(229 days)
The Mammotome elite® Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.
• The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
· The Mammotome elite® 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 be readily determined from the 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 elite® Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue 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.
The Mammotome elite® Biopsy System consists of a reusable Holster (MEH1) and a single-patient use, sterile Probe (MEP10 and MEP13) that is used with ultrasound imaging guidance to excise and collect diagnostic samples with a single insertion of the Probe. Introducer Stylets (MEI10 and MEI13) are also available as optional accessories that can be used with the Mammotome elite® Biopsy System. The components of the System are designed to operate safely when used together for diagnostic sampling of tissue during a biopsy procedure.
The Holster is a self-contained, handheld, reusable electro-mechanical vacuum-assisted biopsy device that consists of a rechargeable lithium-polymer battery and includes a charging base with AC power adapter. The Probe consists of an outer trocar shaft, a telescoping inner hollow coaxial cutter and an integrated coaxial cannula. The Probe incorporates a distal needle aperture and a proximal specimen collection cup with a tissue sample basket and specimen collection cap. The Holster contains one alignment tab that inserts into the holster notch located on the body of the Probe. The Probe body also contains two locking tabs to secure the Probe into the Holster. The Holster creates vacuum inside the device to assist in pulling tissue into the aperture while the sharpened inner cutter rotates at high speeds and extends across the aperture to acquire targeted tissue. The tissue sample is transported by vacuum to the specimen collection cup at the proximal end of the Probe. The integrated coaxial cannula may be detached either after the biopsy and remain in the breast to retain a track to the biopsy site when placing a biopsy site identifier or prior to the procedure when used in conjunction with the Introducer Stylet. The Introducer Stylet/integrated coaxial cannula combination is an option that is available for those physicians who are trained in percutaneous needle techniques for tissue collection.
The provided FDA 510(k) summary for the Mammotome elite® Biopsy System details its performance testing. However, it does not explicitly state numerical acceptance criteria for many of the tests, nor does it provide detailed quantitative results for the device performance against those criteria. Instead, it generally states that the device is "comparable to the predicate," or "complies with" certain standards.
Below is an attempt to extract the available information and structure it as requested, acknowledging the limitations of the provided document.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in Document) | Reported Device Performance |
|---|---|---|
| Biocompatibility | - Cytotoxicity: Acceptable | Complies with ISO 10993-1. |
| - Sensitization: Acceptable | Complies with ISO 10993-1. | |
| - Irritation: Acceptable | Complies with ISO 10993-1. | |
| - Systemic toxicity: Acceptable | Complies with ISO 10993-1. | |
| Electrical Safety & EMC | - Compliance with specified standards (e.g., IEC 60601-1, AAMI ES 60601-1, IEC 60601-1-2) | Complies with applicable portions of listed electrical/electromagnetic standards. |
| Software V&V | - Mitigated hazards such that failure of device software does not result in minor injury to patient or user. | Software verification and validation testing conducted, documentation provided as recommended by FDA guidance. Considered "moderate" level of concern. |
| Animal Testing | ||
| - Tissue Sample Weight | Acquire tissue sample weights comparable to the predicate device. | Performed comparable to the identified predicate device. |
| - Tissue Transport Efficiency | Deliver similar performance as the predicate system in terms of the percent of samples acquired to the number of samples attempted. | Performed comparable to the identified predicate device. |
| - Sample Quality | Not alter the characteristics of the acquired tissue in such a way as to affect the ability to achieve optimal histological assessment and is comparable to the predicate device. | Performed comparable to the identified predicate device; comparable to predicate. |
| Bench Testing | Force to penetrate comparable to the predicate system. | Bench testing confirmed comparable performance to the predicate device. |
2. Sample size used for the test set and the data provenance
The document explicitly mentions "In these studies, acquisition of tissue samples from a single insertion site was evaluated..." but does not provide specific numerical sample sizes for the animal testing. It also does not provide details on the data provenance (e.g., country of origin, retrospective/prospective). It only states an "in vivo porcine animal model was used."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth, particularly for the histological assessment of sample quality. It states, "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" and "Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care," implying histological assessment is handled by standard professional practice, but not specifying details for this particular study.
4. Adjudication method for the test set
The document does not describe any specific adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done, nor does the device involve AI. The device is a biopsy system and the testing involved evaluating its physical performance (e.g., tissue acquisition, transport, quality) compared to a predicate device, not diagnostic effectiveness with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical biopsy system, not a software algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the tissue sample quality evaluation in animal testing, the ground truth was histological assessment (implied by "optimal histological assessment"). For other performance aspects like sample weight and transport efficiency, the "ground truth" was direct measurement and comparison to the predicate device's measured performance.
