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The PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI HPICC III is 6 mL/sec.

The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The Maximal Barrier Nursing Kit with BioFlo Midline Catheter is indicated for short term access (

The PICC Maximal Barrier Nursing Kit is a packaging configuration containing a specified NMI PICC along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices based upon recommendations of Center of Disease Control and Prevention (CDC).

This document describes a 510(k) premarket notification for "PICC Maximal Barrier Nursing Kits" by Navilyst Medical, Inc. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

The document primarily focuses on a packaging change for the kit and vendor changes for several kit accessories. It does not detail new device performance, clinical studies for efficacy, or the development of an AI/ML model. Therefore, many of your requested points regarding acceptance criteria, study details for device performance (beyond packaging integrity), expert adjudication, AI/ML impact, and ground truth establishment are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• AAMI/ANSI/ISO 11607-1 Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems, and packaging systems (2006)
• AAMI/ANSI/ISO 11607-2 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes (2006)
  The document states "Based on results of packaging testing performed according to recognized standards, the proposed PICC Maximal Barrier Nursing Kit is determined to be substantially equivalent to the predicate PICC Maximal Barrier Nursing Kit."
  (Specific test results or quantitative performance metrics for packaging integrity are not provided in this summary but are implied to meet the standards.) |
  | Equivalence to Predicate Device (Overall) | "The proposed PICC indications for use, technological characteristics, materials and operating principles are identical."
  "The performance evaluation... is the result of design verification and validation activities, and risk assessment."
  "Based on results of packaging testing performed according to recognized standards, the proposed PICC Maximal Barrier Nursing Kit is determined to be substantially equivalent to the predicate PICC Maximal Barrier Nursing Kit." |

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

Not applicable. This submission is for packaging and accessory vendor changes, not a new device requiring a clinical test set with patient data. The "test set" here refers to samples of the new packaging and components subjected to engineering and packaging validation tests. Specific sample sizes for these engineering tests are not provided in this summary.

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

Not applicable. This pertains to a packaging and component change, not a diagnostic or AI device requiring expert-established ground truth.

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

Not applicable. This pertains to a packaging and component change, not a diagnostic or AI device requiring adjudication of results.

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. There is no mention of AI or machine learning in this submission.

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

Not applicable. There is no mention of AI or machine learning in this submission.

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

Not applicable. For this submission, "ground truth" relates to the compliance of the new packaging and components with established engineering and regulatory standards (e.g., sterility, seal integrity, material compatibility).

8. The sample size for the training set

Not applicable. There is no mention of AI or machine learning, and therefore no training set.

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

Not applicable. There is no mention of AI or machine learning, and therefore no training set or ground truth for it.

Summary of Device and Changes:

The device, "PICC Maximal Barrier Nursing Kits," includes various PICC catheter types (BioFlo Hybrid, BioFlo, Xcela Hybrid, Xcela) packaged with procedural aides and maximal barrier precautions. The "indications for use, technological characteristics, materials and operating principles are identical" to the predicate device. The only "differences" are a packaging change (outer tray with Tyvek lid replaced with a Tyvek/Nylon Pouch) and changes in vendors for "several kit accessories." The entire submission focuses on demonstrating that these changes do not alter the substantial equivalence to the predicate device, primarily through performance testing of the new packaging configuration against recognized international standards.

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The NMI PICC III is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI PICC III is 6 mL/sec.

The NMI PICC III with PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The Xcela Hybrid PICC with PASV Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec.

for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The PICC Maximal Barrier Nursing Kit is a packaging configuration containing a specified NMI PICC, along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices based upon recommendations of Center of Disease Control and Prevention (CDC). The associated accessories include: Sterile Kit: Ampule Breaker, Cannula 1 ¾" Filtered Straw, Cap, male, non-vented, Cover, Transducer, 4" x 58", CSR Wrap, Dilator/Sheath, 3-6F x 5 or 7 cm peelable, (sized to PICC), Drape, Full Body, Drape, Under arm, Drape, Fenestrated, Dressing, Tegaderm, Chloraprep 3mL clear and orange tint, Gauze 4" x 4", 4 ply, Gown, Surgical Extra Large, Guidewire, 0.18" x 45 cm, Hairnet, 24" large, Lidocaine ampule, Mask with earloops, Needle, echogenic 21G x 1.575" or 2.75" (sized to PICC), Needle, 25G x 5/8", Needle, safety 21 G x 2.75", PICC (based on family and size), Scalpel, #11, Safety, Scissors, Blunt, Sharps container, single, Skin Protectant Swab Stick, Statlock Plus Fixed Post (stabilization), Stiffening Stylet 0.014" or 0.016" x 70 cm (size to PICC), Syringe 5cc, Tape Measure, 36" Paper, Tape, Surgical 3/4" x 24", Tourniquet, 18" x 1", Towel, 14" x 25", Tuohy Borst Adapter w/side arm. Tandem Package (Pouch): Sterile OEM Devices in 'as received' packaging, Gloves, Surgeons, Pre-Filled Syringes, Saline.

