(122 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of disposable syringes and accessories for contrast media injection, with no mention of AI or ML.
No.
The device is intended for the injection of contrast media or saline, which are diagnostic/imaging agents, not therapeutic agents. It facilitates a diagnostic procedure rather than providing treatment.
No
This device is intended for the injection of contrast media or saline, which are used to enhance images for diagnostic purposes, but the device itself does not perform any diagnostic function. It is an accessory to imaging procedures, not a diagnostic tool.
No
The device description explicitly lists physical components such as syringes, connection tubes, J shape tubes, and spikes, and the performance studies describe nonclinical tests on these physical components.
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 "injection of contrast media or saline." This is a direct administration of substances into the body for imaging purposes, not for testing samples in vitro (outside the body).
- Device Description: The components described (syringes, connection tubes, J shape tube, spike) are all designed for the physical process of drawing and injecting fluids. They are not designed to analyze biological samples or provide diagnostic information based on those samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic results based on testing.
The device is clearly intended for use in a medical procedure (angiography) involving the administration of substances, which falls under the category of medical devices used for treatment or diagnosis through direct intervention, not in vitro testing.
N/A
Intended Use / Indications for Use
Single-use Sterile High-pressure Angiographic Syringe and Accessories are intended for the injection of contrast media or saline, they shall be used with U.S. legally marketed angiographic injectors.
Product codes (comma separated list FDA assigned to the subject device)
DXT
Device Description
The proposed device is intended for the injection of contrast media or saline. It includes disposable syringes, connection tube, J shape tube, and spike.
Syringe: The syringes are intended to be used with an U.S. legally marketed angiographic injector.
Connection tube: it is used to connect the syringe and the catheter. The tubes (extension tube) are also available in various configurations, which are Type B (used with single shot syringe, highlighted in Red mark), renamed "Straight tube" to "Type B" and added a new model (400204) connecting tube in the Table. The product structure, manufacturing process, product materials have not changed. Type Y and type T tube are used with dual shots syringe.
J shape tube: it is used to draw contrast media/saline into the syringe barrel before installation.
Spike: it is used to draw contrast media/saline into the syringe barrel before the syringe installation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Nonclinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-7:2008 Biological evaluation of Medical device- Part 7: Ethylene oxide sterilization residuals;
ASTM F88/F88M-23 Standard test method for seal strength of flexible barrier materials: ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration;
USP-NF Bacterial Endotoxin Limit;
ISO 7886-1: 2017 Sterile hypodemic syringes for Single-use-Part 1: Syringes for manual use; ISO 7886-2: 2020 Sterile hypodemic syringes for Single-use-Part 2: Syringes for use with power-driven syringe pumps;
- The test items include Lubricant weight, Graduated capacity tolerance, overall length of । scale, syringe dimension, nozzle lumen, dead space, liquid leakage, air leakage and flow characteristics;
ISO 80369-7: 2021 Small-bore connectors for liquids and gases in healthcare applications -Part 7: Connectors for intravascular or hypodermic applications ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: Tests for In Vitro Cytotoxicity;
ISO 10993-10:2021 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization;
ISO 10993-4: 2017 Biological Evaluation of Medical Device -Part 4: Selection of tests for interactions with blood:
ASTM F756: 2017, Standard Practice for Assessment of Hemolytic Properties of Materials USP-NF Pyrogen Test
Compatibility Test Report includes information between injectors, syringe, connection tube and spike/J shape tube. The compatibility test demonstrated that each device meets performance under maximum sustained pressure specifications.
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.
Not Found
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
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image 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.
August 22, 2024
Shenzhen Boon Medical Supply Co., Ltd. Shengyu Fan International Regulation Commissioner No.18 Jirong Road, Shenkeng, Henggang Street Longgang District Shenzhen, Guangdong 518173, China
Re: K241109
Trade/Device Name: Single-use Sterile High-pressure Angiographic Syringes and Accessories Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: July 20, 2024 Received: July 22, 2024
Dear Shengyu Fan:
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).
