(9 days)
Not Found
No
The summary describes a physical needle system for aspiration and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is used for fine needle aspiration for diagnostic purposes, not for treating a condition.
No
The device is used for fine needle aspiration (FNA) of lesions, which is a procedure to collect tissue samples for further analysis. While the collected samples are used for diagnosis, the device itself is a tool for sample collection, not for producing diagnostic information directly.
No
The device description explicitly states it is a "complete one-piece needle system" and a "disposable instrument," indicating it is a physical hardware device, not software only.
Based on the provided information, the SonoTip II Endobronchial Ultrasound-Guided Transbronchial Fine Needle Aspiration (EBUS-TBNA) Needle System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes the device as being used for ultrasonically guided fine needle aspiration (FNA) of lesions. This is a procedure to collect tissue samples from within the body.
- Device Description: The device is described as a needle system for FNA, a tool used to perform the aspiration procedure.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. The SonoTip II is used in vivo to collect the sample.
The device is a tool used to obtain a sample that might then be used in an IVD test (e.g., the collected tissue sample could be sent to a lab for analysis). However, the SonoTip II itself is the instrument for the sample collection procedure, not the diagnostic test performed on the sample.
N/A
Intended Use / Indications for Use
The SonoTip II Endobronchial Ultrasound-Guided Transbronchial Fine Needle Aspiration, (EBUS-TBNA) Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II EBUS-TBNA Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract.
Product codes (comma separated list FDA assigned to the subject device)
FCG
Device Description
The Medi-Globe SonoTip II EBUS-TBNA Needle System is a complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonically guided
Anatomical Site
Tracheobronchial Tree and Gastrointestinal Tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Design verification data has demonstrated that the proposed Medi-Globe SonoTip II EBUS-TBNA Needle System meets the same performance requirements and is as safe and effective as Medi-Globe's currently cleared predicate device. The SonoTip II EBUS-TBNA Needle System is considered to have the same intended diagnostic/therapeutic effect, method of introduction/use, technical characteristics and general range of descriptive features as the predicate Medi-Globe SonoTip II Ultrasound Needle System (K070129).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
091257 or 2
MAY - 8 2009
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
- A. Submitter Information:
Date Prepared: March 9, 2009
Submitter's Name: Medi-Globe Corporation
Submitter's Address: 110 West Orion Street #136 Tempe, Arizona 85283
Contact Person: Scott Karler
Contact Person's Telephone Number: (480) 897-2772 ext. 208
Contact Person's FAX Number: (480) 897-2878
Contact Person's Email Address: skarler(@mediglobe.com
- B. Device Name: Medi-Globe SonoTip II EBUS-TBNA Needle System
- C. Predicate Devices: Medi-Globe SonoTip II Ultrasound Needle System (K070129)
Medi-Globe SonoTip II Ultrasound Needle System (K051247)
Olympus Medical Single Use Aspiration Needle NA-201SX-4022, (K050503)
D. Device Description:
The Medi-Globe SonoTip II EBUS-TBNA Needle System is a complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only.
-
A. Intended Use:
The SonoTip II EBUS-TBNA Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II EBUS-TBNA Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract. -
F. Technological Characteristics Summary:
1
The Medi-Globe SonoTip II EBUS-TBNA Needle System utilizes endoscopic ultrasound technology which, when used with an ultrasound endoscope, allows the user to ultrasonically guide the biopsy needle to its intended target within or adjacent to the Tracheobronchial Tree or Gastrointestinal Tract,
్ర. Performance Data:
Design verification data has demonstrated that the proposed Medi-Globe SonoTip II EBUS-TBNA Needle System meets the same performance requirements and is as safe and effective as Medi-Globe's currently cleared predicate device. The SonoTip II EBUS-TBNA Needle System is considered to have the same intended diagnostic/therapeutic effect, method of introduction/use, technical characteristics and general range of descriptive features as the predicate Medi-Globe SonoTip II Ultrasound Needle System (K070129).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three parallel lines forming the body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
MAY - 8 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medi-Globe Corporation % Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 E. Auora Road, Unit B7 TWINSBURG OH 44087
Re: K091257
Trade/Device Name: SonoTip II EBUS-TBNA Needle System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG Dated: April 28, 2009
Received: April 29, 2009
Dear Mr. Kogoma:
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 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.
3
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): IBG KO91259
Device Name: SonoTip // EBUS-TBNA Needle System
Indications for Use: The SonoTip II Endobronchial Ultrasound-Guided Transbronchial Fine Needle Aspiration, (EBUS-TBNA) Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II EBUS-TBNA Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Colin M. Pollend
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number