High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
Device Facts
| Record ID | K253048 |
|---|---|
| Device Name | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube |
| Applicant | Shenzhen Maiwei Biotech Co., Ltd. |
| Product Code | DXT · Cardiovascular |
| Decision Date | Apr 16, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1650 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The high pressure syringe, pressure connecting tube, quick fill tube, spike and transfer tube are intended to connect with US legally marketed angiographic injectors for the injection of Contrast media or saline. They are for single use and provided sterile. For a complete list of compatible device models, accessories, and compatible injectors, refer to the device Instructions for Use.
Device Story
Single-use sterile accessories for angiographic injectors; includes high-pressure syringes, pressure connecting tubes, spikes, transfer tubes, and quick fill tubes. Devices connect to power-driven injectors to facilitate delivery of contrast media or saline into patient vasculature during imaging procedures. Syringes hold media; connecting tubes link syringe to catheter; spikes/transfer tubes/quick fill tubes enable drawing media from vials into syringe. Operated by clinicians in clinical settings. Output is the controlled delivery of contrast/saline; enables visualization of vascular structures during angiography. Benefits include reliable, sterile fluid delivery and compatibility with various injector systems.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (cytotoxicity, sensitization, reactivity, pyrogenicity, acute toxicity, hemocompatibility), sterilization validation (ISO 11135), shelf-life (ASTM F1980-21), and mechanical performance testing (ISO 8536-4, ISO 80369-7, ISO 7886-1/2, USP <788>, USP <85>).
Technological Characteristics
Materials: PC, PP, PE, PVC (DEHP-free), ABS, polydimethylsiloxane lubricant. Sensing/Actuation: Passive fluid path for power-driven injectors. Connectivity: Mechanical Luer connectors (ISO 80369-7). Sterilization: Ethylene Oxide (EO). Form factor: Various syringe volumes (60-200ml) and tube lengths/configurations. Pressure ratings: 350psi and 1200psi.
Indications for Use
Indicated for connection to US legally marketed angiographic injectors for the injection of contrast media or saline in patients requiring angiographic procedures. Not intended for infant or neonatal use.
Regulatory Classification
Special Controls
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Predicate Devices
- Sterile High-pressure Angiographic Syringes for single-use (K211564)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 16, 2026
Shenzhen Maiwei Biotech Co., Ltd.
% Jie Yang, Consultant
Chonconn Consulting Co., Ltd.
Room 504, Block C, No. 1029 Nanhai Avenue,
Nanshan District
Shenzhen, Guangdong 518067, China
Re: K253048
Trade/Device Name: High Pressure Syringe; Pressure Connecting Tube; Spike; Transfer Tube; Quick Fill Tube
Regulation Number: 21 CFR 870.1650
Regulation Name: Angiographic Injector And Syringe
Regulatory Class: Class II
Product Code: DXT
Dated: March 19, 2026
Received: March 19, 2026
Dear Jie Yang:
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).
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253048 - Jie Yang
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Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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 Rule"). 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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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K253048 - Jie Yang
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Sincerely,
Shruti N. Mistry -S
Shruti Mistry
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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253048 | |
| Device Name High Pressure Syringe; Pressure Connecting Tube; Spike; Transfer Tube; Quick fill tube | |
| Indications for Use (Describe) The high pressure syringe, pressure connecting tube, quick fill tube, spike and transfer tube are intended to connect with US legally marketed angiographic injectors for the injection of Contrast media or saline. They are for single use and provided sterile. For a complete list of compatible device models, accessories, and compatible injectors, refer to the device Instructions for Use. | |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." | |
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510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
K253048
Prepared Date: 2026/04/16
1. Submission sponsor
Name: Shenzhen Maiwei Biotech Co., Ltd.
Address: 2-10 Jinlong Blvd. South, Pingshan District, Shenzhen 518118, China
Contact person: Woody Chen
Title: Management Representative
E-mail: woody.chen@maiweibio.com
Tel: +86-755-85222663
2. Submission correspondent
Name: Chonconn Consulting Co., Ltd.
Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China
Contact person: Yang Jie
E-mail: yangjie@chonconn.com
Tel: +86-755 33941160
3. Subject Device Information
| Trade/Device Name | High Pressure Syringe;
Pressure Connecting Tube;
Spike;
Transfer tube;
Quick fill tube |
| --- | --- |
| Common Name | Angiographic injector and syringe |
| Classification Name | Injector And Syringe, Angiographic |
| Regulation Number | 870.1650 |
| Product code | DXT |
4. Predicate Device
Predicate #:K211564
Trade name: Sterile High-pressure Angiographic Syringes for single-use
Product code: DXT
5. Device Description
The subject devices, including high pressure syringe, pressure connecting tube, quick fill tube, spike and transfer tube, are available in different configuration and models. All devices are for single use and provided sterile.
