(30 days)
Not Found
No
The description focuses on the mechanical aspects of the biopsy device and does not mention any AI or ML components or functions.
No
The device is used for obtaining biopsies, which is a diagnostic procedure, not a therapeutic one. It collects tissue samples for analysis rather than treating a condition.
No
Explanation: The device is used to obtain biopsies, which are then analyzed to provide a diagnosis. The device itself is not performing the diagnostic function but is rather a tool for sample collection.
No
The device description explicitly details physical components such as a stainless steel cutting cannula, rotating coring cannula, stylet, and plastic housing containing mechanically actuated components. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain biopsies from soft tissues. This is a procedure to collect a sample of tissue from a living organism.
- Device Description: The device is a mechanical tool for obtaining tissue samples. It does not perform any diagnostic testing on the sample itself.
- Lack of Diagnostic Function: IVD devices are designed to perform tests on samples (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device's function is solely to collect the sample.
The tissue sample obtained by this device would likely be sent to a laboratory for in vitro diagnostic testing (e.g., pathology, histology), but the device itself is not performing that diagnostic function.
N/A
Intended Use / Indications for Use
The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The EliteCore™ Full Core Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula with spoon, rotating coring cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The key performance attribute of the EliteCore™ Full Core Biopsy Device is the capability of obtaining a full core specimen. A variable throw feature allows the user to choose a throw setting ranging from 13 to 25 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.
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)
Performance testing confirms that the quality of samples obtained with the EliteCore™ Full Core Biopsy Device is equivalent to that of the predicate device as shown below:
-Package inspection: Visually inspect packaging for damage, loose components, tip protector secure, and variable throw set at 22mm. Identical testing performed on predicate device w/ equivalent results.
-Burst test: Measure pressure at which sealed tray fails. Identical testing performed on predicate device. w/ equivalent results.
-Device inspection: Visually inspect device for damage. Identical testing performed on predicate device w/ equivalent results.
-Dimensional: Measure variable throw desired vs. actual. Identical testing performed on predicate device w/ equivalent results.
-Tissue test: Measure variable throw after dry fires, desired vs. actual. Identical testing performed on predicate device w/ equivalent results.
-Tissue test cont.: Measure force to fire front triggers (RH / LH). Identical testing performed on predicate device w/ equivalent results. Measure force to fire rear trigger. Additional testing that was not performed on predicate. Able to take tissue sample in chicken and liver. Identical testing performed on predicate device w/ equivalent results. Able to take tissue samples at various throw distances. Identical testing performed on predicate device w/ equivalent results. Measure 1st sample as compared to last sample for sample weight and verify no loss of effectiveness. Identical testing performed on predicate device w/ equivalent results. Mates with adjustable coaxial and able to take sample. Identical testing performed on predicate device w/ equivalent results.
-Verify weld integrity: Visually inspect device for damage along weld joints after functional testing. Identical testing performed on predicate device w/ equivalent results.
-Dimensional: Measure cannula, spoon, and stylet for migration. Identical testing performed on predicate device w/ equivalent results. Measure the joint strength for the cannula, spoon, and stylet. Identical testing performed on predicate device w/ equivalent results.
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.
K090611– Revolution® Full Core Biopsy Device
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.
Not Found
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.
0
NOV - 3 2011
Image /page/0/Picture/2 description: The image shows the word "INRAD" in bold, black letters. To the left of the word is a black square with a white diagonal line running from the top left corner to the bottom right corner. A small "R" with a circle around it is in the top right corner of the image.
