The Caris™ MiniTome Biopsy Instrument is indicated to provide breast tissue samples for histologic examination with partial or complete removal of an imaged abnormality.

The extent of an histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of an imaged abnormality does not predict the extent of removal of its 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 Caris™ MiniTome Biopsy Instrument is percutaneous device that removes a single intact biopsy sample. The Caris MiniTome is hand-held and may be used with common imaging modalities such as ultrasound and upright mammography. The system consists of imaging modulities outchation needle, which also acts as a guidewire, the Caris™ MiniTome Biopsy Instrument, and a control module with flexible drive cable.

The Caris™ MiniTome Biopsy Instrument consists of a hand piece that has a stainless steel rno outlo - mirih a tungsten cutting wire loop. A guidewire extension runs through the central lumen of the device and attaches to a localization needle. The Caris™ MiniTome is placed over a localization needle, which is placed through or adjacent to the targeted tissue site. The localization needle has a braided mesh at the distal tip that is deployed to anchor the needle in place.

Once the MiniTome has been guided over the localization needle and is in position, the start button on the controller is pressed. This activates a controller sequence which first allows RF energy from a standard electrosurgical generator to pass through the cutting wire, deploys the cutting wire into a loop, rotates the distal tip and cutting wire a predefined number of rotations, then shuts off the RF current from the electrosurgical generator. Thus, the cutting loop automatically rotates through the desired excision zone to resect the tissue sample. An integral "Python" sleeve, which is a component of the Caris™ MiniTome, is manually advanced to encapsulate the excised specimen. Then the device and specimen is removed through the percutaneous incision.

AI/ML Overview

Here's a summary of the acceptance criteria and the study information based on the provided text, with a focus on what's available and an indication of what's not explicitly stated:

The provided document is a 510(k) summary for a medical device called the Caris™ MiniTome Biopsy Instrument, seeking clearance from the FDA. It does not describe an AI/ML powered device or a diagnostic algorithm that requires a comparative effectiveness study or extensive standalone performance metric reporting. Instead, it describes a physical biopsy instrument. Therefore, many of the requested points related to AI/ML performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies are not applicable to this type of device and are not present in the document.

The document focuses on demonstrating substantial equivalence to predicate devices and proving the physical device's safety and functionality through various engineering and biological tests relevant to a physical medical instrument.

Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly present a table of "acceptance criteria" for a diagnostic algorithm's performance (e.g., sensitivity, specificity thresholds). Instead, "acceptance criteria" here implicitly refer to meeting established standards and demonstrating functional performance suitable for its intended use as a physical biopsy device.

Acceptance Criteria (Implicit for a Physical Biopsy Instrument)	Reported Device Performance
Biopsy Sample Quality: Ability to provide sufficient, intact, un-fragmented tissue samples for histopathologic evaluation.	Data from studies (on animal and human tissues, including freshly excised human breast tissue) demonstrate that the Caris™ MiniTome Biopsy Instrument: - Operates at a power level and operation speed suitable for breast biopsy samples. - Is effective at cutting and retrieving intact, un-fragmented biopsy specimens suitable for post-biopsy histopathologic evaluation.
Biocompatibility: Device materials must not be harmful to the body.	Biocompatibility testing performed on the final product, demonstrating compliance with ISO 10993 standard. Tests passed: - Cytotoxicity (ISO Elution Method) - In Vitro Hemolysis Study (Modified ASTM-Extraction Method) - ISO Acute Intracutaneous Reactivity Study in the Rabbit - ISO Sensitization Study in the Guinea Pig (Maximization Method) - ISO Acute Systemic Toxicity Study in the Mouse - Pyrogen Test (Rabbit)
Electrical Safety: Device must be safe for electrical operation.	Electrical safety testing conducted, including compliance to relevant sections of EN 60601-1-2, EN60601-2-2, and EN60601-2-18. Testing demonstrated that the Caris™ MiniTome is safe for its intended use.
Functional Equivalence: Similar principles of operation, technological characteristics to predicate devices.	The Caris™ MiniTome Biopsy Instrument has the same general intended use, similar principles of operation (electrosurgical cutting, entrapment mechanism), and similar technological characteristics to predicate breast biopsy devices (Auto Suture ABBI System, Site Select Breast Biopsy Device, BMI Mammotome, Mammotome Hand Held Probe, En Bloc Biopsy System, Core Tissue Biopsy System). It does not introduce new technological issues.

