(28 days)
Not Found
No
The summary describes a mechanical biopsy system and does not mention any AI or ML components or functionalities.
No
The device is used to obtain tissue samples for diagnostic sampling, not for treatment.
Yes
Explanation: The device is described as providing "tissue samples for diagnostic sampling of breast abnormalities." This tissue is then used for "histologic examination," which is a diagnostic process to determine the nature of the abnormality.
No
The device description explicitly states that the system is comprised of three primary subsystems: a sterile, single-use probe, a reusable holster, and a reusable control unit. These are all hardware components.
Based on the provided information, the Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Mammotome® revolve system is a device used to collect tissue samples from the breast. It is a tool for obtaining the material that will then be used for diagnostic testing (histologic examination).
- Intended Use: The intended use clearly states that the system is indicated to "provide tissue samples for diagnostic sampling of breast abnormalities." It is the sampling device, not the diagnostic test itself.
- Device Description: The description details the mechanical components used for tissue collection.
- Performance Studies: The performance studies focus on the quality and quantity of the tissue sample collected, comparing it to a predicate device that also collects tissue samples. There are no studies related to the diagnostic accuracy of analyzing the collected tissue.
In summary, the Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System is a medical device used for tissue acquisition, which is a step before the in vitro diagnostic process of examining the tissue for diagnosis.
N/A
Intended Use / Indications for Use
The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
- The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System is intended to . provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
- The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) 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® revolve Dual Vacuum Assisted Biopsy (VAB) 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® revolve Dual Vacuum Assisted Biopsy (VAB) System is a mechanical breast biopsy device indicated to provide tissue samples for diagnostic sampling of beast abnormalities for histologic examination.
The Mammotome® revolve Dual VAB System is comprised of three primary subsystems:
-
- a sterile, single-use probe
-
- a reusable holster, and
-
- a reusable control unit.
The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System, facilitates the diagnostic removal of tissue through a combination of vacuum and rotational/translational cutting functions. The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System utilizes the same primary subsystems as identified in the predicate device to achieve its intended use:
- a sterile single-use probe containing trocar tipped biopsy needle, rotating cutter, 1) specimen collection chambers, and vacuum tubing/valving which enables tissue sample acquisition under vacuum, tissue cutting, and tissue transport to the specimen collection chambers;
-
- a reusable holster containing the drive motors, gear trains and user activation switches, which provides the basic functionality for the procedure including the rotation, advancement and retraction of the cutting mechanism of the probe, as well as the specimen management system rotation; and
-
- a reusable control unit that houses the vacuum pump, power supply, valve actuators, software, user interface touchscreen and control electronics, which provides the primary electrical, electronic, mechanical and vacuum control of the system.
In addition, several accessories are available including remote keypad and footswitch controls, a transport cart and probe guides for various stereotactic (ST) tables.
The Mammotome® revolve Dual VAB System is an updated version of the currently marketed system, incorporating changes to improve efficiency and ease of use, while maintaining the basic technology, functionality and clinical outcomes of the predicate system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Stereotactic, Ultrasound, Magnetic Resonance and Advanced Molecular Imaging.
Anatomical Site
Breast
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 predicate device, side-by-side comparison of tissue sample collection, using an in vivo porcine model, was performed.
The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System and the predicate device were each used to obtain tissue sample and evaluated against the following criteria:
- Sample weight
- Sampling reliability
- Sample quality
Testing results confirmed that the Mammotome® revolve Vacuum Assisted Biopsy (VAB) System would retrieve a tissue sample comparable to that of the predicate device.
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
510(k) Premarket Notification Mammotome® revolve Dual Vacuum Assisted Biopsy System Devicor Medical Products, Inc. August 13, 2012
K 123259
510(k) Summary
NOV 1 5 2012
The following information is provided as required by 21 CFR § 807.87 for the Mammotome® revolve Vacuum Assisted Biopsy (VAB) 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 13, 2012
Proprietary Name: Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System
Common Name: Biopsy System
Regulation: 21 CFR 876.1075
Regulatory Class: II
Product Codes: KNW
Classification Name: Biopsy Instrument
Predicate Device: Mammotome® Biopsy System, K033700
Device Description: The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System is a mechanical breast biopsy device indicated to provide tissue samples for diagnostic sampling of beast abnormalities for histologic examination.
