(57 days)
Not Found
No
The summary describes a mechanical aspiration needle and does not mention any AI or ML components or functionalities.
No
The device is an aspiration needle used for diagnostic sampling (fine needle aspiration), not for treating a condition.
No
The device is an aspiration needle used for obtaining tissue samples (FNA), which are then typically sent for laboratory analysis to diagnose conditions. The needle itself is a tool for obtaining samples, not for directly performing diagnosis.
No
The device is described as an "Aspiration Needle" and is intended to be used with an "ultrasound gastroscope," indicating it is a physical medical device, not software.
Based on the provided information, the Olympus NA-10J-1 Aspiration Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for fine needle aspiration (FNA) within the gastrointestinal tract, guided by ultrasound. This is a procedure to collect tissue or fluid samples from the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The device itself is not performing the diagnostic test on the sample. It is the tool used to obtain the sample.
- Lack of Diagnostic Function: The description focuses on the mechanical function of the needle for aspiration, not on any analytical or diagnostic capabilities of the device itself.
The aspiration needle is a medical device used in a procedure that may lead to an in vitro diagnostic test being performed on the collected sample, but the needle itself is not the IVD.
N/A
Intended Use / Indications for Use
The Olympus NA-10J-1 Aspiration Needle is specifically designed to be used with the Olympus GF-UM30P ultrasound gastroscope for ultrasonically guided fine needle aspiration (FNA) within the gastrointestinal tract.
Product codes
Not Found
Device Description
Olympus NA-10J-1 Aspiration Needle
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Olympus NA-1C Aspiration Needle (K904667)
Reference Device(s)
Not Found
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/0 description: The image shows a handwritten alphanumeric string. The string is "K970563". The characters are written in a cursive style.
APR 11 1997
510 (k) SUMMARY OLYMPUS NA-10J-1 ASPIRATION NEEDLE
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.
| Device Name: | Olympus NA-10J-1 Aspiration Needle |
|---|---|
| Common/Usual Name: | Biopsy Instruments |
| Classification Name: | 21 CFR 876.1075 |
| Gastroenterology-Urology Biopsy Instruments | |
| Predicate Devices: | Olympus NA-1C Aspiration Needle (K904667) |
| Prepared & Submitted By: Mr. Subhash Patel | |
| (Contact Person) | Olympus America Inc. |
| Endoscope Division | |
| Two Corporate Center Drive | |
| Melville, New York 11747-3157 | |
| (516) 844-5481 | |
| Summary Preparation | |
| Date: | 02/11/97 |
Statement of Intended Use:
The Olympus NA-10J-1 Aspiration Needle is specifically designed to be used with the Olympus GF-UM30P ultrasound gastroscope for ultrasonically guided fine needle aspiration (FNA) within the gastrointestinal tract.