Ecomed Disposable Administration Sets

K234129 · Ecomed Solutions, LLC · FPA · Sep 20, 2024 · General Hospital

Device Facts

• Record ID: K234129
• Device Name: Ecomed Disposable Administration Sets
• Applicant: Ecomed Solutions, LLC
• Product Code: FPA · General Hospital
• Decision Date: Sep 20, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Ecomed Disposable Administration sets are used to transfer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

Device Story

Ecomed Disposable Administration Sets are sterile, single-use gravity-fed infusion sets; used in professional healthcare facilities and transport environments. Components include spikes, drip chambers, tubing, roller/slide clamps, flow regulators, filters, burettes, and needle-free injection sites. Device connects to IV fluid containers and patient vascular access devices (needles/catheters) via luer connectors. Healthcare professionals (doctors, nurses, technicians) operate the device to administer fluids. Output is the controlled delivery of fluids to the patient's vascular system. Benefits include reliable fluid administration for prolonged use (up to 30 days).

Clinical Evidence

Bench testing only. Conformance demonstrated with ISO 8536-4, -5, -12, -13, -14, and ISO 80369-7. Sterilization validated per ISO 11135 (EO, SAL 10^-6). Shelf-life (2 years) confirmed via ASTM F1980 accelerated aging. Sterile barrier packaging tested per ISO 11607-1. Biocompatibility evaluated per ISO 10993-1 (cytotoxicity, sensitization, irritation, acute toxicity, pyrogenicity, hemocompatibility). Microbial ingress testing performed per ANSI AAMI CN27. Particulate testing performed per USP <788>.

Technological Characteristics

Gravity-fed infusion set. Materials: ABS, PVC, PETG, PC, PP, silicone, polyester, PTFE. Components: spike, drip chamber (20/60 drop), tubing (0.8mm/3mm ID), clamps, flow regulators, filters (2um), burette, needle-free injection site. Connectivity: Luer lock (ISO 80369-7). Sterilization: Ethylene Oxide. Standards: ISO 8536-4, 8536-5, 8536-12, 8536-13, 8536-14, ISO 10993-1.

Indications for Use

Indicated for adult and pediatric patients requiring fluid transfer from a container to the vascular system via a needle or catheter inserted into a vein.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Disposable Infusion Set (WeiGao) (K090012)

Reference Devices

• K060082

Submission Summary (Full Text)

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September 20, 2024

Ecomed Solutions, LLC Christina Bloxton Regulatory 214 Terrace Drive Mundelein, Illinois 60060

Re: K234129

Trade/Device Name: Ecomed Disposable Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: August 21, 2024 Received: August 21, 2024

Dear Christina Bloxton:

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" (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).

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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 QS 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-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 medical devices and radiation-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,

David Walloschek

David Wolloscheck, 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) K234129

Device Name Ecomed Disposable Administration Sets

Indications for Use (Describe)

Ecomed Disposable Administration sets are used to transfer to a patients vascular system through a needle or catheter inserted into the vein.

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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# K234129.510K SUMMARY

Prepared on: 9-12-2024

# CONTACT DETAILS

Applicant Name: Ecomed Solutions, LLC Applicant Address: 214 Terrace Drive Mundelein IL 60060 United States Applicant Contact Telephone: [phone] Applicant Contact: Mr. David Yurek Applicant Contact Email: [e-mail] Correspondent Name: Ecomed Solutions, LLC Correspondent Address: 214 Terrace Drive Mundelein IL 60060 United States Correspondent Contact Telephone: [phone] Correspondent Contact: Ms. Christina Bloxton Correspondent Contact Email: [e-mail] 1.1 DEVICE NAME

Device Trade Name: Ecomed Disposable Administration Sets

Classification Name: Set, Administration, Intravascular

Regulation Number: 880.5440

Product Code(s): FPA

Device Class: Class II

# 1.2 LEGALLY MARKETED PREDICATE DEVICES

Predicate: K090012 , Disposable Infusion Set (WeiGao)

#### 1.3 DEVICE DESCRIPTION SUMMARY

The Ecomed Disposable Administration Sets are a family of sterile, single use gravity sets composed of common components that are used to administer fluids.

Each set is comprised of a subset of common components which are broadly used throughout industry including roller clamp, slide clamp, a flow regulator, a drip chamber, an infusion line filter, fluid delivery tubing, Burette w/ needle-free injection site and vent/cap and drip chamber 60 drop,

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injection site, connectors between parts of the set, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

This family of sets and components is broken down into the following main categories: Primary set, Tee set, Flow Controller Set, Filter Set, and Burette Set.

# 1.4 INTENDED USE/INDICATIONS FOR USE

Ecomed Disposable Administration sets are used to transfer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

# 1.5 INDICATIONS FOR USE COMPARISON

The indications for the proposed and predicate devices are the same.

