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510(k) Data Aggregation
(128 days)
Facet Technologies, LLC
The Facet Aurora Reusable Lancet Base (commonly referred to as a lancing device) is a non-sterile reusable device which provides a spring-loaded mechanism to quickly eject and retract a lancet of proprietary design to effect a lancing event for the purpose of obtaining a droplet of capillary blood for diagnostic testing in children, adolescents, and adults in a home setting.
The device is designed to be cleaned and disinfected between uses on a single patient.
The Facet Aurora Reuseable Lancet Base is a blood sampling device used in conjunction with a lancet blade of proprietary design to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.
The lancing device has been in commercial distribution in the United States for over 10 years. There have been no significant design changes over the life of the device.
The provided text describes a 510(k) premarket notification for the "Facet Aurora Reusable Lancet Base." However, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing of its mechanical properties and materials. It does not contain information about:
- Acceptance criteria related to the performance of a device that uses AI/algorithm, such as sensitivity, specificity, or AUC.
- A study proving the device meets acceptance criteria for an AI/algorithm.
- Sample sizes for AI/algorithm test sets or data provenance.
- Details about experts establishing ground truth or adjudication methods for an AI/algorithm's performance evaluation.
- MRMC studies or standalone AI performance.
- Training set details for an AI/algorithm.
The device in question is a mechanical lancing device, not an AI or algorithm-based device. The non-clinical testing listed (e.g., Endcap Removal Force, Depth of Puncture, Life Cycle Test) are standard mechanical and durability tests for such a device.
Therefore, based on the provided text, I cannot describe acceptance criteria and a study that proves the device meets those criteria in the context of an AI/algorithm, as the information is not present. The document focuses on physical and mechanical properties and biocompatibility.
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(101 days)
Facet Technologies LLC
The NeatNick Heel Safety Lancet is a single use device with a sterile blade that is used by medical professionals to obtain a blood sample from the heel of neonates and infants for subsequent diagnostic testing.
The NeatNick Heel Safety Lancet is a single use, blood sampling device with a sterile blade that are used by medical professionals to obtain a blood sample from the feet of neonates and infants for diagnostic purposes. The NeatNick Lancet incorporates an integral sharps injury prevention feature that also prevents reuse of the lancet.
The NeatNick Lancet has been in commercial distribution since 2006.
NeatNick Lancets are available in two configurations (Preemie and Full Term) are intended to be used by medical professionals to obtain a blood sample for diagnostic testing. The lancets consist of a stainless steel blade overmolded with low density polyethylene (LDPE) which protects the blade until use and functions as a sterile barrier. The lancet is single use, disposable and is sterilized by gamma radiation to a SAL of 10-6.
Biocompatibility testing has been conducted per ISO 10993 at a GLP testing facility. The lancet is classified as Class II.
The lancet is currently in commercial distribution in the United States and Canada. Since commercial distribution of the current lancets began, there have been no design changes.
The provided text is a 510(k) Pre-Market Notification for the NeatNick Heel Safety Lancet. This type of FDA submission focuses on demonstrating substantial equivalence to an already legally marketed device (predicate device) rather than proving general safety and effectiveness through extensive clinical trials with specific acceptance criteria and detailed study results.
Therefore, the document does not contain the detailed information typically associated with a study proving a device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would. It explicitly states, "Clinical testing is not applicable as the risk analysis confirmed that all identified risks were addressed and mitigated appropriately."
However, based on the non-clinical testing mentioned and the comparison table, here's what can be inferred and what information is missing:
1. Table of acceptance criteria and the reported device performance:
The document describes "predetermined criteria" being met for non-clinical bench testing and satisfaction of "special controls (21 CFR 878.4850)". The comparison table (Table 1) essentially serves as a performance comparison against the predicate device, where "Same" for the subject device implies it meets or performs comparably to the predicate for those characteristics.