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High pressure syringe: The syringes are compatible with various US legally marketed angiographic injectors, as listed in Table 1: Compatibility Between Syringes and Injectors. An accessory prime tube is specified for use with syringes A03103 and A03106.
Pressure connecting tube: Pressure connecting tubes, used to connect the syringe to the catheter, are available in multiple configurations: straight tube, coil tube, Type Y, and Type T. Their pressure specifications are detailed in Table 2: Pressure Connecting Tube Specifications.
Spike: Spikes are used to draw contrast media/saline into the syringe barrel before the syringe is installed. Pressure specifications for spikes are provided in Table 3: Pressure Specifications for Spikes.
Transfer tube: A transfer tube combines a pressure connecting tube and a spike, connected via a T-valve. It facilitates drawing contrast media/saline into the syringe barrel (using the spike end) and connecting the syringe to the catheter (via the other two ends). Pressure specifications are listed in Table 4: Pressure Specifications for Transfer Tubes.
Quick Fill Tube: Quick fill tubes serve the same purpose as spikes for pre-installation media/saline drawing. Their pressure specifications are outlined in Table 5: Specifications for Quick Fill Tubes.
Table 1 Compatibility between Syringe and Injectors
| Model | Volume (ml) | Pressure Limit | Injector |
| --- | --- | --- | --- |
| A01101 | 200 | 350psi | VCT610, K991557
ECT710, K934086 |
| A03103 | 200 | 350psi | Stellant-S, K182273 |
| A03106 | 200/200 | 350psi | Stellant-D, K182273 |
| A02203 | 150 | 1200psi | Mark V, K822536 |
| A03201 | 200 | 1200psi | |
| A05203 | 200 | 1200psi | Mark VII, K112086 |
| A01305 | 65/65 | 350psi | Spectris, K935668 |
| A02305 | 65/115 | 350psi | Spectris, K935668 |
| B03203 | 150 | 1200psi | Angiomat Illumena, K963071 |
| B02203 | 150 | 1200psi | Angiomat 6000, K944875 |
| B04106 | 200/200 | 350psi | OptiVantage Dual, K063503 |
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| Model | Volume (ml) | Pressure Limit | Injector |
| --- | --- | --- | --- |
| B01103 | 200 | 350psi | CT OptiOne, K152361 CT9000 & CT9000ADV, K912944 |
| B06106 | 125/125 | 350psi | CT OptiOne, K152361 |
| B06103 | 125 | 350psi | CT OptiOne, K152361 |
| B01305 | 60/60 | 350psi | OPTISTAR, K073592 |
| B01301 | 60 | 350psi | OPTISTAR MR, K984088 |
| C06106 | 200/200 | 350psi | Dual Shot,Dual K052633 |
| C07106 | 100/100 | 350psi | Dual Shot,Dual K052633 |
| C02203 | 125 | 1200psi | 120S K092896 |
| C03203 | 150 | 1200psi | Rempress, K092896 |
| C01305 | 60/60 | 350psi | Sonic Shot K091734 |
| F02106 | 200/200 | 350psi | Empower CT K071378 |
| F02103 | 200 | 350psi | EmpowerCT and Empower CTA Injector Systems K063029 |
| F01305 | 100/100 | 350psi | Empower MRI K062449 |
Table 2 Pressure Connecting Tube Specifications
| Model | Length | Pressure limit | Type |
| --- | --- | --- | --- |
| S0L062 | 320cm | 350psi | Straight |
| S0L150 | 250cm | 350psi | Coil |
| D0L100 | 320cm | 350psi | Y, Straight |
| D0L100C | 320cm | 350psi | Y, Coil |
| D0L100T | 320cm | 350psi | T, Straight |
| D0L100TC | 320cm | 350psi | T, Coil |
| S0H150 | 150cm | 1200psi | Straight |
| S0H250 | 250cm | 1200psi | Straight |
Table 3 Pressure Specifications for Spike
| Model | Length | Pressure limit | Type |
| --- | --- | --- | --- |
| S0L000 | 43.2mm | / | Small spike |
| S0L003 | 52.3mm | / | Large spike |
| S1L020 | 120cm | 350psi | Transfer set |
| S1L031 | 150cm | 350psi | Transfer set with one inline drip chamber |
| S1L032 | 150cm | 350psi | Transfer set with Clip |
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Table 4 Pressure Specifications for Transfer Tube
| Model | Length | Pressure limit | Type |
| --- | --- | --- | --- |
| D1L006 | 150cm | 350psi | Transfer Tube with two inline drip chambers |
| D1L151 | 150cm | 350psi | Transfer Tube |
Table 5 Specifications for Quick Fill Tube
| Model | Length |
| --- | --- |
| S0L001 | 240mm |
## 6. Intended use & Indication for use
The high pressure syringe, pressure connecting tube, quick fill tube, spike and transfer tube are intended to connect with US legally marketed angiographic injectors for the injection of Contrast media or saline.
