Who is the manufacturer of PRESTO BREAST BIOPSY DEVICE?

Sontina Medical, LLC filed the 510(k) submission for PRESTO BREAST BIOPSY DEVICE (K133702).

What is the FDA product code for PRESTO BREAST BIOPSY DEVICE?

KNW. It is classified under 21 CFR 876.1075 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for PRESTO BREAST BIOPSY DEVICE?

510(k) clearance (submission type: Special).

What are the predicate devices for PRESTO BREAST BIOPSY DEVICE?

Presto Breast Biopsy Device (K120440); Rubicor Magic Breast Biopsy Device (K071048); Mammotome Hand Held 8 Gauge Probe (K003297).

Who can help prepare an FDA 510(k) submission like PRESTO BREAST BIOPSY DEVICE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PRESTO BREAST BIOPSY DEVICE

K133702 · Sontina Medical, LLC · KNW · Feb 28, 2014 · Gastroenterology, Urology

Device Facts

Record ID	K133702
Device Name	PRESTO BREAST BIOPSY DEVICE
Applicant	Sontina Medical, LLC
Product Code	KNW · Gastroenterology, Urology
Decision Date	Feb 28, 2014
Decision	SESE
Submission Type	Special
Regulation	21 CFR 876.1075
Device Class	Class 2

Intended Use

The Presto Breast Biopsy Device is intended for diagnostic sampling of 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 Story

Sterile, single-use percutaneous biopsy device; used in physician offices or ORs. Input: manual operator actuation via button. Mechanism: DC motor (12V power supply) rotates stainless steel coring cannula with razor edge; stationary coil transports tissue samples to collection chamber. Partoff button mechanically adjusts distal end for tissue severing. Output: breast tissue samples for histologic examination. Healthcare provider uses device under ultrasound guidance to core and remove tissue; output allows histologic diagnosis of breast abnormalities. Benefits: enables minimally invasive diagnostic sampling of suspicious lesions.

Clinical Evidence

Bench testing only. Studies included ex-vivo device performance, tensile strength, fatigue, biocompatibility (ISO 10993), and simulated use testing. Results confirmed device meets specifications for cannula buckling (>15lbf), tissue transport (>0.13g), weld strength (>15lbf), and partoff tab durability (>30 cycles). Biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, pyrogenicity) passed all criteria.

Technological Characteristics

Materials: stainless steel cannula/coil with PTFE coating. Energy: 12V DC motor. Form factor: handheld, single-use disposable device with reusable AC/DC power supply. Connectivity: none. Sterilization: EO. Standards: ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety).

Indications for Use

Indicated for diagnostic sampling of breast abnormalities in adults with suspicious soft-tissue lesions. Designed for histologic examination via partial or complete removal of imaged abnormalities. Contraindicated for therapeutic use.

Regulatory Classification

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.

Predicate Devices

Presto Breast Biopsy Device (K120440)
Rubicor Magic Breast Biopsy Device (K071048)
Mammotome Hand Held 8 Gauge Probe (K003297)

