(134 days)
The Novasys Transurethral RF System is indicated for the transurethral treatment of female stress urinary incontinence due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy.
The Novasys Transurethral RF Generator delivers controlled, low-level radiofrequency energy through the Novasys Transurethral RF Probe for localized collagen denaturation.
The provided text pertains to a 510(k) premarket notification for the Novasys Transurethral RF System. The document focuses on establishing substantial equivalence to predicate devices, rather than a detailed report of a clinical trial designed to explicitly define and meet acceptance criteria with specific performance metrics.
Therefore, much of the requested information cannot be extracted directly from this document. However, I can provide what is available, and note what is not.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly stated in the provided document in the format of a table with specific acceptance criteria and numerical performance values. The document focuses on demonstrating substantial equivalence based on the device functioning "as clinically designed and intended" and improving quality of life and other clinical measures.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document mentions "clinical trials (both the Pilot Clinical Trial and the subsequent U.S. Multicenter Clinical Trial)," but does not specify the sample size for either of these trials.
- Data Provenance:
- Country of Origin: At least one of the clinical trials was a "U.S. Multicenter Clinical Trial." The country of origin for the Pilot Clinical Trial is not specified, though it's likely also US-based given the context of a US submission.
- Retrospective or Prospective: The description of "clinical trials" generally implies prospective studies. The document also states, "Sufficient data has been gathered from clinical investigations to determine..." which supports a prospective approach.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document describes clinical trials but does not detail how specific "ground truth" for patient outcomes or safety was established by experts, nor does it quantify the number or qualifications of such experts if they were involved in this specific capacity.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the document. The device in question is a therapeutic medical device (Transurethral RF System), not an AI-assisted diagnostic tool, so an MRMC study with human readers and AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a therapeutic system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context appears to be based on clinical outcomes data from the patients treated in the clinical trials. The document mentions:
- "improvement in quality of life"
- "reduction in number of daily incontinence episodes"
- "reduction in daily incontinence pad use"
- "improvement in Valsalva leak point pressure"
- "no Serious Adverse Events and only limited Anticipated Adverse Events"
These are all clinical outcome measures.
8. The sample size for the training set
This information is not applicable because the Novasys Transurethral RF System is a hardware/software medical device for treatment, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's development would involve design, bench testing, and pre-clinical/clinical validation, but not a "training set" like that used for machine learning.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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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 caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Debra Reisenthel President and Chief Executive Officer Novasys Medical, Inc. 39684 Eureka Drive Newark, California 94560
JUL 2 2 2005
Re: K042132
Trade/Device Name: Novasys Medical's Transurethral RF System Regulation Number: 21 CFR 878.4400 Regulation Name: Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women Regulatory Class: Class II Product Code: NVJ Dated: July 14, 2005 Received: July 14, 2005
Dear Ms. Reisenthel:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Parl 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality
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Page 2 - Ms. Debra Reisenthel
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
N. Cartel
Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
f
Enclosure
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Indications for Use
510(k) Number (if known): K042132
Device Name: Novasys Transurethral RF System
Indications For Use: .
The Novasys Transurethral RF System is indicated for the transurethral treatment of female stress urinary incontinence due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy.
Prescription Use × (Part 21 CFR 801 Subpart D)
:
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Hacem
7/22/05
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510(k) Premarket Notification Novasys Transurethral RF System
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442
203
16 SUMMARY
.
510(k) SUMMARY (AS REQUIRED BY 21 CFR 807.92) 16.1
CONCLUSION 16.2
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16.1 510(k) SUMMARY (AS REQUIRED BY 21 CFR 807.92)
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Novasys Medical. Inc., is providing a summary of the safety and effectiveness information available for the Novasys Transurethral RF System, as well as the substantial equivalence decision-making process used for the Novasys Transurethral RF System.
SPONSOR/APPLICANT NAME AND ADDRESS
Novasys Medical, Inc. 39684 Eureka Drive Newark. CA 94560 (510) 226-4060 (telephone) (510) 353-0524 (facsimile)
SPONSOR/APPLICANT CONTACT INFORMATION
Debra Reisenthel President & Chief Executive Officer Novasys Medical, Inc. 39684 Eureka Drive Newark, CA 94560 (510) 226-4060 (telephone) (510) 421-0878 (cell phone) (510) 353-0524 (facsimile)
DATE OF PREPARATION OF 510(k) SUMMARY
August 6, 2004
DEVICE TRADE OR PROPRIETARY NAME
Novasys Transurethral RF System
DEVICE COMMON NAME
Electrosurgical System
DEVICE CLASSIFICATION NAME
Electrosurgical Cutting and Coagulation Device and Accessories (per 21 CFR 878.4400)
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510(k) Premarket Notification Novasys Transurethral RF System
DEVICE PRODUCT CODE
GEI
DEVICE PANEL
General and Plastic Surgery
IDENTIFICATION OF THE LEGALLY MARKETED DEVICES AGAINST WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
1. Technological Characteristics Predicate Devices
- Novasys Electrosurgical Electrode Family . Novasys Medical, Inc. K001150
- · Novasys "Ariel" RF Electrosurgical Control Module and Accessories Novasys Medical, Inc. K013730
2. Indication for Use Statement Predicate Device
- . SURx RF System SURx, Inc. K020952
DEVICE DESCRIPTION
The Novasys Transurethral RF Generator delivers controlled, low-level radiofrequency energy through the Novasys Transurethral RF Probe for localized collagen denaturation.