8. The sample size for the training set
No training set is mentioned or applicable as this is a physical medical device, not an AI or machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable as there is no training set for this physical device.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 8, 2016
Devicor Medical Products, Inc. Ms. Shawna Rose Director, Regulatory Affairs 300 E-Business Way, Fifth Floor Cincinnati, OH 45241
Re: K153709
Trade/Device Name: Mammotome elite Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: July 8, 2016 Received: July 11, 2016
Dear Ms. Rose:
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 (21
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CFR Part 807); labeling (21 CFR Part 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Christopher J. Ronk -S
- For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153709
Device Name Mammotome elite® Biopsy System
Indications for Use (Describe)
The Mammotome elite® Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.
• The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
· The Mammotome elite® 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 be readily determined from the 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 elite® Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K153709
The following information is provided as required by 21 CFR § 807.92 for the Mammotome elite® Biopsy System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990 the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
| General Provisions | Submitter Name: | Devicor® Medical Products, Inc. |
|---|---|---|
| Address: | 300 E-Business Way, Fifth Floor45241 Cincinnati, OH | |
| Establishment Registration Number: | 3008492462 | |
| Contact Person: | Shawna RoseDirector, Regulatory Affairs | |
| Telephone Number: | 513-864-9178 | |
| Fax Number: | 513-864-9011 | |
| E-mail Address: | srose@mammotome.com | |
| Date of Preparation: | December 21, 2015 | |
| Subject Device | Trade Name: | Mammotome elite® Biopsy System |
| Classification Name: | Instrument, Biopsy | |
| Regulation: | 21 CFR §876.1075 | |
| Product Code: | KNW | |
| Classification: | Class II | |
| Predicate Device | Trade Name: | Mammotome® elite Biopsy System |
| Classification Name: | Instrument, Biopsy | |
| Premarket Notification # | K112411 | |
| Manufacturer | Devicor® Medical Products, Inc. | |
| Device Description | The Mammotome elite® Biopsy System consists of a reusable Holster (MEH1) and asingle-patient use, sterile Probe (MEP10 and MEP13) that is used with ultrasoundimaging guidance to excise and collect diagnostic samples with a single insertion of theProbe. Introducer Stylets (MEI10 and MEI13) are also available as optional accessoriesthat can be used with the Mammotome elite® Biopsy System. The components of theSystem are designed to operate safely when used together for diagnostic sampling oftissue during a biopsy procedure. | |
| The Holster is a self-contained, handheld, reusable electro-mechanical vacuum-assistedbiopsy device that consists of a rechargeable lithium-polymer battery and includes acharging base with AC power adapter. The Probe consists of an outer trocar shaft, atelescoping inner hollow coaxial cutter and an integrated coaxial cannula. The Probeincorporates a distal needle aperture and a proximal specimen collection cup with a | ||
| body also contains two locking tabs to secure the Probe into the Holster. The Holstercreates vacuum inside the device to assist in pulling tissue into the aperture while thesharpened inner cutter rotates at high speeds and extends across the aperture toacquire targeted tissue. The tissue sample is transported by vacuum to the specimencollection cup at the proximal end of the Probe. The integrated coaxial cannula may bedetached either after the biopsy and remain in the breast to retain a track to the biopsysite when placing a biopsy site identifier or prior to the procedure when used inconjunction with the Introducer Stylet. The Introducer Stylet/integrated coaxialcannula combination is an option that is available for those physicians who are trainedin percutaneous needle techniques for tissue collection. | ||
| Intended Use | The Mammotome elite® Biopsy System is intended to provide breast or axillary lymphnode tissue samples for diagnostic analysis of imaged or palpated breast abnormalities. | |
| Indications ForUse | The Mammotome elite® Biopsy System is indicated to obtain tissue samples from thebreast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. Mammotome elite® 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 be readily determined from the 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 elite® Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue 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. | |
| PerformanceTests | The following performance data were provided in support of the substantialequivalence determination.Biocompatibility TestingThe biocompatibility evaluation for the Mammotome elite® Biopsy System wasconducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use ofInternational Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1:Evaluation and Testing,'" May 1, 1995, and International Standard ISO 10993-1"Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a |
tissue sample basket and specimen collection cap. The Holster contains one alignment tab that inserts into the holster notch located on the body of the Probe. The Probe
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Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- . Cytotoxicity
- Sensitization ●
- Irritation
- Systemic toxicity ●
The Mammotome elite® Biopsy System is considered tissue contacting for a duration of less than 24 hours.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Mammotome elite® Biopsy System, which consists of a reusable, rechargeable Holster, a single-patient use Probe (10G or 13G), and an optional single-patient use Introducer Stylet (MEI10 or MEI13). The system was tested in accordance to, and complies with, the applicable portions of the following electrical/electromagnetic standards:
Second Edition:
- IEC 60601 -1:1988 + A1:1991 + A2:1995
- · UL 60601-1:2003
- · CAN/CSA-C22.2 No. 601.1-M90
- EN 60601-1:1990 +A1+A2+A3
- · IEC 60601-1-2:2004
Third Edition:
- IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007
- AAMI ES 60601-1:2005
- · CSA C22.2 No. 60601-1:2008
- EN 60601-1:2006
- · EN/IEC 60601-1-2:2007
- IEC 60601-1-6:2010
- · IEC 62366:2007
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since prior to mitigations of the hazards, a failure of the device Software could result in Minor Injury, either to a patient or to a user of the device.