Related Devices

K120440 — PRESTO BREAST BIOPSY DEVICE · Sontina Medical, LLC · May 17, 2012
K053151 — RUBICOR MAGIC BREAST BIOPSY DEVICE · Rubicor Medical, Inc. · Nov 18, 2005
K173316 — SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device · Transmed7, LLC · Jun 19, 2018
K013641 — SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS · Senorx, Inc. · Jan 29, 2002
K212079 — TeesuVac Breast Biopsy Device Mark 1 · Teesuvac Aps · Feb 2, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ # A. 510(k) Summary This summary of special 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. Date Prepared: February 5, 2014 510(k) number: _K133702 #### 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: | Class II | |----------------------|-------------------------------------| | Trade Name: | Presto Breast Biopsy Device | | Common Name: | Biopsy Instrument | | Classification Name: | Biopsy Instrument (21 CFR 876.1075) | | Product Code: | KNW | #### Predicate Device Information: The subject device is substantially equivalent in intended use and/or method of operation to the devices listed in Table A.1. | Device Name | Manufacturer | 510(k) # | |------------------------------------|------------------------------------------|----------| | Presto Breast Biopsy Device | Sontina Medical (San Francisco, CA | K120440 | | Rubicor Magic Breast Biopsy Device | Encapsule Medical (San Francisco, CA) | K071048 | | Mammotome Hand Held 8 Gauge Probe | Devicor Medical (Cincinnati, OH) | K003297 | #### Table A.1 Predicate Device Information #### Device Description: The Presto Breast Biopsy Device is a stetle, single-use percuraneous 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 conng cannula - allowing the operator to core and transport tissue samples to the collection chamber. The device is used with a coaxial introducer. Actuating the partoff button mechanically adjusts the distal end of the coring cannula between a coring & partoff configuration. {1}------------------------------------------------ #### Intended Use: The Presto Breast Biopsy Device is intended for diagnostic sampling of 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 rediably 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 Comparison: The Presto Breast Biopsy device shares many similarities with the predicate devices (K120440, K071048 and K003297). Table A.2 below provides a comparison of the modified device and the predicate devices (K120440, K071048 and K003297). Please note that categories which are equivalent to another 510(k) are denoted as "Same", followed by the 510(k) # in parentheses; categories which are very similar to another 510(k) are denoted "Similar", followed by the 510(k) # in parentheses. | | K120440 (Sontina) | K071048 (Rubicor) | K003297 (Mammotome) | Modified Device (K133702) | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------| | 510(k) # | K120440 | K071048 | K003297 | K133702 | | Product Code | KNW | KNW | KNW | Same (K120440, K071048, K003297) | | Guidance Method | Ultrasound | Ultrasound | Ultrasound | Same (K120440, K071048, K003297) | | Shaft Diameter | 12 Gauge | 10 Gauge | 8 Gauge | Same (K120440, K071048, K003297) | | Method of Device Insertion | Working end of device introduced through coaxial introducer | Working end of device introduced without coaxial introducer. | Working end of device introduced without coaxial introducer. | Same (K120440) | | Method of Tissue Dissection | Rotating, forward- advanced round cutter w/ specimen transport element. | Rotating, forward- advancing round cutter w/ specimen severing/ transport elements | Rotating, forward- advancing round cutter engages w/ sample notch in trocar | Same (K071048) Similar (K120440, K003297) | | Optimal Sample length | Operator control; about 2cm | 2cm | 2cm | Same (K120440, K071048, K003297) | | Method of Tissue Collection/ Transport | Screw-like interaction between stationary coil & spinning outer round cutter | Interaction between inner tubes and spinning outer round cutter. | Interaction between inner features and round cutter. | Same (K120440) Similar (K071048, K003297) | | | K120440 (Sontina) | K071048 (Rubicor) | K003297 (Mammotome) | Modified Device (K133702) | | Patient Contacting Materials | Stainless Steel tube & Stainless Steel coil (with lubricious coating) | Stainless Steel | Stainless Steel | Same (K120440) Similar (K071048, K003297) | | Power Source | DC motor, medical grade 12V AC-DC power supply | DC motor, medical grade 12V AC-DC power supply | Pneumatic & AC-DC power supply | Same (K120440, K071048) | | Hand-held procedure | Yes | Yes | Yes | Same (K120440, K071048, K003297) | | Disposable Device | Yes (reusable AC/DC adapter) | Yes (reusable AC/DC adapter) | Yes (reusable holster) | Same (K120440, K071048) Similar (K003297) | | Target Population | Adults with suspicious soft- tissue lesion(s) | Adults with suspicious soft- tissue lesion(s) | Adults with suspicious soft-tissue lesion(s) | Same (K120440, K071048, K003297) | | Anatomical Site | Breast Tissue | Breast Tissue | Breast Tissue | Same (K120440, K071048, K003297) | | Location Used | Physician's office or OR | Physician's office or OR | Physician's office or OR | Same (K120440, K071048, K003297) | | Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | Same (K120440, K071048, K003297) | | Device Sterility | EO sterilization | ETO sterilization | ETO sterilization | Same (K120440, K071048, K003297) | | Electrical Safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | Same (K120440, K071048, K003297) | | Prescription vs. O.T.C. | Prescription | Prescription | Prescription | Same (K120440, K071048, K003297) | | Compatibility w/ other devices | Coaxial Introducer | None | None | Same (K120440) | | Indications for Use | 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 | The Rubicor MagicTM 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 Rubicor MagicTM Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for | The Mammotome® Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. The Mammotome® Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The Mammotome® Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always | Same (K120440, K071048, K003297) | | K120440 (Sontina) | K071048 (Rubicor) | K003297 (Mammotome) | Modified Device (K133702) | | | 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. | 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. | be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or 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. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome® Biopsy System may also be used to partially remove such palpable lesions. Whenever breast ussue is removed, histological evaluation of the tissue is the standard of care. 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. | | | Table A.2 Predicate Device Comparison Table {2}------------------------------------------------ CONFIDENTIAL . {3}------------------------------------------------ {4}------------------------------------------------ # Non-Clinical Performance Data: The Presto Breast Biopsy Device was evaluated in the following non-clinical studies: ex-vivo device performance, tensile strength & fatigue, biocompatibility and simulated use testing. These tests are summarized in Table A.3, below. | Test ID | Risk | Test Method | Acceptance Criteria…