(41 days)
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.
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 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.
Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain explicit acceptance criteria in a numerical or categorical format, nor does it present device performance data against such criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance or clinical study results with acceptance criteria.
The "device description" and "indications for use" sections describe what the devices (PainPump1 and PainPump2) are intended to do and how they function (deliver medication at an hourly flow rate, PainPump2 also offers bolus dosing). They also mention an intended outcome: "significantly decrease narcotic use and pain when used to deliver local anesthetics...when compared with narcotic only pain management." However, these are statements of intent and claims, not specific, measurable acceptance criteria with performance statistics.
Therefore, I cannot populate a table with acceptance criteria and reported device performance from this document.
2. Sample size used for the test set and the data provenance
The document does not mention a test set sample size or data provenance (e.g., country of origin, retrospective or prospective). As a 510(k) summary, it focuses on comparing the proposed device to predicate devices rather than detailing independent clinical or performance studies with a distinct test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information about experts used to establish ground truth or their qualifications. This type of detail is typically found in study protocols or results, which are not present in this 510(k) summary.
4. Adjudication method for the test set
The document does not describe any adjudication method for a test set.
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
The devices are "Infusion Pumps" (PainPump1 and PainPump2), which are mechanical devices for drug delivery. They are not AI-powered imaging or diagnostic devices that would involve "human readers" or "AI assistance" in the context of an MRMC study. Therefore, an MRMC comparative effectiveness study, as typically understood in the context of AI in healthcare, was not performed and is not relevant to these devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Again, as mechanical infusion pumps, the concept of a "standalone algorithm" is not applicable. The devices are physical instruments that deliver medication. Performance would be assessed through engineering tests (e.g., flow rate accuracy, pressure limits, battery life, alarm functionality), not through purely algorithmic assessment. The document does not provide details on such standalone performance tests for these mechanical functions, beyond implying they meet safety and efficacy standards for infusion pumps.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given that these are infusion pumps, "ground truth" would relate to the accuracy of medication delivery, safety features, and clinical outcomes (e.g., pain reduction, decreased narcotic use) as stated in the indications for use. However, the document does not specify the type of "ground truth" data used for performance or clinical validation. It merely claims the devices are intended to achieve certain outcomes, but doesn't detail the studies or the ground truth against which those claims were evaluated.
8. The sample size for the training set
The concept of a "training set" is relevant for machine learning algorithms. Since the PainPump devices are mechanical infusion pumps and not AI/ML-driven, there is no training set in the sense of data used to train an algorithm.
9. How the ground truth for the training set was established
As there is no training set for an AI/ML algorithm, this question is not applicable to the devices described.
In summary:
The provided 510(k) summary for the Stryker PainPump1 and PainPump2 devices primarily focuses on establishing substantial equivalence to previously cleared predicate devices (K031249, K030661, K040337). It describes the devices' functions and indications for use. However, it does not contain the detailed clinical study design, performance metrics, acceptance criteria, sample sizes (for test or training sets), expert qualifications, or adjudication methods typically found in documents describing performance studies for diagnostic or AI-powered devices. The acceptance is based on the devices being functionally equivalent to already-approved devices, rather than on new, independent, detailed performance studies with explicit acceptance criteria provided in this summary.
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K04 2405
OCT 1 4 2004
4100 F. Milham Avenue
Kalamazoo, MI 49001
1: 269 323 7700 f: 800 965 6505 www.stryker.com
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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-FlowElastomeric Pump w/ Bolus |
| Device Description: | PainPump1PainPump1 is a disposable syringe infuser which uses sustained vacuum pressure todeliver a continuous infusion of medication to the patient for pain managementan/or antibiotic delivery. Medication is delivered to the treatment site using anhourly flow rate. The routes of administration may be intramuscular orsubcutaneous. |
| PainPump2PainPump2 is an electromechanical pump designed to deliver controlled amounts ofmedication to the patient for pain management and/or antibiotic delivery.Medication is delivered to the treatment site using an hourly flow rate orcombination of hourly flow rate and bolus PCA (Patient Controlled Analgesia)dosing option. The routes of administration may be intramuscular or subcutaneous. | |
| Indications for Use: | PainPump1The Stryker PainPump1 delivers controlled amounts of medication directly to theintraoperative site for pain management and/or antibiotic administration. The pumpinfuses the medication at an hourly flow rate. Medications are infused throughintramuscular or subcutaneous routes.The Stryker PainPump1 is also intended for controlled delivery of local anestheticsin close proximity to nerves for postoperative regional anesthesia and painmanagement. Routes of administration may be intraoperative, perineural, orpercutaneous. |
| The Stryker PainPump1 is also intended to significantly decrease narcotic use andpain when used to deliver local anesthetics to surgical wound sites or closeproximity to nerves when compared with narcotic only pain management. |
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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
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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.
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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
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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 theintraoperative site for pain management and/or antibiotic administration.The pump infuses the medication at an hourly flow rate. Medications areinfused intraoperatively and postoperatively through intramuscular orsubcutaneous routes.PainPump1 is also intended for controlled delivery of local anesthetics inclose proximity to nerves for postoperative regional anesthesia and painmanagement. Routes of administration may be intraoperative, perineural,or percutaneous.PainPump1 is also intended to significantly decrease narcotic useand pain when used to deliver local anesthetics to surgical woundsites or close proximity to nerves when compared with narcoticonly pain management.PainPump2 delivers controlled amounts of medication directly to theintraoperative site for pain management and/or antibiotic administration.The pump infuses the medication at an hourly flow rate and provides theoption for patient controlled bolus doses. Medications are infusedintraoperatively and postoperatively through intramuscular orsubcutaneous routes.PainPump2 is also intended for controlled delivery of local anesthetics inclose proximity to nerves for postoperative regional anesthesia and painmanagement. Routes of administration may be intraoperative, perineural,or percutaneous.PainPump2 is also intended to significantly decrease narcotic useand pain when used to deliver local anesthetics to surgical woundsites or close proximity to nerves when compared with narcoticonly pain management. |
| Prescription UseX(Per 21 CFR 801 Subpart D) | OROver-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
§ 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).