(63 days)
No
The device description and performance studies focus on the mechanical and physical properties of the aspiration needle and its interaction with the ultrasound endoscope, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is designed for collecting specimens (aspiration) for diagnostic purposes, not for treating a disease or condition.
Yes
The device is used for fine needle aspiration (FNA) to collect specimens, which are then typically used for diagnostic purposes to identify submucosal and extramural lesions.
No
The device description clearly outlines a physical aspiration needle with a handle, insertion section, sheath, needle, and stylet. It also mentions being used with an endoscope and a syringe, all of which are hardware components.
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 and the gastrointestinal tract." This describes a procedure to collect a sample from within the body.
- Device Description: The device is a needle designed to puncture tissue and aspirate a specimen. It's used in conjunction with an endoscope and ultrasound for guidance.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples outside of the body (in vitro). The purpose is to obtain the sample, not to perform diagnostic tests on it.
- Performance Studies: The performance studies focus on the physical and functional aspects of the needle itself (inserting, flexibility, piercing, aspiration, etc.), not on the diagnostic accuracy of any test performed on the collected sample.
IVD devices are specifically designed to be used on samples taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is a tool for collecting the sample, which might then be used in an IVD test, but the needle itself is not the IVD.
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 and the gastrointestinal tract.
Product codes (comma separated list FDA assigned to the subject device)
FCG
Device Description
The single use aspiration needle NA-U401SX (aka ViziShot 2) is intended to be used in conjunction with Olympus ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA). It consists 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 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 that was punctured with the needle. The needle is dimpled for echo enhancement and also consists of an oval portion for better angulation.
The subject device will be sold with or without medallion syringe manufactured by Merit Medical, which consists of VACLOK Syringe and Stopcock.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
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)
Performance testing was conducted on the following items to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.
- inserting into endoscope
- Flexibility of the insertion portion
- Piercing
- Ultrasound visibility
- Needle extraction and retraction
- Aspiration
- Withdrawal from endoscope
- Locking force of handle portion
- Limitation of needle depth
Risk analysis was carried out 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.
Biocompatibility testing is performed in accordance with the FDA Guidance," Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-1".
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
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 22, 2016
Olympus Medical Systems Corp. % Sheri Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkwav, Po Box 610 Center Valley, PA 18034-0610
Re: K160098
Trade/Device Name: Single Use Aspiration Needle NA-U401SX Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: FCG Dated: January 15, 2016 Received: January 19, 2016
Dear Sheri Musgnung,
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. 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.
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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Single Use Aspiration Needle NA-U401SX
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 and the gastrointestinal tract.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the 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 of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Image /page/3/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. A thin, yellow line is underneath the word. Below the line, the words "Your Vision, Our Future" are written in a smaller, black font.
510(k) SUMMARY Single Use Aspiration Needle NA-U401SX
January 15, 2016
5.1 General Information
| ■ Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507,
Japan
Establishment Registration No: 8010047 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Official Correspondent: | Sheri L. Musgnung
Manager, Regulatory Affairs
Olympus Corporation of the Americas
3500 Corporate Parkway PO Box 610
Center Valley, PA 18034-0610, USA
Phone: 484-896-3147
FAX: 484-896-7128
Email: sheri.musgnung@olympus.com |
| ■ Manufacturer: | Aomori Olympus Co., Ltd.
2-248-1 Okkonoki, Kuroishi-shi, Aomori, 036-0357,
Japan
Establishment Registration No.: 9614691 |
| 5.2 Device Identification | |
| ■ Device Trade Name: | Single Use Aspiration Needle NA-U401SX |
- Common Name: Aspiration Needle
- Regulation Number: 876.1075
- Regulation Name: Gastroenterology-urology biopsy instrument
- Regulatory Class: II
- Classification Panel: Gastroenterology and urology
- Product Code: FCG
Section 5 510(k) Summary Page 2 of 5
4
Image /page/4/Picture/0 description: The image displays the logo for OLYMPUS. The word "OLYMPUS" is written in large, bold, dark blue letters. A thin, gold line is underneath the word. Below the gold line, the words "Your Vision, Our Future" are written in a smaller font.
5.3 Predicate Device Information
| ■ Device Name: | Single Use Aspiration Needle NA-201SX-4022 |
|---|---|
| ■ Common Name: | Aspiration Needle |
| ■ Applicant | Olympus Medical Systems Corp. |
| ■ 510(k) No. | K050503 |
5.4 Device Description
The single use aspiration needle NA-U401SX (aka ViziShot 2) is intended to be used in conjunction with Olympus ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA). It consists 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 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 that was punctured with the needle. The needle is dimpled for echo enhancement and also consists of an oval portion for better angulation.
The subject device will be sold with or without medallion syringe manufactured by Merit Medical, which consists of VACLOK Syringe and Stopcock.
ર્સ્ડ 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 and the gastrointestinal tract.
5.6 Comparison of Technological Characteristics
Compared to the predicate device, the proposed subject device; Single Use Aspiration Needle NA-U401SX, has similar technological characteristics except for the following differences.
- Needle tube shape on proximal side
- Sheath composition
- Materials
5
Image /page/5/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, horizontal, yellow line. Below the line is the text "Your Vision, Our Future".
The needle tube of the subject device has a part of oval portion on its proximal side whereas the predicate device consisted of a round shape. The sheath design is similar to another 510(k) cleared device, Olympus Aspiration Biopsy Needle (#K904667). The subject device utilizes new patient contact materials compared to PD.
Validation testing demonstrated that these technological features do not affect the safety or effectiveness of the subject devices.
5.7 Summary of non-clinical testing
· Performance testing was conducted on the following items to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.
- inserting into endoscope
- Flexibility of the insertion portion
- Piercing
- Ultrasound visibility
- Needle extraction and retraction
- Aspiration
- Withdrawal from endoscope
- Locking force of handle portion
- Limitation of needle depth
· Risk analysis was carried out 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.
· Biocompatibility testing is performed in accordance with the FDA Guidance," Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-1".
The following standards have been applied to the Single Use Aspiration Needle NA-U401SX.
. ISO 10993-1 ·ISO 10993-5 · ISO 10993-10 · ISO 10993-11 ·ISO 11135 · ISO 14971 · ASTM F-1980-07
5.8 Conclusion
When compared to the predicate device, the Single Use Aspiration Needle NA-U401SX
6
Image /page/6/Picture/0 description: The image features the word "OLYMPUS" in large, bold, blue letters. A thin, yellow line is underneath the word. Below the line, the text "Your Vision, Our Future" is written in a smaller, blue font. The logo is simple and clean, with a focus on the company name and tagline.
does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.