(152 days)
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.
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.
This document is a 510(k) summary for Sterile High-pressure Angiographic Syringes for Single-use. It primarily focuses on demonstrating substantial equivalence to a predicate device (K192657) and does not contain information about a study proving specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity for AI/ML technologies.
This type of submission typically demonstrates the device meets a set of performance standards or specifications, rather than a "study that proves the device meets the acceptance criteria" in the way a clinical trial or AI performance study would. The acceptance criteria here relate to physical, chemical, and biological properties, as well as compatibility.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, and training set details, are not applicable to this type of device submission.
Here's the available information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various non-clinical tests and standards that the device complies with, along with some performance specifications.
| Item | Acceptance Criteria (Standard/Test/Specification) | Reported Device Performance |
|---|---|---|
| Product Code | DXT | DXT |
| Regulation Number | CFR 870.1650 | CFR 870.1650 |
| Indications for Use | For injection of contrast media or saline with 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 US legally marketed angiographic injectors. |
| Mode of operation | Power-driven operation, single use | Power-driven operation, single use |
| Sterility | EO Sterilized | EO Sterilized |
| Single Use | Yes | Yes |
| Max. Withstanding Pressure (Syringe) | 300psi, 400psi, 1200psi | 300psi, 400psi, 1200psi (per specific models, e.g., 100101 at 400psi, 300101 at 1200psi) |
| Max. Withstanding Pressure (Connection Tube) | 300psi, 400psi, 1200psi | 300psi, 400psi, 1200psi (per specific models) |
| Max. Withstanding Pressure (Spike) | 400 psi | 400 psi (for specific models) |
| Syringe Performance | ISO 7886 | ISO 7886 |
| Luer Connector | ISO 594-1; ISO 594-2 | ISO 594-1; ISO 594-2 |
| Compatibility | Pass (with specific injectors outlined in Tables 1, 2, 3) | Pass |
| Biocompatibility | No Cytotoxicity, No Irritation, No Sensitization, No Pyrogen, No Acute Toxicity, No Hemolysis | No Cytotoxicity, No Irritation, No Sensitization, No Pyrogen, No Acute Toxicity, No Hemolysis |
| Endotoxin Limit | 20 EU per device | 20 EU per device |
| EO/ECH Residue Limit | Limited Contact: ≤ 24h, EO: 0.6mg/day, ECH: 1.28mg/day for 10kg patient (Children) as per ISO 10993-7 | 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. (This is a specific test mentioned to justify the change in labeling regarding pediatric use compared to the predicate). |
| Sterilization Residuals | ISO 10993-7:2008 (AMD1:2019) | Complies with standard |
| Seal Strength | ASTM F88/F88M-15 | Complies with standard |
| Seal Leak Detection | ASTM F1929-15 | Complies with standard |
| Bacterial Endotoxins | USP 41-NF36 2018 <85> | Complies with standard |
| Sterile Hypodermic Syringes (Manual Use) | ISO 7886-1:2017 | Complies with standard |
| Sterile Hypodermic Syringes (Power-driven) | ISO 7886-2:1996 | Complies with standard |
| Conical fittings (Luer taper) | ISO594-1:1986, ISO594-2:1998 | Complies with standards |
| In Vitro Cytotoxicity | ISO 10993-5:2009 | Complies with standard (No Cytotoxicity) |
| Irritation and Skin Sensitization | ISO 10993-10:2010 | Complies with standard (No Irritation, No Sensitization) |
| Interactions with Blood | ISO 10993-4:2017 | Complies with standard (No Hemolysis) |
| Hemolytic Properties | ASTM F756:2017 | Complies with standard (No Hemolysis) |
| Pyrogen Test | USP 41 NF 36<151> | Complies with standard (No Pyrogen) |
| Sterilization Process | ISO 11135:2014 | Complies with standard |
| Particulate Matter | USP <788> | Complies with standard |
| Shelf life | 5 years | 5 years |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for the individual non-clinical tests (e.g., number of syringes tested for pressure, number of samples for biocompatibility).
- Data provenance: Not explicitly stated, but the submission is from Shenzhen Boon Medical Supply Co., Ltd. in China, suggesting the tests were likely conducted in China. The submission itself is dated August 13, 2021, and received August 23, 2021, implying these are retrospective test results for device validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This is not applicable. The "ground truth" for this medical device (angiographic syringes) involves meeting engineering specifications and biological safety standards, not diagnostic interpretations that require expert consensus. The compliance is against defined standards (e.g., ISO, ASTM, USP) and internal specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This is not applicable for this type of device. Adjudication methods are typically used in clinical studies for diagnostic accuracy, where disagreements between readers or algorithms need resolution. Here, the tests yield objective pass/fail results against established criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable. The device is a physical medical instrument (syringe), not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable. The device is a physical medical instrument (syringe), not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is defined by international and national standards (e.g., ISO 10993, ASTM F88, USP 41) and the device's own engineering specifications (e.g., maximum pressure resistance, volume, material properties). Compliance is measured against these objective criteria.
