(87 days)
Not Found
No
The device description focuses on mechanical components and operation, with no mention of AI/ML, image processing, or data analysis beyond the physical collection of tissue samples.
No
The 'Intended Use / Indications for Use' section explicitly states, "It is to be used for diagnostic purposes only and is not intended for therapeutic uses."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic sampling of breast biopsy procedures" and "is to be used for diagnostic purposes only".
No
The device description explicitly details physical components like a stainless steel coring cannula, handle with buttons, drive mechanism, and power jack, indicating it is a hardware device.
Based on the provided information, the Presto Breast Biopsy Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Presto Breast Biopsy Device is a tool used to obtain the tissue sample. It is a mechanical device that physically removes tissue from the breast.
- Intended Use: The intended use clearly states it is for "diagnostic sampling of breast biopsy procedures" and to "provide breast tissue samples for diagnostic sampling." It is the tissue sample itself that will be used for the in vitro diagnostic testing (histologic examination).
- Lack of IVD Components: The device description focuses on the mechanical aspects of tissue collection (coring cannula, drive mechanism, power supply). There are no mentions of reagents, assays, or analytical components typically associated with IVD devices.
- Performance Studies: The performance studies described are related to the device's mechanical function and safety (ex-vivo performance, tensile strength, biocompatibility, simulated use), not the analytical performance of a diagnostic test.
In summary, the Presto Breast Biopsy Device is a surgical instrument used to collect a sample that will then be subjected to in vitro diagnostic testing. It is not the diagnostic test itself.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KNW
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 is used with a coaxial introducer. Actuating the partoff button mechanically adjusts the distal end of the coring cannula between a coring & partoff configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Breast Tissue
Indicated Patient Age Range
Adults
Intended User / Care Setting
Physician's office or OR
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Test subjects and results include:
- Cannula buckles during use: Compression testing, Must withstand >15lbf, Pass
- Tissue not cored/transported: Simulated Use, Mass of 5 samples > 0.13g, Pass
- Weld breaks: Weld force testing, Weld must withstand >15lbf, Pass
- Partoff tab breaks: Cycling in & out of tissue, Tab must last >30 cycles, Pass
- Cytoxicity (biocompatibility): Per ISO 10993-5:2009, None of the cell cultures exposed to the test sample shall show greater than mild reactivity defined as: ≤ 50% of cells round, devoid of intracytoplasmic granules; no extensive cell lysis; and ≤ 50% growth inhibition present. Positive and negative control samples must demonstrate test system suitability, Pass (discrete granules, no lysis, no reduction of growth)
- Sensitization (biocompatibility): Per ISO 10993-10:2010, The material will be considered acceptable if it has an overall grade of "0" (no visible change) or "1" (discrete or patchy erythema). The reagent blank must show no sensitization reaction, Pass (grade "0", no sensitization reaction)
- Irritation or Intracutaneous reactivity (biocompatibility): Per ISO 10993-10:2010, The sample will be considered a non-irritant if the difference between the test extracts and the corresponding control mean score is 1.0 or less, Pass (overall mean difference (test article - reagent control) was 0.0 for all extracts)
- Systemic Toxicity (biocompatibility): Per ISO 10993-11:2006, The sample will be considered non-toxic if all of the following conditions are met: a) none of the test extract animals exhibit a significantly greater reaction than the corresponding control animals; b) no more than one animal dies; c) no more than 1 animal displays abnormal behavior such as convulsions or prostration, and c) no more than 2 animals display a body weight loss > 2 grams, Pass (no mortality, morbidity or weight loss observed)
- Hemocompatibility (biocompatibility): Per ISO 10993-4:2002, The test article shall have a hemolytic index below 2% (nonhemolytic). Positive and negative control samples must demonstrate test system suitability (the negative control must have a blank corrected % hemolysis value 30 times, Pass
- Introducer does not engage w/ device: Simulated Use, Device must operate with introducer attached, Pass
- Partoff tab actuated prematurely: Simulated Use, Mass of 5 samples > 0.13g, Pass
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 | Results |
|---|---|---|---|---|
| 1 | Cannula buckles | |||
| during use | Compression | |||
| testing | Tube must withstand >15lbf | Pass | ||
| 2 | Tissue not | |||
| cored/transported | Simulated Use | Mass of 5 samples > 0.13g | Pass | |
| 3 | Weld breaks | Weld force | ||
| testing | Weld must withstand >15lbf | Pass | ||
| 4 | Partoff tab breaks | Cycling in & | ||
| out of tissue | Tab must last >30 cycles | Pass | ||
| 5 | Cytoxicity | |||
| (biocompatility) | Per ISO | |||
| 10993-5:2009 | None of the cell cultures exposed to the test | |||
| sample shall show greater than mild reactivity | ||||
| defined as: ≤ 50% of cells round, devoid of | ||||
| intracytoplasmic granules; no extensive cell | ||||
| lysis; and ≤ 50% growth inhibition present. | ||||
| Positive and negative control samples must | ||||
| demonstrate test system suitability | Pass | |||
| (discrete | ||||
| granules, no | ||||
| lysis, no | ||||
| reduction of | ||||
| growth) | ||||
| 6 | Sensitization | |||
