(251 days)
No
The device description and performance studies focus on mechanical functionality and sterilization, with no mention of AI or ML.
No
The device is a syringe lever intended for administering sterile materials, not for directly treating a disease or condition. It is an aid for administration, not the therapeutic agent itself.
No
Explanation: The device is described as a syringe lever device for administering sterile materials, which is an interventional or therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical, manually operated syringe lever with mechanical components (syringe housing, dispensing mechanism, knob, clutch mechanism). It also mentions cleaning and sterilization procedures, which are relevant to hardware devices. There is no mention of software in the description or performance studies.
Based on the provided information, the Uroject 12 Syringe Lever Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "administration of sterile materials" in a clinical setting. This describes a device used to deliver substances into the body, not to perform tests on samples taken from the body.
- Device Description: The description focuses on the mechanical aspects of holding and dispensing from a syringe. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on testing biological materials.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) to provide information about a person's health or condition. The Uroject 12 Syringe Lever Device is a delivery system, not a diagnostic testing system.
N/A
Intended Use / Indications for Use
The Uroject 12 Syringe Lever Device is intended for use in the administration of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of a physician.
Product codes
QBL
Device Description
The Uroject12 Syringe Lever body contains syringe housing for holding a standard 20 mL syringe and a dispensing mechanism that is manually operated by rotating a knob that presses the syringe piston. A clutch mechanism facilitates fast adaptation of the injection mechanism to the syringe piston position. The Uroject12 Syringe Lever is a reusable, reprocessed device to be sterilized before each use and cleaned after use.
The compatible syringes to be used with the Uroject12 are: 20 mL MEDALLION® syringe (Catalog Number MSS121, Merit Medical, Salt Lake City, UT, USA) and 20 mL MEDALLION® COP syringe (Catalog Number COP121PC, Merit Medical, Salt Lake City, UT, USA).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician / clinical urology setting
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
Bench Testing: Instillation Pressure and Force Testing, Extreme Dispensing Resistance Testing, Residual Volume Testing, Clutch Mechanism Functionality Testing, Lifetime Functionality Testing.
Cleaning and Sterilization: The Uroject12 Syringe Lever is provided non-sterile and is a reusable, reprocessed device. The Uroject12 device is intended to be cleaned and sterilized before each use. The cleaning instructions were validated in accordance with AAMI TIR30:2011. The sterilization instructions were validated to demonstrate a sterility assurance level (SAL) of
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
October 17, 2018
UroGen Pharma Ltd. James G. Ottinger, R.Ph. Vice President, Regulatory Affairs 499 Park Avenue, 12th Floor, Suite 1200 New York, NY 10022
Re: K180345 Trade/Device Name: Uroject12 Syringe Lever Regulation Number: 21 CFR§ 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: QBL Dated: September 14, 2018 Received: September 18, 2018
Dear James G. Ottinger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark R. Kreitz -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K180345
Device Name Uroject12 Syringe Lever
Indications for Use (Describe)
The Uroject 12 Syringe Lever Device is intended for use in the administration of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of a physician.
| 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
9 Ha'Ta'asiya St. POB 2397 Ra'anana 4365405, Israel Tel.: +972 - 9 - 770 - 7600 Fax:+972 - 77 - 417 - 1410 e-mail: info@urogen.com
510(K) SUMMARY
Uroject12 Svringe Lever
510(k) Number K180345
Date Prepared: September 17, 2018
I. SUBMITTER
Applicant's Name:
UroGen Pharma Ltd. 9 HaTaasiya Street Ra'anana, Israel, 4365405 Tel: +972-9-770-7600 Fax: +972-77-4171410
Primary Contact:
James G. Ottinger, R.Ph. Vice President, Regulatory Affairs UroGen Pharma Ltd. Telephone: 610-745-1230 Fax: (646) 918-1262 e-mail: jim.ottinger(@urogen.com
II. DEVICE
Trade Name: Uroject12 Syringe Lever Common or Usual Name: Syringe Lever Classification: Product Code: QBL (Piston Syringe Lever) Regulation: 21 CFR 880.5860 (Piston Syringe) Class: II Panel: General Hospital
III. PREDICATE DEVICES
Predicate device: iSecure Syringe Cartridge Holder, by Hospira, Product code FMF 21 CFR 880.5860; K063180
Reference device: Medi-SIS Syringe Infusion System; by: I-Flow Corp.; Product code: MEB, 21 CFR 880.5725 (K953028, K954059, K972173); FRN, LZH, 21 CFR 880.5725 (K111381)
IV. DEVICE DESCRIPTION
007 510k summary
Image /page/3/Picture/18 description: The image contains the logo for UroGen Pharma. The logo features a stylized kidney shape in blue, with a lighter blue splash-like design inside. Below the kidney graphic, the word "UroGen" is written in a bold, light blue font. Underneath "UroGen", the word "Pharma" is written in a smaller, less bold, light blue font.
4
Image /page/4/Picture/1 description: The image shows the logo for UroGen Pharma. The logo features a stylized kidney shape in blue, with a lighter blue abstract design inside. Below the kidney graphic, the word "UroGen" is written in a bold, blue sans-serif font. Underneath "UroGen", the word "Pharma" is written in a smaller, lighter blue font.
