Search Results
Found 2 results
510(k) Data Aggregation
(110 days)
OneTouch® Delica® Safety is a single use blood lancet with sharps prevention feature to protect the user from a needlestick injury and that is intended for capillary blood sampling from a fingertip.
HemoCue® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Assure® Lance Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Assure® Lance Plus Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Capiject® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Heel Lancet Newborn is single use and intended for capillary blood sampling from a heel for newborn. Sharps prevention feature protects the user from needlestick injury.
Heel Lancet Preemie is single use and intended for capillary blood sampling from a heel for preemie. Sharps prevention feature protects the user from needlestick injury.
The Single Use Blood Lancets are hand-held, sterile, needle or blade-like devices with a pull-off or twistoff cap and integral sharps injury prevention feature for controlled skin puncture to obtain a capillary blood specimen; typically at the fingertip or heel of the patient. The housing of the devices are made of plastic and have a spring-loaded mechanism which enables the tip of the needle or blade to puncture the fingertip or heel to a predetermined depth, whereby blood is subsequently squeezed out of the puncture site. These devices are made available in various needle and blade sizes which are distinguished by their different colors. Until activation, the lancet is contained within its housing (holder). Immediately after use, the needle or blade is automatically retracted back into its holder until the device is disposed of in an appropriate manner.
This document is a 510(k) premarket notification for "Single Use Blood Lancets" by Asahi Polyslider Company, Ltd. It seeks to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria in the format of pass/fail metrics. Instead, it states that "Results confirm that the design inputs and performance specifications for the subject devices are met." and "The Single Use Blood Lancets passed all required testing in accordance with internal requirements, national standards, and international standards shown below, supporting their safety and effectiveness and substantial equivalence to the predicate device."
The tests performed and their outcomes are listed in Section 9 "Non-Clinical Performance Data":
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Specifications | Materials of Construction Specifications met |
| Visual, Physical & Dimensional Verification | Specifications met |
| Functional Testing | Specifications met |
| Performance Testing | Specifications met |
| Cytotoxicity Testing (ISO 10993-5) | Passed |
| Sensitization Testing (ISO 10993-10) | Passed |
| Irritation Testing (ISO 10993-10) | Passed |
| Sterilization Validation (ISO 11137-1/-2) | Demonstrates SAL 10⁻⁶ |
| Product Sterility (ISO 11737-1) | Demonstrates product is free of microorganisms |
| Shelf-life Testing (ASTM F1980) | Supports a shelf-life of 5 years |
| Transportation Testing (ASTM 4169) | Demonstrates package integrity is maintained |
| Risk Analysis (ISO 14971) | Hazards identified, ranked and risk mitigation measures implemented |
2. Sample sizes used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test. It broadly states that "Asahi Polyslider completed the following verification and validation activities, including non-clinical tests." and "The Single Use Blood Lancets passed all required testing...".
Data provenance: The tests were conducted to support a submission by a Japanese company (Asahi Polyslider Company, Ltd. located in Japan). The nature of the non-clinical tests (e.g., cytotoxicity, sterilization, shelf-life) suggests they are laboratory-based and likely prospective, specifically designed to evaluate the subject devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are primarily engineering and biocompatibility evaluations, which are typically performed by qualified laboratory personnel and statisticians, rather than clinical experts establishing a ground truth in the context of diagnostic performance.
4. Adjudication method for the test set
This information is not provided as it's not relevant for the type of non-clinical tests detailed (e.g., material testing, sterilization validation). Adjudication methods are typically used in clinical studies or image-based diagnostic studies to resolve discrepancies in expert interpretations.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation, which is not the case for a mechanical blood lancet.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a manual surgical instrument (blood lancet), not an algorithm or AI system. Its performance is entirely mechanical and physical.
7. The type of ground truth used
The "ground truth" for the non-clinical tests listed are based on:
- Established standards and specifications: e.g., ISO 10993-5 for cytotoxicity, ISO 11137-1/-2 for sterilization validation, ASTM F1980 for shelf-life, and ASTM 4169 for transportation.
- Internal requirements: "internal requirements... supporting their safety and effectiveness" (Section 9).
- Predicate device characteristics: The substantial equivalence comparison heavily relies on showing similar technological characteristics and performance to the SurgiLance® Safety Lance (K101145) and other reference devices.
For example, for cytotoxicity, the ground truth is simply whether the device material exhibits cytotoxic effects above defined thresholds in the ISO standard. For sterilization, it's achieving a specified Sterility Assurance Level (SAL).
8. The sample size for the training set
This information is not applicable as this device is a physical medical instrument, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
Ask a specific question about this device
(77 days)
Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.
Safety Lancet, could be divided into Model XY, Model XH and Model XA according to the design features and key functional elements.The device is sterilized by Gamma ray(Co-60 or e-beam) and for single use. The shelf life is 5 years.
The provided document is a 510(k) summary for the "Safety Lancet" device, which makes an equivalence claim to previously cleared predicate devices. Since this is an equivalence claim, the studies described are primarily non-clinical bench testing to demonstrate that the subject device performs as safely and effectively as the predicate devices. It does not contain information about clinical studies with human participants.
