(307 days)
No
The description focuses on the mechanical aspects of the needle and its use with ultrasound, with no mention of AI or ML capabilities.
No
The device is described as an aspiration needle for collecting tissue specimens, which is a diagnostic procedure, not a therapeutic one.
Yes
Explanation: The device is used for fine needle aspiration to collect specimens from the tracheobronchial tree for diagnostic purposes. While the device itself is not making a diagnosis, it is performing a critical step in the diagnostic process by enabling the collection of biological samples for further analysis.
No
The device description clearly outlines a physical medical device consisting of a handle, insertion section (sheath, needle, stylet), and components for aspiration, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree." This describes a procedure to collect a sample from within the body.
- Device Description: The device is a needle used to puncture tissue and aspirate a specimen. It is used in conjunction with an ultrasound endoscope to guide the procedure.
- No Mention of In Vitro Analysis: There is no mention of the device being used to analyze a sample outside of the body (in vitro). The device's function is to obtain the sample, not to perform a diagnostic test on it.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a tool for sample collection, which is a step that precedes any potential in vitro diagnostic testing that might be performed on the collected sample.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree.
Product codes (comma separated list FDA assigned to the subject device)
KTI
Device Description
The Single Use Aspiration Needle NA-U401SX-4025N (aka ViziShot 2) is used in conjunction with Olympus ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA).
The subject devices consist of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port via the single use adapter biopsy valve (MAJ-1414). The insertion section is composed of the sheath, needle and stylet. The needle tube is stored in the sheath and extended from the sheath to puncture the target tissue to collect specimen by moving the needle slider on the handle. A syringe is attached to the aspiration port on the handle section to aspirate the specimen. The needle is dimpled for echo enhancement.
The subject devices will be sold with or without the medallion syringe manufactured by Merit Medical, which consists of the VACLOK Syringe and Stopcock.
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
Not Found
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)
- Sterilization/Shelf-life testing: Sterilization/shelf-life testing for the Single Use Aspiration Needle NA-U401SX-4025N was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Accelerated aging test for the NA-U401SX-4025N was conducted in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. The real-time aging test for three years will be performed to demonstrate longer stability and support the results of the accelerated aging test.
- Biocompatibility testing: Biocompatibility testing for the Single Use Aspiration Needle NA-U401SX-4025N was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1:2009, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The following tests were completed:
- Cytotoxicity
- Intracutaneous Study
- Sensitization
- Systemic Toxicity
- Pyrogen Study
- Performance testing - Bench: Bench testing for the Single Use Aspiration Needle NA-U401SX-4025N as listed below was conducted to ensure that the subject devices perform as intended and meet design specifications.
- Piercing
- Ultrasound visibility
- Needle extraction and retraction
- Aspiration
- Endoscope compatibility
- Handle function
- Joint Pull Strength
- Breakage Strength
- Performance testing - Animal: No animal study was performed to demonstrate substantial equivalence.
- Performance testing - Clinical: No clinical study was performed to demonstrate substantial equivalence.
- Risk analysis: A Risk analysis for the Single Use Aspiration Needle NA-U401SX-4025N was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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December 10, 2019
Olympus Medical Systems Corp. % Daphney Germain-Kolawole Senior Project Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610
Re: K190239
Trade/Device Name: Single Use Aspiration Needle Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: KTI Dated: November 25, 2019 Received: November 26, 2019
Dear Daphney Germain-Kolawole:
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,
for James J. Lee Ph.D. Assistant Director DHT1C: Division of ENT, 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
510(k) Number (if known) K190239
Device Name Single Use Aspiration Needle
Indications for Use (Describe)
This instrument has been designed to be used with ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree.
| 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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3
Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The letters are closely spaced and appear to be a sans-serif font. A thin, horizontal gold bar is located directly beneath the word, adding a subtle accent to the logo. The background is plain white.
November 25, 2019
510(k) Summary
1 GENERAL INFORMATION
■ 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
■ Contact Person: Lisa M. Boyle Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3676 Fax: 484-896-7128 Email: lisa.boyle@olympus.com
2 DEVICE IDENTIFICATION
| ■ Device Name | Single Use Aspiration Needle |
|---|---|
| ■ Model Name | NA-U401SX-4025N |
| ■ Common Name | Aspiration Needle |
| ■ Regulation Number | 21 CFR 874.4680 |
| ■ Regulation Name | Bronchoscope (flexible or rigid) and accessories |
| ■ Regulatory Class | II |
| ■ Product Code | KTI |
| ■ Classification Panel | Ear Nose & Throat |
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Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are sans-serif and appear to be a custom font. A thin, horizontal, yellow bar is located underneath the word. The logo is simple and modern.
3 PREDICATE DEVICE
■ Predicate device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| ViziShot 2 FLEX (NA-U403SX-4019) | Olympus Surgical Technologies | |
| America | K163469 |
■ Reference device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| Single Use Aspiration Needle | ||
| NA-U401SX | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K160098 | |
| Echotip Ultra Endobronchial High | ||
| Definition Ultrasound Needle, Echotip | ||
| Procore Endobronchial High | ||
| Definition Ultrasound Biopsy Needle | Cook Ireland Ltd. | K160229 |
4 DEVICE DESCRIPTION
■ General Description of the subject device
The Single Use Aspiration Needle NA-U401SX-4025N (aka ViziShot 2) is used in conjunction with Olympus ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA).