Study Details (as applicable to a physical medical device)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "a variety of animal and human tissues, including freshly excised human breast tissue" were used for performance testing. Specific numbers of tissue samples or study participants are not provided.
- Data Provenance: The studies were conducted by the manufacturer, Artemis Medical, Inc. The country of origin for the studies or tissues is not specified (though the company is based in Hayward, California, USA). The studies appear to be for device verification, not clinical trials in the sense of prospective patient outcomes. They are likely laboratory-based and may include retrospective use of excised tissue.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept (experts establishing ground truth for a diagnostic algorithm's test set) is not applicable to this type of physical device clearance. The "ground truth" for the device's function is the direct observation of its ability to cut and retrieve tissue, which is then assessed (presumably by pathologists) for its suitability for "histopathologic evaluation." The document doesn't specify how many pathologists or their qualifications were involved in verifying the "suitability" of the retrieved samples.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable as it pertains to expert consensus for a diagnostic ground truth, which is not described for this physical instrument.
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:
- No, an MRMC comparative effectiveness study was not conducted or described. This type of study is relevant for AI-powered diagnostic aids, not for a physical biopsy instrument.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical instrument, not a standalone diagnostic algorithm. It requires a human operator for its use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance claim regarding sample quality, the "ground truth" is based on histopathologic evaluation of the retrieved tissue samples. The text states the samples were "suitable for post-biopsy histopathologic evaluation."
- For biocompatibility and electrical safety, the "ground truth" is compliance with established international standards (ISO 10993, EN 60601 series) based on the results of specific standardized tests.
The sample size for the training set:
- Not applicable. This device is hardware; there is no "training set" in the context of machine learning.
How the ground truth for the training set was established:
- Not applicable. This device is hardware; there is no "training set" or "ground truth" establishment in the context of machine learning.

Summary

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APR 0 3 2002

510(k) Summary of Safety and Effectiveness

December 21, 2001

K020024

Submitted by:	Artemis Medical, Inc.21021 Corsair Blvd.Suite 100Hayward, CA 94545Contact: Allan L. Abati, Ph.D.Phone: (510) 259-3150FAX: (510) 723-0617
Device Name:	Caris™ MiniTome Biopsy Instrument
Common Name:	Biopsy Device
Classification Name:	Instrument, Biopsy, 21 CFR §876.1075

Predicate Devices:

The Caris™ MiniTome Biopsy Instrument has the same general intended use, similar principles of operation, similar technological characteristics, and is substantially equivalent to the following predicate breast biopsy devices:

Auto Suture ABBI System, by United States Surgical Corp. (#K983296, K963825) .
Site Select Breast Biopsy Device, by Imagyn Surgical (#K993936) .
BMI Mammotome, by Biopsys Medical (now Ethicon/Johnson & Johnson) . (#K970565)
Mammotome Hand Held Probe, by Ethicon Endo-Surgery (#K003297) .
En Bloc Biopsy System, by Neothermia (#K003190) .
Core Tissue Biopsy System, by Sanarus (#K003528) .

Intended Use:

The Caris™ MiniTome Biopsy Instrument is indicated to provide breast tissue samples for histologic examination with partial or complete removal of an imaged abnormality.

