(28 days)
No
The summary describes a mechanical biopsy system and does not mention any AI or ML components or functions.
No.
The device is used for diagnostic sampling of breast abnormalities to obtain tissue samples for histologic examination, not for treating a condition.
Yes
The device is indicated to "provide tissue samples for diagnostic sampling of breast abnormalities for histologic examination," which directly supports its use in diagnosing.
No
The device description explicitly states it is an "electromechanical breast biopsy device" comprised of a sterile probe, reusable holster, and reusable control unit, indicating it includes significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease. This examination is performed in vitro (outside the living organism).
- Device Function: The Mammotome revolve Dual Vacuum Assisted Biopsy (VAB) System is a device used to obtain tissue samples from the breast. It is a tool for collecting the specimen.
- Intended Use: The intended use clearly states that the system is indicated to "provide tissue samples for diagnostic sampling of breast abnormalities." The tissue samples are then used for "histologic examination," which is the in vitro diagnostic process performed by a pathologist.
- Device Description: The description details the electromechanical system used for the biopsy procedure, not a system for analyzing the tissue itself.
The device is a tool used before the in vitro diagnostic process (histologic examination) takes place. It facilitates the collection of the sample that will then be used for IVD testing.
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 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
KNW
Device Description
The Mammotome revolve EX System is an electromechanical breast biopsy device indicated to provide tissue samples for diagnostic sampling of beast abnormalities for histologic examination.
The Mammotome revolve EX System is comprised of three primary subsystems:
- a sterile, single-use Probe
- a reusable Holster, and
- a reusable control unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
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
Non-Clinical Bench Performance Testing was conducted on the Mammotome revolve EX System [subject device]. The table below includes the list of the performance testing results submitted, referenced, or relied on in this premarket notification submission for a determination of substantial equivalence.
Sterilization and Shelf Life Testing
- Sterility Testing
- Test Results: PASSED
- FDA Recognized Testing Standards: ISO 11137-1:2006/AMD 2:2018; ISO 11137-2:2013; ANSI/AAMI/ISO TIR13004:2013.
- Conclusion Supporting Substantial Equivalence: The results of the Sterility Testing conducted on the Mammotome revolve EX Probes demonstrates that the subject device is as safe, as effective, and performs as well as, the legally marketed predicate device. This testing supports a determination of substantial equivalence of the Mammotome revolve EX System [subject device] when compared to the Mammotome revolve Vacuum Assisted Biopsy (VAB) System device (K152989) [predicate device].
Biocompatibility Testing
- Biocompatibility Testing including: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity.
- Test Results: PASSED
- FDA Recognized Testing Standards: ISO 10993-1:2018; ISO 10993-5:2009; ISO 10993-10:2010; ISO 10993-11:2017; ISO 10993-12:2012.
- Conclusion Supporting Substantial Equivalence: The results of the Biocompatibility Testing conducted on the Mammotome revolve EX Probes demonstrates that the subject device is as safe, as effective, and performs as well as, the legally marketed predicate device. This testing supports a determination of substantial equivalence of the Mammotome revolve EX System [subject device] when compared to the Mammotome revolve Vacuum Assisted Biopsy (VAB) System device (K152989) [predicate device].
Software Verification and Validation Testing
- Functional Testing including: Software Unit Testing, System Integration Testing, Software Verification Testing.
- Test Results: PASSED
- Conclusion Supporting Substantial Equivalence: The results of the Software Testing conducted on the Mammotome revolve EX System demonstrates that the subject device is as safe, as effective, and performs as well as, the legally marketed predicate device. This testing supports a determination of substantial equivalence of the Mammotome revolve EX System [subject device] when compared to the Mammotome revolve Vacuum Assisted Biopsy (VAB) System device (K152989) [predicate device].
Electrical Safety and Electromagnetic Compatibility (EMC) Testing
- Functional Testing including: Electrical Safety, Electromagnetic Compatibility.
- Test Results: PASSED
- FDA Recognized Testing Standards: IEC 60601-1:2005 + AMD1:2012; IEC 60601-1-2:2014.
- Conclusion Supporting Substantial Equivalence: The results of the Electrical Safety and Electromagnetic Compatibility (EMC) Testing conducted on the Mammotome revolve EX System demonstrates that the subject device is as safe, as effective, and performs as well as, the legally marketed predicate device. This testing supports a determination of substantial equivalence of the Mammotome revolve EX System [subject device] when compared to the Mammotome revolve Vacuum Assisted Biopsy (VAB) System device (K152989) [predicate device].
Animal Lab Study
- Tissue Sample Testing: Sample Weight, Sample Reliability, Sample Quality.
