Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states it is a "100% mechanical device" and there is no mention of AI, ML, or any computational elements in the intended use, device description, or performance studies.

Therapeutic

Yes.
The device delivers medication for pain management and regional anesthesia, falling under the definition of a therapeutic device.

Diagnostic

No

This device is designed for the delivery of medication for pain management, not for diagnosing medical conditions. It functions as a component of a patient-controlled analgesia (PCA) infusion pump.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "100% mechanical device" and describes physical components and their functions (catheters, elastomeric pumps, flow splitter, levers). There is no mention of software as a component or its function in the device's operation.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for delivering medication for pain management and regional anesthesia. This involves administering substances into the body, not testing samples from the body to diagnose a condition.
Device Description: The device is a mechanical pump designed to deliver medication. It is integrated with elastomeric pumps and catheters. This is consistent with a drug delivery system, not a diagnostic device.
Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
Performance Studies: The performance studies focus on the mechanical function of the pump (volume accuracy, velocity, lock-out time, leaks, etc.) and sterilization/packaging integrity. These are relevant to a drug delivery device, not an IVD.

In vitro diagnostics are devices used to perform tests on samples taken from the human body to detect diseases, conditions, or infections. This device's function is to deliver medication, which is a therapeutic action, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, percutaneous, subcutaneous, intramuscular and epidural.

Product codes (comma separated list FDA assigned to the subject device)

MEB, MEA

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.

MFS's MultiBolus II™ has the same indication for use and is substantially equivalent to the predicate devices selected by MFS in order to determine substantial equivalence as following detailed in this submission. The combination of these predicate-devices indication for use, technologies and performances supports our MultiBolus II™ substantial equivalency.

Body contact materials were evaluated for biocompatibility with accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2009.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

surgical wound site and/or close proximity to nerves

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Provider: "authorized medical team member", "physician". Patient.
Care Setting: hospital, clinic, home environment

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

MFS's MultiBolus II'M has been successfully tested through bench, usability and safety tests to support the determination of substantial equivalence with predicate devices.

The summary of performance data is following presented in order to support substantial equivalency and safety/efficacy of our device:

No. 1 Test Name: Operating Cycles
Purpose: Assuring the device capability to function in multi iteration (repeatedly)
Method: 30 activation iteration of each device.
Acceptance Criteria: 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).
Results:
• Device performed as intended.
• Under the test conditions the 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.
Conclusion: Under the Test's conditions all acceptance criteria were met.

No. 2 Test Name: Priming
Purpose: Verifying priming efficiency and 0.2µ filter effectiveness in trapping air bubbles in order to make priming for the parallel set model (option to exclude priming of the MultiBolus IITM device).
Method: Conducting priming according to IFU in the basal path flow only (parallel set model)
Acceptance Criteria: No air bubbles after the 0.2µ filter are allowed.
Results: No air bubbles after the 0.2µ filter were detected.
Conclusion: 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.

Test name: Verifying priming efficiency
Method: Conducting priming according to IFU (in-line set model with the MultiBolus IITM)
Acceptance Criteria:
• 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.
Results:
• No air bubbles after the 0.2µ filter were detected.
• Results were according to spec.
Conclusion: Under the test condition, all results met acceptance criteria.

No. 3 Test Name: Volumes
Purpose: Verifying that actual volume is within the spec
Method: Measuring the actual infused bolus volumes with and without catheter after semi-automatic, manual activation (from set volumes of 3, 4, 5, 6 ml.
Acceptance Criteria: Actual infused bolus volume range should be according to spec.
Results: Under the test's conditions the actual delivered volume in both semi-automatic and manual activation was according to spec.
Conclusion: Under the test condition, all results met acceptance criteria.

No. 4 Test Name: Velocity
Purpose: Verifying actual velocity is within the spec
Method: Measuring the actual velocity at 6ml volume with 21G catheter
Acceptance Criteria: Velocity should be at-least 5 ml/minute
Results: Under the test's conditions all results were greater than 5ml/minute.
Conclusion: Under the test condition, all results met acceptance criteria.

