(31 days)
MBL0173
No
The document describes a mechanical needle system for fine needle aspiration and does not mention any AI or ML components or capabilities.
No
The device is used for fine needle aspiration (FNA) which is a diagnostic procedure to obtain tissue samples, not to treat a disease or condition.
No
The device is used for fine needle aspiration (FNA) which is a biopsy procedure to collect samples. While these samples are then used for diagnosis, the device itself is a tool for sample collection, not for performing the diagnosis. The "Summary of Performance Studies" states the device has "the same intended diagnostic/therapeutic effect," but this refers to the effect of the procedure it facilitates (biopsy leading to diagnosis), not that the device itself performs the diagnosis.
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.
Based on the provided information, the SonoTip II Ultrasound Needle System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for ultrasonically guided fine needle aspiration (FNA) of lesions. This is a procedure to collect a sample of tissue or fluid from the body.
- Device Description: The device is a needle system for aspiration.
- Lack of IVD Characteristics: An IVD is a device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic purposes. The SonoTip II is used in vivo (inside the body) to collect the specimen.
While the collected sample may be used for subsequent in vitro diagnostic testing, the SonoTip II itself is the tool for obtaining the sample, not for performing the diagnostic test on the sample.
N/A
Intended Use / Indications for Use
The SonoTip II Ultrasound Needle System for Fine Needle Aspiration (FNA), is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II needle system is used 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
FCG
Device Description
The SonoTip 11 Ultrasound Needle System is complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single 101 I mo Noode Aspirature allowing the length of the outer metal sheath to be adjusted has been incorporated into the SonoTip II needle system. This provides adjusted has been miss to precisely adjust the working length of the instrument to that of the specific ultrasound endoscope scope being used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonically guided
Anatomical Site
submucosal and extra-luminal lesions of the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification data has demonstrated that the SonoTip II Ultrasonic Needle Dosign verfication autamas requirements and is as safe and effective as Bystem mobile portonio por comoTip II Needle System is considered to have the same intended diagnostic/therapeutic effect, method of introduction/use, technical sharacteristics and general range of descriptive features as the predicate Medi-Globe Ultrasound Needle System (K990220).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
JUN 16 2005
K05 1247
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
- Submitter Information: A.
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
Contact Person's FAX Number: (480) 897-2878
- Device Name: B. SonoTip 11 Ultrasound Needle System
- ட் Predicate Devices: GIP/Medi-Globe GI Ultrasound Needle System (K990220)
Device Description: D.
The SonoTip 11 Ultrasound Needle System is complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single 101 I mo Noode Aspirature allowing the length of the outer metal sheath to be adjusted has been incorporated into the SonoTip II needle system. This provides adjusted has been miss to precisely adjust the working length of the instrument to that of the specific ultrasound endoscope scope being used.
1
K051247
Page 2 of 2
Intended Use: E.
The SonoTip II Ultrasound Needle System for Fine Needle Aspiration (FNA), is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II needle system is used 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).
-
Technological Characteristics Summary: F.
The SonoTip Il Ultrasound Needle System utilizes endoscopic ultrasound The BonoTip in Ottasound with an ultrasound endoscope guides the biopsy needle to its intended target within or adjacent to the gastrointestinal system. -
Performance Data: G.
Design verification data has demonstrated that the SonoTip II Ultrasonic Needle Dosign verfication autamas requirements and is as safe and effective as Bystem mobile portonio por comoTip II Needle System is considered to have the same intended diagnostic/therapeutic effect, method of introduction/use, technical sharacteristics and general range of descriptive features as the predicate Medi-Globe Ultrasound Needle System (K990220).
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 caduceus symbol, which is often associated with healthcare. The caduceus is depicted with a staff and two snakes intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville*MD 20050
JUN 16 2005
Mr. Scott Karler Product Manager Medi-Globe Corporation 110 West Orion Street, Suite 136 TEMPE AZ 85248
Re: K051247
Trade/Device Name: SonoTip II Ultrasound Needle System Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: FCG Dated: May 11, 2005 Received: May 18, 2005
Dear Mr. Karler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have fevelved your botten beees is substantially equivalent (for the indications for use stated in above and have decemined the ed predicate devices marketed in interstate commerce prior to the enclosure) to tegary matterical Device Anendments, or to devices that have been May 20, 1770, and chanance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordation than exproval application (PMA). You may, therefore, market the do not require approval or a premiance approvisions of the Act. The general controls provisions of the Act device, subjox to the general ookies, prion, 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 If your de riod is oldssined (000 acch additional controls. Existing major regulations affecting your Apployal), it they of subject to seen aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA device our of found mouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FICASE or advirsed that I DA s issualled of eevice complies with other requirements of the Act or any FDA has made a decemination administered by other Federal agencies. You must comply with all the read and roguirements, including, but not limited to registration and listing (21 CFR Part 807); labeling ACL S requirements, moduling, but not a mactice requirements as set forth in the quality systems (QS) (ZT CFR Part 8017, good manatacallang Peace, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k)
10 iegal This letter will allow you to oegni marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The FDA Inding of substantial equil 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), pleased
and the may be and of the one of the consumbers, based on the regulation If you desire specific advice for your device on our laceming regarities (
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Risonation on your responsibilities under the Act from the 807.97). You may obtain other gelleral intornational on your repeat its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
050-2011 or (3.gov/cdrh/industry/support/index.html.
Sincercly yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number (if known): | TBD |
|---|---|
| Device Name: | SonoTip 11 Ultrasound Needle System |
| Indications For Use: | The SonoTip II Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used 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
S OF THE WRITE BELOW THIS VEFENED) IF NEEDED) ______________________________________________________________________________________________________________________________________________________________________________
:
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ |
|---|---|
| OR | Over-The-Counter Use |
| (Optional Format 1-2-96) |
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K051247 |
|---|---|
| --------------- | --------- |
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