Animal Testing
Animal testing was conducted to validate the performance of the Mammotome elite® Biopsy System for acquisition of tissue, specifically for tissue sample weight, tissue transport reliability, and sample quality. An in vivo porcine animal model was used,
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which has historically been used to evaluate the ability for Mammotome biopsy devices for this purpose, and was used for both the predicate and proposed Mammotome elite® Biopsy Systems. All animal studies were conducted in compliance with 21 CFR Part 58, Good Laboratory Practices.
In these studies, acquisition of tissue samples from a single insertion site was evaluated against the following criteria and requirements:
- Tissue sample weight: The Mammotome elite® Biopsy System should acquire tissue sample weights that are comparable to the predicate device.
- . Tissue transport efficiency: The Mammotome elite® Biopsy System should deliver similar performance as the predicate system in terms of the percent of samples acquired to the number of samples attempted.
- Sample quality: The Mammotome elite® Biopsy System should not alter the characteristics of the acquired tissue in such a way as to affect the ability to achieve optimal histological assessment and is comparable to the predicate device.
Additionally, bench testing was done to evaluate force to penetrate for the Mammotome elite® Biopsy System compared to the predicate System.
The animal and bench testing results confirm that the Mammotome elite® Biopsy System performed comparable to that of the identified predicate device.
| DeviceComparison toPredicateDevice | The Mammotome elite® Biopsy System, used with ultrasound imaging guidance, facilitates the diagnostic removal of tissue through a combination of vacuum and rotational/translational cutting functions. The Mammotome elite® Biopsy System utilizes the same primary components as identified in the predicate device to achieve its intended use: a Probe, Holster, and Charging Base with AC power adapter.The Mammotome elite® Biopsy System is identical to the predicate device in the following ways:• Intended Use• Indications for Use• Target Population• Fundamental Scientific Technology• Operating Principles• Driver Mechanical Design• Performance Characteristics• Product Requirements• Packaging• Sterility• Biocompatibility |
|---|---|
| ------------------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| The subject device and the predicate device are different in the following ways: |
|---|
| • Addition of a 10G Probe (MEP10) |
| • Addition of a 10G (MEI10) and 13G (MEI13) Introducer Stylet |
| • Updates to the Holster (MEH1) battery configuration for increased performancereliability |
| These changes provide more product offerings for physician preference and improvedsystem reliability. |
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Page 6 of 9
| Table 1: Mammotome elite® Biopsy System Holster and Probe Side-by-SideComparison to Legally Marketed Device | |||
|---|---|---|---|
| DeviceCharacteristics | Marketed DeviceMammotome® eliteBiopsy System | Proposed DeviceMammotome elite®Biopsy System | Changes |
| 510K | K112411 | Proposed | |
| Indications for Use | Breast Biopsy & AxillaryLymph Nodes/complete, partialremoval of imagedabnormality/ partialremoval of palpatedabnormality | Breast Biopsy & AxillaryLymph Nodes/complete, partialremoval of imagedabnormality/ partialremoval of palpatedabnormality | No change |
| Holster Assembly | |||
| Mechanical DriveType | Onboard electricalmotors and drive train | Onboard electricalmotors and drive train | No change |
| Electrical PowerSource | Tetherless,rechargeable, lithiumbattery, charging basewith AC power adapter | Tetherless,rechargeable, lithiumbattery, charging basewith AC power adapter | No change |
| Vacuum | Self-contained,reusableelectromechanicallycreated source | Self-contained,reusableelectromechanicallycreated source | No change |
| Software Version | V. 2.70 | V.2.94.7.0 | Batterycharging andcommunicationimprovements |
| Firmware Version | V.2.92.3 | V.4.1.9 | Batterycharging andcommunicationimprovements |
| Probe Needle Subassembly | |||
| Needle InsertionMethod | Manual | Manual | No change |
| Tip Type | Bladed trocar | Bladed trocar | No change |
| Tip Material | Stainless Steel | Stainless Steel | No change |