No. 5 Test Name: Lock-Out Time
Purpose: Verifying that actual re-filling time at nominal volume of 6ml is within the spec.
Method: Verifying the actual filling time of 6 ml volume is between 48-72minutes (state chosen as worst case representing all volumes)
Acceptance Criteria: Filling time was between 48-72 minutes of nominal volume.
Results: 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. No leaks (stable pressure level) occurred during test's procedure.
Conclusion: Under the test condition, all results met acceptance criteria.

No. 6 Test Name: Leaks
Purpose: Verify the device design withstand operation pressure
Method: Reservoir and tubing connection withstand air pressure of 3 bar at 10 seconds
Acceptance Criteria: No leaks are allowed within at-least 10 seconds under 3 bar.
Results: No leaks (stable pressure level) occurred during test's procedure.
Conclusion: Under the test condition, acceptance criteria was met.

No. 7 Test Name: Tube bonding
Purpose: Verify the device's tubing connection withstand the forces during use.
Method: Apply puling force of 1.5Kg on each tube for at-least 10 seconds.
Acceptance Criteria:
• Tube remains connected to the device.
• No leaks after applying 1.5Kg.
Results: During test, no tubing disconnections were detected and no leaks afterwards (according to same method as in test #6).
Conclusion: Under the test conditions, acceptance criteria was met.

No. 8 Test Name: Hydraulic check valve
Purpose: Verify no flow through the device when not activated
Method: Connect the device to filled-out reservoir for 14 days in a static position and evaluate against acceptance criteria.
Acceptance Criteria: During test period, the following are not allowed:
• Observed leaks;
• Gross weight of the device after 14 days is equal or up to 10 gram less than day 0 (baseline).
Results: During the test's period, no leaks occurred. Maximum gross weight reduction was within defined acceptance criteria.
Conclusion: Under the test conditions, all tested samples met the acceptance criteria.

No. 9 Test Name: External force during use
Purpose: Verify the device withstand reasonable external forces may be applied during use
Method: Tested samples went through two free falls from one meter height. Then, they were filled with saline, activated according to IFU and observed against acceptance criteria.
Acceptance Criteria: During test, the following are not allowed:
• Cracks in the device cover (shells), or other plastic parts,
• Leaks,
• Device shall be properly activated and function.
Results: Following the test conditions, no cracks, leaks or malfunctioning were detected.
Conclusion: Under the test conditions, all acceptance criteria were met.

No. 10 Test Name: Shelf life equal to 1 year real-time (post accelerated aging)
Purpose: Verify that the device will function well throughout its shelf life.
Method: After accelerate aging for 45 days under 52°C to simulate 1 year shelf life, products were tested using 19-21G catheters by filling 6ml, priming, delivered volume weight, testing volume post 45&72minutes and activate bolus delivery (simulating the real use 5 times).
Acceptance Criteria: 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).
Results: Under the test method all filled volumes; lockout times; sealing state (no-parallel flow); no-cracks and leaks tests passed successfully.
Conclusion: All tested samples met the acceptance criteria and the product was qualified for 1 year shelf life.

No. 11 Test Name: EtO Sterilization validation
Purpose: Validate that the device may be sterilized for SAL 10-6 through EtO established cycle using overkill approach (also called: Half Cycle Method).
Method: Per written protocol with accordance to ISO 11135-1:2007, Annex B.
Acceptance Criteria: 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
Results: All tests' results were determined to be within the standards' acceptance criteria. More details are available in section 14 of this submission.
Conclusion: Following the sterilization validation, SAL 10-6 was established for MFS's MultiBolus II TM device.

No. 12 Test Name: Packaging Integrity
Purpose: Verify that the shipping packaging the device provides sufficient protection to the device during shipping
Method: Based on ASTM D5276-98 (drop) & ISO 2248 (vertical impact by dropping)
Acceptance Criteria:
• All packages shall remain whole, unopened and complete.
• No physical damages to the sealed sterile unit are allowed.
Results: 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.
Conclusion: 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.

