(12 days)
The Medi-Globe Rota-Cut® Sphincterotome is intended for transendoscopic cannulation of the Biliary system and sphincterotomy of the Papilla of Vater an/or the Sphincter of Oddi.
The proposed Medi-Globe Rota-Cut® Sphincterotome is available in single, double or triple lumen models and allows incremental, rotational orientation of the distal catheter tip and cutting wire. Device models are compatible with either .021 or .035" guide wires and allow simultaneous injection of contrast medium during use.
This is a 510(k) premarket notification for a medical device, the Medi-Globe Rota-Cut® Sphincterotome. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria and performance metrics for a novel technology. Therefore, the information requested in your prompt regarding acceptance criteria, performance data, sample sizes, ground truth, and expert involvement is largely not applicable in the context of this specific regulatory document.
Here's an explanation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. The 510(k) submission for the Medi-Globe Rota-Cut® Sphincterotome does not present specific quantitative acceptance criteria or detailed device performance metrics in the way a novel AI or diagnostic device would. Instead, it relies on demonstrating substantial equivalence to predicate devices.
The "Performance Data" section states: "Design verification tests have demonstrated that the proposed Rota-Cut® sphincterotomes meet the same performance standards and biocompatibility requirements and is as safe and effective as the currently cleared GIP/Medi-Globe device, (K943629/A)."
This implies that the acceptance criterion for the new device is to perform as well as or equivalently to the predicate device in terms of "performance standards and biocompatibility requirements" and be "as safe and effective." However, no explicit numerical criteria or specific performance values are listed in this document.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. No specific "test set" in the context of clinical data for performance evaluation is described. The "design verification tests" are likely referring to bench testing, engineering validation, and biocompatibility testing as per standard medical device development. No human subject data (retrospective or prospective) is mentioned as being used to prove the device's performance against specific metrics through a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. Ground truth, in the sense of expert consensus on clinical findings, is not established for any test set because there is no clinical test set described in this document to evaluate the device's diagnostic or predictive performance.
4. Adjudication Method
Not Applicable. Since there is no test set with clinical findings requiring ground truth establishment, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a medical device for surgical intervention (sphincterotomy), not an imaging or diagnostic AI device. MRMC studies are typically used for assessing the impact of AI on human readers' diagnostic accuracy. This is not relevant to the Rota-Cut® Sphincterotome.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. The Medi-Globe Rota-Cut® Sphincterotome is a physical surgical instrument, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable.
7. The Type of Ground Truth Used
Not Applicable. As explained above, no clinical "ground truth" for diagnostic or predictive outcomes is mentioned because the performance evaluation is based on substantial equivalence to an existing device, focusing on "performance standards, biocompatibility requirements," and being "as safe and effective." The ground truth for these types of evaluations is often established through well-defined engineering specifications, material standards, and preclinical (e.g., animal or bench) testing protocols.
8. The Sample Size for the Training Set
Not Applicable. Since the device is a physical instrument and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an AI algorithm, this question is not applicable.
In summary, the provided document is a 510(k) summary for a substantial equivalence claim for a physical medical device. It focuses on comparing the new device's technological characteristics, intended use, and safety/effectiveness to previously cleared predicate devices. The detailed performance and clinical study information, including acceptance criteria, sample sizes, and ground truth methodologies, as typically found for novel AI/diagnostic devices, are not present in this type of regulatory submission and are not relevant to demonstrating substantial equivalence for a device like a sphincterotome. The "study" mentioned is "Design verification tests," which are engineering and biocompatibility tests intended to show equivalence to the predicate, not clinical trials with human subjects as implied by many of your questions.
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0616 CG. 1 0 = 2
JUN 2 7 2006
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
A.Submitter Information:
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
B.Device Name: Medi-Globe Rota-Cut® Sphincterotome
C.Predicate Devices: GIP/Medi-Globe Papillotome (K943629/A)
Boston Scientific Needle Knife Sphincterotome (K973826) AutoTome RX Model (K013153)
Wilson-Cook Medical Needle Knife Papillotome (K972674) Tri-Tome Select Plus (K033203)
D.Device Description:
The proposed Medi-Globe Rota-Cut® Sphincterotome is available in single, double or triple lumen models and allows incremental, rotational orientation of the distal catheter tip and cutting wire. Device models are compatible with either .021 or .035" guide wires and allow simultaneous injection of contrast medium during use.
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KC61684
PG. 2 of 2
E.Intended Use:
Medi-Globe Rota-Cut® Sphincterotome is used The proposed for transendoscopic cannulation of the biliary system and sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi.
F. Technological Characteristics Summary:
Sphincterotomes are substantially The Rota-Cut® equivalent to sphincterotomes currently cleared for sale in the United States. The proposed Rota-Cut® sphincterotomes are manufactured from similar medical grade plastics and stainless steel as the predicate devices.
G.Performance Data:
Design verification tests have demonstrated that the proposed Rota-Cut® sphincterotomes meet the same performance standards and biocompatibility requirements and is as safe and effective as the currently cleared GIP/Medi-Globe device, (K943629/A). The Rota-Cut® Sphincterotome is considered to have the same intended diagnostic/therapeutic effect, method of introduction/use, technical characteristics and general range of descriptive features as the GIP/Medi-Globe predicate devices.
Prepared by: Scott Karler Date: April 6, 2006
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN 2 7 2006
Medi-globe® Corporation c/o Mr. Daniel W. Lehtonen Intertek Testing Services 2307 East Aurora Road, Unit B7 TWINSBURG OH 44087
Re: K061684
Trade/Device Name: Rota-Cut® Sphincterotome Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: June 14, 2006 Received: June 15, 2006
Dear Mr. Lehtonen:
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.
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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Protecting and Promoting Public Health
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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 (OS) 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 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), 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 894.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). 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/cdrl/industry/support/index.html.
Sincerely vours.
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
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Indications for Use
K-061689 510(k) Number (if known): 千田田
Device Name: Medi-Globe Rota-Cut® Sphincterotome
Indications for Use: The Medi-Globe Rota-Cut® Sphincterotome is intended for transendoscopic cannulation of the Biliary system and sphincterotomy of the Papilla of Vater an/or the Sphincter of Oddi.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Ab doming and Radiological Devic 510(k) Number
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).