1
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, Shruti N. Mistry -S
Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K241109
Device Name
Single-use Sterile High-pressure Angiographic Syringes and Accessories
Indications for Use (Describe)
Single-use Sterile High-pressure Angiographic Syringe and Accessories are intended for the injection of contrast media or saline, they shall be used with U.S. legally marketed angiographic injectors.
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
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
-
- Date of Preparation: March 3, 2024
2. Applicant Identification: Shenzhen Boon Medical Supply Co., Ltd. No.18 Jirong Road, Shenkeng, Henggang Street, Longgang District Shenzhen Guangdong, China 518173
Establishment Registration Number: 3012395857 Contract Person: Gui Wenjuan
Position: Management Representative Tel: +86-755-28638515
Fax: +86-755-28638033 E-mail: guiwenjuan@szboon.com
Subject Device Information:
The assigned 510(k) Number: K241109 Trade Name: Single-use Sterile High-pressure Angiographic Syringes and Accessories Common Name: Disposable angiographic syringe Models
Regulatory Information:
Classification Name: Injector And Syringe, Angiographic Classification: II Product Code: DXT Regulation Number: 21 CFR 870.1650 Review Panel: General Hospital
3. Identification of Predicate Device
510(k) Number: K211564 Product Name: Sterile High-pressure Angiographic Syringes for Single-use Manufacturer: Shenzhen Boon Medical Supply Co., Ltd.
-
- Designated Submission Correspondent Shengyu Fan (Primary Contact Person) E-mail:
faguibu07@szboon.com
DARCO International Co., Ltd. 510 Shotgun Rd. Suite 520, Sunrise, FI 33326
Tel: 954-380-8595
Fax: 877-804-4505
4
E-mail: ahr@darcointernational.net
5
5. Description of Proposed Device
| Product Name | Models |
|---|---|
| Syringe | 100101, 100103, 100113, 200101, 200102, 300101, 300105, 100104, |
| 100114, 200103, 300103, 100111, 100121, 100123, 100124, 100125, | |
| 200104, 100108, 100118, 100129, 100130, 100109, 100119, 200107, | |
| 300102, 300108, 300110, 300111, 300112, 100110, 100120, 100112, | |
| 100122, 300107, 200105, 200113, 200110, 200111 | |
| Connection Tube | 400101, 400102, 400103, 600101, 600102, 500105, 500106, 500107, |
| 500108, 400201, 400202, 400203, 400204, 600201, 600202, 500101, | |
| 500102, 500103, 500104, 500201, 500202, 500203, 500204, 500205, | |
| 500206, 500207, 500208 | |
| J Shape tube | 700103 |
| Spike | 700101, 700102, 700104-1, 700104-2, |
| 700105-1, 700105-2, 700106, 700107-1, 700107-2, | |
| 700204-1, 700204-2, | |
| 700205-1, 700205-2, 700206, 700207-1, 700207-2 |
Indications for Use:
Single-use Sterile High-pressure Angiographic Syringe and Accessories are intended for the injection of contrast media or saline, they shall be used with U.S. legally marketed angiographic injectors.
Device Description:
The proposed device is intended for the injection of contrast media or saline. It includes disposable syringes, connection tube, J shape tube, and spike.
Syringe: The syringes are intended to be used with an U.S. legally marketed angiographic injector.
Compatibility is shown in the Table 1 Compatibility between Syringe and Injectors. (Note: the newly added and the difference between K211564 and the proposed device is highlighted in Red.)
