BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT by MEDICAL DEVICE TECHNOLOGIES, INC.

The automatic BioPince™ Ultra Full Core Biopsy Instrument is intended for multiple percutaneous full-core sampling of soft tissue, tumors, or masses for histological analysis. Soft tissue sampling includes, but is not limited to, kidney, liver, breast, prostate and various soft tissue lesions.

Device Description

The BioPince™ Ultra Full Core Biopsy Instrument is an automatic, disposable biopsy instrument that cuts a full core specimen of soft tissue. The instrument is designed to expel the specimen upon re-cocking of the instrument which prepares the instrument for taking another sample (i.e., ready to be fired). The instrument has two firing trigger buttons with an indicator window and safety button. The instrument is available in 14G, 16G, 18G and 20G needle sizes and 10cm, 15cm and 20cm lengths.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria. The document is a 510(k) summary for the BioPince™ Ultra Full Core Biopsy Instrument, primarily focused on establishing substantial equivalence to predicate devices and outlining the device's intended use and technological characteristics.

However, based on the Performance Tests section, we can infer the overarching acceptance criteria and the nature of the study.

Inferred Acceptance Criteria:

The document states, "Performance testing confirms that the BioPince™ Ultra Full Core Biopsy Instrument is equivalent to that of the predicate devices." This implies that the acceptance criteria for the BioPince™ Ultra were to demonstrate equivalency in performance to its predicate devices concerning their functional aspects. While specific quantitative metrics are not provided, these would typically include aspects relevant to biopsy instruments, such as:

Ability to obtain a full-core specimen: The device's primary function.
Specimen expulsion mechanism: Ensuring the sample is released upon re-cocking.
Reliability of firing mechanism: Consistent operation of the trigger buttons.
Safety features: Proper functioning of the safety button.
Material compatibility/biocompatibility: Though not explicitly a "performance test" in the functional sense, it's a key aspect for medical devices.
Sterility: As a disposable device.

Inferred Study to Prove Acceptance Criteria:

The document states, "Performance testing confirms that the BioPince™ Ultra Full Core Biopsy Instrument is equivalent to that of the predicate devices." This indicates that a comparative performance study was conducted.

Here's an attempt to populate the requested table and sections based on the available information and common practices for 510(k) submissions of this nature:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Device performance equivalent to predicate devices.	Confirmed through performance testing to be equivalent to predicate devices.
Ability to cut a full-core specimen of soft tissue.	The device is designed to cut a full-core specimen, implied to perform as intended.
Reliable specimen expulsion upon re-cocking.	Designed to expel specimen upon re-cocking, implied to function correctly.
Consistent and reliable firing mechanism (two trigger buttons).	Implied to function reliably as part of the overall performance equivalency.
Functional safety mechanism (safety button).	Implied to function reliably as part of the overall performance equivalency.
All available needle sizes (14G, 16G, 18G, 20G) and lengths (10cm, 15cm, 20cm) perform as intended.	Implied that all configurations meet performance equivalency.

Note: The document does not provide specific quantitative metrics or detailed results for these performance aspects. The "reported device performance" is a high-level statement of equivalency.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified. It's likely an in-house or contracted laboratory study, common for medical device performance testing, rather than patient data. Given the regulatory submission is from Canada (Angiotech contact) to the US FDA, the provenance could be international, but this is not stated. It is a prospective study if referring to the controlled performance tests conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of performance testing for a biopsy instrument typically does not involve human experts establishing a "ground truth" in the sense of clinical diagnosis or interpretation of images. The ground truth would be objectively measured physical characteristics of the biopsy samples (e.g., core length, tissue integrity) or functional aspects of the device (e.g., successful firing, effective specimen expulsion).
The "experts" involved would likely be engineers, quality assurance personnel, and potentially histologists or pathologists to evaluate the quality of the tissue samples obtained, but this is not explicitly stated. Their qualifications would be relevant to their specific roles (e.g., biomedical engineers, certified histotechnologists).

