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Stat Medical Lancing Device Systems are intended for the hygienic collection of capillary blood for testing purposes from the side of a finger and from alternate site, such as the palm, the upper arm, and the forearm. The Stat Medical Lancing Device Systems are for single patient use in a home setting.

The Stat Medical Lancing Device Systems consist of two types of lancing devices: ULTIMATE Lancing Device and TRIO Lancing Device. Both are single-person, multiple-use devices made of ABS plastic and SUS304 stainless-steel springs. The ULTIMATE has 8 depth-setting choices, and the TRIO has 5 depth-setting choices and a Lancet Ejector. The systems also consist of two types of representative (generic) lancets: COMFORT THIN Twist-Off Lancets and COMFORT THIN Pull-Off Lancets. Both are sterile, single-person, single use devices made of plastic with a SUS304 stainless-steel needle tip and a protective plastic cover. The ULTIMATE and TRIO Lancing Devices have optional Alternative Site Test (AST) Caps.

The provided text is a 510(k) summary for the "STAT Medical Lancing Device Systems." It discusses the device's intended use, technological comparison to predicate devices, and results of non-clinical testing. However, it explicitly states that clinical testing was not applicable and therefore, it does not contain information about a study that proves the device meets specific acceptance criteria based on clinical performance metrics such as reader studies or algorithm performance.

The document mainly focuses on demonstrating substantial equivalence to predicate devices through technical specifications and non-clinical performance (mechanical testing and biocompatibility).

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study that proves the device meets the acceptance criteria in the context of clinical performance (like a multi-reader multi-case study, standalone algorithm performance, or human-in-the-loop improvement) because such information is not present in the provided text.

The information that is available and can be extracted relates to the acceptance criteria for non-clinical performance tests.

Non-Clinical Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful completion and compliance with the listed ISO standards and the performance tests. The reported performance indicates that the device met these criteria.

Regarding the specific points asked for in the prompt, based on the provided text:

1. A table of acceptance criteria and the reported device performance: See table above, derived from the "Non-clinical Testing Summary and Conclusions" and the "Similarities and Differences" table.
2. Sample sized used for the test set and the data provenance:
   • Sample Size: For "Range of Depth (mm)" and "Range of Depth + AST Cap (mm)" measurements, a sample size of 30 samples is explicitly mentioned for both the Ultimate and TRIO Lancing Devices. For other mechanical tests (Pen testing, cock force, insertion force, removal force, migration distance), sample sizes are not explicitly stated but are implied to be sufficient for compliance.
   • Data Provenance: The document does not specify the country of origin for the data or whether the tests were retrospective or prospective. These are non-clinical lab tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document is about a lancet device, not an AI/imaging device requiring expert ground truth for image interpretation. The testing performed is mechanical and biocompatibility, which does not involve human expert interpretation as ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no expert adjudication process described for the mechanical or biocompatibility testing.
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. The device is a lancing system, not an AI-assisted diagnostic tool. Clinical testing was explicitly stated as "not applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. The device is a lancing system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. For mechanical tests, the "ground truth" is adherence to engineering specifications and performance within defined ranges. For biocompatibility, it's compliance with ISO standards.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

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The EasyTouch™ Lancing Device is for use with FreeStyle Lancets to collect capillary blood for testing purposes from the fingertip and from alternate sites, such as the palm, the upper arm, or the forearm. The EasyTouch Lancing Device is for single patient use in a home setting.

