(267 days)
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.
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.
The provided text is a 510(k) premarket notification for a medical device: Ecomed Disposable Administration Sets. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for reporting the results of an AI algorithm study or an MRMC study.
Therefore, many of the requested criteria (e.g., acceptance criteria for an AI algorithm's performance, sample size for AI test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, training set details) are not applicable to this document, as it describes a non-AI, non-software medical device.
The document primarily focuses on establishing substantial equivalence through performance testing of physical device properties, biocompatibility, and sterilization/packaging, all in conformance with recognized international standards.
However, I can extract information related to the acceptance criteria and proof of adherence for this specific type of device from the provided text.
Analysis of the Provided Document (K234129)
This 510(k) submission is for "Ecomed Disposable Administration Sets," which are physical medical devices (intravenous administration sets). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the regulatory requirements and performance specifications that the device must meet to demonstrate substantial equivalence to a predicate device, as opposed to performance metrics for an AI/software algorithm.
Here's a breakdown based on the closest applicable information in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical "acceptance criteria" table with numerical targets and measured performance, as would be common for an AI algorithm. Instead, it lists the international consensus standards to which the device was tested and found compliant. Compliance with these standards is the acceptance criteria for a device of this type.
| Acceptance Criteria Category | Specific Acceptance Criteria (Referenced Standards/Requirements) | Reported Device Performance (Compliance) |
|---|---|---|
| Performance Testing | ISO 8536-4:2019 (Infusion sets for single use gravity feed) | Conforms to standard |
| ISO 8536-5:2004 (Burette infusion sets for single use, gravity feed) | Conforms to standard | |
| ISO 8536-12:2021 (Check valves for single use) | Conforms to standard | |
| ISO 8536-13:2016 (Graduated flow regulators for single use with fluid contact) | Conforms to standard | |
| ISO 8536-14:2016 (Clamps and flow regulators for transfusion and infusion equipment without fluid contact) | Conforms to standard | |
| ISO 80369-7:2021 (Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications) | Conforms to standard | |
| Sterilization Assurance | ISO 11135:2014 (Ethylene oxide sterilization with minimum SAL of 10-6) | Sterilized via EO; SAL of 10-6 confirmed across 5 process cycles (1 sublethal, 3 half, 1 full exposure) |
| ANSI/AAMI/ISO 10993-7:2008 (EO residuals) | EO residuals found acceptable | |
| Shelf-Life & Packaging | ASTM F1980-07 (Reapproved 2011) (Accelerated aging) | 2-year shelf-life confirmed via accelerated aging |
| ISO 11607-1 (Packaging for terminally sterilized medical devices) | Packaging tested for Visual inspection, Seal strength, Dye penetration | |
| Microbial Ingress (Needle-free access site) | ANSI AAMI CN27 Annex B.17 (Microbial ingress testing) | Performed as per standard |
| Biocompatibility | FDA guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16, 2016) | Biocompatibility evaluation conducted in accordance with guidance. |
| ISO 10993-1:2009 (External communicating device - blood path, indirect, prolonged contact 24 hours < 30 days) | Testing completed: Cytotoxicity, Sensitization, Irritation, Acute Toxicity, Pyrogenicity, Hemocompatibility | |
| Solution Particulate | USP <788> (Modified drug solution particulate test) | Completed to confirm device particulate level |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: The document does not explicitly state the numerical sample sizes for each specific test (e.g., how many infusion sets were tested for flow rate, how many for biocompatibility). It references the standards, implying that the sample sizes were in accordance with the prescribed methodologies of those standards.
- Data Provenance: The document does not specify the country of origin of the data. It is a premarket notification submitted to the U.S. FDA. The studies are prospective in the sense that they were conducted for the purpose of this submission to demonstrate device performance and safety.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is not applicable. For this type of physical medical device, "ground truth" is not established by human experts interpreting clinical data (like in AI for medical imaging). Instead, the performance is verified against engineering and biological standards using laboratory testing. The "experts" would be the engineers, microbiologists, and other scientific personnel who conducted the testing and verified compliance with the standards, but their number and specific qualifications are not detailed here, as it's not relevant to substantial equivalence in the way an AI study would require.
4. Adjudication Method for the Test Set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI algorithm evaluations where human readers interpret data, and discrepancies need to be resolved. This document pertains to physical device testing against established engineering and biological standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- This is not applicable. MRMC studies are standard for evaluating diagnostic imaging AI algorithms and their impact on human reader performance. This document concerns a physical administration set.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This device is not an algorithm or software. Its performance is inherent in its physical properties and design when used by a healthcare professional.
