Search Results

The LDS Needle is intended for use with a luer-tip syringe for the administration of drugs.

The OcuSafe® LDS Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® LDS Needle is indicated for intravitreal use.

The SteriCap® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The SteriCap Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock'unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick.

The VitreJect® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® LDS Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick. The VitreJect® LDS Safety Needle is indicated for intravitreal use.

The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The Low Dead Space (LDS) needle has a decreased internal volume within the luer taper to reduce fluid volume loss. The LDS Needle and OcuSafe® LDS Needle have a removable cap that is removed prior to the needle's use. The SteriCap® LDS Safety Needle and VitreJect® LDS Safety Needle have a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Needle / SteriCap® LDS Needle are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect® LDS Safety Needle and OcuSafe® LDS Needle are suitable for intravitreal use.

The provided text describes a 510(k) submission for several needle devices, primarily focusing on the addition of a "low dead space (LDS)" specification. The submission claims substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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

The primary new acceptance criterion mentioned is for "Low Dead Space (LDS)".

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

• Low Dead Space (LDS) Testing:

  • Sample Size: 58 samples (for 95% confidence and 95% reliability)
  • Data Provenance: Not specified (country/retrospective/prospective)

• Other Testing (Biocompatibility, Performance, Sterilization, etc.): The specific sample sizes for each of these tests are not provided in the summary. The text implies these tests were conducted as part of the overall validation process, often following international standards (ISO, USP, AAMI, ASTM). No information about data provenance (country, retrospective/prospective) is given for these tests. The text states these characteristics "did not change from devices under the respective previously cleared 510(k)s," suggesting that much of this data might be carried over from previous submissions for very similar devices.

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)

This device is a physical medical needle, not an AI or imaging device that requires expert interpretation for a "ground truth" establishment in the traditional sense of clinical studies. The "ground truth" for the performance characteristics (e.g., dead space volume, material strength, biocompatibility endpoints) is established through standardized laboratory testing and measurement against pre-defined engineering and biological criteria outlined in the referenced ISO, USP, AAMI, and ASTM standards. The summary does not specify the number or qualifications of individuals conducting these laboratory tests.

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

Not applicable. This is not a study requiring expert adjudication of diagnoses or findings. The "test set" here refers to physical samples undergoing laboratory measurements.

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 a medical device (needle) and does not involve AI assistance or human readers for diagnostic interpretation.

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

Not applicable. This is a medical device (needle) and does not involve an algorithm.

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

The "ground truth" for verifying the device's characteristics is based on:

• Direct Measurement/Quantitative Analysis: For specifications like low dead space volume (≤ 5µL), needle length, gauge.
• Standardized Laboratory Tests: For biocompatibility endpoints (e.g., cytotoxicity, endotoxin levels), material properties, sterilization efficacy, and packaging integrity. These tests compare results against established thresholds defined by international standards (ISO, USP, AAMI, ASTM).
• Engineering Specifications: For physical characteristics and design integrity.

8. The sample size for the training set

Not applicable. This is a hardware medical device, not a machine learning model. There is no concept of a "training set" for its development or evaluation as described in this summary.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

This device is intended to inject into or aspirate from, the body.

A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a luer lock or luer slip piston syringes. The devices are intended to be used by doctors, medical- related practitioners and self-injection by patients as directed by doctors or medical-related practitioners. The needle hub or connector of the needle is designed to reduce medication waste. Low dead space needles are operated manually by attaching it to a piston syringe. Target injection sites include subcutaneous, intramuscular, intravascular, and intradermal.

This document is a 510(k) summary for a medical device called "STERiJECT Low Dead Space" and "STERiJECT The INViSIBLE Needle". It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a single table of "acceptance criteria" against which "reported device performance" is explicitly measured in a quantitative manner as one might find for a diagnostic software. Instead, it demonstrates conformance to recognized industry standards, which serve as the implicit acceptance criteria for various aspects of the device. The "reported device performance" is the statement of "conformance" or "meets the requirements".

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each test mentioned (e.g., number of needles tested for tensile strength, number of samples for cytotoxicity). It broadly states that "non-clinical testing data" was used. The data provenance is implied to be from the manufacturer's own testing as part of their device development and validation process in Japan, given the applicant's location. The studies are prospective in the sense that they are performed specifically to validate the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to this type of device submission. The "ground truth" for the performance of a hypodermic needle is established by its adherence to internationally recognized consensus standards, physical measurements, and biological safety tests, not by expert consensus on interpretations of images or clinical data.

4. Adjudication Method for the Test Set

Not applicable. This device is a physical medical instrument, not a diagnostic or AI-driven system requiring adjudication of results from multiple readers.

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-driven or 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 or software device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Conformance to recognized consensus standards (e.g., ISO, ASTM, USP) for physical properties, materials, sterility, packaging, and biocompatibility.
• Bench testing results for specific performance characteristics like low dead space capability.
• Biocompatibility testing to assess the biological response to the device materials.
• Sterilization and shelf-life validation based on established protocols.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Ask a specific question about this device

This product is intended for use to inject fluid into or withdraw fluids from parts of the surface of the skin.

Sterile single use needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub). The needle cap covers intended to provide physical protection to the needle tube. This product is packed by sterile paper and sterilized by EO gas.

The safety guard is placed around the needle after using the product for safety and to prevent reuse. EZ-Injec LDV Sterile Safety Needle helps to decrease fluid volume loss because of its smaller hub inner size.

The provided text describes a 510(k) premarket notification for a medical device, the EZ-Injec LDV Sterile Safety Needle. It details the device's characteristics, comparison to a predicate device, and the performance testing conducted to demonstrate substantial equivalence.

However, the information provided does not contain details about acceptance criteria, study methodologies, or performance results in the context of an AI/ML powered device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance (in terms of AI metrics like sensitivity, specificity, AUC, etc.).
• Sample sizes for test sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for an AI/ML study.
• Any mention of Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
• Information on training set size or how its ground truth was established for an AI/ML model.

The document focuses on the physical and functional aspects of a hypodermic needle, including:

• Mechanical properties: Gauge, length, dead space, sharps prevention function.
• Material composition: Polypropylene, SUS304, Epoxy.
• Sterilization: EO gas.
• Biocompatibility testing: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility, Particulate Matter.
• Shelf-life validation.

The "Performance Testing" section refers to conformance with recognized ISO standards for hypodermic needles and tests for low dead space capability and sharps injury protection. These are engineering and safety standards for the physical device, not performance benchmarks for an AI/ML algorithm.

Therefore, it is not possible to provide the requested information regarding acceptance criteria, study details, and performance for an AI/ML device based on the provided text, as the device in question (EZ-Injec LDV Sterile Safety Needle) is a traditional medical device, not an AI/ML-powered one.

Ask a specific question about this device