(317 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of the syringes and associated tubes, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as intended for the injection of contrast media or saline, which are diagnostic or procedural functions, not therapeutic.
No
The 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 or interpret diagnostic evaluations. It is an accessory to other diagnostic equipment (angiographic injectors).
No
The device description explicitly lists physical components such as disposable syringes, connection tubes, J shape tubes, and spikes, 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 "injection of contrast media or saline." This is a direct intervention on a patient, not a test performed on a sample taken from the body.
- Device Description: The components listed (syringes, tubes, spike) are all used for delivering substances into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for delivering substances during a medical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
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 syringe are intended to be used with an U.S. legally marketed angiography injector. Compatibility are shown in Table 1.
- Connection tube: it is used to connect the syringe and the catheter. The tubes are also available in various configurations, which are straight tube (used with single shot syringe), type Y and type T tube (used with dual shot syringe). The pressure specification for connection tube is provided in Table 2 Pressure Specifications for Connection Tube.
- J shape tube: it is used to draw contrast media/saline into the syringe barrel before the syringe installed.
- Spike: it is used to draw contrast media/saline into the syringe barrel before the syringe installed. The pressure specification for spike is provided in Table 3 Pressure Specifications for Spike
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
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-7:2008 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals;
- ASTM F88/F88M-15Standard test method for seal strength of flexible barrier materials;
- ASTM F1929-15Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration;
- A USP 41-NF36 2018 Bacterial Endotoxins Limit;
- A ISO 7886-1:2017 Sterile hypodermic syringes for single use-Part 1: Syringes for manual use;
- ISO 7886-2:1996 Sterile hypodermic 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
- ISO594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment -Part 1: General Requirements;
The test items include Gauging test, liquid leakage, separation force and stress cracking - A ISO594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment -Part 2: Lock Fitting;
The test items include Liquid leakage, air leakage, separation force, unscrew torque, ease of assembly, resistance to overriding and stress cracking - ISO 10993-5:2009 Biological evaluation of medical devices --Part 5: Tests for In Vitro cytotoxicity;
- A ISO 10993-10:2010 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 41 NF 36 Pyrogen Test
- A ISO 11134:2014, Sterilization of health-care Products-Ethylene Oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices
- USP Particular Matter in Injections
- Compatibility Test Report between injectors, syringe, connection tube and spike/J shape tube. The compatibility test demonstrated that each device meets performance under maximum sustained pressure specification.
No clinical study is included in this submission.
Key Results:
The Conical Lock Fitting Performance Test and Compatibility Test were performed on the proposed device and the test result demonstrated that the syringe, connection tube and spike can withstand the stated maximum pressure.
The different specifications will be selected by physician per surgical condition. In addition, the difference in syringe volume were addressed through ISO 7886 performance testing. The compatibility test and pressure test were performed on connection tube and spike and the test results demonstrated that the different length of connection tube and spike will not cause pressure leakage.
The biocompatibility test was performed on the syringe, connection tube which is made of PVC (Polyvinylchloride with DEHP) and spike. The test results demonstrated that the proposed device does not raise the adverse effect on the material.
The shelf life tests were performed on the proposed device after accelerated aging and the test results demonstrated that the proposed device has a five-year shelf life.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 7, 2020
Shenzhen Boon Medical Supply Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, 200120 Cn
Re: K192657
Trade/Device Name: Sterile High-pressure Angiographic Syringes for Single-use Regulation Number: 21 CFR 870.1650 Regulation Name: Injector And Syringe, Angiographic Regulatory Class: Class II Product Code: DXT Dated: July 1, 2020 Received: July 13, 2020
Dear Diana Hong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For CAPT Alan Stevens 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)
Device Name
Sterile High-pressure Angiographic Syringes for Single-use
Indications for Use (Describe)
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.
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.
The assigned 510(k) Number: K192657
-
- Date of Preparation: 8/5/2020
- Sponsor Identification 2.
Shenzhen Boon Medical Supply Co., Ltd.