The EasyTouch Lancing Device is used with the FreeStyle Lancet, which was cleared under 510(k) K221433 under the device name Facet 28GUniversal Lancet. The intended use of the EasyTouch Lancing Device is to function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing. It is not to be used for assisted blood draws by healthcare providers or at healthcare provision sites. The EasyTouch Lancing Device is made of ABS plastic and SUS304 stainless-steel springs. The EasyTouch Lancing Device has 8 depth-setting choices. The device requires that the lancing device end cap be removed, a single lancet be inserted into the lancet holder and then the lancing device end cap placed back onto the device. The user is able to set the desired depth penetration level by moving the depth selector. The lancing device is then cocked by pulling the back end of the device away from the lancet body. To fire the device the firing button is depressed. Once the lancet has been fired it moves forward to pierce the patients' test site with the lancet. After piercing the skin, the lancet then travels back into the housing of the lancing device. The lancing device end cap is removed and then the lancet is removed. It is then disposed of into an appropriate container. The body and lancing device end cap are cleaned with soap and warm water and allowed to air dry after each use and disinfected per the IFU, as needed. If the patient is testing from a site other than the finger an optional AST Cap may be put onto the device instead of the "standard" lancing device end cap. The EasyTouch Lancing Device has an Alternative Site Test (AST) Cap, which is not sold separately. The AST Cap id only provided with the meter kit alongside the lancing device. The AST Cap allows the user to obtain a blood sample from parts of the body other than the fingers. The lancing device end cap is cleaned after every use and when visibly dirty and before disinfection. Disinfection is performed between each use. Cleaning involves use of a damp cloth and mild detergent to wipe the outside of the lancing device end cap, followed by wiping dry. The device is disinfected via wiping down with a cloth dampened in a bleach wipes) and allowed to air dry. The Alternate Site Testing (AST) Cap is a single-person multi-use optional plastic accessory for the lancing device. It may be used in place of the original lancing device end cap when a patient is taking a blood sample from a site on the body other than the finger. Proper use of the device requires that the user first verify with their physician and the Instructions for Use of the blood glucose test strips or meter they are using to determine if AST testing is appropriate.

Based on the provided text, the Acceptance Criteria and the Study that proves the device meets them relate to a Class II medical device, the EasyTouch Lancing Device, which is used for collecting capillary blood samples. The document is a 510(k) Premarket Notification from the FDA, focusing on the substantial equivalence of the new device to a legally marketed predicate device.

It's crucial to understand that for a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove absolute efficacy or safety through rigorous clinical trials as would be required for a "PMA" (Premarket Approval) device. Therefore, the "acceptance criteria" and "study" described herein are tailored to this regulatory pathway.

Here's a breakdown of the requested information:

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

The document describes non-clinical bench testing for mechanical design verification and validation, as well as biocompatibility. The "acceptance criteria" are implied by the performance of the predicate device and the adherence to special controls and specified requirements. "Reported device performance" is given as meeting these criteria.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: The document does not specify a numerical sample size for the non-clinical bench tests (e.g., how many lancing devices were drop-tested, or how many samples for biocompatibility). It generally states that "non-clinical bench testing was performed" and "a battery of tests" for biocompatibility.
• Data Provenance: The data is from non-clinical bench testing performed by the manufacturer (STAT Medical Devices). The location/country of origin of this specific testing is not explicitly stated, but it's part of a U.S. FDA 510(k) submission. The testing is assumed to be prospective as it was conducted specifically for this premarket submission.

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 in the context of this 510(k) submission for a lancing device. Ground truth established by expert consensus (e.g., radiologists interpreting images) is typically relevant for interpretative devices like AI algorithms for diagnostics, not for mechanical devices like lancing devices. The "ground truth" for the performance of this device is based on objective, quantifiable physical and material properties (e.g., piercing depth measurement, force measurement, chemical reactivity).

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

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers are interpreting data (e.g., medical images) to resolve discrepancies and establish a consensus "ground truth." For the mechanical and biocompatibility testing of a lancing device, the results are objectively measured or observed, and therefore do not require human adjudication in this manner.

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:

• This is not applicable. An MRMC study is designed to evaluate the performance of diagnostic systems (often involving AI) and human readers. The EasyTouch Lancing Device is a mechanical blood collection device, not an interpretative diagnostic device or AI algorithm.

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

• This is not applicable. The device is a mechanical lancing device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the non-clinical testing of the EasyTouch Lancing Device is primarily established through objective engineering measurements, physical property testing, and established laboratory standards for biocompatibility. This is in contrast to "expert consensus" or "pathology" which are typically used for diagnostic devices. For example, "piercing depth" is measured directly, not subjectively interpreted.

