Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the description focuses on standard digital X-ray imaging and image processing adjustments.

Therapeutic

No
The device is used for imaging surgical and biopsy specimens to confirm tissue excision, not for treatment or therapy.

Diagnostic

Yes

Explanation: The device is used to generate X-ray images of excised tissue to confirm the presence of a lesion or calcification, which is a form of diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes hardware components such as an image display monitor, touch-screen control display, and an imaging cabinet.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The Trident® HD Specimen Radiography System is an X-ray imaging system used to visualize surgical and core biopsy specimens after they have been removed from the body. Its purpose is to confirm the presence of the intended tissue or site marker within the excised sample.
No Analysis of Bodily Fluids or Tissues for Diagnostic Information: The system does not perform any biochemical, immunological, or other tests on the specimen itself to provide diagnostic information about the patient's health status. It simply provides an image of the physical specimen.
Focus on Specimen Verification, Not Patient Diagnosis: The intended use is to verify that the correct tissue has been excised during the biopsy procedure, which is a procedural check, not a diagnostic test on the patient.

While the system is used in a medical context and involves biological specimens, its function is imaging and verification of the physical sample, not in vitro analysis for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.

Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.

Product codes

MWP

Device Description

The Trident® HD Specimen Radiography System is a self-contained, direct digital imaging system for imaging surgical and biopsy specimens. The Trident® HD system includes the following major components: an image display monitor, touch-screen control display, and an imaging cabinet.

The system is self-contained. Shielding is incorporated within the cabinet chamber system design, eliminating the need for separate shielding. The unit is mounted on casters to allow for easy transportation.

Dedicated specimen radiography systems are intended for use in the following environments:

. The surgical suite
The stereotactic biopsy suite
The pathology lab ●

Specimen radiography units are utilized to confirm removal of the intended tissue, or site marker in surgical and core biopsy specimens from various anatomical regions. By generating a high-resolution X-ray of the specimen, the presence of a lesion or calcification in the extracted sample can be confirmed by the user reviewing the digital image.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

various anatomical regions

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Used in the surgical suite, the stereotactic biopsy suite, and the pathology lab.

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

The Trident® HD system successfully performed system design control verification and validation tests, which are summarized in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005) based on a moderate level of concern.

The Trident® HD system complies with IEC 61010 standards, as performed by the third-party test house, UL. No clinical studies have been performed. Substantial equivalence has been demonstrated by nonclinical testing. Additional bench testing, including functional testing and usability testing, was also performed on the Trident® HD system. The comparative and other performance testing showed that the overall system demonstrated equivalent performance and equivalent safety and effectiveness as the predicate Trident® Specimen Radiography System (K111508).

Key Metrics

Not Found

Predicate Device(s)

K111508

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 10, 2019

Hologic, Inc. % Meghan Wakeford Regulatory Affairs Specialist 36 Apple Ridge Road DANBURY CT 06810

Re: K182727

Trade/Device Name: Trident HD Specimen Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MWP Dated: December 11, 2018 Received: December 13, 2018

Dear Ms. Wakeford:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 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 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,

Hse 2. Nils

for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Trident HD Specimen Radiography System

Indications for Use (Describe)

A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.

Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92

Date Prepared:	December 11, 2018
Manufacturer:	Hologic, Inc.
36 Apple Ridge Road
Danbury, CT 06810 USA
Establishment Registration #:	1220984
Contact Person:	Meghan Wakeford
Regulatory Affairs Specialist
P: 203.702.7819
Identification of the Device:
Proprietary/Trade Name:	Trident® HD Specimen Radiography System
Classification Name:	Cabinet X-Ray System
Regulatory Number:	21 CFR 892.1680
Product Code:	MWP
Device Class:	Class II
Review Panel:	Radiology
Identification of the Legally Marketed Predicate Device:

Trade Name:	Trident® Specimen Radiography System
Classification Name:	Cabinet X-Ray System
Regulatory Number:	21 CFR 892.1680
Product Code:	MWP
Device Class:	Class II
Review Panel:	Radiology
Submitter/510(k) Holder:	Hologic, Inc.
Clearance:	K111508 (cleared August 19, 2011)

Device Description:

The Trident® HD Specimen Radiography System is a self-contained, direct digital imaging system for imaging surgical and biopsy specimens. The Trident® HD system includes the following major components: an image display monitor, touch-screen control display, and an imaging cabinet.

The system is self-contained. Shielding is incorporated within the cabinet chamber system design, eliminating the need for separate shielding. The unit is mounted on casters to allow for easy transportation.

