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.

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.

AI/ML Overview

This 510(k) submission (K093399) for the PreciseCore™ Biopsy Device primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing. However, it does not provide detailed acceptance criteria, specific performance metrics in a tabular format, or a comprehensive study report with the kind of information typically requested (e.g., sample sizes for different sets, ground truth establishment details, expert qualifications, MRMC studies).

Here's an analysis based on the provided text, highlighting what is and is not present:

Acceptance Criteria and Device Performance (Based on available information)

The document states: "Performance testing confirms that the quality of samples obtained with the PreciseCore™ Biopsy Device is equivalent to that of the predicate device." This implies the acceptance criterion was "equivalence in sample quality" to the predicate, but no specific metrics or thresholds are provided.

Acceptance Criteria (Inferred)	Reported Device Performance
Equivalent sample quality to predicate device (K994272 – Promex Automated Core Biopsy Device, also known as Inrad® AccuCore Single Action Core Biopsy Device and US Biopsy SABD)	Confirmed to be equivalent to the predicate device in sample quality.

Missing Information (Based on the provided text):

The provided 510(k) summary does not contain the following details:

Sample sizes used for the test set and the data provenance: There is no mention of a specific clinical "test set" in terms of patient or tissue samples. The performance testing appears to be functional or mechanical, comparing the device's output (sample quality) to a predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as there isn't a described "test set" requiring expert ground truth establishment in the context of clinical images or diagnostic outcomes. The "quality of samples" likely refers to characteristics like length, integrity, or cellularity, evaluated by laboratory personnel or pathologists, but no specifics are given.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the reasons above.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not applicable. The device is a physical biopsy instrument, not an AI-powered diagnostic or imaging tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not applicable, as it is a physical biopsy device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While the "quality of samples" would likely refer to histopathological evaluation, the specific method of establishing this ground truth for the comparison is not detailed.
The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary of Study (Based on provided text):

The submission relies on a "Performance Testing Summary" to demonstrate substantial equivalence.

Study Design/Purpose: To confirm that the quality of samples obtained with the PreciseCore™ Biopsy Device is equivalent to that of the predicate device (K994272 – Promex Automated Core Biopsy Device, Inrad® AccuCore Single Action Core Biopsy Device, and US Biopsy SABD).
Methodology (General): "Performance testing" was conducted. While no specifics are given, for a biopsy device, this typically involves mechanical testing (e.g., penetration force, firing reliability) and potentially benchtop testing on tissue phantoms or ex vivo tissue to assess core length, integrity, and cellular yield when compared to the predicate device.
Data Provenance: Not specified, but likely laboratory/benchtop testing rather than clinical data from a specific country.
Result: The testing "confirms that the quality of samples obtained with the PreciseCore™ Biopsy Device is equivalent to that of the predicate device."

Conclusion:

The K093399 submission successfully demonstrated substantial equivalence for the PreciseCore™ Biopsy Device by asserting that its performance testing confirmed sample quality equivalent to its predicate. However, it lacks the detailed breakdown of acceptance criteria, specific performance metrics, and clinical study information (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies) that would be expected for an AI/ML device or a device requiring detailed clinical validation data. This is typical for 510(k)s for predicate-based medical devices where the equivalence is often shown through functional, mechanical, and benchtop testing rather than extensive clinical efficacy trials.

Summary

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K093399

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

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

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Device Description

Indications for 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

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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

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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,

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

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SECTION 4: INDICATIONS FOR USE STATEMENT

Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

PreciseCore™ Biopsy Device

K0933999

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)

Naf Rkble far 1 km

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093399

Section 4 - 1

INRAD, INC. - CONFIDENTIAL

Regulation Number and Section

§ 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.

SECTION 5: 510(k) SUMMARY

Contact Information

Company Information

Device Name(s)

Name of Predicate(s) or Legally Marketed Device(s)

Section 5 - 1

Device Description

Indications for Use

Substantial Equivalence

Performance Testing Summary

Section 5 - 2

NOV 1 9 2009

SECTION 4: INDICATIONS FOR USE STATEMENT

Indications for Use

§ 876.1075 Gastroenterology-urology biopsy instrument.