Sterile High-pressure Angiographic Syringes for Single-use
Device Facts
| Record ID | K211564 |
|---|---|
| Device Name | Sterile High-pressure Angiographic Syringes for Single-use |
| Applicant | Shenzhen Boon Medical Supply Co., Ltd. |
| Product Code | DXT · Cardiovascular |
| Decision Date | Oct 19, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1650 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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 US legally marketed angiographic injectors.
Device Story
Disposable sterile high-pressure angiographic syringes, connection tubes, J-shape tubes, and spikes; used with power-driven angiographic injectors to deliver contrast media or saline. Device components connect to injectors and catheters to facilitate fluid delivery during angiography. Operated by clinicians in clinical settings. Output is controlled fluid injection; clinical decision-making relies on resulting diagnostic images. Benefits include reliable, sterile, high-pressure fluid delivery for imaging procedures. Subject device is identical to predicate K192657, with updated labeling to include pediatric patients (≥10kg) and validated EO/ECH residuals for this population.
Clinical Evidence
No clinical data. Bench testing only, including biocompatibility (ISO 10993), sterilization residuals (ISO 10993-7), seal strength (ASTM F88), leak detection (ASTM F1929), and mechanical compatibility with various angiographic injectors.
Technological Characteristics
Materials: PP/PET (syringe barrel), polyisoprene (piston), polydimethylsiloxane (lubricant), PVC/PU (tubing), PC (connectors), ABS (spike). Standards: ISO 7886-1/2, ISO 594-1/2, ISO 10993, ASTM F88, ASTM F1929, USP <85>, <788>. Sterilization: Ethylene Oxide (EO). Connectivity: Mechanical Luer lock. Form factor: Disposable syringe/tube/spike sets.
Indications for Use
Indicated for injection of contrast media or saline using US legally marketed angiographic injectors. Intended for use in patients including pediatric populations (≥10kg), excluding infants and neonates.
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 (K192657)
Submission Summary (Full Text)
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October 19, 2021
Shenzhen Boon Medical Supply Co., Ltd Baihan Feng Regulatory Affair Manager No.18 Jirong Road, Shenkeng, Henggang Street, Longgang District Shenzhen, Guangdong 518173 China
Re: K211564
Trade/Device Name: Sterile High-pressure Angiographic Syringes for Single-use Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: August 13, 2021 Received: August 23, 2021
Dear Baihan Feng:
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
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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 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 (QS) 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 medical devices and radiation-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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211564
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 US legally marketed angiographic injectors.
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)
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# K211564 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR
- Date of Preparation: 10/19/2021 1.
- Sponsor Identification 2.
# Shenzhen Boon Medical Supply Co., Ltd.
No.18 Jirong Road, Shenkeng, Henggang Street, Longgang District, Shenzhen, 518173, China
Establishment Registration Number: 3012395857
Contact Person: Baihan Feng Position: Regulatory Affair Manager Tel: +86-755-28638515 Fax: +86-755-28638033 Email: faguibu-feng@szboon.com
- 3. Identification of Subject Device
Trade Name: Sterile High-pressure Angiographic Syringes for Single-use;
Common Name: Disposable angiographic syringe
| Product Name | Models |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Syringe | 100101, 100103, 100113, 200101, 200102, 300101,<br>300105, 100104, 100114, 200103, 300103,100111,<br>100121, 100124, 200104, 100108, 100118, 100129,<br>100130,100109, 100119, 200107, 300102, 300108,<br>300110, 300111, 300112 |
| Connection Tube | 400101, 400102, 400103, 600101, 600102, 500105,<br>500106, 500107, 500108, 400201, 400202, 400203,<br>600201, 600202, 500101, 500102, 500103, 500104,<br>500201, 500202, 500203, 500204, 500205, 500206,<br>500207, 500208 |
| J shape tube | 700103 |
| Spike | 700101, 700102, 700104-1, 700104-2, 700105-1, 700105-<br>2, 700106, 700107-1, 700107-2 |
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### Regulatory Information
Classification Name: Angiographic injector and syringe 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 US legally marketed angiographic injectors.
Device Description:
The subject devices are identical to all models of predicate devices of K192657. It includes disposable syringes, connection tube, J shape tube and spike. Labeling of subject device now includes pediatrics in the patient population.