7. The Type of Ground Truth Used:
- The "ground truth" (or basis for evaluation/acceptance) here is compliance with recognized international consensus standards and regulatory requirements. This includes laboratory test results verifying physical parameters (e.g., flow rate, material integrity), biological safety (biocompatibility, sterility), and packaging integrity. It's not a clinical outcome or expert consensus on clinical data.
8. The Sample Size for the Training Set:
- This is not applicable. There is no AI algorithm being trained for this device.
9. How the Ground Truth for the Training Set was Established:
- This is not applicable. As there is no AI algorithm, there is no training set or associated "ground truth" establishment in this context.
Summary regarding the device:
The "Ecomed Disposable Administration Sets" gained 510(k) clearance by demonstrating substantial equivalence to existing predicate devices. This was achieved by showing that the device meets well-defined international performance, sterilization, biocompatibility, and packaging standards, applicable to its intended use as an intravascular administration set. The changes from the predicate device (e.g., additional components, different tubing sizes, absence of pre-attached needle) were assessed to ensure they do not raise new questions of safety or effectiveness.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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,
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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
| IdentificationName | Proposed Device | Predicate Device,(Primary)Disposable Infusion Set(WeiGao) | Explanation of Variation | |
|---|---|---|---|---|
| Ecomed DisposableAdministration Sets | ||||
| Regulatory Information | 510(k)# | This submission | K090012 | N/A |
| Predicates | K090012 | K060082 | N/A | |
| Product Code | FPA | FPA | Same | |
| Subsequentproduct code | N/A | N/A | N/A | |
| Class | 2 | 2 | Same. | |
| CombinationProduct | No | No | Same | |
| Regulation Number | 880.5440 | 880.5440 | Same | |
| Regulation GenericName | Intravascularadministration set | Intravascularadministration set | Same. | |
| RegulationIntended Use | An intravascularadministration set is adevice used to administerfluids from a container to apatient's vascular systemthrough a needle orcatheter inserted into avein. | An intravascularadministration set is adevice used to administerfluids from a container to apatient's vascular systemthrough a needle orcatheter inserted into avein. | Same. | |
| Intended use | Indications | Ecomed DisposableAdministration sets areused to transfer fluidsfrom a container to apatients vascular systemthrough a needle orcatheter inserted into thevein. | Disposable Infusion set isused to transfer fluidsfrom a container to apatients vascular systemthrough a needle orcatheter inserted into thevein. | Same. |
| Intended (target)population | Adult and Pediatric | Adult and Pediatric | Same. | |
| Identification | Proposed Device | Predicate Device,(Primary) | ||
| Name | Ecomed DisposableAdministration 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 HealthcareFacility, Transport(ambulatory) Environment | Professional HealthcareFacility, Transport(ambulatory) Environment | Same. | |
| Anatomical sites | Peripheral Intravenous | Peripheral Intravenous | Same. | |
| Contact Type | External communicatingdevice -blood path,indirect | External communicatingdevice -blood path,indirect | Same. | |
| Contact duration | Prolonged 24hours < 30days | Prolonged 24hours < 30days | 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 hasconfirmed the stability andequivalence of the proposeddevice. | |
| Performance | ISO 8536-4 | ISO 8536-4 | Same. | |
| Mode of fluiddelivery | Gravity | Gravity | Same. | |
| Technology | Controlmechanism | Roller Clamp ABSSlide Clamp PEFlow Regulator PEISO 8536-4ISO 8536-13ISO 8536-14ISO 10993-1 | Flow Regulator ABS or PEISO 8536-4ISO 10993-1 | Different.The subject device includesadditional industry standardcomponents included in the sameconsensus standard (ISO 8536-4)that the predicate devices arecompliant to for othercomponents. Both manual andgraduated flow controllers areindustry standard componentsincluded in the same consensusstandard (ISO 8536-4) used for thesame purpose. The differencedoes not raise any new issues ofsafety and effectivity.Since the predicate was cleared,the standard has been updated tosplit out the flow controllerrequirements in two separate newstandards (ISO 8536-13 & ISO8536-14) and the newcomponents are compliant to thecurrent revisions. |
| Tubing (ID X OD) | 3mm x 4mm0.8mm x 2.4mmISO 8536-4ISO 10993-1 | 3mm X 4mmISO 8536-4ISO 10993-1 | Different. The subject devicesinclude 0.8mm x 2.4mm tubingsize in addition to the standard3mm x 4mm tubing in thepredicate. | |
| IdentificationName | Proposed DeviceEcomed DisposableAdministration Sets | Predicate Device,(Primary)Disposable Infusion Set(WeiGao) | Explanation of Variation | |
