Who is the manufacturer of Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)?

Nemoto Kyorindo Co., Ltd. filed the 510(k) submission for Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) (K242212).

What is the FDA product code for Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)?

DXT. It is classified under 21 CFR 870.1650 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)

Q: What are the predicate devices for Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)?

Disposable CT/MR Syringes for Nemoto Injectors (K051799); Disposable Angiographic Syringes for Nemoto Injectors (K090487); Disposable 330 psi extension lines (K120892).

K242212 · Nemoto Kyorindo Co., Ltd. · DXT · Aug 27, 2024 · Cardiovascular

Device Facts

Record ID	K242212
Device Name	Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)
Applicant	Nemoto Kyorindo Co., Ltd.
Product Code	DXT · Cardiovascular
Decision Date	Aug 27, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1650
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended Use

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: 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.

Device Story

Disposable Syringe (Kit) consists of plastic syringes, extension tubing, and J-tube for contrast media/saline transfer; designed for use with Nemoto power injection systems. Syringes available in 100 mL, 150 mL, and 200 mL volumes. J-tube facilitates media transfer from vials to syringe barrel; extension tube connects syringe to patient needle/catheter. Used in CT, MRI, and angiography environments. Operated by trained medical professionals. System controls pressure and flow rates: up to 300 PSI/10 mL/s for CT/MRI; up to 1200 PSI/30 mL/s for angiography. Output is controlled delivery of diagnostic fluids to patient vascular system. Benefits include standardized, reliable contrast delivery for imaging procedures.

Clinical Evidence

No clinical data was necessary to determine substantial equivalence. Bench testing only, including biocompatibility, sterility, shelf-life, transportation, and mechanical performance (pressure resistance, leakage, tensile strength) per ISO and USP standards.

Technological Characteristics

Materials: Thermoplastic Vulcanizate, PCTG, Polypropylene, Silicone, Polycarbonate, POM, PVC, HDPE, LDPE. Sensing/Actuation: Mechanical syringe driven by Nemoto power injector. Connectivity: None (mechanical interface). Sterilization: EtO. Standards: ISO 7886-1:2017, ISO 80369-7:2021, ISO 8536-9:2015, ISO 10993-1.

Indications for Use

Indicated for delivery of contrast media or saline into adult patients during CT, MR, or angiographic imaging procedures using Nemoto power injectors. Prescription use only.

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

Disposable CT/MR Syringes for Nemoto Injectors (K051799)
Disposable Angiographic Syringes for Nemoto Injectors (K090487)
Disposable 330 psi extension lines (K120892)

