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This device is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

The subject device is a polypropylene plastic syringe filled with 0.9% Sodium Chloride for Injection, USP, and capped with a polypropylene plastic cap. The device will be terminally sterilized by gamma radiation sterilization. The device will be marketed as a 12 mL syringe with a 3 mL, 5 mL, or 10 mL fill volume.

This document describes a 510(k) premarket notification for a medical device called "Normal Saline Flush" by Nurse Assist, Inc. The purpose of the submission is to demonstrate substantial equivalence to previously marketed predicate devices. It is not a study proving clinical effectiveness of an AI device.

Therefore, many of the requested categories for describing an AI study are not applicable to this document. I will fill in the relevant information from the provided text.

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

• Seal Testing: no leaks (15 in-Hg for 15 minutes)
• Sterility: confirmation of sterile barrier and product sterility (no growth present) | - Visual Inspection: no major compromise of packaging
• Seal Testing: no leaks
• Sterility: confirmation of sterile barrier and product sterility—no growth present |
  | Shelf Life (Stability) | - Visual: no leaks, holes or cracks
• Seal: no leaks
• Appearance/Color: clear liquid
• Odor: no objectionable or unusual odors
• pH: 4.5 – 7.0
• Sodium Chloride: 0.885 – 0.945%
• Heavy Metals: USP & limits
• Sterility: confirmation of sterile barrier and product sterility (no growth present)
• Particulate: USP limits | - Visual: no leaks, cracks or holes
• Seal: no leaks
• Appearance/Color: no discoloration or cloudiness
• Odor: no objectionable odors
• pH: within upper and lower limits
• Sodium Chloride: within upper and lower limits
• Heavy metals: USP : less than 10 ppm (0.001%), USP : less than 2 ppm
• Sterility: confirmation of sterile barrier and product sterility—no growth present
• Particulate: less than 3,000 for 10 μm and 300 for 25 μm |
  | Biocompatibility (Qualitative) | - Cytotoxicity: Grade 0 (no reactivity)
• Hemocompatibility: Non-hemolytic
• Acute Systemic Toxicity: Non-toxic
• Intracutaneous Irritation: Non-irritant
• Contact Sensitization: Non-sensitizer
• Pyrogenicity: Nonpyrogenic | - Cytotoxicity: Grade 0 (no reactivity)
• Hemocompatibility: Hemolytic index of 0.0% (non-hemolytic)
• Acute Systemic Toxicity: Non-toxic
• Intracutaneous Irritation: Non-irritant
• Contact Sensitization: Non-sensitizer
• Pyrogenicity: Nonpyrogenic |
  | Endotoxin | Less than 0.25 EU/ml | All samples tested at an endpoint of 0.03 EU/ml. Sensitivity of Lysate (AntiLog10 of Mean): 0.03 EU/ml (This implies the results were below or at the detection limit, and below the acceptance criteria.) |

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

This document pertains to the physical and chemical properties, and biocompatibility of a medical device (a saline flush syringe), not an AI algorithm. Therefore, there is no "test set" in the context of an AI study. The data provenance is from non-clinical laboratory testing of the device. The country of origin of the testing is not specified but is implicitly associated with the manufacturer, Nurse Assist, Inc. (Haltom City, TX 76117, USA).

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. This is not an AI study. The "ground truth" for these tests are laboratory standards, analytical methods, and biological responses to the device materials.

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

Not applicable. This is not an AI study.

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 study.

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

Not applicable. This is not an AI study.

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

The "ground truth" for this device consists of established scientific and regulatory standards for device safety, performance, and sterility. This includes:

• Physical integrity specifications (e.g., no leaks, cracks).
• Chemical composition standards (e.g., pH range, sodium chloride concentration, heavy metals limits).
• Sterility assurance levels (S.A.L. of $10^{-6}$).
• Biocompatibility standards (e.g., ISO, ASTM, USP guidelines for cytotoxicity, hemocompatibility, toxicity, irritation, sensitization, pyrogenicity).
• Endotoxin limits (USP ).

8. The sample size for the training set

Not applicable. This is not an AI study.

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

Not applicable. This is not an AI study.

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For Prescription Use: For easing the insertion of medical devices such as scopes and catheters into body orifices.

The subject device is a terminally gamma sterilized 10cc polypropylene plastic syringe filled with United Guardian lubricating jel and capped with a polypropylene plastic cap. United Guardian has a Master File Reference for its lubrication jel, Master File for Devices MAF-613 pertaining to Lubrajel RR. All components of the device are gamma irradiation stable.

The provided document describes a 510(k) premarket notification for a medical device, specifically a "Sterile Lube Jelly Pre-Filled Syringe," asserting its substantial equivalence to a legally marketed predicate device. The information details non-clinical performance data rather than a clinical study involving human patients or a complex AI algorithm. Therefore, many of the requested categories related to clinical trials, AI, ground truth, and expert evaluation are not applicable to this submission.

Here's a breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The device, the Nurse Assist Lube Jelly Pre-Filled Syringe, aims to demonstrate substantial equivalence to the predicate device, the Horizon Steri-Lub Lubrication Gel. The acceptance criteria are implicit in showing that the device's characteristics and performance are comparable to the predicate.

Study Details

This submission relies on non-clinical performance data and a comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical study the way an AI/software device would.

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to samples of the device undergoing various performance tests (e.g., syringe seal, stain, viscosity, accelerated aging, biocompatibility). The number of units tested for each specific non-clinical test is not provided in this summary. The data provenance is from internal testing conducted by Nurse Assist Incorporated.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical performance tests is established through standardized testing protocols (e.g., ISO 10993 for biocompatibility, physical property measurements for viscosity, pH, volume, etc.), not expert consensus in the diagnostic sense.
3. Adjudication method: Not applicable. Standard laboratory testing procedures would be followed.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. This device is a pre-filled lubricant syringe, not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
6. The type of ground truth used: For the non-clinical performance tests, the "ground truth" is defined by established scientific and regulatory standards (e.g., specific viscosity ranges, pH levels, sterility tests, ISO 10993 for biocompatibility) that the device must meet.
7. The sample size for the training set: Not applicable. There is no AI training set.
8. How the ground truth for the training set was established: Not applicable. There is no AI training set.

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For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. For Prescription Use: For moistening absorbent wound dressings and for moistening, . debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

The Wound Flush, Sterile Water & Sterile Normal Saline device is a wound and device cleansing solution that is intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile saline for irrigation and meets all of the associated requirements defined in the USP . The subject device is offered in various bottle and cup sizes with and without a spray applicator

This 510(k) summary describes a wound and device cleansing solution, but it does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The document details:

• Device name: Wound Flush, Sterile Water & Sterile Normal Saline
• Manufacturer: Nurse Assist Incorporated
• Intended Use/Indications for Use: For moistening dressings and cleaning various wound types (minor cuts, burns, abrasions) for both OTC and prescription use, and for device irrigation.
• Technological Characteristics: The mechanical action of fluid aids in the removal of foreign objects.
• Predicate devices: Several legally marketed sterile water/saline and wound care products are listed.
• Regulatory classification: Unclassified, pre-amendment device (Product code FRO).
• FDA determination: Substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria or a study proving the device meets those criteria, as it is not present in the provided text.

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