PRESTO BREAST BIOPSY DEVICE
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 |
Indications for 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)
Submission Summary (Full Text)
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# 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,<br>CA | K120440 |
| Rubicor Magic Breast Biopsy Device | Encapsule Medical (San Francisco,<br>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.
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#### 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<br>(Sontina) | K071048 (Rubicor) | K003297<br>(Mammotome) | Modified Device<br>(K133702) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| 510(k) # | K120440 | K071048 | K003297 | K133702 |
| Product Code | KNW | KNW | KNW | Same (K120440,<br>K071048, K003297) |
| Guidance<br>Method | Ultrasound | Ultrasound | Ultrasound | Same (K120440,<br>K071048, K003297) |
| Shaft Diameter | 12 Gauge | 10 Gauge | 8 Gauge | Same (K120440,<br>K071048, K003297) |
| Method of<br>Device Insertion | Working end of<br>device introduced<br>through coaxial<br>introducer | Working end of<br>device introduced<br>without coaxial<br>introducer. | Working end of<br>device introduced<br>without coaxial<br>introducer. | Same (K120440) |
| Method of<br>Tissue<br>Dissection | Rotating, forward-<br>advanced round<br>cutter w/<br>specimen transport<br>element. | Rotating, forward-<br>advancing round<br>cutter w/<br>specimen<br>severing/ transport<br>elements | Rotating, forward-<br>advancing round cutter<br>engages w/ sample<br>notch in trocar | Same (K071048)<br>Similar (K120440,<br>K003297) |
| Optimal Sample<br>length | Operator control;<br>about 2cm | 2cm | 2cm | Same (K120440,<br>K071048, K003297) |
| Method of<br>Tissue<br>Collection/<br>Transport | Screw-like<br>interaction<br>between stationary<br>coil & spinning<br>outer round cutter | Interaction<br>between inner<br>tubes and<br>spinning outer<br>round cutter. | Interaction between<br>inner features and<br>round cutter. | Same (K120440)<br>Similar (K071048,<br>K003297) |
| | K120440<br>(Sontina) | K071048 (Rubicor) | K003297<br>(Mammotome) | Modified Device<br>(K133702) |
| Patient<br>Contacting<br>Materials | Stainless Steel tube<br>& Stainless Steel<br>coil (with<br>lubricious coating) | Stainless Steel | Stainless Steel | Same (K120440)<br>Similar (K071048,<br>K003297) |
| Power Source | DC motor, medical<br>grade 12V AC-DC<br>power supply | DC motor,<br>medical grade 12V<br>AC-DC power<br>supply | Pneumatic & AC-DC<br>power supply | Same (K120440,<br>K071048) |
| Hand-held<br>procedure | Yes | Yes | Yes | Same (K120440,<br>K071048, K003297) |
| Disposable<br>Device | Yes (reusable<br>AC/DC adapter) | Yes (reusable<br>AC/DC adapter) | Yes (reusable holster) | Same (K120440,<br>K071048)<br>Similar (K003297) |
| Target<br>Population | Adults with<br>suspicious soft-<br>tissue lesion(s) | Adults with<br>suspicious soft-<br>tissue lesion(s) | Adults with<br>suspicious soft-tissue<br>lesion(s) | Same (K120440,<br>K071048, K003297) |
| Anatomical Site | Breast Tissue | Breast Tissue | Breast Tissue | Same (K120440,<br>K071048, K003297) |
| Location Used | Physician's office<br>or OR | Physician's office<br>or OR | Physician's office or<br>OR | Same (K120440,<br>K071048, K003297) |
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | Same (K120440,<br>K071048, K003297) |
| Device Sterility | EO sterilization | ETO sterilization | ETO sterilization | Same (K120440,<br>K071048, K003297) |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | Same (K120440,<br>K071048, K003297) |
| Prescription vs.<br>O.T.C. | Prescription | Prescription | Prescription | Same (K120440,<br>K071048, K003297) |
| Compatibility<br>w/ other devices | Coaxial Introducer | None | None | Same (K120440) |
