Evacore Fully Disposable Vacuum Assist Biopsy Device

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is the logo for the Department of Health and Human Services (HHS). The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. Inside the circle is a stylized image of three human profiles facing right, with flowing lines extending from the first profile. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Pin-Point Care Corporation Mr. Jeff M. Hathaway President N1723 Center Street Lebanon, Wisconsin 53047 July 20, 2015 Re: K150088 Trade/Device Name: Evacore Fully Disposable Vacuum Assist Biopsy Device Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: June 26, 2015 Received: June 26, 2015 Dear Mr. Hathaway: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. For Sincerely yours, Joshua Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Pin-Point Care Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K150088 Device Name Evacore Fully Disposable Vacuum Assist Biopsy Device ### Indications for Use (Describe) To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes. When used for breast biopsy, the product is for diagnosis only. The extent histological abnormality in breast tissue cannot be reliably determined from mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not guarantee the complete removal of the affected tissue. When the sampled abnormality is not benign, it is necessary that the tissue margins be examined to ensure that the area of suspicion (e.g., malignancy) has been completely removed using standard surgical procedures. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </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}------------------------------------------------ Pin-Point Care # Date Prepared: 30 December, 2014 ## 510(k) Summary (As required per 21 CFR: §807.92) # Evacore Fully Disposable Vacuum Assist Biopsy Device ### I. Applicant Information: Pin-Point Care Corporation N1723 Center Street Lebanon, WI 53047 ### II. Contact Person: | Jeff M. Hathaway | |------------------------------------------------------------------------------| | Phone Number........................(262)623-1149 | | Fax Number........................(262)806-7499 | | Email........................................jeff.hathaway@pin-pointcare.com | #### III. Device Information: | Classification | Class II | |---------------------|-----------------------------------------------------------------| | Trade Name | Evacore Fully Disposable Vacuum<br>Assist Biopsy Device | | Common Name | Biopsy Instrument | | Classification Name | Gastroenterology-Urology Biopsy<br>Instrument (21 CFR 876.1075) | | Panel | 78 Gastroenterology/Urology | | Product Code | KNW | ### Predicate Device Information: IV. | Manufacturer | Hologic - Suros Surgical Systems | |---------------|---------------------------------------------------------| | Device | Celero Vacuum Assisted Spring Loaded Core Biopsy Device | | 510(k) Number | K034021 | ### V. Device Description: The Evacore Fully Disposable Vacuum Assist Biopsy Device is a gamma sterilized, single-use percutaneous biopsy device. The working end of the device consist of a stainless steel outer needle with a lateral aperture for sample acquisition (sample aperture), a stainless steel inner cutting cannula with a sharp edge, and a solid stainless steel stylet located inside the cutting cannula. The handle of the device contains (2) release buttons, a reset handle for the vacuum generator (thumb), a reset handle for the cutting cannula (two fingers), and a needle hub to adjust the needle {4}------------------------------------------------ aperture orientation based on the location of the lesion. When the release buttons are depressed (consecutively or concurrently) a vacuum is generated at the needle sample aperture drawing tissue into the needle, then the cutting cannula is activated automatically, traversing across the sample aperture dissevering the tissue sample. The solid stainless steel stylet prevents the tissue sample from migrating towards the handle once it has been separated from the patient. The device is then removed from the patient and reset via the reset handles allowing the tissue sample to be removed. #### VI. Indications for Use: The Evacore Fully Disposable Vacuum Assist Biopsy Device is a Biopsy Instrument as described under the provisions of 21 CFR §876.1075 and is medically prescribed to obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes. When used for breast biopsy, the product is for diagnosis only. The extent histological abnormality in breast tissue cannot be reliably determined from mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not guarantee the complete removal of the affected tissue. When the sampled abnormality is not benign, it is necessary that the tissue margins be examined to ensure that the area of suspicion (e.g., malignancy) has been completely removed using standard surgical procedures. # VII. Device Comparison: Note: Unless otherwise stated, the Device Comparison for the Evacore Fully Disposable Vacuum Assist Biopsy Device is for