(29 days)
100 mL/200 mL Syringe: The Disposable Syringe (Kit) (100 mL or 200 mL Syringe for the injection of contrast media orsaline for CT and MR imaging, for use on Nemoto injectors. 150 mL Syringe: The Disposable Syringe (Kit) (150 mL Syringe for the injection of contrast media or saline forangiography. for use on Nemoto injectors. J-Tube: J-Tube is to aid in transferring a media from its container (typically a vial or bottle) into the barrel of the Disposable Syringe (Kit). Extension Tubes: The Extension Tube is to provide a connection between the syringe barrel and the needle or catheter into the patient.
The "Disposable Syringe (Kit)" (Subject Device) is specifically designed for use with the Nemoto power injection systems marketed and sold in the USA using 510(k) references K133189, K071691, K173450, K092896, K091734. The Subject Device is a package provided to the end user that contains one or two plastic syringes, plastic tubing used for connecting syringe to needle or catheter (Extension Tubing) and a plastic J-shaped tube for transferring contrast media or physiological saline into the plastic syringe (J-Tube). The Subject Device, in accordance with the Indications for Use, may be used in conjunction with CT or MRI applications or in conjunction with angiographic applications. The key difference in the application as it relates to the Subject Device is the pressure required and the flow rates required for the Subject Device. The Subject Device when used for the CT and MRI applications must support a maximum pressure of 300PSI and a maximum flow rate of 10mL/second. The Subject Device when used for the angiographic applications must support a maximum pressure of 1200PSI and a maximum flow rate of 30ml/second. The maximum values related to the application are controlled by the Nemoto power injection system which are fully described in the aforementioned 510(k)s.
The provided text is a 510(k) summary for a medical device (Disposable Syringe (Kit)) and does not contain information about an AI/ML device. Therefore, the questions related to AI/ML device acceptance criteria and study details cannot be answered based on the provided input.
However, I can provide a summary of the non-clinical performance data presented for the Disposable Syringe (Kit), which demonstrates it meets its acceptance criteria based on established standards.
Non-Clinical Performance Data for Nemoto Disposable Syringe (Kit)
The Nemoto Disposable Syringe (Kit) underwent extensive non-clinical testing to demonstrate substantial equivalence to its predicate devices. The device passed numerous tests in accordance with internal requirements, national standards, and international standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test / Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity testing (ISO 10993-5) | Passed |
| Sensitization testing (ISO 10993-10) | Passed | |
| Irritation testing (ISO 10993-23) | Passed | |
| Acute systemic toxicity testing (ISO 10993-11) | Passed | |
| Hemolysis testing (ISO 10993-4, ASTM F 756) | Passed | |
| Pyrogenicity testing (ISO 10993-11, USP-NF 38 <151>) | Passed | |
| Sterility & Contamination | Particulate Contamination testing (USP <788>) | Passed |
| Endotoxin testing (USP-NF <85> and <161>) | Passed | |
| Sterilization validation (demonstrates SAL of 10-6) | Passed | |
| Ethylene Oxide Sterilization Residuals (ISO 10993-7) | Passed | |
| Syringe Mechanical Performance | Lubricant testing (modified ISO 7886-1) | Passed |
| Tolerance on Graduated Capacity (ISO 7886-1) | Passed | |
| Scale testing (ISO 7886-1) | Passed | |
| Numbering of Scales testing (ISO 7886-1) | Passed | |
| Overall length of scale to nominal capacity line (ISO 7886-1) | Passed | |
| Position of Scale testing (ISO 7886-1) | Passed | |
| Barrel testing (ISO 7886-1) | Passed | |
| Plunger Stopper/Plunger Assembly testing (ISO 7886-1) | Passed | |
| Nozzle Lumen testing (ISO 7886-1) | Passed | |
| Dead Space testing (ISO 7886-1) | Passed | |
| Freedom from Air past Plunger Stopper (ISO 7886-1) | Passed | |
| Fit of Plunger Stopper/Plunger in Barrel (ISO 7886-1) | Passed | |
| Liquid Leakage past Plunger Stopper (in-house pressure) | Passed | |
| Chemical testing (ISO 7886-1, ISO 8536-9) | Passed | |
