(301 days)
No
The device description and performance studies focus on the mechanical and material properties of a needle used for tissue sampling, with no mention of AI or ML for image analysis, guidance, or other functions.
No
The device is used to sample lesions for diagnostic purposes, not to treat or cure a disease.
Yes
Explanation: The device is used to "sample targeted submucosal and extramural lesions" for the purpose of diagnosis. Sampling tissue for analysis is a key step in diagnosing diseases.
No
The device description clearly outlines physical components such as a needle, sheath, handle, adaptors, and a negative suction device, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Endobronchial Ultrasound Aspiration Needle is a surgical/interventional device used to obtain a sample of tissue from the tracheobronchial tree. It is a tool for collecting the sample, not for analyzing it or performing a diagnostic test on it.
- Intended Use: The intended use clearly states it is used "to sample targeted submucosal and extramural lesions." This describes the act of obtaining a sample, not performing a diagnostic test on that sample.
- Device Description: The description details the physical components and how the device is used to penetrate tissue and aspirate a sample. It does not mention any components or processes related to analyzing the collected sample for diagnostic purposes.
- Performance Studies: The performance studies focus on the physical characteristics, safety, and functionality of the device itself (biocompatibility, sterilization, shelf-life, bench tests like puncture force, aspiration capability, etc.). They do not involve evaluating the diagnostic accuracy of any test performed on the collected samples.
While the collected sample may be used for subsequent in vitro diagnostic testing (e.g., pathology or cytology), the needle itself is the instrument for obtaining the sample, not the diagnostic test itself.
N/A
Intended Use / Indications for Use
The Endobronchial Ultrasound Aspiration Needle is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree.
Product codes
KTI
Device Description
The proposed device Endobronchial Ultrasound Aspiration Needle is a sterile, single-use bronchoscopic device, is designed to sample targeted submucosal and extramural lesions of the tracheobronchial tree. The Endobronchial Ultrasound Aspiration Needle consists of an Aspiration Needle, Adaptors and Negative suction device (Stopcock and Syringe). Wherein, the Aspiration Needle consists of a handle, sheath, needle, and stylet. The handle is connected to the channel port of a bronchoscope via the proper adaptor. The needle is deployed in the sheath and projected from the sheath to penetrate the target lesion to serve sample by advancement of handle. The stylet is in place in order to provide protection to the inside of the needle tube and sheath during device passage, and also used to expel the sample after the procedure. The adaptors are provided different bronchoscopes with compatibility and attached onto the channel port as the middleware between a bronchoscope and the aspiration needle. The negative suction device is connected to the proximal end of the handle to aspirate the removed tissue.
The Endobronchial Ultrasound Aspiration Needle has echogenic features and is visible under ultrasound at the distal end to facilitate real time visualization of the device under ultrasound.
The proposed device has six models, and the main differences of these models are diameter and tip type of the needle. The Endobronchial Ultrasound Aspiration Needle offers 19G, 22G, 25G needles by size or gauge to respond various clinical options of accessing and sampling. There are two kinds of different tip design (bevel and trident) of needles for FNA (Fine Needle Aspiration) and FNB (Fine Needle Biopsy). The device is identified as is Areus™ Endobronchial Ultrasound Aspiration Needle and Trident™ Endobronchial Ultrasound Aspiration Needle by trade name.
The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10th and placed in a sterility maintenance package to ensure a shelf life of 3 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Tracheobronchial tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical suite, endoscopy or bronchoscopy suite, used with a bronchoscope
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)
The biocompatibility evaluation for the Endobronchial Ultrasound Aspiration Needle was conducted in accordance with FDA Guidance, Use of International Standard ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on September 4, 2020, the following tests were conducted:
- a) Cytotoxicity
- b) Sensitization
- C) Irritation
- d) Acute System Toxicity
- Pyrogen e)
- Hemocompatibility (Hemolysis, thrombogenicity and complement activation testing) f)
Sterilization validation of Endobronchial Ultrasound Aspiration Needle was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
Shelf-life testing and packaging integrity testing of Endobronchial Ultrasound Aspiration Needle was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. Three-years accelerated aging test have been performed to demonstrate the stability during the shelf life.
