(27 days)
Not Found
No
The summary describes a mechanical biopsy device and does not mention any software, image analysis, or AI/ML capabilities.
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 EnCapsule™ 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 "The EnCapsule Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities."
No
The device description is not found, but the intended use and performance studies clearly describe a physical "Breast Biopsy Device" used for tissue sampling, indicating it is a hardware device, not software-only.
Based on the provided information, the EnCapsule™ Breast Biopsy Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The EnCapsule™ device is used to obtain the specimen (breast tissue) from the body.
- IVDs perform tests on the specimen. The EnCapsule™ device's function is to collect the tissue, not to analyze it or perform diagnostic tests on it. The tissue collected by this device is then sent for histologic examination, which is where the diagnostic testing happens, likely using IVD devices or procedures.
- The intended use describes the sampling of tissue for diagnostic purposes, not the diagnostic testing itself.
The device is a tool for collecting a sample that will then be used in an in vitro diagnostic process (histologic examination).
N/A
Intended Use / Indications for Use
The EnCapsule™ 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 EnCapsule 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
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 Rubicor EnCapsule™ Breast Biopsy Device is safe and effective for its intended function.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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: August 18, 2003
510(k) number: Ko32584
Applicant Information:
Rubicor Medical, Inc. 849 Veterans Blvd. Redwood City, CA 94063
| Contact Person: | Ary Chernomorsky |
|---|---|
| Phone Number: | (650) 556-1070 |
| Fax Number: | (650) 556-1821 |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | Rubicor EnCapsule™ Breast Biopsy Device |
| Classification Name: | Electrosurgical Device and accessories (21 CFR 870.4400) |
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 (K023601 & K030049)
Intended Use:
The EnCapsule™ 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 EnCapsule 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 EnCapsule™ Breast Biopsy Device is safe and effective for its intended function.
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 consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "U.S. HEALTH & HUMAN SERVICES" is written around the upper half of the circle.
SEP 1 7 2003
Food and Drug Administra 9200 Corporate Boulevard Rockville MD 20850
Rubicor Medical. Inc c/o Robert J. Chin. Ph.I). Regulatory Consultant 25 Hartford Avenue San Carlos, California 94070
Re: K032584
Trade/Device Name: Rubicor EnCapsule™ Breast Biopsy Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 18, 2003 Received: August 22, 2003
Dear Dr. Chin:
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 scr 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.
3
Page 2 - Robert J. Chin, Ph.D.
This letter will allow you to begin marketing vour 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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Mark N. Milkeerson
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
4
Indication for Use Statement
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K032584 |
| Device Name: | Rubicor EnCapsule™ Breast Biopsy Device |
Indications for Use:
The EnCapsule™ 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 EnCapsule 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 Off)
eral, Restorative
510(k) Number K032584
Prescription Use (Per 21 CFR 801.109)
OR
Over-the Counter Use