Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states it is a "mechanical (non-electric, non-electronic) infusion pump" and there is no mention of AI or ML in the document.

Therapeutic

Yes
The device is used to infuse medications for various medical conditions, including pain management, antibiotic delivery, and chemotherapy, which are all forms of therapy.

Diagnostic

No

Explanation: The device is described as an infusion pump intended for continuous infusion of medications, not for diagnosis. Its purpose is to deliver substances to the body, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "mechanical (non-electric, non-electronic) infusion pump" and describes physical components like an elastomeric fluid reservoir and administration line.

IVD (In Vitro Diagnostic)

Based on the provided text, the SMARTeZ Pump is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states the device is for the "continuous infusion of medications" for various purposes (pain management, antibiotic delivery, chemotherapy). This involves administering substances into the patient's body.
Device Description: The description details a mechanical pump that delivers fluid into the patient. It explicitly states it's for "administer infusion therapies only."
Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The SMARTeZ Pump does not perform any such analysis of bodily specimens.

Therefore, the SMARTeZ Pump is a medical device used for drug delivery, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management.
• Routes of administration: intravenous and subcutaneous.
The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery.
• Route of administration: intravenous.
The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.
• Routes of administration: intravenous and intra-arterial.

Product codes

MEB

Device Description

The SMARTeZ™ Elastomeric Infusion Pump (SMARTeZ™ Pump) is a sterile, single-use, mechanical (non-electric, non-electronic) infusion pump that consists of an elastomeric fluid reservoir as an energy source and an administration line. The constriction of the elastomeric fluid reservoir drives the fluid through the administration tubing and eventually through a flow restrictor, into the patient connection.

The SMARTeZ™ Pump is intended to administer infusion therapies only, and not for fluid storage.

This Special 510(k) Submission is to inform FDA of the addition to the thirty-nine (39) existing SMARTeZ™ Pump offerings, four (4) new models of different nominal volumes, flow rates and time: 498111: 100 ml, 0.5 ml/h, 200 h; 498121: 100 ml, 1 ml/h, 100 h: 498131: 50 ml, 0.5 ml/h, 100 h: 498141: 50 ml. 1 ml/h, 50 h. with KVO (Keep Vein Open) infusion pump labeling.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Adequately trained health care professionals/clinical setting

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

Not Found

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

Not Found

Summary of Performance Studies

Functional Performance:
Bench performance verifications and validations were performed on the Subject device (pump and administration tubing connected) and referred-to existing devices (K151650) in conformance with ISO 28620:2020 and ISO 80369-7:2021.

Flow rate test: under nominal conditions, various ambient temperatures, various solution viscosity, after resistance to pressure, after resistance to traction, after refrigeration, under non-ambient pressure (simulating influences of routes of administration); to ISO 28620:2020, subclause 6.2 & 6.6.
Leak-proof test: under resistance to pressure, after drop test, after resistance to traction, after refrigeration; to ISO 28620:2020, subclause 6.3, 6.4, 6.5 & 6.6.
Retrograde flow of infusate test.
Luer lock connection tests (on the new Luer lock connectors): positive pressure fluid leakage test, sub-atmospheric pressure air leakage test, stress cracking test, resistance to separation from axial load test, resistance to separation from unscrewing test, resistance to overriding test, to ISO 80369-7:2021 performed on the Subject device.

Biocompatibility (Testing performed on referred-to cleared devices, and conducted on the Subject device according to ISO 10993-1:2018):

Cytotoxicity to ISO 10993-5 under K151650
Sensitization to ISO 10993-10 under K151650
Intracutaneous Reactivity to ISO 10993-10 under K151650
Acute Systemic Toxicity to ISO 10993-11 under K151650
In-vitro Hemolysis Assessment to ISO 10993-4 under K151650
Chemical Characterization and Toxicological Risk Assessment to ISO 10993-18 and ISO 10993-17, under K151650

Sterility, Shipping, and Shelf-Life (Testing/evaluations under K151650, complying with ISO 11135:2014):

Package Integrity Tests per ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009.
Pyrogen Tests per ANSI/AAMI ST72/2019, USP 40 , USP-NF , USP-NF .
Shelf-life of 3 years validated using ASTM 1980-21.

Key Results: Testing confirmed the device was safe and effective.

Key Metrics

Not Found

Predicate Device(s)

K151650

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.5725 Infusion pump.

