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PainPump2 is an electromechanical pump which delivers a controlled amount of medication to the patient for the purpose of managing pain. The pump delivers medication using one or both of the following drug delivery profiles: an hourly flow rate and a bolus PCA (patient controlled anesthetic) dosing option. Routes of administration may be intraoperative, subcutaneous, or percutaneous. Dosage rates and patient lock out times are programmed into the PainPump II unit by the physician. The PainPump II is contraindicated for infusion of blood and blood products, insulin, or life-supporting medication.

The Stryker PainPump2 is intended an electromechanical pump which delivers a controlled amount of medication to the patient for the purpose of managing pain. The pump delivers medication using one or both of the following drug delivery profiles: an hourly flow rate and a bolus PCA (patient controlled anesthetic) dosing option. Routes of administration may be intraoperative, subcutaneous or percutaneous. Dosage rates and patient lock out times are programmed into the PainPump2 unit by the physician.

This document, K030885, concerns a 510(k) premarket notification for the Stryker PainPump2. It is a submission for substantial equivalence to legally marketed predicate devices, not a study proving device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not available within this document.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

This document does not contain a table of acceptance criteria or reported device performance. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed performance study against specific acceptance criteria.

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. This document does not describe a clinical study or a test set with sample sizes.

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. This document does not describe the establishment of a ground truth by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This document does not describe an 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

Not applicable. This document is for an electromechanical infusion pump and does not involve AI or human readers for diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI or algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. This document does not refer to a ground truth as it pertains to a performance study.

8. The sample size for the training set

Not applicable. There is no mention of a training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable. There is no mention of a training set or ground truth for it.

Summary of what the document does provide:

• Device Name: Stryker PainPump2
• Intended Use: An electromechanical pump to deliver a controlled amount of medication for pain management, using hourly flow rates and/or bolus PCA dosing. Routes of administration can be intraoperative, subcutaneous, or percutaneous.
• Contraindications: Infusion of blood products, insulin, or life-supporting medication.
• Regulatory Basis: The submission is a 510(k) premarket notification, seeking substantial equivalence to existing infusion pump systems marketed by I-Flow Corporation.
• Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, meaning it does not raise new safety and efficacy concerns compared to existing devices.

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