InfuLife

K240624 · First Medical Source, LLC · MEB · Nov 5, 2024 · General Hospital

Device Facts

• Record ID: K240624
• Device Name: InfuLife
• Applicant: First Medical Source, LLC
• Product Code: MEB · General Hospital
• Decision Date: Nov 5, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

InfuLife is a single-use, sterile, disposable elastomeric infusion pump intended for continuous and/or intermittent infusion of medications for general infusion at home, in a hospital, or in alternate sites. InfuLife is indicated for delivery of antibiotics, chemotherapy, and pain management, as directed by a physician or licensed healthcare professional. Routes of administration include intravenous, intra-arterial, subcutaneous, intramuscular, and epidural. Additionally, InfuLife is indicated for continuous and/or intermittent delivery of medication, such as local anesthetics or narcotics, to surgical wound sites and/or proximity to nerves for preoperative, perioperative, and postoperative regional anesthesia and pain management. InfuLife is intended for use by physicians, clinicians, pharmacists, and other licensed healthcare professionals.

Device Story

InfuLife is a non-electrically driven, portable, fixed-flow elastomeric infusion pump. It utilizes a silicon reservoir that exerts pressure on fluid, forcing it through a calibrated flow restrictor in the tubing. Flow rate is determined by Hagen-Poiseuille theory based on fluid viscosity, pipe diameter, pressure, and temperature. The device is used by physicians, clinicians, and pharmacists in hospitals, homes, or alternate sites to deliver medications (antibiotics, chemotherapy, pain management) via various routes (IV, intra-arterial, subcutaneous, intramuscular, epidural, or surgical wound sites). It provides a passive, continuous, or intermittent infusion mechanism. The device benefits patients by enabling controlled medication delivery without external power sources. It is a single-use, sterile, disposable device.

Clinical Evidence

No clinical or animal study data provided. Substantial equivalence is supported by bench testing, including fluid delivery performance (AAMI TIR101), biocompatibility (ISO 10993 series), sterilization validation (ISO 11135), and packaging integrity (ASTM standards).

Technological Characteristics

Non-electrically driven elastomeric pump. Materials: Silicon reservoir. Flow control: Calibrated restrictor based on Hagen-Poiseuille theory. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Shelf-life: 3 years. Dimensions: Various sizes (3.0-7.48 inches). Connectivity: None (standalone).

Indications for Use

Indicated for continuous/intermittent infusion of antibiotics, chemotherapy, and pain management medications in adults and children >20 kg. Routes: IV, intra-arterial, subcutaneous, intramuscular, epidural, and surgical wound/perineural sites. Contraindicated for intra-articular infusion, blood/blood products, insulin, critical/life-supporting medications, incompatible solutions, and patients unable to self-administer or lacking a caregiver. Contraindicated for neonates/infants/children <20 kg.

Regulatory Classification

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.

Predicate Devices

• SMARTez elastomeric infusion pump (K151650)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 5, 2024

First Medical Source, LLC Mark Shal CEO 28581 Springfield Drive Laguna Niguel, California 92677

Re: K240624

Trade/Device Name: InfuLife Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MEB Dated: October 3, 2024 Received: October 3, 2024

Dear Mark Shal:

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 enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Jake K. Lindstrom -S

Jake Lindstrom, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K246024

Device Name InfuLife

#### Indications for Use (Describe)

Inful.ife is a single-use, sterile, disposable elastomeric infusion pump intended for intermittent infusion of medications for general infusion at home, in a hospital, or in alternate sites. InfuLife is indicated for delivery of antibiotics, chemotherapy, and pain management, as directed by a physician or licensed healthcare professional. Routes of administration include intravenous, intra-arterial, subcutaneous, and epidural. Additionally, InfuLife is indicated for continuous and/or intermittent delivery of medication, such as local anesthetics or narcotics, to surgical wound sites and/or proximity to nerves for preoperative, and postoperative regional anesthesia and pain management. InfuLife is intended for use by physicians, clinicians, pharmacısts, and other licensed healthcare professionals.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# K240624 510(k) Summary

This 510(k) Summary of safety and effectiveness information is prepared in accordance with the requirements of CFR Part 807.92.

