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The enFlow IV Fluid Warmer System is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

The Insulated Strap is an accessory to the enFlow IV Fluid Warmer which is used to secure the warmer component of the enFlow IV Fluid Warmer System to the patient during transport. The Insulated strap consists of a silicone strap, an insulating element and a mounting plate, into which the user can secure the enFlow IV Fluid Warmer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the enFlow IV Fluid Warmer Insulated Strap:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (510(k) Summary for K130867) does not list specific numerical acceptance criteria or performance metrics for the enFlow IV Fluid Warmer Insulated Strap. Instead, it focuses on qualitative compliance and equivalence.

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The document mentions "User Validation Testing" and "Design & Performance Verification Testing" but does not quantify the number of units or tests involved.
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission from a US company (GE Healthcare, Totowa, NJ), the testing was likely conducted in the US, but this is not confirmed. The testing appears to be retrospective in the sense that it's evaluating a developed accessory against established standards and a predicate device, rather than a prospective clinical trial.

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

• Number of Experts: Not explicitly stated. The section mentions "User Validation Testing" but does not specify how many users were involved or if they were considered "experts" for establishing ground truth, and if so, their qualifications. The other tests (biocompatibility, design/performance verification, risk analysis) would involve qualified engineers and scientists, but these are not referred to as "experts establishing ground truth" in the context of clinical or diagnostic performance.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified. For non-clinical tests like material biocompatibility, functional verification, and risk analysis, formal adjudication methods like 2+1 or 3+1 are typically not applied in the same way they would be for expert review of images in a diagnostic AI study. Decisions would be based on test results meeting predefined specifications or standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study Done? No. The document explicitly states: "The subject of this premarket submission, enFlow IV Fluid Warmer Insulated Strap, did not require clinical studies to support substantial equivalence." This means no comparative effectiveness study with human readers was conducted, as the device is an IV fluid warmer accessory, not a diagnostic imaging device.
• Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as there was no MRMC study or AI component in this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Standalone Study Done? Not applicable. This device is an IV fluid warmer accessory and does not involve an algorithm or AI for diagnostic or predictive purposes. Its performance is related to warming fluids and material properties.

7. Type of Ground Truth Used:

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus for disease presence or absence) is not directly applicable here. For this device, the "ground truth" or reference for evaluating its performance comes from:

• Defined Specifications: For functional, packaging, and labeling evaluations.
• Voluntary Standards: For overall compliance.
• ISO 10993: For biocompatibility requirements.
• Intended Use: For user validation testing.
• Predicate Device Performance: For establishing substantial equivalence.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This device is a hardware accessory and does not involve a "training set" in the context of machine learning or AI models.
• How Ground Truth for Training Set was Established: Not applicable.

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The enFlow IV Fluid Warmer System is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

The Vital Signs, Inc. enFlow IV Fluid Warmer consists of a Warmer, Controller (Power Supply) and single use sterile disposable cartridges, which are available with or without an IV tube extension set. The warmer will deliver infusate to a patient at a temperature of up to 40°C at flow rates of KVO (Keep vein open) to a maximum of 200ml/min. The sterile disposable cartridges consist of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path. The Controller serves as the power supply for the Warmer unit. The basis for this submission is to notify the FDA of the addition of a Warmer Strap to the enFlow IV Fluid Warmer. The Strap is an accessory whose function is to secure the enflow IV Fluid Warmer to the arm.

Here's an analysis of the provided text regarding the acceptance criteria and study for the enFlow IV Fluid Warmer Strap device:

Important Note: The provided document (K121775) is for a modification to an already cleared device (enFlow IV Fluid Warmer, K112902). The modification is specifically the addition of a Strap as an accessory. Therefore, the core performance of the fluid warmer itself is not being re-evaluated in this submission. The focus is on the impact of the strap.

Acceptance Criteria and Reported Device Performance

The submission states: "The basis for this submission is to notify the FDA of the addition of a Warmer Strap to the enFlow IV Fluid Warmer. The Strap is an accessory whose function is to secure the enflow IV Fluid Warmer to the arm." And "[t]here have been no changes to either the intended use of the device or the fundamental scientific technology of the device."