During design verification, the following bench tests were performed on Endobronchial Ultrasound Aspiration Needle:
-
Dimension;
- A Sheath and Needle Insertion and Withdrawal force;
-
Stylet Insertion and Withdrawal Force;
-
Puncture Force;
-
Ultrasound Visibility;
-
Locking Force of Handle Portion;
- Adjustment Length; >
-
Attach and Detach Adaptor to Scope;
- A Tensile Strength;
-
Durability;
- A Aspiration Capability.
-
Transmission Force
- A Needle Deformation Angle
The results of all the performance testing demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device Vizishot 2 Flex.
No animal study is included in this submission.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K163248, K151895, K190239, K172309
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 for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States.
Micro-Tech (Nanjing) Co., Ltd. Sally He R A Engineer No. 10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone Nanjing, Jiangsu Province 210032 China
Re: K213060
Trade/Device Name: AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: KTI Dated: June 17, 2022 Received: June 21, 2022
Dear Sally He:
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 medical devices and radiation-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.
Brandon Blakely Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Endobronchial Ultrasound Aspiration Needle
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
The Endobronchial Ultrasound Aspiration Needle is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree.
| ☑ 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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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
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Image /page/3/Picture/0 description: The image shows a logo with the letters "MT" in a stylized, three-dimensional block font. The letters are in a dark blue color, and the logo has a registered trademark symbol (®) in the upper right corner. The logo appears to be designed to give a sense of depth and solidity.
510K Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with
requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K213060
1. Sponsor Identification
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing, Jiangsu Province,
PRC
Establishment Registration Number: 3004837686
Contact Person: Sally He
Position: RA Engineer
Tel: +86-25-58646395
Fax: +86-25-58350006
Email: RA.Micro-Tech@outlook.com
2. Identification of Proposed Device
Product Name: Endobronchial Ultrasound Aspiration Needle
Trade Name:
Areus™ Endobronchial Ultrasound Aspiration Needle Trident™ Endobronchial Ultrasound Aspiration Needle
Common Name: Aspiration Needle
Regulatory Information
Classification Name: Bronchoscope (flexible or rigid) and accessories
Classification: 2
Product Code: KTI
Regulation Number: 874.4680
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Image /page/4/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the right. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. The logo has a modern and corporate feel.
Identification of Predicate Device 3.
Predicate Device :
510(k) Number: K163469
Device Name: Vizishot 2 Flex
Manufacture: Olympus Surgical Technologies America
Reference Device 1:
510(k) Number: K163248, K151895
Device Name: Aquire™ Pulmonary Endobronchial Ultrasound Fine Needle Biopsy (FNB) Device
Manufacture: Boston Scientific Corporation
Note: This reference device is used to as a reference for the FNB needle of proposed device.
Reference Device 2:
510(k) Number: K190239
Device Name: Single Use Aspiration Needle
Manufacture: Olympus Surgical Technologies America
Note: This reference device is used to as a reference for the 25G needle of proposed device.
Reference Device 3:
510(k) Number: K172309
Device Name: Endoscopic Ultrasound Aspiration Needle
Manufacture: Micro-Tech (Nanjing) CO, Ltd.
Note: This reference device is used to as a reference for the selected acceptance criteria of puncture force of proposed device.
4. Indications for Use
The Endobronchial Ultrasound Aspiration Needle is used with ultrasound endoscope to sample targeted submucosal and extramural lesions of the tracheobronchial tree.
5
Device Description 5.
The proposed device Endobronchial Ultrasound Aspiration Needle is a sterile, single-use bronchoscopic device, is designed to sample targeted submucosal and extramural lesions of the tracheobronchial tree. The Endobronchial Ultrasound Aspiration Needle consists of an Aspiration Needle, Adaptors and Negative suction device (Stopcock and Syringe). Wherein, the Aspiration Needle consists of a handle, sheath, needle, and stylet. The handle is connected to the channel port of a bronchoscope via the proper adaptor. The needle is deployed in the sheath and projected from the sheath to penetrate the target lesion to serve sample by advancement of handle. The stylet is in place in order to provide protection to the inside of the needle tube and sheath during device passage, and also used to expel the sample after the procedure. The adaptors are provided different bronchoscopes with compatibility and attached onto the channel port as the middleware between a bronchoscope and the aspiration needle. The negative suction device is connected to the proximal end of the handle to aspirate the removed tissue.