| Injection site(needle-free) | Y injection site PC & ABSwith silicone portISO 8536-4ANSI/AAMI CN 27ISO 10993-1 | None. | Both sizes are made by the samesupplier as the predicate with thesame material.All tubing sizes meet theperformance requirements of ISO8536-4 therefore the differencedoes not raise any new issues ofsafety and effectivity.Different.The needle-free injection site is anadditional input source which isan industry standard componentstandardized to ISO 8536-4 &ANSI/AAMI CN 27.The testing to ANSI/AAMI CN 27demonstrates that the productcan be safely utilized withoutmicrobial ingress therefore thedifference does not raise any newissues of safety and effectivity. | |
| Injection site(needle) | T injection site ABS withpolyisoprene portISO 8536-4ISO 10993-1 | None. | Different.The subject device includes anadditional industry standardcomponent included in the sameconsensus standard (ISO 8536-4)that the predicate devices arecompliant to for othercomponents. The additionalcomponent meets theperformance requirements of ISO8536-4 therefore the differencedoes not raise any new issues ofsafety and effectivity. | |
| Drip chamber | 60 drop ABS & PVC20 drop ABS & PVCFiberglass ventISO 8536-4ISO 10993-1 | 60 drop ABS & PVCFiberglass ventISO 8536-4ISO 10993-1 | Different.Both devices include industrystandard drip chamberscompliant to ISO 8536-4. Theadditional component meets theperformance requirements of ISO8536-4 therefore the differencedoes not raise any new issues ofsafety and effectivity. | |
| Filter | 2 um Acrylic andPolyester (PES) /Polytetrafluoroethylenes(PTFE)ISO 8536-4ISO 10993-1 | 200 ums unknownISO 8536-4ISO 10993-1 | Different.The filters are both intended toremove particulate. Both arecompliant to the same standard,ISO 8536-4. The smaller filter sizemeets the performancerequirements of ISO 8536-4therefore the difference does notraise any new issues of safety andeffectivity. | |
| Burette | PETG + ABS + PVCISO 8536-5ISO 10993-1 | None. | Different.The burette is an additional inputsource which is an industrystandard componentstandardized to ISO 8536-5. Theadditional component meets theperformance requirements of ISO8536-5 therefore the differencedoes not raise any new issues ofsafety and effectivity. | |
| Spike | ABSISO 8536-4ISO 10993-1 | ABSISO 8536-4ISO 10993-1 | Different. The component issourced from a different supplier.Both devices include industrystandard spikes compliant to ISO8536-4 with geometry andmaterials compliant to ISO 8536-4and ISO 10993-1 and therefore thedifference does not raise any newissues of safety and effectivity. | |
| Check valve | ABSISO 8536-12 | None | Different.The subject device includes anadditional industry standard | |
| Connectors | Luers (male, female)Female Luer w/ Cap PC + PP Male Luer Lock w/ Cap ABS, PP ISO 594/ISO 80369-7ISO 10993-1 | Infusion needleISO 10993-1 | component which is which isstandardized to ISO 8536-12. Theadditional component meets theperformance requirements of ISO8536-4 therefore the differencedoes not raise any new issues ofsafety and effectivity.Different.In the proposed device, Luers areused to attach the administrationset to the luer connection of aneedle or catheter inserted intothe vein (separate device),whereas in the predicates, theinfusion needle is pre attached tothe luer of the IV set. The absenceof the infusion needle does notchange the intended use of thedevice as the device will beattached to a needle or catheterfor use. The difference does notraise any new issues of safety andeffectivity.Since there is no needle on thesubject device, the subject deviceis considered an indirect bloodcontact device, whereas thepredicate with needle is a directblood contact device. As such,the biocompatibility category ofthe subject device is lower(indirect blood vs direct blood) socertain biocompatibility testingcompleted for the predicatedevice (direct hemolysis testing)is not applicable to the subject | |
| Priming volume | Primary Set: 12.9 mLBurette Set: 12.9 mLExtension Set: 2.7 mLTee Set: 0.5 mLFlow Control Set: 3.2 mLISO 8536-4 | Approximately 12-13 mLISO 8536-4 | Different. The subject devicesinclude a wider range of primingvolumes.Set sizing is based on clinicaluses. The complete set meets theperformance requirements of ISO8536-4 therefore the differencedoes not raise any new issues ofsafety and effectivity. | |
| Residual Volume inNeedless AccessPort | Microclave: 0.04 mLISO 8536-4ANSI/AAMI CN 27ISO 10993-1 | N/A | Different. The subject adds aneedleless access valve.The needle-free injection site isan additional input source whichis standardized to ISO 8536-4 &ANSI/AAMI CN 27. |
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| The subject device has a low residual volume which is included on the label. Additionally, site protocols require flushing after needleless access port use. Therefore, the difference does not raise any new issues of safety and effectivity. |
|---|
1.7 Non-Clinical and/or Clinical Tests Summary & Conclusions
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
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- 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 <788> 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.
§ 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.