6
510(K) Summary Table 1 Compatibility between Syringe and Injectors
| Model
(Syringe) | Volume (ml) | Type | Resistant
liquid leak
pressure (psi) | Injector |
|--------------------|-------------|-------------|--------------------------------------------|----------------------------------------------------------------------------------|
| 100101 | 200ml | Single shot | 400 | MCT&MCT Plus CT, K924116
Vistron CT, K991557
EnVision CT, K934086 |
| 100103 | 200ml | Single shot | 400 | Stellant-S, K182273 |
| 100113 | 200/200ml | Dual shots | 400 | Stellant-D, K182273 |
| 200101 | 65/65ml | Dual shots | 300 | Spectris, K935668 |
| 200102 | 65/115ml | Dual shots | 300 | Solaris MRI, K033247 |
| 300101 | 150ml | Single shot | 1200 | Mark V, K822536 |
| 300105 | 130ml | Single shot | 1200 | Mark III&Mark IV, K822536 |
| 100104 | 200ml | Single shot | 400 | CT 9000&CT9000 ADV, K912944
CT OptiVantage, K063503 |
| 100114 | 200/200ml | Dual shots | 400 | CT 9000&CT9000 ADV, K912944
CT OptiVantage, K063503 |
| 200103 | 60/60ml | Dual shots | 300 | Optistar LF, Elite, K073592 |
| 300103 | 150ml | Single shot | 1200 | ILLUMENA, K963071 |
| 100111 | 200ml | Single shot | 400 | Empower CT, K071378 |
| 100121 | 200/200ml | Dual shots | 400 | Empower CT, K071378 |
| 100123 | 100/200ml | Dual shots | 400 | Dual Shots, K052633
Dual shots Alpha, K062168 |
| 100124 | 60/100ml | Dual shots | 400 | Dual Shots, K052633
Dual shots Alpha, K062168 |
| 100125 | 60/200ml | Dual shots | 400 | Dual Shots, K052633
Dual shots Alpha, K062168 |
| 200104 | 60/60ml | Dual shots | 300 | Sonic Shot, K091743 |
| 100108 | 200ml | Single shot | 400 | Dual shots CT, K062168
Dual shots Alpha, K062168 |
| 100118 | 200/200ml | Dual shots | 400 | Dual shots CT, K133189
Dual shots Alpha, K062168 |
| 100129 | 125ml | Single shot | 400 | CT Optione, K152361 CT
OptiVantage, K063503 CT 9000&CT
9000ADV,
K912944 |
| 100130 | 125/125ml | Dual shots | 400 | CT Optione, K152361 CT
OptiVantage, K063503 CT 9000&CT
9000ADV,
K912944 |
| | | | | |
| 100109 | 100ml | Single shot | 400 | Dual Shots, K062168
Dual shots Alpha, K062168 |
| 100119 | 100/100ml | Dual shots | 400 | Dual Shots, K062168
Dual shots Alpha, K062168 |
| 200107 | 100/100ml | Dual shots | 300 | EZEM Empower MR, K062449 |
| 300102 | 125ml | Single shot | 1200 | 120S, K092896 |
| 300108 | 150ml | Single shot | 1200 | Mark VII, K122086 |
| 300110 | 150ml | Single shot | 1200 | Rempress, K092896 |
| 300111 | 150ml | Single shot | 1200 | Angiomat 6000, K944875 |
| 300112 | 200ml | Single shot | 1200 | Illumena, K963071 |
| 100110 | 200ml | Single shot | 400 | Medrad V Plus, K903390 |
| 100120 | 200/200ml | Dual shots | 400 | Medrad V Plus, K903390 |
| 100112 | 200ml | Single shot | 400 | Accutron CT& Accutron CT-D |
| 100122 | 200/200ml | Dual shots | 400 | Accutron CT-D |
| 300107 | 200ml | Single shot | 1200 | Accutron HP& Accutron HP-D |
| 200105 | 65/65ml | Dual shots | 300 | Accutron MR, |
| 200113 | 65/200ml | Dual shots | 300 | Accutron MR, |
| 200110 | 65/115ml | Dual shots | 300 | Medrad MRXperion,
K182276 |
| 200111 | 115ml | Single shot | 300 | Spectris&Solaris, K033247 |
7
Connection tube: it is used to connect the syringe and the catheter. The tubes (extension tube) are also available in various configurations, which are Type B (used with single shot syringe, highlighted in Red mark), renamed "Straight tube" to "Type B" and added a new model (400204) connecting tube in the Table. The product structure, manufacturing process, product materials have not changed. Type Y and type T tube are used with dual shots syringe. The pressure specification for connection tube is provided in Table 2 Pressure Specifications for Connection Tube. (Note: the newly added and the difference between K211564 and proposed device is highlighted in Red)
