(231 days)
No
The device description and performance studies indicate a purely mechanical, manually operated device with no mention of AI or ML components.
No
The device is described as a "Syringe Lever Device" intended for "administration of sterile materials," and it "presses the syringe piston." This indicates it's an accessory to facilitate drug delivery, rather than a device that directly performs a therapeutic action on a patient.
No
The device is described as a "Syringe Lever Device" intended for "administration of sterile materials." Its function involves holding a syringe and dispensing its contents. There is no mention of it collecting data, analyzing patient conditions, or providing information for diagnosis.
No
The device description clearly outlines a physical, manually operated syringe lever with mechanical components (syringe housing, dispensing mechanism, knob, clutch mechanism). It is described as a reusable, reprocessed device requiring sterilization and cleaning, indicating a hardware component.
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 details a mechanical device for holding and dispensing from a syringe. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic purposes (identifying a disease or condition)
- Reagents or test kits
The device is clearly intended for therapeutic or procedural use, not for diagnostic testing.
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
a clinician and in accordance with the best judgment of a physician, in a 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The only testing included in this submission pertains to the validation activities for the high-level disinfection and automated cleaning processes.
The results of the validation testing demonstrated that the Uroject12 Syringe Lever is considered safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 2, 2019
UroGen Pharma Ltd. % James Ottinger, R.Ph. Vice President, Regulatory Affairs UroGen Pharma Inc. 499 Park Avenue, 12th Floor, Suite 1200 New York, NY 10022
Re: K190987
Trade/Device Name: Uroject12 Syringe Lever Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: QBL Dated: November 7, 2019 Received: November 8, 2019
Dear James 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 may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
for Sharon M. Andrews Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190987
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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K190987 Page 1 of 3
Image /page/3/Picture/1 description: The image contains the logo for UroGen Pharma. The logo consists of a blue circular graphic with a stylized molecular structure inside, followed by the text "UroGen" in a larger, bolder blue font. Below "UroGen" is the word "Pharma" 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
510(K) SUMMARY K190987 Uroject12 Syringe Lever
Date Prepared: November 07, 2019
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
| Device Name: | Uroject12 Syringe Lever |
|---|---|
| Common/Usual Name: | Piston Syringe Lever |
Classification: Device Reg. Description Target Area
Review Panel Product Code
Reg, Number
Device Class
Piston Syringe Lever Piston syringe Urology General Hospital QBL 880.5860 2
III. PREDICATE DEVICE
Predicate device Uroject12 Syringe Lever, by UroGen Pharma, Ltd., Product code QBL, cleared under K180345.
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K190987 Page 2 of 3
Image /page/4/Picture/1 description: The image shows the logo for UroGen Pharma. The logo consists of a blue circular graphic with a stylized molecular structure inside, followed by the text "UroGen" in a larger, bolder blue font. Below "UroGen" is the word "Pharma" 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
IV. 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).
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. SUBSTANTIAL EQUIVALENCE
The Uroject12 Syringe Lever is substantially equivalent to the predicate device based on the following:
Intended Use
The intended use of the proposed device is identical to that of the cleared device.
Technology
No device modifications were made to the Uroject 12 and therefore the technological characteristics of both devices are identical. The only modifications to the device are in the Instructions for Use: specifically, the inclusion of high-level disinfection and automated cleaning processes.
Discussion
A direct comparison of characteristics demonstrates that the Uroject12 Syringe Lever is substantially equivalent to its predicate device. The submitted validation testing supports our claim that the Uroject 2 device is as safe and as effective as its predicate without raising any new safety and effectiveness concerns.
VII. PERFORMANCE DATA
Validation Testing
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K190987 Page 3 of 3
Image /page/5/Picture/1 description: The image shows the logo for UroGen Pharma. The logo consists of a blue circular graphic with a stylized molecular structure inside, followed by the text "UroGen" in a larger, bolder blue font. Below "UroGen" is the word "Pharma" 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 only testing included in this submission pertains to the validation activities for the high-level disinfection and automated cleaning processes.
The results of the validation testing demonstrated that the Uroject12 Syringe Lever is considered safe and effective for its intended use.
VIII. CONCLUSION
UroGen has demonstrated that the Uroject12 Syringe Lever is substantially equivalent to the predicate device. Differences between the proposed Uroject12 Syringe Lever and the predicate device do not raise new questions of safety or efficacy.