The Acueity Excisor Bioptome is a multiple action biopsy system intended for obtaining a soft tissue breast biopsy. The instruments are to be used for diagnostic purposes only and are not intended for therapeutic use.

Device Description

The Excisor Bioptome is a percutaneous, mechanical coring device utilizing imaging quidance such as ultrasound and X-ray for breast biopsy. The basic structure of the device includes a Motorized Cutter and detachable stainless steel Introducer with aluminum handle or finger piece and aspiration port and a stainless steel trocar.

AI/ML Overview

The provided text describes a 510(k) submission for the Acueity Excisor Bioptome, a breast biopsy device. However, it does not contain details about acceptance criteria, device performance metrics, or study design for clinical or standalone performance evaluation.

The submission states:

"All necessary testing will be performed on the Exisor Bioptome to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness." (Section H)
The FDA's response confirms substantial equivalence based on the provided information but does not detail the specific tests or results.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based solely on the provided text.

The document focuses on the regulatory submission process, intended use, and substantial equivalence to predicate devices (US Biopsy Single Action Bioipsy Device (K954231) and Ethicon Mammotome Hand Held System (K991980)), rather than on detailed performance study results.

Summary

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K03284-7

510(k) Notification Excisor Bioptome

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Name. Address, Phone and Fax number of the Applicant A.

Acueity, Inc. 100 Hamilton Avenue, Suite 140 Palo Alto, CA 94301

(650) 473-9910 Telephone: Fax: (650) 473-9306

Contact Person B.

Nancy Lincé Regulatory Affairs Consultant

Telephone: (650) 759-6186

C. Date Prepared

August 12, 2003

D. Device Name

Trade Name: Excisor Bioptome Classification Name: Instrument, Biopsy

E. Device Description

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Intended Use F.

G. Substantial Equivalence

The Excisor Bioptome is substantially equivalent to the US Biopsy Single Action Bioipsy Device (K954231) and the Ethicon Mammotome Hand Held System (K991980). It has the same intended use, materials and principles of operation as the predicate devices. All three devices are designed to perform percutaneous breast biopsy using a tubular cannula with trocar/needle to penetrate the tissue and access the biopsy site.

H. Device Testing Results and Conclusion

All necessary testing will be performed on the Exisor Bioptome to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness.

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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 with three stripes forming its body and wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the border. The text is in all caps and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2003

Acueity, Inc. c/o Mr. Peter N. Ruvs N.V. KEMA P.O. 9035 6800 Et Arnhem Arnhem, Netherlands

Re: K032847

Trade/Device Name: Excisor Bioptome Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: September 11. 2003 Received: September 12, 2003

Dear Mr. Ruys:

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 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. Peter N. Ruys

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. 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 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.

Miriam C. Provost

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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Acueity, Inc.

510(k) Number (if known): K__________________________________________________________________________________________________________________________________________________

Device Name: Excisor Bioptome

Indications For Use:

Miriame. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K032847

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

OR (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.