(87 days)
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.
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.
Here's an analysis of the acceptance criteria and study information for the Presto Breast Biopsy Device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test ID | Risk | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| 1 | Cannula buckles during use | Tube must withstand >15lbf | Pass |
| 2 | Tissue not cored/transported | Mass of 5 samples > 0.13g | Pass |
| 3 | Weld breaks | Weld must withstand >15lbf | Pass |
| 4 | Partoff tab breaks | Tab must last >30 cycles | Pass |
| 5 | Cytotoxicity (biocompatibility) | 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) | 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) | 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) | 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) | 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 < 2% and the positive control must have a blank corrected % hemolysis value ≥ 5%). | Pass (hemolytic index of 0.1% in direct blood contact, 0.0% as extract) |
| 10 | Pyrogenicity (biocompatibility) | The material is considered non-pyrogenic if each of the three animals does not experience a temperature rise ≥ 0.5°C above its baseline temperature following injection of the test extract. The material is considered pyrogenic if the total maximum temperature rise for all three animals exceeds 3.3°C. | Pass (non-pyrogenic, temp rises were 0.3°C, 0.1°C & 0.0°C) |
| 11 | Device stalls during use | Device must cycle w/ 0.8lbf side load | Pass |
| 12 | Device becomes nonfunctional | Device must cycle >30 times | Pass |
| 13 | Introducer does not engage w/ device | Device must operate with introducer attached | Pass |
| 14 | Partoff tab actuated prematurely | Mass of 5 samples > 0.13g | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" in the context of a clinical study or human performance evaluation. The performance data presented are from non-clinical studies.
-
Sample sizes mentioned for non-clinical tests:
- Test #2 (Tissue not cored/transported): "Mass of 5 samples > 0.13g"
- Test #8 (Systemic Toxicity): "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... and c) no more than 2 animals display a body weight loss > 2 grams."
- Test #10 (Pyrogenicity): "each of the three animals does not experience a temperature rise ≥ 0.5°C"
- Test #14 (Partoff tab actuated prematurely): "Mass of 5 samples > 0.13g"
-
Data Provenance: The studies are described as "non-clinical performance data" and include "ex-vivo device performance," "tensile strength & fatigue," "biocompatibility," and "simulated use testing." This indicates the data is from laboratory and bench testing, rather than retrospective or prospective human data from a specific country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The reported studies are non-clinical (bench testing, simulated use, biocompatibility). There is no mention of a "test set" requiring expert-established ground truth in a clinical context.
4. Adjudication Method for the Test Set
Not applicable. As the studies are non-clinical and do not involve human readers or interpretation of medical images/data, no adjudication method is mentioned or required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses solely on non-clinical performance data and a substantial equivalence comparison to predicate devices, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Study was Done
No, a standalone algorithm performance study was not mentioned. The device described is a physical medical instrument (a breast biopsy device), not an artificial intelligence algorithm. The device's performance is evaluated based on its mechanical function and material properties.
7. The Type of Ground Truth Used
For the non-clinical studies described, the "ground truth" is established by:
- Engineering specifications and measurements: For mechanical tests like compression, weld force, and cycling tests (e.g., tube must withstand >15lbf, mass of samples > 0.13g, tab must last >30 cycles).
- Standardized biological/chemical assays: For biocompatibility tests, following ISO 10993 standards (e.g., cell reactivity, sensitization, irritation scores, hemolytic index, temperature rises in animal models).
This is not a clinical "ground truth" derived from expert consensus, pathology, or outcomes data, as it is a non-clinical device evaluation.
8. The Sample Size for the Training Set
Not applicable. This document describes the evaluation of a physical medical device (biopsy device), not an AI algorithm that would require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI algorithm or training set discussed, there is no mention of how ground truth was established for such a set.
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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,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.
