(30 days)
Not Found
No
The summary describes a system for treating BPH using water vapor therapy and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
The device is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH, which are therapeutic actions.
No
The device description and intended use indicate that the Rezūm System is a treatment device, designed to relieve symptoms and reduce prostate tissue, rather than to diagnose medical conditions.
No
The device description clearly lists multiple hardware components, including a generator, power cord, delivery device, syringe, spike adaptor, and water vial. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "relieve symptoms, obstructions, and reduce prostate tissue associated with BPH." This describes a therapeutic intervention performed directly on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device components (generator, delivery device, syringe, water vial) are consistent with a system used for a medical procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is a therapeutic device used to treat a condition directly.
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. The Rezum System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
Product codes
KNS
Device Description
The reusable Rezūm Generator is provided with the following reusable components:
- Generator
- One Power Cord
The Rezūm Delivery Device Kit contains the following disposable components: - One sterile Delivery Device with cable and tubing
- One sterile Syringe
- One sterile Spike Adaptor
- One 50 ml Sterile Water Vial
Additional spike adaptor and syringe accessory is provided as an Accessory Pack.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate
Indicated Patient Age Range
men > 50 years of age
Intended User / Care Setting
Not Found
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
The predicate Rezūm System has been tested and meets all its physical and performance specifications on the bench including:
- Dimensions
- Tensile strength tests
- Full functional tests
- Calories tests
- Hardware tests
- Software verification and validation
- Packaging tests
- Distribution tests
The device has also been tested in 3 clinical studies: 65 patients in the feasibility and pilot open label studies and in a 197 patient randomized placebo controlled study. All these studies showed that the device is safe and effective.
The design changes to the candidate Rezūm System have been tested to ensure compliance to the initial specifications. Based on the change assessment, the following design verification tests were repeated on the Delivery Device. The test methods used are the same as those submitted for the predicate.
- Tensile/Bond strength tests including the new vented drip chamber and flush tubing before and after 12-month aging
- Tubing tests (tubing compliance, kink, burst, etc.)
- Functional tests (temperature, pressure, etc.)
- Calories tests
- Biocompatibility
The conclusion of the assessments demonstrates that the device continues to function as intended. Testing showed that the modified device is as safe and effective as the predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 19, 2016
NxThera, Inc. Julie Bodmer Regulatory Consultant Libra Medical, Inc. 8401 73rd Ave North, Suite 63 Brooklyn Park, MN 55428
K160417 Trade/Device Name: Rezūm System Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KNS Dated: February 12, 2016 Received: February 16, 2016
Dear Julie Bodmer,
Re
This letter corrects our substantially equivalent letter of March 17, 2016
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
2
Indications for Use
510(k) Number (if known)
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. 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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3
510(K) SUMMARY 8
8.1 ADMINISTRATIVE INFORMATION
Date of Summary Preparation: February 12 2016
CONTACT INFORMATION 8.1.1
| Submitter/Manufacturer | NxThera Inc
7351 Kirkwood Lane N, Suite 138
Maple Grove, MN 55369 USA
Tel: 763-515-0404
Fax: 763-515-2084 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Submission Contact | Julie Bodmer
Regulatory Consultant, Libra Medical, Inc.
8401 73rd Ave North, Suite 63
Brooklyn Park, MN 55428
Cell: 612-910-3412
Fax: 763-477-6357
Email: jbodmer@libramed.com |
| Secondary Submission Contact | Sew-Wah Tay
Regulatory Consultant, Libra Medical, Inc.
8401 73rd Ave North, Suite 63
Brooklyn Park, MN 55428
Cell: 612-801-6782
Fax: 763-477-6357
Email: swtay@libramed.com |
| 8.1.2 DEVICE INFORMATION | |
| Trade Name | Rezūm System |
| Common Name | Vapor BPH Ablation Device |
| Classification Name | Endoscopic electrosurgical unit and accessories |
| Classification Regulation | 876.4300 |
| Class | II |
PREDICATE DEVICE
Panel
8.2
Product Code
The modified device is substantially equivalent to the NxThera Rezūm System (K150786).
KNS
Gastroenterology/Urology
4
DEVICE DESCRIPTION 8.3
The reusable Rezūm Generator is provided with the following reusable components:
- Generator ●
- One Power Cord ●
The Rezūm Delivery Device Kit contains the following disposable components:
- One sterile Delivery Device with cable and tubing
- One sterile Syringe ●
- One sterile Spike Adaptor ●
- One 50 ml Sterile Water Vial ●
Additional spike adaptor and syringe accessory is provided as an Accessory Pack.
8.4 INTENDED USE
The Rezūm System is intended to ablate prostate tissue.
8.5 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 ≤ 80cm². The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
TECHNOLOGICAL CHARACTERISTICS 8.6
The device 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.
The differences between this device and the predicate are minor and include replacing two minor parts due to obsolescence and a change to a higher viscosity lubricant to improve the ease of application during manufacture. The only technological difference lies in the use of a vented drip chamber for the saline flush tubing instead of the predicate non-vented drip chamber. This change allows for the use of hard plastic bottles of saline in addition to saline bags. The technological characteristics remain equivalent to the predicate device.
PERFORMANCE DATA 8.7
The predicate Rezūm System has been tested and meets all its physical and performance specifications on the bench including:
- Dimensions
- Tensile strength tests
- Full functional tests ●
5
NxTHERA
- . Calories tests
- Hardware tests ●
- Software verification and validation ●
- Packaging tests
- Distribution tests ●
The device has also been tested in 3 clinical studies: 65 patients in the feasibility and pilot open label studies and in a 197 patient randomized placebo controlled study. All these studies showed that the device is safe and effective.
The design changes to the candidate Rezūm System have been tested to ensure compliance to the initial specifications. Based on the change assessment, the following design verification tests were repeated on the Delivery Device. The test methods used are the same as those submitted for the predicate.
- . Tensile/Bond strength tests including the new vented drip chamber and flush tubing before and after 12-month aging
- Tubing tests (tubing compliance, kink, burst, etc.)
- Functional tests (temperature, pressure, etc.) ●
- Calories tests
- Biocompatibility
The conclusion of the assessments demonstrates that the device continues to function as intended. Testing showed that the modified device is as safe and effective as the predicate.
SUBSTANTIAL EQUIVALENCE 8.8
The modified NxThera Rezūm System is substantially equivalent to the NxThera Rezūm System (K150786). It has the same intended use for thermal ablation of BPH tissue. The generator and delivery device remain the same.
8.9 CONCLUSION
Based on the test data and the same intended use, the modified Rezum System is found to be substantially equivalent to its predicate.