(12 days)
K943629/A
No
The summary describes a mechanical device for surgical procedures and does not mention any AI/ML components or capabilities.
Yes
The device is described as having a "therapeutic effect" and is used for sphincterotomy, which is a therapeutic procedure.
No
The device is described as allowing 'transendoscopic cannulation of the Biliary system and sphincterotomy of the Papilla of Vater an/or the Sphincter of Oddi', which are interventional procedures, not diagnostic ones. Although the "Summary of Performance Studies" mentions "intended diagnostic/therapeutic effect", the primary stated use is therapeutic (cutting tissue).
No
The device description clearly indicates a physical, invasive medical device (sphincterotome) with lumens, a cutting wire, and compatibility with guide wires. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "transendoscopic cannulation of the Biliary system and sphincterotomy of the Papilla of Vater an/or the Sphincter of Oddi." This describes a surgical or therapeutic procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a physical device used for cutting and manipulation within the body, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The proposed Medi-Globe Rota-Cut® Sphincterotome is used for transendoscopic cannulation of the biliary system and sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi.
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.
Product codes
KNS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Biliary system, Papilla of Vater, Sphincter of Oddi
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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 curved lines representing the bird's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "FDA Centennial" in the center. The letters "FDA" are prominently displayed in a stylized font above the word "Centennial". There are three stars below the word "Centennial". The text around the circle reads "U.S. Department of Health and Human Services".
Protecting and Promoting Public Health
3
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
4
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