(200 days)
Not Found
No
The device description and performance studies focus on the mechanical function of a spring-loaded biopsy device and do not mention any computational or analytical capabilities that would suggest the use of AI/ML.
No.
The device is described as a biopsy device intended to obtain tissue samples for diagnosis, not for treating a condition or disease.
Yes
The document explicitly states, "When used for breast biopsy, the product is for diagnosis only." This indicates its primary purpose is diagnostic.
No
The device description clearly describes a physical, hand-held, spring-loaded core biopsy device with needles and a cutting cannula, indicating it is a hardware device.
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 outside of the body (in vitro).
- Device Function: The Sertera Biopsy Device is used to obtain a tissue sample from the body (in vivo). It is a tool for collecting the sample, not for analyzing it.
- Intended Use: The intended use clearly states it is for obtaining percutaneous core biopsy samples for diagnosis. The diagnosis itself would be made by examining the tissue sample after it has been obtained by this device, likely through histological analysis in a laboratory.
The device is a tool used in the process of obtaining a sample that will then be used for in vitro diagnostic testing, but the device itself is not an IVD.
N/A
Intended Use / Indications for Use
The Sertera Biopsy Device is intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast. When used for breast biopsy, the product is for diagnosis only. It is not intended for use in bone.
Product codes
KNW
Device Description
The Hologic Sertera Biopsy Device is a spring-loaded core biopsy device to be used primarily in ultrasound-guided breast biopsies. The Sertera Biopsy Device is a disposable, hand-held springloaded core biopsy device that is fully operable with one hand. The Sertera Biopsy Device consists of a hand piece, which advances an inner needle with a side aperture to penetrate into the tissue, and a sharpened outer cutting cannula that extends over the aperture with sufficient force to slice the tissue. The Sertera Biopsy Device is available with 12 and 14 gauge needles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound-guided
Anatomical Site
soft tissue, and tumors of the 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 Sertera Biopsy Device demonstrated equivalent performance to the predicate devices, 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/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," arranged in a circular pattern around the edge. At the center of the seal is a stylized emblem consisting of three human profiles facing to the right, stacked on top of each other, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 14, 2015
Hologic Incorporated Ms. Brenda M. Geary Regulatory Affairs Specialist 250 Campus Drive Marlborough, Massachusetts 01752
Re: K150169
Trade/Device Name: Sertera Biopsy Device Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: July 16, 2015 Received: July 17, 2015
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 practice, labeling, 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 (reporting of medical
1
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): N/A
Device Name: Sertera Biopsy Device
Indications For Use: The Sertera Biopsy Device is intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast. When used for breast biopsy, the product is for diagnosis only. It is not intended for use in bone.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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6.0 510(k) Summary
6.1 Date: January 19, 2015
6.2 510(k) Submitter:
Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Attn: Brenda M. Geary P: 508.263.8819 F: 508.263.8872
6.3 Establishment Registration Number: 1222780
6.4 Trade Name: Sertera Biopsy Device
6.5 Common/Usual Name: Biopsy Instrument, 21.CFR.Reg 876.1075 Product Code: KNW
- 6.6 Classification: Class II
- 6.7 Panel: Gastroenterology/Urology
6.8 PREDICATE DEVICES
6.8.1 Tradename: Achieve Programmable Automatic Biopsy Needle Submitter / 510(k) Holder: (Bauer Medical) CareFusion (Cardinal Health) 510(k) #: K960064 Classification code: KNW and Regulation: 21.CFR.876.1075.
6.8.2 Tradename: Monopty Disposable Core Biopsy Instrument Submitter / 510(k) Holder: C.R. Bard, Inc. 510(k) #: K922939 Classification code: KNW and Regulation: 21.CFR.876.1075.
6.9 DEVICE DESCRIPTION
The Hologic Sertera Biopsy Device is a spring-loaded core biopsy device to be used primarily in ultrasound-guided breast biopsies. The Sertera Biopsy Device is a disposable, hand-held springloaded core biopsy device that is fully operable with one hand. The Sertera Biopsy Device consists of a hand piece, which advances an inner needle with a side aperture to penetrate into the tissue, and a sharpened outer cutting cannula that extends over the aperture with sufficient force to slice the tissue. The Sertera Biopsy Device is available with 12 and 14 gauge needles.
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6.10 INTENDED USE:
The Sertera Biopsy Device is intended to obtain percutaneous core biopsy samples from soft tissue, and tumors of the breast. When used for breast biopsy, the product is for diagnosis only. It is not intended for use in bone.
6.11 Comparison to Predicate Devices:
| | ACHIEVE
(K960064) | MONOPTY
(K922939) | Sertera Biopsy Device
(SUBJECT DEVICE) | COMPARISON TO
PREDICATES |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Intended for use in
obtaining core biopsy
samples from soft
tissue such as breast,
kidney, liver, prostate
and various soft tissue
masses. Not intended
for use in bone. | The core needle
biopsy device is
intended for use in
obtaining biopsies
from soft tissues such
as liver, kidney,
prostate, spleen,
lymph nodes and
various soft tissue
tumors. It is not
intended for use in
bone. | The Sertera Biopsy
Device is intended to
obtain percutaneous
core biopsy samples
from soft tissue, and
tumors of the breast.
When used for breast
biopsy, the product is
for diagnosis only. It is
not intended for use
in bone. | SUBJECT DEVICE is
substantially
equivalent to both
predicate devices |
| | Method of
Use | Minimally-invasive
excision of breast
tissue. After local
anesthetic is
applied and incision
is made, biopsy
needle is
introduced to
breast. Physician
targets area of
interest and
collects tissue. | Minimally-invasive
excision of breast
tissue. After local
anesthetic is
applied and incision
is made, biopsy
needle is
introduced to
breast. Physician
targets area of
interest and collects
tissue. | Minimally-invasive
excision of breast
tissue. After local
anesthetic is
applied and incision
is made, biopsy
needle is
introduced to
breast. Physician
targets area of
interest and collects
tissue. |
| | | Mechanism
of Action | Collection of
specimens into
needle aperture,
and inner cannula
excision of
specimen. | Collection of
specimens into
needle aperture,
and inner cannula
excision of
specimen. |
| | | | Mode of
Operation | Handheld biopsy
device |
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6.12 Performance Testing
Bench testing of the Sertera Biopsy Device demonstrated equivalent performance to the predicate devices, and met all acceptance criteria.
6.13 CONCLUSION
The Sertera Biopsy Device met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs. The Sertera Biopsy Device is substantially equivalent to the legally marketed predicate devices (Care Fusion Achieve Programmable Automatic Biopsy Needle and C.R. Bard Inc.'s Monopty Disposable Core Biopsy Instrument).