### Submitter Information

| 510(k) Sponsor | First Medical Source, LLC<br>28581 Springfield Drive Laguna Niguel CA 92677 United States |
|-------------------|-------------------------------------------------------------------------------------------|
| Contact Person(s) | Dr. Mark Shal<br>CEO<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | October 3, 2024 |

## Proposed Device: K240624

| Common/Usual Name: | Elastomeric Infusion pump |
|-------------------------|-----------------------------|
| Trade/Proprietary Name: | InfuLife |
| Classification Name: | Pump, Infusion, Elastomeric |
| Device Classification: | 880.5725 |
| Product Code: | MEB, FRN |
| Class: | II |
| Device Panel: | General Hospital |

# Predicate Device: K151650

| Common/Usual Name: | Elastomeric Infusion pump |
|-------------------------|-----------------------------------|
| Trade/Proprietary Name: | SMARTEz elastomeric infusion pump |
| Classification Name: | Pump, Infusion, Elastomeric |
| Device Classification: | 880.5725 |
| Product Code: | MEB |
| Class: | II |
| Device Panel: | General Hospital |

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## Device Description

InfuLife is a non-electrically driven, portable fixed flow rate infusion pump. The fluid is pushed forward by the pressure of the elastomeric bladder. The flow rate of the device is predetermined by the manufacturer using Hagen-Poiseuille theory, which calculates the volumetric flow rate of a fluid with certain viscosity passing through a cylindrical pipe with a known diameter, at a given pressure and temperature.

### Indications for Use

InfuLife is a single-use. sterile, disposable elastomeric infusion pump intended for continuous and/or intermittent infusion of medications for general infusion at home, in a hospital, or in alternate sites.

InfuLife is indicated for delivery of antibiotics, chemotherapy, and pain management, as directed by a physician or licensed healthcare professional. Routes of administration include intravenous, intraarterial, subcutaneous, intramuscular, and epidural. Additionally, InfuLife is indicated for continuous and/or intermittent delivery of medication, such as local anesthetics or narcotics, to surgical wound sites and/or proximity to nerves for preoperative, perioperative, and postoperative regional anesthesia and pain management.

InfuLife is intended for use by physicians, clinicians, pharmacists, and other licensed healthcare professionals.

InfuLife is intended for use by adult patients, and children weighing more than 20 Kg.

#### Contraindications

InfuLife is contraindicated for intra-articular infusion of anesthetics and for infusion of blood and blood products, infusion of insulin, infusion of critical or life-supporting medications, infusion of any solution that is not compatible with the fluid path materials; and use in ambulatory regimens by patients not capable of self-administering their therapy or not under the care of a responsible individual.

#### Residual Risks

InfuLife is contraindicated for use on neonates, infants, and children weighing less than 20 Kg due to potential exposure to EO residuals.

### Substantial Equivalence Discussion

The table below compares the characteristics of the subject device to the predicate device.