- Test Results: PASSED
- FDA Recognized Testing Standards: GPL regulation 21 CFR Part 58.
- Conclusion Supporting Substantial Equivalence: The results of the Animal Lab conducted on the Mammotome revolve EX System demonstrates that the subject device is as safe, as effective, and performs as well as, the legally marketed predicate device. This testing supports a determination of substantial equivalence of the Mammotome revolve EX System [subject device] when compared to the Mammotome revolve Vacuum Assisted Biopsy (VAB) System device (K152989) [predicate device].
Usability Testing
- Test Results: PASSED
- Conclusion Supporting Substantial Equivalence: The results of the Usability Testing conducted on the Mammotome revolve EX System demonstrates that the subject device is as safe, as effective, and performs as well as, the legally marketed predicate device. This testing supports a determination of substantial equivalence of the Mammotome revolve EX System [subject device] when compared to the the Mammotome revolve Vacuum Assisted Biopsy (VAB) System device (K152989) [predicate device].
Conclusion: The results of the Non-Clinical Performance Bench Testing support the safety of the device and demonstrate that the Mammotome revolve EX System (subject device) performs as intended in the specified use conditions and comparably in terms of safety, effectiveness, and performance to the Mammotome revolve Vacuum Assisted Biopsy (VAB) System device (K152989) [predicate device] which is currently marketed for the same intended use. Therefore, this Non-Clinical Performance Bench Testing supports a determination of substantial equivalence of the Mammotome revolve EX System [subject device] when compared to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Mammotome revolve Dual Vacuum Assisted Biopsy (VAB) System, K152989
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
August 18, 2020
Devicor Medical Products, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k Saint Paul, Minnesota 55114
Re: K202012
Trade/Device Name: Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: July 20, 2020 Received: July 21, 2020
Dear Prithul Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Mammotome revolve Dual Vacuum Assisted Biopsy (VAB) System
Indications for Use (Describe)
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 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.
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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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3
Image /page/3/Picture/1 description: The image shows the logo for Devicor Medical Products, Inc. The logo features a stylized, light blue graphic element on the left, resembling two crescent shapes facing each other. To the right of this graphic is the word "DEVICOR" in bold, black, sans-serif font. Below "DEVICOR" is the text "MEDICAL PRODUCTS, INC." in a smaller, lighter font.
510(k) Summary
The following information is provided as required by 21 CFR § 807.92 for the Mammotome revolve EX 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:
Gwendolyn Payne Regulatory Affairs Manager Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 Ph: 513-864-9186 Fax: 513-864-9011 E-mail: Gwendolyn.Payne@mammotome.com
Date of Submission: June 9, 2020
Proprietary Name: Mammotome revolve EX
Common Name: Biopsy System
Regulation: 21 CFR 876.1075
Regulatory Class: II
Product Codes: KNW
Classification Name: Biopsy Instrument
Predicate Device: Mammotome revolve Dual Vacuum Assisted Biopsy (VAB) System, K152989
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Page 2 of 9
Image /page/4/Picture/3 description: The image shows the logo for Devicor Medical Products, Inc. The logo features a stylized, light blue graphic to the left of the company name. The word "DEVICOR" is written in bold, black letters, with "COR" in a lighter blue color. Below "COR" is the text "MEDICAL PRODUCTS, INC." in a smaller font, also in light blue.
Device Description: The Mammotome revolve EX System is an electromechanical breast biopsy device indicated to provide tissue samples for diagnostic sampling of beast abnormalities for histologic examination.
The Mammotome revolve EX 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.
- 0 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 EX System facilitates the diagnostic removal of tissue through a combination of vacuum and rotational/translational cutting functions. The Mammotome
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Image /page/5/Picture/4 description: The image shows the logo for Devicor Medical Products, Inc. The logo features a stylized, light blue graphic to the left of the company name. The word "DEVICOR" is written in bold, black letters, with the "OR" in light blue. Below the company name, in smaller light blue letters, is the text "MEDICAL PRODUCTS, INC."
revolve EX System utilizes the same primary subsystems as identified in the predicate device to achieve its intended use:
-
- a sterile single use Probe containing a trocar tipped biopsy needle, rotating cutter, specimen collection chambers, and vacuum tubing/valving;
-
- a reusable Holster, containing the drive motors, gear trains, and user activation switches; and
-
- a reusable Control Module, containing the vacuum pump, power supply, valve actuators, user interface touchscreen, control electronics, and software.
In addition, several optional accessories that function with the EX system are available as part of the total Mammotome revolve Dual Vacuum Assisted Biopsy (VAB) System including remote keypad and footswitch controls, a transport cart, and a holster holder for the new EX Holster.