| Extension Tubes & Connectors | Transparency testing (ISO 8536-9) | Passed |
| Tensile Strength testing (ISO 8536-9) | Passed | |
| Leakage testing (ISO 8536-9) | Passed | |
| Injection Needle testing (ISO 8536-9) | Passed | |
| Connection force (in-house testing) | Passed | |
| Positive Pressure Liquid Leakage (ISO 80369-7) | Passed | |
| Sub-Atmospheric Pressure Air Leakage (ISO 80369-7) | Passed | |
| Stress Cracking testing (ISO 80369-7) | Passed | |
| Resistance to Separation from Axial Load (ISO 80369-7) | Passed | |
| Resistance to Separation from Unscrewing (ISO 80369-7) | Passed | |
| Resistance to Overriding testing (ISO 80369-7) | Passed | |
| Overall Device Performance | Compatibility (in-house testing) | Passed |
| Shelf Life Testing (supports 5 years) | Passed | |
| Transportation Testing (ASTM F88/88M, etc.) | Passed | |
| Usability Engineering (IEC 62366-1) | Evaluated |
2. Sample Size for Test Set and Data Provenance:
The document does not specify the sample sizes used for each non-clinical test. The tests are general performance and materials tests, not based on patient data.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. These are non-clinical engineering and laboratory tests, not clinical studies requiring expert ground truth for interpretation.
4. Adjudication Method:
Not applicable. This is not a clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device.
7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is defined by the specific parameters and thresholds set by the relevant ISO standards (e.g., ISO 10993, ISO 7886-1, ISO 8536-9, ISO 80369-7) and internal requirements. These standards specify acceptable limits for various properties like cytotoxicity, leakage, tensile strength, and dimensions.
8. Sample Size for Training Set:
Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.
9. How Ground Truth for Training Set Was Established:
Not applicable.
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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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 27, 2024
Nemoto Kyorindo Co., Ltd. % Dave Yungvirt, CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K242212
Trade/Device Name: Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: July 26, 2024 Received: July 29, 2024
Dear Dave Yungvirt:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Shruti N. Mistry -S
Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K242212
Device Name
Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)
Indications for Use (Describe)
100 mL/200 mL Syringe:
The Disposable Syringe (Kit) (100 mL or 200 mL Syringe for the injection of contrast media orsaline for CT and MR imaging, for use on Nemoto injectors.
150 mL Syringe:
The Disposable Syringe (Kit) (150 mL Syringe for the injection of contrast media or saline forangiography. for use on Nemoto injectors.
J-Tube:
J-Tube is to aid in transferring a media from its container (typically a vial or bottle) into the barrel of the Disposable Syringe (Kit).
Extension Tubes:
The Extension Tube is to provide a connection between the syringe barrel and the needle or catheter into the patient.
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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K242212 510(k) Summary
Disposable Syringe (Kit), Nemoto Disposable Syringe (Kit)
1. Submission Sponsor
Nemoto Kyorindo Co., Ltd. 2-27-20 Hongo, Bunkyo-ku, Tokyo, 113-0033 Japan Contact: Jim Knipfer Title: GM, Overseas Department Office Phone: +81 3 5842 8571 Email: jim@nemoto-do.co.jp
2. Submission Correspondent
Nemoto Kyorindo Co., Ltd. 2-27-20 Hongo, Bunkyo-ku, Tokyo, 113-0033 Japan Contact: Jim Knipfer Title: GM, Overseas Department Office Phone: +81 3 5842 8571 Email: jim@nemoto-do.co.jp
3. Date Prepared
July 26, 2024
4. Device Identification
| Trade/Proprietary Name: Disposable Syringe (Kit), Nemoto Disposable Syringe (Kit) | |
|---|---|
| Classification Name: | Injector and Syringe, Angiographic |
| Regulation Number(s): | 870.1650 |
| Product Code(s): | DXT |
| Class: | II |
| Classification Panel: | Cardiovascular |
5. Legally Marketed Predicate Device(s)
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Device name: Disposable CT/MR Syringes for Nemoto Injectors 510(k) number: K051799 Manufacturer: Coeur Inc.