Given this, the acceptance criteria are implicitly that the addition of the strap does not negatively impact the safety and effectiveness of the previously cleared enFlow IV Fluid Warmer.

Study Details

Based on the provided K121775 submission:

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

   • No specific test set sample size is mentioned for the strap itself.
   • The document explicitly states: "The modifications made to the enFlow IV Fluid Warmer did not require clinical testing to support substantial equivalence." This means there was no clinical test set in the traditional sense for the strap.
   • Non-clinical studies (Risk Analysis, Biocompatibility Testing, Performance Testing) were conducted, but details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these tests specific to the strap are not provided in this summary. These would typically be detailed in a more comprehensive testing report.

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

   • Not applicable. No clinical test set requiring expert ground truth was performed for this specific modification.

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

   • Not applicable. No clinical test set was performed.

4. 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 device is a medical fluid warmer, not an AI-powered diagnostic or assistive technology.

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

   • Not applicable. This is not an algorithmic device.

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

   • For the non-clinical tests (Risk Analysis, Biocompatibility, Performance Testing), the ground truth would be based on engineering specifications, regulatory standards, and established laboratory testing methodologies. No human-derived ground truth (like expert consensus or pathology) is relevant here.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable.

Summary of the Study for this Specific Submission (K121775):

The submission K121775 is a "Special 510(k) Premarket Notification" for a minor change (adding a strap) to an already cleared device. As such, the "study" is primarily a demonstration of substantial equivalence to the predicate device (K112902) despite the modification, based on non-clinical data.

The relevant non-clinical studies mentioned are:

• Risk Analysis: To ensure the strap does not introduce new unacceptable risks.
• Biocompatibility Testing: To ensure the strap material is safe for patient contact (if applicable, though its primary function is to secure the warmer to the arm, not direct patient contact, the material's interaction with the warmer itself or incidental human contact could be considered).
• Performance Testing: To ensure the strap functions as intended (securing the warmer) and does not impede the warmer's performance.

The key finding is that these non-clinical tests supported substantial equivalence and that clinical testing was not required due to the nature of the modification. This implies that the strap was assessed to be safe and effective and did not alter the fundamental characteristics or performance of the fluid warmer.

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The enFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

The Vital Signs, Inc. enFlow IV Fluid Warmer consists of a Warmer, Controller (Power Supply) and single use sterile disposable cartridges, which are available with or without an IV tube extension set. The warmer will deliver infuscate to a patient at a temperature of up to 40°C at flow rates of 1 ml/min to a maximum of 200 ml/min.

The sterile disposable cartridges consist of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path. The Controller serves as the power supply for the Warmer unit.

The provided document is a 510(k) premarket notification for the enFlow IV Fluid Warmer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI/medical device might.

Therefore, the specific information requested about acceptance criteria, detailed study design, sample sizes for test and training sets, and expert involvement for ground truth establishment cannot be fully provided from this document.

Here's an explanation based on the document's content:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or diagnostic accuracy. Instead, it states that the device is substantially equivalent to a predicate device and lists a series of non-clinical studies for verification and validation.

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. The document states that clinical testing was not required to support substantial equivalence due to the nature of the modifications (minor labeling, shelf life, design, and software modifications). Therefore, there is no clinical test set for which to determine sample size or data provenance.

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 no clinical test set was used for this 510(k) submission.

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

Not applicable, as no clinical test set was used for this 510(k) 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

Not applicable. The enFlow IV Fluid Warmer is a physical medical device (an IV fluid warmer), not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable, as this is a physical medical device, not an algorithm.

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

Not applicable, as no clinical ground truth was established for this submission. The "ground truth" for this device's performance would be its ability to warm fluids to a specific temperature range, which is verified through engineering specifications and performance testing, not clinical outcomes in a study. The document mentions "Performance/Functional Verification and Validation" in the non-clinical studies section, implying engineering and bench testing.

8. The sample size for the training set

Not applicable, as this is a physical medical device and 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 no training set was used.