No.18 Jirong Road, Shenkeng, Henggang Street, Longgang District Shenzhen Guangdong, China 518173
Establishment Registration Number: 3012395857 Contact Person: Mingan Mu Position: General Manager Tel: +86-755-28638515 Fax: +86-755-28638033 Email: boon@szboon.com
- Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Sterile High-pressure Angiographic Syringes for Single-use Common Name: Disposable angiographic syringe Models: Product Name Models Syringe 100101, 100103, 100113, 200101, 200102, 300101, 300105, 100104, 100114, 200103, 300103,100111, 100121, 100124, 200104, 100108, 100118, 100129, 100130,100109, 100119, 200107, 300102, 300108, 300110, 300111, 300112 Connection 400101, 400102, 400103, 600101, 600102, 500105, 500106, 500107, 500108, 400201, 400202, 400203, 600201, 600202, 500101, Tube 500102, 500103, 500104, 500201, 500202, 500203, 500204, 500205, 500206, 500207, 500208 700103 J shape tube 700101, 700102, 700104-1, 700104-2, 700105-1, 700105-2, Spike 700106, 700107-1, 700107-2
Regulatory Information
Classification Name: Injector And Syringe, Angiographic Classification: II Product Code: DXT Regulation Number: 21 CFR 870.1650 Review Panel: Cardiovascular
Indications for Use:
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.
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 syringe are intended to be used with an U.S. legally marketed angiography injector. > Compatibility are shown in Table 1.
5
| 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 |
| 100114 | 200/200ml | Dual Shots | 400 | CT 9000 & CT9000 ADV, K912944 |
| 200103 | 60/60ml | Dual Shots | 300 | Optistar LE, 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 |
| 100124 | 60/100ml | Dual Shots | 400 | Dual Shot, Κ052633 |
| 200104 | 60/60ml | Dual Shots | 300 | Sonic Shot, K091734 |
| 100108 | 200ml | Single Shot | 400 | Dual shot CТ, К062168 |
| 100118 | 200/200ml | Dual Shots | 400 | Dual shot CT, K133189 |
| 100129 | 125ml | Single Shot | 400 | CT Optione, K152361 |
| 100130 | 125/125ml | Dual Shots | 400 | CT Optione, K152361 |
| 100109 | 100ml | Single Shot | 400 | Dual shot, K062168 |
| 100119 | 100/100ml | Dual Shots | 400 | Duat shot, K062168 |
| 200107 | 100/100ml | Dual Shots | 300 | EZEM Empower, K062449 |
| 300102 | 125ml | Single Shot | 1200 | 120S, K092896 |
| 300108 | 150ml | Single Shot | 1200 | Mark VII , K112086 |
| 300110 | 150ml | Single Shot | 1200 | Rempress, K092896 |
| 300111 | 150ml | Single Shot | 1200 | Angiomat 6000, K944875 |
| 300112 | 200ml | Single Shot | 1200 | Illumena K963071 |
Table 1 Compatibility between Syringe and Injectors
A Connection tube: it is used to connect the syringe and the catheter. The tubes are also available in various configurations, which are straight tube (used with single shot syringe), type Y and type T tube (used with dual shot syringe). The pressure specification for connection tube is provided in Table 2 Pressure Specifications for Connection Tube.
6
| Maximum | ||
|---|---|---|
| Model | Withstanding Pressure | |
| (psi) | Type | |
| 400101 | 400 | Straight |
| 400102 | 400 | Type Y |
| 400103 | 400 | Type T |
| 600101 | 400 | Type T |
| 600102 | 400 | Type Y |
| 500105 | 1200 | Straight |
| 500106 | 1200 | Straight |
| 500107 | 1200 | Straight |
| 500108 | 1200 | Straight |
| 400201 | 400 | Straight |
| 400202 | 400 | Type Y |
| 400203 | 400 | Type T |
| 600201 | 400 | Type T |
| 600202 | 400 | Type Y |
| 500101 | 1200 | Straight |
| 500102 | 1200 | Straight |
| 500103 | 1200 | Straight |
| 500104 | 1200 | Straight |
| 500201 | 1200 | Straight |
| 500202 | 1200 | Straight |
| 500203 | 1200 | Straight |
| 500204 | 1200 | Straight |
| 500205 | 1200 | Straight |
| 500206 | 1200 | Straight |
| 500207 | 1200 | Straight |
| 500208 | 1200 | Straight |
Table 2 Pressure Specifications for Connection Tube
-
J shape tube: it is used to draw contrast media/saline into the syringe barrel before the syringe installed.
