(94 days)
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No
The document describes a mechanical infusion pump with fixed flow rates and does not mention any AI/ML components or capabilities.
Yes.
The device delivers medication for pain management and antibiotic administration, which are therapeutic interventions.
No
The device is a pump that delivers medication for pain management and antibiotic administration, it does not diagnose conditions.
No
The device description explicitly states that the Stryker PainPump kit consists of a pump, introducer needle(s), infusion set(s), syringe(s), dressing(s), attachment strap, and accessories, indicating it is a hardware device with multiple physical components.
Based on the provided information, the Stryker PainPump 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 PainPump Function: The Stryker PainPump is designed to deliver medication directly into the body (intramuscular, subcutaneous, perineural, percutaneous routes) for pain management and antibiotic administration. This is an in vivo (within the living body) function, not an in vitro diagnostic test.
The description clearly outlines its purpose as a drug delivery system, not a device for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Stryker PainPump 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 PainPump 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 (comma separated list FDA assigned to the subject device)
II
Device Description
The Stryker PainPump 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 PainPump 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 PainPump kit models are available in fill volumes from 120 to 270 cc and flow rates from 0.60 - 8.32 cc/hr. Each pump kit consists of a pump, introducer needle(s), infusion set(s), syringe(s), dressing(s), attachment strap, and accessories.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
JUL 2 1 2003
K03 1249
INSTRUMENTS
4100 East Million Avenue Kalamazço, MI 40001 Phone (209) 323-7 /00 (300) 253-3210
Device Name:
| Trade Name: | Stryker PainPump |
|---|---|
| Common Name: | Infusion Pump |
| Classification Name: | Pump, Infusion: 21 CFR 880.5725, Class I |
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 PainPump 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 PainPump 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 PainPump kit models are available in fill volumes from 120 to 270 cc and flow rates from 0.60 - 8.32 cc/hr. Each pump kit consists of a pump, introducer needle(s), infusion set(s), syringe(s), dressing(s), attachment strap, and accessories.
The Stryker PainPump infusion pump is equivalent in intended use, safety, and effectiveness to existing infusion pump systems being marketed by Stryker, I-Flow Corporation, and Sgarlato,
The Stryker PainPump catheters are equivalent in intended use, safety, and effectiveness to existing catheters being marketed by companies such as Styker, I-Flow and Sims Portex.
The Stryker PainPump does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. The Stryker PainPump is substantially equivalent to these existing devices.
By: Nicole Petty
Regulatory Analyst
Dated: 7-15-03
1
Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle are three stylized human profiles facing to the right, with wavy lines below them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2003
Ms. Nicole Petty Regulatory Affairs Analyst Stryker Instruments 4100 East Miiham Avenue Kalamazoo, Michigan 49001
Re: K031249
Trade/Device Name: Stryker Painpump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: FRN Product Code: II Dated: April 17, 2003 Received: April 18, 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 dc 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. Nicole 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 (OS) 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.
Sincerely yours,
Susan Runner, DDDS, 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
KO31249
510(k) Number:
Device Name:
Stryker PainPump
Indications For Use:
The Stryker PainPump 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 PainPump 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)
Van Nostrum
y, General Hospital. Intection Control, Dental Devic
510(k) Number: