(64 days)
No
The device description and performance studies focus on the physical components and functional performance of an administration set for an infusion pump, with no mention of AI or ML capabilities.
No
The device is described as an administration set for delivering fluids, not for treating a disease or condition itself.
No
The device description clearly states its purpose is for "delivery of fluids from a container or bag to the patient's vascular system," which indicates a therapeutic or administration function, not a diagnostic one.
No
The device description clearly outlines physical components like tubing, spike, clamp, luer lock, filters, cassette, and key, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of fluids from a container or bag to the patient's vascular system." This describes a device used for administering substances directly into the body, not for testing samples taken from the body.
- Device Description: The description details components like tubing, spikes, clamps, filters, and connectors, all consistent with an infusion set used for delivering fluids. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on aspects like flow rate accuracy, occlusion detection, biocompatibility, sterility, and shelf life – all relevant to a device used for fluid administration. There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with IVDs.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This device's function is to deliver substances into the body, not to analyze samples from the body.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
DJF Administration Sets are sterile/non-pyrogenic, single use, non-DEHP PVC tubing with a Universal Spike, Slide Clamp, Luer Lock (male) with integral anti-free flow valve (AFF) {optional, separately provided}, 0.2 micron or 1.2 micron filters, Yellow Cassette and Blue key (locator pin) for use with the Curlin IV pump. Three (3) new sets are:
- DJFCUR001: Administration set compatible with Curlin Pump
- DJFCUR002: Administration set with 0.2 micron filter compatible with Curlin Pump
- DJFCUR003: Administration set with 1.2 micron filter compatible with Curlin Pump
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)
1. Performance Testing:
The sterile, single use DJF Intravascular Administration Sets intended 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
Additional functional testing was conducted to evaluate the administration set performance with Curlin (Moog) pump:
-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.
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.
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). 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 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)
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3
K230992- 510K Summary
| Submitter Information | |
|---|---|
| Submitted By: | Yangzhou Wei De Li Trade Co. Ltd. |
| Address | Li Xin Bridge, Touqiao Township. Yangzhou City, |
| 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 | |
| which equivalence is claimed | K121803 – Intravascular Administration Set (ACTA Medical |
| LLC) | |
| Reason for 510(k) | New devices to offer an alternative infusion set for use with |
| the Curlin (MOOG) infusion pump. | |
| Device Description | DJF Administration Sets are sterile/non-pyrogenic, single use, |
| non-DEHP PVC tubing with a Universal Spike, Slide Clamp, Luer | |
| Lock (male) with integral anti-free flow valve (AFF) {optional, | |
| separately provided}, 0.2 micron or 1.2 micron filters, Yellow | |
| Cassette and Blue key (locator pin) for use with the Curlin IV | |
| pump. Three (3) new sets are: |
- DJFCUR001: Administration set compatible with Curlin
Pump - DJFCUR002: Administration set with 0.2 micron filter
compatible with Curlin Pump - DJFCUR003: Administration set with 1.2 micron filter
compatible with Curlin Pump |
| Technological Characteristics | The subject devices have the same technological material,
fit, form and functional characteristics with predicate
devices. |
| Indications for Use | DJF Intravascular Administration Sets are intended for use
with Curlin (Moog) Infusion Pump, for the delivery of fluids
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
Device DJF IV
Administration
Sets, K230992 | Predicate
Device K121803 | Discussion |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Indications for
use | DJF Intravascular
Administration
Sets are
intended for use
with Curlin
(Moog) Infusion
Pump, for
delivery of fluids
from a container
or bag to
patient's
vascular system | Intravascular
Administration
Sets intended
for delivery of
fluids from a
container or bag
to patient's
vascular system | Indications for
use are
fundamentally
substantially
equivalent |
| ABS Container
Spike | ABS Container
Spike, Non
Vented | ABS Container
Spike, Universal | Substantially
Equivalent |
| PVC Tubing,
TOTM | PVC Tubing,
TOTM | PVC Tubing,
TOTM | Substantially
Equivalent |
| PVC Tubing,
TOTM, Pump
Segment | PVC Tubing,
TOTM, Pump
Segment | NA | Different
See comment
#1 |
| Blue, ABS.
Locator Pin | Blue. ABS,
Locator Pin | NA | Different
See Comment
#2 |
| Yellow, Flow
Stop, ABS Box
with 316L Spring | Yellow, Flow
Stop, ABS Box
with 316L Spring | NA | Different
See Comment
#3 |
| ABS Male Luer | ABS Male Luer | ABS Male Luer | Substantially
Equivalent |
| Slide Clamp | Slide Clamp | Slide Clamp | Substantially
Equivalent |
| Sterilization, SAL
10-6 | Gamma
Radiation,
VDmax25 | Gamma
Radiation,
VDmax25 | SAL Substantially
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.
-
- 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.
-
- 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.
-
- 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.