(57 days)
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or image processing that would typically indicate the presence of AI/ML in a medical device. The description focuses on the hardware components and the intended use for BPH treatment.
Yes
The device is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH, which are all therapeutic actions.
No
The device description and intended use indicate it is for treatment of BPH by relieving symptoms, obstructions, and reducing prostate tissue, rather than for diagnosis.
No
The device description explicitly lists hardware components (Generator, Power Cord, Delivery Device, Syringe, Spike Adaptor, Water Vial) which are integral to the system's function.
Based on the provided information, the Rezūm System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a therapeutic procedure to relieve symptoms and reduce prostate tissue associated with BPH. This is a treatment, not a diagnostic test performed on samples outside the body.
- Device Description: The components listed are for a surgical/procedural system (generator, delivery device, syringe, water vial). These are used for direct intervention on the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Rezūm System is a therapeutic device used to treat a condition within the body.
N/A
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 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 Rezum 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The labeling and sterilizations to the subject Rezum System have been evaluated in comparison to the predicate. Based on the change assessment including risk analysis, sterility testing (i.e., lethality and sterilant residual testing) was repeated. The test methods used were equivalent to those submitted for the predicate. Based on the change assessment and risk analsyis all other performance testing was leveraged from the predicate Rezum System (K190093). 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
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Build Correspondence
Image /page/0/Picture/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 2, 2019
NxThera (A Boston Scientific Company) Justin Kapitan Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K191505
Trade/Device Name: Rezum System Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: KNS Dated: July 3, 2019 Received: July 5, 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 may, 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 aware 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.
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Glenn B. Bell, Ph.D. Assistant Division Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191505
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 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 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
Yunus Gulmez Regulatory Affairs Specialist II 508-683-5320 yunus.gulmez@bsci.com
C. Proposed Device
| Trade name: | Rezūm System |
|---|---|
| Common/usual name: | Vapor Ablation Device |
| Regulation Number: | 21 CFR 876.4300 |
| Regulation Name: | Endoscopic electrosurgical unit and accessories |
| Classification: | Class II |
| Product Code: | KNS |
D. Predicate Device
| Trade name: | Rezūm System |
|---|---|
| Common/usual name: | Vapor Ablation Device |
| Regulation Number: | 21 CFR 876.4300 |
| Regulation Name: | Endoscopic electrosurgical unit and accessories |
| Classification: | Class II |
| Product Code: | KNS |
| Identification of Predicate Device: NxThera Rezum System, K190093 |
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K191505 Page 2 of 3
E. Device(s) Description
The reusable Rezum 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 ●
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 Rezum 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 water vapor therapy 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. Specifically, the modifications subject to this submission are limited to updates to the device labeling, change in sterilizer, and change in sterilization cycle. Therefore, the technological characteristics remain equivalent to the predicate device.
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K191505 Page 3 of 3
H. Substantial Equivalence
The modified NxThera Rezūm System is substantially equivalent to the NxThera Rezūm System (K190093). 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 on the Rezum System (K190093) to show that all patient contacting materials meet applicable biocompatibility standards per ISO 10993-112009 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 labeling and sterilization modifications that are the subject of this submission did not affect the materials of the device or the fact that it is biocompatible for its intended use.
J. Performance Testing
The labeling and sterilizations to the subject Rezūm System have been evaluated in comparison to the predicate. Based on the change assessment including risk analysis, sterility testing (i.e., lethality and sterilant residual testing) was repeated. The test methods used were equivalent to those submitted for the predicate. Based on the change assessment and risk analsyis all other performance testing was leveraged from the predicate Rezum System (K190093).
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, K190093.