(24 days)
No
The description focuses on the mechanical and electrical components of a sphincterotome for endoscopic procedures, with no mention of AI or ML capabilities.
Yes
The device is used for medical procedures like selective cannulation and transendoscopic sphincterotomy to treat conditions related to the bile ducts and sphincters.
Yes
The "Intended Use / Indications for Use" section states: "The Sphincterotome can also be used to inject contrast medium." and the "Device Description" section clarifies: "The sphincterotome can deliver contrast medium to the distal tip yia an iniection channel to aid in fluoroscopic visualization." Contrast medium injection for visualization is a diagnostic function. Additionally, the "Device Description" states it is used for "diagnostic and/or therapeutic endoscopic biliary procedures".
No
The device description clearly details a physical medical device (sphincterotome) with a cutting wire, lumens, and specific dimensions, indicating it is hardware, not software only.
Based on the provided text, the Autotome Pro RX Sphincterotome is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on samples like blood, urine, or tissue outside of the body.
- Device Function: The description clearly states the Autotome Pro RX Sphincterotome is used within the body for procedures like cannulation, sphincterotomy, and contrast injection. It is a surgical/interventional device used directly on anatomical structures.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. Its function is mechanical (cutting), electrical (cauterizing), and for delivering contrast medium.
Therefore, the Autotome Pro RX Sphincterotome falls under the category of a surgical or interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Autotome Pro RX Sphincterotome is indicated for use in the selective cannulation of the Common Bile Ducts (CBD) and the transendoscopic sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi. The Sphincterotome can also be used to inject contrast medium.
Product codes
KNS
Device Description
The Autotome Pro RX Sphincterotome is used for cannulation of the bile duct when performing diagnostic and/or therapeutic endoscopic biliary procedures. The sphincterotome can deliver contrast medium to the distal tip yia an iniection channel to aid in fluoroscopic visualization. The sphincterotome consists of a cutting wire on the distal end to cut and cauterize the Papilla of Vater and/or Sphincter of Oddi when connected to a monopolar electrosurgical generator. The sphincterotome is designed for use with endoscopes that have a working channel of 2.8mm or larger.
The Autotome Pro RX Sphincterotome is a 200cm, triple lumen sphincterotome available in 2 sizes: 3.9Fr and 4.4Fr. The Autotome Pro RX 39 Sphincterotome is capable of accepting a 0.025" (0.64mm) guidewire and the Autotome Pro RX 44 Sphincterotome is capable of accepting a 0.035" (0.89mm) or 0.025" (0.64mm) guidewire. The Autotome Pro RX Sphincterotome includes insulation on the proximal end of the cut wire. The Autotome Pro RX Sphincterotome is also available with a pre-loaded guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Common Bile Ducts (CBD), 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
Non-clinical performance bench testing, simulated use testing and biocompatibility testing (per the requirements of ISO 10993-1) were completed to evaluate the design of the proposed Autotome Pro RX Sphincterotome.
Bench Testing included:
- Exposed Cut Wire Length
- Distal Shaft Drawdown Length
- Depth and Reference Markers
- Length of Rapid Exchange
- Non-Insulated Cut Wire Length
- Initial Tip Orientation
- Tip Rotation
- Tip Bowing
- Tip Bow Holding
- Injection Flow Rate
- Tissue Cutting
- System Leakage
- Insulation Durability
- Insulation Dielectric Strength
- Endoscope Capability
- Guidewire Passage/Compatibility
- Guidewire Exchangeability
- Biopsy Cap Compatibility
- In-Plane Bowing
Biocompatibility Testing included:
- Cytotoxicity
- Sensitization
- Irritation
All testing produced passing results and demonstrates the device's ability to fulfill non-clinical performance bench testing, simulated use testing, and biocompatibility requirements.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 14, 2023
Boston Scientific Corporation Stephanie Gorman Sr. Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, Massachusetts 01752
Re: K232162
Trade/Device Name: Autotome Pro RX 39 Sphincterotome: Autotome Pro RX 44 Sphincterotome: Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome
Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit And Accessories Regulatory Class: Class II Product Code: KNS Dated: July 20, 2023 Received: July 21, 2023
Dear Stephanie Gorman:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Glenn B. Bell -S