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

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 7, 2024

Epic Medical Pte. Ltd. Freddie Lee CEO/MD 105 Cecil Street #20-04, The Octagon Singapore. SG 069534 Singapore

Re: K242152

Trade/Device Name: SMARTeZ™ Elastomeric Infusion Pump (498111, 498131, 498141) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MEB Dated: September 9, 2024 Received: September 9, 2024

Dear Freddie Lee:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Juliane C. Lessard -S

Juliane C. Lessard, Ph.D. 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242152

Device Name

SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)

Indications for Use (Describe)

The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management.

· Routes of administration: intravenous and subcutaneous.

The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery.

· Route of administration: intravenous.

The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.

· Routes of administration: intravenous and intra-arterial.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K242152 – 510(k) Summary

I. Submitter

Epic Medical Pte. Ltd. 105 Cecil Street #20-04, The Octagon, Singapore 069534. Phone: +65 9635 2618 / +66 81 761 5292 Contact Person: Mr. Freddie LEE, Chief Executive Officer/ Managing Director Date Prepared: September 9, 2024 Content and Format: Prepared in accordance with 21 CFR 807.92 Type of Submission: Special

II. Subject Device

510(k) Number:	K242152
Trade/ Device Name:	SMARTEzTM Elastomeric Infusion Pump
Common/ Usual Name:	Pump, Infusion, Elastomeric
Regulation Number:	21 CFR 880.5725
Regulation Name:	Infusion Pump
Regulatory Class:	Class: II
Product Code:	MEB

III. Predicate

510(k) Number:	K151650
Trade/ Device Name:	SMARTeZTM Elastomeric Infusion Pump
Common/ Usual Name:	Pump, Infusion, Elastomeric
Regulation Number:	21 CFR 880.5725
Regulation Name:	Infusion Pump
Regulatory Class:	Class: II
Product Code:	MEB

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IV. Purpose of Submission and Device Description

The SMARTeZ™ Elastomeric Infusion Pump (SMARTeZ™ Pump) is a sterile, single-use, mechanical (non-electric, non-electronic) infusion pump that consists of an elastomeric fluid reservoir as an energy source and an administration line. The constriction of the elastomeric fluid reservoir drives the fluid through the administration tubing and eventually through a flow restrictor, into the patient connection.

The SMARTeZ™ Pump is intended to administer infusion therapies only, and not for fluid storage.

This Special 510(k) Submission is to inform FDA of the addition to the thirty-nine (39) existing SMARTeZ™ Pump offerings, four (4) new models of different nominal volumes, flow rates and time: 498111: 100 ml, 0.5 ml/h, 200 h; 498121: 100 ml, 1 ml/h, 100 h: 498131: 50 ml, 0.5 ml/h, 100 h: 498141: 50 ml. 1 ml/h, 50 h. with KVO (Keep Vein Open) infusion pump labeling.

V. Indications for Use Statement

The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management.

Routes of administration: intravenous and subcutaneous. .
The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery.
. Route of administration: intravenous.
The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.
. Routes of administration: intravenous and intra-arterial.

VI. Comparison of Intended Use & Technological Characteristics

The Subject device and the Predicate device share the following characteristics:

Intended Use comparison

1. Indications for use statements
1. Primary product code and regulation number
1. Intended user population/ intended use environment
1. Routes of the infusion
1. Medical delivery method
1. Single use or reusable
1. Prescription use or over-the-counter use
10)Labeling specifications
1. Intended drug type
1. Type of infusion

Technological characteristics comparison

Equivalencies - Technology & Design

The Subject device and the Predicate device share the following design characteristics, and from the evaluation in the comparison table, there was no substantial difference from the Predicate device identified, that would raise a safety or performance issue/ concern:

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Image /page/6/Picture/0 description: The image shows the word "EPIC" in a stylized, bold, sans-serif font. The letters are connected at the bottom by a thick line. The "E" has a circular dot in the upper left corner, and the "P" has a unique shape with a curved top that extends slightly beyond the vertical line.

1. Principles of operation
1. Energy source
1. Device construction (major components, construction of materials, fill port, fluid reservoir, administration tubing, outer shell, flow restrictor)
1. Performance specification
1. Sterile barrier packaging
1. Sterilization process
1. Shelf-life

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An overview table summarizing the comparison between the Subject and the Subject and the Predicate device is provided hereunder.

| Characteristic
compared | Predicate Device (K151650)
SMARTeZ™ Elastomeric Infusion Pump | Subject Device (K242152)
SMARTeZ™ Elastomeric Infusion Pump | Comment/
Discussion | |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------------------------|
| Intended use
and
Indications for Use
statement | "The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management.
• Routes of administration: intravenous and subcutaneous.