| Device & Predicate<br>Device(s): | K240624 | K151650 | Comments |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| General Device | | | |
| Characteristics | | | |
| Classification<br>Regulation | 880.5725 | Same | |
| Product Code | MEB | Same | |
| Intended Use | General non-life sustaining<br>infusion | Same | |
| Indications for Use | InfuLife is a single-use, sterile,<br>disposable elastomeric infusion<br>pump intended for continuous<br>and/or intermittent infusion of<br>medications for general infusion<br>at home, in a hospital, or in<br>alternate sites. InfuLife is<br>indicated for delivery of<br>antibiotics, chemotherapy, and<br>pain management, as directed by<br>a physician or licensed healthcare<br>professional. Routes of<br>administration include<br>intravenous, intra-arterial,<br>subcutaneous, intramuscular, and<br>epidural. Additionally, InfuLife is<br>indicated for continuous and/or<br>intermittent delivery of<br>medication, such as local<br>anesthetics or narcotics, to<br>surgical wound sites and/or<br>proximity to nerves for<br>preoperative, perioperative, and<br>postoperative regional anesthesia<br>and pain management. InfuLife is<br>intended for use by physicians,<br>clinicians, pharmacists, and other<br>licensed healthcare professionals. | The SMARTez Elastomeric<br>Infusion Pump is intended for<br>continuous and/or intermittent<br>infusion of medications for general<br>infusion use, including antibiotic<br>delivery, chemotherapy and pain<br>management. Routes of<br>administration include the<br>following: intravenous, intra-<br>arterial, subcutaneous,<br>intramuscular and epidural. The<br>device is also intended for<br>continuous and/or intermittent<br>delivery of medication (such as<br>local anesthetics or narcotics) to<br>surgical wound sites and/or close<br>proximity to nerves for<br>preoperative, perioperative and<br>postoperative regional anesthesia<br>and pain management. Routes of<br>administration may be intra-<br>operative, perineural or<br>percutaneous. | The indications for use,<br>routes of<br>administration, and<br>user base is the same. |
| Operating Principle | Pressure created by a silicon<br>reservoir pushes a fluid through a<br>tubing which integrates a<br>calibrated flow restrictor. | Same | |
| Bolus | N/A | Same | The sponsor notes that<br>a dedicated bolus cord<br>will be provided in a<br>later submission<br>update. |

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| Weight and<br>Dimensions | Pump size<br>(inch) | Length<br>pump<br>(inch) | Length<br>administration<br>tube (inch) | Length<br>flow<br>control<br>tube (inch) | Weight<br>(g) | 1.Similar. Any size and<br>weight differences<br>between the subject<br>and predicate device<br>are negligible. |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------------------|------------------------------------------|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Small | 3.94 | 35.43 | 5.90-15.75 | 53 | |
| | Medium | 5.12 | 35.43 | 5.90-15.75 | 61 | |
| | Large | 6.30 | 35.43 | 5.90-15.75 | 73 | |
| | XLarge | 7.48 | 35.43 | 5.90-15.75 | 87 | |
| | Small | 3.54 | 42.68 | 2.16-15.12 | 33 | |
| | Medium | 4.72 | 42.68 | 2.16-15.12 | 41 | |
| | Large | 5.90 | 42.68 | 2.16-15.12 | 53 | |
| | XLarge | 5.90 | 42.68 | 2.16-15.12 | 67 | |
| | Small | 3.0 | 35.0 | 5.12-17.72 | 44 | |
| | Medium | 3.0 | 35.0 | 5.12-17.72 | 46 | |
| | Large | 3.0 | 35.0 | 5.12-17.72 | 47 | |
| InfuLife weight and dimensions<br>are highlighted in yellow | | | | | | |
| Flow Accuracy and<br>Rate | | | | | | 2.The flow rates and<br>flow accuracies of the<br>subject device is<br>encompassed within<br>the predicate device. |
| | Low Flow pump<br>Rates <0.5 to 10 mL/hr<br>High Flow Pumps<br>Rates 50 to 250 mL/hr<br>Accuracy: Flow within ± 12%<br>nominal fill volume | | | | | |
| Material | | | | | | 3.The material<br>composition of the<br>predicate device is not<br>provided, however, it is<br>not needed as the<br>appropriate<br>biocompatibility<br>endpoint testing will be<br>reviewed for subject<br>device material-tissue/<br>skin compatibility. |
| | Accuracy: Flow within ± 15% of<br>the labelled flow rate. | | | | | |

