(47 days)
The device is indicated for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition the system is intended for use in the following indications:
General Surgery
- Ablation of breast fibroadenoma .
- Localization of breast lesions .
Gynecology
- Ablation of malignant neoplasia or benign dysplasia of the female genitalia .
Oncology - Ablation of cancerous or malignant tissue .
- Ablation of benign tumors ●
- Palliative intervention
The Visica Treatment System consists of a control unit that controls one single-use, disposable (Visica Treatment Device or "cryoprobe"). The system utilizes incrt argon gas as a cooling agent and helium for thawing. The cystem unit operates from standard 120/240 VAC wall power and is control by a CPLD (Complex Programmable Logic Device). An LED screen displays the status of the system. System control is accomplished directly through keys on the console itself.
The cryoprobe operates on the Joule-Thompson principle and the refrigerative capacity is limited only the distal tip of the probe. The cryoprobe incorporates a thermocouple to measure temperature near the probe tip. The thermocouple is mounted inside the cryoprobe tip and its signal is used to monitor and control some operations of the system. The control unit can also accommodate two independent on the ts manitant to monitor temperatures in the surrounding tissues. The temperature probes use standard T-type needle thermocouples.
The provided text is a 510(k) summary for the Sanarus Visica Treatment System, which is a cryosurgical unit. This document is a regulatory submission to the FDA, primarily focusing on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the way new AI/ML device submissions might.
Therefore, much of the requested information regarding acceptance criteria, performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, and human-in-the-loop studies is not present in this document. The 510(k) summary aims to show that the modified device has the "same indications for use and technological characteristics" as its predicate and that "performance testing confirms that modifications to the Instructions for Use meet applicable specifications and performance standards and are equivalent to the predicate device."
However, I can extract the available information and indicate what is not present.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided 510(k) summary. The document states that "Performance testing confirms that modifications to the Instructions for Use meet applicable specifications and performance standards and are equivalent to the predicate device," but it does not detail specific acceptance criteria or the reported performance metrics of those tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided 510(k) summary. The document does not describe a clinical study with a test set of data for performance evaluation in the context of AI/ML device assessment.
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 present in the provided 510(k) summary. Since this is a cryosurgical device, and not an AI/ML diagnostic tool, the concept of "ground truth" derived from expert consensus on a test set (as typically seen in AI/ML performance studies) is not applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided 510(k) summary.
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 present in the provided 510(k) summary. This type of study is relevant for AI/ML diagnostic systems, not for a cryosurgical treatment device like the Sanarus Visica Treatment System.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present in the provided 510(k) summary. The device is a physical cryosurgical system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided 510(k) summary.
8. The sample size for the training set
This information is not present in the provided 510(k) summary. Training sets are typically associated with AI/ML model development, which is not the focus of this 510(k) for a physical cryosurgical device.
9. How the ground truth for the training set was established
This information is not present in the provided 510(k) summary.
Summary of Device and Regulatory Context (based on provided text):
- Device Name: Sanarus Visica® Treatment System
- Device Type: Cryosurgical unit and accessories (Class II, Product Code: GEH)
- Indications for Use:
- General Surgery: Ablation of breast fibroadenoma, Localization of breast lesions.
- Gynecology: Ablation of malignant neoplasia or benign dysplasia of the female genitalia.
- Oncology: Ablation of cancerous or malignant tissue, Ablation of benign tumors, Palliative intervention.
- Predicate Device: Sanarus Visica Treatment System (K022314, Oct 15, 2002; K052861, Nov 15, 2005)
- Substantial Equivalence Claim: The current device has the "same indications for use and technological characteristics as the predicate device," including identical patient contact components, materials, packaging, sterilization methods, and sterility assurance level.
- Performance Testing Mention: "Performance testing confirms that modifications to the Instructions for Use meet applicable specifications and performance standards and are equivalent to the predicate device." This statement implies that engineering and functional tests were conducted to ensure the device performs as intended and equivalently to its predicate, but the details of these tests, acceptance criteria, and specific performance results are not included in this summary.