The Endobronchial Ultrasound Aspiration Needle has echogenic features and is visible under ultrasound at the distal end to facilitate real time visualization of the device under ultrasound.
The proposed device has six models, and the main differences of these models are diameter and tip type of the needle. The Endobronchial Ultrasound Aspiration Needle offers 19G, 22G, 25G needles by size or gauge to respond various clinical options of accessing and sampling. There are two kinds of different tip design (bevel and trident) of needles for FNA (Fine Needle Aspiration) and FNB (Fine Needle Biopsy). The device is identified as is Areus™ Endobronchial Ultrasound Aspiration Needle and Trident™ Endobronchial Ultrasound Aspiration Needle by trade name.
The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10th and placed in a sterility maintenance package to ensure a shelf life of 3 years.
6. Comparison of Technological Characteristics
The Endobronchial Ultrasound Aspiration Needle incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Vizishot 2 Flex (K163469).
Comparison to Predicate Devices:
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Image /page/6/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are bold and appear to be interconnected, creating a sense of unity and strength. A registered trademark symbol is located in the upper right corner of the logo.
| Item | Proposed Device
Endobronchial Ultrasound
Aspiration Needle | Predicate Device
Vizishot 2 Flex (K163469) | Remark |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | KTI | KTI | Identical |
| Regulation No. | 874.4680 | 874.4680 | Identical |
| Class | 2 | 2 | Identical |
| Indications for
Use | The Endobronchial Ultrasound
Aspiration Needle is used with
ultrasound endoscope to sample
targeted submucosal and
extramural lesions of the
tracheobronchial tree. | The ViziShot 2 FLEX has been
designed to be used with
ultrasound endoscopes for
ultrasound guided fine needle
aspiration (FNA) of submucosal
and extramural lesions of the
tracheobronchial tree. Do not use
this device for any purpose other
than its intended use. | SE |
| Use Condition | Surgical suite, endoscopy or
bronchoscopy suite, used with a
bronchoscope | Surgical suite, endoscopy or
bronchoscopy suite, used with a
bronchoscope | SE |
| Mechanics of
Action | Manual | Manual | SE |
| Mode of Action | Single/multiple puncture and
aspirate | Single/multiple puncture and
aspirate | SE |
| General
Configuration | Needle Assebly: Handle, Sheath, Needle, Stylet; Syringe with stopcock Adapter | Needle Assebly: Handle, Sheath, Needle, Stylet; Syringe with stopcock Adapter | SE |
| Main Materials | PVDF, Nitinol | Stainless Steel, PTFE,
PEBAX, Nitinol | Different, the
material of proposed
device meet the
requirement of ISO
10993 series standard |
| Needle Gauge | 19G, 22G, 25G | 19G | Different, more |
| Needle Diameter
/mm | 1.1, 0.7, 0.5 | 1.1 | options than
predicate device. For |
| Needle Tip | Bevel, Trident | Bevel | the different models,
reference 1 and
reference 2 were used |
| Item | Proposed Device
Endobronchial Ultrasound
Aspiration Needle | Predicate Device
Vizishot 2 Flex (K163469) | Remark |
| | | | and the side-by-side
comparison testing
was conducted to
ensure the safety and
effectiveness. |
| Stylet OD (inch) | 0.030, 0.016, 0.011 | 0.020 | Different, different
needle gauge match
different stylet.
