(17 days)
Not Found
No
The description focuses on the mechanical aspects of the biopsy device and does not mention any AI/ML components or functions.
No
The device is described as being for "obtaining biopsies" and "for diagnosis only - not for therapeutic use." This indicates it's used for diagnostic purposes (tissue collection) rather than treating a condition.
Yes
The "Intended Use / Indications for Use" states, "For breast biopsy this product is for diagnosis only." This indicates its role in obtaining tissue for diagnostic purposes.
No
The device description clearly states it is a sterile, disposable device with physical components like a stainless steel cutting cannula, stylet, and plastic housing containing mechanically actuated components. This indicates a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
- This device is used to obtain the tissue sample (biopsy) from the body. It's a tool for collecting the specimen, not for analyzing it.
The description clearly states its purpose is "for use in obtaining biopsies from soft tissues." While the obtained tissue will likely be used for in vitro diagnostic testing later, the biopsy device itself is a surgical or procedural tool, not an IVD.
N/A
Intended Use / Indications for Use
The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The PreciseCore™ Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The stylet of the device is stationary, therefore acquiring tissue without an advancement of the needle set beyond the visualized tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues such as liver, breast, 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 PreciseCore™ Biopsy Device is equivalent to that of the predicate device.
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.
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
SECTION 5: 510(k) SUMMARY
Image /page/0/Picture/2 description: The image shows the logo for INRAD Optics. The logo consists of a square with a checkmark inside, followed by the word "INRAD" in large, bold letters. A small "R" in a circle is located to the right of the letter "D".
NOV 1 9 2009
November 12, 2009
Contact Information
Melissa Lalomia Director of Quality & Regulatory Affairs Phone: 616-301-7800, ext. 102 616-301-7799 Fax: E-mail: mlalomia@inrad-inc.com
Company Information
Inrad, Inc 4375 Donker Court SE Kentwood, MI 49512 616-301-7800 Phone: 616-301-7799 Fax:
Device Name(s)
PreciseCore™ Biopsy Device Device Summary Trade or Proprietary Name: PreciseCore™ Biopsy Device Common or Usual Name: Classification Name:
Biopsy Instrument Gastroenterology-urology biopsy instrument (21 CFR 876.1075, Product code KNW)
Name of Predicate(s) or Legally Marketed Device(s)
K994272 – Promex Automated Core Biopsy Device
Also known as:
-
SABD™ Disposable Core Biopsy System(US Biopsy is a division of Promex Technologies)
-
Inrad® AccuCore Single Action Core Biopsy Device (manufactured for Inrad by US Biopsy)
Section 5 - 1
INRAD, INC. - CONFIDENTIAL
1
Device Description
The PreciseCore™ Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The stylet of the device is stationary, therefore acquiring tissue without an advancement of the needle set beyond the visualized tip.
Indications for Use
The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.
Substantial Equivalence
The PreciseCore™ Biopsy Device has the same intended use as the Inrad® AccuCore Single Action Core Biopsy Device and US Biopsy SABD. The device and the predicate devices 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 PreciseCore™ Biopsy Device is equivalent to that of the predicate device.
Section 5 - 2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, depicted with stylized lines to represent its wings and body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Inrad, Inc. % Ms. Melissa Lalomia Director of Quality and Regulatory Affairs 4375 Donker Court SE Kentwood, Michigan 49512
NOV 1 9 2009
Re: K093399
Trade/Device Name: PreciseCore™ Biopsy Device Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: October 28, 2009 Received: November 2, 2009
Dear Ms. Lalomia:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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
3
Page 2 - Ms. Melissa Lalomia
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); 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/cdrl/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4: INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
PreciseCore™ Biopsy Device
K0933999
The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.
Prescription Use X (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)
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093399
Section 4 - 1
INRAD, INC. - CONFIDENTIAL