(317 days)
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.
The proposed device is intended for the injection of contrast media or saline. It includes disposable syringes, connection tube, J shape tube and spike.
The provided text is a 510(k) Summary for a medical device (Sterile High-pressure Angiographic Syringes for Single-use). It describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria in a clinical setting.
Therefore, I cannot provide information regarding:
- Acceptance Criteria and Reported Device Performance for clinical outcomes: The document focuses on performance specifications (e.g., pressure, sterility, biocompatibility) of the device components, not clinical performance metrics or specific acceptance criteria for a clinical study.
- Sample size for the test set and data provenance: No clinical test set is described. The "test set" here refers to samples used for non-clinical engineering and biological tests.
- Number of experts and qualifications, and adjudication method: These pertain to clinical studies with a ground truth established by experts, which is not applicable here.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This is a type of clinical study not performed or referenced in this document.
- Effect size of human readers with/without AI assistance: This is irrelevant as the device is a syringe and connection tube, not an AI-assisted diagnostic tool.
- Standalone (algorithm only without human-in-the-loop performance): This is also irrelevant for this type of medical device.
- Type of ground truth used: Ground truth, typically defined by expert consensus or pathology in a clinical context, is not applicable here. The "ground truth" for these non-clinical tests is adherence to established engineering and biological standards.
- Sample size for the training set and how the ground truth for the training set was established: These concepts are related to machine learning and AI, which are not relevant to the described device.
What the document does provide in relation to "acceptance criteria" and "study that proves the device meets the acceptance criteria" (within the scope of a 510(k) for a physical medical device):
The document details a series of non-clinical tests performed to demonstrate that the proposed device meets established performance standards and is substantially equivalent to a predicate device. These standards effectively act as the "acceptance criteria" for the device's design and manufacturing.
Here's a summary of the non-clinical acceptance criteria (standards/tests) and the reported performance:
1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| Biocompatibility | |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Complies (implied by "Non clinical tests were conducted to verify... met all design specifications") |
| ISO 10993-5:2009 (Tests for In Vitro cytotoxicity) | No Cytotoxicity |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | No Irritation, No Sensitization |
| ISO 10993-4:2017 (Selection of tests for interactions with blood) & ASTM F756:2017 (Hemolytic Properties) | No Hemolysis |
| USP 41 NF 36 <151> (Pyrogen Test) | No Pyrogen |
| Endotoxin Limit (USP 41-NF36 2018 <85>) | 20 EU per device |
| Functionality & Performance | |
| ISO 7886-1:2017 (Sterile hypodermic syringes for manual use) | Complies with test items (Overall length of scale, syringe dimension, nozzle lumen, dead space, liquid leakage, air leakage, flow characteristics) |
| ISO 7886-2:1996 (Sterile hypodermic syringes for use with power-driven syringe pumps) | Complies with test items (Lubricant weight, Graduated capacity tolerance, overall length of scale, syringe dimension, nozzle lumen, dead space, liquid leakage, air leakage and flow characteristics) |
| ISO 594-1:1986 (Conical fittings with a 6% (Luer) taper - General Requirements) | Complies with test items (Gauging test, liquid leakage, separation force and stress cracking) |
| ISO 594-2:1998 (Conical fittings with a 6% (Luer) taper - Lock Fitting) | Complies with test items (Liquid leakage, air leakage, separation force, unscrew torque, ease of assembly, resistance to overriding and stress cracking) |
| Compatibility Test Report (Injectors, syringe, connection tube, spike/J shape tube) | Each device meets performance under maximum sustained pressure specification. Syringe, connection tube, and spike can withstand stated maximum pressure. |
| Sterilization & Packaging | |
| ASTM F88/F88M-15 (Seal strength of flexible barrier materials) | Complies |
| ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Package by Dye Penetration) | Complies |
| ISO 11134:2014 (Ethylene Oxide Sterilization) | Complies |
| USP <788> (Particular Matter in Injections) | Complies |
| Shelf Life Testing | 5-year shelf life demonstrated after accelerated aging. |
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (number of units) used for each non-clinical test. It generally states that "Non clinical tests were conducted."
- The data provenance is from non-clinical laboratory testing performed by the manufacturer (Shenzhen Boon Medical Supply Co., Ltd) in China, as per the sponsor identification. These are not human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context refers to established engineering and biological standards (e.g., ISO, ASTM, USP), not expert clinical adjudication. Compliance with these standards is determined by trained technicians/engineers through validated testing methods.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept relates to multi-expert clinical review, which is not relevant for non-clinical device testing verifying adherence to standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No. This is not relevant to a sterile syringe product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm.
7. The type of ground truth used:
- For this device, the "ground truth" for proving it meets "acceptance criteria" is adherence to recognized international and national standards for medical device performance, biocompatibility, and sterility (e.g., ISO 7886, ISO 594, ISO 10993, ASTM F88, USP monographs).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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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
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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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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
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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.
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| Model (Syringe) | Volume (ml) | Type | Resistant liquid leak pressure (psi) | Injector |
|---|---|---|---|---|
| 100101 | 200ml | Single Shot | 400 | MCT & MCT plus CT, K924116Vistron CT, K991557EnVision 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.
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| 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
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| Maximum | ||
|---|---|---|
| Model | Withstanding Pressure(psi) | Type |
| 700101 | / | Long spike |
| 700102 | / | Short spike |
| 700104-1 | 400 psi | Single Air ChamberTransfer Set |
| 700104-2 | 400 psi | Single Air ChamberTransfer Set with ExtensionTube |
| 700105-1 | 400 psi | Dual Air Chamber TranferSet |
| 700105-2 | 400 psi | Dual Air Chamber TranferSet with extension tube |
| 700106 | / | Transfer Set With C-Clamp |
| 700107-1 | / | Transfer set with Claveconnector |
| 700107-2 | / | Clave connector Transferset 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;
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- A USP 41-NF36 2018 <85> 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<151> 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 <788> 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.
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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, sterileHigh-pressure AngiographicSyringes for Single-use areintended for the injection ofContrast media or saline; theyshall be used with an US legallymarketed angiographicinjectors. | Sterile High-pressureAngiographic Syringes forSingle-use are intended for theinjection of contrast media orsaline; they shall be used withan US legally marketedangiographic injectors. | Same | |
| Prescription only (Rx) | Prescription only (Rx) | Prescription only (Rx) | Same | |
| Mode of operation | Power-driven operation, singleuse | Power-driven operation, singleuse | Same | |
| Configuration | Angiographic SyringeConnecting tubeJ shape tube/Spike | Angiographic SyringeConnecting tubeJ shape tube/Spike | Same | |
| Sterility | EO Sterilized | EO Sterilized | Same | |
| Single Use | Yes | Yes | Same | |
| Maximumwithstandingpressure | 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 | 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 | |
| Connectiontube | Tubing | PVC (Polyvinylchloride withDEHP) or PVC(Polyvinylchloride withoutDEHP) 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-piercingdevice | 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
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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
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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.
§ 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.