- Syringe: the syringe is intended to be used with an U.S. legally marketed angiography injector. A Compatibility is shown in Table 1.
| Model<br>(Syringe) | Volume (ml) | Type | Resistant liquid<br>leak pressure<br>(psi) | Injector |
|--------------------|-------------|-------------|--------------------------------------------|---------------------------------------------------------------------------|
| 100101 | 200ml | Single Shot | 400 | MCT & MCT plus CT, K924116<br>Vistron CT, K991557<br>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 |
Table 1 Compatibility between Syringe and Injectors
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| 100124 | 60/100ml | Dual Shots | 400 | Dual Shot, K052633 |
|--------|-----------|-------------|------|------------------------|
| 200104 | 60/60ml | Dual Shots | 300 | Sonic Shot, K091734 |
| 100108 | 200ml | Single Shot | 400 | Dual shot CT, K062168 |
| 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 |
- > Connection tube: 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.
| Model | Maximum<br>Withstanding<br>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 |
Table 2 Pressure Specifications for Connection Tube
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| 500202 | 1200 | Straight |
|--------|------|----------|
| 500203 | 1200 | Straight |
| 500204 | 1200 | Straight |
| 500205 | 1200 | Straight |
| 500206 | 1200 | Straight |
| 500207 | 1200 | Straight |
| 500208 | 1200 | Straight |
- > J shape tube: used to draw contrast media/saline into the syringe barrel before the syringe installed.
- > Spike: 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
| Table 3 Pressure Specifications for Spike | | |
|-------------------------------------------|-------------------------------------------|-----------------------------------------------------------|
| Model | Maximum<br>Withstanding<br>Pressure (psi) | Type |
| 700101 | / | Long spike |
| 700102 | / | Short spike |
| 700104-<br>1 | 400 psi | Single Air Chamber<br>Transfer Set |
| 700104-<br>2 | 400 psi | Single Air Chamber<br>Transfer Set with<br>Extension Tube |
| 700105-<br>1 | 400 psi | Dual Air Chamber<br>Tranfer Set |
| 700105-<br>2 | 400 psi | Dual Air Chamber<br>Tranfer Set with<br>extension tube |
| 700106 | / | Transfer Set With C-<br>Clamp |
| 700107-<br>1 | / | Transfer set with Clave<br>connector |
| 700107-<br>2 | / | Clave connector Transfer<br>set with Check valve |
Table 3 Pressure Specifications for Spike
- 4. Identification of Predicate
Device 510k Number: K192657
Product Name: Sterile High-pressure Angiographic Syringes for Single-use; Manufacturer: Shenzhen Boon Medical Supply Co., Ltd.
- ર. Non-Clinical Test Conclusion
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The non-clinical tests for the predicate device in K192657 are applicable for proposed device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-7:2008 (AMD1:2019) Biological evaluation of medical devices-Part 7: Ethylene oxide > sterilization residuals;
- ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials; A
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by A Dye Penetration:
- > USP 41-NF36 2018 <85> Bacterial Endotoxins Limit;
- > 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 svringe pumps:
- > ISO594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment -Part 1: General Requirements;
- > ISO594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment -Part 2: Lock Fitting;
- > ISO 10993-5:2009 Biological evaluation of medical devices --Part 5: Tests for In Vitro cytotoxicity;
- > 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 11135:2014, 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 meet performance under maximum sustained pressure specification.
- 6. Clinical Test Conclusion No clinical study is included in this submission.