No. 12.1 Test Name: Packaging Integrity
Purpose: Verify sterile single unit package integrity in order to maintain product's sterility along 3 years shelf life.
Method: Exposing the packaging unit (single and shipping box) to all treatments undergo or might undergo in real-life (sterilization and drop). Products undergo real-time aging for 3 years under room temp: 22 ± 1°C for three years and then tested for: visual defects, sterility, peel, dye and burst tests.
Acceptance Criteria: Sterile package integrity tests per each test acceptance criteria (as further detailed in section 18 and appendix C of this submission.
Results: All tested items met acceptance criteria for visual test, sterility test, and package integrity tests (peel, dye, burst) as further detailed in section 18 and appendix C of this submission.
Conclusion: Shelf life of 3 years real-time was established for the sterile unit package.

No. 13 Test Name: Usability (Physicians)
Purpose: 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.
Method: Provide dummy regulating set with the device and filled reservoir (saline) to a person who "simulates a physician" (educated participant) accompany by physician IFU. Train this person on the device and then ask him to perform the following activating missions per IFU:

Assemble the regulating set to the reservoir (already filled with saline).
Prime the system.
Set and secure of the active volume.
Activate the device.
Re-set the device volume.
Permanently lock the active volume.
Acceptance Criteria: All 'physicians' participates shall operate the device through the "activation missions" successfully with according to the IFU.
Results: All participants have fulfilled successfully all "activation missions" according to the relevant accompanied IFU.
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.

Test Name: Usability (Patients)
Method: Provide dummy devices connected to an elastomeric pump and filled with Saline. Provide general information on the device and review the IFU for patients. Then, ask the patient to activate the device.
Acceptance Criteria: All 'patients' participants shall appropriately activate the device, i.e., squeeze the activating lever all the way until it 'clicks'
Results: Not Found
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K051253, K063530

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K072053

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

Image /page/0/Picture/1 description: The image shows a logo for Medical Flow Systems Ltd. The logo consists of the letters "mfs" in a stylized font, with a water droplet shape incorporated into the letter "f". The text "Medical Flow Systems Ltd." is written in a smaller font below the letters.

Image /page/0/Picture/3 description: The image is a circular seal with the words "Quality Systems Certified" around the edge. In the center of the seal, the text "ISO 9001:2008" and "ISO 13485:2003" are stacked on top of each other. The seal appears to be used to indicate that a company or organization has met the requirements of the ISO 9001 and ISO 13485 standards.

510(K) SUMMARY FOR MFS - MEDICAL FLOW SYSTEMS' MULTIBOLUS IITM

DATE PREPARED: MARCH 31, 2013

1. 510(K) OWNER NAME
  AUG 1 4 2013

MFS - Medical Flow Systems Ltd. ELT Building, Dora Industrial Zone, Shlomi 22832, Israel Tel: +972 4 9808280, Fax: +972-4-9875565, E mail: info@mfs-medical.com.

Contact person name: Mr. Ofer Shay, Managing Director. Telephone: +972-4-9114876, Fax: +972-4-9875565, E mail: offers@mfs-medical.com.

DEVICE NAME 2.
Common/Usual Name: Disposable Pain Management System Proprietary/Trade name: MultiBolus II™ ('Parallel' and 'In-line' modules) Classification: MFS's MultiBolus IITM device has been classified as Class II device under the following classification names:

Classification Name	Product Code	21 CFR Ref.	Panel
Pump, Infusion, Elastomeric	80-MEB	880.5725	General Hospital
Pump, Infusion, Pca	80-MEA

PREDICATE DEVICES 3.

MFS's MultiBolus II™ device is substantially equivalent to the following Predicate Devices:

3.1 Baxter Healthcare Corporation Multirate Infusor (LV and SV) with PCM, cleared under 510(k) number K051253 and;
3.2 I-Flow Corporation ON-Q Pump, cleared under 510(k) number K063530.

1

Image /page/1/Picture/0 description: The image shows a logo for Medical Flow Systems Ltd. The logo consists of the letters "mfs" in a stylized font, with a teardrop shape replacing the vertical line of the "f". The text "Medical Flow Systems Ltd." is written below the letters in a smaller font.

Image /page/1/Picture/2 description: The image is a circular seal with the words "Quality Systems Certified" around the outer edge. Inside the circle are the text "ISO 9001:2008" and "ISO 13485:2003" stacked on top of each other. The seal appears to be a certification mark related to quality management systems.

DEVICE DESCRIPTION র্বা