8. The sample size for the training set
- This is not applicable. There is no AI/ML component, therefore no "training set."
9. How the ground truth for the training set was established
- This is not applicable. There is no AI/ML component, therefore no "training set" ground truth.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
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
{1}------------------------------------------------
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
-
- Identification of Subject Device
Trade Name: Sterile High-pressure Angiographic Syringes for Single-use;
- Identification of Subject Device
Common Name: Disposable angiographic syringe
| 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 Tube | 400101, 400102, 400103, 600101, 600102, 500105,500106, 500107, 500108, 400201, 400202, 400203,600201, 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 |
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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(Syringe) | Volume (ml) | Type | Resistant liquidleak 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 |
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 | MaximumWithstandingPressure (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 | MaximumWithstandingPressure (psi) | Type |
| 700101 | / | Long spike |
| 700102 | / | Short spike |
| 700104-1 | 400 psi | Single Air ChamberTransfer Set |
| 700104-2 | 400 psi | Single Air ChamberTransfer Set withExtension Tube |
| 700105-1 | 400 psi | Dual Air ChamberTranfer Set |
| 700105-2 | 400 psi | Dual Air ChamberTranfer Set withextension 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
-
- Identification of Predicate
Device 510k Number: K192657
- Identification of Predicate
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.
-
- Clinical Test Conclusion No clinical study is included in this submission.
| Item | Subject Device | Predicate DeviceK192657 | |
|---|---|---|---|
| Product Code | DXT | DXT | |
| Regulation Number | CFR 870.1650 | CFR 870.1650 | |
| Indications for Use | Sterile High-pressureAngiographic Syringes for | Sterile High-pressureAngiographic Syringes for | |
| Single-use are intended for | Single-use are intended for | ||
| the injection of Contrastmedia or saline; they shall be | the injection of Contrastmedia or saline; they shall be | ||
| used with an US legally | used with an US legally | ||
| marketed angiographicinjectors. | angiographicmarketed injectors. | ||
| Mode of operation | Power-driven operation,single use | Power-driven operation,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 | ||
| Maximumwithstandingpressure | 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(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, 125, 130, 100,200/200, 60/100, 125/125,100/100, 65/65, 65/115,60/60, 50/50 |
| Connectiontube (overallLength, mm) | 200 | 200 | |
| J shape tube(overallLength, mm) | 240 | 240 | |
| Spike(overallLength, 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, 260, 340, 420,500, 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(Polyethylene terephthalate) | PP (polypropylene) or PET(Polyethylene terephthalate) |
| Piston | Polyisoprene rubber | Polyisoprene rubber | |
| Lubricant | Polydimethylsiloxane | Polydimethylsiloxane | |
| Connectiontube | Tubing | PVC (Polyvinylchloride) orPVC (Polyvinylchloride notmade with DEHP) or PU | PVC (Polyvinylchloride) orPVC (Polyvinylchloride notmade with DEHP ) or PU |
| ( Polyurethane ) | ( Polyurethane ) | ||
| Luerconnectors | PC (Polycarbonate) | PC (Polycarbonate) | |
| UV adhesive | Ultraviolet adhesive | Ultraviolet adhesive | |
| Spike | Closure-piercingdevice | ABS (acrylonitrile-butadiene-styrene) | ABS (acrylonitrile-butadiene-styrene) |
| Filtermembrane | PP (polypropylene) | PP (polypropylene) | |
| Tube | Polyvinyl chloride (PVC) | Polyvinyl chloride (PVC) | |
| LuerConnector | Polycarbonate (PC) | Polycarbonate (PC) | |
| Protective cap | Acrylonitrile-butadiene-styrene (ABS) | Acrylonitrile-butadiene-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: ≤ 24hEO: 0.6mg/ dayECH: 1.28mg /dayFor 10kg patient (Children)as per ISO 10993-7 | Limited Contact: ≤ 24hEO: 4 mg/dayECH: 9 mg/dayFor 70kg patient (Adult) ISO10993-7 | |
| Population | Not intended for infant orneonatal use | Not intended for pediatric orneonatal 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.
§ 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.