The document is a 510(k) premarket notification for a medical device called the "PICC Maximal Barrier Nursing Kit" (K142616) submitted by Navilyst Medical, Incorporated. This document evaluates the substantial equivalence of the new device to a predicate device (K131038) based on packaging changes.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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

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 test set or the data provenance. It only states that "results of package testing" were performed.

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)

The document does not mention the use of experts to establish ground truth for the packaging test. The evaluation relies on compliance with recognized international standards for packaging.

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

The document does not describe an adjudication method. The assessment of the packaging is based on adherence to AAMI/ANSI/ISO standards.

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 was not done. This device is a physical medical kit (catheter, procedural aides, and barrier precautions), not an AI-assisted diagnostic or treatment device.

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

A standalone performance study was not done in the context of an algorithm. The performance evaluation relates to the physical packaging of a medical device.

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

The "ground truth" for the packaging study is adherence to the specifications and performance requirements outlined in the AAMI/ANSI/ISO 11607-1 and 11607-2 standards for medical device packaging. There is no biological or diagnostic ground truth involved.

8. The sample size for the training set

The concept of a "training set" is not applicable as this is not a machine learning device. The study evaluated the physical packaging.

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

Not applicable.

Summary of the Study:

The study proving the device meets the acceptance criteria is a packaging performance evaluation. The new "PICC Maximal Barrier Nursing Kit" differs from its predicate device only in its "new outer tray lid and adhesive." The purpose of the study was to demonstrate that this new packaging maintains the sterile barrier and overall integrity of the device, similar to the predicate.

The study was conducted in accordance with the following national/international standards:

• AAMI/ANSI/ISO 11607-1: Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems, and packaging systems (2006)
• AAMI/ANSI/ISO 11607-2: Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes (2006)

The conclusion states that "Based on results of package testing performed according to recognized standards, the proposed PICC Maximal Barrier Nursing Kit is determined to be substantially equivalent to the predicate PICC Maximal Barrier Nursing Kit."

The document does not provide details on the specific number of units tested, the methodology of the tests (e.g., accelerated aging, transit testing, seal strength), or the exact numerical results. It only affirms that the testing was performed according to the cited standards and led to a conclusion of substantial equivalence for the packaging.

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The NMI HPICC III is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for central venous pressure monitoring and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI HPICC III is 6 mL/sec.

The NMI PICC III is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids. medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The NMI PICC III with PASV Vale Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec.

for short or long-term peripheral access to the central venous system for intravenous therapy. including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The PICC Maximal Barrier Nursing Kit is a packaging configuration containing a specified NMI PICC, along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices based upon recommendations of Center of Disease Control and Prevention (CDC).

The Navilyst Medical PICC Maximal Barrier Nursing Kit is a medical device that combines a Peripherally Inserted Central Catheter (PICC) with procedural aides and maximal barrier precaution devices. The 510(k) premarket notification K131038 states that the device's performance evaluation was conducted based on a risk analysis and included testing in accordance with national/international standards and FDA guidance documents.

Here's an analysis 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:

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

The document does not explicitly state the sample sizes used for the packaging standards testing or EO sterilization testing. It mentions that "All packaging is manufactured from packaging materials that are well characterized and commonly used in the medical industry." However, it does not specify the number of units tested.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. The studies were conducted by Navilyst Medical.

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

This information is not provided in the document. The performance evaluation relied on standardized testing, not expert-based ground truth for the device's main components. The "maximal barrier precaution devices" are based on recommendations from the Center of Disease Control and Prevention (CDC), implying general clinical best practices rather than specific expert review of test outcomes.

4. Adjudication Method for the Test Set:

An adjudication method (such as 2+1 or 3+1) is not mentioned in the document. The testing described (packaging, sterilization) typically relies on objective measurements against established standards, rather than subjective expert review requiring adjudication.

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 typically used for diagnostic devices involving human interpretation of results, which is not applicable to the PICC Maximal Barrier Nursing Kit, whose performance is primarily evaluated through physical and biological property testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable as the PICC Maximal Barrier Nursing Kit is a physical medical device, not an algorithm or AI system. Its performance relates to its physical characteristics, sterility, and packaging integrity, not software performance.

7. The Type of Ground Truth Used:

The ground truth used for this device's evaluation was primarily established by national/international standards and recognized FDA guidance documents. For example, ISO 10993-7 sets acceptance limits for ethylene oxide residuals, and ISO 11607 outlines requirements for packaging systems. The "successful results" indicate that the device met these objective, pre-defined criteria.

8. The Sample Size for the Training Set:

This question is not applicable as there is no "training set" for this device. The device is not based on a learning algorithm that requires training data.

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

This question is not applicable as there is no training set for this device.

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