(98 days)
Not Found
No
The device description focuses on mechanical components and tactile/auditory feedback for dose delivery, with no mention of AI or ML terms or functionalities. The performance studies are limited to bench testing and biocompatibility, further indicating a lack of AI/ML components.
No
The device is described as an injection system for delivering drugs, rather than directly providing therapy itself.
No
Explanation: The Repris Bladder Injection System is indicated for the injection of drugs to treat abnormal physiology, not to identify or determine the nature of a disease or condition. It is a drug delivery device.
No
The device description clearly outlines physical components (introducer, needle, metered syringe) and mentions bench testing related to hardware performance (design verification/validation, packaging, biocompatibility). There is no mention of software as a component or its function.
Based on the provided information, the Repris Bladder Injection System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "injection of drugs to address abnormal physiology in the lower urinary tract of adults." This describes a therapeutic or interventional use, not a diagnostic one.
- Device Description: The description details a system for delivering substances into the body (injection), which is characteristic of a therapeutic or surgical device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine samples of human origin (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases, conditions, or to monitor health. The Repris Bladder Injection System's function is to deliver medication directly into tissue, which is a treatment method.
N/A
Intended Use / Indications for Use
The Repris Bladder Injection System is indicated for injection of drugs to address abnormal physiology in the lower urinary tract of adults. It is intended to deliver a variety of legally marketed drugs into tissue structures during cystoscopic procedures. It is provided sterile for single use.
Product codes
FBK
Device Description
The Repris Bladder Injection System consists of an introducer that is positioned onto the shaft of a cystoscope lens, a needle that is contained within a lumen in the wall of the introducer, and a metered syringe. The fully assembled Repris device has an overall length of 32.4 cm (12.75 inches); the introducer's working length is 20.4 cm (8.06 inches). External to the introducer is a metered syringe that is attached to the luer connection at the proximal end of the needle. The metered syringe delivers a pre-determined dose for each of the multiple injection sites as the plunger is advanced. The syringe provides the user with a tactile and auditory feedback when the exact dose is delivered.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower urinary tract, Bladder Wall
Indicated Patient Age Range
adults
Intended User / Care Setting
Hospitals, clinics, and physician offices
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)
All necessary performance testing was conducted with bench testing and included:
Design verification and validation studies; Packaging and shelf-life studies; and Biocompatibility testing.
Testing was conducted on the device to verify that it is compliant with biocompatibility requirements for a short duration indwelling device, as specified in ISO 10993 - Part 1.
No animal or clinical testing was necessary to support this submission.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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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 and 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.
May 3, 2018
URO-1, Inc. Thomas Lawson Regulatory Consultant 391 Technology Way, Suite 168 Winston Salem, NC 27101
Re: K180214
Trade/Device Name: Repris Bladder Injection System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FBK Dated: March 28, 2018 Received: March 29, 2018
Dear Thomas Lawson:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold, sans-serif font. The text is black and appears to be centered on a white background. The letters are well-defined and easy to read, with consistent spacing between them.
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
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Indications for Use
510(k) Number (if known): To be assigned K180214
Device Name: Repris Bladder Injection System
Indications for Use:
The Repris Bladder Injection System is indicated for injection of drugs to address abnormal physiology in the lower urinary tract of adults. It is intended to deliver a variety of legally marketed drugs into tissue structures during cystoscopic procedures. It is provided sterile for single use.
Prescription Use: (21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use: (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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510(k) Summary
I. SUBMITER:
URO-1, Inc. 391 Technology Way Suite 168 Winston Salem, NC 27101
Phone: 336 930 5464
Contact Person: Thomas Lawson, PhD
Phone: 510 206 1794 eMail: drthomlawson(@gmail.com
Submission Date: May 2, 2018
II. DEVICE
| Device Name: | Repris Bladder Injection System |
|---|---|
| Common Name: | Bladder Injection Needle |
| Classification Panel: | Gastroenterology and Urology |
| Classification Number: | 21 CFR 876.1500 |
| Classification Name: | Endoscope and Accessories |
| Product Code: | FBK |
| Product Code Name: | Endoscopic Injection Needle, |
| Gastroenterology-Urology | |
| Regulatory Class: | II |
Regulatory Class:
III. PREDICATE DEVICE
injeTAK Adjustable Tip Needle. K090830
Note: This predicate device has not been subject to a design-related recall.
DEVICE DESCRIPTION IV.