The Mammotome revolve Vacuum Assisted Biopsy (VAB) System has been updated to integrate the new EX system while maintaining the basic technology, functionality and clinical outcomes of the predicate system. Consistent with the Mammotome revolve Dual VAB US System, the EX system is configured for use in the Ultrasound imaging modality.
The system relies on software to operate many of its functions including utilization of closed loop control on cutter position. In both the EX and predicate software systems, the focus of the software is to aid in system set-up and facilitate biopsy functions. The Mammotome revolve EX System software has been updated to include functionality with the new EX Probe.
A side-by-side comparison of the marketed and proposed devices is provided below.
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Image /page/6/Picture/3 description: The image shows the logo for Devicor Medical Products, Inc. The logo features a stylized, light blue symbol resembling two crescent moons facing each other. To the right of the symbol, the word "DEVICOR" is written in bold, black letters, with the "COR" portion in a lighter blue color. Below "DEVICOR", the words "MEDICAL PRODUCTS, INC." are written in a smaller, sans-serif font.
Side-by-Side Comparison to Legally Marketed Device
Table 1a: Side-by-Side Comparison of Mammotome revolve EX Holster and Control Module to previous Mammotome revolve ST and U/S Holsters and Control Module
| Device
Characteristics:
Holster / Control
Module | Marketed Device:
Mammotome revolve
(ST and U/S) Biopsy
System (K152989) | Proposed Device:
Mammotome revolve
(EX) Biopsy System | Comparison:
Same, Similiarities, and
Differences with
Supporting Rationale |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | Same |
| User interface
Mechanisms | Buttons on Holster, Buttons
on Remote Keypad, Pedals
on Footswitch, Touchscreen | Buttons on Holster, Buttons
on Remote Keypad, Pedals
on Footswitch, Touchscreen | Same |
| Microprocessor and
upgradeable software | Yes | Yes | Same |
| Display | Yes, LCD display | Yes, LCD display | Same |
| Translational Cutter
Movement | Automatic | Automatic | Same |
| Rotational Cutter
Movement | Automatic with cutter
advancement | Automatic with cutter
advancement | Same |
| Rotational and
Translation Speed
control | Yes, Closed loop control | Yes, Closed loop control | Same |
| Drive Train Type | On board Motor and Gear
Train | On board Motor and Gear
Train | Same |
| Independent Lateral
and Axial Vacuum
System | Yes | Yes | Same |
| Remote Footswitch /
Keypad Capability | Yes | Yes | Same |
| Device
Characteristics:
Probes | Marketed Device:
Mammotome revolve
(ST and U/S) Biopsy
System (K152989) | Proposed Device:
Mammotome revolve
(EX) Biopsy System | Comparison:
Same, Similiarities, and
Differences with
Supporting Rationale |
| Needle Insertion
Method | Fired or Manual | Manual | Same as Mammotome
revolve U/S. Mammotome
revolve EX offers manual
insertion only. |
| Tip Type | Bladed trocar | Bladed trocar | Same |
| Tip Material | Stainless steel | Stainless steel | Same |
| Needle Configuration | Dual lumen | Dual lumen | Same |
| Needle Material | Stainless steel | Stainless steel | Same |
| Needle Diameter Sizes | 8G and 10G | 8G | Same as 8G (ST and U/S) |
| Vacuum Port
Attachment | Yes, tethered to Control
Module | Yes, tethered to Control
Module | Same |
| Specimen Retrieval /
Collection Method | Automatic | Automatic | Same |
| Housing Material | Plastic | Plastic | Same |
| Cutting Method | Rotation and translation of inner cutter | Rotation and translation of inner cutter | Same |
| Tissue Transport Method | Vacuum | Vacuum | Same |
| Cutter Material | Stainless steel | Stainless steel | Same |
| Packaging Type | PETG with Tyvek Cover | LDPE Pouch with Tyvek Header | Different. The difference in packaging material does not raise new or different questions of safety or effectiveness. Sterilization and Shelf Life (Section 15) provides evidence of package integrity and the ability to maintain sterile barrier for this change in packaging type. |
| Sterilization Method | Cobalt 60 Irradiation | Cobalt 60 Irradiation | Same |
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Image /page/7/Picture/4 description: The image shows the logo for Devicor Medical Products, Inc. The logo features a stylized blue symbol on the left, followed by the word "DEVICOR" in bold, with the first half in black and the second half in blue. Below "DEVICOR" are the words "MEDICAL PRODUCTS, INC." in a smaller, lighter font, also in blue. The logo is clean and professional, suggesting a company in the medical field.
