(28 days)
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
| Acceptance Criteria (Study Objective) | Reported Device Performance |
|---|---|
| Packaging integrity and sterile barrier maintenance for terminally sterilized medical devices. | Packaging tested according to AAMI/ANSI/ISO 11607-1 and 11607-2 standards was determined to be substantially equivalent to the predicate device. |
| Validation of forming, sealing, and assembly processes for packaging. | (Implicit in "determined to be substantially equivalent") |
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.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”