They are for single use and provided sterile.
For a complete list of compatible device models, accessories, and compatible injectors, refer to the device Instructions for Use.
## 7. Comparison to the Predicate Device
| Characteristic | Subject device K253048 | Primary Predicate device K211564 | Remarks |
| --- | --- | --- | --- |
| Device name | high pressure syringe | Syringe | Same |
| | pressure connecting tube | Connection Tube | Same |
| | quick fill tube spike transfer tube | J shape tube Spike | Different. Note 1. |
| Product Code | DXT | DXT | Same |
| Regulation Number | 21 CFR 870.1650 | 21 CFR 870.1650 | Same |
| Indications for use | The high pressure syringe, pressure connecting tube, quick fill tube, spike and transfer tube are intended to connect with US legally marketed | Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of Contrast media or saline; they shall be used with US legally | Different, Note 2 |
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| | | angiographic injectors for the injection of Contrast media or saline. They are for single use and provided sterile. For a complete list of compatible device models, accessories, and compatible injectors, refer to the device Instructions for Use. | marketed angiographic injectors | |
| --- | --- | --- | --- | --- |
| Mode of operation | | Power-driven operation, single use | Power-driven operation, single use | Same |
| Sterility | | EO Sterilized | EO Sterilized | Same |
| Single Use | | Yes | Yes | Same |
| Accessory | | Prime tube | N/A | Different, note 3 |
| Maximum withstanding pressure | Syringe | 350psi, 1200psi | 300psi, 400psi, 1200psi | Different, note 4 |
| | Pressure Connecting tube | 350psi, 1200psi | 300psi, 400psi, 1200psi | Different, note 4 |
| | Quick fill tube/ J shape tube | NA | NA | Same |
| | Spike(including transfer tube) | 350psi | 400psi | Different , note 4 |
| Dimensi ons | Syringe (Volume, ml) | 60, 125, 150, 200, 200/200, 100/100, 65/65,125/125 65/115, 60/60 | 200, 150, 125, 130, 100, 200/200, 100/100, 65/65, 65/115, 60/60, 50/50 | Different, note 5 |
| | Pressure connecting Tube (length, mm) | 1500~3200, 1500,2500, 3200 | 200~2500, 1500~2500, 1500, 1800, 2000, 2500, 500, 750, 1000, 1200 | Different, note 5 |
| | Quick fill tube/ J | 240 | 240 | Same |
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| | shape tube
(length, mm) | | | |
| --- | --- | --- | --- | --- |
| | Spike and Transfer Tube
(length, mm) | 43.2, 52.3, 1200,1500 | 58.8, 47.3, 1000, 2800, 1200, 2900, 180, 260, 340, 420, 500, 450, 550, 600 | Different, note 5 |
| Performance | | | | |
| Syringe | | ISO 7886 | ISO 7886 | Same |
| Luer connector | | ISO 80369-7 | ISO 594-1; ISO 594-2 | Different, note 6 |
| Compatibility Testing with Corresponding Injectors”, respectively | | Pass | Pass | Same |
| Patient-Contact Material | | | | |
| Syringe | Barrel | PC (Polycarbonate) or PP (Polypropylene) | PP (polypropylene) or PET (Polyethylene terephthalate) | Different, note 7 |
| | Plunger | PE (Polyethylene) | Polyisoprene rubber | Different, note 7 |
| | Lubricant | Polydimethylsiloxane | Polydimethylsiloxane | Same |
| Pressure connecting tube | Tubing | PVC (Polyvinylchloride not made with DEHP) | PVC (Polyvinylchloride) or PVC (Polyvinylchloride not made with DEHP)or PU(Polyurethane) | Different, note 7 |
| | Luer Connectors | PC (Polycarbonate) | PC (Polycarbonate) | Same |
| | UV adhesive | Ultraviolet adhesive | Ultraviolet adhesive | Same |
| Spike/Transfer tube | Closure-piercing device | ABS (acrylonitrilebutadiene-styrene) | ABS (acrylonitrilebutadiene-styrene) | Same |
| | Filter membrane | PP (polypropylene) | PP (polypropylene) | Same |
| | Tube | Polyvinyl chloride (PVC) | Polyvinyl chloride (PVC) | Same |
| | Luer | Polycarbonate (PC) | Polycarbonate (PC) | Same |
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| | Connector | | | |
| --- | --- | --- | --- | --- |
| | Protective cap | PP (Polypropylene) | ABS (acrylonitrilebutadiene-styrene) | Different, note 7 |
| Quick fill tube/J shape tube | Tube | PE (Polyethylene) | PE (Polyethylene) | Same |
| Biocompatibility | No Cytotoxicity | No Cytotoxicity | Same | |
| | | No Irritation | No Irritation | Same |
| | | No Sensitization | No Sensitization | Same |
| | | No Pyrogen | No Pyrogen | Same |
| | | No Acute Toxicity | No Acute Toxicity | Same |
| | | No Hemolysis | No Hemolysis | Same |
| Endotoxin Limit | | 20 EU per device | 20 EU per device | Same |
| EO/ECH residue limit | | Limited Contact:≤ 24h
EO: 0.6mg/ day
ECH: 1.28mg /day
For 10kg patient (Children) as per ISO 10993-7 | Limited Contact:≤ 24h