| Acceptance Criteria (Implied from Predicate Characteristics/Special Controls) | Reported Device Performance (Subject Device) |
|---|---|
| Indication for Use: Obtain blood sample from heel of neonates and infants for diagnostic testing. | Same (as predicate) |
| Intended Use: Single-use, by medical professionals, for blood sample from neonates and infants for diagnostic testing, with spring-actuated sterile sweeping action blade that retracts and renders device inoperable. | Same (as predicate) |
| Trigger Actuation Force: 8N-36N | Same (as predicate) |
| Length of Cut (Full term): 2.9mm-4.1mm | Same (as predicate) |
| Length of Cut (Preemie): 1.8mm-3.0mm | Same (as predicate) |
| Depth of Cut (Full term): 1.0mm-1.5mm | Same (as predicate) |
| Depth of Cut (Preemie): 0.65mm-1.25mm | Same (as predicate) |
| Biocompatibility: Conforms to ISO10993-1 | Same (as predicate) |
| Blade Sterility: Sterilized by Gamma Radiation, SAL = 10^-6 | Same (as predicate) |
| Mechanical Design: Verification and validation to ensure risks managed and mechanical functions suitable for shelf life. | Non-clinical bench testing performed to ensure criteria met and special controls satisfied. |
Missing Information:
- Specific quantitative acceptance limits for the "mechanical design verification and validation testing" are not provided. The document only states these tests were performed and criteria were met.
- Actual measured values for the subject device's Trigger actuation force, Length of cut, and Depth of cut are not provided, only that they are "Same" as the predicate, which also presents a range.
The following questions cannot be answered from the provided document as it describes a 510(k) submission for a physical medical device (lancet), not an AI/software device or a study involving human readers or ground truth derived from expert consensus/pathology. The document explicitly states "Clinical testing is not applicable".
2. Sample size(s) used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable/Not Provided: This type of information is relevant for clinical or algorithm performance studies, which were not conducted for this 510(k) submission. Non-clinical bench testing was performed, but sample sizes for these tests are not specified.
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/Not Provided: This information pertains to studies where ground truth is established by experts (e.g., in imagery or diagnostic tasks). This submission relies on engineering specifications and bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable/Not Provided: This is relevant for expert-based ground truth establishment or clinical trial adjudication, neither of which occurred.
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/Not Provided: This is specific to AI-assisted diagnostic tools and human reader performance studies. The device is a physical lancet.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable/Not Provided: This is specific to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable/Not Provided (in the context of clinical "ground truth"): For the non-clinical testing, the "ground truth" would be the engineering specifications and established test standards (e.g., ISO 10993-1 for biocompatibility, SAL of 10^-6 for sterility, and the specified ranges for cut length/depth and actuation force).
8. The sample size for the training set
Not Applicable/Not Provided: This is specific to machine learning/AI models.
9. How the ground truth for the training set was established
Not Applicable/Not Provided: This is specific to machine learning/AI models.
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(59 days)
Facet Technologies LLC
The Facet Manatee Reusable Lancet Base (commonly referred to as a lancing device) is a non-sterile reusable device which provides a spring-loaded mechanism to quickly eject and retract a standard or regular version lancet to effect a lancing event for the purpose of obtaining a blood sample for diagnostic testing in children, adolescents (use on children and adolescents should be by or under supervision of an adult), and adults in a home setting. The device is designed to be cleaned and disinfected between uses on a single patient.
The Facet Manatee Reuseable Lancet Base is a reuseable blood sampling device used in conjunction with a standard or universal lancet blade to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.
The provided text describes the Facet Manatee Reusable Lancet Base, a reusable lancing device for obtaining blood samples for diagnostic testing. The submission is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the information typically requested regarding AI/CAD efficacy studies, such as effects on human readers, ground truth establishment for AI models, and training set details, is not applicable or present in this document.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical bench testing performed to ensure the device meets predetermined criteria and satisfies special controls. While specific numerical acceptance values are not provided, the "Importance" column outlines the intended performance. The conclusion states that the tests demonstrate the candidate device is substantially equivalent to the predicate.