9 Ha'Ta'asiya St. POB 2397 Ra'anana 4365405. Israel Tel.: +972 - 9 - 770 - 7600 Fax:+972 - 77 - 417 - 1410 e-mail: info@urogen.com
The Uroject12 Syringe Lever body contains syringe housing for holding a standard 20 mL syringe and a dispensing mechanism that is manually operated by rotating a knob that presses the syringe piston. A clutch mechanism facilitates fast adaptation of the injection mechanism to the syringe piston position. The Uroject12 Syringe Lever is a reusable, reprocessed device to be sterilized before each use and cleaned after use.
The compatible syringes to be used with the Uroject12 are: 20 mL MEDALLION® syringe (Catalog Number MSS121, Merit Medical, Salt Lake City, UT, USA) and 20 mL MEDALLION® COP syringe (Catalog Number COP121PC, Merit Medical, Salt Lake City, UT, USA).
V. INDICATIONS FOR USE
The Uroject12 Syringe Lever Device is intended for use in the administration of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of a physician.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The principle of operation of the Uroject12 Syringe Lever device is similar to the predicate device, the iSecure Syringe Cartridge Holder, in that:
- Both devices encase a syringe to actuate an injection a.
- b. Both devices are used with a container closure system containing a drug solution with no direct contact to the drug.
The design and operating principles of the Uroject12 Syringe Lever Device are similar to those of the Medi-SIS Syringe Infusion System reference device. Both devices:
- a. Consist of an outer syringe holder and an inner syringe driver;
- b. Are used for injection of substances from a standard syringe;
- Are operated by the user rotating a rotary driver mechanism in order to apply C. pressure on the housed syringe plunger, thereby pushing out the fluid in the syringe in a controlled and accurate manner; and
- d. Are designed to provide visual markings on the syringe and allows visualization of the drug volume during administration
E. SUBSTANTIAL EQUIVALENCE
The Uroject12 Syringe Lever is substantially equivalent to the predicate device based on the following:
Intended Use
007 510k summary
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Image /page/5/Picture/1 description: The image contains the logo for UroGen Pharma. The logo features a stylized kidney shape in blue, with a lighter blue abstract design inside. Below the kidney graphic, the text "UroGen" is written in a bold, sans-serif font, also in blue. Underneath "UroGen", the word "Pharma" is written in a smaller, less bold font.
9 Ha'Ta'asiya St. POB 2397 Ra'anana 4365405. Israel Tel.: +972 - 9 - 770 - 7600 Fax:+972 - 77 - 417 - 1410 e-mail: info@urogen.com
The intended use of the proposed Uroject 12 Syringe Lever is similar to the predicate device, the iSecure Syringe Cartridge Holder, in which both devices are intended to administer sterile materials under aseptic conditions in accordance with the best judgement of the physician. While not identical to the predicate device, the intended use of the Uroject12 is limited to administration of fluids compared to the predicate device, which includes both administration and withdrawal. Performance of the Uroject12 in a urological setting has been demonstrated through bench testing and supports that these differences do not raise new questions of safety and effectiveness of the Uroject12 device.
Technology
The proposed Uroject12 Syringe Lever is similar in technology to the predicate device, the iSecure Syringe Cartridge Holder, on the basis that the devices are used in conjunction with a pre-loaded syringe to perform administration of fluids operated by the user. The technological characteristics of the Uroject12 Syringe Lever is supported by the reference device, the Medi-Sis Syringe Infusion System, which uses the same principle of operation (rotary mechanism). The technological characteristics of the Uroject12 device have also been demonstrated through performance testing.
Discussion
A direct comparison of characteristics demonstrates that the Uroject12 Syringe Lever is substantially equivalent to the iSecure Syringe Cartridge Holder by intended use and the principle of operation. The reference device, the Medi-SIS Syringe Infusion System, further supports the technological characteristics of the Uroject12 device. Performance characteristics demonstrate that the proposed Uroject12 Syringe Lever is as safe and effective as the predicate device for use in a urological setting.
F. PERFORMANCE DATA
Bench Testing
Performance of the Uroject12 Syringe Lever has been demonstrated through the following:
- Instillation Pressure and Force Testing ●
- Extreme Dispensing Resistance Testing ●
- Residual Volume Testing ●
- Clutch Mechanism Functionality Testing
- Lifetime Functionality Testing
Cleaning and Sterilization
The Uroject12 Syringe Lever is provided non-sterile and is a reusable, reprocessed device. The Uroject12 device is intended to be cleaned and sterilized before each
6
Image /page/6/Picture/1 description: The image shows the logo for UroGen Pharma. The logo features a stylized kidney shape in blue, with a lighter blue splash-like design inside. Below the kidney graphic, the word "UroGen" is written in a bold, sans-serif font, also in blue. Underneath "UroGen," the word "Pharma" is written in a smaller, lighter blue font.
9 Ha'Ta'asiya St. POB 2397
Ra'anana 4365405, Israel Tel.: +972 - 9 - 770 - 7600 Fax:+972 - 77 - 417 – 1410 e-mail: info@urogen.com
use. The cleaning instructions were validated in accordance with AAMI TIR30:2011. The sterilization instructions were validated to demonstrate a sterility assurance level (SAL) of