(41 days)
Not Found
No
The description focuses on controlled medication delivery via vacuum pressure or electromechanical pump with fixed flow rates and optional patient-controlled boluses. There is no mention of adaptive algorithms, learning from data, or any other characteristics typically associated with AI/ML.
Yes
The devices, PainPump1 and PainPump2, are intended to deliver medication for pain management and antibiotic administration, directly addressing a health condition (pain, infection) with the aim of alleviating or improving it.
No
The provided text explicitly states that PainPump1 and PainPump2 "deliver controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration." Their function is to administer therapy (medication) rather than to diagnose conditions.
No
The device descriptions explicitly state that PainPump1 is a "disposable syringe infuser" and PainPump2 is an "electromechanical pump," indicating they are hardware devices that deliver medication.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 for diagnosis, monitoring, or screening.
- PainPump Function: The PainPump devices described deliver medication directly to the patient's body for pain management and/or antibiotic administration. They are therapeutic devices, not diagnostic ones.
- Lack of Specimen Analysis: The descriptions do not mention any analysis of biological specimens. The devices are focused on drug delivery.
Therefore, the PainPump devices fall under the category of therapeutic medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
PainPump1 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. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes.
PainPump1 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.
PainPump1 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.
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 intraoperatively and postoperatively 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
PainPump1: PainPump1 is a disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medication to the patient for pain management an/or antibiotic delivery. Medication is delivered to the treatment site using an hourly flow rate. The routes of administration may be intramuscular or subcutaneous.
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. The 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, surgical wound sites, 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
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
K04 2405
OCT 1 4 2004
4100 F. Milham Avenue
Kalamazoo, MI 49001
1: 269 323 7700 f: 800 965 6505 www.stryker.com
Image /page/0/Picture/3 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase except for the "S", which is uppercase. There is a small registered trademark symbol to the upper right of the "r".
Instruments
510(k) Summary
| Trade Names: | Stryker PainPump1 and Stryker PainPump2 |
|---|---|
| Common Name: | Infusion Pump; Electromechanical Ambulatory Infusion Pump |
| Classification Name: | Pump, Infusion, PCA |
| Equivalent to: | K031249, Stryker PainPump1; K030661, PainPump2, |
| K040337; I-Flow | |
| Elastomeric Pump w/ Bolus | |
| Device Description: | PainPump1 |
| PainPump1 is a disposable syringe infuser which uses sustained vacuum pressure to | |
| deliver a continuous infusion of medication to the patient for pain management | |
| an/or antibiotic delivery. Medication is delivered to the treatment site using an | |
| hourly flow rate. The routes of administration may be intramuscular or | |
| subcutaneous. | |
| 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. The routes of administration may be intramuscular or subcutaneous. | |
| Indications for Use: | PainPump1 |
| The Stryker PainPump1 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. Medications are infused through | |
| intramuscular or subcutaneous routes. |
The Stryker PainPump1 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 PainPump1 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. |
1
PainPump2
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 Medications are infused through intramuscular, or controlled bolus doses. subcutaneous routes.
The Stryker PainPump2 is intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain Routes of administration may be intraoperative, perineural, or management. 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.
Submitted by:
Jennifer Mars Regulatory Affairs Representative
Jennifer Mars
Signature
Date submitted:
October 13, 2004
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized graphic of three human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 2004
Ms. Jennifer Mars Regulatory Affairs Representative Stryker Corporation Instrument Division 4100 E. Milham Avenue Kalamazoo, Michigan 49001
Re: K042405
Trade/Device Name: PainPump1 and PainPump2 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: August 31, 2004 Received: September 7, 2004
Dear Ms. Mars:
We have reviewed your Section 510(k) premarket notification of intent to market the device We liave reviewed your becalen by (1) process is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the energently is cogniture date of the Medical Device interstate collimitelee prior to that have been reclassified in accordance with the provisions of Amendinents, or to devices mat nave oose (Act) that do not require approval of a premarket the Federal Pood, Drug, and Cosmette 190 (1920) - ...
approval application (PMA). You may, therefore, market the device, subject to the general approval application (1 he Act. The general controls provisions of the Act include controls provisions of the Fict. "The gistration, 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 II your device is classified (boo as a vierns. Existing major regulations affecting (1 MA), it may of subject to back ademic to begulations, Title 21, Parts 800 to 898. In your device can be found in firsher announcements concerning your device in the Federal Register.
3
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 moan that I Drived statutes and regulations administered by other Federal agencies. or the Free of any I vath all the Act's requirements, including, but not limited to: registration r ou muse compry wart 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 es result of the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet resist 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), 11 Jou donto 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/dsma/dsmamain.html
Sincerely yours,
Susan Ruoppes
Dr. Chia-Lin, Ph.D.
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
05
Indications for Use Statement
| 510(k) Number: | K042405 |
|---|---|
| Device Name: | Stryker PainPump: PainPump1 and PainPump2 |
| Indications for Use: | PainPump1 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. Medications are | |
| infused intraoperatively and postoperatively through intramuscular or | |
| subcutaneous routes. |
PainPump1 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.
PainPump1 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.
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
intraoperatively and postoperatively 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.
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
X
(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)
Chris Lowe
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K042465