Related Devices

K051799 — DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS · Coeur, Inc. · Nov 2, 2005
K182289 — Sterile High-pressure Angiographic Syringes for Single-use · Shenzhen Baoan Medical Supplies Co., Ltd. · Oct 10, 2018
K241109 — Single-use Sterile High-pressure Angiographic Syringes and Accessories · Shenzhen Boon Medical Supply Co., Ltd. · Aug 22, 2024
K172694 — Sterile Disposable Syringes · Shenyang Mastech Medical Device Co., Ltd. · Jul 6, 2018
K152906 — Disposable High Pressure Injector Syringe · Wuxi Yushou Medical Appliances Co., Ltd. · Nov 22, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ 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). {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-------------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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) {4}------------------------------------------------ Page 2 of 15 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: {5}------------------------------------------------ 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 Syringes for Nemoto Injectors | Comparison | |-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | - | K051799 | - | | Product Code | DXT | DXT | Same | | Regulation Number | 870.1650 | 870.1650 | Same | | Indications for Use | The Nemoto Disposable Syringe (Kit) is specifically designed for use with Nemoto Injectors and are intended to be used for the administration of contrast media or physiological saline into a patient in conjunction with CT and MR examinations. | The Disposable CT/MR Syringe for Nemoto Injectors is a syringe for the injection of contrast media or saline for CT and MR imaging, for use on Nemoto injectors | Same meaning | | Intended users | To be used by medical professionals who are trained and qualified to deliver contrast media or normal saline into adult | To be used by medical professionals who are trained and qualified to deliver contrast media or normal 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: 153.21 200 mL Syringe: Barrel length: 157.81 | 100 mL Syringe: Barrel length: 153.21 200 mL Syringe: Barrel length: 157.81 | Same | | Diameter | 100 mL Syringe: Outer diameter: 49.60-49.70 Inner diameter: 45.90-46.00 200 mL Syringe: Outer diameter: 31.95-32.05 Inner diameter: 35.39-35.61 | 100 mL Syringe: Outer diameter: 49.60-49.70 Inner diameter: 45.90-46.00 200 mL Syringe: Outer diameter: 31.95-32.05 Inner diameter: 35.39-35.61 | Same | | Nozzle type | ISO 80369-7: 2021 compliant | ISO 594 compliant | Same ISO 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 Syringes for Nemoto Injectors | Comparison | | Scale | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standard applied | | Numbering of scales | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standard applied | | Overall length of scale to nominal capacity line | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standard applied | | Position of scale | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standard applied | | Barrel | ISO 7886-1:2017 compliant | While syringe is technically ISO 7886-1:1993 compliant by Design of flange, the syringe is intended for use with injector. | Same standard applied | | Plunger stopper/plunger assembly | ISO 7886-1:2017 compliant | N/A – Syring is intended for use with injector. | While the predicate device does not apply ISO 7886-1 but, what the subject device complies with ISO 7886-1 does not raise additional risk. | | Nozzle lumen | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standard applied | | Dead space | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standard applied | | Freedom from air and liquid leakage past plunger stopper | Freedom from air: ISO 7886-1:2017 compliant Liquid leakage past plunger stopper: Pressure resistance testing (300 psi) | ISO 7886-1:1993 compliant | Same standard applied | | Fit of plunger stopper/plunger in barrel | ISO 7886-1:2017 compliant | ISO 7886-1:1993 compliant | Same standard applied | | Attribute | SUBJECT DEVICE | Predicate: Disposable CT/MR Syringes for Nemoto Injectors | Comparison | | Materials | Thermoplastic Vulcanizate Poly Cyclohexylenedimethylene Terephthalate glycol- modified (PCTG) Polypropylene Silicone | PET | The subject device complies with biocompatibility, ISO 7886-1 and pressure limit testing that is appropriate. | | Sterility | EtO Sterilized | EtO Sterilized | Same | | Single-Use | Single use | Single use | Same | | Shelf Life | 5 years | 5 years | Same | | Complies with ISO 10993-1 | Compliance | Compliance | Same | #### Comparison of Characteristics (100 mL or 200 mL Syringe) {6}------------------------------------------------ ## Page 4 of 15 {7}------------------------------------------------ ## Page 5 of 15 {8}------------------------------------------------ ## Page 6 of 15 ## Comparison of Characteristics (150 mL Syringe) | Attribute | SUBJECT DEVICE | Predicate: Disposable Angiographic Syringes for Nemoto Injectors | Comparison | |----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | - | K090487 | - | | Product Code | DXT | DXT | Same | | Regulation Number | 870.1650 | 870.1650 | Same | | Indications for Use | The Nemoto Disposable Syringe (Kit) is specifically designed for use with Nemoto Injectors and are intended to be used for the administration of contrast media or