- Spike: it is used to draw contrast media/saline into the syringe barrel before the syringe installed. > The pressure specification for spike is provided in Table 3 Pressure Specifications for Spike
7
| Maximum | ||
|---|---|---|
| Model | Withstanding Pressure | |
| (psi) | Type | |
| 700101 | / | Long spike |
| 700102 | / | Short spike |
| 700104-1 | 400 psi | Single Air Chamber |
| Transfer Set | ||
| 700104-2 | 400 psi | Single Air Chamber |
| Transfer Set with Extension | ||
| Tube | ||
| 700105-1 | 400 psi | Dual Air Chamber Tranfer |
| Set | ||
| 700105-2 | 400 psi | Dual Air Chamber Tranfer |
| Set with extension tube | ||
| 700106 | / | Transfer Set With C-Clamp |
| 700107-1 | / | Transfer set with Clave |
| connector | ||
| 700107-2 | / | Clave connector Transfer |
| set with Check valve |
Table 3 Pressure Specifications for Spike
- ડ. Identification of Predicate Device
510(k) Number: K151960
Product Name: Sterile High-pressure Angiographic Syringes for Single-use Manufacturer: Shenzhen Boon Medical Supply Co., Ltd
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
ISO 10993-7:2008 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals;
-
ASTM F88/F88M-15Standard test method for seal strength of flexible barrier materials;
-
ASTM F1929-15Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration;
8
- A USP 41-NF36 2018 Bacterial Endotoxins Limit;
- A ISO 7886-1:2017 Sterile hypodermic syringes for single use-Part 1: Syringes for manual use;
-
ISO 7886-2:1996 Sterile hypodermic 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
-
ISO594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment -Part 1: General Requirements;
The test items include Gauging test, liquid leakage, separation force and stress cracking -
A ISO594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment -Part 2: Lock Fitting;
The test items include Liquid leakage, air leakage, separation force, unscrew torque, ease of assembly, resistance to overriding and stress cracking -
ISO 10993-5:2009 Biological evaluation of medical devices --Part 5: Tests for In Vitro cytotoxicity;
-
A ISO 10993-10:2010 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 41 NF 36 Pyrogen Test
-
A ISO 11134:2014, Sterilization of health-care Products-Ethylene Oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices
-
USP Particular Matter in Injections
-
Compatibility Test Report between injectors, syringe, connection tube and spike/J shape tube. The compatibility test demonstrated that each device meets performance under maximum sustained pressure specification.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
9
Substantially Equivalent (SE) Comparison 8.
| Table 4 Comparison of Technology Characteristics | ||||
|---|---|---|---|---|
| Item | Proposed Device | Predicate Device | Comments | |
| Product Code | DXT | DXT | Same | |
| Regulation Number | CFR 870.1650 | CFR 870.1650 | Same | |
| Indications for Use | The proposed 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. | 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. | Same | |||
| 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 | |||
| Connecting tube | ||||
| J shape tube/Spike | Angiographic Syringe | |||
| Connecting tube | ||||
| J shape tube/Spike | Same | |||
| Sterility | EO Sterilized | EO Sterilized | Same | |
| Single Use | Yes | Yes | Same | |
| Maximum | ||||
| withstanding | ||||
| pressure | Syringe | 300psi, 400psi, 1200psi | 300psi, 1200psi | Difference #1 |
| Connection tube | 300psi, 400psi, 1200psi | 300psi, 1200psi | Difference #1 | |
| J shape tube | / | / | Same | |
| Spike | 400 psi | / | Difference #1 | |
| Specification | Syringe | |||
| (Volume, ml) | 200, 150, 125, 130, 100, | |||
| 200/200, 60/100, 125/125, | ||||
| 100/100, 65/65, 65/115, 60/60, | ||||
| 50/50 | 200, 150, 130, 200/200, 60/100, | |||
| 65/65, 65/115, 60/60, 50/50, | Difference #2 | |||
| Connection tube | ||||
| (overall Length, | ||||
| mm) | 200 | |||
| 1800, 2000, 2500, 500, 750, | ||||
| 1000, 1200 | 1500, 1800, 500, 750, 1000, | |||
| 1200 | Difference #2 | |||
| J shape tube | ||||
| (overall Length, | ||||
| mm) | 240 | 240 | Same | |
| Spike | ||||
| (overall Length, | 58.8, 47.3, 1000, 2800, 1200, | |||
| 2900, 180, 260, 340, 420, 500 | 58.85, 47.35 | Difference #2 | ||
| mm) | 450, 550, 600 | |||
| Performance | ||||
| Syringe | ISO 7886 | ISO 7886 | Same | |