Device name: Disposable Angiographic Syringes for Nemoto Injectors 510(k) number: K090487 Manufacturer: Coeur Inc.
Device name: Disposable 330 psi extension lines 510(k) number: K120892 Manufacturer: Coeur Inc.
6. Device Description
The "Disposable Syringe (Kit)" (Subject Device) is specifically designed for use with the Nemoto power injection systems marketed and sold in the USA using 510(k) references K133189, K071691, K173450, K092896, K091734. The Subject Device is a package provided to the end user that contains one or two plastic syringes, plastic tubing used for connecting syringe to needle or catheter (Extension Tubing) and a plastic J-shaped tube for transferring contrast media or physiological saline into the plastic syringe (J-Tube). The Subject Device, in accordance with the Indications for Use, may be used in conjunction with CT or MRI applications or in conjunction with angiographic applications. The key difference in the application as it relates to the Subject Device is the pressure required and the flow rates required for the Subject Device. The Subject Device when used for the CT and MRI applications must support a maximum pressure of 300PSI and a maximum flow rate of 10mL/second. The Subject Device when used for the angiographic applications must support a maximum pressure of 1200PSI and a maximum flow rate of 30ml/second. The maximum values related to the application are controlled by the Nemoto power injection system which are fully described in the aforementioned 510(k)s.
7. Indication for Use Statement
100 mL/200 mL Syringe:
The Disposable Syringe (Kit) (100 mL or 200 mL Syringe for the injection of contrast media or saline for CT and MR imaging, for use on Nemoto injectors.
150 mL Syringe:
The Disposable Syringe (Kit) (150 mL Syringe for the injection of contrast media or saline for angiography, for use on Nemoto injectors.
J-Tube:
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J-Tube is to aid in transferring a media from its container (typically a vial or bottle) into the barrel of the syringe of the Disposable Syringe (Kit).
Extension Tubes:
The Extension Tube is to provide a connection between the syringe barrel and the needle or catheter that is punctured into the patient.
7.1 Intended users
To be used by medical professionals who are trained and qualified to deliver contrast media or normal saline into adult patients. Prescription Use Only.
8. Substantial Equivalence Discussion
The following table compares the Disposable Syringe (Kit) to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
| Attribute | SUBJECT DEVICE | Predicate:Disposable CT/MR Syringesfor Nemoto Injectors | Comparison |
|---|---|---|---|
| 510(k) Number | - | K051799 | - |
| Product Code | DXT | DXT | Same |
| Regulation Number | 870.1650 | 870.1650 | Same |
| Indications for Use | The Nemoto DisposableSyringe (Kit) is specificallydesigned for use withNemoto Injectors and areintended to be used for theadministration of contrastmedia or physiologicalsaline into a patient inconjunction with CT andMR examinations. | The Disposable CT/MRSyringe for NemotoInjectors is a syringe for theinjection of contrast mediaor saline for CT and MRimaging, for use on Nemotoinjectors | Same meaning |
| Intended users | To be used by medicalprofessionals who aretrained and qualified todeliver contrast media ornormal saline into adult | To be used by medicalprofessionals who aretrained and qualified todeliver contrast media ornormal saline into adult | Same |
| Attribute | SUBJECT DEVICE | Predicate: Disposable CT/MR Syringes for Nemoto Injectors | Comparison |
| patients. Prescription Use Only. | patients. Prescription Use Only. | ||
| Syringe type/Environment od use | CT and MRI applications | CT and MRI applications | Same |
| Specific drug use | Contrast media or saline | Contrast media or saline | Same |
| Volume | 100 mL, 200 mL | 20 mL, 50 mL, 100 mL and 200mL | The predicate device includes volumes of the subject device. |