8. The sample size for the training set:

• This is not applicable. "Training set" refers to data used to train machine learning models (AI). The EasyTouch Lancing Device is a mechanical device, not an AI or machine learning product.

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

• This is not applicable as there is no AI training set for this mechanical device.

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The One Drop Lancing Device is for use with One Drop branded Lancets to collect capillary blood for testing purposes from the fingertip. The One Drop Lancing Device is for single patient use in a home setting.

The One Drop Lancing Device is used with the One Drop branded Lancet, which was cleared under 510(k) K221383 under the device name MedtFine Blood Lancet. The intended use of the One Drop Lancing Device is to function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing. It is not to be used for assisted blood draws by healthcare providers or at healthcare provision sites. The One Drop Lancing Device is made of ABS plastic and aluminum plated with Polycarbonate and SUS304 stainless-steel springs. The One Drop Lancing Device has 5 depth-setting choices. The device requires that the lancing device end cap be removed, a single lancet be inserted into the lancet holder and then the lancing device end cap placed back onto the device. The user is able to set the desired depth penetration level by moving the depth selector. The lancing device is then cocked by pulling the back end of the device away from the lancet body. To fire the device the firing button is depressed. Once the lancet has been fired it moves forward to pierce the patients' test site with the lancet. After piercing the skin, the lancet then travels back into the housing of the lancing device. The lancing device end cap is removed and then the lancet is safely removed by using the ejector sleeve feature. It is then disposed of into an appropriate container. The body and lancing device end cap are cleaned with disinfecting wipes and allowed to air dry after each use and disinfected per the IFU, as needed. The lancing device end cap is cleaned after every use and when visibly dirty and before disinfection. Disinfection is performed between each use. Cleaning involves use of a disinfecting wipe to wipe the outside of the lancing device end cap, followed by wiping dry. The device is cleaned & disinfected using Super Sani-Cloth Germicidal Disposable Wipes and allowed to air dry.

The provided documentation describes the One Drop Lancing Device, which is intended for collecting capillary blood from the fingertip for testing purposes in a home setting. The document confirms that the device is substantially equivalent to legally marketed predicate devices.

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 explicitly states that "Non-clinical bench testing was performed to ensure predetermined criteria were met and the special controls (21 CFR 878.4850) were satisfied." It also mentions "mechanical design verification and validation testing in order to ensure the risks were appropriately managed in addition to verifying that the device continued to meet the specified requirements."

While the document indicates that these criteria were met, it does not provide a specific table detailing the acceptance criteria values and the device's measured performance against each. It only lists the types of tests conducted.

2. Sample size used for the test set and the data provenance:

The document does not specify the sample sizes used for the non-clinical bench tests. It also does not provide information on data provenance (e.g., country of origin of the data, retrospective or prospective) as the testing described is non-clinical bench testing, not clinical human studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Since the testing described is non-clinical bench testing of a mechanical device, the concept of "experts used to establish the ground truth" in the context of clinical interpretation (like radiologists for imaging) is not applicable. The "ground truth" would be the engineering specifications and regulatory requirements, and the tests were performed by engineers/technicians in a lab setting.

4. Adjudication method for the test set:

Not applicable, as this was non-clinical bench testing against engineering specifications, not a clinical study requiring adjudicated 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:

This is not applicable to the One Drop Lancing Device. This device is a mechanical lancing device, not an AI-powered diagnostic tool requiring human reader interpretation or assistance.

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

This is not applicable to the One Drop Lancing Device, as it is a mechanical device without an algorithm.

7. The type of ground truth used:

The ground truth for the non-clinical testing of the One Drop Lancing Device can be inferred as:

• Engineering specifications and design requirements: For dimensional measurements, function reliability, piercing depth, and cock force.
• International standards (ISO 10993-1): For biocompatibility.
• Regulatory Special Controls (21 CFR 878.4850): For overall regulatory compliance.

8. The sample size for the training set:

Not applicable, as there is no "training set" for a mechanical lancing device; it does not involve machine learning or AI.

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

Not applicable, as there is no "training set."