Table 1b: Side-by-Side Comparison of Mammotome revolve EX Probes to previous Mammotome revolve ST and U/S Probes
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The following Performance Data is provided in support of the substantial equivalence (SE) determination.
| Summary of Non-Clinical Bench Performance Testing | ||
|---|---|---|
| Non-Clinical Bench Performance Testing was conducted on the Mammotome revolve EX System [subject | ||
| device]. The table below includes the list of the performance testing results submitted, referenced, or relied on | ||
| in this premarket notification submission for a determination of substantial equivalence. | ||
| Sterilization and Shelf Life Testing | ||
| • | Sterility Testing | Test Results: PASSED |
| FDA Recognized Testing Standards: | The results of these Non-Clinical Bench Performance Data are | |
| provided in support of the substantial equivalence determination. | ||
| o ISO 11137-1:2006/AMD 2:2018 - | ||
| Sterilization of health care products | ||
| – Radiation – Part 1: Requirements | ||
| for development, validation and | ||
| routine control of a sterilixation | Conclusion Supporting Substantial Equivalence: The results of the | |
| Sterility Testing conducted on the Mammotome revolve EX Probes | ||
| demonstrates that the subject device is as safe, as effective, and | ||
| performs as well as, the legally marketed predicate device. This | ||
| ο | process for medical devices | |
| ISO 11137-2:2013 - Sterilization of | ||
| health care products – Radiation – | ||
| Part 2: Establishing the sterilization | ||
| dose | testing supports a determination of substantial equivalence of the | |
| Mammotome revolve EX System [subject device] when compared to | ||
| the Mammotome revolve Vacuum Assisted Biopsy (VAB) System | ||
| device (K152989) [predicate device]. | ||
| ο | ANSI/AAMI/ISO TIR13004:2013- | |
| Sterilization of health care products | ||
| — Radiation — Substantiation of a | ||
| selected sterilization dose: Method | ||
| VDmax SD | ||
| Biocompatibility Testing | ||
| ● | Biocompatibility Testing including: | Test Results: PASSED |
| - Cytotoxicity | The results of these Non-Clinical Bench Performance Data are | |
| - Sensitization | provided in support of the substantial equivalence determination. | |
| - Irritation | ||
| - Acute Systemic Toxicity | Conclusion Supporting Substantial Equivalence: The results of the | |
| Biocompatibility Testing conducted on the Mammotome revolve EX | ||
| Probes demonstrates that the subject device is as safe, as effective, | ||
| and performs as well as, the legally marketed predicate device. This | ||
| testing supports a determination of substantial equivalence of the | ||
| Mammotome revolve EX System [subject device] when compared to | ||
| the Mammotome revolve Vacuum Assisted Biopsy (VAB) System | ||
| device (K152989) [predicate device]. | ||
| - Material Mediated Pyrogenicity | ||
| FDA Recognized Testing Standards: | ||
| ο | ISO 10993-1:2018-Biological | |
| Evaluation of Medical Devices – | ||
| Part 1: Evaluation and Testing | ||
| Within a Risk Management Process | ||
| ο | ISO 10993-5:2009-Biological | |
| Evaluation of Medical Devices – | ||
| Part 5: Tests for In Vitro | ||
| Cytotoxicity | ||
| ο | ISO 10993-10:2010-Biological | |
| Evaluation of Medical Devices – | ||
| Part 10: Tests for Irritation and Skin | ||
| Sensitization | ||
| ο | ISO 10993-11:2017-Biological | |
| Evaluation of Medical Devices - | ||
| Part 11: Tests for Systemic Toxicity | ||
| ο | ISO 10993-12:2012-Biological | |
| Evaluation of Medical Devices – | ||
| Part 12: Sample preparation and | ||
| reference materials. | ||
| Software Verification and Validation Testing | ||
| ● | Functional Testing including: |
- Software Unit Testing
- System Integration Testing
- Software Verification Testing | Test Results: PASSED
The results of these Non-Clinical Bench Performance Data are
provided in support of the substantial equivalence determination.
Conclusion Supporting Substantial Equivalence: The results of the
Software Testing conducted on the Mammotome revolve EX System
demonstrates that the subject device is as safe, as effective, and
performs as well as, the legally marketed predicate device. This
testing supports a determination of substantial equivalence of the
Mammotome revolve EX System [subject device] when compared to
the Mammotome revolve Vacuum Assisted Biopsy (VAB) System
device (K152989) [predicate device]. |
| Electrical Safety and Electromagnetic Compatibilty (EMC) Testing | | |
| ● | Functional Testing including:
- Electrical Safety
- Electromagnetic Compatibility | Test Results: PASSED
The results of these Non-Clinical Bench Performance Data are
provided in support of the substantial equivalence determination.
