(351 days)
For use in moistening and lubricating absorbent wound dressings for cuts, bruises and minor burns prior to removal from the wound area
The subject AMSure® Single Use Saline Topical Solution device is normal saline 0.9% w/v Sodium Chloride. It is used in moistening and lubricating absorbent wound dressings for cuts, bruises, and minor burns prior to removal from the wound area. They are intended to be used in clinical and should only be used by clinicians familiar with the treatment of possible complications.
The subject device of normal saline topical solution 0.9% w/v is a unit-dose low density polyethylene (LDPE) vial contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives. The subject device is using blow fill seal technology. The devices are offered in 15mL, 35mL, 50mL.
The provided text is a 510(k) Premarket Notification summary for a medical device called "AMSure® Single Use Saline Topical Solution". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance-based acceptance criteria through an independent study.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, specifically:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, ground truth establishment, expert involvement, or adjudication methods.
- Information about MRMC effectiveness studies or standalone algorithm performance.
- Details on training set sample size or how its ground truth was established.
Instead, the document details:
- Device Name: AMSure® Single Use Saline Topical Solution
- Regulatory Class: Unclassified
- Product Code: FRO
- Intended Use: For use in moistening and lubricating absorbent wound dressings for cuts, bruises, and minor burns prior to removal from the wound area.
- Predicate Device: K993969 SALJET single dose sterile saline topical solution.
- Substantial Equivalence Discussion: The document argues that the subject device is substantially equivalent to the predicate device based on:
- Similar Technological Characteristics: Both are 0.9% w/v Sodium Chloride solutions in LDPE vials. The principle of operation is the mechanical action of fluid for removing foreign objects.
- Similar Intended Use: Both are used for moistening and lubricating wound dressings.
- Difference in Sterility: The subject device uses aseptic blow-fill-seal technology, while the predicate is terminally sterilized. The submission argues this difference does not affect safety or effectiveness due to aseptic process validation and biocompatibility testing.
- Nonclinical Testing (Bench):
- Design Verification Testing: Tests performed to ensure predetermined acceptance criteria were met for:
- Identify Assay % NaCl
- pH
- Endotoxin
- Sterility
- Leak Testing
- Net Fill Volume
- (Note: Specific acceptance criteria values and reported performance values are NOT provided in this summary.)
- Biocompatibility Testing: Conducted in accordance with ISO 10993-1, including:
- In Vitro Cytotoxicity (ISO 10993-5)
- Acute Systemic Toxicity (ISO 10993-11)
- Intracutaneous Reactivity (ISO 10993-10)
- Skin Sensitization (ISO 10993-10)
- Material-mediated pyrogenicity (USP )
- Chemical characterization and toxicological risk assessment.
- Design Verification Testing: Tests performed to ensure predetermined acceptance criteria were met for:
In summary, this document is a regulatory submission for a medical device demonstrating substantial equivalence, not a clinical study report or a detailed performance validation study with specific acceptance criteria and results. The "performance testing" mentioned is bench testing for design verification and biocompatibility, not a clinical study involving human patients, algorithms, or expert readers.
N/A