(147 days)
Not Found
No
The description focuses on the mechanical function of a needle for aspiration and does not mention any computational or analytical capabilities that would suggest AI/ML.
No.
The device is used for obtaining tissue samples (biopsy) for diagnostic purposes, not for treating a disease or condition.
No
This device is a fine needle aspiration (FNA) needle designed to collect tissue samples. While these samples are then used for diagnosis, the device itself is a tool for obtaining the specimen, not for performing the diagnosis directly.
No
The device description clearly outlines physical components (handle section, needle section, sheath section) and their interaction with a syringe and ultrasound endoscope, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a needle used to obtain a specimen (tissue) from within the body. It is a tool for sample collection, not a test that analyzes the sample to provide diagnostic information.
- Intended Use: The intended use is to facilitate the aspiration of tissue from lesions. This is a procedural step, not a diagnostic test performed on the collected sample.
While the collected specimen may be used for subsequent in vitro diagnostic testing (e.g., pathology or cytology), the needle itself is a surgical/procedural device, not an IVD.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with an Olympus 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 subject device is a Single Use Aspiration Needle NA-U200H 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).
The subject device consists of a handle section, needle section, and sheath section. When users use the device, the syringe needs to be attached to the subject device. The subject device is used to obtain an acceptable specimen. The lesion is punctured by the Needle equipped at the distal end of the subject device and aspirated by the syringe. Subsequently, the tissue of the lesion in the needle is taken out by feeding air from the syringe or pushing the tissue with the stylet for sampling.
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
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
Performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2015
Olympus Medical Systems Corp. % Daphney Germain-Kolawole Project Manager, Regulatory Affairs Olympus Corporation of The Americas 3500 Corporate Parkway Po Box 610 Center Valley, PA 18034-0610
Re: K151738
Trade/Device Name: Single Use Aspiration Needle NA-U200H Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: FCG Dated: October 19, 2015 Received: October 20, 2015
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. 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Single Use Aspiration Needle NA-U200H
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
This instrument has been designed to be used with an Olympus 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).
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
Single Use Aspiration Needle NA-U200H
June 25, 2015
5.1 General Information
| ■ Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan
192-8507
Establishment Registration No: 8010047 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Official Correspondent: | Daphney Germain-Kolawole
Olympus Corporation of the Americas, Inc.
3500 Corporate Parkway
PO Box 610
Center Valley, PA 18034-0610, USA
Phone: 484-896-5691
FAX: 484-896-7128
Email: daphney.germain-kolawole@olympus.com |
| ■ Manufacturer: | Aomori Olympus Co., Ltd.
248-1 Okkonoki 2-chome Kuroishi-shi,
Aomori, Japan 036-0357
Establishment Registration No .: 9614641 |
5.2 Device Identification
| ■ Device Trade Name: | Single Use Aspiration Needle NA-U200H |
|---|---|
| ■ 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 |
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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, gold line. Underneath the line, the words "Your Vision, Our Future" are written in a smaller font.
Predicate Device Information 5.3
| Device Trade
| Name | Common Name | Applicant | 510(k) No. |
|---|---|---|---|
| Disposable | |||
| Aspiration | |||
| Needle | |||
| NA-200H | Aspiration | ||
| Needle | OLYMPUS OPTICAL Co., | ||
| Ltd. | K023272 | ||
| Olympus | |||
| NA-10J-1 | |||
| Aspiration | |||
| Needle | Biopsy | ||
| Instruments | OLYMPUS AMERICA, INC. | K973128 | |
| ExpectTM | |||
| Endoscopic | |||
| Aspiration | |||
| Needle | - | BOSTON SCIENTIFIC | |
| CORPORATION | K112198 |
5.4 Device Description
The subject device is a Single Use Aspiration Needle NA-U200H 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).
The subject device consists of a handle section, needle section, and sheath section. When users use the device, the syringe needs to be attached to the subject device. The subject device is used to obtain an acceptable specimen. The lesion is punctured by the Needle equipped at the distal end of the subject device and aspirated by the syringe. Subsequently, the tissue of the lesion in the needle is taken out by feeding air from the syringe or pushing the tissue with the stylet for sampling.
Indications for Use 5.5
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
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Image /page/5/Picture/0 description: The image displays the logo for OLYMPUS. The word "OLYMPUS" is written in large, bold, dark blue letters. A thin, horizontal, golden line is underneath the company name. Below the line, the text "Your Vision, Our Future" is written in a smaller, dark font.
masses and lymph nodes).
5.6 Comparison of Technological Characteristics
Compared to the predicate device, the proposed subject device, Single Use Aspiration Needle NA-U200H, has similar technological characteristics. There is no significant difference that affects the safety or effectiveness of the subject device.
5.7 Summary of non-clinical testing
· Performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.
· 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-U200H.
- · ISO 10993-1 ·ISO 10993-5 · ISO 10993-10 · ISO 10993-11 ·ISO 11135 · ISO 14971 · ASTM F1980-07
5.8 Conclusion
When compared to the predicate device, the Single Use Aspiration Needle NA-U200H 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.