| Model | Maximum Withstanding Pressure
(psi) | Type |
|--------|----------------------------------------|--------|
| 400101 | 400 | Type B |
| 400102 | 400 | Type Y |
| 400103 | 400 | Type T |
| 600101 | 400 | Type T |
| 600102 | 400 | Type Y |
| 500105 | 1200 | Type B |
Table 2 Pressure Specifications for Connection Tube
8
| 510(K) Summary | ||
|---|---|---|
| 500106 | 1200 | Type B |
| 500107 | 1200 | Type B |
| 500108 | 1200 | Type B |
| 400201 | 400 | Type B |
| 400202 | 400 | Type Y |
| 400203 | 400 | Type T |
| 400204 | 400 | Type B |
| 600201 | 400 | Type T |
| 600202 | 400 | Type Y |
| 500101 | 1200 | Type B |
| 500102 | 1200 | Type B |
| 500103 | 1200 | Type B |
| 500104 | 1200 | Type B |
| 500201 | 1200 | Type B |
| 500202 | 1200 | Type B |
| 500203 | 1200 | Type B |
| 500204 | 1200 | Type B |
| 500205 | 1200 | Type B |
| 500206 | 1200 | Type B |
| 500207 | 1200 | Type B |
| 500208 | 1200 | Type B |
J shape tube: it is used to draw contrast media/saline into the syringe barrel before installation.
Spike: it is used to draw contrast media/saline into the syringe barrel before the syringe installation. The pressure specification for the spike is provided in the following table as Table 3 Pressure Specifications for Spike (Note: this model is only used to distinguish whether it is made with or without DEHP). The product materials, manufacturing process and product structure have not changed. Spikes not made with DEHP are marked with Red. The new additions of spike models are: 700204- 1, 700204-2,700205-1, 700205-2, 700206, 700207-1, 700207-2)
| Table 3 Pressure Specifications for Spike | ||
|---|---|---|
| Model (contains
DEHP)
Original | Model (not
made with DEHP)
New
added | Maximum
Withstanding
Pressure (psi) | Type |
|--------------------------------------|-----------------------------------------------|-------------------------------------------|------------------------------------|
| 700101 | / | / | Long Spike |
| 700102 | / | / | Short Spike |
| 700104-1 | 700204-1 | 400 | Single Air
Chamber Transfer Set |
9
| 700104-2 | 700204-2 | 400 | Single Air Chamber
Transfer Set with
Extension
Tube |
|----------|----------|-----|--------------------------------------------------------------|
| 700105-1 | 700205-1 | 400 | Dual Air Chamber
Transfer Set |
| 700105-2 | 700205-2 | 400 | Dual Air Chamber
Transfer Set with
Extension Tube |
| 700106 | 700206 | / | Transfer Set with
C-Clamp |
| 700107-1 | 700207-1 | / | Transfer Set with
Clave Connector |
| 700107-2 | 700207-2 | / | Clave connector
ansfer set with Check
valve |
6. Non-Clinical Test Conclusion
Nonclinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-7:2008 Biological evaluation of Medical device- Part 7: Ethylene oxide sterilization residuals;
ASTM F88/F88M-23 Standard test method for seal strength of flexible barrier materials: ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration;
USP-NF Bacterial Endotoxin Limit;
ISO 7886-1: 2017 Sterile hypodemic syringes for Single-use-Part 1: Syringes for manual use; ISO 7886-2: 2020 Sterile hypodemic syringes for Single-use-Part 2: Syringes for use with power-driven syringe pumps;
- The test items include Lubricant weight, Graduated capacity tolerance, overall length of । scale, syringe dimension, nozzle lumen, dead space, liquid leakage, air leakage and flow characteristics;
ISO 80369-7: 2021 Small-bore connectors for liquids and gases in healthcare applications -Part 7: Connectors for intravascular or hypodermic applications ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: Tests for In Vitro Cytotoxicity;
