(88 days)
Not Found
No
The summary describes a mechanical biopsy device and does not mention any software, image processing, or AI/ML terms.
No.
The intended use explicitly states, "The Rubicor Breast Biopsy Device 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 Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure" and "The Rubicor Breast Biopsy Device is to be used for diagnostic purposes only".
No
The device description and intended use clearly indicate a physical breast biopsy device, not a software-only product. The predicate devices are also physical biopsy systems.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Rubicor Breast Biopsy Device is used to obtain the tissue sample from the breast. It is a tool used during a medical procedure on the patient's body.
- Intended Use: The intended use clearly states "diagnostic sampling of breast tissue during breast biopsy procedure." This is a procedure performed on the patient, not a test performed on a sample outside the body.
While the tissue sample obtained by this device will likely be used for in vitro diagnostic testing (e.g., pathology examination), the device itself is not an IVD. It's a surgical/procedural device used to collect the sample.
N/A
Intended Use / Indications for Use
The Rubicor Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure. The Rubicor Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.
Product codes
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 tissue
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
Results of in-vitro testing demonstrate that the Breast Biopsy Device is safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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: December 21, 2001
510(k) number: K020047
APR = 5 2002
Applicant Information:
Rubicor Medical, Inc. 849 Veterans Blvd. Redwood City, CA 94063
Contact Person: Arv Chernomorsky (650) 556-1070 Phone Number: Fax Number: (650) 556-1821
Device Information:
Classification: Trade Name: Classification Name: Class II Rubicor Breast Biopsy Device Electrosurgical Device and accessories (21 CFR 870.4400)
Equivalent Device:
The subject device is substantially equivalent in intended use and/or method of operation to the Neothermia En Bloc Biopsy System (K003190), the Ethicon Mammotome Hand-Held System (K991980) and the USSC Autosuture Endo Catch (K922123).
Intended Use:
The Rubicor Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure.
The Rubicor Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.
Test Results:
Performance
Results of in-vitro testing demonstrate that the Breast Biopsy Device is safe and effective for its intended use.
Biocompatibility
The materials used in the Rubicor Breast Biopsy Device meets the requirements of ISO 10993-1.
Summary: Based on the intended use, product, performance and biocompatability information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.
1
Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle. The text is in all caps and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ary Chernomorsky Vice President, Research and Development Rubicor Medical, Inc. 849 Veterans Boulevard Redwood City, CA 94063
APR - 5 2002
Re: K020047
Trade/Device Name: Rubicor Breast Biopsy Device Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 4, 2002 Received: January 7, 2002
Dear Mr. Chernomorsky:
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 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.
2
Page 2 - Mr. Ary Chernomorsky
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 premation of interior. The 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 -11 - 11 - 11 - 1659. Additionally, for questions on the promotion and advertising of Compliance w (201) of the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general 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/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
For Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Kozoo47
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 procedure.
The Rubicor Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
OR
510(k) Number_
Prescription Use
(Per 21 CFR 801.109) ✓
Over-the Coun
020047
Over-the Counter Use
(Optional Format 1-2-96)