1
K123259 2/6
The Mammotome® revolve Dual VAB System is comprised of three primary subsystems:
-
- a sterile, single-use probe
-
- a reusable holster, and
-
- a reusable control unit.
Intended Use: The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
- The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
- The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) 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® revolve Dual Vacuum Assisted Biopsy (VAB) 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.
Technological Characteristics:
The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System, facilitates the diagnostic removal of tissue through a combination of vacuum and rotational/translational cutting functions. The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System utilizes the same primary subsystems as identified in the predicate device to achieve its intended use:
- a sterile single-use probe containing trocar tipped biopsy needle, rotating cutter, 1) specimen collection chambers, and vacuum tubing/valving which enables tissue sample
2
123259
acquisition under vacuum, tissue cutting, and tissue transport to the specimen collection chambers;
3/6
-
- a reusable holster containing the drive motors, gear trains and user activation switches, which provides the basic functionality for the procedure including the rotation, advancement and retraction of the cutting mechanism of the probe, as well as the specimen management system rotation; and
-
- a reusable control unit that houses the vacuum pump, power supply, valve actuators, software, user interface touchscreen and control electronics, which provides the primary electrical, electronic, mechanical and vacuum control of the system.
In addition, several accessories are available including remote keypad and footswitch controls, a transport cart and probe guides for various stereotactic (ST) tables.
The Mammotome® revolve Dual VAB System is an updated version of the currently marketed system, incorporating changes to improve efficiency and ease of use, while maintaining the basic technology, functionality and clinical outcomes of the predicate system. Consistent with the configuration of the currently marketed system, the Mammotome® revolve VAB System will be configured for use in multiple imaging modalities, including Stereotactic, Ultrasound, Magnetic Resonance and Advanced Molecular Imaging.
The system relies on software to operate many of its functions including utilization of closed loop control on cutter position. As with the predicate system, the focus of the software is to aid in system set-up and facilitate biopsy functions. The Mammotome® revolve Dual VAB System software has been updated to simplify the touch screen display used to set up the system and create a single button push Biopsy function that transports the tissue sample back to a collection system for retrieval and analysis.
A side-by-side comparison of the marketed and proposed devices is provided below.
3
123259 416
Side-by-Side Comparison to Legally Marketed Device
| Device Characteristics | Marketed Device Mammotome® ST
System | Proposed Device Mammotome®
revolve Biopsy System |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Indications for Use | Breast Biopsy/complete, partial
removal of imaged abnormality/partial
removal of palpated abnormality | Breast Biopsy / complete, partial
removal of imaged abnormality/partial
removal of palpated abnormality |
| Needle Assembly | | |
| Needle Insertion Method | Fired or Manual | Fired or Manual |
| Tip Type | Bladed trocar | Bladed trocar |
| Tip Material | Stainless steel | Stainless steel |
| Needle Configuration | Dual lumen | Dual lumen |
| Needle Material | Stainless steel | Stainless steel |
| Sample Aperture
Configuration | Lateral aperture in needle | Lateral aperture in needle |
| Needle Diameter Sizes | 8G, 11G, and 14G | 8 G & 10 G |
| Needle Rotation Method | Manual, Remote Thumbwheel | Manual, Remote Thumbwheel |
| Probe Housing | | |
| Vacuum Port
Attachment (Valve
Cartridge) | Yes, tethered to control module | Yes, tethered to Control Module |
| Specimen Retrieval /
Collection Method | Manual | Automatic |
| Housing Material | Plastic | Plastic |
| Probe Cutter Subassembly | | |
| Cutting Method | Rotation and translation of inner cutter | Rotation and translation of inner cutter |
| Tissue Transport Method | Mechanical and Vacuum | Vacuum |
| Cutter Material | Stainless steel | Stainless steel |
| Cutter Sealing
Mechanism | Yes | Yes |
| Cutter Sealing Material | Elastomer/Thermoplastic | Elastomer/Thermoplastic |
| Knockout Sub Assembly | | |