| NeedleConfiguration | Single Lumen | Single Lumen | No change |
| Needle Material | Stainless Steel | Stainless Steel | No change |
| Sample ApertureConfiguration | Lateral Aperture | Lateral Aperture | No change |
| Needle RotationMethod | Manual | Manual | No change |
| DeviceCharacteristics | Marketed DeviceMammotome® eliteBiopsy System | Proposed DeviceMammotome elite®Biopsy System | Changes |
| 510K | K112411 | Proposed | |
| Probe Needle Dimensions | |||
| Gauge | 13G | 13G, 10G | Addition ofProbe(MEP10/10G) |
| Needle Length - tipto Needle RotationKnob (mm) | 136mm | 136mm | No Change |
| Needle Length - Tipto Coaxial Release(mm) | 122mm | 122mm | No Change |
| Aperture Length(mm) | 19.1mm | 19.1mm (13G),18.4mm (10G) | Slightdifference dueto additionalgauge size |
| Tip length (mm) | 10.0mm | 10.0mm (13G),10.4mm (10G) | Slightdifference dueto additionalgauge size |
| Probe Housing | |||
| Specimen RetrievalMethod | Automatic | Automatic | No change |
| Housing Material | Plastic | Plastic | No change |
| Probe Cutter Subassembly | |||
| Cutting Method | Rotation andTranslation of InnerCutter | Rotation andTranslation of InnerCutter | No change |
| Tissue TransportMethod | Vacuum | Vacuum | No change |
| Cutter Material | Stainless Steel | Stainless Steel | No change |
| Cutter SealingMechanism | Yes | Yes | No change |
| Cutter SealingMaterial | Elastomer/Thermoplastic | Elastomer/Thermoplastic | No change |
| Site Marker Access | |||
| Marking Method | Through Probe CoaxialCannula | Through Probe CoaxialCannula | No change |
| Sterilization (both Probe and Introducer Stylet) | |||
| Method | Cobalt 60 Irradiation | Cobalt 60 Irradiation | No change |
| DeviceCharacteristics | Marketed DeviceMammotome® eliteBiopsy System | Proposed DeviceMammotome elite®Biopsy System | Changes |
| 510K | K112411 | Proposed | |
| Indications for Use | N/A | Breast Biopsy &Axillary LymphNodes/ complete,partial removal ofimaged abnormality/partial removal ofpalpated abnormality | No change withaddition ofIntroducerStylets |
| Introducer Needle Dimensions | |||
| Gauge | N/A | 13G, 10G | Addition of TwoIntroducerStylets(MEI13/13G andMEI10/10G) |
| Needle Length - tipto Needle RotationKnob (mm) | N/A | 136mm | No Differencebetween Probeand IntroducerStylet |
| Needle Length - Tipto Coaxial Release(mm) | N/A | 122mm | No Differencebetween Probeand IntroducerStylet |
| Aperture Length(mm) | N/A | N/A | No aperture asnot used fortissueacquisition; usedto aid in tissuepenetration |
| Tip length (mm) | N/A | 8.0mm (13G), 8.4mm(10G) | Differencebetween ProbeNeedle Tip andIntroducerNeedle Tip dueto apertureopening in Probe– longer tipneeded forstrength |
| DeviceCharacteristics | Marketed DeviceMammotome® eliteBiopsy System | Proposed DeviceMammotome elite®Biopsy System | Changes |
| 510K | K112411 | Proposed | |
| Introducer Stylet Needle Subassembly | |||
| Needle InsertionMethod | N/A | Manual | No changebetween Probeand IntroducerStylet |
| Tip Type | N/A | Bladed trocar | No changebetween Probeand IntroducerStylet |
| Tip Material | N/A | Stainless Steel | No changebetween Probeand IntroducerStylet |
| NeedleConfiguration | N/A | Single Lumen | No changebetween Probeand IntroducerStylet |
| Needle Material | N/A | Stainless Steel | No changebetween Probeand IntroducerStylet |
| Sample ApertureConfiguration | N/A | None | No aperture asnot used fortissueacquisition; usedto aid in tissuepenetration |
| Sterilization | |||
| Method | N/A | Cobalt-60 Irradiation | Same as forProbes |
Summary of Substantial Equivalence
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Table 2: Mammotome elite® Biopsy System Introducer Side-by-Side Comparison to Legally Marketed Device
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Side-by-side comparison of the Mammotome elite® Biopsy System to the predicate Conclusion device was performed on the technical characteristics of design, product components, materials of construction, system functionality, and clinical application through bench and animal testing (specifically, tissue sample characteristics).
Follow up communication with the FDA during review of this application confirmed that the performance testing conducted on the Mammotome elite® Biopsy System is acceptable and supports a substantial equivalency determination.
§ 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.