(155 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies. The device description and performance studies focus on thermal ablation and clinical trial outcomes.
Yes
The device is described as "intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH," which directly addresses a health condition.
No
The device is described as a system intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly lists hardware components (Generator, Power Cord, Delivery Device Kit with disposable components) and the performance studies include hardware tests and physical/performance specifications, indicating it is not a software-only device.
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 description details a generator, delivery device, syringe, and water vial. These are components used for a surgical or procedural treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device is a therapeutic device used for treating a medical condition (BPH) through a 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 Rezūm 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 Rezum System has been tested to meet the FDA 2010 BPH guidance where applicable for preclinical and clinical testing.
The Rezum 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
In addition, the Delivery Device was tested for biocompatibility per ISO 10993-1 for short duration contact with tissue and mucosal membrane (
§ 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 12, 2016
NxThera, Inc. % Sew-Wah Tay. Ph.D. Regulatory Consultant Libra Medical, Inc. 8401 73rd Avenue North, Suite 63 Brooklyn Park, MN 55428
Re: K150786 Trade/Device Name: Rezūm System Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurqical unit and accessories Regulatory Class: II Product Code: KNS Dated: August 21, 2015 Received: August 24, 2015
Dear Sew-Wah Tay:
This letter corrects our substantially equivalent letter of August 27, 2015.
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.
1
Page 2 - Sew-Wah Tay, Ph.D.
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 Part 807); labeling (21 CFR Part 801); medical device reporting (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.
If vou 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" (21CFR 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,
For Division
Douglas Silverstein -S 2016.09.12 16:11:58 -04'00'
Benjamin Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
|---|
| 510(k) Number ( if known ) | K150786 |
|---|---|
| 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 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 ) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (Part 21 CFR 801 Subpart C) |
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3
510(K) SUMMARY (K150786) 1
ADMINISTRATIVE INFORMATION 1.1
Date of Summary Preparation: June 12 2015
1.2 CONTACT INFORMATION
| Primary Submission Contact | Sew-Wah Tay, PhD
Regulatory Consultant,
Libra Medical Inc. |
| ---------------------------- | ------------------------------------------------------------------ |
|---|
| Secondary Submission Contact | Julie Bodmer |
|---|---|
| Regulatory Consultant, | |
| Libra Medical Inc. |
1.3 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 |
| Panel | Gastroenterology/Urology |
| Product Code | KNS |
1.4 510(K) TYPE AND REASON FOR SUBMISSION
This 510(k) is a traditional 510(k) and is submitted to obtain marketing clearance for a new device - the Rezūm System.
1.5 PREDICATE DEVICE
The Rezūm System is substantially equivalent to the Medtronic Prostiva devices (K113380 and K142248).
1.6 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:
- 0 One sterile Delivery Device with cable and tubing
4
- 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.
INDICATIONS FOR USE / INTENDED USE 1.7
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 ≤ 80 cm³. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
1.8 TECHNOLOGICAL CHARACTERISTICS
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.
1.9 PERFORMANCE DATA
The Rezūm System has been tested to meet the FDA 2010 BPH guidance where applicable for preclinical and clinical testing.
The Rezum 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
In addition, the Delivery Device was tested for biocompatibility per ISO 10993-1 for short duration contact with tissue and mucosal membrane (