FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The MultiBolus II™ is intended to provide intermittent delivery of medication on patient demand, using patient control module allowing bolus doses, at relatively rapid velocity in parallel to a continuous basal flow or without continuous basal flow, to/or around surgical wound site and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous, subcutaneous, intramuscular and epidural.

Device Description

MFS's MultiBolus II™ is a semiautomatic disposable 100% mechanical device used as a complementary to MFS's pain management system to be controlled by the patient as prescribed and set by an authorized medical team member using either one or two catheters.

The device is to be integrated with the existing cleared MFS's elastomeric pumps and is designed to provide a bolus delivery of pain relief medication with or without parallel continuous basal flow.

The MultiBolus IITM, together with the elastomeric pump creates a PCA (Patient Control Analgesia) infusion pump.

The MultiBolus II™ with Parallel set configuration is used when the delivery of a bolus medication is required to be executed parallel to a continuous basal flow.

The MultiBolus II™ with In-Line set configuration is used when the delivery of a bolus medication is required only.

Both configurations may be used during a dual catheter administration when a flow splitter such as; MFS's FlowSplitter™ (cleared within MFS's 510(k) number: K072053) device is assembled at the set exit port.

The device was developed by MFS to assist patients with pain management following surgical procedures or other pain managements. The device may be used in the hospital, at the clinic and at the home environment for out-patients subject to the physician decision.

AI/ML Overview

The provided document describes the MFS MultiBolus IITM device and outlines its performance data through various tests to support its substantial equivalence to predicate devices and ensure its safety and efficacy.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Device: MFS MultiBolus II™ (disposable pain management system)

No.	Test Name	Purpose	Acceptance Criteria	Reported Device Performance (Results)	Conclusion
Functional Tests
1	Operating Cycles	Assuring the device capability to function in multi iteration (repeatedly)	- Activate semi-automatically according to spec in terms of functionality and in all volumes (3, 4, 5, & 6ml).

Lockout time according to spec (not completely filled after the specified time).
No parallel flow is allowed when not activated (scale monitor should show: 0.0). | - Device performed as intended.
Maximum volume tolerance was -0.75ml. No result exceeding +0.0ml was detected.
When nominal set to 6ml, no complete filling after the specified time occurred.
Before activation scale monitor showed: 0.0. | Under the Test's conditions all acceptance criteria were met. |
| 2 | Priming | Verifying priming efficiency and 0.2µ filter effectiveness in trapping air bubbles (Parallel set model) | - No air bubbles after the 0.2µ filter are allowed. | - No air bubbles after the 0.2µ filter were detected. | Under the test condition, all results met acceptance criteria. All air bubbles were trapped by the 0.2µ filter in priming for the parallel set model. |
| | Priming (In-line set model) | Verifying priming efficiency | - No air bubbles in the tubing between the 0.2µ filter and the exit port after 1st activation are allowed.
Volume of 2nd & 3rd activations should be as specified. | - No air bubbles after the 0.2µ filter were detected.
Results were according to spec. | Under the test condition, all results met acceptance criteria. |
| 3 | Volumes | Verifying that actual volume is within the spec | Actual infused bolus volume range should be according to spec. | Under the test's conditions the actual delivered volume in both semi-automatic and manual activation was according to spec. | Under the test condition, all results met acceptance criteria. |
| 4 | Velocity | Verifying actual velocity is within the spec | Velocity should be at-least 5 ml/minute. | Under the test's conditions all results were greater than 5ml/minute. | Under the test condition, all results met acceptance criteria. |
| 5 | Lock-Out Time | Verifying that actual re-filling time at nominal volume of 6ml is within the spec. | Filling time was between 48-72 minutes of nominal volume. | After the specified time reservoirs were not completely filled. After 72 min. all reservoirs were completely filled. Volumes in semi-automatic mode were as specified. | Under the test condition, all results met acceptance criteria. |
| 6 | Leaks | Verify the device design withstand operation pressure. | No leaks are allowed within at-least 10 seconds under 3 bar. | No leaks (stable pressure level) occurred during test's procedure. | Under the test condition, acceptance criteria was met. |
| 7 | Tube bonding | Verify the device's tubing connection withstand the forces during use. | - Tube remains connected to the device.
No leaks after applying 1.5Kg. | During test, no tubing disconnections were detected and no leaks afterwards (according to same method as in test #6). | Under the test conditions, acceptance criteria was met. |
| 8 | Hydraulic check valve | Verify no flow through the device when not activated. | - Observed leaks;
Gross weight of the device after 14 days is equal or up to 10 gram less than day 0 (baseline). | During the test's period, no leaks occurred. Maximum gross weight reduction was within defined acceptance criteria. | Under the test conditions, all tested samples met the acceptance criteria. |
| 9 | External force during use | Verify the device withstand reasonable external forces may be applied during use. | - Cracks in the device cover (shells), or other plastic parts;
Leaks;
Device shall be properly activated and function. | Following the test conditions, no cracks, leaks or malfunctioning were detected. | Under the test conditions, all acceptance criteria were met. |
| 10 | Shelf life equal to 1 year real-time (post accelerated aging) | Verify that the device will function well throughout its shelf life. | Under the test method the product should be operated and functioned according to its spec.
Volume filled (per test 3),
Lockout time (per test 5),
No parallel flow, when not activated (per test 8),
No visible cracks (per test 9),
No visual leaks (per test 9). | Under the test method all filled volumes; lockout times; sealing state (no-parallel flow); no-cracks and leaks tests passed successfully. | All tested samples met the acceptance criteria and the product was qualified for 1 year shelf life. |
| Sterilization | | | | | |
| 11 | EtO Sterilization validation | Validate that the device may be sterilized for SAL 10-6 through EtO established cycle using overkill approach (also called: Half Cycle Method). | With accordance to the following standards:
Bio Burden: ISO 11737-1:2006, ISO 11135-1:2007
ETO/ECH Residues: ISO 10993-7:2008
LAL Endotoxin: USP 32:2009 Transfusion and Infusion Assemblies and Similar Medical Devices and; FDA's Guidance for Pyrojen & Endotoxins testing (Q&A), June 2012
Sterility: ISO 11135-1:2007, ISO 11737-2:2010 | All tests' results were determined to be within the standards' acceptance criteria. | Following the sterilization validation, SAL 10-6 was established for MFS's MultiBolus II™ device. |
| Packaging Integrity | | | | | |
| 12 | Packaging Integrity | Verify that the shipping packaging the device provides sufficient protection to the device during shipping. | - All packages shall remain whole, unopened and complete.
No physical damages to the sealed sterile unit are allowed. | None of the below defects have been occurred:
No significant damage to shipping cases and internal boxes.
No significant (tears, open) damage to sterile pouches.
No functional damage to the device. | Following sterile unit's package integrity tests, all acceptance criteria were met and it was concluded that sterility will be maintained along the product's shelf life. |
| 12.1 | Packaging Integrity | Verify sterile single unit package integrity in order to maintain product's sterility along 3 years shelf life. | Sterile package integrity tests per each test acceptance criteria (as further detailed in section 18 and appendix C of this submission). | All tested items met acceptance criteria for visual test, sterility test, and package integrity tests (peel, dye, burst). | Shelf life of 3 years real-time was established for the sterile unit package. |
| Usability | | | | | |
| 13 | Usability (Physicians) | Validate that users of each group (physicians and home users) are capable to properly, safely and effectively set and operate the device and that the device is intuitive for activating. | All 'physicians' participates shall operate the device through the "activation missions" successfully with according to the IFU. | All participants have fulfilled successfully all "activation missions" according to the relevant accompanied IFU. | It was concluded from the usability results that the device is "usable" by its intended users (both physicians and patients) with accordance to IFU. The device met all test's acceptance criteria. |
| | Usability (Patients) | Validate that users of each group (physicians and home users) are capable to properly, safely and effectively set and operate the device and that the device is intuitive for activating. | All 'patients' participants shall appropriately activate the device, i.e., squeeze the activating lever all the way until it 'clicks'. | (Results for patients not explicitly detailed but implied to meet success based on the overall conclusion.) | It was concluded from the usability results that the device is "usable" by its intended users (both physicians and patients) with accordance to IFU. The device met all test's acceptance criteria. |