| Property/Characteristic | Test Method | Importance (Acceptance Criteria) | Reported Performance (Implied by Conclusion) |
|---|---|---|---|
| Endcap Removal Force | Tensile strength tester | Ensure cap can be removed easily to insert lancet blade. | Test was performed and criteria met (device is substantially equivalent). |
| Endcap Attachment Force | Tensile strength tester | Ensure cap will remain on lancet base during lancing event. | Test was performed and criteria met (device is substantially equivalent). |
| Depth of Puncture | Calibrated High Speed Video | Ensure depth of puncture is repeatable for various depth settings. | Test was performed and criteria met (device is substantially equivalent). |
| Over-Charging Force | Tensile force gauge | Ensure that device can be charged to engage actuation spring. | Test was performed and criteria met (device is substantially equivalent). |
| Charging Force | Tensile force gauge | Ensure device can be charged to engage actuation spring. | Test was performed and criteria met (device is substantially equivalent). |
| Lancet Insertion Force | Tensile force gauge | Ensure lancet can be easily inserted. | Test was performed and criteria met (device is substantially equivalent). |
| Depth Adjust Torque | Torque gauge | Ensure that depth adjustment can be easily adjusted and that adjustment will not change during use. | Test was performed and criteria met (device is substantially equivalent). |
| Button Activation Force | Tensile force gauge | Ensure activation force is within specification. | Test was performed and criteria met (device is substantially equivalent). |
| Lancet Rotation | Torque gauge | Ensure lancet does not rotate during device actuation. | Test was performed and criteria met (device is substantially equivalent). |
| Drop Test | Simulated Use after drop | Ensure that device can withstand a 1 meter drop to a hard surface and still function. | Test was performed and criteria met (device is substantially equivalent). |
| Life Cycle Test | Simulated use | Ensure device can withstand 3 years of expected use. | Test was performed and criteria met (device is substantially equivalent). |
| Chemical Test | Cleaning and disinfection studies | Ensure device can withstand recommended cleaning and disinfection over useful life. | Test was performed and criteria met (device is substantially equivalent). |
| Storage Temperature Test | Simulated Use | Ensure device can function after exposure to heat and cold cycles. | Test was performed and criteria met (device is substantially equivalent). |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Acute Systemic toxicity (materials mediated pyrogen) | Ensure material of construction are biocompatible for their intended use. | Conducted per ISO 10993 at a GLP testing facility; tests were performed and criteria met (device is substantially equivalent). |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical bench testing. It does not specify a "test set" in the context of patient data or clinical trials, nor does it provide details on sample sizes for each bench test beyond the phrase "non-clinical bench testing was performed." The provenance of this data would be laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a non-clinical device submission not involving expert review of diagnostic images or interpretations.
4. Adjudication method for the test set:
Not applicable. This is a non-clinical device submission.
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 MRMC study was done. This device is a mechanical lancing device, not an AI-assisted diagnostic tool. Clinical testing was deemed "not applicable" as per the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical lancing device, not an algorithm.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by the engineering specifications and performance requirements for the device (e.g., specific force values for button activation, a device functioning after a 1-meter drop). For biocompatibility, the ground truth is established by the relevant ISO 10993 standards and the results from GLP testing, demonstrating the material's biological safety.
8. The sample size for the training set:
Not applicable. This is a non-clinical device submission and does not involve AI/ML training.
9. How the ground truth for the training set was established:
Not applicable. This is a non-clinical device submission and does not involve AI/ML training.
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(88 days)
Facet Technologies LLC
The Facet Lancet is a sterile, disposable single used with a compatible proprietary lancet base (lancing device) to obtain a droplet of capillary blood from the finger for subsequent diagnostic testing. The Lancet is to be properly disposed of after a single use on an individual child, adolescent, or adult patient in a home setting.
The Facet Lancet is a sterile, single use, blood sampling device used to obtain a sample of capillary blood for diagnostic primarily for blood glucose monitoring in diabetic patients. The lancet is available in two needle sizes, 30 gauge and 33 gauge.
Facet lancets are intended to be used by diabetic patients to obtain a blood sample for assistance in self-monitoring of their blood glucose levels. The lancets consist of a 30G or 33G stainless steel needle overmolded with low density polyethylene (LDPE) and integral sterility cap. The lancet is single use, disposable and is sterilized by gamma radiation to a SAL of 10-9.