The Repris Bladder Injection System consists of an introducer that is positioned onto the shaft of a cystoscope lens, a needle that is contained within a lumen in the wall of the introducer, and a metered syringe. The fully assembled Repris device has an overall length of 32.4 cm (12.75 inches); the introducer's working length is 20.4 cm (8.06 inches). External to the introducer is a metered syringe that is attached to the luer connection at the proximal end of the needle. The metered syringe delivers a pre-determined dose for each of the multiple injection sites as the plunger is advanced. The syringe provides the user with a tactile and auditory feedback when the exact dose is delivered.
4
INDICATIONS FOR USE
The Repris bladder injection system is indicated for injection of drugs to address abnormal physiology in the lower urinary tract of adults. It is intended to deliver a variety of legally marketed drugs into tissue structures during cystoscopic procedures. It is provided sterile for single use.
V. SUBSTANTIAL EQUIVALENCE
The Repris Bladder Injection System is substantially equivalent to the injeTAK Adjustable Tip Needle manufactured by Laborie Medical Technologies, Corp. (K090830) in terms of indications for use, route the devices are introduced and advanced within the body, capability to injection medications or solutions into the wall of the bladder, and being made from biocompatible materials.
Table I. Comparison of the Repris Bladder Injection System to the predicate device, the InjeTAK Adjustable Tip Needle (K090830).
| Subject device | Predicate device | |
|---|---|---|
| Repris Bladder Injection System | injeTAK Adjustable Needle | |
| URO-1, Inc. | Laborie Medical Technologies, | |
| Corp. | ||
| (this submission) | (K090830) | |
| Indication for use | Injection of drugs to address | |
| abnormal physiology in the | ||
| lower urinary tract of adults. | Injection of drugs to address | |
| abnormal physiology in the lower | ||
| urinary tract | ||
| Intended Use | To deliver a variety of legally | |
| marketed drugs into tissue | ||
| structures during cystoscopic | ||
| procedures. It is provided sterile | ||
| for single use. | To deliver a variety of legally | |
| marketed drugs into tissue | ||
| structures during cystoscopic | ||
| procedures. It is provided sterile | ||
| for single use. | ||
| Route of | ||
| Advancement | Advanced to the bladder via the | |
| urethra in tandem with a | ||
| cystoscope | Advanced to the bladder via the | |
| urethra through the working | ||
| channel of a cystoscope | ||
| Target Populations | Female | Male & Female |
| Location of Injection | Bladder Wall | Bladder Wall |
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| Site of Use | Hospitals, clinics, and physician offices | Hospitals, clinics, and physician offices |
|---|---|---|
| Device Features | ||
| Components | Introducer | |
| Injection Needle | ||
| Syringe | Injection Needle | |
| Size of Needle | 23 ga | 25 ga |
| Size of Needle | ||
| Assembly (Outer | ||
| Diameter) | 0.648 inch (1.6 mm) | 4.8 Fr (1.6 mm) |
| Length of Needle | ||
| Assembly | 32.4 cm | 35 and 70 cm |
| Introducer Size | ||
| (Outer Diameter) | 7 mm | N/A |
| Performance | ||
| Duration of use | ≤ 24 hours | ≤ 24 hours |
| Sterilization | Provided sterile. | |
| Sterilized by gamma radiation | ||
| (gamma). | Provided sterile. | |
| Sterilized by ethylene oxide | ||
| (EtO). | ||
| Frequency of use | Single patient use. | Single patient use. |
| Tissue contact | ||
| materials | Compliant with ISO 10993 | Compliant with ISO 10993 |
Any differences between the Repris Bladder Injection System and the predicate device do not alter the intended use of the Repris Bladder Injection System.
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VI. PERFORMANCE DATA
All necessary performance testing was conducted with bench testing and included:
Design verification and validation studies; Packaging and shelf-life studies; and Biocompatibility testing.
Testing was conducted on the device to verify that it is compliant with biocompatibility requirements for a short duration indwelling device, as specified in ISO 10993 - Part 1.
No animal or clinical testing was necessary to support this submission.
CONCLUSION VII.
The Repris Bladder Injection System and the injeTAK Adjustable Tip Needle have the same intended use and indications for use and have equivalent technological characteristics. The minor differences between the Repris Bladder Injection System and the predicate device do not raise any new issues of safety or effectiveness. Therefore, the Repris Bladder Injection System is substantially equivalent to the identified predicate device.