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Device Description

Technological Characteristics

The Caris™ MiniTome Biopsy Instrument and its predicates have similar technological characteristics. The Caris™ MiniTome removes biopsy samples by electrosurgical cutting of the tissue. This is accomplished by using a standard, existing and available off-the-shelf electrosurgical generator in a cutting mode. In the ABBI device, the ABBI is fired by pulling the electrocautery trigger, which pulls a cautery snare and transects tissue with electrocautery. The Neothermia En Bloc biopsy device also uses electrosurgical cutting to biopsy the breast tissue.

Similar to the ABBI and Neothermia En Bloc systems, the Caris™ MiniTome Biopsy Instrument has an entrapment mechanism at the distal end of the probe to help encapsulate the biopsy tissue specimen.

The Caris™ MiniTome, ABBI, Neothermia, and Sanarus Core Biopsy Systems each remove a single biopsy tissue sample sufficient for histopathologic evaluation.

The Caris™ MiniTome does not introduce new technological issues.

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Performance Data

Extensive performance testing has been completed with the device on a variety of animal and human tissues, including freshly excised human breast tissue. Data from these studies demonstrate that the Caris™ MiniTome Biopsy Instrument has been designed to operate at a power level and operation speed that will provide preast biopsy samples, and that the MiniTome is effective at cutting and retrieving intact, un-fragmented biopsy specimens suitable for post-biopsy histopathologic evaluation.

Biocompatibility testing has been performed on the final product to demonstrate compliance with the ISO 10993 standard. The following tests were performed:

Cytotoxicity (ISO Elution Method) .
In Vitro Hemolysis Study (Modified ASTM-Extraction Method) .
. ISO Acute Intracutaneous Reactivity Study in the Rabbit
. ISO Sensitization Study in the Guinea Pig (Maximization Method)
ISO Acute Systemic Toxicity Study in the Mouse .
Pyrogen Test (Rabbit) .

The product passed all tests, demonstrating that the Caris MiniTome instrument is biocompatible.

Various electrical safety testing was conducted to demonstrate electrical safety of the Caris™ MiniTome Biopsy Instrument, including compliance to relevant sections of EN 60601-1-2 , EN60601-2-2 and EN60601-2-18. The electrical safety testing performed demonstrates that the Caris™ MiniTome is safe for its intended use.

Summary

The Caris™ MiniTome Biopsy Instrument is substantially equivalent in intended use, overall design, materials used, and operating characteristics compared to various predicate devices. Extensive performance and verification studies have demonstrated the ability of the Caris™ MiniTome to cut and capture suitable samples of excised tissue for histopathologic examination.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle or bird-like figure with three stylized lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top and left side of the seal in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 0 3 2002

Artemis Medical, Inc. Alan L. Abati, Ph.D. Vice President, Regulatory/Clinical Affairs and Quality Assurance 21021 Corsair Boulevard, Suite 100 Hayward, California 94545

Re: K020024

Trade Name: Caris Minitome Biopsy Instrument Regulation Number: 876.1075 Regulation Name: Gastroenterology/Urology Biopsy Instrument Regulatory Class: II Product Code: KNW Dated: December 21, 2001 Received: January 3, 2002

Dear Dr. Abati:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 - Dr. Allan Abati

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow yourse over finding of substantial equivalence of your device to a legally prematication of the 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF Far 8659. Additionally, for questions on the promotion and advertising of Compinance at (301) 59 + + the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Ingulation on the new and in responsibilities under the Act may be obtained from the Oiner general into.ilances, 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

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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INDICATION FOR USE STATEMENT

510(k) Number: K020024

Device Name:

Caris™ MiniTome Biopsy Instrument

Indication for Use:

The Caris™ MiniTome Biopsy Instrument is indicated to provide breast tissue samples The Carb - Hillia Fore Brops abnormalities. The instrument is intended to provide for attagic banipining ic examination with partial or complete removal of an 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 its histologic abnormality, e.g., an abnormancy does no campled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

(Optional Format 1-2-96) (Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020024

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.