physiological saline into a patient in conjunction with angiographic examinations. | for injecting contrast media and saline, for angiography | Same meaning | | Intended users | To be used by medical professionals who are trained and qualified to deliver contrast media or normal saline into adult | To be used by medical professionals who are trained and qualified to deliver contrast media or normal saline into adult | Same | | Attribute | SUBJECT DEVICE | Predicate: Disposable Angiographic Syringes for Nemoto Injectors | Comparison | | | patients. Prescription Use Only. | patients. Prescription Use Only. | | | Syringe type/Environment od 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 mm Overall: 239.8 mm | Barrel: 141 mm Overall: 239.8 mm | Same | | Diameter | O.D. 43.52 mm I.D. 40.2 mm | 0.D. 43.52 mm I.D. 40.2 mm | Same | | Nozzle type | Luer male connector, ISO 80369-7: 2021 compliant | Luer connection, ISO 594 compliant | Same ISO 594 was replaced by ISO 80369-7. | | Pressure Limit | Up to 1200 psi | Up to 1200 psi | Same | | Particle matter | ISO 7886-1:2017 compliant | ISO7886-1:1993 | Same standard applied | | Chemical test (Extractable metals and Limits for acidity or alkalinity) | ISO 7886-1:2017 compliant | ISO7886-1:1993 | Same standard applied | | Barrel | ISO 7886-1:2017 compliant | ISO7886-1:1993 | Same standard applied | | Pressure resistance | 1200 psi compliant | 1200 psi compliant | Same | | Materials | Polycarbonate, Polypropylene, Polyoxymethylene (POM), Silicone | Polypropylene, Silicone | The subject device complies with biocompatibility. ISO 7886-1 and pressure limit testing that is appropriate. | | Sterility | EtO Sterilized | EtO Sterilized | Same | | Single-Use | Single use | Single use | Same | | Shelf Life | 5 years | 5 years | Same | | Complies with ISO 10993-1 | Compliance | Compliance | Same | | Attribute | SUBJECT DEVICE | Predicate: Disposable 330 psi extension 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 to provide a connection between the syringe barrel and the needle or catheter that is punctured into the patient. | To be used as an interface between (an) Angiographic, CT, or MR Syringe(s) and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system. | Same meaning | | 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. | To be used by medical professionals who are trained and qualified to deliver contrast media or normal saline into adult patients. Prescription Use Only. | Same | | Syringe type/Environment od use | CT and MRI applications | CT, MRI, and Angio applications | The predicate device includes environment of use of the subject 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 mm I.D.: 1.77-1.85 mm | O.D.: 3.87-3.95 mm I.D.: 2.31-2.39 mm *Manually measured | Different, but the subject device complies with ISO 8536-9, Infusion equipment for medical use – part 9: fluid lines for single use with pressure infusion | | Attribute | SUBJECT DEVICE | Predicate: Disposable 330 psi extension lines | Comparison | | Connector type | ISO 80369-7: 2021 compliant | ISO 594 compliant | Same ISO 594 was replaced by ISO 80369-7. | | Pressure Limit | 300 psi | 330 psi | Nominal pressure is different, however, the compatible injector can apply pressure up to 300 psi and there is no additional risk raised. | | Transparency | ISO 8536-9:2015 compliance | Allows clear view | The same visual testing | | Particulate contamination | ISO 8536-9:2015 compliance | Visual inspection | The subject device was conducted more severe testing and no additional risk is raised. | | Tensile strength | ISO 8536-9:2015 compliance | Must hold 8lb for a minimum of 10 seconds without breakage of the bond or the tubing | The subject device complies with current ISO standard and does not raise additional risk. | | Leakage | Air leakage: ISO 8536-9:2015 compliance Water leakage: Pressure resistance testing (300 psi) | Air leakage requirement – 2psi without leakage Water leakage: Pressure resistance testing (330 psi) | Air leakage: The subject device complies with current ISO | | Attribute | SUBJECT DEVICE | Predicate: Disposable 330 psi extension lines | Comparison | | | | | standard and does not raise additional risk. Water leakage: Nominal pressure is different, however, the compatible injector can apply pressure up to 300 psi and there is no additional risk raised. | | Material | Poly Vinyl Chloride (PVC), High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE), Polypropylene, Poly Carbonate (PC) | No information | The subject device complies with biocompatibility, ISO 8536-9 and pressure limit testing that is appropriate. | | Sterility | EtO Sterilized | EtO Sterilized | Same | | Single-Use | Single use | Single use | Same | | Shelf Life | 5 years | 5 years | Same | | Complies with ISO 10993-1 | Compliance | Compliance | Same | {9}------------------------------------------------ ## Page 7 of 15 {10}------------------------------------------------ ## Comparison of Characteristics (Extension Tubes) {11}------------------------------------------------ ## Page 9 of 15 {12}------------------------------------------------ # Page 10 of 15 ## Comparison of Characteristics (J-Tube) | Attribute | SUBJECT DEVICE | Predicate: Disposable Angiographic Syringes for Nemoto Injectors | Comparison | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------…