Summary of the Study:

The study was a series of non-clinical bench tests conducted to evaluate the mechanical performance, safety, and compatibility of the One Drop Lancing Device. These tests aimed to ensure the device met predetermined engineering specifications, international standards (ISO 10993-1 for biocompatibility), and regulatory special controls (21 CFR 878.4850). The tests included:

• Dimensional measurements
• Function reliability drop test
• Piercing depth test
• Cock force test
• Biocompatibility testing
• Compatibility with One Drop branded Lancets (by reference to K221383)

The document concludes that "The intended use, technology, non-clinical testing, and functionality of the One Drop Lancing Device demonstrate a substantially equivalent safety and effectiveness profile to the predicate device."

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The Stat Medical Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin. This is the same intended use as previously cleared for the Stat Medical Pen Needle, K042917.

The Stat Medical Pen needle consists of 4 parts, the needle hub, the needle protector and the outer cover. The cannula is manufactured from 304 stainless steel. The cannula is produced into three sizes for the device (the 29g 12.7 mm (1/2 in), 31g 5mm (3/16 in) and the 31g 8mm (5/16 in). The cannula length and inner diameter are a constant for these three sizes, which differ in the outer diameter of the cannula.

The hub is molded from medical grade polypropylene, and medical grade silicon. The needle is glued into place in the hub and is coated with a medical grade silicon/lube. The silicone oil/lube is non-toxic, pyrogen free, and free from contamination. After assembly, the hub and needle assembly are tested, packaged, and sterilized.

The Stat Pen Needle is provided sterile via EO sterilization and is for Single Use only.

The modification to the original filing is the correction of where the silicon coating is applied to the device, and a change in the product labeling to include the identification of the silicon coating. Product labeling may be found in section 9 of this submission.

This document is a 510(k) summary for a medical device (Stat Medical Pen Needle), not a study analyzing device performance against acceptance criteria in the context of AI/ML or comparative effectiveness. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and AI performance metrics is not applicable.

Here's a breakdown of what can be extracted and what cannot:

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

This document does not specify quantitative acceptance criteria or provide performance data from a study for the device. It focuses on demonstrating substantial equivalence to a predicate device.

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

Not applicable. This is a 510(k) submission document for a physical medical device, not an AI/ML-driven study. There is no "test set" in the context of evaluating algorithm performance.

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. There is no "ground truth" to establish in this context as it's not an AI/ML study. The determination of device characteristics and substantial equivalence is based on engineering specifications and comparison to a predicate device, not expert consensus on data.

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

Not applicable. There is no test set for adjudication.

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 MRMC comparative effectiveness study involving human readers and AI.

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

Not applicable. This is not a study of an algorithm; it's a submission for a physical medical device.

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

Not applicable. There is no ground truth in the context of an AI/ML study mentioned here. The "truth" for this device revolves around its physical properties, manufacturing processes, and adherence to safety and performance standards equivalent to a predicate device.

8. The sample size for the training set:

Not applicable. There is no training set mentioned, as this is not an AI/ML study.

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

Not applicable. There is no training set and therefore no ground truth establishment for a training set.

Summary of Device and 510(k) Filing Information (from the document):

• Name of Device: Stat Medical Pen Needle / Super-Fine Pen Needle
• Common Name: Sterile disposable hypodermic needle
• Intended Use: For use with a pen injector device for the subcutaneous injection of insulin.
• Description: Consists of a needle hub, needle protector, outer cover, and a cannula made of 304 stainless steel. Available in 29g 12.7mm, 31g 5mm, and 31g 8mm. The hub is molded from medical grade polypropylene and silicon. The needle is silicon coated, glued, tested, packaged, and sterilized by EO.
• Modification: Correction of where the silicon coating is applied and a change in product labeling to include identification of the silicon coating.
• Substantial Equivalence Claim: Based on same indication for use, same operating principle, incorporation of same materials, same sterilization and packaging, and same basic design as a predicate device (K042917).
• Regulatory Status: Cleared via 510(k) (K092016) on October 2, 2009. Classified as Class II, product code FMI (Hypodermic single lumen needle).

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