"The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery.
• Route of administration: intravenous.

"The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.
• Routes of administration: intravenous and intra-arterial." | "The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management.
• Routes of administration: intravenous and subcutaneous.

"The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery.
• Route of administration: intravenous.

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Discussion of difference in technological characteristics

Comment #1

The administration tube, which is presented in the same unit package, is to be attached by the health care professional, The Subject device with the change was subjected to testing to ISO 28620:2020 - with the administration tube portion attached to the pump portion - and the new Luer connectors, to ISO 80369-7:2021. Testing confirmed the device was safe and effective. The Subject device and Predicate (existing) device different questions of safety and effectiveness. Its testing summary is provided in VII.A, hereunder.

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Performance Data Supporting Substantial Equivalence VII.

A. Functional Performance

The Subject device in this Summary was evaluated to be in conformance with the following ISO standards document:

ISO 28620:2020, Medical devices Non-electrically driven portable infusion devices ●
ISO 80369-7 Second edition 2021-05 Small-bore connectors for liguids and gases in ● healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

Bench performance verifications and validations performed on the Subject device (pump and administration tubing connected) and referred-to existing devices (K151650):

. Flow rate test under these conditions - nominal (on Subject device), various ambient temperature, various solution viscosity, after resistance to pressure (on Subject device), after resistance to traction test (on Subject device), after refrigeration, under nonambient pressure (simulating influences of routes of administration); to ISO 28620:2020, subclause 6.2 & 6.6, all under K151650 and where indicated, on the Subject device as well
Leak-proof test under these conditions resistance to pressure (on Subject device), after . drop test, after resistance to traction test (on Subject device), after refrigeration; to ISO 28620:2020, subclause 6.3, 6.4, 6.5 & 6.6, All under K151650 and where indicated, on the Subject device as well
Retrograde flow of infusate test, under K151650 .
Luer lock connection tests on the new Luer lock connectors positive pressure fluid . leakage test, sub-atmospheric pressure air leakage test, stress cracking test, resistance to separation from axial load test, resistance to separation from unscrewing test, resistance to overriding test, to ISO 80369-7:2021 performed on the Subject device

B. Biocompatibility

In accordance with ISO 10993-1:2018, the Subject device just like the existing SMARTeZ™ Pump, is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing were performed on referred-to cleared devices, and conducted on the Subject device:

Cytotoxicity to ISO 10993-5 under K151650 ●
. Sensitization to ISO 10993-10 under K151650
Intracutaneous Reactivity to ISO 10993-10 under K151650 .
. Acute Systemic Toxicity to ISO 10993-11 under K151650
In-vitro Hemolysis Assessment to ISO 10993-4 under K151650 ●
Chemical Characterization and Toxicological Risk Assessment to ISO 10993-18 and ● ISO 10993-17, under K151650

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6010

C. Sterility, Shipping, and Shelf-Life

The Subject device, like the existing SMARTeZ™ Pump, complies with sterilization requirements of ISO 11135:2014, Sterilization of Health Care Products - Ethylene Oxide -Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices and the following testing/ evaluations under K151650:

Package Integrity Tests per ASTM F1980-21, Standard guide for accelerated aging of ● sterile barrier systems for medical devices and Sterile Barrier Packaging Testing performed on the proposed device: Seal strength - ASTM F88/F88M-21, Standard test method for seal strength of flexible barrier materials; Dye Penetration – ASTM F1929-23. Standard test method for detecting seal leaks in porous medical device packaging by dye penetration; EN 868-5:2009, Packaging materials and systems for medical devices which are to be sterilized – Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods
Pyrogen Tests per ANSI/AAMI ST72/2019, Bacterial endotoxins Test methods, . routing monitoring, and alternatives to batch testing, USP 40 , Pyrogen test (USP rabbit test), USP-NF , Medical Devices-Bacterial Endotoxin and Pyrogen Tests, USP-NF , Bacterial Endotoxins Test
Shelf-life of 3 years has been validated using the FDA recognized standard, ASTM ● 1980-21,

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

VIII. Clinical Tests

Not applicable.

IX. Conclusion

The difference between the Predicate and the Subject device does not raise any new or different questions of safety or effectiveness. The Subject device – SMARTeZ™ Elastomeric Infusion Pump (submitted under K242152) - is substantially equivalent to the Predicate device, and existing device, the SMARTeZ™ Elastomeric Infusion Pump (cleared under K151650) – with respect to its indications for use, principles of operation and technological characteristics.