Who is the manufacturer of Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System?

Devicor Medical Products, Inc. filed the 510(k) submission for Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System (K202012).

What is the FDA product code for Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System?

KNW. It is classified under 21 CFR 876.1075 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System

K202012 · Devicor Medical Products, Inc. · KNW · Aug 18, 2020 · Gastroenterology, Urology

Device Facts

Record ID	K202012
Device Name	Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
Applicant	Devicor Medical Products, Inc.
Product Code	KNW · Gastroenterology, Urology
Decision Date	Aug 18, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1075
Device Class	Class 2
Attributes	3rd-Party Reviewed

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 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.

Device Story

Electromechanical breast biopsy system; utilizes vacuum and rotational/translational cutting to obtain tissue samples. Comprised of sterile single-use probe (trocar-tipped needle, cutter, collection chambers), reusable holster (motors, gear trains, switches), and reusable control module (vacuum pump, power supply, touchscreen UI). Used in clinical settings under ultrasound guidance; operated by healthcare professionals. System employs closed-loop control for cutter position and speed. Provides tissue for histologic examination; aids in diagnosis of breast abnormalities. Benefits include efficient, automated tissue retrieval and standardized biopsy performance.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench performance testing, including sterility, biocompatibility (ISO 10993), software verification/validation, electrical safety/EMC (IEC 60601), animal lab study (tissue sample quality/reliability), and usability testing.

Technological Characteristics

Electromechanical biopsy system. Materials: stainless steel (needle/cutter), plastic (housing). Vacuum-assisted rotational/translational cutting. Dimensions: 8G needle. Connectivity: touchscreen UI, remote keypad/footswitch. Sterilization: Cobalt 60 irradiation. Software: closed-loop control for cutter position/speed. Standards: ISO 11137, ISO 10993, IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for diagnostic sampling of breast abnormalities in patients requiring histologic examination of tissue via partial or complete removal of imaged abnormalities or partial removal of palpable abnormalities.

Regulatory Classification

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.

Predicate Devices

Mammotome revolve Dual Vacuum Assisted Biopsy (VAB) System (K152989)

Related Devices

K123259 — MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM · Devicor Medical Products, Inc. · Nov 15, 2012
K152989 — Mammotome revolve Dual Vacuum Assist Biopsy System · Devicor Medical Products, Inc. · Feb 25, 2016
K033700 — MAMMOTOME EX HAND HELD SYSTEM · Ethicon Endo-Surgery, Inc. · Feb 20, 2004
K030472 — MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM · Ethicon Endo-Surgery, Inc. · Oct 9, 2003
K171890 — BEXCORE Breast Biopsy System, Biopsy Needle · Medical Park Co., Ltd. · Aug 20, 2018

Submission Summary (Full Text)

{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) K202012 ### 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) | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | <table><tr><td><div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div></td><td><div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></table> | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995.#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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. K202012 ## 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 {4}------------------------------------------------ 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: - 1) a sterile, single-use Probe - 2) a reusable Holster, and - 3) 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 {5}------------------------------------------------ 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: - 1) a sterile single use Probe containing a trocar tipped biopsy needle, rotating cutter, specimen collection chambers, and vacuum tubing/valving; - 2) a reusable Holster, containing the drive motors, gear trains, and user activation switches; and - 3) 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. {6}------------------------------------------------ Page 4 of 9 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 | {7}------------------------------------------------ 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 {8}------------------------------------------------ Image /page/8/Picture/3 description: The image shows the text "Page 6 of 9". The text is written in a simple, sans-serif font and is positioned in the top left corner of the image. The numbers indicate that this is page 6 of a document that has a total of 9 pages. Image /page/8/Picture/4 description: The image shows the logo for Devicor Medical Products, Inc. The logo features a stylized hourglass shape in light blue on the left. To the right of the hourglass is the word "DEVICOR" in bold, with "MEDICAL PRODUCTS, INC." in smaller letters underneath. 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]. | |…