(34 days)
The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features.
The I.V. Extension Set may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.
Not Found
1. Acceptance Criteria and Reported Device Performance:
This document is a 510(k) clearance letter for an "I.V. Administration Set." It is a regulatory document stating that the FDA has reviewed the manufacturer's premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.
Crucially, this type of document is a clearance, not a study report. It does not contain acceptance criteria (e.g., specific performance metrics like sensitivity, specificity, or precision) or reported device performance data in the way one would see for a novel AI/ML device or a device requiring specific clinical efficacy or safety studies for its primary function.
For a traditional medical device like an I.V. Administration Set, "acceptance criteria" are implicitly met through the demonstration of substantial equivalence to a predicate device. This typically involves:
- Design and Material Specifications: The new device must meet comparable specifications to the predicate in terms of materials, dimensions, and construction.
- Performance Benchmarking: The new device must perform comparably to the predicate for its intended function (e.g., flow rate, pressure resistance, sterility, biocompatibility). These are usually physical and chemical tests rather than clinical performance studies with human subjects that yield metrics like sensitivity.
- Safety Standards: The device must comply with relevant safety standards (e.g., ISO standards for blood compatibility, sterility, and biocompatibility).
The document does not provide a table of acceptance criteria or reported device performance in the format requested because this information is part of the underlying 510(k) submission, not the public-facing clearance letter. The clearance letter only states that the FDA found the device "substantially equivalent" based on the submitted data.
If this were an AI/ML device submission, a table like the one requested would be a key component of the FDA's summary of the submission. Since it's a conventional I.V. administration set, the clearance is based on established equivalence.
Therefore, for questions 2-9, the answer directly from the provided text is that the information is not present, as this is a regulatory clearance letter, not a clinical study report.
Here's how to interpret the lack of information for a device like an I.V. Administration Set in the context of the questions:
2. Sample size used for the test set and the data provenance:
- Not Applicable (N/A) / Not provided in this document. For an I.V. Administration Set, "test sets" would refer to engineering and biocompatibility tests rather than clinical imaging data sets. The document is a regulatory decision, not a study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A / Not provided in this document. "Ground truth" in this context would likely refer to the established performance characteristics and safety profiles of predicate devices and the new device's ability to meet those. This would involve engineering experts, material scientists, and quality control professionals, not typically "radiologists" as the example suggests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A / Not provided in this document. Clinical adjudication methods are not typically part of the regulatory review for a simple administration set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study is relevant for AI-powered diagnostic devices where human interpretation is involved. This device is an I.V. administration set, which is a physical fluid delivery device, not a diagnostic or AI-assisted interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This question pertains to AI algorithms. The device is a traditional medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A / Not provided in this document explicitly. For this device, ground truth would be established through:
- Engineering specifications and test standards: Meeting validated physical and chemical properties (e.g., flow rate, pressure, material integrity).
- Biocompatibility testing: Compliance with ISO 10993 series standards.
- Sterility testing: Compliance with relevant sterility assurance levels.
8. The sample size for the training set:
- N/A. This question refers to training data for AI/ML models. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- N/A. This question refers to AI/ML models. This is not an AI/ML device.
In summary: The provided document is a 510(k) clearance letter for a conventional medical device (I.V. Administration Set). It confirms regulatory approval based on "substantial equivalence" to existing devices, but it does not contain the detailed study data or performance metrics that would be found in a clinical study report, especially for an AI-powered device. The questions posed are highly relevant to AI/ML medical devices but are mostly not applicable to the information contained within this specific regulatory letter for a traditional device.
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August 22, 2024
BQ Plus medical Co.,Ltd. % Eva Li Consultant Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave. Shanghai. 200122 China
Re: K242126
Trade/Device Name: I.V. Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: July 19, 2024 Received: July 19, 2024
Dear Eva Li:
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.
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).
Sincerely, Porsche Bennett
Porsche Bennett for 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
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Indications for Use
510(k) Number (if known) K242126
Device Name I.V. Administration Set
Indications for Use (Describe)
The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features.
The I.V. Extension Set may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.
| 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) |
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§ 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.