a hardware device with mechanical and electrical components, not solely software.
Based on the provided information, the Stryker PainPump2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Stryker PainPump2 Function: The Stryker PainPump2 is a device that delivers medication directly into the patient's body (in vivo) for pain management and/or antibiotic administration. It does not perform any testing on specimens taken from the body.
The device description and intended use clearly indicate that its function is to administer substances to the patient, not to diagnose conditions based on in vitro testing.
N/A
Intended Use / Indications for Use
The Stryker PainPump2 delivers controlled amounts of medication and narcotics directly to the intraoperative site for pain management. The pump infuses the medication at an hourly flow rate and provided the option for patient controlled bolus doses. Medications and narcotics are infused through intramuscular, subcutaneous, and epidural routes.
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 provided the option for patient controlled bolus doses. Medications are infused through intramuscular and subcutaneous routes.
The Stryker PainPump2 is intended for controlled delivery of local anesthetics and narcotics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.
The Stryker PainPump2 is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management. This results in a reduction of hospital length of stay.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
PainPump2 is an electromechanical pump designed to deliver controlled amounts of medication to the patient for pain management and/or antibiotic delivery. Medication is delivered to the treatment site using an hourly flow rate or combination of hourly flow rate and bolus PCA (Patient Controlled Analgesia) dosing option. Pain Management routes of administration may be intramuscular, subcutaneous or epidural. Antibiotic routes of administration may be intramuscular or subcutaneous.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoperative site, nerves, surgical wound sites
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.
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
§ 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
4100 E. Milham Avenue
Kalamazoo, MI 49001 t: 269 323 7700 f: 800 965 6505 www.stryker.com
stryker
instruments
510(k) Summary
| Trade Name: | Stryker PainPump2. Stryker PainPump2 Blockaid |
|---|---|
| Common Name: | Infusion Pump; Electromechanical Ambulatory Infusion Pump |
| Classification Name: | Pump, Infusion, PCA |
| Equivalent to: | K042405, Stryker PainPump1 and Stryker PainPump2; K040337, I-Flow Elastomeric Pump w/ Bolus |
| Device Description: | PainPump2 |
| PainPump2 is an electromechanical pump designed to deliver controlled amounts of medication to the patient for pain management and/or antibiotic delivery. Medication is delivered to the treatment site using an hourly flow rate or combination of hourly flow rate and bolus PCA (Patient Controlled Analgesia) dosing option. Pain Management routes of administration may be intramuscular, subcutaneous or epidural. Antibiotic routes of administration may be intramuscular or subcutaneous. | |
| Indications for Use: | PainPump2 |
| The Stryker PainPump2 delivers controlled amounts of medication and narcotics directly to the intraoperative site for pain management. The pump infuses the medication at an hourly flow rate and provided the option for patient controlled bolus doses. Medications and narcotics are infused through intramuscular, subcutaneous, and epidural routes. |
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 provided the option for patient controlled bolus doses. Medications are infused through intramuscular and subcutaneous routes.
The Stryker PainPump2 is intended for controlled delivery of local anesthetics and narcotics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.
The Stryker PainPump2 is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management. This results in a reduction of hospital length of stay. |
| Submitted by: | Jennifer Mars
Regulatory Affairs Representative |
| Date submitted: | Signature |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three lines above them that resemble a flag or banner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 0 2005
Ms. Jennifer Mars Senior Regulatory Affairs Representative Stryker Instruments Instruments Division 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K043466
Trade/Device Name: Stryker PainPump2 Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: April 18, 2005 Received: April 19, 2005
Dear Ms. Mars:
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 - Ms. Mars
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,
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 Statement
510(k) Number:
Device Name:
Stryker PainPump2
Indications for Use:
The Stryker PainPump2 delivers controlled amounts of medication and narcotics directly to the intraoperative site for pain management. The pump infuses the medication at an hourly flow rate and provided the option for patient controlled bolus doses. Medications and narcotics are infused through intramuscular, subcutaneous, and epidural routes.
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 provided the option for patient controlled bolus doses. Medications are infused through intramuscular and subcutaneous routes.
The Stryker PainPump2 is intended for controlled delivery of local anesthetics and narcotics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutancous.
The Stryker PainPump2 is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
Prescription Use (Per 21 CFR 801 Subpart D)
OR
Over-The- Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Cen On
Anesthesiology, General Hospital, nimi Dontal Davis
Number: K043461