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.

Device Description

The reusable Rezūm Generator is provided with the following reusable components:

Generator
One Power Cord

The single-use Rezum Delivery Device contains the following disposable components:

One sterile Delivery Device with integrated cable and tubing
One sterile Syringe
One sterile Spike Adaptor
One 50 ml Sterile Water Vial

AI/ML Overview

This document is a 510(k) summary for the Rezum System, a device intended to relieve symptoms of BPH. It describes the device, its intended use, and the performance testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided text to extract the requested information regarding acceptance criteria and the study proving the device meets them:

Important Note: The provided text is a 510(k) summary for a device modification, not a new device. Therefore, the "study that proves the device meets the acceptance criteria" primarily refers to testing demonstrating that the modified device performs identically to the predicate device, which had already established its safety and effectiveness. This explains why some typical AI/ML study components (like expert consensus for ground truth, MRMC studies, training set details) are not present or applicable here. The focus is on demonstrating that the modifications do not introduce new safety or effectiveness concerns and maintain the same performance as the previously cleared predicate.

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

The document does not explicitly present a table of "acceptance criteria" for the clinical performance of the device (e.g., symptom relief, prostate tissue reduction metrics) in the context of this 510(k) for a modified device. Instead, it focuses on demonstrating that the modified device meets the same physical and performance specifications as the predicate device.

The performance testing mentioned is primarily related to engineering and material specifications. The acceptance criteria are implied to be meeting the prior specifications of the predicate device.

Acceptance Criteria (Implied: Meets same specifications as predicate)	Reported Device Performance
Dimensions	Tested with passing results; meets specifications
Tensile strength tests	Tested with passing results; meets specifications
Full functional tests (temperature, pressure, etc.)	Tested with passing results; meets specifications
Calories tests / Calorimetry	Tested with passing results; meets specifications
Hardware tests	Tested with passing results; meets specifications
Software verification and validation	Tested with passing results; meets specifications and current V&V
Packaging tests	Tested with passing results; meets specifications
Distribution tests	Tested with passing results; meets specifications
Applicable IEC 60601 tests	Tested with passing results; meets specifications
Tubing (compliance, kink, burst, etc.)	Tested with passing results; meets specifications
Corrosion Resistance	Tested with passing results; meets specifications
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity)	All tests performed with passing results per ISO 10993-1:2009 and FDA guidance
Sterilization (SAL 10⁻⁶ level)	Device continues to be sterilized by ethylene oxide (EO) to this level
Shelf life	Extended shelf life demonstrated through testing

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the engineering and material tests, nor does it specify the country of origin or whether the data was retrospective or prospective. These are typically bench tests performed on a defined number of device units. The provenance for this type of testing is usually the manufacturer's facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This 510(k) is for a physical device modification, not an AI/ML diagnostic or image analysis tool. Therefore, there were no clinical experts (like radiologists) involved in establishing ground truth for the "test set" in the sense of clinical interpretations or diagnoses. The ground truth for the device's functional integrity is established by engineering specifications and direct physical/chemical measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this is for a physical device modification, not a diagnostic AI/ML tool requiring human expert adjudication of clinical outcomes.

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 for a physical device modification, not an AI/ML product where MRMC studies are relevant.

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

Not applicable. This describes a medical device (Vapor Ablation Device), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is its adherence to predeteremined engineering, material, and functional specifications, as well as established biocompatibility standards (e.g., ISO 10993). This is determined by bench testing results against defined physical and chemical parameters, not clinical expert consensus or pathology.

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. This is not an AI/ML device requiring a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 25, 2019

NxThera (A Boston Scientific Company) Justin Kapitan Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752

Re: K190093

Trade/Device Name: Rezum System Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: KNS Dated: February 25, 2019 Received: February 27, 2019

Dear Justin Kapitan:

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 mav, 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 avare 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.

