(66 days)
No
The summary describes a system for treating BPH using water vapor therapy and does not mention any AI or ML components in the device description, intended use, or performance studies.
Yes.
The device is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH, directly treating a medical condition.
No
The Rezūm System is described as a treatment device intended to relieve symptoms and reduce prostate tissue associated with BPH, not to diagnose medical conditions.
No
The device description explicitly lists hardware components (Generator, Power Cord, Delivery Device, Syringe, Spike Adaptor, Water Vial) and the performance studies include hardware testing and verification/validation, indicating it is a hardware-based medical device with associated software.
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.
- Device Description: The device description details a system for delivering therapy (water vapor) to the prostate. It includes a generator, delivery device, syringe, and water vial. These are components used in a surgical or procedural setting.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are designed to provide information for diagnosis, monitoring, or screening.
The Rezūm System is a therapeutic device used for treating BPH, not for diagnosing it or any other condition.
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 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
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 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
- Hardware tests
- Software verification and validation
- Packaging tests
- Distribution tests
- Applicable IEC 60601 tests
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
- Tensile strength tests
- Full Functionality (temperature, pressure, etc.)
- Tubing (compliance, kink, burst, etc.)
- Calorimetry
- Corrosion Resistance
- Packaging and Distribution
- Applicable IEC 60601 tests
- Software verification and validation
- Biocompatibility
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/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.
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) 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 SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number (if known)
To be determined K190093 | |
| Device Name
Rezum 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) |
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| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740
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| ---------------------- | ------------- | ---------------------------------------------- |
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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
or
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
5
- 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 ●
6
- 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.