Summary of the Study that Proves the Device Meets the Acceptance Criteria (based on the document):

The document states that "The modifications made to the enFlow IV Fluid Warmer did not require clinical testing to support substantial equivalence." (Page 2, Section 9).

Instead, the substantiation for this 510(k) submission relies on a series of non-clinical studies and design control measures applied to the development of the enFlow IV Fluid Warming system. These studies confirm that the device, even with the minor modifications, continues to be substantially equivalent to its predicate device (eFlow Model 100 IV Fluid Warmer, K060537).

The "acceptance criteria" in this context are not clinical performance metrics but rather the demonstration through these non-clinical studies that the modified device functions safely and effectively within its intended use and is equivalent to the predicate. The "study" proving this consists of:

• Risk Analysis
• Requirements Development and Reviews
• Software Verification and Validation (for the device's inherent software, not an AI algorithm)
• Performance/Functional Verification and Validation (bench testing to confirm the device performs as intended, e.g., heats fluids to the specified temperature and flow rates)
• Biocompatibility Testing
• Sterilization and Shelf-Life Testing
• Electrical Safety and EMC Testing

The document specifically highlights that "There have been no changes to the fundamental scientific technology of the device" (Page 1, Section 7), further supporting the reliance on non-clinical data for substantial equivalence. The FDA ultimately found the device substantially equivalent based on this information (Pages 3-5).

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This device is intended to be used with positive airway pressure devices operating at or above 4cmH2O for the treatment of adult obstructive sleep apnea.

A nasal CPAP mask that is used with positive airway pressure equipment recommended by a physician, sleep technician, or respiratory therapist.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The provided document describes a 510(k) Premarket Notification for the iMask™ Nasal CPAP Mask. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than outright proving safety and effectiveness through extensive clinical trials for de novo approval. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of substantial equivalence to the predicate device, the SleepNet IQ™ Mask.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially the characteristics and performance attributes of the predicate device (SleepNet IQ™ Mask). The "reported device performance" refers to how the iMask™ meets or is substantially equivalent to these attributes.

Study Proving Acceptance Criteria (Substantial Equivalence):

The "study" proving the device meets the acceptance criteria is a substantial equivalence comparison to the predicate device, the SleepNet IQ™ Mask. This is not a traditional efficacy study, but rather a demonstration that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

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

• Test Set Sample Size: The document does not specify a "test set" in the context of clinical data for performance assessment of the iMask™ against specific patient outcomes. The evaluation is primarily a comparison of technical and material specifications against the predicate device and relevant standards.
• Data Provenance: The data primarily consists of bench testing results (e.g., meeting ASTM, ISO standards, leakage rates) and material biocompatibility testing. This is not patient-derived data in the typical sense. It is likely prospective for the iMask™'s own testing. The country of origin of the data is not explicitly stated but would be assumed to be from the manufacturer's testing facilities (Marquest Medical Products, Inc. in Englewood, CO, USA) or their chosen test labs.

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

• Number of Experts & Qualifications: This information is not provided and is generally not applicable in this type of 510(k) submission. "Ground truth" in this context refers to established engineering standards (ASTM, ISO), material science standards (USP Class VI), and the characteristics of the predicate device. These are objectively measurable or documented attributes, not subjective expert interpretations of clinical data.

4. Adjudication Method for the Test Set:

• Adjudication Method: This information is not provided and is not typically relevant for a substantial equivalence determination based on technical specifications and bench testing. There is no ambiguous clinical data requiring adjudication.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is used to assess the impact of a device on reader performance (e.g., radiologists interpreting images with or without AI assistance). The iMask™ is a physical medical device (CPAP mask), not an interpretive or diagnostic AI system.

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

• Standalone Performance: No, this concept is not applicable. The iMask™ is a physical medical device, not an algorithm, and doesn't operate in a "standalone" algorithmic capacity. Its performance is assessed through bench testing and material compatibility, and its intended use is with a human patient and CPAP machine.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's validation is primarily based on:
  • Established engineering standards: ASTM F1054-87, ISO 5356-1, ISO 17510-2:2003.
  • Biocompatibility standards: USP Class VI for materials.
  • Characteristics and performance of the legally marketed predicate device: SleepNet IQ™ Mask.
  • Bench test results (e.g., mask leakage at specified pressure).