| Indications for<br>Use | The Presto Breast<br>Biopsy Device is<br>intended for<br>diagnostic sampling<br>of breast tissue<br>during breast biopsy<br>procedures. It is to<br>be used for<br>diagnostic purposes<br>only and is not<br>intended for<br>therapeutic uses.<br>The Presto Breast<br>Biopsy Device is<br>indicated to provide<br>breast tissue samples<br>for diagnostic<br>sampling of breast<br>abnormalities. It is<br>designed to provide | The Rubicor MagicTM<br>Breast Biopsy Device<br>is intended for<br>diagnostic sampling of<br>breast tissue during<br>breast biopsy<br>procedures. It is to be<br>used for diagnostic<br>purposes only and is<br>not intended for<br>therapeutic uses.<br>The Rubicor MagicTM<br>Breast Biopsy Device<br>is indicated to provide<br>breast tissue samples<br>for diagnostic<br>sampling of breast<br>abnormalities. It is<br>designed to provide<br>breast tissue for | The Mammotome®<br>Biopsy System is indicated<br>to provide tissue samples<br>for diagnostic sampling of<br>breast abnormalities.<br>The Mammotome®<br>Biopsy System is intended<br>to provide breast tissue<br>for histologic examination<br>with partial or complete<br>removal of the imaged<br>abnormality.<br>The Mammotome®<br>Biopsy System is intended<br>to provide breast tissue<br>for histologic examination<br>with partial removal of a<br>palpable abnormality.<br>The extent of a histologic<br>abnormality cannot always | Same (K120440,<br>K071048, K003297) |
| K120440<br>(Sontina) | K071048 (Rubicor) | K003297<br>(Mammotome) | Modified Device<br>(K133702) | |
| breast tissue for<br>histologic<br>examination with<br>partial or complete<br>removal of the<br>imaged abnormality.<br>The extent of<br>histologic<br>abnormality cannot<br>be reliably<br>determined from its<br>mammographic<br>appearance.<br>Therefore, the extent<br>of removal of the<br>imaged evidence of<br>an abnormality does<br>not predict the extent<br>of removal of a<br>histologic<br>abnormality (e.g.,<br>malignancy). When<br>the sampled<br>abnormality is not<br>histologically benign,<br>it is essential that the<br>tissue margins be<br>examined for<br>completeness of<br>removal using<br>standard surgical<br>procedures. | histologic examination<br>with partial or<br>complete removal of<br>the imaged<br>abnormality.<br>The extent of<br>histologic abnormality<br>cannot be reliably<br>determined from its<br>mammographic<br>appearance.<br>Therefore, the extent<br>of removal of the<br>imaged evidence of an<br>abnormality does not<br>predict the extent of<br>removal of a<br>histologic abnormality<br>(e.g., malignancy).<br>When the sampled<br>abnormality is not<br>histologically benign,<br>it is essential that the<br>tissue margins be<br>examined for<br>completeness of<br>removal using<br>standard surgical<br>procedures. | be readily determined<br>from palpation or imaged<br>appearance. Therefore,<br>the extent of removal of<br>the palpated or imaged<br>evidence of an<br>abnormality does not<br>predict the extent of<br>removal of a histologic<br>abnormality, e.g.,<br>malignancy. When the<br>sampled abnormality is<br>not histologically benign,<br>it is essential that the<br>tissue margins be<br>examined for<br>completeness of removal<br>using standard surgical<br>procedures.<br>In instances when a<br>patient presents with a<br>palpable abnormality that<br>has been classified as<br>benign through clinical<br>and/or radiological<br>criteria (e.g.,<br>fibroadenoma, fibrocystic<br>lesion), the<br>Mammotome® Biopsy<br>System may also be used<br>to partially remove such<br>palpable lesions.<br>Whenever breast ussue is<br>removed, histological<br>evaluation of the tissue is<br>the standard of care.<br>When the sampled<br>abnormality is not<br>histologically benign, it is<br>essential that the tissue<br>margins be examined for<br>completeness of removal<br>using standard surgical<br>procedures. | | |
Table A.2 Predicate Device Comparison Table
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CONFIDENTIAL
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# 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<br>ID | Risk | Test Method | Acceptance Criteria…