Dedicated specimen radiography systems are intended for use in the following environments:

. The surgical suite
The stereotactic biopsy suite
The pathology lab ●

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Specimen radiography units are utilized to confirm removal of the intended tissue, or site marker in surgical and core biopsy specimens from various anatomical regions. By generating a high-resolution X-ray of the specimen, the presence of a lesion or calcification in the extracted sample can be confirmed by the user reviewing the digital image.

Indications for Use:

A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.

Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.

Standards:

UL 61010-1:2012 Safety Requirements for Electrical Equipment for Measurement, Control, ● and Laboratory Use; Part 1: General Requirements
IEC 61010-1:2010 Safety Requirements for Electrical Equipment for Measurement, Control, ● and Laboratory Use, Part 1: General Requirements
IEC 61010-2-091:2012 Safety Requirements for Electrical Equipment for Measurement, ● Control. and Laboratory Use, Part 2-091: Particular Requirements for Cabinet X-ray Systems
EN 61326-1:2013 Electrical Equipment for Measurement, Control, and Laboratory Use EMC ● Requirements, General Requirements
EN 55011 and CISPR 11 (Class A) Industrial, Scientific and Medical (ISM) Radio-Frequency ● Equipment - Electromagnetic Disturbance Characteristics - Limits and Methods of Measurement
ISO 14971: 2012 – Medical devices – Application of Risk Management to Medical Devices

FDA Guidance Documents:

"Applying Human Factors and Usability Engineering to Medical Devices," issued on February 3. ● 2016
. "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices," issued on September 1, 2016
. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued on May 11, 2005
"Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software," ● issued on January 14, 2005
"Radio Frequency Wireless Technology in Medical Devices," issued on August 14, 2013 ●
. "Off-the-Shelf Software Use in Medical Devices," issued on September 9, 1999

Comparison with Predicate Device:

The Trident® HD System and its predicate device, the Trident® Specimen Radiography System, have the same intended use, general configuration, principles of operation, and operating parameters.

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Substantial Equivalence:

| | Trident® Specimen
Radiography System | Trident® HD Specimen
Radiography System | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate (K111508) | Proposed | Comparison |
| Indications for Use | A cabinet X-ray system
used to provide digital
X-ray images of surgical
and core biopsy
specimens from various
anatomical regions in
order to allow rapid
verification that the
correct tissue has been
excised during the
biopsy procedure. | A cabinet X-ray system
used to provide digital X-
ray images of surgical
and core biopsy
specimens from various
anatomical regions in
order to allow rapid
verification that the
correct tissue has been
excised during the biopsy
procedure. | Same |
| | Doing the verification in
the same room as the
procedure or nearby
improves workflow, thus
reducing the time the
patient needs to be under
examination. | Doing the verification in
the same room as the
procedure or nearby
improves workflow, thus
reducing the time the
patient needs to be under
examination. | |
| Level of Concern | Moderate | Moderate | Same |
| Method of Use | Cabinet X-ray system
used for imaging small
to medium biopsy and
surgical specimens | Cabinet X-ray system
used for imaging small to
large biopsy and surgical
specimens | Expanded specimen
size capabilities with
larger detector |
| Mechanism of
Action | Sample verification:
obtain correct margins,
specimen of interest, etc. | Sample verification:
obtain correct margins,
specimen of interest, etc. | Same |
| Physical | | | |
| Construction | Shielded cabinet on
moveable cart | Fully integrated system
with movable base
casters | Similar; redesigned for
ease of use and
transportation |
| Size (W x D x H)
(in.) | 26.5 x 37.5 x 68.3 | 24 x 26 x 66.5 | Similar; reduced
footprint for ease of use
and transportation |
| Weight (lb.) | 275
325 with UPS | 278 (with MFD)
291 (with HDT) | Similar; minor weight
changes due to design
change |
| Digital Image Receptor | | | |
| Detector
Technology | TFT-based direct
capture technology | TFT-based direct capture
technology | Same |
| X-ray Absorption
Material | Amorphous selenium | Amorphous selenium | Same |
| Active Imaging
Area Size | 12 cm x 14 cm | 12 cm x 14 cm (MFD)
20 cm x 20 cm (HDT) | Trident® HD is
available with two |
| | | | detectors for variety in
image size and
preference |
| Digital Detector | Detector used on
predicate, K111508, was
approved for use with
the Selenia FFDM
system, in P010025. | MFD used on the Affirm
Prone Biopsy System,
cleared under K153486.