Note: the Stylet OD
of predicate device is
tested by us. |
| Maximum Needle
Length /mm | 40 | 40 | SE |
| Working Length
/mm | 720-760 | 700 | SE |
| Maximum
Insertion Portion
Diameter /mm | 1.8 | 2.1 | Different, smaller
sheath diameter can
match smaller |
| Compatible
endoscopy
working channel | Minimum 2.0mm | Minimum 2.2mm | endoscopy working
channel. More
options than
predicate device. |
| Single Use | Yes | Yes | SE |
| Supplied in
Sterile | Yes | Yes | SE |
| Packaging | 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. | Needle assembly in tray with snap
downs. Tray placed in pouch.
Pouch placed in shelf box (dust
cover) for sterilization.
After sterilization, the sterile
pouched syringe and sterile
pouched adapter will be added to
the dust cover. | Different, the
packaging of
proposed device have
passed the packaging
validation according
to ISO 11607-1 and
ISO 11607-2 |
| Item | Proposed Device
Endobronchial Ultrasound
Aspiration Needle | Predicate Device
Vizishot 2 Flex (K163469) | Remark |
| Shelf Life | Three years | Three years | SE |
| Biocompatibility | Conform to ISO 10993-1 | Conform to ISO 10993-1 | SE |
| Sterilization | EO Sterilized, SAL:10-6 | EO Sterilized, SAL:10-6 | SE |
| Labeling | Conform to 21 CFR part 801 | Conform to 21 CFR part 801 | SE |
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Image /page/7/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, blocky font. The letters are interconnected and have a three-dimensional appearance, with the left side of the "M" appearing to recede into the background. A registered trademark symbol (®) is positioned in the upper right corner of the logo.
8
Image /page/8/Picture/0 description: The image shows a logo with the letters 'MT' in a stylized, three-dimensional font. The letters are in a dark blue color. The 'M' is on the left, and the 'T' is on the right, with the 'T' slightly overlapping the 'M'. A circled 'R' trademark symbol is located in the upper right corner of the image.
The proposed device is similar in design to Vizishot 2 Flex, the main needle diameter and needle tip of proposed device are different to that of predicate device. For the difference, two reference devices (Aquire™ Pulmonary Endobronchial Ultrasound Fine Needle Biopsy (FNB) Device from Boston Scientific Corporation and Single Use Aspiration Needle from Olympus Surgical Technologies America) was selected. All comparative nonclinical performance testing have been tested and have met the requirements of substantial equivalence to the predicate device/reference device.
Therefore, the difference between proposed device and predicated device is considered not to affect the substantially equivalency between the proposed and predicate devices concerning the safety and effectiveness.
Performance Data 7.
The biocompatibility evaluation for the Endobronchial Ultrasound Aspiration Needle was conducted in accordance with FDA Guidance, Use of International Standard ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on September 4, 2020, the following tests were conducted:
- a) Cytotoxicity
- b) Sensitization
- C) Irritation
- d) Acute System Toxicity
- Pyrogen e)
- Hemocompatibility (Hemolysis, thrombogenicity and complement activation testing) f)
9
Sterilization validation of Endobronchial Ultrasound Aspiration Needle was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
Shelf-life testing and packaging integrity testing of Endobronchial Ultrasound Aspiration Needle was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. Three-years accelerated aging test have been performed to demonstrate the stability during the shelf life.
During design verification, the following bench tests were performed on Endobronchial Ultrasound Aspiration Needle:
-
Dimension;
- A Sheath and Needle Insertion and Withdrawal force;
-
Stylet Insertion and Withdrawal Force;
-
Puncture Force;
-
Ultrasound Visibility;
-
Locking Force of Handle Portion;
- Adjustment Length; >
-
Attach and Detach Adaptor to Scope;
- A Tensile Strength;
-
Durability;
- A Aspiration Capability.
-
Transmission Force
- A Needle Deformation Angle
The results of all the performance testing demonstrated that the proposed device met the predetermined
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Image /page/10/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be stacked on top of each other, creating a blocky, geometric design. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
acceptance criteria and is substantial equivalence to the predicate device Vizishot 2 Flex.
8. Animal Test Conclusion
No animal study is included in this submission.
9. Clinical Test Conclusion
No clinical study is included in this submission.
10. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the
Endobronchial Ultrasound Aspiration Needle has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device Vizishot 2 Flex (K163469).