all noted needle lengths and gauges. | Comparison | Predicate Device - (K034021)<br>Vacuum Assisted Spring<br>Loaded Core Biopsy Device | Evacore Fully Disposable<br>Vacuum Assist Biopsy Device | |---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------| | Intended Use | To obtain percutaneous core<br>biopsy samples from soft tissue<br>and tumors of such organs as<br>the liver, spleen, kidney,<br>prostate, lung, breast, and<br>lymph nodes. When used for<br>breast biopsy, the product is<br>for diagnosis only. | Same | | Target Population | Patients with suspicious soft<br>tissue lesion(s) | Same | | Product Code | KNW | Same | | Outer Needle Diameter(s) | 12 Guage | 7, 11, and 14 Guage | | Needle Length | ≈123mm | 115mm and 145mm | | Number of samples | Unknown | 16 samples | | Method of Device<br>Insertion | Working end of the device<br>introduced without or with<br>coaxial introducer | Same | | Method of Tissue Collection | Insert the needle in the correct position, activate the device and wait for the device to finish cycling (automatic), remove the device from the patient, reset the device and manually extract the tissue sample. | Same | | Optimal Sample Notch Length | 22mm | 19mm | | Core Type | Partial Diameter | Full Diameter | | Weight | 135g | 95g, 84g, and 79g<br>(145mm needle length) | | Selectable Sample Length | No | Yes (19mm or 11mm length) | | Echogenic Needle Description: Used for enhancing ultrsound imaging. | Yes | Yes | | Disposable Device | Fully disposable single patient use | Same | | Device Sterility | Gamma Sterilization | Same | | Sterile Barrier | Thermoformed tray with heat sealed Tyvek™ cover | Same | | Shelf Life | 3 years | Same | | Electrical Safety | The device operates on mechanical principles only. Therefore, the device has no electrical components | Same | | Method of Tissue<br>Dissection | Cutting cannula advances across tissue aperture | Same | | Mechanics of action | Automatic | Same | | Needle Advancement/<br>Penetration Depth | 25mm | N/A | | Mode of Action | Single puncture and sample, or<br>single puncture and multiple<br>samples with introducer | Same | | Non-Contact Materials | Colored polymer housings with<br>metal springs as the energy<br>source | Same | | Patient Contact Materials | 300 Series Stainless Steel | Same | | Vacuum Energy Source | Spring operated vacuum<br>generator | Same | | Cutting Cannula Energy<br>Source | Spring operated cutting<br>cannula | Same | | Dual interlocks (manual)<br>for vacuum generator<br>release | No | Yes | | Dual interlocks (automatic)<br>for cutting cannula release | No | Yes | | Rotating Cutting Cannula | No | Yes | | Manual reset of the device | Yes | Yes | | Hand-Held Procedure | Yes | Yes | | Location Used | Physician's Office or O.R. | Same | | Prescription vs. O.T.C. | Prescription | Same | | Performance | Equivalency to white paper<br>performance data | Bench test equivalency | | Method of placement | CT/Ultrasound/Fluoroscopy/<br>Manual | Same | ## Predicate Device Comparison Table {5}------------------------------------------------ ### Traditional 510(k) Evacore Fully Disposable Vaccum Assist Biopsy Device {6}------------------------------------------------ # VIII. Non-Clinical Performance Data: The Evacore Fully Disposable Vacuum Assist Biopsy Device was performance tested using empirical testing. {7}------------------------------------------------ | Risk | Test Method | Acceptance Criteria | Results | |-----------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------|---------| | 7 gauge 115mm & 145mm<br>needle length tissue<br>sample size is inadequate | Simulated and<br>supported with<br>bench testing | Average volume of a sample > .105cm3 | PASS | | 11 gauge 115mm & 145mm<br>needle length tissue<br>sample size is inadequate | Simulated and<br>supported with<br>bench testing | Average volume of a samples >.033cm3 | PASS | | 14 gauge 115mm & 145mm<br>needle length tissue<br>sample size is inadequate | Simulated and<br>supported with<br>bench testing | Average mass of 8 samples > .018cm3 | PASS | ## Summary of Non-Clinical Performance Data ### IX. Substantial Equivalency: The flow chart shown below is a duplicate of the one that can be found in "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications" in "Appendix A. 510(k) Decision-Making Flowchart". The pathway illustrates how the Evacore Fully Disposable Vacuum Assist Biopsy Device is substantially equivalent to the legally marketed predicate device. The Predicate Device Comparison Table demonstrates that the Evacore Fully Disposable Vacuum Assist Biopsy Device has the same technological characteristics as the predicate device in terms of but not limited to, intended use, energy source, operating principals, optimal sample notch length, target population, device sterility, and method of tissue collection. ## Conclusion: Based on the Non-Clinical Performance Data provided in this summary, the Evacore Fully Disposable Vacuum Assist Biopsy Device has been shown to be substantially equivalent to the predicate device. Note: See following page for flow chart.