(32 days)
Not Found
No
The summary describes a mechanical biopsy device and does not mention any software, image processing, or AI/ML capabilities.
No.
The device is explicitly stated to be for "diagnostic sampling" and "diagnostic purposes only," and "is not intended for therapeutic uses."
Yes
The device is explicitly stated to be for "diagnostic sampling of breast tissue" and "to be used for diagnostic purposes only".
No
The device is described as a "Breast Biopsy Device" and the intended use clearly indicates it is used for "diagnostic sampling of breast tissue during breast biopsy procedures." This strongly suggests a physical device used to obtain tissue samples, not a software-only application. The lack of a device description further supports this interpretation, as a software-only device would typically have a description focusing on its software functionalities.
Based on the provided information, the Rubicor Breast Biopsy Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the sampling of breast tissue for diagnostic purposes. It is a tool used to obtain the sample, not to perform the diagnostic test itself.
- Diagnostic Process: The tissue samples obtained by this device are then sent for histologic examination. This examination, which involves analyzing the tissue under a microscope, is the actual diagnostic process that happens in vitro (outside the body).
- Device Function: The device's function is to physically remove tissue from the body. IVD devices, on the other hand, are typically used to analyze samples of bodily fluids, tissues, or other materials in vitro to provide diagnostic information.
In summary, the Rubicor Breast Biopsy Device is a medical device used to collect a sample that will then be used in an IVD process (histologic examination). It is not the IVD itself.
N/A
Intended Use / Indications for Use
The Rubicor Breast Biopsy Device 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.
The Rubicor Breast Biopsy Device 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)
KNW
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 Rubicor Breast Biopsy Device 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.
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
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
K0.71048
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: April 11, 2007
510(k) number: _______________________________________________________________________________________________________________________________________________________________
Applicant Information:
Rubicor Medical, Inc. 600 Chesapeake Drive Redwood City, CA 94063
| Contact Person: | Chris Daniel |
|---|---|
| Phone Number: | (650) 556-1070 |
| Fax Number: | (650) 556-1821 |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | Rubicor Breast Biopsy Device |
| Classification Name: | Biopsy Instrument (21 CFR 876.1075) |
Equivalent Device:
The subject device and accessory are substantially equivalent in intended use and/or method of operation to the Rubicor Magic™ Breast Biopsy Device (K053151)
Intended Use:
The Rubicor Breast Biopsy Device 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.
The Rubicor Breast Biopsy Device 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.
Test Results:
Performance
Results of in-vitro testing demonstrate that the Rubicor Breast Biopsy Device is safe and effective for its intended function.
MAY 1 5 2007
1
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 and unmodified predicate device.
:
.
_
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rubicor Medical, Inc. % Mr. Chris Daniel Vice President, R&D 600 Chesapeake Drive Redwood City, California 94063
MAY 1 5 2007
Re: K071048
Trade/Device Name: Rubicor Breast Biopsy Device Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: April 11, 2007 Received: April 16, 2007
Dear Mr. Daniel:
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. Chris Daniel
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, permitts 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 Omall Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .
Sincerely yours,
Mark N. Melkerson Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use Statement
510(k) Number (if known):
Device Name:
Rubicor Breast Biopsy Device
Indications for Use:
The Rubicor Breast Biopsy Device 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.
The Rubicor Breast Biopsy Device 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Division of General, Restorative, and Neurological Devices
1671048
510(k) Summary
(Per 21 CFR 801.109)
Over-the Counter Use
Rubicor Medical, Inc.
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