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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(Sontina) | K071048 (Rubicor) | K003297(Mammotome) | Modified Device(K133702) | |
|---|---|---|---|---|
| 510(k) # | K120440 | K071048 | K003297 | K133702 |
| Product Code | KNW | KNW | KNW | Same (K120440,K071048, K003297) |
| GuidanceMethod | Ultrasound | Ultrasound | Ultrasound | Same (K120440,K071048, K003297) |
| Shaft Diameter | 12 Gauge | 10 Gauge | 8 Gauge | Same (K120440,K071048, K003297) |
| Method ofDevice Insertion | Working end ofdevice introducedthrough coaxialintroducer | Working end ofdevice introducedwithout coaxialintroducer. | Working end ofdevice introducedwithout coaxialintroducer. | Same (K120440) |
| Method ofTissueDissection | Rotating, forward-advanced roundcutter w/specimen transportelement. | Rotating, forward-advancing roundcutter w/specimensevering/ transportelements | Rotating, forward-advancing round cutterengages w/ samplenotch in trocar | Same (K071048)Similar (K120440,K003297) |
| Optimal Samplelength | Operator control;about 2cm | 2cm | 2cm | Same (K120440,K071048, K003297) |
| Method ofTissueCollection/Transport | Screw-likeinteractionbetween stationarycoil & spinningouter round cutter | Interactionbetween innertubes andspinning outerround cutter. | Interaction betweeninner features andround cutter. | Same (K120440)Similar (K071048,K003297) |
| K120440(Sontina) | K071048 (Rubicor) | K003297(Mammotome) | Modified Device(K133702) | |
| PatientContactingMaterials | Stainless Steel tube& Stainless Steelcoil (withlubricious coating) | Stainless Steel | Stainless Steel | Same (K120440)Similar (K071048,K003297) |
| Power Source | DC motor, medicalgrade 12V AC-DCpower supply | DC motor,medical grade 12VAC-DC powersupply | Pneumatic & AC-DCpower supply | Same (K120440,K071048) |
| Hand-heldprocedure | Yes | Yes | Yes | Same (K120440,K071048, K003297) |
| DisposableDevice | Yes (reusableAC/DC adapter) | Yes (reusableAC/DC adapter) | Yes (reusable holster) | Same (K120440,K071048)Similar (K003297) |
| TargetPopulation | Adults withsuspicious soft-tissue lesion(s) | Adults withsuspicious soft-tissue lesion(s) | Adults withsuspicious soft-tissuelesion(s) | Same (K120440,K071048, K003297) |
| Anatomical Site | Breast Tissue | Breast Tissue | Breast Tissue | Same (K120440,K071048, K003297) |
| Location Used | Physician's officeor OR | Physician's officeor OR | Physician's office orOR | 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) |
| Compatibilityw/ other devices | Coaxial Introducer | None | None | Same (K120440) |
| Indications forUse | The Presto BreastBiopsy Device isintended fordiagnostic samplingof breast tissueduring breast biopsyprocedures. It is tobe used fordiagnostic purposesonly and is notintended fortherapeutic uses.The Presto BreastBiopsy Device isindicated to providebreast tissue samplesfor diagnosticsampling of breastabnormalities. It isdesigned to provide | The Rubicor MagicTMBreast Biopsy Deviceis intended fordiagnostic sampling ofbreast tissue duringbreast biopsyprocedures. It is to beused for diagnosticpurposes only and isnot intended fortherapeutic uses.The Rubicor MagicTMBreast Biopsy Deviceis indicated to providebreast tissue samplesfor diagnosticsampling of breastabnormalities. It isdesigned to providebreast tissue for | The Mammotome®Biopsy System is indicatedto provide tissue samplesfor diagnostic sampling ofbreast abnormalities.The Mammotome®Biopsy System is intendedto provide breast tissuefor histologic examinationwith partial or completeremoval of the imagedabnormality.The Mammotome®Biopsy System is intendedto provide breast tissuefor histologic examinationwith partial removal of apalpable abnormality.The extent of a histologicabnormality cannot always | Same (K120440,K071048, K003297) |
| K120440(Sontina) | K071048 (Rubicor) | K003297(Mammotome) | Modified Device(K133702) | |
| breast tissue forhistologicexamination withpartial or completeremoval of theimaged abnormality.The extent ofhistologicabnormality cannotbe reliablydetermined from itsmammographicappearance.Therefore, the extentof removal of theimaged evidence ofan abnormality doesnot predict the extentof removal of ahistologicabnormality (e.g.,malignancy). Whenthe sampledabnormality is nothistologically benign,it is essential that thetissue margins beexamined forcompleteness ofremoval usingstandard surgicalprocedures. | histologic examinationwith partial orcomplete removal ofthe imagedabnormality.The extent ofhistologic abnormalitycannot be reliablydetermined from itsmammographicappearance.Therefore, the extentof removal of theimaged evidence of anabnormality does notpredict the extent ofremoval of ahistologic abnormality(e.g., malignancy).When the sampledabnormality is nothistologically benign,it is essential that thetissue margins beexamined forcompleteness ofremoval usingstandard surgicalprocedures. | be readily determinedfrom palpation or imagedappearance. Therefore,the extent of removal ofthe palpated or imagedevidence of anabnormality does notpredict the extent ofremoval of a histologicabnormality, e.g.,malignancy. When thesampled abnormality isnot histologically benign,it is essential that thetissue margins beexamined forcompleteness of removalusing standard surgicalprocedures.In instances when apatient presents with apalpable abnormality thathas been classified asbenign through clinicaland/or radiologicalcriteria (e.g.,fibroadenoma, fibrocysticlesion), theMammotome® BiopsySystem may also be usedto partially remove suchpalpable lesions.Whenever breast ussue isremoved, histologicalevaluation of the tissue isthe standard of care.When the sampledabnormality is nothistologically benign, it isessential that the tissuemargins be examined forcompleteness of removalusing standard surgicalprocedures. |
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.
