The BIP VacuFlash® Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Device Description

The BIP VacuFlash® Biopsy System is a mechanical device that may be used with imaging quidance (such as ultrasound, X-Ray, stereotaxy, CT, or MR) to provide breast tissue samples for histologic examination with partial or complete removal of the imaged abnormality.

The VacuFlash® Biopsy System consists of three major components: a disposable trocar tipped needle with a vacuum cylinder, a disposable introducer with stylette, and a reusable device housing containing the control module, touch pad with control buttons and LEDs indicating device status, and vacuum/air pressure generators. The disposable needle/vacuum cylinder will be available in several different lengths. A battery recharger/table top stand is the only provided accessory. Mounting brackets to attach the VacuFlash® Biopsy System to the Fischer Mammotest® and to the Lorad stereotactic tables are optional accessories. In addition, brackets to attaché the VacuFlash to the Siemens stereotactic mammography and to the Siemens MR Mammography Biopsy systems are available. Sterile bushings for the above devices, including CytoGuide stereotactic and GE DMR Mammography systems are also available.

The needle inner cannula incorporates a distal sampling with sharpened edges. During the biopsy procedure, tissue is vacuum aspirated into the inner cannula and cut using both the sampling window edges and the rotating edge of the outer cannula. Once the needle is removed from the patient's body, the sampling window is opened and the specimen removed. Tissue samples may be collected in radial order so that when imaging guidance is used, sampling positions may be retrospectively correlated with the imaging display.

AI/ML Overview

This document, a 510(k) Summary of Safety and Effectiveness for the VacuFlash® Biopsy System, does not describe specific acceptance criteria and a study proving the device meets those criteria in a quantitative manner as would typically be found for an AI/ML medical device. Instead, it focuses on demonstrating substantial equivalence to predicate devices through qualitative statements and preclinical testing.

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

Missing Information (Typical for AI/ML device studies):

Specific performance metrics (e.g., sensitivity, specificity, accuracy, AUC).
Quantitative acceptance criteria for those metrics.
Detailed study design, including a defined test set sample size with associated data provenance.
Information on ground truth establishment for the test set (number/qualifications of experts, adjudication methods).
Any mention of AI, machine learning, or algorithms.
Multi-reader multi-case (MRMC) comparative effectiveness study or standalone performance study in the context of AI.
Sample size or ground truth establishment for a training set (as this is not an AI device).

Analysis of the Provided Text (in the context of a non-AI medical device submission):

The submission for the VacuFlash® Biopsy System is a 510(k) Pre-Market Notification, which primarily aims to demonstrate substantial equivalence to legally marketed predicate devices. For mechanical devices like this, detailed performance metrics against specific acceptance criteria (as you might expect for AI) are often replaced by comparisons of intended use, technological characteristics, and qualitative performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of quantitative acceptance criteria. Instead, it relies on a qualitative statement of performance relative to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Device performs as intended for breast tissue biopsy.	"Preclinical testing demonstrated satisfactory performance in breast tissue biopsy."
Quality of samples obtained is equivalent to predicate devices.	"Preclinical testing confirms the quality of samples obtained with the BIP VacuFlash® Biopsy System is equivalent to those obtained with the predicate devices."
Does not raise significant new questions of safety and effectiveness.	"Based on the indications for use, technological characteristics and testing results, the BIP VacuFlash® Biopsy System does not raise significant new questions of safety and effectiveness."
Equivalent to predicate devices in intended use and technological characteristics.	The document explicitly states: "The BIP VacuFlash® Biopsy System has similar indications for use and technological characteristics as the predicate devices. The patient contact components and component materials for obtaining core biopsy samples in both the new and predicate devices are equivalent. The packaging materials, packaging configuration, sterilization methods and sterility assurance level are also equivalent."

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not explicitly stated. The document refers to "Preclinical testing" but does not give a number of cases or samples.
Data provenance: Not specified. It's implied to be preclinical data, likely from an in-vitro or ex-vivo setting, rather than patient data. No country of origin is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. Since it's a mechanical device and not an AI interpreting images, this type of ground truth establishment by experts is not described. The "quality of samples" likely refers to histological evaluation, which would implicitly involve pathologists, but details are absent.

