(245 days)
InfuLife 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, pharmacists, and other licensed healthcare professionals.
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.
The provided text describes InfuLife, an elastomeric infusion pump, and its 510(k) submission for FDA clearance. The document focuses on demonstrating substantial equivalence to a predicate device and outlines performance testing against various standards. However, it does NOT contain the specific information requested regarding AI/algorithm performance studies, ground truth establishment, or multi-reader multi-case (MRMC) studies, as this device appears to be a hardware-based medical device (infusion pump) and not an AI/software-as-a-medical-device (SaMD).
Therefore, I cannot provide the requested information about acceptance criteria for an AI algorithm, its performance, or details of studies involving human readers and AI assistance, as these are not relevant to the InfuLife device described.
The document explicitly states:
- "No animal study or clinical trial data was obtained in support of this submission." (Page 10)
- The performance data refers to testing against engineering and biological safety standards (e.g., flow rate accuracy, biocompatibility, sterilization, shelf-life, packaging integrity) for a physical medical device. (Page 9)
If you have a document describing an AI/SaMD, please provide that.
{0}------------------------------------------------
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"
{1}------------------------------------------------
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
{2}------------------------------------------------
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
{3}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
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, LLC28581 Springfield Drive Laguna Niguel CA 92677 United States |
|---|---|
| Contact Person(s) | Dr. Mark ShalCEOPhone: (949) 637-5222Email: mshal@firstmedicalsource.com |
| 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 |
{5}------------------------------------------------
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 & PredicateDevice(s): | K240624 | K151650 | Comments |
|---|---|---|---|
| General Device | |||
| Characteristics | |||
| ClassificationRegulation | 880.5725 | Same | |
| Product Code | MEB | Same | |
| Intended Use | General non-life sustaininginfusion | Same | |
| Indications for Use | InfuLife is a single-use, sterile,disposable elastomeric infusionpump intended for continuousand/or intermittent infusion ofmedications for general infusionat home, in a hospital, or inalternate sites. InfuLife isindicated for delivery ofantibiotics, chemotherapy, andpain management, as directed bya physician or licensed healthcareprofessional. Routes ofadministration includeintravenous, intra-arterial,subcutaneous, intramuscular, andepidural. Additionally, InfuLife isindicated for continuous and/orintermittent delivery ofmedication, such as localanesthetics or narcotics, tosurgical wound sites and/orproximity to nerves forpreoperative, perioperative, andpostoperative regional anesthesiaand pain management. InfuLife isintended for use by physicians,clinicians, pharmacists, and otherlicensed healthcare professionals. | The SMARTez ElastomericInfusion Pump is intended forcontinuous and/or intermittentinfusion of medications for generalinfusion use, including antibioticdelivery, chemotherapy and painmanagement. Routes ofadministration include thefollowing: intravenous, intra-arterial, subcutaneous,intramuscular and epidural. Thedevice is also intended forcontinuous and/or intermittentdelivery of medication (such aslocal anesthetics or narcotics) tosurgical wound sites and/or closeproximity to nerves forpreoperative, perioperative andpostoperative regional anesthesiaand pain management. Routes ofadministration may be intra-operative, perineural orpercutaneous. | The indications for use,routes ofadministration, anduser base is the same. |
| Operating Principle | Pressure created by a siliconreservoir pushes a fluid through atubing which integrates acalibrated flow restrictor. | Same | |
| Bolus | N/A | Same | The sponsor notes thata dedicated bolus cordwill be provided in alater submissionupdate. |
{6}------------------------------------------------
{7}------------------------------------------------
| Weight andDimensions | Pump size(inch) | Lengthpump(inch) | Lengthadministrationtube (inch) | Lengthflowcontroltube (inch) | Weight(g) | 1.Similar. Any size andweight differencesbetween the subjectand predicate deviceare 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 dimensionsare highlighted in yellow | ||||||
| Flow Accuracy andRate | 2.The flow rates andflow accuracies of thesubject device isencompassed withinthe predicate device. | |||||
| Low Flow pumpRates <0.5 to 10 mL/hrHigh Flow PumpsRates 50 to 250 mL/hrAccuracy: Flow within ± 12%nominal fill volume | ||||||
| Material | 3.The materialcomposition of thepredicate device is notprovided, however, it isnot needed as theappropriatebiocompatibilityendpoint testing will bereviewed for subjectdevice material-tissue/skin compatibility. | |||||
| Accuracy: Flow within ± 15% ofthe labelled flow rate. |
{8}------------------------------------------------
| Biocompatibility | CytotoxicityAcute Systemic ToxicityIntracutaneous ReactivityHemocompatibilityBacterial EndotoxinJustification -Subacute/Subchronic ToxicitySensitization | CytotoxicitySensitizationIrritation or IntracutaneousReactivitySystemic Toxicity (Acute)Hemocompatibility | The subject devicebiocompatibility testingencompasses predicatedevice endpoint testing. |
|---|---|---|---|
| Sterilization | EOSterility Assurance Level (SAL)of 10-6 | Same | |
| Shelf-Life | 3 years | Same | |
| Environment of Use | Professional Healthcare FacilityHome EnvironmentMagnetic Resonance (MR)EnvironmentTransport (Ambulatory)Environment | Different | 4.The subject device isnot intended forambulatory use, whilethe predicate is. Thisdeviation does notaffect the intended useof the subject device,as performance testingof the subject devicewill reflect operatoryconditions. |
| Clinical Studies | Not Required | Same |
- 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.
{9}------------------------------------------------
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.
{10}------------------------------------------------
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.
§ 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).