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 <161> 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

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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.

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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

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.

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.

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Image /page/2/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 water droplet incorporated into the 'f'. The words 'Medical Flow Systems Ltd.' are written below the letters in a smaller font. The logo is black and white.

Image /page/2/Picture/2 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 is black and white, and the text is in a simple sans-serif font.

ડ. INTENDED USE

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The MultiBolus II™ is a semi-automatic 100% mechanical device to be activated by the patient after integrating with one of MFS's cleared elastomeric pumps (SmartBlock™ or SmartInfuser™).

MultiBolus II™ controls the medication flow through the system utilizing a built-in hydraulic mechanism that responds to the pressure differential between the pressure at the bolus device internal reservoir and the pressure at the pumps' reservoir. This mechanism enables an automatic medication filling into the bolus' reservoir when becomes empty, and to eliminate any flow out of the bolus device when not being activated and/or once the bolus' reservoir is empty ("stand-by" position).

The comparison table with the predicate devices is following presented:

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Image /page/3/Picture/0 description: The image shows a logo for Medical Flow Systems Ltd. The logo features the letters "mfs" in a stylized font, with a water droplet replacing the dot on the "i". The text "Medical Flow Systems Ltd." is written in a smaller font below the letters.

Image /page/3/Picture/2 description: The image is a circular seal with the words "Quality Systems Certified" around the outer edge. In the center of the seal are the text "ISO 9001:2008" and "ISO 13485:2003", stacked on top of each other. The text is in a simple, sans-serif font and is surrounded by a thick black border.

Feature	MFS'sMultiBolus IITM	Baxter HelthcareMultirate Infusor	I-Flow CorporationON-Q Pump
	-New Device -	510(k) no. K051253	510(k) no. K063530
Intend of use	The MultiBolus IITM isintended to provideintermittent delivery ofmedication (such as localanesthetic and/or narcotics) onpatient demand at relativelyrapid velocity, parallel to acontinuous basal flow or withno continuous basal flow, to/oraround surgical wound siteand/or close proximity tonerves for preoperative,periopertative andpostoperative regionalanesthesia and painmanagement.	The intended use of theMultirate Infusor withPatient Control Moduleincludes slow, continuous,subcutaneous or epiduraladministration of painmedications. It may alsoinclude the slow,continuous infusion ofpain medications directlyinto an intra-operativesite, subcutaneously forpostoperative painmanagement or thecontinuous infusion of alocal anesthetic near anerve for regionalanesthesia. The PatientControl Module allowsfor intermittent bolusdoses of pain medicationon patient demand.Prescription	1. The ON-Q Pump isintended for continuousand/or intermittentdelivery of medication(such as localanesthetics or narcotics)to or around surgicalwound sites and/or closeproximity to nerves forpreoperative,perioperative andpostoperative regionalanesthesia and painmanagement. Routes ofadministration may beintraoperative,perineural, percutaneousand epidural.[2. The ON-Q Pumpis...] - Note: Section 2 isirrelevant to MultiBolusIITM since it does notcontain pump.
OperationPrinciple	Mechanical, semi-automatic	Mechanical	Mechanical, semi-automatic
Safety	• No alarm• Secure/lock of selectedvolume• Sealing by Hydraulicindependent valve to avoidcontinuous flow when notactivated.	• No alarm• Per-define volume• Mechanical• Mechanical closure(not necessarilysealed) thuscontinuous flow whennot activated may bepossible.	• No alarm• Per-define volume• Sealing bymechanical valve(
Feature	MFS'sMultiBolus IITM	Baxter HelthcareMultirate Infusor	I-Flow CorporationON-Q Pump
	-New Device -0ml, 3ml, 4ml, 5ml & 6ml.• Lock Out flow rate:6 ml/hr• Velocity (through 21GCatheter): 6ml/minute.• Accuracy -Volume (manual): +5%/-10%;Lock-Out: ±20%	510(k) no. K051253device: 0.5ml or 2.0 ml.• Lock-out flow rate0.5ml/hr, 2ml/hr• Velocity (through 21GCatheter): no dataavailable (estimation:1 ml/minute).• Accuracy -No data	510(k) no. K0635305.0ml• Lock-out flow rateper device:5ml/hr or 10ml/hr• Velocity (through21G Catheter):1.5 ml/minute (testedby us).• Accuracy -Volume:+10% / -20%Lock-Out: ±20%
Bolus Injectionon patientdemand	Yes. User needs to press once.	Yes. User needs to holduntil bolus is completed.	Yes. User needs to pressonce.
ParallelContinuous flowand 'on-demand'bolus	Yes (the 'Parallel' model only)	Yes	Yes
Materials	Biocompatible Polymers,Elastomers per: ISO 10993parts 1, 4, 5, 6, 10 & 11.	Similar	Similar
PCM - PatientControl Module	Yes	Yes	Yes
UseEnvironment	Hospital, clinic, home use	Same	same
Sterility	Sterile. EtO	Sterile, EtO	Sterile, EtO

