The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume ≥ 30cm3 and ≤ 80cm3. The Rezum System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

Device Description

The Rezum System consists of a reusable Generator and a sterile Delivery Device Kit consisting of one Delivery Device with cable and tubing, one syringe, one spike adaptor, and one 50mL sterile water vial. The Delivery Device is EtO sterilized.

The Rezūm System converts water into vapor outside of the body with the vapor delivered to the prostate tissue via a needle within the sterile Delivery Device. The vapor ablates the targeted tissue within the prostate via thermal ablation as energy is transferred from the vapor to the prostate tissue. The amount of vapor delivered is controlled by a Radiofrequency (RF) Generator which also control the amount of saline flush used to cool the urethra during the treatment.

AI/ML Overview

The provided text is a 510(k) summary for the Rezūm System, a medical device used to treat Benign Prostatic Hyperplasia (BPH). It describes design modifications to a previously cleared device (K160417) and argues for substantial equivalence to this predicate.

The document does not contain acceptance criteria or a study proving that the device meets specific performance criteria related to clinical efficacy or diagnostic accuracy. Instead, it focuses on demonstrating that the modified device performs equivalently to the predicate device regarding its physical performance and safety following design changes.

Therefore, most of the requested information regarding acceptance criteria and clinical study details cannot be extracted from this document in the typical sense of a diagnostic or predictive AI device.

However, I can extract information regarding the performance data provided to ensure substantial equivalence of the modified device to its predicate.

Here's the information based on what is available in the document:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide specific quantitative acceptance criteria or detailed reported device performance in a table format for clinical efficacy. Instead, it states that the modifications were tested to ensure compliance with initial device specifications and equivalent function to the predicate device.

Acceptance Criteria (Implied for design modifications)	Reported Performance (for design modifications)
Compliance to initial device specifications	"The modifications made to the subject Rezūm System have been tested to ensure compliance to the initial device specifications."
Equivalent function to the predicate device	"The conclusion of the performance assessments demonstrate that the device continues to function as intended in a manner equivalent to the predicate device, and that there are no new issues of safety or effectiveness with the implementation of the above listed modifications."
Met listed design verification tests	All listed tests (Dimensional, Tensile/bond strength, Full Functional, Fluid resistance, Calorimetry, Corrosion resistance, Packaging and distribution, Sterility validation, Shelf-life aging, Software V&V, Hardware, Electrical safety (IEC 60601-1), EMC (IEC 60601-1-2)) were repeated on the C2 Delivery Device using the same methods as the predicate device.

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not specified for any of the listed performance assessments.
Data provenance: Not specified. This typically refers to the testing of the physical device or components, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/not specified. The "ground truth" for these engineering and performance tests would be established through defined measurement standards and engineering principles, not expert clinical consensus.

4. Adjudication method for the test set:

Not applicable/not specified.

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 medical device for treatment, not an AI diagnostic or assistive imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device for treatment. Software verification and validation were performed, but this is related to the device's operational software, not a standalone AI algorithm for interpretation.

7. The type of ground truth used:

For the physical and electrical performance tests listed (e.g., Dimensional, Tensile, Electrical safety, EMC), the "ground truth" would be established by validated test methods, reference standards, and compliance with relevant industry standards (e.g., IEC 60601-1).

8. The sample size for the training set:

Not applicable. The document describes modifications to a physical device, not an AI/ML algorithm that requires a training set of data in the typical sense. Software verification and validation would have been performed on the device's operational software.

9. How the ground truth for the training set was established:

Not applicable. (See #8)

Summary

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February 27, 2018

NxThera, Inc. Kathy Simpson VP Quality and Regulatory Affairs 7351 Kirkwood Land North, Suite 138 Maple Grove, MN 55369

Re: K180237

Trade/Device Name: Rezūm System Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: KNS Dated: January 25, 2018 Received: February 1, 2018

Dear Kathy Simpson:

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,

Benjamin R. Fisher -S

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) K180237

Device Name Rezūm System

Indications for Use (Describe)

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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510(k) Summary

l. SUBMITTER

NxThera, Inc. 7351 Kirkwood Lane North Suite 138 Maple Grove, MN 55369

Phone: (763) 515-0404 Fax: (763) 515-2085

Contact Person:	Kathy Simpson
Date Prepared:	January 18, 2018

ll. DEVICE

Name of Device:	Rezūm® System
Common or Usual Name:	Vapor Ablation System
Classification Name:	Endoscopic electrosurgical unit and accessories(21 CFR §876.4300)
Regulatory Class:	II
Product Code:	KNS

lll. PREDICATE DEVICE

Rezūm System, K160417

IV. DEVICE DESCRIPTION

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INDICATIONS FOR USE V.

The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume ≥ 30cm³ and ≤ 80cm³. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

At a high level, the subject and predicate devices are based on the following technological elements that remain equivalent between the two devices:

. Cystoscope used within the Delivery Device to visualize the target treatment area
Device is inserted into the urethra to reach the targeted prostate tissue ●
Generation of water vapor via a specific caloric / energy requirement
Thermal ablation of the prostate tissue ●
Use of saline flush to cool the urethra during treatment .

The following technological differences exist between the subject and predicate devices:

. Design enhancements of the user interface:
- Reduced device handle envelope distance, improve handle angle o and improve fit and feel
- Changed needle delivery and retraction mechanism from o mechanical to electrical
. Design changes to enhance manufacturability and reliability of the Delivery Device:
- Change vapor coil material to a more efficient material o
- Relocate temperature monitoring on vapor coil O
- Group switching functions on one printed circuit board O
- Cable changes including a plastic non-locking connector to O improve manufacturability
- Replace prior adhesive with equivalent adhesive O
- Removal of the device rotation capability O
. Design changes to accommodate device updates, manage component obsolescence, enhance manufacturability and reliability of the Generator:
- Update circuit boards and software for new electrical needle o delivery and retraction mechanism, to manage obsolescence and improve manufacturability
- о Update RF power supply to accommodate new vapor coil material

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Move ESD protection from Device to Generator o
Update wiring and connectors for manufacturability and servicing O

VII. PERFORMANCE DATA

The modifications made to the subject Rezūm System have been tested to ensure compliance to the initial device specifications. Based on the change assessment, the following design verification tests were repeated on the C2 Delivery Device. The test methods used were the same as those submitted for the predicate device:

Dimensional
Tensile / bond strength tests ●
Full Functional tests ●
Fluid resistance ●
Calorimetry tests ●
Corrosion resistance ●
Packaging and distribution testing
Sterility validation
Shelf-life aging ●
Software verification and validation ●
Hardware tests ●
Electrical safety testing (per IEC 60601-1)
Electromagnetic compatibility testing (per IEC 60601-1-2) ●

The conclusion of the performance assessments demonstrate that the device continues to function as intended in a manner equivalent to the predicate device, and that there are no new issues of safety or effectiveness with the implementation of the above listed modifications.

VIII. CONCLUSION

Based on the test data and other characteristics of the subject device as compared to the predicate, the modified Rezūm System is substantially equivalent to its predicate Rezūm System.

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).