The provided text describes a 510(k) premarket notification for the Facet Blood Lancets, seeking to demonstrate substantial equivalence to a predicate device. The information focuses on non-clinical bench testing to ensure the device meets predetermined criteria and special controls.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides a "Summary of Nonclinical Tests Performed" (Table 2) which lists the properties/characteristics tested and their importance. While it doesn't explicitly state quantitative acceptance criteria for each test, it implies that meeting these criteria demonstrates acceptable performance for substantial equivalence. The reported performance is generally stated as "met predetermined criteria" in the text, rather than specific numerical results.
| Property/Characteristic | Test Method | Importance | Reported Device Performance |
|---|---|---|---|
| Bond Strength of lancet blade to lancet body | Tensile strength tester | Ensure needle does not detach from lancet body during use | Met predetermined criteria; substantially equivalent to predicate device |
| Sterility Cap Torque | Torque tester | Ensure that the cap can be easily removed by user when desired | Met predetermined criteria; substantially equivalent to predicate device |
| Compatibility with lancet bases | Simulated use | Ensure usability with commercially available lancet bases | Met predetermined criteria; substantially equivalent to predicate device |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Acute Systemic toxicity (materials mediated pyrogen) | Ensure material of construction are biocompatible for their intended use | Met predetermined criteria; substantially equivalent to predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the non-clinical bench tests (test set). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective), but given it describes a 510(k) submission, the tests were conducted by or for the manufacturer (Facet Technologies LLC) as part of a prospective evaluation for regulatory approval.
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 type of information is not applicable to the non-clinical, bench testing described for this device. Ground truth, in the context of expert consensus, is typically relevant for studies involving human interpretation or diagnosis, which is not the nature of these mechanical and biocompatibility tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods are typically associated with studies involving human interpretation or subjective assessments. For the objective, non-clinical bench tests described here, an adjudication method is not applicable. The results would be based on direct measurements and adherence to specified test procedures.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. These studies are typically used for diagnostic imaging devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The Facet Blood Lancet is a physical medical device for blood sampling, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone" algorithm performance assessment is not applicable here as the Facet Blood Lancet is a physical medical device and does not involve any algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- Bond Strength and Cap Torque: The "ground truth" would be established by the engineer's design specifications and defined pass/fail criteria based on mechanical engineering principles and relevant standards.
- Compatibility: The "ground truth" would be successful operation with commercially available lancing devices, likely defined by visual inspection and ease of use.
- Biocompatibility: The "ground truth" is established by adherence to recognized international standards (ISO 10993 series) which dictate the acceptable biological response to device materials.
8. The sample size for the training set
This device does not involve a "training set" in the context of machine learning or AI models. The tests performed are physical and biological evaluations of the device itself.
9. How the ground truth for the training set was established
As there is no "training set" for this type of device and study, this question is not applicable.
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(59 days)
Facet Technologies LLC
The Facet 28G Universal Lancet is a sterile, disposable single used to obtain a droplet of capillary blood for subsequent diagnostic testing from the finger or an alternative site, such as the palm, upper arm, or forearm. The Lancet is to be properly disposed of after a single use on an individual child, adolescent, or adult patient in a home setting.
The Facet 28G Universal Lancet) is a sterile, single use, blood sampling device used to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients. The lancets consist of a 28G stainless steel needle overmolded with low density polyethylene (LDPE) and integral sterility cap. The lancet is single use, disposable and is sterilized by gamma radiation to a SAL of 10-9.
This document is a 510(k) summary for the Facet 28G Universal Lancet, a medical device. It does not describe an AI/ML-enabled device, nor does it contain information about clinical studies with human participants, expert ground truth establishment, or multi-reader multi-case (MRMC) studies. Therefore, many of the requested points regarding acceptance criteria and study details for AI/ML devices cannot be answered from this document.
However, I can extract the acceptance criteria and performance related to the non-clinical bench testing for this physical device.
Device: Facet 28G Universal Lancet
Nature of the Device: This is a physical medical device (blood lancet), not an AI/ML software device. The acceptance criteria and performance data presented are for physical and material properties, and compatibility, not for diagnostic accuracy or algorithmic performance.
1. Table of Acceptance Criteria and the Reported Device Performance
The document describes non-clinical bench testing, which serves as the "study" to prove the device meets pre-determined criteria. The reported performance is not explicitly given in numerical terms for all tests, but rather stated that "predetermined criteria were met" and "risks were appropriately managed." However, the acceptance criteria (requirements) are provided.