Glenn B.Bell, Ph.D. Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Autotome Pro RX 39 Sphincterotome;
Autotome Pro RX 44 Sphincterotome;
Jagtome Pro RX 44 Sphincterotome;
Jagtome Pro RX 39 Sphincterotome;
Dreamtome Pro RX 44 Sphincterotome;
Hydratome Pro RX 44 Sphincterotome;
Jagtome Revolution Pro RX 39 Sphincterotome
Indications for Use (Describe)
The Autotome Pro RX Sphincterotome is indicated for use in the selective cannulation of the Common Bile Ducts (CBD) and the transendoscopic sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi. The Sphincterotome can also be used to inject contrast medium.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary (per 21 CFR 807.92)
| Submitter: | Boston Scientific Corporation |
|---|---|
| 100 Boston Scientific Way | |
| Marlborough, MA 01752 | |
| Contact: | Stephanie Gorman |
| Sr. Regulatory Affairs Specialist | |
| 508.382.0441 | |
| Stephanie.Gorman@bsci.com | |
| Date Prepared: | July 20, 2023 |
Proposed Device Information:
| Trade Name: | Autotome Pro RX 39 Cannulating Sphincterotome |
|---|---|
| Autotome Pro RX 44 Cannulating Sphincterotome | |
| Dreamtome Pro RX 44 Sphincterotome | |
| Hydratome Pro RX 44 Sphincterotome | |
| Jagtome Pro RX 39 Sphincterotome | |
| Jagtome Pro RX 44 Sphincterotome | |
| Jagtome Revolution Pro RX 39 Sphincterotome | |
| Common Name: | Sphincterotome |
| Classification Name: | Endoscopic electrosurgical unit and accessories |
| Regulation Number: | 21 CFR 876.4300 |
| Product Code: | KNS |
| Device Class: | Class II |
| Panel: | Gastroenterology/Urology |
Predicate Device Information:
| Trade Name: | Autotome RX Sphincterotome |
|---|---|
| 510(k) Number: | K013153 |
| Common Name: | Sphincterotome |
| Classification Name: | Endoscopic electrosurgical unit and accessories |
| Regulation Number: | 21 CFR 876.4300 |
| Product Code: | KNS |
| Device Class: | Class II |
| Panel: | Gastroenterology/Urology |
Reference Device Information:
| Device Name: | Single Use Preloaded Sphincterotome V |
|---|---|
| 510(k) Number: | K122505 |
| Classification Name: | Endoscopic electrosurgical unit and accessories |
| Regulation Number: | 21 CFR 876.4300 |
| Product Code: | KNS |
| Device Class: | Class II |
| Panel: | Gastroenterology/Urology |
4
Device Description:
The Autotome Pro RX Sphincterotome is used for cannulation of the bile duct when performing diagnostic and/or therapeutic endoscopic biliary procedures. The sphincterotome can deliver contrast medium to the distal tip yia an iniection channel to aid in fluoroscopic visualization. The sphincterotome consists of a cutting wire on the distal end to cut and cauterize the Papilla of Vater and/or Sphincter of Oddi when connected to a monopolar electrosurgical generator. The sphincterotome is designed for use with endoscopes that have a working channel of 2.8mm or larger.
The Autotome Pro RX Sphincterotome is a 200cm, triple lumen sphincterotome available in 2 sizes: 3.9Fr and 4.4Fr. The Autotome Pro RX 39 Sphincterotome is capable of accepting a 0.025" (0.64mm) guidewire and the Autotome Pro RX 44 Sphincterotome is capable of accepting a 0.035" (0.89mm) or 0.025" (0.64mm) guidewire. The Autotome Pro RX Sphincterotome includes insulation on the proximal end of the cut wire. The Autotome Pro RX Sphincterotome is also available with a pre-loaded guidewire.
Indications for Use:
The Autotome Pro RX Sphincterotome is indicated for use in the selective cannulation of the Common Bile Ducts (CBD) and the transendoscopic sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi. The Sphincterotome can also be used to inject contrast medium.
Performance Data:
Non-clinical performance bench testing, simulated use testing and biocompatibility testing (per the requirements of ISO 10993-1) were completed to evaluate the design of the proposed Autotome Pro RX Sphincterotome.
Bench Testing included:
- Exposed Cut Wire Length ●
- Distal Shaft Drawdown Length ●
- Depth and Reference Markers ●
- Length of Rapid Exchange
- Non-Insulated Cut Wire Length
- Initial Tip Orientation ●
- Tip Rotation
- Tip Bowing ●
- Tip Bow Holding
- Injection Flow Rate .
Biocompatibility Testing included:
- Cytotoxicity ●
- Sensitization ●
- Irritation
- Tissue Cutting ●
- System Leakage ●
- Insulation Durability ●
- Insulation Dielectric Strength
- Endoscope Capability
- Guidewire Passage/Compatibility ●
- Guidewire Exchangeability ●
- Biopsy Cap Compatibility ●
- In-Plane Bowing .
All testing produced passing results and demonstrates the device's ability to fulfill non-clinical performance bench testing, simulated use testing, and biocompatibility requirements.
5
Conclusion:
Boston Scientific has demonstrated that the proposed Autotome Pro RX Sphincterotome is substantially equivalent to the currently marketed Autotome RX Sphincterotomes (K013153).