(68 days)
Not Found
No
The summary describes a mechanical needle system for FNA and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as a needle system for diagnostic fine needle aspiration (FNA), which is a diagnostic procedure to obtain samples for analysis, not a therapeutic treatment.
No
Explanation: This device is designed for fine needle aspiration to collect samples, which is a part of the diagnostic process but not a diagnostic device itself. Diagnostic devices perform the analysis or interpretation of data to arrive at a diagnosis.
No
The device description and intended use clearly describe a "Needle System" which is a physical medical device used for fine needle aspiration. 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 for fine needle aspiration (FNA), which is a procedure to collect tissue or fluid samples from within the body. This is an in vivo procedure (performed within a living organism).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) outside of the body to provide information about a person's health.
This device is a tool used to obtain the sample, not to analyze it. The analysis of the collected sample would likely be performed using IVD methods, but the needle system itself is not an IVD.
N/A
Intended Use / Indications for Use
The GIP/ Medi-Globe Needle System for Ultrasonic FNA is specifically designed for ultrasonically guided fine needle aspiration (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).
The Medi-Globe Needle System for Ultrasonic FNA is designed to be used with the Pentax FG32, 34, 36, 38 UA ultrasound endoscopes for ultrasonically guided fine needle aspiration (FNA of submucosal and extra-luminal lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).
Product codes
78 FCG
Device Description
Not Found
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, peri-pancreatic 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
3/31/99
K990220
101
510(k) Summary
GIP/Medi-Globe Needle System for Ultrasonic FNA
This 510(k) summary of safety and effectiveness is being submitted in accordance to with
the requirements of SMDA 1990 and 21 CFR, Section 807.92.
| Device Name : | GIP/Medi-Globe Needle System for Ultrasonic FNA |
|---|---|
| Common/User Name : | Ultrasound Needle for Ultrasonic Fine Needle Aspiration |
| Classification : | Gastro-Urology Biopsy Instruments; 21 CFR 876-1075 |
| Proprietary Name : | Various Brand Names of Aspiration Needles |
| Predicate Device : | GIP/Medi-Globe GI Ultrasound Needle System |
| K935844 | |
| Prepared & Submitted By : | Michelle L. Fields |
| Project Manager | |
| Medi-Globe Corporation | |
| 6202 S. Maple Avenue, Suite 131 | |
| Tempe, Arizona 85283 | |
| (602) 897-2772 | |
| Preparation Date : | January 7, 1999 |
| Indications for Use : | The GIP/ Medi-Globe Needle System for Ultrasonic FNA is |
| specifically designed for ultrasonically guided fine needle | |
| aspiration (FNA) of submucosal and extra-luminal lesions of | |
| the Gastrointestinal tract (i.e., pancreatic masses, mediastinal | |
| masses, peri-pancreatic masses, and lymph nodes). |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, superimposed over two human profiles facing each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the central emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 1999
Ms. Michelle L. Fields Project Manager Medi-Globe® Corporation 6202 S. Maple Avenue, #131 Tempe, AZ 85283
Re: K990220 GIP/Medi-Globe Ultrasound Needle System Dated: January 7, 1999 Received: January 13, 1999 Regulatory Class: II 21 CFR 876.1075/Procode: 78 FCG
Dear Ms. Fields:
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 redassified 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 II (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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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,
APT 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
2
×990220 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:_GIP/Medi-Globe Ultrasound Needle System
Indications for Use:
The Medi-Globe Needle System for Ultrasonic FNA is designed to be used with the Pentax FG32, 34, 36, 38 UA ultrasound endoscopes for ultrasonically guided fine needle aspiration (FNA of submucosal and extra-luminal lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaiuation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
David h. Slegman
(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological Dey 510(k) Number