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Moisturizing of Wound Dressings, Device Irrigation and Jet Lavage for Tissue Debridement

This device is USP purified water or saline sealed in 100mL HDPE bottles or 120mL HIPS cups and terminally sterilized using gamma irradiation. All materials are latex free.

The provided text is a 510(k) summary for a medical device: "Primary Care Solutions Sterile Water and Sterile Saline for Device Irrigation, Moisturizing of Wound Dressings and for use in Jet Lavage for Tissue Debridement".

This is a submission for an unclassified medical device, specifically sterile water and sterile saline. The 510(k) is for an expanded label usage of an existing device, not for a new device concept or a device relying on complex algorithms or imaging for diagnosis/treatment.

Therefore, the concepts of "acceptance criteria" and "studies proving the device meets acceptance criteria" as they relate to performance metrics like sensitivity, specificity, or effect sizes for AI-powered diagnostics do not apply to this type of submission.

Instead, for devices like sterile water and saline, acceptance criteria revolve around:

• Sterility: The product must be free of viable microorganisms.
• Purity: The water/saline must meet USP (United States Pharmacopeia) standards for purified water or saline.
• Material Compatibility: The packaging materials (HDPE bottles, HIPS cups) must be safe and compatible with the contents.
• Terminal Sterilization Effectiveness: The gamma irradiation process must effectively sterilize the product.
• Packaging Integrity: The seal and container must maintain sterility and product quality.
• Labeling Accuracy: The label must accurately reflect the contents and intended use.
• Predicate Device Equivalence: The product must be substantially equivalent to previously cleared devices in terms of materials, intended use, and performance claims.

The "study" in this context is the manufacturer's verification and validation (V&V) testing to ensure these criteria are met. This would typically involve:

• Sterility testing: USP <71> Sterility Tests.
• Chemical/Physical tests: To ensure USP compliance for purified water or saline (e.g., pH, conductivity, endotoxin levels, particulate matter).
• Biocompatibility testing: For the packaging materials if there's a new or modified material.
• Gamma irradiation validation: Dosimetry and bioburden measurements to confirm effective sterilization.
• Package integrity/shelf-life studies: To ensure the product remains sterile and stable over its intended shelf life.

Since the submission is for expanded label usage of an existing device (K000265, K000266), the focus of the 510(k) is on demonstrating that the expanded indications ("Moisturizing of Wound Dressings, Device Irrigation and Jet Lavage for Tissue Debridement") do not introduce new questions of safety or effectiveness and are consistent with the predicate devices. The document explicitly states: "There is no material change involved in this notice to expand labeling. Compliance With Special Controls: No applicable mandatory performance standards or special controls exist for these devices."

Therefore, many of the specific questions about AI/diagnostic study design are not applicable to this documentation.

Here's how to interpret the request in the context of the provided 510(k) for this specific device:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable in the traditional sense for a diagnostic device. This is a physical, sterile fluid product. Testing would involve process validation and material testing, not clinical "test sets" for diagnostic accuracy. The 510(k) summary does not mention specific sample sizes for V&V tests, as this is typically part of internal design controls and test reports, not the public 510(k) summary for such a low-risk device. Data provenance would be from internal manufacturing and testing facilities.

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. There is no "ground truth" to establish in the diagnostic/AI sense for sterile water or saline. The "ground truth" for sterility is the absence of microorganisms confirmed by lab tests. The "ground truth" for purity is compliance with USP standards, confirmed by chemical analysis. These are objective laboratory measurements, not subjective expert assessment.

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

• Not Applicable. No expert adjudication is involved.

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 is not an AI-powered diagnostic device.

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

• Not Applicable. This is not an algorithm.

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

• For sterility: Laboratory culture results (absence of growth).
• For purity: Analytical chemistry results (USP compliance).
• For packaging integrity: Physical integrity tests and shelf-life stability studies.
• The "ground truth" for this 510(k) filing is primarily that the device meets established standards (USP) and regulatory requirements (sterilization validation, substantial equivalence).

8. The sample size for the training set

• Not Applicable. There is no AI training set for this device.

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

• Not Applicable. There is no AI training set for this device.

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The 10cc and 30cc pre-filled syringes are intended to be used for foley catheter balloon inflation. The intended use of the device is identical to that of the predicate device and other similar devices in the market. The syringe is employed by connecting the syringe tip to the valve on the side arm of foley catheter and forcing sterile water through a lumen into the balloon for inflation.

A sterile water pre-filled syringe for use in inflating foley catheter balloon

The device is a 10cc and 30cc syringe pre-filled with USP purified water and gamma irradiated. The syringe is produced using polypropylene for the device barrel and plunger and pharmaceutical grade latex free rubber for both the plunger gasket and syringe tip cover.

The provided text is a 510(k) summary for a medical device: "Primary Care Solutions Prefilled 10cc and Prefilled 30cc Inflation Syringes with Sterile Water."

This document does not describe an AI/ML powered device, nor does it detail a study proving the device meets acceptance criteria in the way typically expected for such technologies. Instead, it is a submission for a conventional medical device (pre-filled syringes for foley catheter balloon inflation) seeking clearance based on substantial equivalence to an existing predicate device.

Therefore, many of the requested elements for describing an AI/ML study (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission.

The "acceptance criteria" here refer to meeting the requirements for substantial equivalence to a predicate device, primarily focusing on materials, intended use, and general performance characteristics rather than complex performance metrics like sensitivity or specificity.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission for a simple medical device, there aren't explicit quantifiable "acceptance criteria" and "reported device performance" in the way one would see for diagnostic AI. Instead, the "performance" is implicitly demonstrated by the device's identical materials and intended use compared to the predicate device.

Regarding the study that "proves the device meets the acceptance criteria":

The "study" in this context is the comparison to the identified predicate device (K943836 - Pre-Filled 10cc Inflation Syringe with Sterile Water from Orion Medical Products, Inc.) and the determination of substantial equivalence by the FDA. The document explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..."

The core "proof" is the detailed comparison in the submission (summarized here) highlighting the identical material components and identical intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This is a substantial equivalence submission for a non-AI/ML device. There is no "test set" in the context of data for an algorithm. The evaluation is based on device design, materials, and intended use comparison to a predicate.

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. No expert consensus "ground truth" for a test set is involved. The FDA regulatory body makes a determination of substantial equivalence based on the submitted application and its comparison to the predicate device.

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

• Not applicable. No test set or expert adjudication is relevant to this type of device submission.

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 is not an AI/ML device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

• Not applicable. This is not an AI/ML device.

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

• Not applicable. For this submission, the "ground truth" (if one could even call it that) is the legally marketed status and characteristics of the predicate device to which substantial equivalence is claimed.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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Ask a specific question about this device