(9 days)
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.
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.
The provided text describes a medical device submission (510(k)) for the Medi-Globe SonoTip II EBUS-TBNA Needle System. However, it does not contain the detailed information required to answer your specific questions about acceptance criteria and the study proving the device meets those criteria.
The document makes a general statement about 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."
This indicates that the device's performance was compared to a predicate device, and it was found to be "as safe and effective." However, it does not provide the specifics of:
- A table of acceptance criteria and the reported device performance: This information is not present. The document only states the device "meets the same performance requirements" as the predicate.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. This type of study is more common for diagnostic imaging AI algorithms, not typically for a needle system.
- If a standalone performance study was done: The wording suggests performance was evaluated relative to a predicate, not necessarily in a standalone clinical trial with specific performance metrics.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not applicable as this is a physical medical device, not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on its intended use, technological characteristics, and general range of descriptive features. It does not include a detailed breakdown of specific performance acceptance criteria or the study data proving those criteria were met, which is typical for a 510(k) summary that emphasizes equivalence rather than novel performance claims backed by clinical trials.
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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.
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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:
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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).
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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.
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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
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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
§ 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.