(188 days)
No
The summary does not mention AI, ML, image processing, or any related concepts, and the device description focuses on a mechanical biopsy tool.
No.
This device is designed to sample tissue for diagnostic purposes, not to treat a condition or restore health.
No
The device is used for tissue sampling (biopsy), which is a procedure to obtain samples, not to diagnose directly. While the samples may be used for a diagnostic process, the device itself is a tool for sample collection.
No
The description explicitly states the device is used "with ultrasound endoscope" and is a "fine needle aspiration (FNA) and fine needle biopsy (FNB)" device, indicating it is a physical medical device, not software only. Performance studies also include biocompatibility, electromagnetic compatibility, and electrical safety, which are typical for hardware devices.
Based on the provided information, the Praxis Medical EndoCore is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used in vitro (in glass, or outside the body) to provide information about a patient's health status.
- The EndoCore is a device used within the human body to obtain a specimen. It is a tool for tissue sampling (biopsy and aspiration) from lesions within the tracheobronchial tree.
The device's intended use and description clearly indicate it's a surgical/interventional tool for obtaining tissue samples, not for analyzing those samples once they've been collected. The analysis of the collected tissue would likely be performed using IVD methods in a laboratory setting, but the EndoCore itself is not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
KTI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Tracheobronchial tree.
Indicated Patient Age Range
18 years and older
Intended User / Care Setting
Hospitals, sub-acute, clinics and physician office settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: Performance testing demonstrated that the subject device met its acceptance criteria. Testing included Biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, Bacterial Endotoxin), Electromagnetic Compatibility and Electrical Safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6), and Bench Testing (ISO 80369-1, ISO 80369-7, ISO 80369-20, ISO 11070, Mechanical, Drop and Transit Testing, EndoCore EBUS Adapter Leakage, Needle Wobble, Radiopacity, Scope Compatibility, Ultrasound Compatibility).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
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)
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
4
| 510(k) Summary
| Page 1 of 7 | |
|---|---|
| Date Prepared: | 21-Sep-2023 |
| Praxis Medical, LLC | |
| 500 N Willow Ave. Ste 101 | |
| Tampa, FL 33606 | |
| 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 |
| Bronchoscope (Flexible or Rigid) And Accessories | |
| Predicate Device: | Endobronchial Ultrasound Aspiration Needle - K213060 |
| Device Description: | 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. | |
| Principle of Operation: | EndoCore is inserted through an endoscope working |
| channel to the target lesion area. Once in place, the | |
| healthcare provider pushes a button to activate a battery | |
| powered internal motor to rotate the needle to facilitate | |
| cellular material collection. | |
| Indications for Use: | 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. |
5
K230778 510(k) Summary Page 2 of 7
Table 1: Comparison of Subject vs. Predicate and Reference Devices
| | Subject Device
Praxis Medical
EndoCore | Predicate Device
Micro-Tech (Nanjing) Co.,
Ltd.
Endobronchial Ultrasound
Aspiration Needle | Reference Device
Praxis Medical
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
Rigid) And Accessories | Bronchoscope (Flexible or
Rigid) And Accessories | Instrument, Biopsy | Similar |
| Indications for Use | 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 Endobronchial Ultrasound
Aspiration Needle is used with
ultrasound endoscope to sample
targeted submucosal and
extramural lesions of the
tracheobronchial tree. | The CytoCore is a device to
hold a syringe for performing
a biopsy of an identified mass
with one hand. | We have included the CytoCore
as a reference device because of
the technological difference in
needle movement between the
subject and predicate device. The
rotational needle movement of
the subject device is identical to
the reference device. |
| Environment of Use | Hospitals, sub-acute, clinics
and physician office settings. | Surgical suite, endoscopy or
bronchoscopy suite, used with a
bronchoscope. | Hospitals, sub-acute, clinics
and physician office settings. | Similar |
| Components | Needle Assembly: Handle,
Sheath, Needle, and Stylet
Syringe with stopcock
Adapter | Needle Assembly: Handle,
Sheath, Needle, and Stylet
Syringe with stopcock
Adapter | The Praxis Medical CytoCore
is a syringe-holding device
for performing a biopsy of
soft tissue for diagnostic
sampling. CytoCore does not
contain a needle. | Similar - The subject device and
predicate device have the same
components in that each device
includes a needle, syringe with
stopcock and adapter.
The reference device is a syringe
holding device and is only
referenced to support the rotating
mechanism. |
6
510(k) Summary Page 3 of 7
| | Subject Device
Praxis Medical
EndoCore | Predicate Device
Micro-Tech (Nanjing) Co.,
Ltd.