4. Adjudication method for the test set:

Not applicable/Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, this type of study is not mentioned. This is a mechanical biopsy device, not an image analysis or diagnostic AI tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No, an algorithm is not involved in this device.

7. The type of ground truth used:

The "quality of samples" likely refers to histologic examination of tissue samples obtained by the device. This would be the "ground truth" for assessing the device's ability to acquire sufficient and high-quality tissue. The statement "Preclinical testing confirms the quality of samples obtained with the BIP VacuFlash® Biopsy System is equivalent to those obtained with the predicate devices" supports this inference.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set in the typical sense.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Appendix VIII: 510(k) Summary of Safety and Effectiveness

VacuFlash® Biopsy System

Company:

BIP USA Inc. 345 Third Street, Suite 400 Niagara Falls, NY 14303

MAR 11 2003

Contact

Siegfried Gruchot, XYZ General Manager (716) 284-1581, telephone (716) 284-1583, fax

Date Prepared

03 December 2002

Name of Device

Trade Name: VacuFlash® Biopsy System Classification Name: Biopsy Needle

Predicate Devices

Ethicon Mammotome® Hand Held 8 Gauge Probe Ethicon Mammotome® Hand Held System Ethicon Mammotome® Suros ATEC® Vacuum Assisted Core Biopsy System

Device Description

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K024089 2/2

Intended Use

Substantial Equivalence

The BIP VacuFlash® Biopsy System is substantially equivalent to the Mammotome® that was determined to be substantially equivalent on 28 March 1997 (K970565). The BIP VacuFlash® Biopsy System is also substantially equivalent to the Mammotome® Hand Held System that was determined to be substantially equivalent on 17 August 1999 (K991980) and the Mammotome® Hand Held 8 Gauge Probe that was determined to be substantially equivalent on 18 January 2001 (K003297). In addition, the VacuFlash® Biopsy System is also substantially equivalent to the Suros Surgical Systems ATEC® Vacuum Assisted Core Biopsy System that was determined to be substantially equivalent on 24 May 2001 (K010400).

The BIP VacuFlash® Biopsy System has similar indications for use and technological characteristics as the predicate devices. The patient contact components and component materials for obtaining core biopsy samples in both the new and predicate devices are equivalent. The packaging materials, packaging configuration, sterilization methods and sterility assurance level are also equivalent.

The hand-held or mounted biopsy device, used with or without imaging modalities, provides for the diagnostic removal of tissue with fluid management through a combination of vacuum and radial cutting functions. The proposed and predicate devices contain the same primary components to achieve these functions: a needle/probe, housing/handle/holster, and a control module.

In the proposed device, the housing contains the motor and control module as well as an integrated battery and vacuum/air pressure generation equipment. A touch pad is also integrated into the device with buttons for operational control and LED indicator lights provide feedback. The needle/probe and the device weigh approximately 14 oz. Integration of all components into the handle/housing makes the device portable and facilitates user and patient interface. The control module allows the VacuFlash® Biopsy System to provide semi-automatic and automatic modes of operation for cutter advancement, cutter rotation, and specimen retrieval. In addition, the variability of user interaction is minimized.

Preclinical testing confirms the quality of samples obtained with the BIP VacuFlash® Biopsy System is equivalent to those obtained with the predicate devices.

Based on the indications for use, technological characteristics and testing results, the BIP VacuFlash® Biopsy System does not raise significant new questions of safety and effectiveness.

Performance Data

Preclinical testing was performed to confirm the device performs as intended. Testing demonstrated satisfactory performance in breast tissue biopsy.

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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 stylized eagle or bird symbol, with three curved lines representing the bird's head and body. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 11 2003

Mr. Siegfried Gruchot General Manager BIP USA, Inc. 345 Third Street, Suite 400 Niagara Falls, New York 14303

Re: K024089

Trade/Device Name: VacuFlash Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: December 3, 2002 Received: December 11, 2002

Dear Mr. Gruchot:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Siegfried Gruchot

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

For Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number (if known): KO24089

Device Name:

VacuFlash Biopsy System

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ OR Over-The-Counter Use _
Per 21 CFR 801.109

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K024089

510(k) Notification BIP USA, Inc.

03 Dec 2002

CONFIDENTIAL page 4

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.