EO: 0.6mg/ day
ECH: 1.28mg /day
For 10kg patient (Children) as per ISO 10993-7 | Same |
| Population | | Not intended for infant or neonatal use | Not intended for infant or neonatal use | Same |
| Shelf life | | 5 years | 5 years | Same |
Note 1:
The transfer tube has same design as the spike of the predicate device. They are substantially equivalent. The quick fill tube corresponds to the J shape tube of the predicate device. The difference of the device name does not raise new questions of safety and effectiveness when compared to the predicate device.
Note 2:
The indications for use are substantially equivalent. The difference in wording reflects a descriptive variation only and does not change the intended use of the devices. The difference does not raise new questions of safety and effectiveness when compared to the predicate device.
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Note 3:
The accessory prime tube is specified for use with syringes A03103 and A03106 which is compatible with Stellant-S/ Stellant-D, K182273. The prime tube is composed of polyethylene (PE) tubing and a PET particle filter. It is used only for priming and is removed before patient connection. Biocompatibility evaluation and bench performance testing has been conducted for the priming. Furthermore, it does not affect the safety or performance of the main device during patient use. Therefore, this difference does not raise new questions of safety and effectiveness when compared to the predicate device.
Note 4:
The subject devices offer fewer options for maximum withstanding pressure.
Specifically, some subject devices claim a value of 350 psi, which falls between the 300 psi and 400 psi claims of the predicate device. The claimed pressure values have been verified through performance testing, so this difference does not raise new questions of safety and effectiveness when compared to the predicate device.
Note 5:
There are differences in the available volume or length options between the subject devices and the predicate device. However, the available values are similar and within a comparable range. These differences merely provide additional clinical choices rather than new variations. Therefore, the differences do not raise new questions of safety and effectiveness when compared to the predicate device.
Note 6:
The subject devices comply with the latest effective version of the standard for verifying Luer connectors, whereas the predicate device adheres to an older version. Therefore, this difference does not raise new questions of safety and effectiveness when compared to the predicate device.
Note 7:
The subject devices use different materials for certain components compared to the predicate device. Patient-contacting materials have been evaluated through biocompatibility testing in accordance with ISO 10993-1. Therefore, this difference does not raise new questions of safety and effectiveness when compared to the predicate device.
8. Performance Data
The subject device was subjected to the following applicable testing to assure reliable design and performance under the specified testing parameters:
Biocompatibility Testing:
Per ISO 10993-1: 2018 and FDA guidance, the following tests were performed to ensure
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the biocompatibility of the subject device.
- Cytotoxicity
- Sensitization
- intracutaneous reactivity
- Material mediated pyrogenicity
- Acute systemic toxicity
- Hemocompatibility
## Sterilization and shelf life testing
Sterilization Process has been validated accordance with ISO 11135:2014.
EO/ECH residual test was performed according to ISO 10993-7.
The shelf life is determined by accelerated aging test according to ASTM F1980-21.
Package validation was conducted according to ISO 11607-1:2019.
## Mechanical and Bench Testing:
ISO 8536-4 Sixth edition 2019-09 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
ISO 80369-7 Second edition 2021-05 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
USP-NF M98830_02_01 <85> Bacterial Endotoxins Test
ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
ISO 7886-2 Second edition 2020-04 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
USP <788> Particular Matter in Injections
## 9. Clinical study
No clinical study is included in this submission
## 10. Conclusion
Substantial equivalence comparisons, performance testing and compliance with voluntary standards demonstrate that the subject device is substantially equivalent to the predicate device.
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