(56 days)
The Stryker InterPulse Lavage System is intended for wound debridement, soft tissue debridement and cleansing of the surgical or medical/clinical site.
The Stryker InterPulse Lavage System is intended for wound debridement, soft tissue debridement and cleansing of a medical, clinical, or surgical site. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin on burn wounds, and cleansing wounds incurred from trauma.
The Stryker InterPulse System is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields.
The Stryker InterPulse Handpiece is operated by batteries which are either located and sealed within the handpiece housing or in an external battery pack. The flow of irrigation is variable between approximately 100ml/min and 1500ml/min depending on which irrigation tip is attached to the handpiece as well as the amount of displacement of the handpiece trigger.
The InterPulse system includes an assortment of tips which provide a variation in irrigant flow rate and irrigation flow pattern. Tips that are indicated for wound and soft tissue debridement do not exceed a pressure of 15 psi at the wound site. A Protective Plug allows the user to reuse the InterPulse handpiece on the same patient for subsequent hydrodebridement of chronic wounds. A lighted irrigation tip provides illumination of the irrigating site. This tip has a bulb that is illuminated by batteries located within the tip.
The provided document is a 510(k) premarket notification for the Stryker InterPulse Lavage System. This type of submission is for demonstrating "substantial equivalence" to a predicate device, rather than proving safety and efficacy through a standalone study with defined acceptance criteria and rigorous testing.
Therefore, the document does not contain the specific information requested about acceptance criteria, detailed study design, sample sizes, ground truth establishment, or multi-reader multi-case studies typically found in a clinical trial report for novel devices or software.
Here's a breakdown of why the requested information is not available in this 510(k) and what information is present:
Key Takeaways from the document relevant to your request, but highlighting the absence of typical clinical study details:
- Device Type: The Stryker InterPulse Lavage System is a pulsed lavage system for wound debridement and cleansing. This is a physical medical device, not an AI/software device, which typically involves different types of validation.
- Regulatory Pathway: 510(k) pathway, which establishes "substantial equivalence" to a legally marketed predicate device, meaning it is as safe and effective. It does not require new clinical trials to prove efficacy from scratch if existing data on predicate devices is sufficient.
- Predicate Device: The document states the Stryker InterPulse Lavage System is equivalent to existing marketed products by companies such as Davol and Davis+Geck.
- "Study" (Equivalence Justification): The "Summary of Safety and Effectiveness" serves as the justification for equivalence. It highlights that the device's "Power modality, intended use, and safety risks are all substantially equivalent," and it "does not raise any new safety and efficacy concerns when compared to similar legally marketed devices." This is the "proof" the device meets the regulatory requirements for market clearance under this pathway.
Specific answers to your questions based on the provided text, acknowledging limitations:
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Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics (e.g., sensitivity, specificity, or specific pressure ranges for efficacy). The overarching acceptance criterion for a 510(k) is "substantial equivalence" to predicate devices in terms of intended use, technological characteristics, and safety/effectiveness profiles.
- Reported Device Performance:
- Intended Use: Wound debridement, soft tissue debridement, and cleansing of the surgical or medical/clinical site.
- Flow Rate: Variable between approximately 100ml/min and 1500ml/min.
- Pressure: Tips indicated for wound and soft tissue debridement do not exceed a pressure of 15 psi at the wound site.
- Safety: Single patient use, sterile, disposable.
- Power Modality: Battery-operated.
- Equivalence: Stated to be "substantially equivalent" to marketed products by Davol and Davis+Geck in terms of power modality, intended use, and safety risks.
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Sample size used for the test set and the data provenance: Not applicable. No "test set" in the sense of a clinical or technical study proving a performance metric was conducted within the scope described in this 510(k). The equivalence argument relies on comparison to known predicate devices.
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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. No such "ground truth" establishment for performance metrics is described in this 510(k). The regulatory body (FDA) reviews the equivalence argument presented by the manufacturer.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.
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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 device is a physical medical instrument, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of performance metrics for this 510(k). The "ground truth" for clearance is the regulatory determination of "substantial equivalence" based on comparison to existing predicate devices whose safety and efficacy have already been established through their own regulatory pathways or market history.
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The sample size for the training set: Not applicable. There is no "training set" as this is a physical device and not an AI/ML model being developed.
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How the ground truth for the training set was established: Not applicable for the reasons stated above.
In summary, the provided document is a regulatory submission for premarket clearance via the 510(k) pathway for a non-software medical device. It focuses on demonstrating "substantial equivalence" rather than presenting detailed clinical trial results or performance studies with specific acceptance criteria in the way one might expect for a novel drug or a high-risk AI diagnostic device.
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.