(211 days)
Not Found
No
The device description focuses on the mechanical and electromechanical aspects of tissue sampling. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is indicated for obtaining tissue samples for diagnostic analysis, not for treating a condition or disease.
Yes
The device is indicated to obtain tissue samples for "diagnostic analysis of breast abnormalities" and "histologic examination," which are diagnostic processes.
No
The device description clearly outlines physical hardware components including a reusable Holster (electromechanical vacuum-assisted device with battery) and a single-patient use, sterile Probe (outer trocar shaft, inner cutter, cannula, etc.). This is not a software-only device.
Based on the provided information, the Mammotome® elite Biopsy System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. They perform tests on samples like blood, urine, tissue, etc., outside of the body to provide information about a person's health.
- The Mammotome® elite Biopsy System is a device used to obtain tissue samples from the body. Its primary function is the physical removal of tissue for subsequent diagnostic analysis.
- The diagnostic analysis itself would be performed using IVD devices or methods. The tissue samples obtained by the Mammotome® elite would then be sent to a lab for examination using techniques like histology, which often involves IVD reagents and equipment.
In summary, the Mammotome® elite is a biopsy device, which is a tool used in the process of obtaining a sample for diagnosis, but it does not perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The Mammotome® elite Biopsy System is composed of a reusable Holster and a single-patient use, sterile Probe that may be used with ultrasound imaging guidance to excise and collect diagnostic samples with a single insertion of the Probe. 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 electromechanical vacuum-assisted biopsy device that consists of a rechargeable lithium-polymer battery and includes AC power cord and accessories. 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 body also contains two locking tabs to secure the Probe into 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. The integrated coaxial cannula may be detached after the biopsy and remain in the breast to the biopsy site when placing a biopsy site identifier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound imaging
Anatomical Site
breast or axillary lymph nodes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
To demonstrate substantial equivalence of the proposed device to the two identified predicate devices, side-by-side comparison of tissue sample collection, using both ex vivo and in vivo models, was performed. These models have historically been used to evaluate the ability for Mammotome® breast biopsy devices to collect tissue samples.
The Mammotome elite Biopsy System and the two identified predicate devices were each used to obtain tissue sample was evaluated against the following criteria:
- Tissue sample weight
- Tissue transport reliability
- Sample quality
Testing results confirmed that the Mammotome elite Biopsy System would retrieve a tissue sample comparable to that of the identified predicate devices.
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.
Mammtome® EX Hand-Held System K033700, Bard Finesse™ Ultra Breast Biopsy System K093068
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
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510(k) Summary
The following information is provided as required by 21 CFR § 807.87 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.
Company:
Devicor® Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 Establishment Registration Number: 3008492462
Contact:
Shawna Rose Director, Regulatory Affairs Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 Ph: 513-864-9178 Fax: 513-864-9011 E-mail: srose@mammotome.com
Date of Submission: August 18, 2011
Proprietary Name: Mammotome® elite Biopsy System
Common Name: Biopsy Instrument
Regulation: 21 CFR 876.1075
Regulatory Class: II
Product Codes: KNW
Predicate Device: Mammtome® EX Hand-Held System K033700; Bard Finesse™ Ultra Breast Biopsy System K093068.
Indication for Use of Device: The Mammotome® elite Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.
1
- . 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 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.
Device Description: The Mammotome® elite Biopsy System is composed of a reusable Holster and a single-patient use, sterile Probe that may be used with ultrasound imaging guidance to excise and collect diagnostic samples with a single insertion of the Probe. 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 electromechanical vacuum-assisted biopsy device that consists of a rechargeable lithium-polymer battery and includes AC power cord and accessories. 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 body also contains two locking tabs to secure the Probe into 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. The integrated coaxial cannula may be detached after the biopsy and remain in the breast to the biopsy site when placing a biopsy site identifier.
Intended Use: The Mammotome® elite Biopsy System is intended to provide breast or axillary lymph node tissue samples for diagnostic analysis of imaged or palpated breast abnormalities.
2
Technological Characteristics:
The Mammotome® elite Biopsy System, used with or without imaging modalities, 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 predicate devices to achieve its intended use: a Probe and housing/Holster and control module componentry.
The Probe needle and cutter are similar in both the Mammotome®elite Biopsy System and predicate devices. The need for the stand alone control module in the predicate device (Mammotome® EX Hand Held System) has been removed through the miniaturization of the components now self-contained in the Mammotome® elite Biopsy System Holster. These physical changes make the Probe/Holster more ergonomic and facilitate ease of use by physicians.
Software was created and integrated into the device (firmware) to eliminate the need for a stand-alone control module and provide the Mammotome®elite Biopsy System the capability for cutter advancement and specimen retrieval, transport and harvesting.
Supplied vacuum is used in the harvesting and transporting of acquired tissue samples, obviating the need for the mechanical specimen transport.
Performance testing:
To demonstrate substantial equivalence of the proposed device to the two identified predicate devices, side-by-side comparison of tissue sample collection, using both ex vivo and in vivo models, was performed. These models have historically been used to evaluate the ability for Mammotome® breast biopsy devices to collect tissue samples.
The Mammotome elite Biopsy System and the two identified predicate devices were each used to obtain tissue sample was evaluated against the following criteria:
- Tissue sample weight
- . Tissue transport reliability
- . Sample quality
Testing results confirmed that the Mammotome elite Biopsy System would retrieve a tissue sample comparable to that of the identified predicate devices.
Conclusion: The claim of substantial equivalence of the Mammotome® elite Biopsy System to the predicate devices is based on the comparison of the intended use, product technical characteristics, and performance characteristics.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Devicor Medical Products, Inc. % Ms. Shawna M. Rose Director of Regulatory Affairs 300 E-Business Way, Fifth Floor Cincinnati, Ohio 45241
Re: K112411
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: March 9, 2012 Received: March 13, 2012
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 r read on 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 or any I edolar statutes and registered to including, but not limited to: registration and listing (21
MAR 2 0 2012
4
Page 2 - Ms. Shawna M. Rose
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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For
Nth cer 212
Mark N. Melkersoi Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number: K112411
Device Name: Mammotome® elite Biopsy System
Indications for Use:
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 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 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogden for mxm
Orthopedic,
10(k) Number K112411
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