INDICATION FOR USE STATEMENT
The Novasys Transurethral RF System is indicated for the transurethral treatment of female stress urinary incontinence due to hypermobility.
SUBSTANTIAL EQUIVALENCE
1. Technological Characteristics Predicate Devices
The technological characteristics of the Novasys Transurethral RF System are equivalent to those of the cited predicate electrosurgical devices and are similar to other legally
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marketed RF devices distributed by other manufacturers. The predicate devices are equivalent in terms of design, materials, principle of operation, and product specifications. Any differences between the Novasys Transurethral RF System and the predicate devices do not raise new issues regarding safety or effectiveness.
2. Indication for Use Statement Predicate Device
Substantial equivalence for the Novasys Transurethral RF System Indication for Use Statement is supported by the cited predicate device with a Indication for Use Statement that is identical in terms of medical disorder (stress urinary incontinence), pathophysiological etiology (hypermobility), and patient population (female). The Indication for Use Statement for the Novasys Transurethral RF System is supported by the results of the clinical trials.
SUMMARY OF NON-CLINICAL AND PRE-CLINICAL DATA
Results of bench testing and pre-clinical (animal) studies demonstrated that the Novasys Transurethral RF System met its performance specifications, was technologically substantially equivalent to its predicate devices, and that no new issues of safety or effectiveness were introduced.
SUMMARY OF CLINICAL DATA
Results of clinical trials (both the Pilot Clinical Trial and the subsequent U.S. Multicenter Clinical Trial) demonstrated that the Novasys Transurethral RF System functioned as clinically designed and intended. Sufficient data has been gathered from clinical investigations to determine that the Novasys Transurethral RF System performs as clinically designed and intended, and that no new issues of safety or effectiveness were introduced.
SUBSTANTIAL EQUIVALENCE DECISION-MAKING PROCESS
The guidance document titled, "Premarket Notification 510(k): Regulatory Requirements for Medical Devices, Substantial Equivalence Decision-making Process (Detailed),"
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revised August 1992 by the Center for Devices and Radiological Health, was used to determine the substantial equivalence for the Novasys Transurethral RF System.
CONCLUSION 16.2
Stress urinary incontinence (SUI), the most common form of urinary incontinence disorder, affects an estimated 17 million Americans, adversely impacting their quality of life. Numerous and varied therapeutic approaches are currently offered to treat this lifealtering disorder, ranging from non-invasive pelvic floor muscle exercises and minimally-invasive pelvic floor muscle electrical stimulation to invasive surgical bladder suspensions and slings.
The overwhelming majority of women suffering from SUI do not select a definitive treatment from the available options. Research has demonstrated that the majority of these women are seeking a treatment which is safe, rapid, non-surgical, associated with minimal recovery requirements, and does not require frequent repeat administration. The treatment effectiveness expected by female SUI patients in return for these treatment characteristics is improvement in their quality of life.
The least invasive currently available SUI treatment options suffer from issues relating to treatment efficacy, durability, chronicity, and patient compliance. The more invasive SUI treatment modalities are plagued by concerns regarding treatment safety and burdensome recovery requirements.
This submission presents evidence that the Novasys Transurethral RF System fulfills the wishes and expectations of women suffering from this disorder. As desired by patients, the Novasys Transurethral RF System treatment has demonstrated safety, with no Serious Adverse Events and only limited Anticipated Adverse Events occurring during the 12 month U.S. Clinical Trial. The non-surgical, outpatient procedure is rapidly performed without the need for general anesthesia and is associated with minimal recovery requirements. Patients have demonstrated improvement in quality of life, reduction in
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number of daily incontinence episodes, reduction in daily incontinence pad use, and improvement in Valsalva leak point pressure 12 months following treatment.
Along with the demonstration of Novasys Transurethral RF System safety and effectiveness, this submission has presented evidence of substantial equivalence to legally marketed predicate devices for both technological characteristics and Indication for Use Statement.
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§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.