8. The Sample Size for the Training Set:

• Training Set Sample Size: This concept is not applicable. The iMask™ is a physical device, not an AI algorithm that undergoes a "training phase" with a dataset.

9. How the Ground Truth for the Training Set was Established:

• Ground Truth for Training Set: This concept is not applicable as there is no "training set" or AI component to the device.

In summary, the provided document details a substantial equivalence argument for a physical medical device (CPAP mask). The "acceptance criteria" are the characteristics of the predicate device and relevant industry standards, and the "study" demonstrating compliance involves bench testing and material biocompatibility assessments, not clinical trials with patient data or expert interpretation.

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The Breas PV10i CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA).

In the treatment of sleep disorders, CPAP is well established and common practice as a means to prevent upper airways from collapsing and therefore avoid breathing problems associated with airway collapse and obstruction. There are a number of devices legally marketed in the United States for this application, including self-adjusting CPAP systems such as the predicate ResMed Sullivan Autoset T. The self-adjusting systems accommodate pressure requirements that may vary (e.g., as patients change bodies positions or enter different sleep stages).

The Breas PV10i CPAP is similar to the predicate Breas PV100 CPAP System, but with the addition of self-adjusting pressure features. Both Breas devices are microprocessor controlled based on firmware (embedded software). Both designs incorporate pressure sensors that monitor output pressure and provide feedback to the microprocessors. The PV10i also incorporates an airflow sensor and flow signal processing means in firmware to provide self-adjusting capability.

The therapy delivered by the Breas PV10i CPAP System can be either:

• 1. Self-adjusting in response to variations in patient breathing patterns (CPAP "i" mode), or
• 2. Set to a constant pressure level (constant CPAP mode).

The primary hardware component is a blower that generates airflow. The blower assembly consists of a brushless DC motor that drives a fan, entraining ambient air through a filter and pressurizing it to provide the prescribed airflow with CPAP for the patient. The microprocessor controls the motor and hence the speed of the fan.

The PV10i pressure range is 4 - 20 cmH20. Starting pressure and self-adjusting pressure limits are settable by clinical personnel in accordance with the patient's prescription.

The CPAP airflow is delivered via a single lumen outlet tube that may be connected to various non-invasive patient interfaces, such as nasal masks. To minimize CO2 rebreathing, masks or other interfaces permitting a leak flow of at least 12 liters/minute at the minimum output pressure setting of 4 cm of H20 are recommended for use with the PV10i.

The pressure transducer incorporated in the PV10i continuously monitors output pressure to the patient and reference ambient pressure. This enables the device to automatically compensate for altitude changes.

The PV10i has an auto-switching power supply that facilitates use in conjunction with international travel (100 - 240 VAC). It can also be used with an external 12 - 24 VDC power source when AC mains line voltage is not available. This DC power source capability is not intended as a battery power back-up system for any critical treatment applications. An accessory Remote Control Module may be connected that enables clinicians to operate the PV10i without using the control and setting panels on the device itself. A PC-based software program may also be supplied that provides an optional means for clinicians to set patient parameters (e.g., start and limit pressures) and track patient compliance.

The PV10i and its accessories are not sterile. The outer dimensions of the PV10i housing are 6.3 × 4.5 × 9.3 inches, and the device weighs 3.7 pounds.

The Breas PV10i CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA). The studies performed aimed to demonstrate the device's efficacy and safety, particularly for its self-adjusting pressure features, and its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes several types of testing rather than explicit, quantified acceptance criteria in a pass/fail table for each feature. However, the overarching acceptance criterion is that the device meets its stated performance specifications and demonstrates substantial equivalence to predicate devices. The reported performance indicates this criterion was met.

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The Disposable Pressure Manometer will be used to provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP Mask or CPAP Circuits.