September 30, 2011
Contact Information
Ryan Goosen President Phone: 616-301-7800, ext. 105 Fax: 616-301-7799 E-mail: rgoosen@inrad-inc.com
Company Information
Inrad, Inc 4375 Donker Court SE Kentwood, MI 49512 Phone: 616-301-7800 616-301-7799 Fax:
Device Name(s)
EliteCore™ Full Core Biopsy Device EliteCore™ Full Core Biopsy Device w/HiLiter®
Device Summary
| Trade or Proprietary Name: | EliteCore™ Full Core Biopsy Device | |
|---|---|---|
| EliteCore™ Full Core Biopsy Device w/HiLiter® | ||
| Common or Usual Name: | Biopsy Instrument | |
| Classification Name: | Gastroenterology-urology biopsy instrument | |
| (21 CFR 876.1075, Product code KNW) |
Name of Predicate(s) or Legally Marketed Device(s)
K090611– Revolution® Full Core Biopsy Device
1
Device Description
The EliteCore™ Full Core Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula with spoon, rotating coring cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The key performance attribute of the EliteCore™ Full Core Biopsy Device is the capability of obtaining a full core specimen. A variable throw feature allows the user to choose a throw setting ranging from 13 to 25 mm.
Indications for Use
The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.
Substantial Equivalence
The EliteCore™ Full Core Biopsy Device has the same intended use as the Revolution® Full Core Biopsy Device with the exception of the omission of the word breast. The device and the predicate device have the same technological characteristics in terms of design and materials.
Performance Testing Summary
Performance testing confirms that the quality of samples obtained with the EliteCore™ Full Core Biopsy Device is equivalent to that of the predicate device as shown below:
| Test | Involved | How Equivalent |
|---|---|---|
| -Package inspection | Visually inspect packaging | |
| for damage, loose components | ||
| tip protector secure, and variable | ||
| throw set at 22mm. | Identical testing | |
| performed on predicate | ||
| device w/ equivalent | ||
| results. | ||
| -Burst test | Measure pressure at which | |
| sealed tray fails. | Identical testing | |
| performed on predicate | ||
| device. w/ equivalent | ||
| results. | ||
| -Device inspection | Visually inspect device | |
| for damage | Identical testing | |
| performed on predicate | ||
| device w/ equivalent | ||
| results. |
2
-Dimensional
-Tissue test
-Tissue test cont.
Measure variable throw desired vs. actual.
Measure variable throw after dry fires, desired vs. actual.
Measure force to fire front triggers (RH / LH)
Measure force to fire rear trigger.
Able to take tissue sample in chicken and liver.
Identical testing performed on predicate device w/ equivalent results.
Identical testing performed on predicate device w/ equivalent results.
Identical testing performed on predicate device w/ equivalent results.
Additional testing that was not performed on predicate.
Identical testing performed on predicate device w/ equivalent results.
Able to take tissue samples at various throw distances.
Measure 1st sample as compared
to last sample for sample weight
and verify no loss of effectiveness.
Identical testing performed on predicate device w/ equivalent results.
Identical testing performed on predicate device w/ equivalent results.
Mates with adjustable coaxial Identical testing And able to take sample. performed on predicate
Section 5 - 3
3
K//2945
device w/ equivalent results.
Identical testing. performed on predicate device w/ equivalent results.
Identical testing performed on predicate device w/ equivalent results.
ldentical testing performed on predicate device w/ equivalent results.
-Verify weld integrity
Visually inspect device for damage along weld joints after functional testing.
-Dimensional
Measure cannula, spoon, and stylet for migration.
Measure the joint strength for the cannula, spoon, and stylet.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the staff and a snake winding around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Ryan Goosen President Inrad Inc. 4375 Donker CT SE GRAND RAPIDS MI 49512
NOV - 3 2011
Re: K112945
Trade/Device Name: EliteCore™ Full Core Biopsy Device EliteCore™ Full Core Biopsy Device w/HiLiter® Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: September 30, 2011 Received: October 4, 2011
Dear Mr. Goosen:
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 of medical device-related
5
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Huker Lemur MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SECTION 4: INDICATIONS FOR USE STATEMENT
Indications for Use
12945
510(k) Number (if known):
Device Name:
Indications for Use:
EliteCore™ Full Core Biopsy Device EliteCore™ Full Core Biopsy Device w/HiLiter®
The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
)Division Sloחס-ח(
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112945
Section 4 - 1