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| Biocompatibility | Cytotoxicity<br>Acute Systemic Toxicity<br>Intracutaneous Reactivity<br>Hemocompatibility<br>Bacterial Endotoxin<br>Justification -<br>Subacute/Subchronic Toxicity<br>Sensitization | Cytotoxicity<br>Sensitization<br>Irritation or Intracutaneous<br>Reactivity<br>Systemic Toxicity (Acute)<br>Hemocompatibility | The subject device<br>biocompatibility testing<br>encompasses predicate<br>device endpoint testing. |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization | EO<br>Sterility Assurance Level (SAL)<br>of 10-6 | Same | |
| Shelf-Life | 3 years | Same | |
| Environment of Use | Professional Healthcare Facility<br>Home Environment<br>Magnetic Resonance (MR)<br>Environment<br>Transport (Ambulatory)<br>Environment | Different | 4.The subject device is<br>not intended for<br>ambulatory use, while<br>the predicate is. This<br>deviation does not<br>affect the intended use<br>of the subject device,<br>as performance testing<br>of the subject device<br>will reflect operatory<br>conditions. |
| Clinical Studies | Not Required | Same | |

1. Weight and Dimensions: Any size and weight differences between the subject and predicate device are negligible, and do not raise new or different questions of device safety and effectiveness.

2.Flow Accuracy and Rate: The subject device flow rates and flow accuracies of the subject device is encompassed within the predicate device. Flow rate and accuracy was confirmed with performance testing, and do not raise new or different questions of device safety and effectiveness.

3.Material: The material composition of the predicate device is not provided, however, it is not needed as the appropriate biocompatibility endpoint testing was provided for subject device material-tissue/ skin compatibility. There are no new or different questions of device safety and effectiveness.

4.Environment of Use: The subject device is not intended for ambulatory use, while the predicate is. This deviation does not affect the intended use of the subject device, as performance testing of the subject device reflects operatory conditions. There are no new or different questions of device safety and effectiveness.

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#### Performance Data

InfuLife was tested to the following standards:

- AAMI TIR101:2021 Fluid Delivery Performance Testing for Infusion Pumps -
- ISO 28620:2020 Medical Devices Non-Electrically Driven Portable Infusion Devices -
- AAMI TIR38:2019 Medical Device Safety and Assurance Guidance -
- ANSI AAMI ISO 14971:2019 Medical Devices Application of Risk Management to -Medical Devices
- ANSI AAMI ISO 10993-1:2018 Biological Evaluation of Medical Devices Part 1: -Evaluation and Testing Within a Risk Management Process
- ANSI AAMI ISO 10993-10:2019/R2014 Biological Evaluation of Medica Devices Part -10: Tests for Irritation and Skin Sensitization
- ANSI AAMI ISO 10993-11:2017 Biological Evaluation of Medical Devices Part 11: -Tests for Systemic Toxicity
- ANSI AAMI ISO 10993-4:2017 Biological Evaluation of Medical Devices Part 4: -Selection of Tests for Interactions with Blood
- ANSI AAMI ISO 10993-5:2009/R2014 Biological Evaluation of Medical Devices Part -5: Tests for in vitro Cytotoxicity
- ANSI AAMI ISO 1135:2014A1:2018 Sterilization of Health-Care Products Ethylene -Oxide - Requirements for the Development Validation and Routine Control of a Sterilization Process for Medical Devices
- ISO 10993-7 Second Editions 2008 Biological Evaluation of Medical Devices Part 7: -Ethylene Oxide Sterilization Residuals
- ANSI AAMI ISO 11607-1:2019 Packaging for Terminally Sterilized Medical Devices --Part 1: Requirements for Materials Sterile Barrier Systems and Packaging Systems
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile barrier Systems for -Medical Devices
- ASTM F209611:2019 Standard Test Method for Detecting Gross Leaks in Packaging by -Internal Pressurization (Bubble Test)
- ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for flexible Packaging by Visual Inspection
- ANSI AAMI ISO 11607-2:2019 Packaging for Terminally Sterilized Medical Devices -part 2: Validation Requirements for Forming, Sealing, and Assembly process
- -USP-NF <85> - Bacterial Endotoxins Test

All tests met acceptance criteria.

#### Animal and Clinical Studies

No animal study or clinical trial data was obtained in support of this submission.

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### Conclusion

The data, test results, and analysis provide evidence that InfuLife is substantially equivalent to the predicate device, and that the device raises no new or different questions of safety and effectiveness.