| Property/Characteristic | Acceptance Criteria (Requirement) | Reported Device Performance (Implied) |
|---|---|---|
| Bond Strength of lancet blade (needle) to lancet body | $\geq$ 13.23 N | Met the criteria (stated "predetermined criteria were met") |
| Sterility Cap Torque | $\leq$ 4.9 N-cm | Met the criteria (stated "predetermined criteria were met") |
| Compatibility with lancet bases (lancing devices) | Ensure usability with commercially available lancet bases | Met the criteria (stated "predetermined criteria were met") |
| Biocompatibility | Meet ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11 requirements (Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Acute Systemic toxicity) | Met the criteria (stated "predetermined criteria were met") |
| Sterility | Sterilized by Gamma Radiation SAL = $10^{-6}$ | Met the criteria (Same as predicate) |
Note: The document only states that the criteria were "met" or that the performance was "same" as the predicate. Specific numerical results of the tests (e.g., the exact bond strength measured) are not provided in this summary.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify the numerical sample sizes for each non-clinical test (e.g., how many lancets were tested for bond strength or cap torque). It broadly states that "non-clinical bench testing was performed."
- Data Provenance: This is not applicable in the context of clinical data for an AI/ML device. For this physical device, the data provenance is from internal non-clinical bench testing performed by Facet Technologies, LLC. The testing ensures the device meets specified engineering and biocompatibility requirements.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. This device is a physical lancet, not an AI/ML system requiring expert interpretation of data. The "ground truth" here is objective measurement of physical properties (e.g., force, torque) and standard biocompatibility testing.
4. Adjudication Method for the Test Set
- Not applicable. There is no human interpretation or adjudication required for the physical property tests or biocompatibility assessments described.
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-enabled device and no MRMC studies were performed or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used
- For physical properties (Bond Strength, Cap Torque): The ground truth is established by objective physical measurements against engineering specifications.
- For Biocompatibility: The ground truth is established by standardized international (ISO 10993 series) and FDA-recognized test methods performed in a laboratory setting.
- For Compatibility: The ground truth is established via simulated use with commercially available lancing devices.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no "training set." The focus is on verifying compliance with design specifications and regulatory standards.
9. How the ground truth for the training set was established
- Not applicable. There is no training set as this is not an AI/ML device.
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(29 days)
FACET TECHNOLOGIES, LLC
The CareFine Pen Needle™ is intended for use with a pen injector device for the subculaneous injection of insulin
CareFine™ Pen Needles are single use, sterile medical devices designed to be used in conjunction with pen injectors and pen cartridges for the subcutaneous injection of insulin. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and the blue needle shield will be offered in 8mm length. CareFine™ Pen Needles are sterile by EtO terminal sterilization, and they are non-toxic and non-pyrogenic.
The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient-end and the cartridgeend of the cannula are lubricated using a silicone based lubricant for ease of injection and rubber septum penetration.
An injection-molded inner shield is assembled over the patient-end of the cannula to protect the point from damage and accidental needle-sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away label to provide a sterile barrier and tamper evident seal. The peel-away label is pre-printed with information, which includes the lot number, needle gauge and needle length.
The individual needle assemblies are packaged in cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to a SAL of 10° by EtO terminal sterilization.
The purpose of this Special 510(k) is to request modification to our CareFine™ Pen Needle family to include blue colored inner needle shield to distinguish the 8mm needle length.
The intended use for the modified device remains the same as the predicate device.
This document describes a Special 510(k) submission for a modification to an insulin pen needle, specifically the addition of a blue colored inner needle shield to distinguish an 8mm needle length. It is not a study that proves the device meets acceptance criteria in the typical sense of a clinical trial for efficacy or diagnostic performance. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
For this specific submission (K141749), which is a Special 510(k) for a color change, the "acceptance criteria" are primarily related to proving that the modification does not raise new issues of safety or effectiveness and that the device remains substantially equivalent to the predicate. The performance data presented are for the original CareFine™ Pen Needle (K133100), not specifically for the blue shield modification.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (Reference to K133100 and K140568) |
|---|---|
| Similar Indication for Use | Identical indication for use: "The CareFine™ Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin." |
| No Labeling Changes Affecting Intended Use | No labeling changes that affect the intended use of the device. |
| No Alteration to Fundamental Scientific Technology | Does not alter the fundamental scientific technology. |
| Same Basic Design | Incorporates the same basic design. |
| Same Operating Principles | Uses the same operating principles. |
| Manufactured from Same Materials (except for color additive) | Manufactured from the same materials (the only difference is the blue color additive to the inner needle shield). |
| Sterilized with Same SAL | Sterilized with a resulting SAL of 10^-6 (EtO terminal sterilization). |
| Same Unit and Case Materials for Packaging | Packaged using same unit and case materials. |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Toxicity, Hemocompatibility) | Performed and submitted with The CareFine™ Pen Needle Traditional 510(k) (K133100) according to ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-4. |
| Needle Shield Assembly Strength | Performed and submitted with The CareFine™ Pen Needle Traditional 510(k) (K133100) according to ASTM F756-8 and an internal test method. |
| Conformance with Applicable Standards & GMP | Manufactured in accordance with the requirements of current Good Manufacturing Practices (21 CFR Subpart C "Design Controls"). All verification and validation activities identified by the risk analysis were performed to demonstrate continued conformance with applicable conformance standards (referenced for K133100). |
| No new safety/effectiveness issues | Based on comparisons, the blue colored inner needle shields "do not raise any new issues of safety and effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a separate "test set" sample size for the color change modification. The referenced non-clinical performance data (biocompatibility, needle shield strength) was performed for the original CareFine™ Pen Needle (K133100). The sample sizes for those specific tests are not provided in this summary.