| Length/mm | 100 mL Syringe:Barrel length: 153.21200 mL Syringe:Barrel length: 157.81 | 100 mL Syringe:Barrel length: 153.21200 mL Syringe:Barrel length: 157.81 | Same |
| Diameter | 100 mL Syringe:Outer diameter: 49.60-49.70Inner diameter: 45.90-46.00200 mL Syringe:Outer diameter: 31.95-32.05Inner diameter: 35.39-35.61 | 100 mL Syringe:Outer diameter: 49.60-49.70Inner diameter: 45.90-46.00200 mL Syringe:Outer diameter: 31.95-32.05Inner diameter: 35.39-35.61 | Same |
| Nozzle type | ISO 80369-7: 2021 compliant | ISO 594 compliant | SameISO 594 was replaced by ISO 80369-7. |
| Pressure Limit | Up to 300psi | Up to 300psi | Same |
| Particle matter | ISO 7886-1:2017 compliant | Meets visual inspection requirements | Equivalent, ISO 7886-1 requires visual check. |
| Chemical test (Extractable metals and Limits for acidity or alkalinity) | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standard applied |
| Tolerance on graduated capacity | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standard applied |
| Attribute | SUBJECT DEVICE | Predicate:Disposable CT/MR Syringesfor Nemoto Injectors | Comparison |
| Scale | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standardapplied |
| Numbering of scales | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standardapplied |
| Overall length ofscale to nominalcapacity line | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standardapplied |
| Position of scale | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standardapplied |
| Barrel | ISO 7886-1:2017 compliant | While syringe is technicallyISO 7886-1:1993 compliantby Design of flange, thesyringe is intended for usewith injector. | Same standardapplied |
| Plungerstopper/plungerassembly | ISO 7886-1:2017 compliant | N/A – Syring is intended foruse with injector. | While thepredicate devicedoes not applyISO 7886-1 but,what the subjectdevice complieswith ISO 7886-1does not raiseadditional risk. |
| Nozzle lumen | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standardapplied |
| Dead space | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standardapplied |
| Freedom from airand liquid leakagepast plunger stopper | Freedom from air: ISO7886-1:2017 compliantLiquid leakage past plungerstopper: Pressureresistance testing (300 psi) | ISO 7886-1:1993 compliant | Same standardapplied |
| Fit of plungerstopper/plunger inbarrel | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standardapplied |
| Attribute | SUBJECT DEVICE | Predicate:Disposable CT/MR Syringesfor Nemoto Injectors | Comparison |
| Materials | Thermoplastic VulcanizatePolyCyclohexylenedimethyleneTerephthalate glycol-modified (PCTG)PolypropyleneSilicone | PET | The subjectdevice complieswithbiocompatibility,ISO 7886-1 andpressure limittesting that isappropriate. |
| Sterility | EtO Sterilized | EtO Sterilized | Same |
| Single-Use | Single use | Single use | Same |
| Shelf Life | 5 years | 5 years | Same |
| Complies with ISO10993-1 | Compliance | Compliance | Same |
Comparison of Characteristics (100 mL or 200 mL Syringe)
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Comparison of Characteristics (150 mL Syringe)
| Attribute | SUBJECT DEVICE | Predicate:Disposable AngiographicSyringes for NemotoInjectors | Comparison |
|---|---|---|---|
| 510(k) Number | - | K090487 | - |
| Product Code | DXT | DXT | Same |
| Regulation Number | 870.1650 | 870.1650 | Same |
| Indications for Use | The Nemoto DisposableSyringe (Kit) is specificallydesigned for use withNemoto Injectors and areintended to be used for theadministration of contrastmedia or physiologicalsaline into a patient inconjunction withangiographic examinations. | for injecting contrast mediaand saline, for angiography | Same meaning |
| Intended users | To be used by medicalprofessionals who aretrained and qualified todeliver contrast media ornormal saline into adult | To be used by medicalprofessionals who aretrained and qualified todeliver contrast media ornormal saline into adult | Same |
| Attribute | SUBJECT DEVICE | Predicate:Disposable AngiographicSyringes for NemotoInjectors | Comparison |
