(29 days)
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No
The document describes a system that uses radiofrequency energy to generate water vapor for thermal ablation. There is no mention of AI or ML in the device description, intended use, or performance studies. The control of vapor delivery and saline flush is described as being managed by the RF Generator, not through AI/ML algorithms.
Yes
The device is described as "intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH" and converts water into vapor to "ablate the targeted tissue within the prostate via thermal ablation," which are therapeutic actions.
No
The device description clearly states its purpose is to "relieve symptoms, obstructions, and reduce prostate tissue associated with BPH" through "thermal ablation." This describes a therapeutic, not a diagnostic, function.
No
The device description explicitly states that the Rezūm System consists of a reusable Generator and a sterile Delivery Device Kit, which are hardware components used to deliver vapor for thermal ablation. The performance studies also include hardware tests, electrical safety testing, and electromagnetic compatibility testing, further indicating it is not a software-only device.
Based on the provided information, the Rezūm System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH by delivering vapor to ablate tissue. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device description details a system that generates and delivers vapor for tissue ablation. This is a physical treatment method.
- Mechanism of Action: The system works by using thermal energy from vapor to ablate tissue. This is a direct physical effect on the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) outside of the body to provide diagnostic information about a patient's condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Rezūm System does not fit this description. It is a therapeutic device used for a surgical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KNS
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
prostate
Indicated Patient Age Range
≥ 50 years of age
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
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,
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)
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.
| 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
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.
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Image /page/4/Picture/1 description: The image shows the word "NxTHERA." in a bold, sans-serif font. The letters are black, and there is a small, stylized graphic of a wave or swoosh in light blue underneath the "x" and "T" in the word. The background is white.
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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Image /page/5/Picture/1 description: The image shows the word "NxTHERA." in a bold, sans-serif font. The "x" in "NxTHERA" is stylized with a swoosh-like design underneath it. The word is followed by a period.
- 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.