(79 days)
Indications for Prescription (Rx) Use:
Saline Wound Wash is intended for use by or under the direction of a professional health care provider in moistening and lubricating absorbent wound dressings, cleansing and maintaining a moist wound environment for traumatic wounds such as pressure sores, leg ulcers of diabetic and vascular origin, cuts abrasions and minor burns.
Indications for Over the Counter (OTC) Use:
Saline Wound Wash is intended for use in moistening and lubricating absorbent wound dressings and for cleansing minor wounds, scrapes and minor burns. If redness, swelling or bleeding continues please seek the help of a nurse, nurses aid, doctor or other medical professional.
Saline Wound Wash is a multi-use, isotonic, sterile saline solution packaged in a bag-in-can aerosol system. Actuation of the device (product can) delivers a consistent flow of sterile isotonic saline solution at published safe and effective wound impact pressures of 4 to 15 psi (Clinical Practice Guideline Number 15, AHCPR, US Department of Health and Human Services). The mechanical action of isotonic saline solution moving across the wound aids in the removal of foreign material, such as dirt and debris, as well as any necrotic tissue, wound exudates, and other extraneous matter. No preservatives are added since the finished device is sterilized by gamma irradiation under parameters that have been validated according to ISO/AAMI 11137 requirements (Sterilization of health care products - Requirements for validation and routine control - radiation sterilization).
Saline Wound Wash passes the USP Sterility Test.
Saline Wound Wash is an Rx and OTC device and will only be labeled for use in wounds.
The Premier Brands of America Inc. Saline Wound Wash (K090848) is a sterile, isotonic saline solution in an aerosol system. The 510(k) summary indicates that the device's performance is demonstrated through its compliance with existing standards and comparison to predicate devices, rather than a clinical study with a specific set of acceptance criteria and a test dataset as might be seen for a novel diagnostic or therapeutic device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility: Must pass USP Sterility Test. | Passes USP Sterility Test. (Paragraph 2, Page 2/3) |
| Sterilization Validation: Sterilized according to validated parameters for radiation sterilization (ISO/AAMI 11137 requirements). | Sterilized by gamma irradiation under parameters that have been validated according to ISO/AAMI 11137 requirements. (Paragraph 2, Page 2/3) |
| Wound Impact Pressure: Delivers consistent flow at safe and effective wound impact pressures of 4 to 15 psi (Clinical Practice Guideline Number 15, AHCPR, US Department of Health and Human Services). | Actuation of the device delivers a consistent flow of sterile isotonic saline solution at published safe and effective wound impact pressures of 4 to 15 psi (Clinical Practice Guideline Number 15, AHCPR, US Department of Health and Human Services). (Paragraph 5, Page 1/3) |
| Purity/Composition: 0.9% sodium chloride solution prepared from sodium Chloride, USP, and purified water, USP. (Implicit from description) | Saline Wound Wash is a clear, colorless 0.9% sodium chloride solution prepared from sodium Chloride, USP, and purified water. USP. (Paragraph 8, Page 2/3) |
| No Preservatives: No preservatives added. | No preservatives are added... (Paragraph 5, Page 1/3) |
| Safety and Effectiveness: As safe and effective as predicate devices. (Implicit from substantial equivalence claim) | Saline Wound Wash is as safe and effective as the predicate devices. Saline Wound Wash has the same intended uses, technological characteristics, and basic principles of operation as its predicate devices and raises no new issues of safety or effectiveness. (Paragraph 9, Page 3/3) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a "test set" in the context of a clinical performance study with human subjects, images, or diagnostic outcomes. The performance is assessed against established physical and chemical standards and through direct comparison of technological characteristics to already approved predicate devices. Therefore, these metrics are not applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is not applicable as there is no "test set" requiring expert ground truth establishment for this type of device. The ground truth for the "performance" aspects is based on established scientific and regulatory standards (e.g., USP, ISO/AAMI 11137, AHCPR guidelines).
4. Adjudication Method for the Test Set:
This is not applicable as there is no "test set" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. The device is a wound wash, not a diagnostic or interventional imaging device where human reader performance would be a primary metric.
6. Standalone (Algorithm Only) Performance Study:
This is not applicable. The device is a physical product (saline wound wash), not an algorithm or AI system. Its performance is intrinsic to its physical and chemical properties and dispensing mechanism.
7. Type of Ground Truth Used:
The "ground truth" for this device's acceptance is based on:
- Established Scientific Standards: e.g., USP for sterility, ISO/AAMI 11137 for sterilization, Clinical Practice Guideline Number 15, AHCPR for wound impact pressures.
- Chemical and Physical Specifications: 0.9% sodium chloride solution purity, absence of preservatives, bag-in-can aerosol system design.
- Substantial Equivalence to Predicate Devices: This implies that the predicate devices themselves have demonstrated acceptable safety and effectiveness.
8. Sample Size for the Training Set:
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no "training set."
Summary of the Study:
The document describes a 510(k) premarket notification for a Saline Wound Wash. The "study" for this device's acceptance is primarily based on bench testing against established standards and demonstration of substantial equivalence to legally marketed predicate devices.
The device's performance is shown through:
- Compliance with Sterility Standards: Passing the USP Sterility Test.
- Validated Sterilization Process: Sterilization by gamma irradiation validated per ISO/AAMI 11137.
- Controlled Dispensing Pressure: Delivery of saline at scientifically recognized safe and effective wound impact pressures (4-15 psi) as per AHCPR guidelines.
- Material Composition: Use of USP-grade Sodium Chloride and purified water, and an inert bag-in-can system.
- Comparison to Predicate Devices: The submission asserts that "Saline Wound Wash is as safe and effective as the predicate devices. Saline Wound Wash has the same intended uses, technological characteristics, and basic principles of operation as its predicate devices and raises no new issues of safety or effectiveness." The predicate devices mentioned are Wound Wash Saline (K083355), Dermacyn™ Wound Dressing (K041161), and Sterile Saline (K082330).
Essentially, the "study" is a demonstration that the new device meets the same safety and performance profiles as similar, already approved devices and complies with relevant industry standards for sterility and product characteristics. This is a common approach for Class II medical devices in the 510(k) pathway, where a direct clinical trial demonstrating efficacy might not be required if substantial equivalence can be demonstrated.
§ 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.