(71 days)
Not Found
No
The summary describes a mechanical biopsy device guided by stereotactic imaging, with no mention of AI/ML, image processing, or data sets for training/testing.
No.
The device is used to obtain tissue samples for diagnostic sampling, not for treating a condition or disease.
No.
The device is used to obtain tissue samples for diagnostic sampling, but it is not itself a diagnostic device as it does not interpret the samples or provide a diagnosis. The tissue samples are subsequently used for "histologic examination" which is a separate diagnostic process.
No
The device description explicitly states it is a "hand-held biopsy device," indicating it is a physical hardware component used for tissue sampling, not solely software.
Based on the provided information, the Eviva Stereotactic Guided Breast Biopsy System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic purposes. This typically involves tests performed on blood, urine, tissue samples, etc., to detect diseases, conditions, or infections.
- The Eviva system is a device used to obtain the tissue sample. Its primary function is to physically remove breast tissue under imaging guidance. While the tissue sample itself will be used for in vitro diagnostic testing (histologic examination), the Eviva device is the tool for collecting that sample.
Think of it this way: A scalpel used to remove a tumor is not an IVD, even though the tumor will be sent for IVD testing. The scalpel is a surgical instrument. Similarly, the Eviva system is a biopsy device used for tissue acquisition.
The description clearly states its purpose is to "provide breast tissue samples for diagnostic sampling" and "provide breast tissue for histologic examination." This confirms its role in the collection phase, not the in vitro testing phase.
N/A
Intended Use / Indications for Use
The Eviva Stereotactic Guided Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities under stereotactic breast biopsy guidance. The Eviva device is intended 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 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 procedure.
Product codes
KNW
Device Description
The Eviva Stereotactic Guided Breast Biopsy System is a hand-held biopsy device that is marketed for guidance with stereotactic imaging. The Eviva device is intended 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 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 procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
stereotactic breast biopsy guidance
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
Bench testing of the Eviva Stereotactic Guided Breast Biopsy System including functional testing, biocompatibility, sterilization and package testing demonstrated equivalent performance, and showed to be as safe and effective as the predicate device, and met all acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure. The FDA acronym is in a blue square, and the full name of the agency, "U.S. Food & Drug Administration," is written in blue text to the right of the square.
April 10, 2018
Hologic. Inc Ms. Brenda Geary Regulatory Affairs Specialist 250 Campus Drive Marlborough, Massachusetts 01752
Re: K180233
Trade/Device Name: Eviva Stereotactic Guided Breast Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: February 8, 2018 Received: February 9, 2018
Dear Ms. Geary:
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, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180233
Device Name
Eviva Stereotactic Guided Breast Biopsy System
Indications for Use (Describe)
The Eviva Stereotactic Guided Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities under stereotactic breast biopsy guidance. The Eviva device is intended 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 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 procedure.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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6.0 510(k) Summary
January 11, 2018
6.1 510(k) Submitter
Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Attn: Brenda Geary P: 508.263.8819 F: 844.223.4956
6.2 Establishment Registration Number: 1222780
- 6.3 Trade Name: Eviva Stereotactic Guided Breast Biopsy System
- 6.4 Common/Usual Name: Biopsy Instrument, 21CFR.876.1075
6.5 Product Code: KNW
- 6.6 Classification: Class II
- 6.7 Panel: Gastroenterology/Urology
6.8 Predicate Device
| Tradename: | ATEC Breast Biopsy System |
|---|---|
| Submitter / 510(k) Holder: | Hologic, Inc. |
| 510(k) #: | K042290 |
| Classification code: | KNW |
| Regulation: | 21.CFR.876.1075 |
6.9 Device Description
The Eviva Stereotactic Guided Breast Biopsy System is a hand-held biopsy device that is marketed for guidance with stereotactic imaging. The Eviva device is intended 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 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 procedure.
4
HOLOGIC, Inc.
Premarket Notification Eviva Stereotactic Guided Breast Biopsy System
6.10 Intended Use:
The Eviva Stereotactic Guided Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities under stereotactic breast biopsy guidance. The Eviva device is intended 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 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 procedure.
| Attribute | Predicate Device
ATEC Breast Biopsy System
(K042290) | Subject Device
Eviva Stereotactic Breast Biopsy
System | Status |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Intended Use | The ATEC Breast Biopsy System is
intended to provide breast tissue for
histologic examination with partial or
complete removal of the imaged
abnormality. The extent of the
histologic abnormality cannot be
reliably determined from its
mammographic appearance.
Therefore, the extent of the removal of
the imaged evidence of an abnormality
does not predict the extent of removal
of 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
procedure. | The Eviva Stereotactic Guided
Breast Biopsy System is indicated
to provide breast tissue samples for
diagnostic sampling of breast
abnormalities under stereotactic
breast biopsy guidance. The Eviva
device is intended 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 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
procedure. | Subject device is
substantially
equivalent to
predicate device |
| Method of Use | Vacuum-assisted device to remove
breast tissue in a minimally invasive
manner.
For use with Ultrasound, Stereotactic
or MRI.
Requires additional Introducer
accessory for marker. | Vacuum-assisted device to remove
breast tissue in a minimally
invasive manner.
For use only in Stereotactic.
Integrated Introducer for marker. | Subject device is
substantially
equivalent to
predicate device |
| Mechanism for
Action | Manually fired.
Rotate all device to acquire tissue
360°. | Pneumatic firing mechanism.
Rotate using thumbwheel and using
"clock position" window. | Subject device is
substantially
equivalent to
predicate device |
| | Tissue retrieval part of device. | Remote tissue retrieval. | |
6.11 Comparison to Predicate Device:
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HOLOGIC, Inc. Premarket Notification Eviva Stereotactic Guided Breast Biopsy System
| Attribute | Predicate Device
ATEC Breast Biopsy System
(K042290) | Subject Device
Eviva Stereotactic Breast Biopsy System | Status |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Mode of
Operation | Tissue acquisition, press down
footswitch and hold.
Pressure and Vacuum from Console
activate internal mechanism to cut
and acquire tissue. | Tissue acquisition, press down
footswitch and hold.
Pressure and Vacuum from Console
activate internal mechanism to cut
and acquire tissue. | Subject device is
substantially
equivalent to
predicate device |
6.12 Performance Testing:
Bench testing of the Eviva Stereotactic Guided Breast Biopsy System including functional testing, biocompatibility, sterilization and package testing demonstrated equivalent performance, and showed to be as safe and effective as the predicate device, and met all acceptance criteria.
6.13 Conclusion:
The Eviva Stereotactic Guided Breast Biopsy System met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs. The Eviva Stereotactic Guided Breast Biopsy System is substantially equivalent to the legally marketed predicate device (Hologic's ATEC Breast Biopsy System K042290).