Therefore, many of the requested fields related to clinical efficacy studies, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to the information provided in this 510(k) summary. These types of studies are typically conducted for new technologies or to demonstrate clinical efficacy, which is not the primary purpose of a 510(k) submission based on substantial equivalence.
Here's the information extracted from the document based on the request:
1. Table of acceptance criteria and the reported device performance:
The document lists performance tests conducted but does not explicitly state "acceptance criteria" and "reported device performance" in a direct side-by-side format with quantitative measures for each criterion. Instead, it states that the performance data were "provided in support of the substantial equivalence determination" and that "The test results show that the product had well sharps injury prevention feature." This implies that the device met the internal (or external standard-based) acceptance criteria for each test.
| Test Item | Implied Acceptance Standard/Goal | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Compliance with ISO 10993 series standards, demonstrating no adverse biological reactions. | Met requirements. "The biocompatibility evaluation items of proposed device were completed for each model and each sterilization method (Co-60 and e-beam) individually. The testing included the following tests: In vitro cytotoxicity, Skin sensitization, Intracutaneous reactivity, Acute systemic toxicity, Pyrogen." The document also notes that the subject device's biocompatibility testing was "more strict" than Predicate Device A. |
| Dimension | To meet specified dimensions and potentially ISO 9626:2016 for needles. | Met requirements. "Dimension/gauge of the needles all meet the requirements ISO 9626:2016." |
| Appearance | To meet visual inspection standards (e.g., no defects, damage). | Met requirements. (Implied, as it's listed as a conducted test without issues). |
| Needle-tip | To meet specified characteristics (e.g., sharpness, integrity). | Met requirements. (Implied, as it's listed as a conducted test without issues). |
| Trigger force | To be within a functional range for intended use. | Met requirements. (Implied, as it's listed as a conducted test without issues). |
| Corrosion resistance feature | To prevent corrosion during shelf life and use. | Met requirements. (Implied, as it's listed as a conducted test without issues). |
| Retractable | To ensure the needle retracts automatically after puncture. | Met requirements. (Implied, as it's listed as a conducted test without issues, and part of the design description). |
| Penetration Depth | To meet specified penetration depths for different models/gauges. | Met requirements. The range for the subject device (1.2mm to 2.8mm) is noted as "the same as the penetration depth of predicate device A." Specific depths for various models are listed in the comparison table. |
| Challenge Safe Mode-Resistance | To ensure the sharps injury prevention feature functions correctly, resisting attempts to expose the needle after use. | Met requirements. "The test results show that the product had well sharps injury prevention feature." (General statement for sharps injury protection features, including this test). |
| Challenge Safe Mode-Needle Tip Exposed | To ensure the needle tip remains shielded after use. | Met requirements. "The test results show that the product had well sharps injury prevention feature." (General statement for sharps injury protection features, including this test). |
| Anti-activation test (Model XH and XA) | To ensure the device does not activate accidentally. | Met requirements. (Implied, as it's listed as a conducted test without issues). |
| Self-destruct performance test | To ensure the device cannot be reused after initial activation. | Met requirements. (Implied, as it's listed as a conducted test without issues, and part of the automatic inactivation mechanism description). |
| Sterility | To achieve a Sterility Assurance Level (SAL) of 10^-6. | Met requirements. "Sterilization SAL:10-6" with Irradiation Sterilization (Co-60 or e-beam). |
| pH and total heavy metal content, Cd content | To meet safety standards for leachable substances. | Met requirements. (Implied, as it's listed as a conducted test without issues). |
| Bacterial Endotoxins | To ensure endotoxin levels are below specified limits. | Met requirements. (Implied, as it's listed as a conducted test without issues). |
| Clinical simulated use testing for sharps injury protection | Compliance with ISO 23908:2011 and FDA Guidance for Medical Devices with Sharps Injury Prevention Features. To demonstrate prevention of sharps injuries. | Met requirements. "we have completed the test of clinical simulated use testing for sharps injury protection for each model. The test results show that the product had well sharps injury prevention feature." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is typically provided in detailed test reports, not in a 510(k) summary. The document does not specify exact sample sizes for each bench test. The studies were non-clinical bench tests. The country of origin for the studies is not explicitly stated, but the manufacturer is Ningbo Medsun Medical Co., Ltd. in China.
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, as this was a non-clinical bench study for a physical medical device (safety lancet), not an AI/software device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this was a non-clinical bench 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, as this was a non-clinical bench study for a physical medical device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable, as this was a non-clinical bench study for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on established engineering standards (e.g., ISO, internal specifications) for mechanical function, material properties, sterility, and biocompatibility. For example, ISO 9626:2016 for needle dimensions or ISO 10993 series for biocompatibility.
8. The sample size for the training set
Not applicable, as this was a non-clinical bench study for a physical medical device, not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this was a non-clinical bench study for a physical medical device.
Ask a specific question about this device
Page 1 of 1