(223 days)
Not Found
No
The device description and performance studies focus on the physical components and material properties of a standard infusion set, with no mention of AI/ML or data processing capabilities.
No.
The device is intended to administer fluids, not to treat a disease or condition directly through a therapeutic action.
No
Explanation: The device is an infusion set for administering fluids, which is a therapeutic function, not a diagnostic one.
No
The device description clearly lists physical components such as protective cap, drip chamber, flexible tube, etc., indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein." This describes a device used on a patient for therapeutic purposes (delivering fluids), not a device used with a sample taken from a patient to provide diagnostic information.
- Device Description: The components listed (spike, drip chamber, tubing, etc.) are all parts of a system for delivering fluids intravenously. They are not designed to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing blood, urine, tissue, or any other biological sample for diagnostic purposes. There's no mention of reagents, assays, or any form of analysis of a sample.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This infusion set is a delivery system, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Infusion Sets for Single Use is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
Product codes
FPA
Device Description
The proposed device consists of basic configuration and optional components. The basic configuration consists of protective cap of spike, drip chamber, drip tube, flow regulator, flexible tube, and conical fitting. Air vent, fluid filter, clamp, and injection site are optional components. The device is provided sterile, single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Tests for in Vitro Cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
- ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
- ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic applications
- ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications-Part 20: Common test methods.
- ISO 8536-4:2019 Infusion equipment for medical use- Part 4: Infusion Sets for Single Use, gravity feed.
- ISO 8536-14:2016 Clamps and flow regulators for transfusion and infusion equipment without fluid contact
- USP Pyrogen Test
- USP Bacterial Endotoxins Test
- USP Particular Matter in Injections.
Key Results:
- Different-Length: "The total length for the proposed device is different from predicate device. However, the performance test has been conducted on the proposed device and the test result can meet the requirements of ISO 8536-4. Therefore, this difference does not raise new questions of safety and effectiveness for the proposed device."
- Different-Capacity: "The total capacity for the proposed device is different from predicate device. However, the performance test has been conducted on the proposed device and the test result can meet the requirements of ISO 8536-4. Therefore, this difference does not raise new questions of safety and effectiveness for the proposed device."
- Different -Patient Contact Material: "The patient contact materials for proposed device are different from predicate device. However, the biocompatibility testing per ISO 10993-1 was performed and the results show there are no adverse effect. Therefore, the differences do not raise new questions of safety and effectiveness for the proposed device."
- Similar- Biocompatibility: "The biocompatibility test was performed on the proposed device and one additional endpoint was evaluated compared to the predicate device, which is subacute toxicity. The test results for the endpoints show there is no adverse effect on the material. Therefore, the provided biocompatibility testing supports substantial equivalence to the predicate device."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.
November 21, 2022
Sichuan Prius Biotechnology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120 China
Re: K221075
Trade/Device Name: Infusion Sets for Single Use Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: October 21, 2022 Received: October 21, 2022
Dear Diana Hong:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
David Walloschek
David Wolloscheck, Ph.D. For Joyce M. Whang, Ph.D. Acting 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
2
Indications for Use
510(k) Number (if known) K221075
Device Name Infusion Sets for Single Use
Indications for Use (Describe)
The Infusion Sets for Single Use is intended to administer fluids from a container to a patient's 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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K221075 - 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K221075
- Date of Preparation: 11/21/2022 1.
-
- Sponsor Identification
Sichuan Prius Biotechnology Co., Ltd.
No.2 Prius Road, Luo Long Industrial Park Nanxi District, 644104 Yibin City, Sichuan Province, PEOPLE'S REPUBLIC OF CHINA
Establishment Registration Number: Not registered yet
Contact Person: Yan Liu Position: Management Representative Tel: +86-831-3839889 Fax: +86-831-3839887 Email: 48363603@qq.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
Identification of Proposed Device 4.
Trade Name: Infusion Sets for Single Use Common Name: Intravascular Administration Set
Regulatory Information Classification Name: Intravascular Administration Set Classification: II Product Code: FPA Regulation Number: 21 CFR 880.5440 Review Panel: General Hospital
Indication for Use Statement:
The Infusion Sets for Single Use is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
Device Description
The proposed device consists of basic configuration and optional components. The basic configuration consists of protective cap of spike, drip chamber, drip tube, flow regulator, flexible tube, and conical fitting. Air vent, fluid filter, clamp, and injection site are optional components. The device is provided sterile, single use.
