(108 days)
No
The device description and performance studies focus on the mechanical aspects of a biopsy needle and syringe, with no mention of AI or ML capabilities.
No
The device is described as an aspiration and biopsy needle used for diagnostic purposes (sampling lesions) rather than directly treating a disease or condition.
Yes
This device is used for fine needle aspiration (FNA) and fine needle biopsy (FNB), which are procedures to collect tissue and cell samples. These samples are then analyzed to diagnose diseases or conditions. Therefore, the device facilitates a diagnostic process.
No
The device description explicitly details physical components (handle section, needle section, sheath section, syringe) and mentions sterilization and packaging, indicating it is a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain tissue samples (fine needle aspiration and biopsy) from lesions within the gastrointestinal tract. This is a procedure to collect a specimen from the body.
- Device Description: The device is a needle designed for aspiration and biopsy. It is used in conjunction with an ultrasound endoscope to guide the collection of the sample.
- Lack of Diagnostic Function: The device itself does not perform any diagnostic testing on the collected sample. It is solely a tool for obtaining the sample. The diagnostic analysis of the collected tissue would be performed separately in a laboratory, likely using IVD methods.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to collect the specimen, not to analyze it.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with an Olympus ultrasonically guided fine needle aspiration(FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
Product codes
FCG
Device Description
The subject devices are single use aspiration needles to be used in conjunction with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
The subject devices consist of a handle section, needle section, and sheath section and needle sizes ranging from 19 to 25G are available. The subject devices are sterilized and packaged in a sterilization package. The Syringe (VACLOK Syringe and Stopcock), which is supplied by Merit Medical System and packaged in an individual sterilization package, is bundled. The subject devices and the Syringe are put in one carton. When users use the device, the syringe is attached to the aspiration port on the handle section of the subject devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonically guided
Anatomical Site
gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes)
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
- Sterilization/Shelf life testing: Sterilization/shelf life testing for the Single Use Aspiration Needle NA-U200H were 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 demonstrating stability of the Single Use Aspiration Needle NA-U200H 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-U200H were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
- Performance testing - Bench: Bench testing has been performed on the proposed Single Use Aspiration Needle NA-U200H. Bench Testing includes: 1. Inserting into endoscope. 2. Advance of needle. 3. Retreat of stylet. 4. Visibility of needle. 5. Aspiration by syringe. 6. Retreat of needle. 7. Withdrawal from endoscope. 8. Extracting specimen from the needle by feeding air using a syringe. 9. Extracting specimen from the needle by advancing a stylet. 10. Repetition test. 11. Needle durability. 12. Package integrated test. 13. Comparison of tissue sampling.
- Performance testing - Animal: This premarket notification does not rely on Animal study data to demonstrate substantial equivalence.
- Performance testing - Clinical: This premarket notification does not rely on clinical study data to demonstrate substantial equivalence.
- Risk analysis: Risk analysis for the Single Use Aspiration Needle NA-U200H 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
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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June 8, 2018
Olympus Medical Systems Corp. Sheri L. Musgnung Regulatory Affairs Manager 3500 Corporate Parkway Center Vallev. PA 18034
Re: K180449
Trade/Device Name: Single Use Aspiration Needle NA-U200H Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: II Product Code: FCG Dated: April 27, 2018 Received: April 30, 2018
Dear Sheri L. 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.
1
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); 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clear and easy to read.
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)
K180449
Device Name
Single Use Aspiration Needle NA-U200H
Indications for Use (Describe)
This instrument has been designed to be used with an Olympus ultrasonically guided fine needle aspiration(FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
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)
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Image /page/3/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, yellow line, and below that is the text "Your Vision, Our Future" in a smaller, blue font.
Traditional 510(k) Notification Single Use Aspiration Needle NA-U200H
February 16, 2018
Section 5 510(k) Summary
5.1 GENERAL INFORMATION
| ■ 510(k) Submitter: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Contact Person: | Sheri L. Musgnung
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 |
5.2 DEVICE IDENTIFICATION
| ■ Device Name | Single Use Aspiration Needle NA-U200H |
|---|---|
| ■ Common Name | Aspiration Needle |
| ■ Regulation Number | 21 CFR 876.1075 |
| ■ Regulation Name | Gastroenterology-urology biopsy instrument |
| ■ Regulatory Class | II |
| ■ Product Code | FCG |
| ■ Classification Panel | Gastroenterology and Urology |
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Image /page/4/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, yellow line. Underneath the line is the text "Your Vision, Our Future".
5.3 PREDICATE DEVICE
1) Primary predicate device
| Table 12-1 Primary predicate device on Single Use Aspiration Needle NA-U200H | ||||
|---|---|---|---|---|
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| Single Use Aspiration Needle | OLYMPUS MEDICAL | K151738 |
| NA-U200H | SYSTEMS CORP. |
2) Reference device
Table 12-2 Reference device on Single Use Aspiration Needle NA-U200H
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| Echotip Procore HD Ultrasound | ||
| Biopsy Needle | COOK IRELAND LTD | K142688 |
5.4 DEVICE DESCRIPTION
The subject devices are single use aspiration needles to be used in conjunction with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
The subject devices consist of a handle section, needle section, and sheath section and needle sizes ranging from 19 to 25G are available. The subject devices are sterilized and packaged in a sterilization package. The Syringe (VACLOK Syringe and Stopcock), which is supplied by Merit Medical System and packaged in an individual sterilization package, is bundled. The subject devices and the Syringe are put in one carton. When users use the device, the syringe is attached to the aspiration port on the handle section of the subject devices.
5
Image /page/5/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Underneath the word is a thin, horizontal, yellow line. Below the line, the words "Your Vision, Our Future" are written in a smaller, blue font.
5.5 INDICATIONS FOR USE
This instrument has been designed to be used with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
5.6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE
The Single Use Aspiration Needle NA-U200H has the same technological characteristics and design as the predicate device except for expanding the indications for use and adding a new 25G needle to a family of needles. The fundamental technology remain unchanged and the performance of new 25G needle was demonstrated by conducting tests simulating ultrasonically guided fine needle aspiration (FNA) or fine needle biopsy (FNB).
5.7 PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
1) Sterilization/Shelf life testing
Sterilization/shelf life testing for the Single Use Aspiration Needle NA-U200H were 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 demonstrating stability of the Single Use Aspiration Needle NA-U200H 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-U200H were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
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Image /page/6/Picture/1 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Below the line are the words "Your Vision, Our Future" in a smaller font.
Traditional 510(k) Notification Single Use Aspiration Needle NA-U200H
3) Performance testing - Bench
Bench testing has been performed on the proposed Single Use Aspiration Needle NA-U200H.Bench Testing includes:
- Inserting into endoscope 1.
-
- Advance of needle
- Retreat of stylet 3.
-
- Visibility of needle
-
- Aspiration by syringe
-
- Retreat of needle
-
- Withdrawal from endoscope
-
- Extracting specimen from the needle by feeding air using a syringe
-
- Extracting specimen from the needle by advancing a stylet
-
- Repetition test
-
- Needle durability
-
- Package integrated test
-
- Comparison of tissue sampling
4) Performance testing - Animal
This premarket notification does not rely on Animal study data to demonstrate substantial equivalence.
5) Performance testing - Clinical
This premarket notification does not rely on clinical study data to demonstrate substantial equivalence.
6) Risk analysis
Risk analysis for the Single Use Aspiration Needle NA-U200H 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.
5.8 CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the Single Use Aspiration Needle NA-U200H raise no new issue of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, efficacy and performance.