Conclusion Supporting Substantial Equivalence: The results of the
Electrical Safety and Electromagnetic Compatibility (EMC) Testing
conducted on the Mammotome revolve EX System demonstrates
that the subject device is as safe, as effective, and performs as well
as, the legally marketed predicate device. This testing supports a
determination of substantial equivalence of the Mammotome
revolve EX System [subject device] when compared to the
Mammotome revolve Vacuum Assisted Biopsy (VAB) System device
(K152989) [predicate device]. |
| | FDA Recognized Testing Standards:
○ IEC 60601-1:2005 + AMD1:2012 –
Medical electrical equipment – Part
1: General requirements for basic
safety and essential performance.
○ IEC 60601-1-2:2014 - Medical
electrical equipment - Part 1-2:
General requirements for basic
safety and essential performance -
Collateral Standard:
Electromagnetic disturbances -
Requirements and tests | |
| Animal Lab Study | | |
| ● | Tissue Sample Testing
- Sample Weight
- Sample Reliability
- Sample Quality | Test Results: PASSED
The results of these Non-Clinical Bench Performance Data are provided in support of the substantial equivalence determination.
Conclusion Supporting Substantial Equivalence: The results of the Animal Lab conducted on the Mammotome revolve EX System demonstrates that the subject device is as safe, as effective, and performs as well as, the legally marketed predicate device. This testing supports a determination of substantial equivalence of the Mammotome revolve EX System [subject device] when compared to the Mammotome revolve Vacuum Assisted Biopsy (VAB) System device (K152989) [predicate device]. |
| | FDA Recognized Testing Standards:
Ο GPL regulation 21 CFR Part 58 | |
| ● | Usability Testing | Test Results: PASSED
The results of these Non-Clinical Bench Performance Data were provided in support of the substantial equivalence determination.
Conclusion Supporting Substantial Equivalence: The results of the Usability Testing conducted on the Mammotome revolve EX System demonstrates that the subject device is as safe, as effective, and performs as well as, the legally marketed predicate device. This testing supports a determination of substantial equivalence of the Mammotome revolve EX System [subject device] when compared to the the Mammotome revolve Vacuum Assisted Biopsy (VAB) System device (K152989) [predicate device]. |
| Conclusion: The results of the Non-Clinical Performance Bench Testing support the safety of the device and demonstrate that the Mammotome revolve EX System (subject device) performs as intended in the specified use conditions and comparably in terms of safety, effectiveness, and performance to the Mammotome revolve Vacuum Assisted Biopsy (VAB) System device (K152989) [predicate device] which is currently marketed for the same intended use. Therefore, this Non-Clinical Performance Bench Testing supports a determination of substantial equivalence of the Mammotome revolve EX System [subject device] when compared to the predicate device | | |
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Image /page/9/Picture/1 description: The image shows the logo for Devicor Medical Products, Inc. The logo features a stylized blue symbol on the left, followed by the word "DEVICOR" in bold, black letters. Below the word "DEVICOR" are the words "MEDICAL PRODUCTS, INC." in smaller, light blue letters. The logo is clean and professional, suggesting a company in the medical field.
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Image /page/10/Picture/1 description: The image shows the alphanumeric string 'K202012' in a simple, sans-serif font. The characters are evenly spaced and of uniform size. The text appears to be a code or identifier, possibly a serial number or product code.
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Image /page/10/Picture/4 description: The image shows the logo for Devicor Medical Products, Inc. The logo features a stylized symbol resembling two overlapping circles in light blue on the left. To the right of the symbol, the word "DEVICOR" is written in bold, dark brown letters. Below "DEVICOR", the words "MEDICAL PRODUCTS, INC." are written in a smaller, lighter font.
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Image /page/11/Picture/1 description: The image shows the logo for Devicor Medical Products, Inc. The logo features a stylized, light blue graphic element on the left, resembling two overlapping circles. To the right of this graphic is the word "DEVICOR" in bold, dark brown letters. Below "DEVICOR" are the words "MEDICAL PRODUCTS, INC." in a smaller, light blue font.
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Conclusion: The data generated from the results of the Non-Clinical Performance Bench Testing conducted on the Mammotome revolve EX System [subject device] demonstrate that the device is as safe, as effective, and performs as well as, the Mammotome revolve Vacuum Assisted Biopsy (VAB) System device (K152989) [predicate device]. Therefore, the data results may be relied on to support a determination of substantial equivalence.