EndoCore

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September 25, 2023 Praxis Medical, LLC % Paul Dryden Consultant Praxis Medical, LLC c/o ProMedic LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704 Re: K230778 Trade/Device Name: EndoCore Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: KTI Dated: September 25, 2023 Received: August 29, 2023 Dear Paul Dryden: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Ethan L. Nyberg -S Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices {2}------------------------------------------------ OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230778 Device Name Praxis Medical EndoCore Indications for Use (Describe) The Praxis Medical EndoCore is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree. For any patient 18 years and older - requiring tissue sampling. Type of Use (Select one or both, as applicable) X 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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" FORM FDA 3881 (6/20) Page 1 of 1 {4}------------------------------------------------ | 510(k) Summary<br>Page 1 of 7 | | |-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | 21-Sep-2023 | | Praxis Medical, LLC<br>500 N Willow Ave. Ste 101<br>Tampa, FL 33606<br>Tel – 727-482-1602 | | | Sponsor Contact: | John Fisher, MD - CEO | | Submission Contact: | Paul Dryden - ProMedic Consulting, LLC | | Proprietary or Trade Name: | Praxis Medical EndoCore | | Common/Usual Name: | Bronchoscope Accessory | | Classification Name: | Product Code – KTI<br>Bronchoscope (Flexible or Rigid) And Accessories | | Predicate Device: | Endobronchial Ultrasound Aspiration Needle - K213060 | | Device Description: | The EndoCore is intended to be used with endoscopes<br>for ultrasound guided fine needle aspiration (FNA) and<br>fine needle biopsy (FNB) of submucosal and extramural<br>lesions of the tracheobronchial tree. | | Principle of Operation: | EndoCore is inserted through an endoscope working<br>channel to the target lesion area. Once in place, the<br>healthcare provider pushes a button to activate a battery<br>powered internal motor to rotate the needle to facilitate<br>cellular material collection. | | Indications for Use: | The Praxis Medical EndoCore is used with ultrasound<br>endoscope to sample targeted submucosal and<br>extramural lesions of the tracheobronchial tree. For any<br>patient 18 years and older requiring tissue sampling. | {5}------------------------------------------------ # K230778 510(k) Summary Page 2 of 7 ## Table 1: Comparison of Subject vs. Predicate and Reference Devices | | Subject Device<br>Praxis Medical<br>EndoCore | Predicate Device<br>Micro-Tech (Nanjing) Co.,<br>Ltd.<br>Endobronchial Ultrasound<br>Aspiration Needle | Reference Device<br>Praxis Medical<br>CytoCore | Comparison | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K# | K230778 | K213060 | K200278 | - | | Product Code | KTI | KTI | KNW | - | | CFR | 21 CFR 874.4680 | 21 CFR 874.4680 | 21 CFR 876.1075 | - | | Regulation Name | Bronchoscope (Flexible or<br>Rigid) And Accessories | Bronchoscope (Flexible or<br>Rigid) And Accessories | Instrument, Biopsy | Similar | | Indications for Use | The Praxis Medical EndoCore<br>is used with ultrasound<br>endoscope to sample targeted<br>submucosal and extramural<br>lesions of the tracheobronchial<br>tree.<br>For any patient 18 years and<br>older requiring tissue sampling | The Endobronchial Ultrasound<br>Aspiration Needle is used with<br>ultrasound endoscope to sample<br>targeted submucosal and<br>extramural lesions of the<br>tracheobronchial tree. | The CytoCore is a device to<br>hold a syringe for performing<br>a biopsy of an identified mass<br>with one hand. | We have included the CytoCore<br>as a reference device because of<br>the technological difference in<br>needle movement between the<br>subject and predicate device. The<br>rotational needle movement of<br>the subject device is identical to<br>the reference device. | | Environment of Use | Hospitals, sub-acute, clinics<br>and physician office settings. | Surgical suite, endoscopy or<br>bronchoscopy suite, used with a<br>bronchoscope. | Hospitals, sub-acute, clinics<br>and physician office settings. | Similar | | Components | Needle Assembly: Handle,<br>Sheath, Needle, and Stylet<br>Syringe with stopcock<br>Adapter | Needle Assembly: Handle,<br>Sheath, Needle, and Stylet<br>Syringe with stopcock<br>Adapter | The Praxis Medical CytoCore<br>is a syringe-holding device<br>for performing a biopsy of<br>soft tissue for diagnostic<br>sampling. CytoCore does not<br>contain a needle. | Similar - The subject device and<br>predicate device have the same<br>components in that each device<br>includes a needle, syringe with<br>stopcock and adapter.<br>The reference device is a syringe<br>holding device and is only<br>referenced to support the rotating<br>mechanism. | {6}------------------------------------------------ K230778 ## 510(k) Summary Page 3 of 7 | | Subject Device<br>Praxis Medical<br>EndoCore | Predicate Device<br>Micro-Tech (Nanjing) Co.,<br>Ltd.<br>Endobronchial Ultrasound<br>Aspiration Needle | Reference Device<br>Praxis Medical<br>CytoCore | Comparison | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Principle of Operation | EndoCore is inserted through<br>an endoscope working channel<br>to the target lesion area. Once<br>in place, the healthcare provider<br>can activate the device to rotate<br>the needle to help facilitate<br>cellular material collection. The<br>syringe is used to collect the<br>tissue sample. Standard<br>vacuum syringe techniques may<br>be applied for biopsy. | The predicate device is inserted<br>through an EBUS endoscope<br>working channel to the target<br>lesion area. The syringe is used<br>to collect the tissue sample.<br>Standard vacuum syringe<br>techniques may be applied for<br>biopsy. | A needle is connected to a<br>syringe and then the needle<br>inserted into a lesion. The<br>syringe plunger is retracted to<br>create suction while the<br>subject device contains a<br>battery-powered internal<br>motor that rotates the needle.<br>This rotation harvests the<br>cellular material in a similar<br>way as the in/out motion. | Both the subject device and<br>predicate device collect the tissue<br>sample with vacuum from a<br>syringe.<br><br>The subject device uses an<br>internal motor to rotate the needle<br>to help collect cellular tissue,<br>whereas the predicate uses a to-<br>and-fro motion to collect cellular<br>tissue. This cellular material<br>collection technology (rotating<br>needle) is the same as cleared<br>under the reference device<br>(K200278). | | Patient Population | Any patient 18 years or older<br>requiring tissue sampling. | No information available. | Any patient population<br>requiring the harvest of<br>cellular material. | Although the predicate device did<br>not indicate a patient population<br>in its 510(k) summary, we<br>believe this stated patient<br>population is appropriate. | | Mode of Action | Single puncture with needle<br>rotation, though multiple<br>punctures are possible, if<br>required by the clinician. | Single/multiple puncture and<br>aspirate. | Single puncture with needle<br>rotation, though multiple<br>punctures are possible, if<br>required by the clinician. | The predicate requires at least a<br>single puncture and possibly<br>multiple punctures to gather<br>cellular material.<br>The subject device can be used as<br>a single puncture, then the needle<br>rotates (identical to the reference<br>device) to collect cellular<br>material. | {7}------------------------------------------------ K230778 ## 510(k) Summary Page 4 of 7 | | Subject Device | Predicate Device | Reference Device | Comparison | |-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Praxis Medical | Micro-Tech (Nanjing) Co., | Praxis Medical | | | | EndoCore | Ltd. | CytoCore | | | | | Endobronchial Ultrasound<br>Aspiration Needle | | | | Method of Sample<br>Collection | Standard vacuum syringe<br>technique for biopsy with a<br>rotating needle to facilitate<br>cellular material collection. | Standard vacuum syringe<br>technique for biopsy. | Standard vacuum syringe<br>technique for biopsy with a<br>rotating needle to facilitate<br>cellular material collection. | EndoCore uses a rotating needle<br>with a vacuum syringe to collect<br>cellular tissue, whereas the<br>predicate used a standard needle<br>and a vacuum syringe. The same<br>cellular material collection<br>technology for the subject device<br>was cleared under reference<br>K200278. | | Method of needle insertion<br>and advancement | Manual positioning. | Manual positioning. | Manual positioning. | Similar | | Image guidance modality | Ultrasound | Ultrasound | N/A | Similar | | Compatible Endoscope<br>Working Channel (mm) | Minimum diameter of 2.1 | Minimum 2.0 | N/A | The minimal difference in<br>working channel diameter does<br>not raise any safety or efficacy<br>concerns. | | Needle Material | Nitinol | Nitinol | No needle provided. | Similar | | Needle Gauge | 22G only | 19G, 22G, 25G | N/A | Similar | | Needle Diameter (mm) | 0.7 only | 1.1, 0.7, 0.5 | N/A | Similar | | Needle Tip | Bevel only | Bevel, Trident | N/A | Similar | | Stylet OD (inch) | 0.016 | 0.030, 0.016, 0.011 | N/A | Similar | | Maximum Needle Length<br>(mm) | 60 | 40 | N/A | The size difference in maximum<br>needle length does not raise any<br>safety or efficacy concerns. | | Working Length<br>(mm) | 665-725 | 720-760 | N/A | The size difference in working<br>length does not raise any safety<br>or efficacy concerns. | {8}------------------------------------------------ # K230778 ## 510(k) Summary Page 5 of 7 | | Subject Device<br>Praxis Medical<br>EndoCore | Predicate Device<br>Micro-Tech (Nanjing) Co.,<br>Ltd.<br>Endobronchial Ultrasound<br>Aspiration Needle | Reference Device<br>Praxis Medical<br>CytoCore | Comparison | |-------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | Maximum Insertion<br>Portion Diameter /mm | 1.6 | 1.8 | N/A | The minimal difference in<br>maximum insertion portion<br>diameter does not raise any safety<br>or efficacy concerns. | | Supplied Sterile | Yes | Yes | Yes | Similar | | Packaging | Device is placed in a 1073B<br>uncoated Tyvek pouch, then<br>sterilized. | Needle assembly, syringe with<br>stopcock and adapter are placed<br>in tray with snap downs. Tray<br>placed in pouch. Pouch placed in<br>case box for sterilization. | N/A | Similar | | Shelf Life | One year | Three years | N/A | The difference in shelf life does<br>not raise any new safety or<br>efficacy questions. | | Biocompatibility | Tested per ISO 10993-1 | Tested per ISO 10993-1 | Tested per ISO 10993-1 | Similar | | Sterilization | Gamma Sterilized using the<br>VDmax25 method<br>SAL:10-6 | EO Sterilized<br>SAL:10-6 | N/A | The difference in sterilization<br>method does not raise any new<br>safety or efficacy questions. | | Labeling | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 | Similar | {9}------------------------------------------------ #### Non-clinical Testing Performance testing demonstrated that the subject device met its acceptance criteria. Testing included: #### Biocompatibility - ISO 10993-1: Biological Evaluation ● - ISO 10993-5: Cytotoxicity ● - ISO 10993-10: Sensitization ● - ISO 10993-10: Intracutaneous Reactivity ● - ISO 10993-11: Acute Systemic Toxicity ● - . ISO 10993-11: Material-Mediated Pyrogenicity - . Bacterial Endotoxin ### Electromagnetic Compatibility and Electrical Safety - IEC 60601-1: 2005 + A1: 2012 Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance - IEC 60601-1-2: 2020 Collateral standard: Electromagnetic Disturbances Requirements ● and Tests - IEC 60601-1-6:2010+AMD1:2013 Medical electrical equipment Part 1-6: General ● requirements for basic safety and essential performance - Collateral standard: Usability #### Bench Testing - ISO 80369-1:2018 Small-bore connectors for liquids and gases in healthcare ● applications - Part 1: General requirements - . ISO 80369-7:2021 - Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications - ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare ● applications - Part 20: Common test methods - . ISO 11070:2014 - Sterile single-use intravascular introducers, dilators and guidewires - . Mechanical, Drop and Transit Testing - . EndoCore EBUS Adapter Leakage - Needle Wobble - Radiopacity ● - Scope Compatibility - Ultrasound Compatibility ● ### Intended Use/ Indications for Use The indications for use for the subject device are identical to the predicate device -Endobronchial Ultrasound Aspiration Needle - K213060. #### Technological Characteristics and Principles of Operation The technological characteristics and principle of operation are similar, with the exception of needle movement (to- and fro- motion vs. needle rotation) to the device – Endobronchial Ultrasound Aspiration Needle - K213060. As stated, the subject device uses an internal motor to rotate the needle to help collect cellular tissue. This cellular material collection technology (rotating needle) is the same as cleared under the reference device (K200278). {10}------------------------------------------------ #### Environment of Use - The environment of use is identical. Discussion - The environments of use are identical to the predicate - Endobronchial Ultrasound Aspiration Needle - K213060. #### Patient Population - Though the predicate device does not list a specific patient population, we have included our proposed patient population. For any patient 18 years and older requiring tissue sampling Discussion - The patient population is equivalent to the predicate device - Endobronchial Ultrasound Aspiration Needle - K213060. #### Conclusion Based upon the performance testing and comparison of technological characteristics, indications for use, the subject device is substantially equivalent to the legally marketed predicate device -Endobronchial Ultrasound Aspiration Needle - K213060.