4. Adjudication Method for the Test Set

Since this is performance testing of a physical device against technical specifications and predicate device performance, an adjudication method like "2+1" or "3+1" (which are typically used for disagreements in human expert assessments, e.g., in radiology studies) is not applicable.
Results would be determined by objective measurements, pass/fail criteria, and comparison to predicate device data or established benchmarks. Any discrepancies during testing would be investigated and resolved through standard engineering and quality control procedures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done.
- MRMC studies are typically used to assess the diagnostic performance of a technology (often AI-based imaging tools) by comparing how human readers perform with and without the technology's assistance across multiple clinical cases.
- The BioPince™ Ultra is a physical biopsy instrument, and its performance is evaluated based on its mechanical function and ability to obtain tissue, not on its interpretation of images or clinical data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable.
- This question pertains to algorithms or AI models. The BioPince™ Ultra is a mechanical device.
- The performance assessment focused on the device itself (its mechanical and functional attributes) rather than an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance testing would be objective physical measurements and functional verification. Examples include:
- Histological confirmation: Examination of tissue cores obtained to ensure they are full-core, intact, and suitable for histological analysis. This might involve pathology review, but not as "experts establishing ground truth" in a diagnostic sense for the device's performance, but rather confirming the quality of the output.
- Engineering specifications: Ensuring firing force, needle throw length, specimen retention/expulsion, and safety features meet design requirements.
- Comparison to predicate device performance: Directly matching or exceeding the performance characteristics of the legally marketed devices mentioned (BioPince™ Full Core, Tru. Core™, V-Core™, Easy Core™).
- It does not involve outcomes data in the clinical sense for this type of submission.

8. The Sample Size for the Training Set

Not applicable / Not specified.
- "Training set" refers to data used to develop and train algorithms (e.g., in machine learning). The BioPince™ Ultra is a mechanical device, not an algorithm.
- Any "training" in the context of this device would refer to design iterations, prototype testing, and manufacturing process validation, not a data training set for an AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable.
- As explained above, there is no "training set" in the context of an algorithm for this device. Design and testing iterations (if any) would use engineering principles and physical measurement for validation.

Summary

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Angiotech - Confidential Information - Not for Public Distribution

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AUG 2 7 2010

Image /page/0/Picture/2 description: The image contains handwritten text that reads 'K101832'. The characters are written in a simple, slightly irregular style, suggesting they were written quickly or by someone without formal calligraphy training. The text appears to be a code or identifier, possibly a serial number or reference number.

Section 5 - 510(k) Summary

Date Prepared: Company:

June 30, 2010

Angiotech 3600 S.W. 47th Ave., Gainesville, FL 32608

Contact:

ﻢ

: 10.

រុក

Trudy D. Estridge, Ph.D. Vice President, Regulatory Affairs Angiotech 1618 Station Street Vancouver, British Columbia Canada V6A 1B6 Voice: 604-221-6916 Fax: 703-673-0061 Email: testridge@aangio.com

BioPince™ Ultra Full Core Biopsy Instrument Device trade name:

Device Common Name:

Device classification:

Instrument, Biopsy Product code KNW 21 CFR 876.1075 Class II

Instrument, Biopsy

K904987 BioPince™ Full Core Biopsy Instrument Legally marketed devices to which the K982960 Tru. Core™ Disposable Automatic Biopsy Instrument device is substantially equivalent:

Description of the device:

K042464 V-Core™ Full Core Breast Biopsy Instrument K050120 Easy Core™ Biopsy System The BioPince™ Ultra Full Core Biopsy Instrument is an automatic, disposable biopsy instrument that cuts a full core specimen of soft tissue. The instrument is designed to expel the specimen upon re-cocking of the instrument which prepares the instrument for taking another sample (i.e., ready to be fired). The instrument has two firing trigger buttons with an indicator

window and safety button. The instrument is available in 14G, 16G, 18G and 20G needle sizes and 10cm, 15cm and 20cm lengths.

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Angiotech - Confidential Information - Not for Public Distribution

Page 2. of 2

Indications for Use:

Substantial Equivalence: The BioPince™ Ultra Full Core Biopsy Instrument has the same intended use as the BioPince™ Full Core Biopsy Instrument and the Easy Core™ Biopsy System, and the same size ranges as the Tru. Core™ Disposable Automatic Biopsy Instrument. The BioPince™ Ultra Full Core Biopsy Instrument has an equivalent cutting mechanism as the V-Core™ Instrument. The BioPince™ Ultra Full Core Biopsy Instrument has the same technological characteristics in terms of design and materials as its predicates.

Performance tests:

Performance testing confirms that the BioPince™ Ultra Full Core Biopsy Instrument is equivalent to that of the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Angiotech % Trudy D. Estridge, Ph.D. Vice President, Regulatory Affairs 1618 Station Street Vancouver, British Columbia Canada V6A 1B6

AUG 2 7 2010

Re: K101832

Trade/Device Name: BioPince™ Ultra Full Core Biopsy Instrument Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: June 30, 2010 Received: July 01, 2010

Dear Dr. Estridge:

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.

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Page 2 - Trudy D. Estridge, Ph.D.

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 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CDRH0ffices/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

Pto Vhm
Dep De

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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Angiotech - Confidential Information - Not for Public Distribution

Section 4 – Indications for Use Statement

510k number if known:

K.101 832

Device Name: BioPince™ Ultra Full Core Biopsy Instrument

Indications for 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Ogden for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101832

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.