DJF Intravascular Administration Set

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". June 9, 2023 Yangzhou Wei De Li Trade Co. Ltd % Aaron Compton President Vesco Devices 541 Lakewood Drive Fairview, Texas 75069 Re: K230992 Trade/Device Name: DJF Intravascular Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: March 13, 2023 Received: April 11, 2023 Dear Aaron Compton: 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). 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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 Walloscher David Wolloscheck, PhD. 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K230992 Device Name DJF Intravascular Administration Set Indications for Use (Describe) DJF Intravascular Administration Sets are intended for use with Curlin (Moog) Infusion Pump, for the delivery of fluids from a container or bag to the patient's vascular system | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K230992- 510K Summary | Submitter Information | | |---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By: | Yangzhou Wei De Li Trade Co. Ltd. | | Address | Li Xin Bridge, Touqiao Township. Yangzhou City,<br>Jiangsu Province, China 225009 | | Phone Number | +86-514-87897887 | | Fax Number | +86-514-87889967 | | Establish Registration No. | 3008808123 | | Name of Contact Person | Aaron Compton | | Contact Person Address | 541 Lakewood Dr., Fairview TX 75069 | | Contact Person Phone No. | 214-533-1416 | | Contact Person email | acompton@vescodevices.com | | Date Prepared | June 9th, 2023 | | Name of Medical Device | | | Trade or proprietary name | DJF Intravascular Administration Set | | Common or usual name | Intravascular Administration Set | | Classification name | Set, Administration, Intravascular | | Classification panel | General Hospital (80) | | Regulation | 21 CFR 880.5440 | | Product Code(s) | FPA | | Device Classification | II | | Legally marketed device(s) to<br>which equivalence is claimed | K121803 – Intravascular Administration Set (ACTA Medical<br>LLC) | | Reason for 510(k) | New devices to offer an alternative infusion set for use with<br>the Curlin (MOOG) infusion pump. | | Device Description | DJF Administration Sets are sterile/non-pyrogenic, single use,<br>non-DEHP PVC tubing with a Universal Spike, Slide Clamp, Luer<br>Lock (male) with integral anti-free flow valve (AFF) {optional,<br>separately provided}, 0.2 micron or 1.2 micron filters, Yellow<br>Cassette and Blue key (locator pin) for use with the Curlin IV<br>pump. Three (3) new sets are:<br>1. DJFCUR001: Administration set compatible with Curlin<br>Pump<br>2. DJFCUR002: Administration set with 0.2 micron filter<br>compatible with Curlin Pump<br>3. DJFCUR003: Administration set with 1.2 micron filter<br>compatible with Curlin Pump | | Technological Characteristics | The subject devices have the same technological material,<br>fit, form and functional characteristics with predicate<br>devices. | | Indications for Use | DJF Intravascular Administration Sets are intended for use<br>with Curlin (Moog) Infusion Pump, for the delivery of fluids<br>from a container or bag to patient's vascular system | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains a logo for "WEI DE LI INTERNATIONAL TRADE". The logo consists of a blue circle with a white stylized "W" inside it. To the right of the circle, the text "WEI DE LI" is written in a bold, sans-serif font, with "INTERNATIONAL TRADE" written in a smaller font below it. Image /page/4/Picture/3 description: The image shows a gray telephone icon in the center of a white circle. A blue arc covers approximately 60% of the circle's circumference, starting from the top and moving clockwise. The telephone icon is a classic rotary phone design, suggesting a vintage or traditional communication method. F Image /page/4/Picture/5 description: The image shows a location pin icon inside of a partial circle. The location pin is dark gray, and the circle is a dark blue color. The circle is not complete, and it is open on the right side. The image is simple and clean, with a white background. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains a logo for "WEI DE LI INTERNATIONAL TRADE". The logo consists of a blue circle with a white stylized "W" inside it. To the right of the circle is the text "WEI DE LI" in a larger font, with the words "INTERNATIONAL TRADE" underneath in a smaller font. ## Substantial Equivalence Summary | Feature | Proposed<br>Device DJF IV<br>Administration<br>Sets, K230992 | Predicate<br>Device K121803 | Discussion | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | Indications for<br>use | DJF Intravascular<br>Administration<br>Sets are<br>intended for use<br>with Curlin<br>(Moog) Infusion<br>Pump, for<br>delivery of fluids<br>from a container<br>or bag to<br>patient's<br>vascular system | Intravascular<br>Administration<br>Sets intended<br>for delivery of<br>fluids from a<br>container or bag<br>to patient's<br>vascular system | Indications for<br>use are<br>fundamentally<br>substantially<br>equivalent | | ABS Container<br>Spike | ABS Container<br>Spike, Non<br>Vented | ABS Container<br>Spike, Universal | Substantially<br>Equivalent | | PVC Tubing,<br>TOTM | PVC Tubing,<br>TOTM | PVC Tubing,<br>TOTM | Substantially<br>Equivalent | | PVC Tubing,<br>TOTM, Pump<br>Segment | PVC Tubing,<br>TOTM, Pump<br>Segment | NA | Different<br>See comment<br>#1 | | Blue, ABS.