(267 days)
No
The device description and performance studies focus on standard components and testing for fluid administration sets, with no mention of AI/ML capabilities or related data/training sets.
No.
The device is used to administer fluids, not provide therapy.
No
The device is an administration set used to deliver fluids to a patient, not to diagnose a condition or disease.
No
The device description clearly outlines physical components like tubing, clamps, filters, and a drip chamber, indicating it is a hardware-based medical device.
Based on the provided information, the Ecomed Disposable Administration Sets are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "transfer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein." This describes a device used for administering substances directly into the body, not for examining specimens in vitro (outside the body).
- Device Description: The components listed (tubing, clamps, drip chamber, spike, etc.) are all consistent with a device used for fluid delivery into a patient. There are no components or descriptions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The performance studies focus on the physical and biological compatibility of the device with the patient and the fluids being administered, not on the accuracy of a diagnostic test.
In summary, the Ecomed Disposable Administration Sets are a medical device used for fluid administration in vivo, not for diagnostic testing in vitro.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
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, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral Intravenous
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
Intended user: Healthcare professional (doctor, nurse, technician)
Environment of use: Professional Healthcare Facility, Transport (ambulatory) Environment
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
The sterile single use Ecomed Disposable Administration Sets described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- . ISO 8536-4 :2019, Infusion equipment for Medical Device Use- Part 4: Infusion sets for single use gravity feed.
- ISO 8536-5:2004 Burette infusion sets for single use, gravity feed.
- ISO 8536-12:2021 Infusion equipment for medical use — Part 12: Check valves for single use
- . ISO 8536-13:2016 Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact
- ISO 8536-14:2016 Infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
- . ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Sterilization, Packaging, Shelf-life Testing:
Sterilization is validated per ISO 11135: 2014: the device is sterilized via ethylene oxide (EO) with a minimum Sterility Assurance Level of SAL of 10-6. A total of five (5) process cycles were conducted during the execution of the product validation; one (1) sub lethal fractional exposure cycle, three (3) half exposure cycles, and one (1) full exposure cycle was executed. EO residuals were evaluated per ANSI/AAMI/ISO 10993-7:2008 and found to be acceptable.
- . The products have a 2 year shelf-life that is confirmed via accelerated aging executed via ASTM F1980-07 (Reapproved 2011), standard guide for accelerated aging of sterile barrier systems for medical devices and Sterile Barrier Packaging Testing.
- . Sterile Barrier Packaging Testing performed on the proposed subject device in accordance with ISO 11607-1 packaging for terminally sterilized medical devices - part 1: requirements for materials, sterile barrier systems and packaging systems [including: amendment 1 (2014)] including the following tests:
- . Visual inspection
- Seal strength
- Dye penetration
Microbial ingress testing for the needle-free access site was performed as per ANSI AAMI CN27 Annex B.17 for microbial ingress testing.
Biocompatibility testing:
The biocompatibility evaluation was conducted in accordance with the FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" published June 16, 2016. This device is categorized in ISO 10993-1:2009 as "External communicating device -blood path, indirect" per section 5.2.2(a). The device will have prolonged contact is likely to exceed 24 hours but not 30 days. Testing completed on this device includes:
- . Cytotoxicity
- Sensitization
- Irritation
- Acute Toxicity
- Pyrogenicity
- Hemocompatibility
Modified drug solution particulate test USP was completed to confirm device particulate level.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: 847-984-0106 Applicant Contact: Mr. David Yurek Applicant Contact Email: david.yurek@ecomed-solutions.com Correspondent Name: Ecomed Solutions, LLC Correspondent Address: 214 Terrace Drive Mundelein IL 60060 United States Correspondent Contact Telephone: 262-220-3463 Correspondent Contact: Ms. Christina Bloxton Correspondent Contact Email: christina.bloxton@ecomed-solutions.com 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,
5
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
Name | Proposed Device | Predicate Device,
(Primary)
Disposable Infusion Set
(WeiGao) | Explanation of Variation | |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ecomed Disposable
Administration Sets | | | |
| Regulatory Information | 510(k)# | This submission | K090012 | N/A |
| | Predicates | K090012 | K060082 | N/A |
| | Product Code | FPA | FPA | Same |
| | Subsequent
product code | N/A | N/A | N/A |
| | Class | 2 | 2 | Same. |
| | Combination
Product | No | No | Same |
| | Regulation Number | 880.5440 | 880.5440 | Same |
| | Regulation Generic
Name | Intravascular
administration set | Intravascular
administration set | Same. |
| | Regulation
Intended Use | 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. | 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. | Same. |
| Intended use | Indications | Ecomed Disposable
Administration sets are
used to transfer fluids
from a container to a
patients vascular system
through a needle or
catheter inserted into the
vein. | Disposable Infusion set is
used to transfer fluids
from a container to a
patients vascular system
through a needle or
catheter inserted into the
vein. | Same. |
| | Intended (target)
population | Adult and Pediatric | Adult and Pediatric | Same. |
| Identification | | Proposed Device | Predicate Device,
(Primary) | |
| Name | | Ecomed Disposable
Administration Sets | Disposable Infusion Set
(WeiGao) | Explanation of Variation |
| | Intended user | Healthcare professional
(doctor, nurse, technician) | Healthcare professional
(doctor, nurse, technician) | Same. |
| | Environment of use | Professional Healthcare
Facility, Transport
(ambulatory) Environment | Professional Healthcare
Facility, Transport
(ambulatory) Environment | Same. |
| | Anatomical sites | Peripheral Intravenous | Peripheral Intravenous | Same. |
| | Contact Type | External communicating
device -blood path,
indirect | External communicating
device -blood path,
indirect | Same. |
| | Contact duration | Prolonged 24hours was completed to confirm device particulate level.
Conclusion:
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The (Ecomed Disposable Administration Sets) is substantially equivalent to the Weigao Disposable Infusion Set with respect to the indications for use, target population, and technological characteristic.