2. Sample size and data provenance for the test set

Sample Size for Test Set:
- Operating Cycles: 30 activation iterations of each device (number of devices tested is not specified for this specific test, but implies multiple devices were tested).
- Shelf Life (1 year): Products were tested after accelerated aging. The number of products tested is not explicitly stated but implies multiple samples.
- Shelf Life (3 years): "All tested items" (number not specified).
- Other tests: The number of devices/samples tested for other functional, sterilization, and packaging tests is not explicitly stated in the provided text. It is generally implied that multiple samples were used for these bench tests.
Data Provenance: The tests were conducted internally by MFS - Medical Flow Systems Ltd., an Israeli company. The data is based on prospective bench testing and usability studies. There is no mention of data from country of origin of patients or retrospective data.

3. Number of experts and qualifications for ground truth

Number of Experts:
- Usability (Physicians): Not explicitly stated how many physicians participated, but referred to as "All 'physicians' participates."
- Usability (Patients): Not explicitly stated how many patients participated, but referred to as "All 'patients' participants."
Qualifications of Experts:
- Physicians: Described as "educated participant[s]" for the usability study, implying they are medical professionals familiar with such devices.
- Patients: Not specified beyond "patients," implying they represent the intended end-users.

4. Adjudication method for the test set

Adjudication method: Not applicable. The studies described are bench tests and usability tests evaluating device performance against pre-defined engineering and usability acceptance criteria. They are not clinical studies requiring expert adjudication of diagnoses or outcomes.

5. Multi-reader multi-case (MRMC) comparative effectiveness study

Was an MRMC study done? No. The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is a mechanical patient-controlled pain management system, not an AI-powered diagnostic or assistive tool.

6. Standalone (algorithm only without human-in-the-loop performance) study

Was a standalone study done? The performance data presented is essentially a standalone evaluation of the device as a mechanical system. The "algorithm" here is the device's inherent mechanical function. The tests (Operating Cycles, Priming, Volumes, Velocity, Lock-Out Time, Leaks, Tube Bonding, Hydraulic Check Valve, External Force, Shelf Life) demonstrate the device's performance without the "human-in-the-loop" interaction for diagnosis or interpretation, but rather its mechanical operation. The usability tests then assess the human interaction with this standalone mechanical device.

7. Type of ground truth used

Main type of ground truth: The ground truth for the performance tests is based on engineering specifications, established standards (e.g., ISO, ASTM, USP), and documented internal protocols that define acceptable ranges for mechanical function, safety, sterility, and packaging integrity.
- For usability, the ground truth is established by the ability of physicians and patients to successfully perform specified "activation missions" according to the device's Instructions for Use (IFU).

8. Sample size for the training set

Sample size for training set: Not applicable. The MultiBolus IITM is a mechanical device, not an AI/machine learning algorithm, so there is no "training set" in the context of model development. The development and testing would involve prototypes and iterative design, but not data-driven model training.

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

How ground truth for training set was established: Not applicable, as there is no training set for this mechanical device.

Summary

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).