# 1.6 TECHNOLOGICAL COMPARISON

| Identification<br>Name | Proposed Device | Predicate Device,<br>(Primary)<br>Disposable Infusion Set<br>(WeiGao) | Explanation of Variation | |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ecomed Disposable<br>Administration Sets | | | |
| Regulatory Information | 510(k)# | This submission | K090012 | N/A |
| | Predicates | K090012 | K060082 | N/A |
| | Product Code | FPA | FPA | Same |
| | Subsequent<br>product code | N/A | N/A | N/A |
| | Class | 2 | 2 | Same. |
| | Combination<br>Product | No | No | Same |
| | Regulation Number | 880.5440 | 880.5440 | Same |
| | Regulation Generic<br>Name | Intravascular<br>administration set | Intravascular<br>administration set | Same. |
| | Regulation<br>Intended Use | An intravascular<br>administration set is a<br>device used to administer<br>fluids from a container to a<br>patient's vascular system<br>through a needle or<br>catheter inserted into a<br>vein. | An intravascular<br>administration set is a<br>device used to administer<br>fluids from a container to a<br>patient's vascular system<br>through a needle or<br>catheter inserted into a<br>vein. | Same. |
| Intended use | Indications | Ecomed Disposable<br>Administration sets are<br>used to transfer fluids<br>from a container to a<br>patients vascular system<br>through a needle or<br>catheter inserted into the<br>vein. | Disposable Infusion set is<br>used to transfer fluids<br>from a container to a<br>patients vascular system<br>through a needle or<br>catheter inserted into the<br>vein. | Same. |
| | Intended (target)<br>population | Adult and Pediatric | Adult and Pediatric | Same. |
| Identification | | Proposed Device | Predicate Device,<br>(Primary) | |
| Name | | Ecomed Disposable<br>Administration Sets | Disposable Infusion Set<br>(WeiGao) | Explanation of Variation |
| | Intended user | Healthcare professional<br>(doctor, nurse, technician) | Healthcare professional<br>(doctor, nurse, technician) | Same. |
| | Environment of use | Professional Healthcare<br>Facility, Transport<br>(ambulatory) Environment | Professional Healthcare<br>Facility, Transport<br>(ambulatory) Environment | Same. |
| | Anatomical sites | Peripheral Intravenous | Peripheral Intravenous | Same. |
| | Contact Type | External communicating<br>device -blood path,<br>indirect | External communicating<br>device -blood path,<br>indirect | Same. |
| | Contact duration | Prolonged 24hours < 30<br>days | Prolonged 24hours < 30<br>days | Same. |
| | Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same. |
| | Storage conditions | General warehouse. | General warehouse. | Same. |
| | Shelf Life | 2 years | 2 years | Same. Shelf-life testing has<br>confirmed the stability and<br>equivalence of the proposed<br>device. |
| | Performance | ISO 8536-4 | ISO 8536-4 | Same. |
| | Mode of fluid<br>delivery | Gravity | Gravity | Same. |
| Technology | Control<br>mechanism | Roller Clamp ABS<br>Slide Clamp PE<br>Flow Regulator PE<br>ISO 8536-4<br>ISO 8536-13<br>ISO 8536-14<br>ISO 10993-1 | Flow Regulator ABS or PE<br>ISO 8536-4<br>ISO 10993-1 | Different.<br>The subject device includes<br>additional industry standard<br>components included in the same<br>consensus standard (ISO 8536-4)<br>that the predicate devices are<br>compliant to for other<br>components. Both manual and<br>graduated flow controllers are<br>industry standard components<br>included in the same consensus<br>standard (ISO 8536-4) used for the<br>same purpose. The difference<br>does not raise any new issues of<br>safety and effectivity.<br>Since the predicate was cleared,<br>the standard has been updated to<br>split out the flow controller<br>requirements in two separate new<br>standards (ISO 8536-13 & ISO<br>8536-14) and the new<br>components are compliant to the<br>current revisions. |
| | Tubing (ID X OD) | 3mm x 4mm<br>0.8mm x 2.4mm<br>ISO 8536-4<br>ISO 10993-1 | 3mm X 4mm<br>ISO 8536-4<br>ISO 10993-1 | Different. The subject devices<br>include 0.8mm x 2.4mm tubing<br>size in addition to the standard<br>3mm x 4mm tubing in the<br>predicate. |
| Identification<br>Name | Proposed Device<br>Ecomed Disposable<br>Administration Sets | Predicate Device,<br>(Primary)<br>Disposable Infusion Set<br>(WeiGao) | Explanation of Variation | |
| Injection site<br>(needle-free) | Y injection site PC & ABS<br>with silicone port<br>ISO 8536-4<br>ANSI/AAMI CN 27<br>ISO 10993-1 | None. | Both sizes are made by the same<br>supplier as the predicate with the<br>same material.<br>All tubing sizes meet the<br>performance requirements of ISO<br>8536-4 therefore the difference<br>does not raise any new issues of<br>safety and effectivity.<br>Different.<br>The needle-free injection site is an<br>additional input source which is<br>an industry standard component<br>standardized to ISO 8536-4 &<br>ANSI/AAMI CN 27.<br>The testing to ANSI/AAMI CN 27<br>demonstrates that the product<br>can be safely utilized without<br>microbial ingress therefore the<br>difference does not raise any new<br>issues of safety and effectivity. |…