-
న. Identification of Predicate Device
510(k) Number: K163160 Product Name: Sterile Single-use Infusion Set -
- Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device
K163160 | Remark |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | FPA | FPA | Same |
| Regulation Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| Class | Class II | Class II | Same |
| Indication for Use | The Infusion Sets for Single Use is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into | The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. | Same |
Table 1 General Comparison
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| the vein. | |||||
|---|---|---|---|---|---|
| Configuration | Basic | ||||
| Configuration | Protective cap of spike | Protector Cap of Spike | Same | ||
| Spike | Spike | Same | |||
| Drip chamber | Drip chamber | Same | |||
| Flexible Tube | Flexible Tube | Same | |||
| Configuration | Conical fitting (luer lock | ||||
| or luer slip) | Conical fitting (luer lock or luer slip) | Same | |||
| Optional | |||||
| configuration | Injection site | Injection Site | Same | ||
| Fluid filter | Fluid filter | Same | |||
| Air vent | Air vent | Same | |||
| Clamp | Clamp | Same | |||
| Operation Mode | For manual use only | For manual use only | Same | ||
| Label/Labeling | Conform with 21 CFR Part 801 | Conform with 21 CFR Part 801 | Same | ||
| Filter Characteristics | 15μm | 15μm | Same | ||
| Tubing Diameter | 3.9mm | 3.9mm | Same | ||
| Length (mm) | 1635mm, 1665mm | 1610, 1900mm | Different | ||
| Capacity (ml) | 18ml | 19, 21ml | Different | ||
| Infusion | |||||
| Performance | Set | Comply with ISO 8536-4 | Comply with ISO 8536-4 | Same | |
| Same | |||||
| Patient contact Material | |||||
| Spike | Acrylonitrile Butadiene Styrene (ABS) | High-density Polyethylene (HDPE) | Different | ||
| Drip chamber | Poly Vinyl Chloride (PVC) | Acrylonitrile Butadiene Styrene (ABS) | Different | ||
| Flexible Tube | Poly Vinyl Chloride (PVC) | Poly Vinyl Chloride (PVC) | Same | ||
| conical fitting | Poly Vinyl Chloride (PVC) | Poly Vinyl Chloride (PVC) | Same | ||
| Injection site | Poly Vinyl Chloride (PVC) | Acrylonitrile Butadiene Styrene (ABS) | Different | ||
| Fluid filter | Acrylonitrile Butadiene Styrene (ABS) | Acrylonitrile Butadiene Styrene (ABS) | Same | ||
| Biocompatibility | |||||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | |||
| Intracutaneous | |||||
| Reactivity | No Intracutaneous Reactivity | No Intracutaneous Reactivity | |||
| Skin Sensitization | No Skin Sensitization | No Skin Sensitization | |||
| Acute Systemic Toxicity | No Acute Systemic Toxicity | No Acute Systemic Toxicity | Same | ||
| Hemolysis | No Hemolysis | No Hemolysis | |||
| Pyrogen | No Pyrogen | No Pyrogen | |||
| Subacute Systemic | |||||
| Toxicity | No subacute systemic toxicity | / |
6
| Method | EO sterilized | EO sterilized | Same |
|---|---|---|---|
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
Different-Length
The total length for the proposed device is different from predicate device. However, the performance test has been conducted on the proposed device and the test result can meet the requirements of ISO 8536-4. Therefore, this difference does not raise new questions of safety and effectiveness for the proposed device.
Different-Capacity
The total capacity for the proposed device is different from predicate device. However, the performance test has been conducted on the proposed device and the test result can meet the requirements of ISO 8536-4. Therefore, this difference does not raise new questions of safety and effectiveness for the proposed device.
Different -Patient Contact Material
The patient contact materials for proposed device are different from predicate device. However, the biocompatibility testing per ISO 10993-1 was performed and the results show there are no adverse effect. Therefore, the differences do not raise new questions of safety and effectiveness for the proposed device.
Similar- Biocompatibility
The biocompatibility test was performed on the proposed device and one additional endpoint was evaluated compared to the predicate device, which is subacute toxicity. The test results for the endpoints show there is no adverse effect on the material. Therefore, the provided biocompatibility testing supports substantial equivalence to the predicate device.
-
Non-Clinical Test Conclusion 7.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Tests for in Vitro Cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and skin sensitization
-
A ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
-
ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials >
-
ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide >
7
Sterilization Residuals
-
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
-
ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
-
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic applications
-
ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications-Part 20: Common test methods.
-
ISO 8536-4:2019 Infusion equipment for medical use- Part 4: Infusion Sets for Single Use, gravity feed.
-
ISO 8536-14:2016 Clamps and flow regulators for transfusion and infusion equipment without fluid contact
-
USP Pyrogen Test
-
USP Bacterial Endotoxins Test
-
USP Particular Matter in Injections.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device with respect to the indications for use, target populations, treatment method, and technological characteristics.