The VSI disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation. The device consists of: A flexible nipple for attachment to a sampling/pressure port, Clear polycarbonate (PC) housing with a printed pressure scale, PC float with indication and a double ended stainless steel spring.

The K022402 submission is for a Disposable Manometer, not an AI/ML device, so many of the requested categories (e.g., training set, number of experts, MRMC study) are not applicable. I will provide the information that is relevant to this traditional medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for performance testing or the exact data provenance (e.g., country of origin, retrospective/prospective). Instead, the submission relies on direct comparison of the proposed device's specifications and performance to a legally marketed predicate device (Engineered Medical System, Inc. - Pressure Manometer - K003497). The "Performance Accuracy" values listed in the table are the specified performance of the device, implying that testing was conducted to demonstrate conformance to these specifications to establish substantial equivalence.

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

Not applicable. This is a hardware medical device; its performance is based on physical accuracy measurements rather than expert-established ground truth in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable. This is a hardware medical device where performance is measured objectively.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI devices where human reader performance is being evaluated, often with and without AI assistance. This device is a measurement tool.

6. If a Standalone Study Was Done

Yes, implicitly a "standalone" performance evaluation was done in the sense that the VSI Disposable Manometer was tested to confirm it met the specified accuracy criteria. The submission states the device's performance accuracy:

• +/- 1 cm H2O / 0-10 cm H2O
• +/- 2 cm H2O / 10-40 cm H2O
• +/- 3 cm H2O / > 40 cm H2O

These values are identical to the predicate device, indicating that the device's performance was measured and found to meet these specifications.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is objective physical measurement of pressure accuracy against a calibrated standard.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device and does not have a "training set."

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

Not applicable. This is not an AI/ML device and does not have a "training set."

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The Sure-Lok™ secondary needle kit contains a needle w/Sure-Lok™ adapter, sheath, and base stand that is intended for use with standard luer-lock and luer-slip arterial blood gas collection syringes. Following sampling, the needle is inserted into the sheath whereby the Sure-Lok™ adapter engages with the sheath, preventing needle exposure.

The device description of the Sure-Lok™ secondary needle kit is as follows.

• Hypodermic single lumen needle, 20G 25G, 5/8" to 1½" length. u
• Adapter attached to needle with 6% (luer) taper for syringe barrel . attachment.
• Needle Sheath that seals the needle tip and locks with the adapter to I prevent needle exposure.
• . Base Stand that holds the sheath in an upright position during engagement of the needle and sheath.
• Individually packaged and sterilized. l

This submission (K021315) for the Sure-Lok™ secondary needle kit is a 510(k) Pre-Market Notification, indicating it's a submission for substantial equivalence to a predicate device. As such, the document focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than establishing acceptance criteria and proving the device meets them through a specific study in the same way a novel device might.

The provided text, therefore, does not contain detailed information on:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, or the number/qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Specific ground truth types for performance studies.
• Training set sample size or ground truth establishment for a training set.

Instead, the submission demonstrates substantial equivalence by comparing the Sure-Lok™ device to two predicate devices (NeedleTrap™ [K950098] and Point-Lok™ [K946289]) across various characteristics.

Here's a summary of what is provided regarding the device's characteristics and its comparison to predicate devices, which implicitly serves as the "proof" of meeting the standards set by already approved devices:

1. Acceptance Criteria and Reported Device Performance (Implied by Substantial Equivalence):

The "acceptance criteria" are implicitly defined by the characteristics and performance of the predicate devices. The Sure-Lok™ device is deemed acceptable because it shares the same intended use, technique, safety features, and material properties as the legally marketed predicate devices.

2. Sample size used for the test set and the data provenance: Not applicable. This submission relies on demonstrating substantial equivalence to already approved predicate devices based on design and material comparisons, not a new performance study with a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method for the test set: Not applicable.

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 device is a mechanical needle safety device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: Not applicable in the context of a new performance study. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices, against which the Sure-Lok™ device is compared. Its compliance with the general controls and regulations for hypodermic single lumen needles, as affirmed by the FDA, serves as validation.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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