(29 days)
No
The device description and performance studies focus on the physical properties and safety of disposable syringes and related accessories for contrast media injection, with no mention of AI or ML.
No
The device is described as a disposable syringe kit used for the injection of contrast media or saline for imaging purposes (CT, MR, angiography), which are diagnostic procedures, not therapeutic ones.
No
The device is a disposable syringe kit used for injecting contrast media or saline during diagnostic imaging procedures (CT, MRI, angiography). It does not perform a diagnostic function itself, but rather aids in the process of acquiring diagnostic images.
No
The device description clearly states it is a package containing physical components: plastic syringes, plastic tubing, and a plastic J-shaped tube. The performance studies also detail testing on physical properties and materials.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "injection of contrast media or saline" for imaging procedures (CT, MR, angiography). This is a direct administration of substances into the patient's body for imaging purposes, not for testing samples in vitro (outside the body).
- Device Description: The description details syringes, tubing, and a J-tube for transferring media. These are all components used for delivering substances into a patient, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening based on in vitro testing.
The device is a medical device used for administering substances during imaging procedures, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MR imaging, angiography
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
medical professionals who are trained and qualified to deliver contrast media or normal saline into adult patients.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
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 Pyrogen Test - Passed
- Particulate Contamination testing per USP – Passed
- Endotoxin testing per USP-NF and – 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
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K133189, K071691, K173450, K092896, K091734
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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7
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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 |
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10
Comparison of Characteristics (Extension Tubes)
11
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Comparison of Characteristics (J-Tube)
| 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 |
| Attribute | SUBJECT DEVICE | Predicate:
Disposable Angiographic
Syringes for Nemoto
Injectors | Comparison |
| Indications for Use | 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). | for injecting contrast media
and saline, for angiography | The indications
for use of the
predicate device
is described in
general including
syringes and
tubing., but no
additional
concerns for
safety and
effectiveness of
the subject
device since J-
Tube performs
just as
transferring a
contrast media
or saline and the
component of
the predicate
device performs
as the same. |
| 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 | 190 mm | Approximately 190 mm | Same |
| Diameter | O.D.: 5.8 mm + 0.15 mm
I.D.: 4.0 mm + 0.1 mm | OD: 5.6mm
ID: 4.2mm | Slightly different,
but the |
| Attribute | SUBJECT DEVICE | Predicate:
Disposable Angiographic
Syringes for Nemoto
Injectors | Comparison |
| | | | difference does
not raise any risk
since the J-Tube
is to be used to
transfer a media
from its
container into
the barrel of the
syringe. |
| Connector type | Luer-slip connection, ISO
80369-7: 2021 compliant | Luer-slip connection | Same |
| Connection force | More than 0.51 kgf (5 N) | Not specified | Different,
however, this
force is sufficient
to prevent
disconnection
between J tube
and syringe
which cause
failure of media
transfer, which
could cause
delay of
procedure but
no injury to
patients. |
| Materials | Low Density Polyethylene
(LDPE) | Polyethylene | Different,
however,
biocompatibility
and connection
verification
between the J-
Tube and the
Disposable
syringes are
completed.
There is no
additional |
| Attribute | SUBJECT DEVICE | Predicate:
Disposable Angiographic
Syringes for Nemoto
Injectors | Comparison |
| | | | concerns for
safety and
effectiveness of
the subject
device. |
| 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 |
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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 Pyrogen Test - Passed
- Particulate Contamination testing per USP – Passed
- Endotoxin testing per USP-NF and – 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.