| (biocompatibility) | Per ISO | |||
| 10993-10:2010 | The material will be considered acceptable if it | |||
| has an overall grade of "0" (no visible change) | ||||
| or "1" (discrete or patchy erythema). The | ||||
| reagent blank must show no sensitization | ||||
| reaction. | Pass (grade | |||
| "0", no | ||||
| sensitization | ||||
| reaction) | ||||
| 7 | Irritation or | |||
| Intracutaneous | ||||
| reactivity | ||||
| (biocompatibility) | Per ISO | |||
| 10993-10:2010 | The sample will be considered a non-irritant if | |||
| the difference between the test extracts and the | ||||
| corresponding control mean score is 1.0 or less. | Pass (overall | |||
| mean | ||||
| difference | ||||
| (test article - | ||||
| reagent | ||||
| control) was | ||||
| 0.0 for all | ||||
| extracts) | ||||
| 8 | Systemic Toxicity | |||
| (biocompatibility) | Per ISO | |||
| 10993-11:2006 | The sample will be considered non-toxic if all | |||
| of the following conditions are met: a) none of | ||||
| the test extract animals exhibit a significantly | ||||
| greater reaction than the corresponding control | ||||
| animals; b) no more than one animal dies; c) no | ||||
| more than 1 animal displays abnormal behavior | ||||
| such as convulsions or prostration, and c) no | ||||
| more than 2 animals display a body weight loss |
2 grams. | Pass (no
mortality,
morbidity or
weight loss
observed) |
| 9 | Hemocompatibility
(biocompatibility) | Per ISO
10993-4:2002 | The test article shall have a hemolytic index
below 2% (nonhemolytic). Positive and
negative control samples must demonstrate test
system suitability (the negative control must
have a blank corrected % hemolysis value 30 times | Pass |
| 13 | Introducer does not
engage w/ device | Simulated Use | Device must operate with introducer attached | Pass |
| 14 | Partoff tab actuated
prematurely | Simulated Use | Mass of 5 samples > 0.13g | Pass |
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.
Substantial Equivalence:
The changes made & non-clinical performance data support substantial equivalence for the following reasons.
6
Image /page/6/Figure/0 description: The image is a flowchart titled "Figure A.1: 510(k) Decision-Making Flowchart". The flowchart outlines the steps to determine if a new device is substantially equivalent to an existing device. The flowchart includes questions such as "Does new device have same indication statement?" and "Are the descriptive characteristics precise enough to ensure equivalence?". The flowchart ends with the conclusion "Substantially Equivalent" if all the questions are answered positively.
The flowchart above (figure A.1) illustrates how the modified device follows the 510(k) "Substantial Equivalence" Decision-Making Process Decision Making Process. The pathway in blue/gray illustrates how the modified device is substantially equivalent to the predicate devices (K120440, K071048 and K003297). Note: test IDs used below, refer to Table A.3.
- . The indication for use is identical.
- . The modified device cores the tissue in the same way as K120440 & K071048: depressing a button spins a DC motor, which in turn spins a forward-cutting cannula to core a section of tissue. In all devices (K120440, K071048, K003297 and modified device), once the tissue samples are cored and contained within the cannula, the tissue samples may be transported proximally into a collection chamber, allowing the operator to obtain additional samples without removing the tool from the tissue. The partoff mechanism of the modified device is substantially equivalent to the partoff mechanism of K071048. The PTFE coating of the modified device is substantially equivalent to the coating of K120440. The size range of the modified device is covered by the range of predicate devices (K120440, K071048 and K003297).
- O Alternate pathway (gray), including support from non-clinical performance data: The modified device includes three potential design changes: i) an additional mechanism to aid in severing the tissue sample once it has been cored (no impact to safety/effectiveness, per test IDs 1-4 and 11-14, S.E. to K071048); ii) an alternative PTFE coating for the coil (no impact to safety/effectiveness, per test IDs 2 & 5-10, S.E. to K120440); and iii) a range of different
Sontina Medical, LLC
CONFIDENTIAL
7
size cutting cannulas (8 - 12 gauge) (no impact to safety/effectiveness, per test IDs 1-4 & 11-15, S.E. to K120440/K071048/K003297).
- . The descriptive characteristics of the modified device are precise enough to ensure equivalence to the predicate devices (K120440, K071048 and K003297).
Conclusion:
Based on the intended use, product, and performance information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed and unmodified predicate devices.
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2014
Sontina Medical, LLC Mr. Robert Peliks President 111 Sutro Heights Avenue San Francisco, California 94121
Re: K133702
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: February 5, 2014 Received: February 6, 2014
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 comply with all the Act's requirements, including, but not limited to: registration and listing (2 1 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
9
Page 2 - Mr. Robert Peliks
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Felipe Aquel
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K133702
Device Name Presto Breast Biopsy Device
Indications for Use (Describe)
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 premoval of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essue margins be examined for completeness of removal using standard surgical procedures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Date: 2014.02.28 14:58:59
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