Table 1: Comparison table with Predicate Devices

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Image /page/4/Picture/0 description: The image shows a logo for Medical Flow Systems Ltd. The logo features the letters 'mfs' in a stylized font, with the 'f' being larger and having a teardrop shape incorporated into it. Below the letters, the full name 'Medical Flow Systems Ltd.' is written in a smaller, simpler font.

Image /page/4/Picture/2 description: The image is a black and white circular seal. The seal has the words "Quality Systems Certified" around the edge of the circle. In the center of the seal are the words "ISO 9001:2008" and "ISO 13485:2003".

Based on the above comparison, it can be shown that in all major features MFS's MultiBolus III" is substantial equivalent to both legally marketed devices selected as predicate devices while our device infuse the medication at a relative higher velocity and also provides a complete sealing preventing any unintentional drug delivery through the bolus device when not activated or when being empty.

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Image /page/5/Picture/0 description: The image shows a logo for Medical Flow Systems Ltd. The logo consists of the letters 'mfs' stacked on top of each other, with the 'f' being the largest and having a teardrop shape in the middle. Below the letters is the text 'Medical Flow Systems Ltd.' in a smaller font. The logo is black and white.

Image /page/5/Picture/2 description: The image shows a circular stamp with the words "Quality Systems Certified" around the edge. In the center of the stamp are the text "ISO 9001:2008" and "ISO 13485:2003". The stamp is black and white and appears to be a certification mark.

7. PERFORMANCE DATA

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.	Test Name	Purpose	Method	Acceptance Criteria	Results	Conclusion
	Functional Tests
1	OperatingCycles	Assuring thedevicecapability tofunction inmulti iteration(repeatedly)	30 activation iteration ofeach device.	Activate semi-automaticallyaccording to spec interms of functionalityand in all volumes 3,4, 5, & 6ml):• Lockout timeaccording to spec(not completelyfilled after thespecified time).• No parallel flow isallowed when notactivated (scalemonitor should show:0.0).	• Deviceperformed asintended.• Under thetest conditionsthe maximumvolumetolerance was:-0.75ml.No resultexceeding+0.0ml wasdetected.• Whennominal set to6ml. nocompletefilling afterthe specifiedtime occurred.• Beforeactivation scalemonitorshowed: 0.0.	Under theTest'sconditions allacceptancecriteria weremet.
2	Priming	Verifyingprimingefficiency and0.2µ filtereffectivenessin trapping airbubbles inorder to makepriming forthe parallel set	Conducting primingaccording to IFU in thebasal path flow only(parallel set model)	• No air bubbles afterthe 0.2µ filter areallowed.	• No airbubbles afterthe 0.2µ filterwere detected.	Under the testcondition, allresults metacceptancecriteria. All airbubbles weretrapped by the0.2µ filter inpriming for the

MFS 510(k) MultiBolus IITM – Revised Summary

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Image /page/6/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 dot on the 'i'. The text 'Medical Flow Systems Ltd.' is written below the letters in a smaller font.