<br>Locator Pin | Blue. ABS,<br>Locator Pin | NA | Different<br>See Comment<br>#2 | | Yellow, Flow<br>Stop, ABS Box<br>with 316L Spring | Yellow, Flow<br>Stop, ABS Box<br>with 316L Spring | NA | Different<br>See Comment<br>#3 | | ABS Male Luer | ABS Male Luer | ABS Male Luer | Substantially<br>Equivalent | | Slide Clamp | Slide Clamp | Slide Clamp | Substantially<br>Equivalent | | Sterilization, SAL<br>10-6 | Gamma<br>Radiation,<br>VDmax25 | Gamma<br>Radiation,<br>VDmax25 | SAL Substantially<br>Equivalent | Image /page/5/Picture/4 description: The image shows a gray telephone icon inside of a white circle. A blue ring surrounds about half of the white circle. The image is cropped on the right side, but it appears to be next to some text. Image /page/5/Picture/6 description: The image shows a gray location pin icon inside of a white circle. A blue arc surrounds the top left portion of the circle. The location pin is centered inside of the circle. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for "WEI DE LI INTERNATIONAL TRADE". The logo consists of a blue circle with a white stylized "W" inside it. To the right of the circle, the text "WEI DE LI" is written in a larger, bolder font, and below it, "INTERNATIONAL TRADE" is written in a smaller font. ### Comment/ Justification. - 1. Comment #1 = The PVC tubing, TOTM, PUMP segment is different dimensionally from the predicate. However, the pump segment was tested in the performance testing using ISO 8536-4. A reference device was used to support this test method. Compatibility with the Moog Curlin infusion pump was assessed by the functional tests listed below. A reference device, K981816, was used to support these test methods. - 2. Comment #2 Blue ABS Locator Pin is not present in the predicate device as it's specific to use with the Moog Curlin infusion pump. It's an externally communicating component required for inserting the infusion set into the pump. Compatibility with the Moog Curlin infusion pump was assessed by the functional tests listed below. A reference device, K981816, was used to support these test methods. - 3. Comment #3 Yellow Flow stop ABS Box with 316L spring is not present in the predicate device as it's specific to use with the Moog Curlin Infusion Pump. It's an externally communicating component required for inserting the infusion set into the pump. Compatibility with the Moog Curlin infusion pump was assessed by the functional tests listed below. A reference device, K981816, was used to support these test methods. ### 1. Performance Testing The sterile, single use DJF Intravascular Administration Setsintended for use with Curlin (Moog) Infusion Pump, described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards. - ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications- Part 7: Connectors for intravascular or hypodermic application. - ISO 8536- 4: 2019, Infusion equipment for medical use-Part 4: Infusion sets for single use, gravity feed. ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems #### ASTM F1886/F1886M: 2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection Image /page/6/Picture/14 description: The image shows a gray telephone icon inside of a circle. The circle is partially filled with a dark blue color, indicating a completion or progress status. To the right of the icon, there is text that is not fully visible. Image /page/6/Picture/16 description: The image shows a gray location pin icon inside of a circle. The circle is partially filled with a dark blue color on the left side and a light gray color on the right side. The location pin is a common symbol used to represent a specific place or address on a map or in a digital interface. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for "WEI DE LI INTERNATIONAL TRADE". The logo consists of a blue circle with a white stylized "W" inside it on the left. To the right of the circle is the text "WEI DE LI" in a larger font, with the words "INTERNATIONAL TRADE" underneath in a smaller font. Additional functional testing was conducted to evaluate the administration set performance with Curlin (Moog) pump. The following functional tests were conducted: - -Rate Accuracy Test - -Set Installation Test - -Upstream Occlusion Test - -Downstream Occlusion Test -Testing data demonstrates that no additional safety and effectiveness issues were identified in the use of the DJF Administration Sets with Curlin (Moog) pump. DJF sets performed substantially equivalent to reference predicate, OEM Curlin pump sets/ ### 2. Biocompatibility Testing In accordance with ISO 10993-1, the DJF Intravascular Administration Sets for Curlin (Moog) Infusion Set is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hrs to 30days). The following biocompatibility tests were conducted on DJF Curlin Pump compatible devices with and without filter: - a. Cytotoxicity - b. Hemolysis - c. Irritation - d. Acute Systemic Toxicity - e. Sensitization - f. Pyrogenicity - g. Sub-Acute/Sub-Chronic Systemic Toxicity - h. Endotoxin - i. Particulate Testing ## 3. Sterility, Shipping, Shelf Life DJF Curlin Pump compatible devices have been validated for sterilization by Gamma Radiation, VDmax25 methodology in compliance with ISO 11137-3: 2017, Sterilization of Healthcare Products Shelf Life of 3 years has been assigned by testing product stored at normal storage environments. Shipping integrity has been tested with ASTM D4169-16 and shows no product damage. ## Conclusion The differences between the DJF Intravascular Administration Set and the predicate device do not raise any new or different questions of safety or effectiveness. The subject device is substantially equivalent with respect to the indications for use and technological characteristics. Image /page/7/Picture/23 description: The image shows a gray telephone icon inside of a white circle. The circle is partially surrounded by a blue arc. To the right of the circle are the words 'Telephone' and 'Fax' in gray text. Image /page/7/Picture/25 description: The image shows a gray location pin icon inside of a circle. The circle is partially filled with a dark blue color. The location pin is a common symbol used to represent a specific place or address on a map or in a digital interface.