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Angel A. Solergarcia -S

for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
Indications for Use
510(k) Number (if known)To be determined K190093
Device NameRezum System
Indications for Use (Describe)
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.
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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

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information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)	Page 1 of 1	PSC Publishing Services (301) 443-6740EF
----------------------	-------------	----------------------------------------------

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510(k) Summary for the Rezum System

A. Sponsor

NxThera Inc (a wholly-owned indirect subsidiary of Boston Scientific Corporation) Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01752

B. Contact

Justin Kapitan Sr. Regulatory Affairs Specialist 508-683-4518 justin.kapitan@bsci.com

Anand Patel Regulatory Affairs Specialist II 508-683-5320 anand.patel(@bsci.com

Date Prepared: February 25, 2019

C. Proposed Device

Trade name:	Rezūm System
Common/usual name:	Vapor Ablation Device
Classification Number:	21 CFR 876.4300
Classification Name:	Endoscopic electrosurgical unit and accessories
Classification:	Class II
Product Code:	KNS
Product Code Name:	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Model Names/Number:	Rezum Delivery Device-D2201; Rezum C2 Generator-G2200

D. Predicate Device

Trade name:	Rezūm System
Common/usual name:	Vapor Ablation Device
Classification Number:	21 CFR 876.4300
Classification Name:	Endoscopic electrosurgical unit and accessories
Classification:	Class II
Product Code:	KNS
Product Code Name:	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Model Names/Number:	Rezum Delivery Device-D2201; Rezum C2 Generator-G2200

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Identification of Predicate Device: NxThera Rezum System, K180237

E. Device(s) Description

The reusable Rezūm Generator is provided with the following reusable components:

Generator
o One Power Cord

The single-use Rezum Delivery Device contains the following disposable components:

One sterile Delivery Device with integrated cable and tubing ●
One sterile Syringe
One sterile Spike Adaptor
One 50 ml Sterile Water Vial ●

F. Intended Use/Indications for Use

The Rezum 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.

G. Technological Characteristics Compared to Predicate

The principles of operation are identical between the predicate and subject devices: The Rezūm System converts water into vapor outside of the body and the vapor is 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 an RF Generator, which also controls the amount of saline flush used to cool the urethra during the procedure.

The differences between the subject device and the predicate are minor. Differences include:

Second source for resin used to manufacture plastic handpiece components -. Additional supplier of equivalent resin to reduce supply disruptions

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Drain Line Addition of plasticizer to current material. The tubing is in indirect ● patient contact.
Flush and Water Lines- Addition of plasticizer to the Flush Line and material ● changes to the Water Line indirect patient contacting components to facilitate extended shelf life.
Drip Chamber Material change to improve durability and remove the need for ● primer during the bonding process. This component is in indirect patient contact.
Shelf life extension in subject device

The technological characteristics remain equivalent to the predicate device because the modifications that are the subject of this submission are limited to improvements to the existing design.

H. Substantial Equivalence

The modified NxThera Rezūm System is substantially equivalent to the NxThera Rezūm System (K180237). It has the same intended use for thermal ablation of BPH tissue and the same indications for use. The system design and principles of operation remain the same.

I. Biocompatibility

Biocompatibility testing was performed to show that all patient contacting materials meet applicable biocompatibility standards per ISO 10993-1:2009 and the FDA guidance: Use of International Standard ISO 10993-1 "Biological evaluation of medical devices. Evaluation and testing within a risk management process."

The following testing was performed with passing results to support the biocompatibility of the device:

Cytotoxicity ●
Sensitization
Irritation and Intractaneous Reactivity ●
Accute Systemic Toxicity ●
Materials Mediated Pyrogenicity ●

J. Performance Testing

The predicate Rezum System has been tested and successfully meets all its physical and performance specifications on the bench including:

Dimensions
Tensile strength tests
Full functional tests ●
Calories tests ●

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Hardware tests ●
Software verification and validation ●
Packaging tests ●
Distribution tests .
Applicable IEC 60601 tests ●

Results of this testing demonstrate that the device meets the same performance criteria as the predicate and is therefore substantially equivalent to the predicate.

The modifications to the subject Rezūm System have been tested in the same manner to ensure compliance to the initial specifications. Based on the change assessment including risk analysis, the following design verification tests were repeated. The test methods used were the same as those submitted for the predicate.

. Delivery Device tests before and after 24-month aging:
- Dimensions O
- Tensile strength tests o
- Full Functionality (temperature, pressure, etc.) O
- Tubing (compliance, kink, burst, etc.) o
- Calorimetry о
- Corrosion Resistance O
- Packaging and Distribution O
- Applicable IEC 60601 tests o
Software verification and validation ●
o Biocompatibility

The device continues to be sterilized by ethylene oxide (EO) to an SAL 106 level.

The conclusion of the assessments demonstrates that the modified device continues to function as intended in a manner equivalent to the predicate device. The modified device raises no new issues of safety or effectiveness compared to the predicate.

K. Conclusion

Based on the test data, the same intended use, and same indications for use, the modified Rezūm System is substantially equivalent to its predicate, K180237.

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).