Image /page/6/Picture/2 description: The image is a circular seal with the words "Quality Systems Certified" around the edge. In the center of the seal, it says "ISO 9001:2008" and "ISO 13485:2003". The text is in black and the background is white. The seal is used to indicate that a company's quality management system has been certified to meet the requirements of the ISO 9001 and ISO 13485 standards.

No.	Test Name	Purpose	Method	Acceptance Criteria	Results	Conclusion
Functional Tests
		model (option to exclude priming of the MultiBolus IITM device).				parallel set model.
	Verifying priming efficiency		Conducting priming according to IFU (in-line set model with the MultiBolus IITM)	• 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:	Measuring the actual infused bolus volumes with and without catheter after semi-automatic, manual activation (from set volumes of 3, 4, 5, 6 ml.	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	Measuring the actual velocity at 6ml volume with 21G catheter	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.	Verifying the actual filling time of 6 ml volume is between 48-72minutes (state chosen as worst case representing all volumes)	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	Under the test condition, all results met acceptance criteria.

MFS 510(k) MultiBolus II™ – Revised Summary

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Image /page/7/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 water droplet shape incorporated into the 'f'. The text 'Medical Flow Systems Ltd.' is written below the letters. The logo is black and white.

Image /page/7/Picture/2 description: The image is a circular seal with the words "Quality Systems Certified" around the perimeter. In the center of the seal are the certifications "ISO 9001:2008" and "ISO 13485:2003". The text is in a bold, sans-serif font and is arranged to fit within the circular shape of the seal. The seal appears to be used to indicate that a product or organization has met certain quality standards.

No.	Test Name	Purpose	Method	Acceptance Criteria	Results	Conclusion
	Functional Tests
6	Leaks	Verify thedevice designwithstandoperationpressure	Reservoir and tubingconnection withstand airpressure of 3 bar at 10seconds	No leaks are allowedwithin at-least 10seconds under 3 bar.	filled.Volumes insemi-automaticmode were asspecified.No leaks(stablepressure level)occurredduring test'sprocedure.	Under the testcondition,acceptancecriteria wasmet.
7	Tubebonding	Verify thedevice'stubingconnectionwithstand theforces duringuse.	Apply puling force of1.5Kg on each tube for at-least 10 seconds.	· Tube remainsconnected to thedevice.· No leaks afterapplying 1.5Kg.	During test, notubingdisconnectionswere detectedand no leaksafterwards(according tosame methodas in test #6).	Under the testconditions,acceptancecriteria wasmet.
8	Hydrauliccheck valve	Verify noflow throughthe devicewhen notactivated	Connect the device tofilled-out reservoir for 14days in a static positionand evaluate againstacceptance criteria.	During test period, thefollowing are notallowed:· Observed leaks;· Gross weight of thedevice after 14 days isequal or up to 10 gramless than day 0(baseline).	During thetest's period,no leaksoccurred.Maximumgross weightreduction waswithin definedacceptancecriteria.	Under the testconditions, alltested samplesmet theacceptancecriteria.
9	Externalforceduring use	Verify thedevicewithstandreasonableexternalforces may beapplied duringuse	Tested samples wentthrough two free falls fromone meter height. Then,they were filled withsaline, activated accordingto IFU and observedagainst acceptance criteria.	During test, thefollowing are notallowed:· Cracks in the devicecover (shells), or otherplastic parts,· Leaks,· Device shall beproperly activated andfunction.	Following thetest conditions,no cracks, leaksormalfunctioningwere detected.	Under the testconditions, allacceptancecriteria weremet.

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Image /page/8/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 dot on the 'i'. The text 'Medical Flow Systems Ltd.' is written in a smaller font below the letters.