| Item | Subject Device | Predicate Device<br>K192657 | |
|-------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Product Code | DXT | DXT | |
| Regulation Number | CFR 870.1650 | CFR 870.1650 | |
| Indications for Use | Sterile High-pressure<br>Angiographic Syringes for | Sterile High-pressure<br>Angiographic Syringes for | |
| | | Single-use are intended for | Single-use are intended for |
| | | the injection of Contrast<br>media or saline; they shall be | the injection of Contrast<br>media or saline; they shall be |
| | | used with an US legally | used with an US legally |
| | | marketed angiographic<br>injectors. | angiographic<br>marketed injectors. |
| Mode of operation | | Power-driven operation,<br>single use | Power-driven operation,<br>single use |
| Configuration | | Angiographic Syringe | Angiographic Syringe |
| | | Connecting tube | Connecting tube |
| | | J shape tube/Spike | J shape tube/Spike |
| Sterility | | EO Sterilized | EO Sterilized |
| Single Use | | Yes | Yes |
| Model | | Same Models | |
| Maximum<br>withstanding<br>pressure | Syringe | 300psi, 400psi, 1200psi | 300psi, 400psi, 1200psi |
| | Connection tube | 300psi, 400psi, 1200psi | 300psi, 400psi, 1200psi |
| | J shape tube | NA | NA |
| | Spike | 400 psi | 400 psi |
| Specification | Syringe<br>(Volume, ml) | 200, 150, 125, 130, 100,<br>200/200, 60/100, 125/125,<br>100/100, 65/65, 65/115,<br>60/60, 50/50 | 200, 150, 125, 130, 100,<br>200/200, 60/100, 125/125,<br>100/100, 65/65, 65/115,<br>60/60, 50/50 |
| | Connection<br>tube (overall<br>Length, mm) | 200~2500, 1500~2500,<br>1500, 1800, 2000, 2500, 500,<br>750, 1000, 1200 | 200~2500, 1500~2500,<br>1500, 1800, 2000, 2500, 500,<br>750, 1000, 1200 |
| | J shape tube<br>(overall<br>Length, mm) | 240 | 240 |
| | Spike<br>(overall<br>Length, mm) | 58.8, 47.3, 1000, 2800, 1200,<br>2900, 180, 260, 340, 420,<br>500, 450, 550, 600 | 58.8, 47.3, 1000, 2800, 1200,<br>2900, 180, 260, 340, 420,<br>500, 450, 550, 600 |
| | | | |
| | | | |
| Performance | | | |
| Syringe | | ISO 7886 | ISO 7886 |
| Luer connector | | ISO 594-1; ISO 594-2 | ISO 594-1; ISO 594-2 |
| Compatibility | | Pass | Pass |
| Patient-Contact Material | | | |
| Syringe | Barrel | PP (polypropylene) or PET<br>(Polyethylene terephthalate) | PP (polypropylene) or PET<br>(Polyethylene terephthalate) |
| | Piston | Polyisoprene rubber | Polyisoprene rubber |
| | Lubricant | Polydimethylsiloxane | Polydimethylsiloxane |
| | | | |
| Connection<br>tube | Tubing | PVC (Polyvinylchloride) or<br>PVC (Polyvinylchloride not<br>made with DEHP) or PU | PVC (Polyvinylchloride) or<br>PVC (Polyvinylchloride not<br>made with DEHP ) or PU |
| | | ( Polyurethane ) | ( Polyurethane ) |
| | Luer<br>connectors | PC (Polycarbonate) | PC (Polycarbonate) |
| | UV adhesive | Ultraviolet adhesive | Ultraviolet adhesive |
| Spike | Closure-<br>piercing<br>device | ABS (acrylonitrile-<br>butadiene-styrene) | ABS (acrylonitrile-<br>butadiene-styrene) |
| | Filter<br>membrane | PP (polypropylene) | PP (polypropylene) |
| | Tube | Polyvinyl chloride (PVC) | Polyvinyl chloride (PVC) |
| | Luer<br>Connector | Polycarbonate (PC) | Polycarbonate (PC) |
| | Protective cap | Acrylonitrile-butadiene-<br>styrene (ABS) | Acrylonitrile-butadiene-<br>styrene (ABS) |
| J shape tube | tube | PE (Polyethylene) | PE (Polyethylene) |
| Biocompatibility | | No Cytotoxicity | No Cytotoxicity |
| | | No Irritation | No Irritation |
| | | No Sensitization | No Sensitization |
| | | No Pyrogen | No Pyrogen |
| | | No Acute Toxicity | No Acute Toxicity |
| | | No Hemolysis | No Hemolysis |
| Endotoxin Limit | | 20 EU per device | 20 EU per device |
| EO/ECH residue limit | | Limited Contact: ≤ 24h<br>EO: 0.6mg/ day<br>ECH: 1.28mg /day<br>For 10kg patient (Children)<br>as per ISO 10993-7 | Limited Contact: ≤ 24h<br>EO: 4 mg/day<br>ECH: 9 mg/day<br>For 70kg patient (Adult) ISO<br>10993-7 |
| Population | | Not intended for infant or<br>neonatal use | Not intended for pediatric or<br>neonatal use |
| Shelf life | | 5 years | 5 years |
#### 7. Substantial Equivalence Comparison
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The only difference between the subject and the predicate is that the labeling states " Not intended for infant or neonatal use" in the subject device, while predicate device states "Not intended for pediatric or neonatal use." For this modification, EO/ECH residual test has been conducted on the models in this submission and test results have demonstrated EO/ECH residue level meet the residue limit for 10kg children group as per ISO 10993-7. Therefore, this difference will not impact the safety and effectiveness of the device.
Substantial Equivalence (SE) Conclusion: 8.
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The subject device is Substantially Equivalent (SE) to the predicate device.
