(170 days)
Not Found
No
The description focuses on the mechanical aspects of a needle aspiration instrument and its use with an ultrasonic endoscope, with no mention of AI or ML capabilities.
No
The device is described for fine needle aspiration (FNA) which is a diagnostic procedure to obtain tissue samples, not a therapeutic intervention.
No
The device is described as an aspiration needle for fine needle aspiration (FNA) which is a biopsy procedure to collect samples for diagnostic purposes, rather than being a diagnostic device itself.
No
The device description explicitly details physical components like a handle section, sheath section, and a spring mechanism, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for ultrasonically guided fine needle aspiration (FNA) of lesions within the body. This is a procedure performed in vivo (within a living organism) to collect tissue samples.
- Device Description: The device is a mechanical instrument designed to facilitate the collection of a sample from a patient's body. It is used in conjunction with an endoscope and a needle.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens outside of the body (in vitro) to provide information about a patient's health status. This device's function is to obtain the specimen, not to analyze it.
Therefore, this device is a surgical/procedural instrument used for sample collection, not an IVD.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with the ultrasonic endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
Product codes
78 FCG
Device Description
This instrument has been designed to be used with the ultrasonic endoscope for ultrasonically guided fine needle aspiration(FNA) of submucosal and extramural lesions of the gastrointestinal tract(i.e. pancreatic masses, mediastinal masses perirectal masses and lymph nodes).
The NA-10J-KB consists of a handle section and a sheath section. This instrument is designed to be used with the needle section, MAJ-363.
The handle section is connected to the endoscope channel opening.
The handle section facilitates to advance the sheath section and the needle section manually. And the handle section projects the needle section rapidly by its spring mechanism. This spring mechanism is equipped to facilitate puncturing of indurated lesions. The projection length by the spring mechanism is adjustable.
The setting for projection length by spring-loaded needle is determined by observing the ultrasonic image.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic
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
Not Found
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.
0
A. Submitter's Name, Address, Phone and Fax Numbers
1. Manufacturer of the subject devices
| Name & Address of manufacturer: | Olympus Optical Co., Ltd.
2-3-1 Shinjyuku Monolis Nishi-Shinjuku
Shinjyuku-ku Tokyo, Tokyo 163-0914
Japan |
|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Registration No.: | 8010047 |
| Address, Phone and Fax Numbers:
of R&D Department,
Endoscope Division | 2951 Ishikawa-Cho,
Hachioji-shi, Tokyo 192-8507
Japan
TEL 0426-42-5101 |
B. Name of Contact Person
Name: Address, Phone and Fax Numbers:
Ms. Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville, New York 11747-3157 TEL: (516) 844-5688 FAX: (516) 844-5416
FAX 0426-46-2786
C. Device Name, Common Name, Classification Name and Predicate Devices
| Trade Name:
Common Name: | Olympus NA-10J-KB Aspiration Needle
Aspiration Needle |
|-----------------------------|---------------------------------------------------------------------------------------------------------------|
| Classification: | Gastroenterology-urology biopsy instrument
21 CFR 876.1075
Endoscope and accessories
21 CFR 876.1500 |
| Predicate Device: | Olympus NA-10J-1 Aspiration Needle K973128 |
1
D. Description of the Device(s)
This instrument has been designed to be used with the ultrasonic endoscope for ultrasonically guided fine needle aspiration(FNA) of submucosal and extramural lesions of the gastrointestinal tract(i.e. pancreatic masses, mediastinal masses perirectal masses and lymph nodes).
The NA-10J-KB consists of a handle section and a sheath section. This instrument is designed to be used with the needle section, MAJ-363.
The handle section is connected to the endoscope channel opening.
The handle section facilitates to advance the sheath section and the needle section manually. And the handle section projects the needle section rapidly by its spring mechanism. This spring mechanism is equipped to facilitate puncturing of indurated lesions. The projection length by the spring mechanism is adjustable.
The setting for projection length by spring-loaded needle is determined by observing the ultrasonic image.
E. Intended Use of the Device(s)
This instrument has been designed to be used with the ultrasonic endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
F. Summary including Conclusions drawn from Non-clinical Tests
When compared to the predicate device, the Olympus NA-10J-KB Aspiration Needle does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its body, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUM. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 1999
Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, NY 11747-3157
Re: K991672 Olympus NA-10J-KB Aspiration Needle Dated: August 10, 1999 Received: November 1, 1999 Requlatory Class: II 21 CFR §876.1075/Procode: 78 FCG
Dear Ms. Storms-Tyler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809,10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: Olympus NA-10J-KB Aspiration Needle
Indications for Use:
This instrument has been designed to be used with the ultrasonic endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K991672/5⁰⁰¹
(Optional Format 1-2-96)