Search Results

The FirmGrip 101 Peripherally Inserted Catheter Device is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling.

The FirmGrip™ peripherally inserted catheter includes a typical midline catheter encapsulated in a specially designed protective sleeve, to produce a self-contained clean catheter insertion field. The catheter contains a stiffening guidewire for additional contribution to ease of insertion and for catheter's internal air volume reduction. Both the catheter and guidewire remain protected throughout the entire catheter insertion procedure and is not exposed to the outer environment or to any hand contact. The protective sleeve back side is closed with a Tortuous Path Disc (TP Disc) which closed it and provides additional protection. Being the catheter protected by the sleeve, may save the need of using a sterile sheet since the sleeve may replace it. The protective sleeve enables manipulation and insertion of the catheter without interfering the protective sleeve's internal clean field. Once the catheter is properly placed in the blood vessel, both protective sleeve and the guidewire are removed and discarded. The FirmGrip™ is packed in an individual sterile pack and is sterilized by EtO. A needle assembly unit contains a specially designed adapter, called "PeelGuard", and a PeelAway needle introducer is supplied with the FirmGrip or separately. The needle assembly unit has its own individual package and is sterilized by EtO as well. The operation mechanism for the modified device is the same as the original device. The protective sleeve's handgrip portion, in its front side, has an accordion-shape which helps to promote the catheter with each intermittent grasping and pushing it forward. Once both the sleeve and the wire are removed, the catheter remains inside the vein. The catheter luer connector and a short portion of the catheter remain outside of the body and used as an access port for the medical treatment. The soft materials used for the catheter and PeelGuard make the connections more flexible, easy to use for the medical staff and more convenient for the patient.

The provided document describes a 510(k) submission for the FirmGrip™ Peripherally Inserted Catheter Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through extensive clinical trials as might be seen for a new drug or a PMA device.

Therefore, the information regarding acceptance criteria and study details will be limited to what is relevant for establishing substantial equivalence for a Class II device of this nature.

Here's an analysis of the provided text with respect to your requested information:

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

The document states: "The modified device was tested with according to Flexicath's legally marketed device specification and all acceptance criteria were met."
However, no specific acceptance criteria or detailed reported device performance are provided within this document. This is typical for a 510(k) summary, which generally does not include proprietary testing details or internal specifications. The conclusion paragraph indicates that nonclinical tests demonstrated the device's safety and effectiveness compared to the predicate.

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

The document mentions "New device verification and validation tests" and "nonclinical performance data," but it does not specify the sample size used for the test set, nor does it detail the data provenance (e.g., country of origin, retrospective or prospective nature). Given that this is a nonclinical performance study for a device, the "data provenance" would typically refer to the testing lab and the conditions under which the tests were performed (e.g., in-house, third-party lab).

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 for ground truth) is not relevant for a nonclinical performance study of a peripherally inserted catheter device. Ground truth established by experts is typically a concept applied to diagnostic devices or AI algorithms that interpret medical images or data. For a catheter, performance is evaluated through engineering tests, biocompatibility tests, and potentially animal or human cadaver studies, not by expert consensus on clinical findings.

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

Similar to point 3, adjudication methods are not applicable to the nonclinical performance testing described for this device. Adjudication is used to resolve disagreements in interpretations, often in clinical trials or studies involving human judgment (e.g., reading medical images).

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 comparative effectiveness study was done, nor would it be expected for this type of medical device. MRMC studies are specific to diagnostic imaging devices or AI-powered interpretative tools where human "readers" (e.g., radiologists) review cases. This device is a catheter, not an interpretive tool. No mention of AI assistance is made.

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

This question is not applicable to the FirmGrip™ Peripherally Inserted Catheter Device. This device is a physical medical instrument, not an algorithm or an AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

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

For this device, "ground truth" would refer to the established engineering specifications and performance benchmarks for catheter functionality (e.g., tensile strength, flow rate, insertion force, biocompatibility, sterility). The document states testing was done "according to Flexicath's legally marketed device specification," implying that the ground truth was established by these internal specifications and relevant industry standards for catheter performance and safety. It would not be based on expert consensus, pathology, or outcomes data in the same way an imaging or diagnostic device would.

8. The sample size for the training set

There is no "training set" for this device in the context of machine learning or AI. Training sets are used to develop and refine algorithms. This is a physical medical device, and its development involves engineering design, material science, and manufacturing processes, not algorithmic training.

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

As there is no "training set" for this device, this question is not applicable.

Ask a specific question about this device

The FirmGrip " Peripherally Inserted Catheter device is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling.