| patients. Prescription UseOnly. | patients. Prescription UseOnly. | ||
| Syringetype/Environmentod use | Angiographic application | Angiographic application | Same |
| Specific drug use | Contrast media or saline | Contrast media or saline | Same |
| Volume | 150 mL | 150 mL | Same |
| Length/mm | Barrel: 141 mmOverall: 239.8 mm | Barrel: 141 mmOverall: 239.8 mm | Same |
| Diameter | O.D. 43.52 mmI.D. 40.2 mm | 0.D. 43.52 mmI.D. 40.2 mm | Same |
| Nozzle type | Luer male connector, ISO80369-7: 2021 compliant | Luer connection, ISO 594compliant | SameISO 594 wasreplaced by ISO80369-7. |
| Pressure Limit | Up to 1200 psi | Up to 1200 psi | Same |
| Particle matter | ISO 7886-1:2017 compliant | ISO7886-1:1993 | Same standardapplied |
| Chemical test(Extractable metalsand Limits for acidityor alkalinity) | ISO 7886-1:2017 compliant | ISO7886-1:1993 | Same standardapplied |
| Barrel | ISO 7886-1:2017 compliant | ISO7886-1:1993 | Same standardapplied |
| Pressure resistance | 1200 psi compliant | 1200 psi compliant | Same |
| Materials | Polycarbonate,Polypropylene,Polyoxymethylene (POM),Silicone | Polypropylene, Silicone | The subjectdevice complieswithbiocompatibility.ISO 7886-1 andpressure limittesting that isappropriate. |
| Sterility | EtO Sterilized | EtO Sterilized | Same |
| Single-Use | Single use | Single use | Same |
| Shelf Life | 5 years | 5 years | Same |
| Complies with ISO10993-1 | Compliance | Compliance | Same |
| Attribute | SUBJECT DEVICE | Predicate:Disposable 330 psiextension lines | Comparison |
| 510(k) Number | - | K120892 | - |
| Product Code | DXT | DXT | Same |
| Regulation Number | 870.1650 | 870.1650 | Same |
| Indications for Use | The Extension Tube is toprovide a connectionbetween the syringe barreland the needle or catheterthat is punctured into thepatient. | To be used as an interfacebetween (an) Angiographic,CT, or MR Syringe(s) and aneedle catheter for thepurpose of deliveringdiagnostic fluids (such ascontrast media and saline)to the vascular system. | Same meaning |
| Intended users | To be used by medicalprofessionals who aretrained and qualified todeliver contrast media ornormal saline into adultpatients. Prescription UseOnly. | To be used by medicalprofessionals who aretrained and qualified todeliver contrast media ornormal saline into adultpatients. Prescription UseOnly. | Same |
| Syringetype/Environmentod use | CT and MRI applications | CT, MRI, and Angioapplications | The predicatedevice includesenvironment ofuse of thesubject device |
| Specific drug use | Contrast media or saline | Contrast media or saline | Same |
| Length/mm | 1500 mm / 1550 mm | 1500 mm / 1550 mm | Same |
| Diameter | O.D.: 3.25-3.33 mmI.D.: 1.77-1.85 mm | O.D.: 3.87-3.95 mmI.D.: 2.31-2.39 mm*Manually measured | Different, butthe subjectdevice complieswith ISO 8536-9,Infusionequipment formedical use –part 9: fluid linesfor single usewith pressureinfusion |
| Attribute | SUBJECT DEVICE | Predicate:Disposable 330 psiextension lines | Comparison |
| Connector type | ISO 80369-7: 2021compliant | ISO 594 compliant | SameISO 594 wasreplaced by ISO80369-7. |
| Pressure Limit | 300 psi | 330 psi | Nominalpressure isdifferent,however, thecompatibleinjector canapply pressureup to 300 psiand there is noadditional riskraised. |
| Transparency | ISO 8536-9:2015compliance | Allows clear view | The same visualtesting |
| Particulatecontamination | ISO 8536-9:2015compliance | Visual inspection | The subjectdevice wasconducted moresevere testingand noadditional risk israised. |
| Tensile strength | ISO 8536-9:2015compliance | Must hold 8lb for aminimum of 10 secondswithout breakage of thebond or the tubing | The subjectdevice complieswith current ISOstandard anddoes not raiseadditional risk. |
| Leakage | Air leakage: ISO 8536-9:2015 complianceWater leakage: Pressureresistance testing (300 psi) | Air leakage requirement –2psi without leakageWater leakage: Pressureresistance testing (330 psi) | Air leakage: Thesubject devicecomplies withcurrent ISO |