| Luer connector | ISO 594-1; ISO 594-2 | ISO 594-1; ISO 594-2 | Same | |
| Compatibility | Pass | Pass | Same | |
| Patient-Contact Material | ||||
| Syringe | Barrel | PP (polypropylene) or PET | ||
| (Polyethylene terephthalate) | PP (polypropylene) or PET | |||
| (Polyethylene terephthalate) | Same | |||
| Piston | Polyisoprene rubber | Polyisoprene rubber | Same | |
| Lubricant | Polydimethylsiloxane | Polydimethylsiloxane | Same | |
| Connection | ||||
| tube | Tubing | PVC (Polyvinylchloride with | ||
| DEHP) or PVC | ||||
| (Polyvinylchloride without | ||||
| DEHP) or PU (Polyurethane) | PVC (Polyvinylchloride) or PU | |||
| (Polyurethane ) | Difference #3 | |||
| Luer connectors | PC (Polycarbonate) | PC (Polycarbonate) | Same | |
| UV adhesive | Ultraviolet adhesive | Ultraviolet adhesive | Same | |
| Closure-piercing | ||||
| device | ABS | |||
| (acrylonitrile-butadiene-styrene) | ABS | |||
| (acrylonitrile-butadiene-styrene) | Same | |||
| Spike | Filter membrane | PP (polypropylene) | PP (polypropylene) | Same |
| Tube | Polyvinyl chloride (PVC) | Difference #3 | ||
| Luer Connector | Polycarbonate (PC) | / | ||
| Protective cap | Acrylonitrile-butadiene-styrene | |||
| (ABS) | ||||
| J shape tube | tube | PE (Polyethylene) | PE (Polyethylene) | Same |
| Biocompatibility | No Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| No Irritation | No Irritation | No Irritation | Same | |
| No Sensitization | No Sensitization | No Sensitization | Same | |
| No Pyrogen | No Pyrogen | No Pyrogen | Same | |
| No Acute Toxicity | No Acute Toxicity | No Acute Toxicity | Same | |
| No Hemolysis | No Hemolysis | No Hemolysis | Same | |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same | |
| Shelf Life | 5 year | 3 year | Difference #4 |
Table 4 Comparison of Technology Characteristics
10
Substantial Equivalence Discussion
Difference #1 – Maximum withstanding pressure
The maximum withstanding pressure for syringe, connection tube and spike of proposed device is different from the predicate device. However, the Conical Lock Fitting Performance Test and Compatibility Test were performed on the proposed device and the test result demonstrated that the
11
syringe, connection tube and spike can withstand the stated maximum pressure. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Difference #2 – Specification
The specification for volume of syringe, length of connection tube and spike is different from the predicate device. However, the different specifications will be selected by physician per surgical condition. In addition, the difference in syringe volume were addressed through ISO 7886 performance testing. The compatibility test and pressure test were performed on connection tube and spike and the test results demonstrated that the different length of connection tube and spike will not cause pressure leakage. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Difference #3 - Patient-Contact Material
The patient-contact material for connection tube and spike of proposed device is different from the predicate device. The material of tubing of connection tube for proposed device, which is made of PVC (Polyvinylchloride without DEHP) or PU (Polyurethane), is the same as the material of tubing of Connection tube for predicate device, which is also manufactured by Shenzhen Boon Medical Supply Co., Ltd. In addition, the biocompatibility test was performed on the syringe, connection tube which is made of PVC (Polyvinylchloride with DEHP) and spike. The test results demonstrated that the proposed device does not raise the adverse effect on the material. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Difference #4 - Shelf Life
The shelf life of the proposed device is different from predicate device. However, the shelf life tests were performed on the proposed device after accelerated aging and the test results demonstrated that the proposed device has a five-year shelf life. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Substantially Equivalent (SE) Conclusion 9.
The results of performance tests performed on the proposed device can demonstrate the proposed devices are complied 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 proposed device are biocompatible.
Based on the comparison above, the proposed device. Sterile High-pressure Angiographic Syringes for Single-use, is determined to be Substantially Equivalent (SE) to the predicate device.