The FirmGrip™ peripherally inserted catheter includes a standard catheter encapsulated in a specially designed protective sleeve. The protective sleeve enables manipulation, handling, and insertion of the catheter . The catheter component is a standard, legally marketed catheter. The FirmGrin™ peripherally inserted catheter contains color coded hubs, one cm markings for easier length determination, and is fully radio-opaque. The catheter is incorporated into the FirmGrip™ sterile protective sleeve. A specially designed adapter, called the PeelGuard, and a Peel Away Needle Introducer are supplied with the Firm Grip The device. The FirmGrip™ protective sleeve comprises a long sheath with a special handgrip and a friction unit at the tip. The handgrip portion is located near the tip of the protective sleeve. The special handgrip is shaped like an accordion and moves back automatically in an accordion-like motion to facilitate the catheter insertion. The catheter is advanced slowly by grasping the catheter through the handgrip portion of the FirmGrip™ protective sleeve and pushing it forward. Pressure is released to allow the accordion-like motion of the protective sleeve to return the handgrip portion to its original position. The catheter is continuously advanced as described above until the catheter is completely in place. The long sheath portion of the protective sleeve contains the catheter and is designed to accommodate the length of a midline catheter. The tip of the catheter is located within the tip of the protective sleeve and the remainder of the catheter lies within the long sheath portion. The tip of the protective sleeve contains butterfly wings for ease of use, holding and securing the catheter in place. The tip of the protective sleeve is closed with a luer cap until use. When ready for use, the luer cap is removed and the specially designed adapter, called the PeelGuard is attached to the tip of the protective sleeve. The tip of the protective sleeve connects to the peel-away needle introducer via the PeelGuard adapter. Upon placement of the catheter within the vein, the remainder of the catheter may be removed from the protective sleeve by pulling back on the hand grip of the protective sleeve. The final device is packaged in a blister pack and sterilized by EtO Sterilization

Here's an analysis of the provided text regarding the acceptance criteria and study for the FirmGrip™ Peripherally Inserted Catheter Device:

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and does not present an extensive study with detailed acceptance criteria and reported device performance in the way one might expect for a novel AI/software device. Instead, it relies on demonstrating compliance with existing standards and material equivalency.

Therefore, many of the requested fields (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, explicit ground truth for test/training sets, and training set size) are not directly applicable or explicitly mentioned in the context of this traditional medical device submission.

However, I can extract the relevant information and structure it to best answer your prompt, noting where details are not provided or are not applicable.

Acceptance Criteria and Device Performance for FirmGrip™ Peripherally Inserted Catheter Device

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The "Non-Clinical Performance Data" section refers to "In-vitro testing" and a "final device performance test" without specifying sample counts for these tests.
• Data Provenance: The device is manufactured by FlexiCath Ltd. in Israel. Testing would have been conducted by or for FlexiCath Ltd. The type of testing (in-vitro, performance tests) suggests laboratory-based data, not patient data from a specific country or retrospective/prospective study.

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

• Not Applicable/Not Provided: This type of information is generally relevant for AI/software validation involving expert human review. For this traditional physical medical device, "ground truth" is established through engineering specifications, material standards (e.g., ISO), and functional testing, not typically by expert consensus of a test set in the same way.

4. Adjudication Method for the Test Set

• Not Applicable/Not Provided: As above, adjudication methods like N+1 consensus are used in clinical studies or expert review processes for diagnostic accuracy, which is not the focus of this device submission.

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

• No: A MRMC study is not mentioned. This type of study is typically performed to evaluate reader performance (e.g., diagnostic accuracy) with or without an AI-aid, which is not relevant for this physical catheter device.

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

• No: This is a physical medical device. There is no "algorithm" in the context of AI/software for which to conduct standalone performance testing.

7. The Type of Ground Truth Used

• Engineering Specifications, Material Standards, and Functional Performance: The "ground truth" for this device's performance relies on:
  • Compliance with international standards (ISO 10993 for biocompatibility, ISO 10555 for sterile, single-use intravascular catheters).
  • Demonstrating that the device's components and materials are the same as or equivalent to legally marketed predicate devices.
  • Verification of proper mechanical function (e.g., catheter advancement through the sleeve).
  • General principles of good manufacturing practices and device safety.

8. The Sample Size for the Training Set

• Not Applicable/Not Provided: There is no "training set" in the context of machine learning for this physical medical device.

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

• Not Applicable/Not Provided: As above, this concept does not apply to this type of device submission.

Ask a specific question about this device