ISO 10993-10:2021 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization;
ISO 10993-4: 2017 Biological Evaluation of Medical Device -Part 4: Selection of tests for interactions with blood:
ASTM F756: 2017, Standard Practice for Assessment of Hemolytic Properties of Materials USP-NF Pyrogen Test
Compatibility Test Report includes information between injectors, syringe, connection tube and spike/J shape tube. The compatibility test demonstrated that each device meets performance
10
under maximum sustained pressure specifications.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
11
8. Substantially Equivalent (SE) Comparison
Table 4 Comparison of Technology Characteristics
| Item | Proposed Device K241109 | Predicate Device K211564 | Comments | |
|---|---|---|---|---|
| Product Code | DXT | DXT | Same | |
| Regulation | ||||
| Number | CFR 870.1650 | CFR 870.1650 | Same | |
| Indications for Use | The proposed device, Single-use | |||
| Sterile High-pressure Angiographic | ||||
| Syringes and Accessories are | ||||
| intended for the injection of contrast | ||||
| media or saline, they shall be used | ||||
| with U.S. legally marketed | ||||
| angiographic injectors. | The predicate device, Sterile High- | |||
| pressure Angiographic Syringes | ||||
| for Single-use are intended for the | ||||
| injection of contrast media or saline; | ||||
| they shall be used with an US legally | ||||
| marketed angiographic injectors | Different 1 | |||
| Prescription only | ||||
| (Rx) | Prescription only (Rx) | Prescription only (Rx) | Same | |
| Mode of operation | Power-driven operation, single-use | Power-driven operation, single-use | Same | |
| Configuration | Angiographic Syringe | Angiographic Syringe | Same | |
| Connection tube | Connection tube | Same | ||
| J shape tube/ Spike | J shape tube/ Spike | |||
| Sterility | EO Sterilized | EO Sterilized | Same | |
| Single Use | Yes | Yes | Same | |
| Syringe | 300psi, 400psi, 1200psi | 300psi, 400psi, 1200psi | Same | |
| Connection tube | 300psi, 400psi, 1200psi | |||
| New model added (400204). | 300psi, 400psi, 1200psi | Different 2 | ||
| J shape tube | / | / | ||
| Spike | 400psi | 400psi | Same | |
| Syringe Specification | ||||
| (Volume/ ml) | 200, 150, 125, 130, 100, 200/200, | |||
| 60/100, 125/125, 100/100, 65/65, 65/ | ||||
| 115, 60/60, 50/50, 100/200, 115, | ||||
| 65/200 | ||||
| 11 new models added. | 200, 150, 125, 130, 100, 200/200, 60/100, | |||
| 125/125,100/100,65/65,65/115,60/60, | ||||
| 50/50 | Different 3 | |||
| Connection tube Specification | ||||
| (overall length,mm) | 200 | |||
| 2000, 2500, 500, 750, 1000, 1200 | 200 | |||
| 2500, 500, 750, 1000, 1200 | Same | |||
| J shape tube Specification | ||||
| (overall length, mm) | 240 | 240 | Same | |
| Spike Specification (overall | ||||
| length,mm) | 58.8,47.3, 1000,2800, 1200,2900, | |||
| 180,260,340,420,500,450,550,600 | 58.8,47.3, 1000,2800, 1200,2900, 180,2 | |||
| 60,340,420,500,450,550,600 | Same | |||
| Performance | ||||
| Syringe | ISO 7886 | ISO 7886 | Same | |
| Luer connector | ISO 80369-7 | ISO 80369-7 | Same | |
| Compatibility | Pass | Pass | Same | |
| Patient-Contact Material | ||||
| Syringe | Barrel | PP (Polypropylene) or PET | ||
| (Polyethylene terephthalate) | PP (Polypropylene) or PET (Polyethylene | |||
| terephthalate) | Same | |||
| Syringe | Piston | Polyisoprene rubber | Polyisoprene rubber | Same |
| Syringe | Lubricant | Polydimethylsiloxane | Polydimethylsiloxane | Same |
| Connection tube | Tubing | PVC (Polyvinylchloride with DEHP) | ||