In essence, this 510(k) summary is for a traditional medical device demonstrating substantial equivalence, not for an AI/ML-driven device, which would typically involve the detailed performance study information you've requested.
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Kobis-10
Appendix A: 510k Summary of Safety and Effectiveness
CONTACT INFORMATION
JUL 1 8 2006
Page 1 of 2
Trena Depel Director, Regulatory and Clinical Affairs Telephone: (925) 460-5731 FAX: (925) 460-0688 e-mail: tdepel@sanarus.com
COMPANY INFORMATION
Sanarus Medical, Inc. 4696 Willow Road Pleasanton, CA 94588 Telephone: (925) 460-6080 FAX: (925) 460-0688
DEVICE NAME
Sanarus Visica® Treatment System
DEVICE DESCRIPTION
The Visica Treatment System consists of a control unit that controls one single-use, disposable (Visica Treatment Device or "cryoprobe"). The system utilizes incrt argon gas as a cooling agent and helium for thawing. The cystem unit operates from standard 120/240 VAC wall power and is control by a CPLD (Complex Programmable Logic Device). An LED screen displays the status of the system. System control is accomplished directly through keys on the console itself.
The cryoprobe operates on the Joule-Thompson principle and the refrigerative capacity is limited only the distal tip of the probe. The cryoprobe incorporates a thermocouple to measure temperature near the probe tip. The thermocouple is mounted inside the cryoprobe tip and its signal is used to monitor and control some operations of the system. The control unit can also accommodate two independent on the
ts manitant to monitor temperatures in the surrounding tissues. The temperature probes use standard T-type needle thermocouples.
INDICATIONS FOR USE
Indications for Use: The device is indicated for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition the system is intended for use in the following indications:
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Premarket Submission: Special 510k
Sanarus Visica Treatment System
Kob1510
General Surgery
Page ref 2
- Ablation of breast fibroadenoma .
- . Localization of breast lesions
Gynecology
- Ablation of malignant neoplasia or benign dysplasia of the female genitalia .
Oncology
- Ablation of cancerous or malignant tissue
- Ablation of benign tumors .
- . Palliative intervention
NAME OF PREDICATE OR LEGALLY MARKETED DEVICE
Sanarus Visica Treatment System
SUBSTANTIAL EQUIVALENCE
The Sanarus Visica Treatment System is substantially equivalent to the Sanarus Visica Treatment System that was determined to be substantially equivalent on Oct 15 2002 (reference K022314) and on Nov 15 2005 (reference K052861).
The Sanarus Visica Treatment System has the same indications for use and technological characteristics as the predicate device. The patient contact components and component materials in both the new and predicate device are the same. The packaging materials, packaging configurations, sterilization methods and sterility assurance level are also equivalent.
Based on the indications for use, technological characteristics and performance testing results, the Sanarus Visica Treatment System does not raise significant new questions of safety and effectiveness.
PERFORMANCE TESTING SUMMARY
Performance testing confirms that modifications to the Instructions for Use meet applicable specifications and performance standards and are equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, along with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular pattern around the symbol. The caduceus is depicted with a staff entwined by two snakes and topped with wings, representing healing and commerce.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2006
Sanarus Medical, Inc. % Ms. Trena Depel Director, Regulatory and Clinical Affairs 4696 Willow Road Pleasanton, California 94588
Re: K061510
Trade/Device Name: Sanarus Visica® Treatment System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: July 5, 2006 Received: July 6, 2006
Dear Ms. Depel:
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 Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Ms. Trena Depel
forth in the quality systems (OS) 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Bruckno
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: Kob1570
Device Name: Sanarus Visica® Treatment System
Indications for Use:
The device is indicated for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition the system is intended for use in the following indications:
General Surgery
- Ablation of breast fibroadenoma .
- Localization of breast lesions .
Gynecology
- Ablation of malignant neoplasia or benign dysplasia of the female genitalia .
Oncology
- Ablation of cancerous or malignant tissue .
- Ablation of benign tumors ●
- Palliative intervention
Prescription Use X (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 IFNEEDED)
Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K061510.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.