| TestID | Risk | Test Method | Acceptance Criteria | Results |
|---|---|---|---|---|
| 1 | Cannula bucklesduring use | Compressiontesting | Tube must withstand >15lbf | Pass |
| 2 | Tissue notcored/transported | Simulated Use | Mass of 5 samples > 0.13g | Pass |
| 3 | Weld breaks | Weld forcetesting | Weld must withstand >15lbf | Pass |
| 4 | Partoff tab breaks | Cycling in &out of tissue | Tab must last >30 cycles | Pass |
| 5 | Cytoxicity(biocompatility) | Per ISO10993-5:2009 | None of the cell cultures exposed to the testsample shall show greater than mild reactivitydefined as: ≤ 50% of cells round, devoid ofintracytoplasmic granules; no extensive celllysis; and ≤ 50% growth inhibition present.Positive and negative control samples mustdemonstrate test system suitability | Pass(discretegranules, nolysis, noreduction ofgrowth) |
| 6 | Sensitization(biocompatibility) | Per ISO10993-10:2010 | The material will be considered acceptable if ithas an overall grade of "0" (no visible change)or "1" (discrete or patchy erythema). Thereagent blank must show no sensitizationreaction. | Pass (grade"0", nosensitizationreaction) |
| 7 | Irritation orIntracutaneousreactivity(biocompatibility) | Per ISO10993-10:2010 | The sample will be considered a non-irritant ifthe difference between the test extracts and thecorresponding control mean score is 1.0 or less. | Pass (overallmeandifference(test article -reagentcontrol) was0.0 for allextracts) |
| 8 | Systemic Toxicity(biocompatibility) | Per ISO10993-11:2006 | The sample will be considered non-toxic if allof the following conditions are met: a) none ofthe test extract animals exhibit a significantlygreater reaction than the corresponding controlanimals; b) no more than one animal dies; c) nomore than 1 animal displays abnormal behaviorsuch as convulsions or prostration, and c) nomore than 2 animals display a body weight loss> 2 grams. | Pass (nomortality,morbidity orweight lossobserved) |
| 9 | Hemocompatibility(biocompatibility) | Per ISO10993-4:2002 | The test article shall have a hemolytic indexbelow 2% (nonhemolytic). Positive andnegative control samples must demonstrate testsystem suitability (the negative control musthave a blank corrected % hemolysis value < 2% | Pass(hemolyticindex of0.1% indirect blood) |
| Table A.3 Summary of Non-Clinical Performance Data | |
|---|---|
.
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| and the positive control must have a blankcorrected % hemolysis value ≥ 5%). | contact,0.0% asextract) | |||
|---|---|---|---|---|
| 10 | Pyrogenicity(biocompatility) | Per ISO10993-11:2006 | The material is considered non-pyrogenic ifeach of the three animals does not experience atemperature rise ≥ 0.5°C above its baselinetemperature following injection of the testextract. The material is considered pyrogenic ifthe total maximum temperature rise for all threeanimals exceeds 3.3°C. | Pass (non-pyrogenic,temp riseswere 0.3°C,0.1°C &0.0°C) |
| 11 | Device stalls duringuse | Simulated Usew/ side load | Device must cycle w/ 0.8lbf side load | Pass |
| 12 | Device becomesnonfunctional | Simulated use | Device must cycle >30 times | Pass |
| 13 | Introducer does notengage w/ device | Simulated Use | Device must operate with introducer attached | Pass |
| 14 | Partoff tab actuatedprematurely | 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.
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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
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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.
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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
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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
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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
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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§ 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.