- Data Provenance: Not explicitly stated for specific test cases, but the tests performed are standard biocompatibility and mechanical tests for medical devices, generally conducted in controlled laboratory environments. The manufacturer is Facet Technologies, LLC, located in Kennesaw, GA, USA, suggesting the data would likely originate domestically or from certified testing labs. The data is retrospective relative to this Special 510(k), as it refers to data submitted with the earlier Traditional 510(k) (K133100).
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 type of information (experts establishing ground truth for a test set) is typically relevant for studies involving subjective interpretation (e.g., image analysis, clinical diagnosis). For this device, which is a physical medical device (insulin pen needle) with a minor aesthetic modification, "ground truth" is established through objective engineering and biocompatibility testing against defined specifications and recognized international standards (e.g., ISO 10993, ASTM F756-8). Therefore, the concept of "experts establishing ground truth" in the way described for AI/diagnostic studies does not apply here. The "experts" would be the certified lab technicians and engineers performing these tests, and the regulatory bodies approving the test methods and results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and submission. Adjudication methods are typically used in clinical trials or studies where subjective assessments or discrepancies in expert opinion need to be resolved. This document focuses on objective performance and equivalence to a predicate device.
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 physical medical device (pen needle), not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies and the concept of "human readers improving with AI" are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for demonstrating the safety and effectiveness of the original pen needle (K133100) was established through objective laboratory testing against recognized standards (ISO, ASTM) and internal test methods to demonstrate physical integrity, sterility, and biocompatibility. For this Special 510(k), the "ground truth" is the demonstrated substantial equivalence to previously cleared devices based on the technical characteristics and the determination that the color change does not impact safety or effectiveness.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set for an AI/ML model is involved.
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(69 days)
FACET TECHNOLOGIES, LLC
The CareFine™ Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin.
CareFine™ Pen Needles are single use, sterile medical devices designed to be used in conjunction with pen injectors and pen cartridges for the subcutaneous injection of insulin. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and lengths (4mm, 5mm, 6mm, and 12.7mm). CareFine™ Pen Needles are sterile by EtO terminal sterilization, and they are non-toxic and non-pyrogenic.
The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient-end and the cartridgeend of the cannula are lubricated using a silicone based lubricant for ease of injection and rubber septum penetration.
An injection-molded inner shield is assembled over the patient-end of the cannula to protect the point from damage and accidental needle-sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away label to provide a sterile barrier and tamper evident seal. The peel-away label is pre-printed with information, which includes the lot number, needle gauge and needle length.
The individual needle assemblies are packaged in cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to a SAL of 10° by EtO terminal sterilization.
The purpose of this Special 510(k) is to request modification to our CareFine™ Pen Needles to include colored inner needle shields to distinguish the needle length.
It is also Facet's intent to notify the Agency of non-significant changes to the cannula point bevel geometry. There are two additional needle point geometries being offered: a 5 bevel configuration corresponding to the QuintaPoint™ marketed name, and a second needle tip geometry identified as the SuperPoint™.
The intended use for the modified device remains the same as the predicate device.
