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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Repris Bladder Injection System." For this type of submission, the focus is on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific, quantitative performance acceptance criteria through the kind of studies you've described for an AI/algorithm-based device.

Therefore, many of the questions you've asked (e.g., acceptance criteria for device performance, sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this document because it pertains to a physical medical device (an injection system) and its assessment for substantial equivalence.

Here's why, based on the provided text:

Type of Device: The Repris Bladder Injection System is a physical medical device (an injection system for drugs), not an AI/algorithm-based diagnostic or assistive system.
Regulatory Pathway: It's a 510(k) premarket notification, which seeks to establish substantial equivalence to a predicate device. This pathway generally relies on comparison of design, materials, and intended use, along with bench testing and biocompatibility. It does not typically require the type of clinical performance studies with "acceptance criteria" for accuracy, sensitivity, specificity, etc., that are common for AI/ML devices.
Performance Data (Section VI): The document explicitly states: "All necessary performance testing was conducted with bench testing and included: Design verification and validation studies; Packaging and shelf-life studies; and Biocompatibility testing. ... No animal or clinical testing was necessary to support this submission." This directly indicates that the types of studies you're asking about (involving human subjects, expert ground truth, MRMC, etc.) were not performed.

However, I can extract the information relevant to the substantial equivalence argument, which serves as the "proof" the device is acceptable for market:

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence):

For a 510(k) submission, the "acceptance criteria" effectively boil down to demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. The "performance" is shown through direct comparison and bench testing.

1. Table of Acceptance Criteria (as interpreted for Substantial Equivalence) and Reported Device Performance:

Feature/Criterion (for Substantial Equivalence)	Predicate Device (injeTAK Adjustable Tip Needle, K090830)	Subject Device (Repris Bladder Injection System)	Met? (Comment)
Indications for Use	Injection of drugs to address abnormal physiology in the lower urinary tract	Injection of drugs to address abnormal physiology in the lower urinary tract of adults	Yes (Identical)
Intended Use	To deliver a variety of legally marketed drugs into tissue structures during cystoscopic procedures. Provided sterile for single use.	To deliver a variety of legally marketed drugs into tissue structures during cystoscopic procedures. Provided sterile for single use.	Yes (Identical)
Route of Advancement	Advanced to the bladder via the urethra through the working channel of a cystoscope	Advanced to the bladder via the urethra in tandem with a cystoscope	Yes (Similar route)
Target Populations	Male & Female	Female	Yes (Subset of predicate, acceptable)
Location of Injection	Bladder Wall	Bladder Wall	Yes (Identical)
Site of Use	Hospitals, clinics, and physician offices	Hospitals, clinics, and physician offices	Yes (Identical)
Components	Injection Needle	Introducer, Injection Needle, Syringe	Yes (Differences do not alter intended use)
Size of Needle	25 ga	23 ga	Yes (Minor difference, acceptable)
Size of Needle Assembly (Outer Diameter)	4.8 Fr (1.6 mm)	0.648 inch (1.6 mm)	Yes (Identical)
Length of Needle Assembly	35 and 70 cm	32.4 cm	Yes (Minor difference, acceptable)
Introducer Size (Outer Diameter)	N/A (Not applicable, as predicate uses working channel)	7 mm	Yes (New component, evaluated in design studies)
Duration of Use	$\le$ 24 hours	$\le$ 24 hours	Yes (Identical)
Sterilization	Ethylene Oxide (EtO)	Gamma radiation (gamma)	Yes (Validated process, acceptable)
Frequency of Use	Single patient use.	Single patient use.	Yes (Identical)
Tissue Contact Materials	Compliant with ISO 10993	Compliant with ISO 10993	Yes (Demonstrated compliance)
Design Verification & Validation Studies	N/A (for predicate, assumed via original clearance)	Conducted (Bench testing)	Yes (Necessary for new device)
Packaging & Shelf-life Studies	N/A	Conducted	Yes
Biocompatibility Testing	N/A	Conducted (Compliant with ISO 10993 - Part 1)	Yes

Conclusion from document: "Any differences between the Repris Bladder Injection System and the predicate device do not alter the intended use of the Repris Bladder Injection System." And "The minor differences between the Repris Bladder Injection System and the predicate device do not raise any new issues of safety or effectiveness."

Regarding the specific questions about clinical study design for AI/ML devices:

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data from human subjects was used. The "test set" for this device comprised bench testing of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert review of clinical cases was performed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical adjudication was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical injection device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in this context refers to engineering specifications, design requirements, and biocompatibility standards (e.g., ISO 10993).
8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter for a physical medical device, not an AI/ML device. Therefore, the detailed questions about AI/ML study design and performance criteria are not addressed or relevant in this context. The "proof" of acceptability lies in the demonstration of substantial equivalence to a predicate device through comparative analysis and bench testing.

Summary

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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.

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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:

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.

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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 addressabnormal physiology in thelower urinary tract of adults.	Injection of drugs to addressabnormal physiology in the lowerurinary tract
Intended Use	To deliver a variety of legallymarketed drugs into tissuestructures during cystoscopicprocedures. It is provided sterilefor single use.	To deliver a variety of legallymarketed drugs into tissuestructures during cystoscopicprocedures. It is provided sterilefor single use.
Route ofAdvancement	Advanced to the bladder via theurethra in tandem with acystoscope	Advanced to the bladder via theurethra through the workingchannel 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	IntroducerInjection NeedleSyringe	Injection Needle
Size of Needle	23 ga	25 ga
Size of NeedleAssembly (OuterDiameter)	0.648 inch (1.6 mm)	4.8 Fr (1.6 mm)
Length of NeedleAssembly	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 contactmaterials	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.

Regulation Number and Section

§ 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.