(231 days)
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.
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).
The provided text describes the Uroject12 Syringe Lever, a device for administering sterile materials in a clinical urology setting. This document is a 510(k) summary submitted to the FDA, asserting substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not list specific numerical acceptance criteria for performance metrics (like accuracy, precision, or specific failure rates) and their corresponding reported device performance values in a table. Instead, it states:
"The results of the validation testing demonstrated that the Uroject12 Syringe Lever is considered safe and effective for its intended use."
The primary "acceptance criterion" appears to be demonstrating substantial equivalence to the predicate device, especially concerning the new reprocessing instructions.
Study Information
Based on the provided document, the study conducted was focused on the reprocessing instructions for the device, not its core operational performance, as the device itself hasn't changed.
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated in terms of the number of devices or cycles tested for the high-level disinfection and automated cleaning processes.
- Data Provenance: Not specified, but generally, validation testing for medical devices is conducted in controlled laboratory settings. The applicant is UroGen Pharma Ltd., located in Israel. The data would be prospective, as it's validation testing for new instructions.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable/Not mentioned. The validation testing pertained to the efficacy of cleaning and disinfection processes, which typically involve microbiological and chemical testing against established standards, not expert clinical interpretation.
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Adjudication Method for the Test Set:
- Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., imaging studies) to resolve discrepancies among experts. This validation focused on objective performance metrics related to reprocessing.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The document focuses on performance validation related to reprocessing, not a comparison of human reader performance with or without AI assistance.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. The Uroject12 Syringe Lever is a physical medical device, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.
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The Type of Ground Truth Used:
- For the validation of high-level disinfection and automated cleaning processes, the "ground truth" would be established microbiological and chemical standards for cleanliness, sterility, and material compatibility after reprocessing. The document implicitly states that the validation "demonstrated that the Uroject12 Syringe Lever is considered safe and effective for its intended use" after these processes.
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The Sample Size for the Training Set:
- Not applicable. The device is not an AI/ML algorithm, so there is no "training set."
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence for a physical medical device, specifically addressing new reprocessing instructions. It does not contain the detailed study design, performance metrics, and expert-based ground truth information typically found for AI/ML devices or clinical trials assessing diagnostic accuracy. The "study" mentioned refers to validation testing of cleaning and disinfection protocols.
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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.
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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.
§ 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).