This document describes a 510(k) submission for an insulin pen needle, which is a medical device, not an AI/ML powered medical device. Therefore, the information typically requested for AI/ML device studies, such as specific acceptance criteria for algorithm performance (e.g., sensitivity, specificity, AUC), sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, is not applicable to this submission.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on material, design, manufacturing, and intended use. The "acceptance criteria" in this context refer to the successful completion of non-clinical performance tests to ensure the device's safety and effectiveness.
Here's a breakdown of the available information based on your request, highlighting where the AI/ML specific criteria do not apply:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Non-Clinical Performance Tests) | Reported Device Performance |
|---|---|
| Cytotoxicity (Per ISO 10993-5) | Performed |
| Sensitization (Per ISO 10993-10) | Performed |
| Intracutaneous Reactivity (Per ISO 10993-10) | Performed |
| Acute Toxicity (Per ISO 10993-11) | Performed |
| Hemocompatibility (Per ISO 10993-4, ASTM F756-8) | Performed |
| Needle Shield Assembly Strength (Internal Test Method) | Performed |
Note: The document states that "All verification and validation activities identified by the risk analysis were performed to demonstrate continued conformance with applicable conformance standards. The principle device demonstrated equivalent performance to the predicate device during testing." Specific numerical results or detailed performance metrics for each test are not provided in this summary, only that they were performed and met the criteria for substantial equivalence.
2. Sample size 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 physical medical device. The "test set" in this context refers to the samples of the device used for the non-clinical performance tests listed above (e.g., biocompatibility testing of materials, mechanical strength testing). The document does not specify the number of individual devices or material samples used for each test. Data provenance in the sense of patient data is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: Ground truth for AI/ML devices typically refers to expert-labeled data. For this physical device, "ground truth" is established by adherence to recognized international standards (e.g., ISO, ASTM) for biocompatibility and mechanical testing, performed by qualified testing personnel in accredited laboratories. The document does not specify the number or qualifications of these testing personnel, as it's assumed to be part of standard quality system practices for medical device manufacturing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable: Adjudication methods are relevant for subjective expert review of data (e.g., imaging in AI/ML studies). For objective non-clinical tests, the results are typically interpreted against pre-defined criteria in the test standard, rather than through an adjudication process.
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 physical medical device. MRMC studies and the concept of human reader improvement with AI assistance are specific to AI/ML powered devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable (in the AI/ML sense): For this device, "ground truth" is established by the results of standardized non-clinical tests (e.g., cytotoxicity assays, sensitization tests, strength tests) as interpreted against the specified criteria within relevant ISO and ASTM standards. The ultimate "ground truth" for regulatory clearance is that the device is substantially equivalent to a legally marketed predicate device, demonstrating equivalent safety and effectiveness based on these tests and design comparisons.
8. The sample size for the training set:
- Not Applicable: This is a physical medical device. There is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established:
- Not Applicable: This is a physical medical device. There is no training set or associated ground truth establishment.
Summary of the Study:
The central "study" presented here is a Special 510(k) submission designed to demonstrate substantial equivalence of a modified insulin pen needle (CareFine™ Pen Needle with colored inner needle shields and new bevel geometries: QuintaPoint™ and SuperPoint™) to its predicate device (CareFine™ Pen Needle, K133100). The changes are described as "non-significant" and primarily relate to aesthetic features (colored shields for length distinction) and minor modifications to the cannula point bevel geometry.
The primary evidence presented to meet acceptance criteria is:
- Design Equivalency: Explicitly stating that the modified device has the same indication for use, does not alter fundamental scientific technology, incorporates the same basic design, uses the same operating principles, is manufactured from the same materials, is sterilized identically, and uses the same packaging.
- Non-Clinical Performance Data: A list of biocompatibility and mechanical tests performed (e.g., Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Toxicity, Hemocompatibility, Needle Shield Assembly Strength) in accordance with relevant ISO and ASTM standards. The document states these tests were "performed" and "demonstrated equivalent performance to the predicate device during testing." This implies the results met the acceptance criteria defined by these standards.
- Clinical Data: The submission explicitly states "Clinical data is not required," further emphasizing the non-AI/ML nature of the review and reliance on substantial equivalence through non-clinical means.
In essence, the study is a regulatory submission that leverages existing predicate device data and specified non-clinical testing to affirm that minor modifications do not compromise the device's safety or effectiveness, thereby meeting the "acceptance criteria" for 510(k) clearance by demonstrating substantial equivalence.
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