Image /page/8/Picture/2 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's quality management system has been certified to meet the requirements of the ISO 9001:2008 and ISO 13485:2003 standards.

No.	Test Name	Purpose	Method	Acceptance Criteria	Results	Conclusion
Functional Tests
10	Shelf lifeequal to 1year real-time (postacceleratedaging)	Verify that thedevice willfunction wellthroughout itsshelf life.	After accelerate aging for45 days under 52°C tosimulate 1 year shelf life,products were tested using19-21G catheters by filling6ml, priming, deliveredvolume weight, testingvolume post45&72minutes andactivate bolus delivery(simulating the real use 5times).	Under the test methodthe product should beoperated andfunctioned accordingto its spec.• Volume filled (pertest 3),• Lockout time (pertest 5),• No parallel flow,when not activated(per test 8),• No visible cracks(per test 9),• No visual leaks (pertest 9).	Under the testmethod allfilled volumes;lockout times;sealing state(no-parallelflow); no-cracks andleaks testspassedsuccessfully.	All testedsamples metthe acceptancecriteria and theproduct wasqualified for 1year shelf life.

No.	Test Name	Purpose	Method	Acceptance Criteria	Results	Conclusion
Sterilization
11	EtOSterilizationvalidation	Validate thatthe device maybe sterilizedfor SAL 10-6through EtOestablishedcycle usingoverkillapproach (alsocalled: HalfCycle Method).	Per written protocol withaccordance to ISO 11135-1:2007, Annex B.	With accordance to thefollowing standards:Bio Burden:ISO 11737-1:2006ISO 11135-1:2007ETO/ECH Residues:ISO 10993-7:2008LAL Endotoxin:USP 32:2009 <161>Transfusion andInfusion Assembliesand Similar MedicalDevices and;FDA's Guidance forPyrojen & Endotoxinstesting (Q&A),June 2012Sterility:ISO 11135-1:2007ISO 11737-2:2010	All tests' resultsweredetermined tobe within thestandards'acceptancecriteria.More details areavailable insection 14 ofthis submission.	Following thesterilizationvalidation, SAL10-6 wasestablished forMFS'sMultiBolus II TMdevice.

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Image /page/9/Picture/0 description: The image shows a logo for Medical Flow Systems Ltd. The logo consists of the letters 'mfs' stacked on top of each other, with the 'f' being larger than the other letters. A water droplet is placed in the middle of the 'f'. The text 'Medical Flow Systems Ltd.' is written in a smaller font below the letters.

Image /page/9/Picture/2 description: The image is a circular seal with the words "Quality Systems Certified" around the perimeter. In the center of the seal, the text "ISO 9001:2008" and "ISO 13485:2003" are stacked on top of each other. The text is in bold and black, and the seal is also black and white.

No.	Test Name	Purpose	Method	Acceptance Criteria	Results	Conclusion
Packaging Integrity
12	PackagingIntegrity	• Verify thatthe shippingpackaging thedeviceprovidessufficientprotection tothe deviceduringshipping	Based on ASTM D5276-98 (drop) & ISO 2248(vertical impact bydropping)	• All packages shallremain whole,unopened andcomplete.• No physicaldamages to the sealedsterile unit areallowed.	None of thebelow defectshave beenoccurred:• Nosignificantdamage toshipping casesand internalboxes.• Nosignificant(tears, open)damage tosterilepouches.• Nofunctionaldamage to thedevice.	Followingsterile unit'spackageintegrity tests,all acceptancecriteria weremet and it wasconcluded thatsterility will bemaintainedalong theproduct's shelflife.
No.	Test Name	Purpose	Method	Acceptance Criteria	Results	Conclusion
Packaging Integrity
12.1	PackagingIntegrity	• Verifysterile singleunit packageintegrity inorder tomaintainproduct'ssterility along3 years shelflife.	Exposing the packagingunit (single and shippingbox) to all treatmentsundergo or might undergoin real-life (sterilizationand drop). Productsundergo real-time agingfor 3 years under roomtemp: 22 $\pm$ 1°C for threeyears and then tested for:visual defects, sterility,peel, dye and burst tests.	• Sterile packageintegrity tests per eachtest acceptance criteria(as further detailed insection 18 andappendix C of thissubmission.	All testeditems metacceptancecriteria forvisual test,sterility test,and packageintegrity tests(peel, dye,burst) asfurtherdetailed insection 18 andappendix C ofthissubmission.	Shelf life of 3years real-timewasestablished forthe sterile unitpackage.