| Attribute | SUBJECT DEVICE | Predicate:Disposable 330 psiextension lines | Comparison |
| standard anddoes not raiseadditional risk.Water leakage:Nominalpressure isdifferent,however, thecompatibleinjector canapply pressureup to 300 psiand there is noadditional riskraised. | |||
| Material | Poly Vinyl Chloride (PVC),High Density Polyethylene(HDPE), Low DensityPolyethylene (LDPE),Polypropylene, PolyCarbonate (PC) | No information | The subjectdevice complieswithbiocompatibility,ISO 8536-9 andpressure limittesting that isappropriate. |
| Sterility | EtO Sterilized | EtO Sterilized | Same |
| Single-Use | Single use | Single use | Same |
| Shelf Life | 5 years | 5 years | Same |
| Complies with ISO10993-1 | Compliance | Compliance | Same |
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Comparison of Characteristics (Extension Tubes)
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Comparison of Characteristics (J-Tube)
| Attribute | SUBJECT DEVICE | Predicate:Disposable AngiographicSyringes for NemotoInjectors | Comparison |
|---|---|---|---|
| 510(k) Number | - | K090487 | - |
| Product Code | DXT | DXT | Same |
| Regulation Number | 870.1650 | 870.1650 | Same |
| Attribute | SUBJECT DEVICE | Predicate:Disposable AngiographicSyringes for NemotoInjectors | Comparison |
| Indications for Use | J-Tube is to aid intransferring a media fromits container (typically a vialor bottle) into the barrel ofthe syringe of theDisposable Syringe (Kit). | for injecting contrast mediaand saline, for angiography | The indicationsfor use of thepredicate deviceis described ingeneral includingsyringes andtubing., but noadditionalconcerns forsafety andeffectiveness ofthe subjectdevice since J-Tube performsjust astransferring acontrast mediaor saline and thecomponent ofthe predicatedevice performsas the same. |
| Intended users | To be used by medicalprofessionals who aretrained and qualified todeliver contrast media ornormal saline into adultpatients. Prescription UseOnly. | To be used by medicalprofessionals who aretrained and qualified todeliver contrast media ornormal saline into adultpatients. Prescription UseOnly. | Same |
| Syringetype/Environmentod use | CT and MRI applications | CT, MRI, and Angioapplications | The predicatedevice includesenvironment ofuse of thesubject device |
| Specific drug use | Contrast media or saline | contrast media or saline | Same |
| Length/mm | 190 mm | Approximately 190 mm | Same |
| Diameter | O.D.: 5.8 mm + 0.15 mmI.D.: 4.0 mm + 0.1 mm | OD: 5.6mmID: 4.2mm | Slightly different,but the |
| Attribute | SUBJECT DEVICE | Predicate:Disposable AngiographicSyringes for NemotoInjectors | Comparison |
| difference doesnot raise any risksince the J-Tubeis to be used totransfer a mediafrom itscontainer intothe barrel of thesyringe. | |||
| Connector type | Luer-slip connection, ISO80369-7: 2021 compliant | Luer-slip connection | Same |
| Connection force | More than 0.51 kgf (5 N) | Not specified | Different,however, thisforce is sufficientto preventdisconnectionbetween J tubeand syringewhich causefailure of mediatransfer, whichcould causedelay ofprocedure butno injury topatients. |
| Materials | Low Density Polyethylene(LDPE) | Polyethylene | Different,however,biocompatibilityand connectionverificationbetween the J-Tube and theDisposablesyringes arecompleted.There is noadditional |
| Attribute | SUBJECT DEVICE | Predicate:Disposable AngiographicSyringes for NemotoInjectors | Comparison |
| concerns forsafety andeffectiveness ofthe subjectdevice. | |||
| Sterility | EtO Sterilized | EtO Sterilized | Same |
| Single-Use | Single use | Single use | Same |
| Shelf Life | 5 years | 5 years | Same |
| Complies with ISO10993-1 | Compliance | Compliance | Same |
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9. Non-Clinical Performance Data
To support substantial equivalence to the predicate device, Nemoto Kyorindo Co., Ltd. completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met.
