The Presto Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.

The Presto Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed 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 Presto Breast Biopsy Device is a sterile, single-use percutaneous biopsy device. The working end of the device includes a stainless steel coring cannula with a razor edge and a stationary coil located within the coring cannula. The handle of the device contains an actuation button, a sample collection chamber, a drive mechanism for rotating the coring cannula and a DC power jack for a 12V input. A reusable, medical grade AC/DC power supply provides 12V to the disposable device. Depressing the button on the handle rotates the coring cannula - allowing the operator to core and transport tissue samples to the collection chamber. The device may be used with a coaxial introducer.

AI/ML Overview

The Presto Breast Biopsy Device, as per the provided information, is a medical device for diagnostic sampling of breast tissue. The submission focuses on its equivalence to predicate devices and its ability to meet established specifications through non-clinical studies.

Here's an analysis of the provided text in relation to the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance
In-vitro device performance	Meets established specifications necessary for consistent performance during its intended use.
Electrical & product safety (IEC 60601-1)	Meets established specifications necessary for consistent performance during its intended use.
Tensile strength & fatigue	Meets established specifications necessary for consistent performance during its intended use.
Biocompatibility	Meets established specifications necessary for consistent performance during its intended use.
Predicate device comparison	Found to be substantially equivalent in intended use, method of operation, indications for use, anatomical target site, features (Single, Insertion -Multiple Sample functionality, One-button user-interface, Compatibility with coaxial introducer, Echogenic working-end), materials, and functionality.
Simulated use testing	Meets established specifications necessary for consistent performance during its intended use.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The provided document describes non-clinical studies (in-vitro device performance, electrical & product safety, tensile strength & fatigue, biocompatibility, predicate device comparison, and simulated use testing). There is no information provided regarding a clinical test set involving human subjects. Therefore, details about sample size, country of origin, or retrospective/prospective nature of a clinical test set are not available in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Since the provided information focuses on non-clinical studies and does not describe a clinical test set with a ground truth established by experts, this information is not applicable / not provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

As there is no clinical test set described, an adjudication method for human readers is not applicable / not provided in this documentation.

5. 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

The document describes a medical device (a breast biopsy device), not an AI assistance system for human readers. Therefore, an MRMC comparative effectiveness study regarding human readers and AI assistance is not applicable / not provided.

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

This device is a physical breast biopsy instrument, not an algorithm. Therefore, a standalone algorithm performance study is not applicable / not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical studies performed, the "ground truth" would be engineering specifications, material properties, electrical safety standards, and functional requirements. For example:

In-vitro device performance: Performance against pre-defined metrics (e.g., tissue sample size, cutting efficiency) in a controlled environment.
Electrical & product safety: Compliance with IEC 60601-1 standards.
Tensile strength & fatigue: Material science standards for strength and durability.
Biocompatibility: ISO 10993 standards for biological safety.
Predicate device comparison: Direct comparison of features, materials, and functionality with existing legally marketed devices.
Simulated use testing: Performance against expected operational parameters in a simulated environment.

There is no mention of ground truth related to human clinical outcomes (e.g., pathology confirmed diagnoses) in this non-clinical submission.

8. The sample size for the training set

The document describes non-clinical testing for a physical device. It does not mention a "training set" in the context of machine learning or AI models. This concept is not applicable / not provided for this type of device submission.

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

Since there is no training set mentioned, this information is not applicable / not provided.

Summary

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Presto Breast Biopsy Device (K120440)

510(k) Notification

2. 510(k) Summary

pg 1 of 2

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

Date Prepared: February 6, 2012

510(k) number: K120440

Applicant Information: Sontina Medical, LLC 111 Sutro Heights Ave San Francisco, CA 94121

Contact Person:	Robert Peliks
Phone Number:	(415) 873 - 3831
Fax Number:	(415) 668 - 4884

Device Information:

Classification: Trade Name: Common Name: Classification Name: Product Code:

Class II Presto Breast Biopsy Device Biopsy Instrument Biopsy Instrument (21 CFR 876.1075) KNW

Predicate Device Information:

The subject device is substantially equivalent in intended use and/or method of operation to the devices listed in Table 2.1. ·

Device Name	Manufacturer	510(k) #
Rubicor Magic Breast Biopsy Device	Encapsule Medical(San Francisco, CA)	K071048
Bard Monopty	Bard Biopsy Systems(Tempe, AZ)	K922939

Table 2.1 Predicate Device Information

Device Description:

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Presto Breast Biopsy Device (K120440)

Intended Use:

Device Comparison:

The Presto Breast Biopsy device shares many similarities with one or all of the predicate devices, including:

. Similar indications for use and anatomical target site;
Similar features, including: .
- Single, Insertion -Multiple Sample functionality 0
- One-button user-interface 0
- Compatibility with coaxial introducer 0
- 0 Echogenic working-end;
Similar materials the working end of all devices is predominantly stainless steel; and ●
. Similar device functionality - a reusable, medical grade AC-DC power supply powers a DC motor which spins a forward advancing, spinning cannula to core & severe the targeted specimen.

Testing Summary:

The Presto Breast Biopsy Device was evaluated in the following non-clinical studies: in-vitro device performance, electrical & product safety (IEC 60601-1), tensile strength & fatigue, biocompatibility, predicate device comparison and simulated use testing.

Results of the testing demonstrate that the materials, manufacturing process and design of the Presto Breast Biopsy Device meet the established specifications necessary for consistent performance during its intended use

Conclusion:

Based on the intended use, product, and performation provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed and unmodified predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

MAY 17 2012

Sontina Medical, LLC % Mr. Robert Peliks 111 Sutro Heights Avenue San Francisco, California 94121

Re: K120440

Trade/Device Name: Presto Breast Biopsy Device Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: April 24, 2012 Received: April 26, 2012

Dear Mr. Peliks:

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.

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

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Page 2 - Mr. Robert Peliks

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 (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/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,

for Pat Mar V.r

Mark N. Malkerson

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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Presto Breast Biopsy Device

KI20440

510(k) Notification

1. Indications for Use Statement

510(k) Number (if known): __

Presto Breast Biopsy Device Device Name:

N/A

Indications for Use:

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the cxtent of temoval 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.

Prescription Use (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

Neif. Rpo. Oisler for $m \times n$

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

510(k) Number K120440

Sontina Medical, LLC

CONFIDENTIAL

1-1 of 1-1

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.