| or PVC | ||||
| (Polyvinylchloride without DEHP) | ||||
| or PU (Polyurethane) | PVC (Polyvinylchlori de with DEHP) or | |||
| PVC | ||||
| (Polyvinylchloride without DEHP) or | ||||
| PU (Polyurethane) | Same | |||
| Connection tube | Luer | |||
| connectors | PC (Polycarbonate) | PC (Polycarbonate) | Same | |
| Connection tube | UV | |||
| adhesive | Ultraviolet adhesive | Ultraviolet adhesive | Same | |
| Spike | Closure- | |||
| piercing | ||||
| device | ABS (acrylonitrile-butadiene | |||
| -styrene) | ABS (acrylonitrile-butadiene | |||
| -styrene) | Same | |||
| Spike | Filter | |||
| membrane | PP | |||
| (polypropylene) | PP | |||
| (polypropylene) | Same | |||
| Spike | Tube | Polyvinyl chloride (PVC) | Polyvinyl chloride (PVC) | Same |
| Spike | Luer | |||
| connector | carbonate (PC) | carbonate (PC) | Same | |
| Spike | Protective | |||
| cap | Acrylonitrile-butadiene | |||
| -styrene (ABS) | Acrylonitrile-butadiene | |||
| -styrene (ABS) | Same | |||
| J shape tube | PE (Polyethylene) | PE (Polyethylene) | Same | |
| No Cytotoxicity | No Cytotoxicity | Same | ||
| No Irritation | No Irritation | Same | ||
| Biocompatibility | 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 | |
| Shelf Life | 5-year | 5-year | Same |
12
13
14
15
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- Equivalence Discussion:
Different #1: Compared to the predicate device, the proposed device changed the product name from Sterile High-pressure Angiographic Syringes for Single-use to: Single-use Sterile Highpressure Angiographic Syringes and Accessories. The indications for use of the product share the same contents.
- Equivalence Discussion:
Different #2: Compared to the predicate device, a new connection tube model 400204 is introduced to the proposed device. Model 400204 is almost identical to 400202, the only difference is that the former has one more check valve than the latter. And the materials, manufacturing process, pressure rating (up to 400 psi, see compatibility test report), wall thickness (0.70±0.05mm) and length (200mm - 2500 mm) of 400204 are the same with the existing models of 400201, 400202 and 400203. The results of performance tests completed on the proposed device demonstrate that the proposed devices comply with FDA recognized standards, which the predicate device also complied with. The results of biocompatibility studies performed on the proposed device demonstrate that the patient materials used in the proposed device are biocompatible
Different #3: Compared the predicated device, the specifications of syringes have added 115ml, 100/200ml and 65/200ml in the proposed device, and the compatibility table between the proposed device and predicate device are shown in Table 1. The difference and the newly added devices are marked in Red.
The results of performance tests completed on the proposed device demonstrate that the proposed devices comply with FDA recognized standards, which the predicate device also complied with. The results of biocompatibility studies performed on the proposed device demonstrate that the patient materials used in the proposed device are biocompatible.
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- Substantial Equivalence Conclusion:
Based on the comparison above, the differences between the subject and predicate devices do not raise any new or different questions of safety and effectiveness when compared to the predicate device. The proposed device, Single-use Sterile High Pressure Angiographic Syringes and Accessories is determined to be Substantially Equivalent (SE) to the predicate device.
- Substantial Equivalence Conclusion: