(188 days)
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.
The EndoCore is intended to be used with endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree.
The Praxis Medical EndoCore is a device used with an ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree in patients 18 years and older requiring tissue sampling. The device utilizes a battery-powered internal motor to rotate the needle, facilitating cellular material collection, and employs standard vacuum syringe techniques for biopsy.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility | ISO 10993-1: Biological Evaluation | Met acceptance criteria. |
| ISO 10993-5: Cytotoxicity | Met acceptance criteria. | |
| ISO 10993-10: Sensitization | Met acceptance criteria. | |
| ISO 10993-10: Intracutaneous Reactivity | Met acceptance criteria. | |
| ISO 10993-11: Acute Systemic Toxicity | Met acceptance criteria. | |
| ISO 10993-11: Material-Mediated Pyrogenicity | Met acceptance criteria. | |
| Bacterial Endotoxin | Met acceptance criteria. | |
| Electromagnetic Compatibility and Electrical Safety | IEC 60601-1: 2005 + A1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance | Met acceptance criteria. |
| IEC 60601-1-2: 2020 Collateral standard: Electromagnetic Disturbances Requirements and Tests | Met acceptance criteria. | |
| IEC 60601-1-6:2010+AMD1:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Met acceptance criteria. | |
| Bench Testing | ISO 80369-1:2018 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements | Met acceptance criteria. |
| ISO 80369-7:2021 - Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications | Met acceptance criteria. | |
| ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods | Met acceptance criteria. | |
| ISO 11070:2014 - Sterile single-use intravascular introducers, dilators and guidewires | Met acceptance criteria. | |
| Mechanical, Drop and Transit Testing | Met acceptance criteria. | |
| EndoCore EBUS Adapter Leakage | Met acceptance criteria. | |
| Needle Wobble | Met acceptance criteria. | |
| Radiopacity | Met acceptance criteria. | |
| Scope Compatibility | Met acceptance criteria. | |
| Ultrasound Compatibility | Met acceptance criteria. | |
| Sterility | Gamma Sterilized using the VDmax25 method SAL:10-6 | The device is supplied sterile with a Sterility Assurance Level (SAL) of 10^-6, indicating an effective sterilization process. |
| Shelf Life | One year | The device has a one-year shelf life. This difference from the predicate's three-year shelf life does not raise new safety or efficacy questions. |
| Labeling | Conforms to 21 CFR part 801 | Labeling is compliant with 21 CFR part 801 requirements. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size used for each "test set" within the non-clinical testing. The non-clinical testing consisted of various laboratory-based tests (Biocompatibility, EMC/Electrical Safety, Bench Testing) and did not involve human patient data test sets. Therefore, data provenance such as "country of origin" or "retrospective/prospective" is not applicable in the context of these specific non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to the provided document. The non-clinical tests described are objective, laboratory-based evaluations against recognized standards (e.g., ISO, IEC). There is no mention of "experts" being used to establish a subjective "ground truth" for these performance tests, nor are there any clinical studies involving expert interpretation of device output.
4. Adjudication Method for the Test Set
This question is not applicable. The non-clinical tests are objective and do not involve adjudication by experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study, AI assistance, or human reader improvement in the provided document. The device is a physical instrument for tissue sampling, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical instrument and does not involve an algorithm working in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical performance tests is represented by established international and national standards (e.g., ISO 10993, IEC 60601, ISO 80369, ISO 11070) for medical device safety and performance. Device performance was evaluated against the requirements outlined in these standards.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical instrument, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as point 8.
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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"
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(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
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OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
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)
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FORM FDA 3881 (6/20)
Page 1 of 1
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| 510(k) SummaryPage 1 of 7 | |
|---|---|
| Date Prepared: | 21-Sep-2023 |
| Praxis Medical, LLC500 N Willow Ave. Ste 101Tampa, FL 33606Tel – 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 – KTIBronchoscope (Flexible or Rigid) And Accessories |
| Predicate Device: | Endobronchial Ultrasound Aspiration Needle - K213060 |
| Device Description: | The EndoCore is intended to be used with endoscopesfor ultrasound guided fine needle aspiration (FNA) andfine needle biopsy (FNB) of submucosal and extramurallesions of the tracheobronchial tree. |
| Principle of Operation: | EndoCore is inserted through an endoscope workingchannel to the target lesion area. Once in place, thehealthcare provider pushes a button to activate a batterypowered internal motor to rotate the needle to facilitatecellular material collection. |
| Indications for Use: | The Praxis Medical EndoCore is used with ultrasoundendoscope to sample targeted submucosal andextramural lesions of the tracheobronchial tree. For anypatient 18 years and older requiring tissue sampling. |
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K230778 510(k) Summary Page 2 of 7
Table 1: Comparison of Subject vs. Predicate and Reference Devices
| Subject DevicePraxis MedicalEndoCore | Predicate DeviceMicro-Tech (Nanjing) Co.,Ltd.Endobronchial UltrasoundAspiration Needle | Reference DevicePraxis MedicalCytoCore | 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 orRigid) And Accessories | Bronchoscope (Flexible orRigid) And Accessories | Instrument, Biopsy | Similar |
| Indications for Use | The Praxis Medical EndoCoreis used with ultrasoundendoscope to sample targetedsubmucosal and extramurallesions of the tracheobronchialtree.For any patient 18 years andolder requiring tissue sampling | The Endobronchial UltrasoundAspiration Needle is used withultrasound endoscope to sampletargeted submucosal andextramural lesions of thetracheobronchial tree. | The CytoCore is a device tohold a syringe for performinga biopsy of an identified masswith one hand. | We have included the CytoCoreas a reference device because ofthe technological difference inneedle movement between thesubject and predicate device. Therotational needle movement ofthe subject device is identical tothe reference device. |
| Environment of Use | Hospitals, sub-acute, clinicsand physician office settings. | Surgical suite, endoscopy orbronchoscopy suite, used with abronchoscope. | Hospitals, sub-acute, clinicsand physician office settings. | Similar |
| Components | Needle Assembly: Handle,Sheath, Needle, and StyletSyringe with stopcockAdapter | Needle Assembly: Handle,Sheath, Needle, and StyletSyringe with stopcockAdapter | The Praxis Medical CytoCoreis a syringe-holding devicefor performing a biopsy ofsoft tissue for diagnosticsampling. CytoCore does notcontain a needle. | Similar - The subject device andpredicate device have the samecomponents in that each deviceincludes a needle, syringe withstopcock and adapter.The reference device is a syringeholding device and is onlyreferenced to support the rotatingmechanism. |
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510(k) Summary Page 3 of 7
| Subject DevicePraxis MedicalEndoCore | Predicate DeviceMicro-Tech (Nanjing) Co.,Ltd.Endobronchial UltrasoundAspiration Needle | Reference DevicePraxis MedicalCytoCore | Comparison | |
|---|---|---|---|---|
| Principle of Operation | EndoCore is inserted throughan endoscope working channelto the target lesion area. Oncein place, the healthcare providercan activate the device to rotatethe needle to help facilitatecellular material collection. Thesyringe is used to collect thetissue sample. Standardvacuum syringe techniques maybe applied for biopsy. | The predicate device is insertedthrough an EBUS endoscopeworking channel to the targetlesion area. The syringe is usedto collect the tissue sample.Standard vacuum syringetechniques may be applied forbiopsy. | A needle is connected to asyringe and then the needleinserted into a lesion. Thesyringe plunger is retracted tocreate suction while thesubject device contains abattery-powered internalmotor that rotates the needle.This rotation harvests thecellular material in a similarway as the in/out motion. | Both the subject device andpredicate device collect the tissuesample with vacuum from asyringe.The subject device uses aninternal motor to rotate the needleto help collect cellular tissue,whereas the predicate uses a to-and-fro motion to collect cellulartissue. This cellular materialcollection technology (rotatingneedle) is the same as clearedunder the reference device(K200278). |
| Patient Population | Any patient 18 years or olderrequiring tissue sampling. | No information available. | Any patient populationrequiring the harvest ofcellular material. | Although the predicate device didnot indicate a patient populationin its 510(k) summary, webelieve this stated patientpopulation is appropriate. |
| Mode of Action | Single puncture with needlerotation, though multiplepunctures are possible, ifrequired by the clinician. | Single/multiple puncture andaspirate. | Single puncture with needlerotation, though multiplepunctures are possible, ifrequired by the clinician. | The predicate requires at least asingle puncture and possiblymultiple punctures to gathercellular material.The subject device can be used asa single puncture, then the needlerotates (identical to the referencedevice) to collect cellularmaterial. |
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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 UltrasoundAspiration Needle | ||||
| Method of SampleCollection | Standard vacuum syringetechnique for biopsy with arotating needle to facilitatecellular material collection. | Standard vacuum syringetechnique for biopsy. | Standard vacuum syringetechnique for biopsy with arotating needle to facilitatecellular material collection. | EndoCore uses a rotating needlewith a vacuum syringe to collectcellular tissue, whereas thepredicate used a standard needleand a vacuum syringe. The samecellular material collectiontechnology for the subject devicewas cleared under referenceK200278. |
| Method of needle insertionand advancement | Manual positioning. | Manual positioning. | Manual positioning. | Similar |
| Image guidance modality | Ultrasound | Ultrasound | N/A | Similar |
| Compatible EndoscopeWorking Channel (mm) | Minimum diameter of 2.1 | Minimum 2.0 | N/A | The minimal difference inworking channel diameter doesnot raise any safety or efficacyconcerns. |
| 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(mm) | 60 | 40 | N/A | The size difference in maximumneedle length does not raise anysafety or efficacy concerns. |
| Working Length(mm) | 665-725 | 720-760 | N/A | The size difference in workinglength does not raise any safetyor efficacy concerns. |
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K230778
510(k) Summary Page 5 of 7
| Subject DevicePraxis MedicalEndoCore | Predicate DeviceMicro-Tech (Nanjing) Co.,Ltd.Endobronchial UltrasoundAspiration Needle | Reference DevicePraxis MedicalCytoCore | Comparison | |
|---|---|---|---|---|
| Maximum InsertionPortion Diameter /mm | 1.6 | 1.8 | N/A | The minimal difference inmaximum insertion portiondiameter does not raise any safetyor efficacy concerns. |
| Supplied Sterile | Yes | Yes | Yes | Similar |
| Packaging | Device is placed in a 1073Buncoated Tyvek pouch, thensterilized. | Needle assembly, syringe withstopcock and adapter are placedin tray with snap downs. Trayplaced in pouch. Pouch placed incase box for sterilization. | N/A | Similar |
| Shelf Life | One year | Three years | N/A | The difference in shelf life doesnot raise any new safety orefficacy questions. |
| Biocompatibility | Tested per ISO 10993-1 | Tested per ISO 10993-1 | Tested per ISO 10993-1 | Similar |
| Sterilization | Gamma Sterilized using theVDmax25 methodSAL:10-6 | EO SterilizedSAL:10-6 | N/A | The difference in sterilizationmethod does not raise any newsafety or efficacy questions. |
| Labeling | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 | Similar |
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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).
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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.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.