Endobronchial Ultrasound
Aspiration Needle | Reference Device
Praxis Medical
CytoCore | Comparison |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of Operation | EndoCore is inserted through
an endoscope working channel
to the target lesion area. Once
in place, the healthcare provider
can activate the device to rotate
the needle to help facilitate
cellular material collection. The
syringe is used to collect the
tissue sample. Standard
vacuum syringe techniques may
be applied for biopsy. | The predicate device is inserted
through an EBUS endoscope
working channel to the target
lesion area. The syringe is used
to collect the tissue sample.
Standard vacuum syringe
techniques may be applied for
biopsy. | A needle is connected to a
syringe and then the needle
inserted into a lesion. The
syringe plunger is retracted to
create suction while the
subject device contains a
battery-powered internal
motor that rotates the needle.
This rotation harvests the
cellular material in a similar
way as the in/out motion. | Both the subject device and
predicate device collect the tissue
sample with vacuum from a
syringe.
The subject device uses an
internal motor to rotate the needle
to help collect cellular tissue,
whereas the predicate uses a to-
and-fro motion to collect cellular
tissue. This cellular material
collection technology (rotating
needle) is the same as cleared
under the reference device
(K200278). |
| Patient Population | Any patient 18 years or older
requiring tissue sampling. | No information available. | Any patient population
requiring the harvest of
cellular material. | Although the predicate device did
not indicate a patient population
in its 510(k) summary, we
believe this stated patient
population is appropriate. |
| Mode of Action | Single puncture with needle
rotation, though multiple
punctures are possible, if
required by the clinician. | Single/multiple puncture and
aspirate. | Single puncture with needle
rotation, though multiple
punctures are possible, if
required by the clinician. | The predicate requires at least a
single puncture and possibly
multiple punctures to gather
cellular material.
The subject device can be used as
a single puncture, then the needle
rotates (identical to the reference
device) to collect cellular
material. |
7
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 | ||||
| Aspiration Needle | ||||
| Method of Sample | ||||
| Collection | Standard vacuum syringe | |||
| technique for biopsy with a | ||||
| rotating needle to facilitate | ||||
| cellular material collection. | Standard vacuum syringe | |||
| technique for biopsy. | Standard vacuum syringe | |||
| technique for biopsy with a | ||||
| rotating needle to facilitate | ||||
| cellular material collection. | EndoCore uses a rotating needle | |||
| with a vacuum syringe to collect | ||||
| cellular tissue, whereas the | ||||
| predicate used a standard needle | ||||
| and a vacuum syringe. The same | ||||
| cellular material collection | ||||
| technology for the subject device | ||||
| was cleared under reference | ||||
| K200278. | ||||
| Method of needle insertion | ||||
| and advancement | Manual positioning. | Manual positioning. | Manual positioning. | Similar |
| Image guidance modality | Ultrasound | Ultrasound | N/A | Similar |
| Compatible Endoscope | ||||
| Working Channel (mm) | Minimum diameter of 2.1 | Minimum 2.0 | N/A | The minimal difference in |
| working channel diameter does | ||||
| not raise any safety or efficacy | ||||
| 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 | ||||
| (mm) | 60 | 40 | N/A | The size difference in maximum |
| needle length does not raise any | ||||
| safety or efficacy concerns. | ||||
| Working Length | ||||
| (mm) | 665-725 | 720-760 | N/A | The size difference in working |
| length does not raise any safety | ||||
| or efficacy concerns. |
8
K230778
510(k) Summary Page 5 of 7
| | Subject Device
Praxis Medical
EndoCore | Predicate Device
Micro-Tech (Nanjing) Co.,
Ltd.
Endobronchial Ultrasound
Aspiration Needle | Reference Device
Praxis Medical
CytoCore | Comparison |
|-------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Maximum Insertion
Portion Diameter /mm | 1.6 | 1.8 | N/A | The minimal difference in
maximum insertion portion
diameter does not raise any safety
or efficacy concerns. |
| Supplied Sterile | Yes | Yes | Yes | Similar |
| Packaging | Device is placed in a 1073B
uncoated Tyvek pouch, then
sterilized. | Needle assembly, syringe with
stopcock and adapter are placed
in tray with snap downs. Tray
placed in pouch. Pouch placed in
case box for sterilization. | N/A | Similar |
| Shelf Life | One year | Three years | N/A | The difference in shelf life does
not raise any new safety or
efficacy questions. |
| Biocompatibility | Tested per ISO 10993-1 | Tested per ISO 10993-1 | Tested per ISO 10993-1 | Similar |
| Sterilization | Gamma Sterilized using the
VDmax25 method
SAL:10-6 | EO Sterilized
SAL:10-6 | N/A | The difference in sterilization
method does not raise any new
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.