(23 days)
The TRUEtome™ Sphincterotome devices are indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The sphincterotome can also be used to cannulate and inject contrast medium.
TRUEtome™ Sphincterotome when connected to a monopolar current may be used to incise the Papilla of Vater and/or the Sphincter of Oddi. The TRUEtome™ Sphincterotome is a 200 cm, triple lumen sphincterotome that tapers from 7 Fr (2.3 mm) to 5.5 Fr (1.8 mm) with an atraumatic tip. The catheter is capable of accepting a 0.035 in (0.89 mm) Boston Scientific Guidewire and a 0.025 in (0.64 mm) Boston Scientific Guidewire, while injecting and/or cutting using other lumens. The sphincterotome may be placed with or without the aid of a guidewire. When connected to a monopolar current, the sphincterotome may be used to incise the Papilla of Vater and/or the Sphincter of Oddi. The sphincterotome is designed for use with endoscopes that have a working channel of 2.8 mm and larger.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TRUEtome™ Sphincterotome:
It's important to note that this document is a 510(k) summary, which is a premarket notification for a medical device. For devices seeking substantial equivalence to a predicate device, the regulatory focus is often on demonstrating that the new device is as safe and effective as the legally marketed predicate, rather than proving efficacy from scratch with extensive clinical trials. Therefore, the "study" described here is primarily a set of performance tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Specification | Reported Device Performance | Study Type |
|---|---|---|
| Cytotoxicity (Biocompatibility) | Met required specifications | In-vitro |
| Intracutaneous Reactivity (Irritation) (Biocompatibility) | