(132 days)
No.
The document clearly states "Mentions AI, DNN, or ML: Not Found" and describes a purely mechanical biopsy device.
No.
The device is intended for obtaining biopsies for diagnostic purposes, not for treating a disease or condition.
Yes
The device is described as obtaining biopsies, which are samples of tissue taken to help diagnose a disease or condition. This clearly indicates a diagnostic purpose.
No
The device description clearly outlines that it is a physical, sterile, single-patient use, hand-held device comprised of a plastic handle and stainless steel needle components. It also describes physical functions like variable throw distance and firing modes. The performance studies further confirm it's a physical device through tests like "Biopsy Sample Collection" and "Finger Cannula Tensile Test". There is no mention of software components.
No.
The device is used to obtain tissue samples for biopsy, which are then analyzed. The device itself does not perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The ExpressCore Full Core Biopsy Device is intended for use in obtaining biopsies from soft tissues.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The ExpressCore Device is a sterile, single patient use, hand held full core biopsy device comprised of a plastic handle and three stainless steel needle components that work in sequence to capture a full core biopsy sample. The device is capable of infinitely variable throw distance between 10 and 30mm and is equipped with multiple firing modes to accommodate procedural requirements and physician preference. Multiple device gauge size and needle option combinations have been developed from 12ga x 10cm to 18ga x 25cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-Clinical Bench Performance Testing was conducted on the INRAD, Inc. ExpressCore Full Core Biopsy Device [subject device] to confirm that the device meets all system requirements and is substantially equivalent (SE) to the INRAD, Inc. Revolution Full Core Biopsy Device (K090611) [predicate device]. The following Verification Data was provided in support of the substantial equivalence (SE) determination.
- Performance Testing – Simulated Use / Bench
- Usability of the Device
- Biopsy Sample Collection
- Finger Cannula Tensile Test
- Spoon Cannula Tensile Test
- Stylet Tensile Test
- Representative Tissue Sampling
- Biocompatibility
- Sterilization
- Packaging
- Shelf Life
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
FDA 510(k) Clearance Letter - ExpressCore Biopsy Device
Page 1
April 29, 2025
INRAD, Inc
Heidi Halverson
RA/QA Manager
4375 Donker Court SE
Kentwood, Michigan 49512
Re: K243886
Trade/Device Name: ExpressCore Biopsy Device
Regulation Number: 21 CFR 876.1075
Regulation Name: Gastroenterology-Urology Biopsy Instrument
Regulatory Class: Class II
Product Code: KNW
Dated: March 28, 2025
Received: March 28, 2025
Dear Heidi Halverson:
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 (the 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 available 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.
Page 2
K243886 - Heidi Halverson Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K243886 - Heidi Halverson Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Carr -S
Jessica Carr, PhD
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 07/31/2026 |
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K243886
Device Name
ExpressCore Full Core Biopsy Device
Indications for Use (Describe)
The ExpressCore Full Core Biopsy Device is intended for use in obtaining biopsies from soft tissues.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 1 of 1
Page 5
ExpressCore Full Core Biopsy Device 510(k) Submission
510(k) Summary
I. SUBMITTER
Sponsor/Manufacturer:
INRAD, Inc.
4375 Donker Court SE,
Kentwood, MI 49512, USA
Establishment Registration Number: 1835568
Contact Person:
Heidi Halverson
RA/QA Manager
INRAD, Inc.
4375 Donker Court SE,
Kentwood, MI 49512, USA
Phone: (616) 301-7800
Fax: (616) 301-7799
Email: hhalverson@inradinc.com
Date Prepared:
12/10/2024
II. DEVICE
Device Name(s): ExpressCore Full Core Biopsy Device
ExpressCore Full Core Biopsy Device w/ HiLiter®
Common or Usual Name: Biopsy Instrument
Classification Name: Gastroenterology-urology Biopsy Instrument (21 CFR 876.1075)
Regulatory Class: II
Product Code: KNW
III. PREDICATE DEVICE
The INRAD, Inc. ExpressCore Full Core Biopsy Device [subject device] is substantially equivalent (SE) to the Sponsor's own predicate device:
Revolution Full Core Biopsy Device, K090611
This predicate device has not been subject to a design related recall.
Reference Devices: EliteCore Full Core Biopsy Device, K112945
AccuCore Biopsy Device, K000612
Page 6
The INRAD, Inc. ExpressCore Full Core Biopsy Device [subject device] is substantially equivalent (SE) to the INRAD, Inc. Revolution Full Core Biopsy Device (K090611) [predicate device] in terms of Indications for Use / Intended Use to obtain biopsies from soft tissues.
Substantial equivalency (SE) of the subject device has also been based on substantially equivalent design, functionality, and performance characteristics as the predicate device.
IV. DEVICE DESCRIPTION
The ExpressCore Device is a sterile, single patient use, hand held full core biopsy device comprised of a plastic handle and three stainless steel needle components that work in sequence to capture a full core biopsy sample. The device is capable of infinitely variable throw distance between 10 and 30mm and is equipped with multiple firing modes to accommodate procedural requirements and physician preference. Multiple device gauge size and needle option combinations have been developed from 12ga x 10cm to 18ga x 25cm.
V. INTENDED USE / INDICATIONS FOR USE
The Intended Use and the Indications for Use are the same for the ExpressCore Full Core Biopsy Device [subject device] and the INRAD, Inc. Revolution Full Core Biopsy Device (K090611) [predicate device] with the exception of specific tissue listings being omitted for ExpressCore.
[subject device]:
The ExpressCore Full Core Biopsy Device is intended for use in obtaining biopsies from soft tissues.
[predicate device]:
The Revolution Full Core Biopsy Device is intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The INRAD, Inc. ExpressCore Full Core Biopsy Device [subject device] is substantially equivalent (SE) to the INRAD, Inc. Revolution Full Core Biopsy Device (K090611) [predicate device] based on the same functional and performance characteristics of the subject device when compared to the predicate device. The difference between the subject device's and predicate device's gauge size, length options and packaging do not raise concerns of safety and effectiveness. To further analyze risks associated with the varying gauge sizes, length options and packaging, additional reference devices; EliteCore and AccuCore by INRAD have been included for reference.
The technological characteristics of design, function, and materials present in both the subject device and the predicate device has been evaluated. The comparisons supporting a determination of substantial equivalency (SE) are provided below.
Page 7
| Comparison Criteria | Subject Device ExpressCore Biopsy Device | Predicate Device Revolution Biopsy Device (K090611) | Reference Device EliteCore Biopsy Device (K112945) | Reference Device AccuCore Biopsy Device (K000612) |
|---|---|---|---|---|
| Manufacturer | INRAD, Inc. | Same | Same | Same |
| Device Class | Class II | Same | Same | Same |
| Device Classification Name | Biopsy Instrument | Same | Same | Same |
| Product Code | KNW | Same | Same | Same |
| Regulation Number | 21 CFR §876.1075 | Same | Same | Same |
| Indications for Use | This device is intended for use in obtaining biopsies from soft tissues. | This device is intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. | This device is intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. | This device is intended to be used as an automated instrument for percutaneous tissue core biopsy of several human organs including, but not limited to, prostate, kidney, liver, spleen, lung, breast, lymph nodes and different tumors. |
Page 8
| Comparison Criteria | Subject Device ExpressCore Biopsy Device | Predicate Device Revolution Biopsy Device (K090611) | Reference Device EliteCore Biopsy Device (K112945) | Reference Device AccuCore Biopsy Device (K000612) |
|---|---|---|---|---|
| Handle Composition (non-patient contact) | ABS, Polycarbonate | ABS, TPE, Polyester, Acetal | ABS, TPE, Polyester, Acetal | Polycarbonate |
| Needle Composition (patient contact) | 304 Stainless Steel | 304 Stainless Steel 17-7 Stainless Steel | 304 Stainless Steel 17-7 Stainless Steel | Same |
| Needle Processing | • Straightening | |||
| • Cut to length | ||||
| • Grit blast | ||||
| • Tip geometry | ||||
| • Electropolish | ||||
| • Depth marks | ||||
| • Clean and passivate | ||||
| • Finger bend | ||||
| • Inspect and pack | Same | Same | Same |
- Notch grind (stylet)
- Finger bend |
| Needle Gauge Size | 12ga, 14ga, 16ga, 18ga | 14ga | 18ga | Same |
| Needle Lengths | 10cm, 15cm, 20cm, 25cm | 10cm, 15cm | Same | Same |
| Needle Echogenicity | HiLiter Stylet (select product codes) | Same | Same | Grit blasted cannula |
| Throw Length | Variable 10-30mm | Variable 13-25mm | Variable 13-25mm | Fixed |
| Mechanism of Throw Adjustment | Thumb Wheel | Same | Same | N/A |
| Mechanism of Arming | Dual Stroke | Same | Same | Single Stroke |
| Firing Modes | Semi or Automatic | Same | Same | Single Action |
| Packaging Configuration | Tyvek / PE pouch | Tyvek / PETG Tray | Tyvek / PETG Tray | Same |
| Sterile | Yes | Same | Same | Same |
| Method of Sterilization | Ethylene Oxide | Same | Same | Same |
| Single-Use, Disposable | Yes | Same | Same | Same |
Page 9
VII. SUMMARY OF VERIFICATION DATA AND VERIFICATION TEST CONCLUSIONS
Non-Clinical Bench Performance Testing was conducted on the INRAD, Inc. ExpressCore Full Core Biopsy Device [subject device] to confirm that the device meets all system requirements and is substantially equivalent (SE) to the INRAD, Inc. Revolution Full Core Biopsy Device (K090611) [predicate device]. The following Verification Data was provided in support of the substantial equivalence (SE) determination.
• Performance Testing – Simulated Use / Bench
- Usability of the Device
- Biopsy Sample Collection
- Finger Cannula Tensile Test
- Spoon Cannula Tensile Test
- Stylet Tensile Test
- Representative Tissue Sampling
• Biocompatibility
• Sterilization
• Packaging
• Shelf Life
VIII. SUBSTANTIAL EQUIVALENCE SUMMARY / CONCLUSIONS:
The data generated from the results of the Verification Testing, Design Validation, and evaluations, along with a side-by-side comparison of the technological characteristics of design, function, and materials between the subject device and the predicate and reference devices, demonstrate that the INRAD, Inc. ExpressCore Full Core Biopsy Device [subject device] is as safe and effective and performs as well as the INRAD, Inc. Revolution Full Core Biopsy Device (K090611) [predicate device].
The similar technological and performance characteristics for the proposed INRAD, Inc. ExpressCore Full Core Biopsy Device [subject device] have been assessed to be substantially equivalent to the predicate device, and the slight differences do not raise concerns of safety and effectiveness when compared to the predicate or reference devices. Therefore, the INRAD, Inc. ExpressCore Full Core Biopsy Device [subject device] is substantially equivalent to the predicate device.