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Image /page/10/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 dot on the 'i'. The text 'Medical Flow Systems Ltd.' is written in a smaller font below the letters.

Image /page/10/Picture/2 description: The image shows a circular seal with the words "Quality Systems Certified" around the edge. Inside the circle, there are two lines of text: "ISO 9001:2008" and "ISO 13485:2003". The seal indicates that the organization has been certified to meet the requirements of these two ISO standards, which relate to quality management systems.

No.	Test Name	Purpose	Method	AcceptanceCriteria	Results	Conclusion
13	Usability(Physicians)	Validate thatusers of eachgroup(physiciansand homeusers) arecapable toproperly,safely andeffectivelyset andoperate thedevice andthat thedevice isintuitive foractivating.	Provide dummy regulating set withthe device and filled reservoir(saline) to a person who "simulatesa physician" (educated participant)accompany by physician IFU.Train this person on the device andthen ask him to perform thefollowing activating missions perIFU:1. Assemble the regulating set tothe reservoir (already filled withsaline).2. Prime the system.3. Set and secure of the activevolume.4. Activate the device.5. Re-set the device volume.6. Permanently lock the activevolume.	All'physicians'participatesshall operatethe devicethrough the"activationmissions"successfullywith accordingto the IFU.	• Allparticipantshave fulfilledsuccessfullyall "activationmissions"according tothe relevantaccompaniedIFU.	It wasconcludedfrom theusabilityresults that thedevice is"usable" by itsintended users(bothphysicians andpatients) withaccordance toIFU. Thedevice met alltest'sacceptancecriteria.
	Usability(Patients)		Provide dummy devices connectedto an elastomeric pump and filledwith Saline.Provide general information on thedevice and review the IFU forpatients. Then, ask the patient toactivate the device.	All 'patients'participantsshallappropriatelyactivate thedevice, i.e.,squeeze theactivatinglever all theway until it'clicks'

Tests results are supporting all labeling claims in order to establish substantial equivalency.

8. CONCLUSIONS

The evaluation of our device performances demonstrates that it is as safe and as effective as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a caduceus, with three curved lines that could be interpreted as arms or wings.

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-God Silver Spring, MD 20993-0002

August 14, 2013

MFS-Medical Flow Systems Limited Mr. Ofer Shay Managing Director ELT Building, Dora Industrial Zone, Shlomi Shlomi Israei 22832

Re: K131247

Trade/Device Name: MultiBolus IITM Disposable Pain Management System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB, MEA Dated: July 9, 2013 Received: July 12, 2013

Dear Mr. Shay:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the cnclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the cnactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Shay

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note

the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/13/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 water droplet replacing the dot on the 'i'. The text 'Medical Flow Systems Ltd.' is written below the letters in a smaller font.

Image /page/13/Picture/2 description: The image is a circular seal with the words "Quality Systems Certified" around the perimeter. 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, specifically referencing the ISO 9001 and ISO 13485 standards.

Indications for Use

510(k) Number (if known): K131247

Device Name: _MultiBolus IITM

[Parallel MultiBolus II'm and; In-Line MultiBolus II' M models]

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.

V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)	Richard C. Chapman2013.08.12 15:13:46-04'00'	Page 1 of 1
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Respiratory, Infection Control and
Dental Devices
510(k) Number: K131247

MFS 510(k) MultiBolus IITM - Revised Indication for Use Statement CONFIDENTIAL

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).