(88 days)
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.
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 provided document is a 510(k) premarket notification for the Stryker PainPump2, which focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This type of submission generally does not include detailed studies with specific acceptance criteria and performance metrics in the way a clinical trial for a novel device or software exhibiting AI/ML capabilities would.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not present in this document. The submission relies on a comparison of intended use, safety, and effectiveness to already cleared devices rather than providing new performance data from a clinical study.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided: The submission does not present specific quantitative acceptance criteria or performance metrics for the Stryker PainPump2 in the way a diagnostic device or AI algorithm would. Its primary claim is substantial equivalence to predicate devices (I-Flow Corporation infusion pump systems and I-Flow/Sims Portex catheters) based on intended use, safety, and effectiveness.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The document does not describe a "test set" in the context of performance evaluation with specific sample sizes. There's no mention of a study involving patient data to assess the device's performance. The substantial equivalence argument is based on comparing the device's design and intended use to existing, cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: As there is no described test set or ground truth establishment process related to a performance study, this information is not relevant to this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable / Not Provided: This question is relevant for AI/ML-powered diagnostic tools. The Stryker PainPump2 is an electromechanical ambulatory infusion pump; it does not involve human readers or AI assistance in the way a diagnostic imaging system would.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This device is a physical infusion pump, not an algorithm. Therefore, no standalone algorithm performance study was conducted or is relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: No performance study with a "ground truth" is described in the document.
8. The sample size for the training set
- Not Applicable / Not Provided: As this is an electromechanical device and not an AI/ML algorithm, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: This question is not relevant for the type of device and submission provided.
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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
§ 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).