(88 days)
The SonoTip II 25-gauge 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.
The Medi-Globe SonoTip II 25-gauge Ultrasound 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 510(k) premarket notification for the Medi-Globe SonoTip II 25-gauge Ultrasound Needle System. This submission is for a new device claiming substantial equivalence to previously cleared predicate devices. Therefore, the acceptance criteria and the study that proves the device meets the acceptance criteria are based on equivalence to predicate devices rather than a standalone performance study with specific metrics.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
This 510(k) summary does not present specific quantitative acceptance criteria or detailed performance metrics against those criteria in the manner one might expect for a new performance claim. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices, meaning the new device has the same intended use and similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | "Design verification data has demonstrated that the proposed Medi-Globe SonoTip II 25-gauge Ultrasound Needle System meets the same performance requirements and is as safe and effective as its predicate device. The 25-gauge SonoTip II Needle System is considered to have the same intended diagnostic/therapeutic effect, method of introduction/use, and intended range of descriptive features as the predicate Medi-Globe SonoTip II Ultrasound Needle System (K070129)." This statement confirms the device fulfills the criteria of having comparable performance, safety, and effectiveness to its predicate, based on design verification. |
| Intended Use Equivalence | The intended use for the SonoTip II 25-gauge is identical to its predicate: "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 Equivalence | The device "utilizes endoscopic ultrasound technology which, when used with an ultrasound endoscope, allows the user to ultrasonically guide the biopsy needle to its intended target." This characteristic is consistent with the described predicate devices. |
| Material/Design Characteristics (Implicit) | The submission implies that any material or design differences (e.g., the 25-gauge size) do not alter the fundamental safety or effectiveness profile as compared to the predicate. No new questions of safety or effectiveness are raised. |
Study Proving Acceptance Criteria
The study described is a design verification as part of a 510(k) submission for substantial equivalence.
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Sample size used for the test set and the data provenance:
- The document states "Design verification data has demonstrated..." but does not specify a sample size for any test set nor the data provenance (e.g., country of origin, retrospective/prospective). Design verification in this context likely refers to internal testing (e.g., mechanical testing, materials testing, functional testing) to ensure the device meets its design specifications and performs comparably to the predicate. It is not presented as a clinical study with human subjects.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was not a study involving expert assessment of diagnostic accuracy against a ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is mentioned.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a medical device for fine needle aspiration, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a clinical ground truth. The "performance requirements" mentioned likely refer to engineering and functional specifications (e.g., needle integrity, fluid aspiration capability, compatibility with ultrasound endoscopes) which would be verified against design specifications, not clinical pathology or outcomes directly in a human cohort during this 510(k) process.
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The sample size for the training set:
- Not applicable. The submission does not refer to a training set for a machine learning algorithm.
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How the ground truth for the training set was established:
- Not applicable. (See point 7).
In summary, the K083802 submission for the Medi-Globe SonoTip II 25-gauge Ultrasound Needle System relies on demonstrating substantial equivalence to an existing, legally marketed predicate device (K070129) through design verification data. This approach means that a comprehensive clinical study with detailed performance metrics, ground truth establishment, or human reader assessments was not required or provided in the 510(k) summary, as the device's fundamental safety and effectiveness are established by its similarity to already approved devices.
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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 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 25-gauge Ultrasound Needle System
- ﻥ Predicate Devices: Medi-Globe SonoTip II Ultrasound Needle System (K070129)
Medi-Globe SonoTip II Ultrasound Needle System (K051247)
Wilson-Cook Ultrasound Biopsy Needle (K013356)
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D. Device Description:
The Medi-Globe SonoTip II 25-gauge Ultrasound Needle System is a complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only. -
E. Intended Use:
The Medi-Globe SonoTip II 25-gauge Ultrasound Needle System for Fine Needle Aspiration (FNA), is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II 25-gauge 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). -
F. Technological Characteristics Summary:
The Medi-Globe SonoTip II Ultrasound 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 gastrointestinal system.
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K08380r
pg 2 of 2
- Performance Data: G.
- Design verification data has demonstrated that the proposed Medi-Globe SonoTip I 25-gauge Design vertilication data the same performance requirements and is as safe and effective as Olirasonic Necule bystem moon the same perice. The 25-gauge SonoTip II Needle System is Medi-Group intended diagnostic/therapeutic effect, method of introduction/use, considered to nave the same mendou cange 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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2009
Mr. Scott Karler Regulatory Affairs Coordinator Medi-Globe Corporation 110 West Orion Street, Suite 136 TEMPE AZ 85283
Re: K083802
Trade/Device Name: SonoTip II 25-Gauge Ultrasound Needle System Regulation Number: 21 CFR 876.1075
Regulation Name: Gastroenterology-urology biopsy instrument
Regulatory Class: II
Product Code: FCG
Dated: December 18, 2008
Received: December 22, 2008
Dear Mr. Karler:
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. Iisting 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 (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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; 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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), please 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.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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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.suppor/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): TBD
Device Name: SonoTip II 25-gauge Ultrasound Needle System
Indications for Use: The SonoTip II 25-gauge 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.
V 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)
Tom Whing
(Division Sign-Off)
Division of Reproductive, Abdominal. and Radiological Device 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.