(94 days)
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 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.
This document is a 510(k) premarket notification for the Stryker PainPump, which is a medical device for infusing medication. The document asserts the device's substantial equivalence to previously marketed devices rather than presenting a study to prove its performance against specific acceptance criteria.
Therefore, most of the requested information cannot be extracted directly from the provided text because it describes a regulatory submission, not a performance study.
Here's a breakdown of what can and cannot be answered based on the provided text:
Acceptance Criteria and Device Performance Study Information
| Information Point | Response from Document |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Cannot be extracted. The document is a 510(k) submission, asserting substantial equivalence to predicate devices, not reporting on a study against specific performance acceptance criteria for the Stryker PainPump itself. It states: "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." |
| 2. Sample size for test set and data provenance | Not applicable / Cannot be extracted. No specific test set or study data is presented for the Stryker PainPump. The claim is based on substantial equivalence. |
| 3. Number and qualifications of experts for ground truth | Not applicable / Cannot be extracted. No ground truth establishment process for a performance study is described. |
| 4. Adjudication method for the test set | Not applicable / Cannot be extracted. No test set or adjudication process is described. |
| 5. Multi-reader multi-case (MRMC) comparative effectiveness study | No. No MRMC study is mentioned. The submission relies on substantial equivalence. |
| 6. Standalone (algorithm only) performance study | No. This device is an infusion pump, which does not involve an algorithm in the sense of AI/image analysis. No standalone performance study is described; the submission relies on substantial equivalence to predicate devices. |
| 7. Type of ground truth used | Not applicable. No ground truth for a performance study is described. The equivalency is based on intended use, safety, and effectiveness compared to existing, legally marketed devices. |
| 8. Sample size for the training set | Not applicable. There is no mention of a training set as this is not an AI/machine learning device, nor is a new performance study's training phase described. The submission focuses on demonstrating equivalence to predicate devices already on the market. |
| 9. How ground truth for the training set was established | Not applicable. As above, no training set or ground truth establishment process for a training set is described in the context of this 510(k) submission. The regulatory approval is based on a comparison to "legally marketed predicate devices." Its "safety and effectiveness" are derived from its similarity to already approved devices. |
Summary of the Document's Approach:
The provided text is a 510(k) Premarket Notification, which is a regulatory pathway to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process does not typically involve conducting new large-scale clinical trials or detailed performance studies against specific acceptance criteria in the way a PMA (Premarket Approval) might.
Instead, the submission for the Stryker PainPump relies on:
- Comparison of Intended Use: The Stryker PainPump's intended use (delivering medication for pain management and/or antibiotic administration) is equivalent to existing infusion pump systems.
- Comparison of Technological Characteristics/Design: The document indirectly implies structural and functional similarity by stating it "does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed."
- Comparison to Predicate Devices: The document explicitly names competitors' devices (Stryker, I-Flow Corporation, Sgarlato for pumps; Styker, I-Flow, and Sims Portex for catheters) as benchmarks for equivalence in intended use, safety, and effectiveness.
Therefore, the "study" proving the device meets criteria is effectively the 510(k) submission itself, where "meeting criteria" means demonstrating substantial equivalence to already approved predicate devices. The acceptance criteria in this context are those required by the FDA for 510(k) clearance, primarily proving that the device is as safe and effective as a legally marketed predicate device.
§ 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).