(39 days)
Not Found
No
The 510(k) summary describes a physical electrosurgical electrode for tissue sampling and cutting, with no mention of software, image processing, AI, ML, or any related computational technologies. The performance studies focus on in-vitro testing of the physical device's function.
No
The "Intended Use / Indications for Use" section explicitly states, "It is to be used for diagnostic purposes only and is not intended for therapeutic uses."
Yes
The "Intended Use / Indications for Use" section explicitly states "The Rubicor Flexible Loop Electrosurgical Electrode is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only..." and "The Rubicor Flexible Loop Electrosurgical Electrode is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities."
No
The device description and intended use clearly describe a physical electrosurgical electrode, which is a hardware component used for cutting and sampling tissue. There is no mention of software as the primary or sole component.
Based on the provided information, the Rubicor Flexible Loop Electrosurgical Electrode is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is for diagnostic sampling of breast tissue during breast biopsy procedures. While the tissue is for diagnostic purposes (histologic examination), the device itself is a tool for collecting the tissue, not for performing the diagnostic test on the tissue.
- Mechanism: The device is an electrosurgical electrode used to cut soft tissue and obtain a sample. This is a surgical/procedural tool, not a reagent, instrument, or system intended for use in vitro for the examination of specimens derived from the human body.
- Lack of IVD Characteristics: The description does not mention any components or functions typical of IVDs, such as reagents, analyzers, or the analysis of biological samples in vitro.
The device is a tool used in vivo to obtain a sample that will then be used in vitro for diagnostic testing (histology). The device itself is not performing the in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Rubicor Flexible Loop Electrosurgical Electrode is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses. It is also intended to cut soft tissue.
The Rubicor Flexible Loop Electrosurgical Electrode is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast
Indicated Patient Age Range
Not Found
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)
Results of in-vitro testing demonstrate that the Flexible Loop Electrosurgical Electrode is safe and effective for its intended function.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K052506, K012799, K020711, K973346
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Rubicor Flexible Loop Electrosurgical Electrode
Page 1 3 2
510(k) Notification
5 510 (k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Date Prepared: January 9, 2007
MAR 0 9 2007
510(k) number: _ K 070275
Applicant Information:
Rubicor Medical, Inc. 600 Chesapeake Dr. Redwood City, CA 94063
| Contact Person: | Chris Daniel |
|---|---|
| Phone Number: | (650) 556-1070 |
| Fax Number: | (650) 556-1821 |
Device Information:
Classification: Common Name: Trade Name: Classification Name: 878.4400)
Class II Electrosurgical Electrode Not yet determined Electrosurgical Device and accessories (21 CFR
Equivalent Device:
The subject device and accessory are substantially equivalent in intended use and/or method of operation to the Rubicor EnCapsule™ Breast Biopsy Device (K052506), SenoRx Shape Select Scalpel (K012799), Wallach LOOP Electrodes (K020711), and Megadyne Electrosurgical Electrode (K973346).
Intended Use:
The Rubicor Flexible Loop Electrosurgical Electrode is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses. It is also intended to cut soft tissue.
The Rubicor Flexible Loop Electrosurgical Electrode is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential
1
Rubicor Flexible Loop Electrosurgical Electrode
Page 2 of 2
510(k) Notification
that the tissue margins be examined for completeness of removal using standard surgical procedures.
Test Results:
Performance
.
Results of in-vitro testing demonstrate that the Flexible Loop Electrosurgical Electrode is safe and effective for its intended function.
Summary:
Based on the intended use, product, and performance information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate device(s).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is positioned to the right of the department's name, which is written in a circular arrangement around the emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rubicor Medical, Inc. % Underwriters Laboratories, Inc. Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Medical Device Services 455 East Trimble Road San Jose, California 95131-1230
MAR 0 9 2007
Re: K070275
Trade/Device Name: Flexible Loop Electrosurgical Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 22, 2007 Received: February 23, 2007
Dear Mr. Christensen:
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
3
Page 2 - Mr. Morten Simon Christensen
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.
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 yours
fol Pdo th
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4 Indication for Use Statement
510(k) Number (if known):
Device Name: Flexible Loop Electrosurgical Electrode
Indications for Use:
The Rubicor Flexible Loop Electrosurgical Electrode is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses. It is also intended to be used to cut soft tissue.
The Rubicor Flexible Loop Electrosurgical Electrode is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | 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 (ODE)
(Division Sign-Off)
Division of Genera Restorative,
and Neurological Devices
| 510(k) Number | 12070275 |
|---|---|
| --------------- | ---------- |
Rubicor Medical, Inc.