(97 days)
No
The device description and performance studies focus on the mechanical and material properties of a single-use aspiration needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is designed for diagnostic sampling (fine needle aspiration) of lesions, not for treating or curing a disease.
No
This device is an aspiration needle used for obtaining tissue samples (fine needle aspiration). While these samples may subsequently be used for diagnostic purposes, the needle itself is a biopsy tool, not a diagnostic device that interprets or analyzes clinical data to diagnose a condition.
No
The device description clearly outlines physical components (handle section, needle section, sheath section, syringe) and mentions sterilization and packaging, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract". This describes a procedure to obtain a sample from within the body.
- Device Description: The device is a "Single Use Aspiration Needle" used in conjunction with an ultrasound endoscope. It is a tool for collecting a sample.
- Lack of Diagnostic Function: The description focuses on the collection of a sample, not the analysis of that sample to provide diagnostic information. IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening.
This device is a tool used in a medical procedure to obtain a sample, which would then likely be sent to a laboratory for in vitro diagnostic testing. The needle itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
These instruments have been designed to be used with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) 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 Single Use Aspiration Needle NA U201H are single use aspiration needles to be used in conjunction with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
The Single Use Aspiration Needle NA U201H consist of a handle section, needle section, and sheath section and needle sizes ranging from 19 to 25G will be available. The Single Use Aspiration Needle NA U201H 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 Single Use Aspiration Needle NA U201H 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
ultrasound
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
Healthcare facility/hospital
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-U201H 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-U201H 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-U201H 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-U201H. Bench Testing includes: Insertion and withdrawal performance, Visibility by using diagnostic ultrasound systems, Aspiration performance, Needle durability and package integrated test.
- 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-U201H 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)
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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October 31, 2018
Olympus Medical Systems Corp. % Mary Anne Patella Senior Specialist, Regulatory Affairs Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772
Re: K181994
Trade/Device Name: Single Use Aspiration Needle NA-U201H Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: II Product Code: FCG Dated: October 3, 2018 Received: October 4, 2018
Dear Mary Anne Patella:
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 mav, 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.
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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/7 description: The image shows the logo of the Food and Drug Administration (FDA). The logo is in white and consists of the letters "FDA" in a stylized font. The letters are connected and have a modern, clean design. The logo is simple and recognizable, representing the FDA's role in regulating and overseeing food and drug products.
Jeffrey W. Cooper -2018.10.31 16:45:48 -04'00
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) K181994
Device Name Single Use Aspiration Needle NA-U201H
Indications for Use (Describe)
These instruments have been designed to be used with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) 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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July 23, 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: | Mary Anne Patella
Olympus Surgical Technologies America
136 Turnpike Road
Southborough, MA 01772, USA
Phone: 508-804-2771
Fax: 508-804-2624
Email: Maryanne.patella@olympus-osta.com |
5.2 DEVICE IDENTIFICATION
| ■ Device Name | Single Use Aspiration Needle NA-U201H |
|---|---|
| ■ 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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K181994 Page 2 of 5
5.3 PREDICATE DEVICE
1) Primary predicate device
| Table 12-1 Primary predicate device on Single Use Aspiration Needle NA-U201H | ||
|---|---|---|
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| Single Use Aspiration Needle | ||
| NA-U200H | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K151738 |
2) Reference device
Table 12-2 Reference device on Single Use Aspiration Needle NA-U201H
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| DISPOSABLE ASPIRATION | ||
| NEEDLE NA-200H | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K023272 | |
| EXPECT ENDOSCOPIC | ||
| ULTRASOUND ASPIRATION | ||
| NEEDLE | BOSTON SCIENTIFIC CORP. | K110030 |
5.4 DEVICE DESCRIPTION
The Single Use Aspiration Needle NA U201H are single use aspiration needles to be used in conjunction with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
The Single Use Aspiration Needle NA U201H consist of a handle section, needle section, and sheath section and needle sizes ranging from 19 to 25G will be available. The Single Use Aspiration Needle NA U201H 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 Single Use Aspiration Needle NA U201H 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
K181994 Page 3 of 5
5.5 INDICATIONS FOR USE
These instruments have been designed to be used with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) 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-U201H has the same technological characteristics and design as the predicate device except for following features:
- Needle width (addition of 25G needle) .
- Maximum insertion portion diameter (smaller diameter)
- . Patient-contacting material (sheath, needle, silicone oil)
- Stylet diameter (smaller diameter for 25G needle) •
- Tip shape of needle (Backcut, Lancet shape) .
- . Sheath type
A side by side comparison of the subject device and the predicate device is provided below.
| Table 12-3 A side by side comparison of the subject device and the predicate device | ||
|---|---|---|
| Item | Subject Device | Predicate Device |
| Single Use Aspiration Needle | ||
| NA-U201H | Single Use Aspiration Needle | |
| NA-U200H (K151738) | ||
| Indications for use | These instruments have been | |
| designed to be used with an | ||
| Olympus ultrasound endoscope | ||
| for ultrasonically guided fine | ||
| needle aspiration (FNA) of | ||
| submucosal and extramural | ||
| lesions within the | ||
| gastrointestinal tract (i.e. | ||
| pancreatic masses, mediastinal | ||
| masses, perirectal masses and | ||
| lymph nodes). | This instrument has been | |
| designed to be used with an | ||
| Olympus ultrasound endoscope | ||
| for ultrasonically guided fine | ||
| needle aspiration (FNA) of | ||
| submucosal and extramural | ||
| lesions within the | ||
| gastrointestinal tract (i.e. | ||
| pancreatic masses, mediastinal | ||
| masses, perirectal masses and | ||
| lymph nodes). | ||
| Common name | Aspiration Needle | Aspiration Needle |
| ra | 876.1075 | 876.1075 |
| Table 12-3 A side by side comparison of the subject device and the predicate device | ||||||
|---|---|---|---|---|---|---|
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| Item | Subject Device | Predicate Device |
|---|---|---|
| Single Use Aspiration Needle | ||
| NA-U201H | Single Use Aspiration Needle | |
| NA-U200H (K151738) | ||
| Regulation name | Gastroenterology-Urology | |
| Biopsy Instrument | Gastroenterology-Urology | |
| Biopsy Instrument | ||
| Regulatory class | II | II |
| Classification panel | Gastroenterology and Urology | Gastroenterology and Urology |
| Product code | FCG | FCG |
| Environment of use | Healthcare facility/hospital | Healthcare facility/hospital |
| Single/repeat use | Single-Use | Single-Use |
| Sterile/non-sterile | Marketed as a sterile device | Marketed as a sterile device |
| Sterilization method | ETO sterile | ETO sterile |
| Patient-contact | ||
| materials | Sheath: PEEK | |
| Needle: Stainless steel | ||
| Stylet: Nitinol | ||
| Silicone oil: Methylphenyl | ||
| Polysiloxane | Sheath: Stainless steel | |
| Needle: Nitinol and Stainless | ||
| steel | ||
| Stylet: Nitinol | ||
| Silicone oil: Not equipped |
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-U201H 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-U201H 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-U201H 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
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K181994 Page 5 of 5
evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
3) Performance testing - Bench
Bench testing has been performed on the proposed Single Use Aspiration Needle NA-U201H.Bench Testing includes:
- Insertion and withdrawal performance
- Visibility by using diagnostic ultrasound systems
- Aspiration performance
- Needle durability and package integrated test
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-U201H 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-U201H raises no new issues of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, effectiveness and performance.