The Disposable Syringe (Kit) passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its substantial equivalence to the predicate device:
- Cytotoxicity testing per ISO 10993-5 Passed ●
- Sensitization testing per ISO 10993-10 – Passed
- Irritation testing per ISO 10993-23 – Passed
- Acute systemic toxicity testing per ISO 10993-11 - Passed
- . Hemolysis testing per ISO 10993-4, ASTM F 756 – Passed
- . Pyrogenicity testing per ISO 10993-11, USP-NF 38 <151> Pyrogen Test - Passed
- Particulate Contamination testing per USP <788> – Passed
- Endotoxin testing per USP-NF <85> and <161> – Passed
- . Lubricant testing per modified ISO 7886-1 – Passed
- Tolerance on Graduated Capacity testing per ISO 7886-1 – Passed
- . Scale testing per ISO 7886-1 – Passed
- . Numbering of Scales testing per ISO 7886-1 – Passed
- Overall length of scale to nominal capacity line per ISO 7886-1 – Passed
- Position of Scale testing per ISO 7886-1 – Passed
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- Barrel testing per ISO 7886-1 Passed ●
- . Plunger Stopper/Plunger Assembly testing per ISO 7886-1 – Passed
- Nozzle Lumen testing per ISO 7886-1 Passed ●
- . Dead Space testing per ISO 7886-1 – Passed
- . Freedom from Air past Plunger Stopper testing per ISO 7886-1 – Passed
- . Fit of Plunger Stopper/Plunger in Barrel per ISO 7886-1 – Passed
- Liquid Leakage past Plunger Stopper testing per in-house pressure resistance testing – Passed
- Transparency testing per ISO 8536-9 – Passed
- Tensile Strength testing per ISO 8536-9 – Passed
- . Leakage testing per ISO 8536-9 - Passed
- Injection Needle testing per ISO 8536-9 - Passed
- Chemical testing per ISO 7886-1, ISO 8536-9 Passed ●
- . Connection force per in-house testing - Passed
- Positive Pressure Liquid Leakage testing per ISO 80369-7 – Passed
- . Sub-Atmospheric Pressure Air Leakage testing per ISO 80369-7 – Passed
- . Stress Cracking testing per ISO 80369-7 - Passed
- Resistance to Separation from Axial Load testing per ISO 80369-7 – Passed
- . Resistance to Separation from Unscrewing testing per ISO 80369-7 – Passed
- Resistance to Overriding testing per ISO 80369-7 - Passed
- Compatibility per in-house testing - Passed
- . Sterilization validation - demonstrates SAL of 10-6
- . Ethylene Oxide Sterilization Residuals testing per ISO 10993-7 - Passed
- . Shelf Life Testing – Supports shelf life of 5 years
- . Transportation Testing per ASTM F88/88M, ASTM F1140/F1140M, ASTM F1929, ASTM F1886/F1886M and ISO 11607-1 – Demonstrates package integrity maintained
- . Usability Engineering per IEC 62366-1 – Evaluated
10. Clinical Performance Data
No clinical data was necessary to determine the substantial equivalence of this device.
11. Statement of Substantial Equivalence
The Disposable Syringe (Kit) has the same indications for use as the predicate devices listed above. Any minor differences in the technological characteristics of the subject device when compared to the predicate devices have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject device, when compared to the predicate device, does not raise any
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new questions of safety and effectiveness. Therefore, the Disposable Syringe (Kit) has been determined to be substantially equivalent to the predicate devices.
§ 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.