The subject devices consist of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port via the single use adapter biopsy valve (MAJ-1414). The insertion section is composed of the sheath, needle and stylet. The needle tube is stored in the sheath and extended from the sheath to puncture the target tissue to collect specimen by moving the needle slider on the handle. A syringe is attached to the aspiration port on the handle section to aspirate the specimen. The needle is dimpled for echo enhancement.
The subject devices will be sold with or without the medallion syringe manufactured by Merit Medical, which consists of the VACLOK Syringe and Stopcock.
5
■ Principle of Operation
Ultrasound emitted by the ultrasound transducer of the ultrasound endoscope diffusely reflects at dimples on the echo-enhanced region of the needle tube.
The ultrasound transducer detects the part of the ultrasound which diffusely reflects and the echo-enhanced region is indicated on an ultrasound image.
The needle tube and stylet are extracted from the sheath by moving the needle slider to the distal side and is drawn into the sheath by moving the needle slider in the counter direction.
The subject devices are used with specified ultrasound endoscopes for aspirating tissue or cells by piercing the target area in an ultrasound image and attaching the medallion syringe to the aspiration port on the handle section.
5 INDICATIONS FOR USE
This instrument 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.
6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE
The Single Use Aspiration Needle NA-U401SX-4025N has the same technological characteristics and design as the predicate device except for the following new features:
- Needle width
- Needle shape
- Needle tip shape
- Sheath composition
Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.
6
A side by side comparison of the subject device and the predicate device is provided below.
| Subject Device | Predicate Device (PD) | |
|---|---|---|
| Item | NA-U401SX-4025N | NA-U403SX-4019 (K163469) |
| Indications for | ||
| Use | This instrument 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. | 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. | ||
| Regulation | ||
| Number | Similar to PD | 874.4680 |
| Regulation | ||
| Name | Identical | Bronchoscope (flexible or rigid) |
| and accessories | ||
| Regulatory | ||
| Class | Identical | II |
| Product Code | Identical | KTI |
| Classification | ||
| Panel | Identical | Ear Nose & Throat |
| Syringe (for | ||
| aspiration) | Identical | Equipped |
| Mode of action | Identical | Single/multiple puncture and |
| aspirate | ||
| Energy used | Identical | Manual |
| Visualization | Identical | Ultrasound guided |
| Product | ||
| Specification | ||
| and Properties | Bench testing confirms that the NA-U401SX-4025N meets its essential | |
| performances, which are technologically equivalent to those of the | ||
| reference device. | ||
| Reprocessing | Identical | Single Use, ETO Sterile |
| Needle Width | 25G | 19G |
| Patient | ||
| Contacting | ||
| Materials | Polytetrafluoroethylene, Stainless | |
| Steel, Nickel titanium | Stainless Steel, PTFE, PEBAX, | |
| Nitinol |
7
7 PERFORMANCE DATA
The following performance data was provided in support of the substantial equivalence determination.
1) Sterilization/Shelf-life testing
Sterilization/shelf-life testing for the Single Use Aspiration Needle NA-U401SX-4025N was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile".
Accelerated aging test for the NA-U401SX-4025N was conducted in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. The real-time aging test for three years will be performed to demonstrate longer stability and support the results of the accelerated aging test.
2) Biocompatibility testing
Biocompatibility testing for the Single Use Aspiration Needle NA-U401SX-4025N was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1:2009, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The following tests were completed:
- Cytotoxicity
- . Intracutaneous Study
- Sensitization
- . Systemic Toxicity
- . Pyrogen Study
3) Performance testing - Bench
Bench testing for the Single Use Aspiration Needle NA-U401SX-4025N as listed below was conducted to ensure that the subject devices perform as intended and meet design specifications.
- Piercing
- Ultrasound visibility
- Needle extraction and retraction
- Aspiration
- Endoscope compatibility ।
- Handle function ।
- Joint Pull Strength
- Breakage Strength
4) Performance testing - Animal
8
Image /page/8/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, and the word is centered in the image. There is a registered trademark symbol to the right of the word. The background is white.
No animal study was performed to demonstrate substantial equivalence.
5) Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence.
6) Risk analysis
A Risk analysis for the Single Use Aspiration Needle NA-U401SX-4025N was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
The following standards have been applied to the Single Use Aspiration Needle NA-U401SX-4025N.
- ISO 10993-1: 2009
- AAMI/ANSI/ISO 10993-5: 2009
- ISO 10993-10: 2010
- ISO 10993-11: 2006
- ISO 11135: 2014
- ISO 10993-7: 2008+Cor1
- ISO 11607-1: 2006+A1
- ISO 11607-2: 2006+A1
- ASTM F1980-16
- ISO 14971: 2007
8 CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the NA-U401SX-4025N raise no new issue of safety and effectiveness. Therefore, the NA-U401SX-4025N is substantially equivalent to the predicate devices.