| Knockout Material | Stainless steel | |
| Knockout Sealing
Mechanism | Yes | No Knockout / Specimen Retrieval |
| Knockout Sealing
Material | Elastomer/Thermoplastic | Automatic |
| Fluid Injection Capability | Yes | |
| Packaging | | |
| Type | C-film with Tyvek Cover | PETG with Tyvek Cover |
| Device Characteristics | Marketed Device Mammotome® ST System | Proposed Device Mammotome® revolve Biopsy System |
| Marking Access | Through Needle | Through Device |
| Sterilization | | |
| Method | Cobalt 60 Irradiation | Cobalt 60 Irradiation |
| Tubing Set | | |
| Physical Properties | | |
| Tubing Material | PVC | PVC with no DEHP |
| Features | | |
| Attachment to Probe | Luer | Luer |
| Attachment to control Module | Cartridge with two parallel vacuum lines leading to probe | Cartridge with two parallel vacuum lines leading to probe + Saline line leading to probe |
| Vacuum Control | Solenoid activated stopcocks | Motor activated Rotary Valves |
| Sterilization | | |
| Method | Cobalt 60 Irradiation | Cobalt 60 Irradiation |
| Holster/Cables / Control Module | | |
| Features | | |
| User interface Mechanisms | Buttons on holster, Pedals on Footswitch or Touchscreen | Buttons on holster, Footswitch Pedals, Touchscreen, Keypad |
| Microprocessor and software with Upgrade Capabilities | Yes | Yes |
| Display | Yes, LCD display | Yes, LCD display |
| Translational Cutter Movement | Automatic or Semi Automatic | Automatic |
| Rotational Cutter Movement | Automatic with cutter advancement | Automatic with cutter advancement |
| Rotational and Translation Speed control | Yes; Closed-loop control | Yes, Closed loop control |
| Automated Initialization of Disposable Probe | Yes | Yes |
| Probe firing capability | Yes | Yes |
| Motor location | Control Module | Holster |
| Drive Train Type | Flexible Mechanical Drive Cable | On board Motor and Gear Train |
| Independent Lateral and Axial Vacuum System | Yes | Yes |
| Remote Footswitch/Keypad Capability | Yes | Yes |
4
510(k) Premarket Notification
Mammotome® revolve Dual Vacuum Assisted Biopsy System
Assisted Biopsy System
K123259 5/6
5
510(k) Premarket Notification Mammotome® revolve Dual Vacuum Assisted Biopsy System Devicor Medical Products, Inc. August 13, 2012
K123259 6/6
Performance testing:
To demonstrate substantial equivalence of the proposed device to the predicate device, sideby-side comparison of tissue sample collection, using an in vivo porcine model, was performed. This model has historically been used to evaluate the ability for Mammotome® breast biopsy devices to collect tissue samples.
The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System and the predicate device were each used to obtain tissue sample was evaluated against the following criteria:
- . Sample weight
- Sampling reliability ●
- Sample quality .
Testing results confirmed that the Mammotome® revolve Vacuum Assisted Biopsy (VAB) System would retrieve a tissue sample comparable to that of the predicate device.
Conclusion: The claim of substantial equivalence of the Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System to the predicate system is based on the comparison of the intended use, product technical characteristics, and performance characteristics.
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing segments, representing health, human services, and the partnership between the federal government and the states. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 15, 2012
Underwriters Laboratories, Incorporated % Mr. Ned Devine Senior Staff Engineer 333 Pfingsten Road Northbrook Road, Illinois 60062
Re: K123259
Trade/Device Name: Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: October 16, 2012 Received: October 18, 2012
Dear Mr. Devine:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
7
Page 2 - Mr. Ned Devine
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use Statement
510(k) Number: K 123259
Device Name: Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System
Indications for Use:
The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
- The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) System is intended to . provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
- The Mammotome® revolve Dual Vacuum Assisted Biopsy (VAB) 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® revolve Dual Vacuum Assisted Biopsy (VAB) 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.
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) | |
|---|---|
oncurrence of CDRH, Office of Device Evaluation (ODE)
I, Orthopedic, (Division Sign-Off Division of Surgical and Restorative Devices
510(k) Number 23,255
ين Page 5-2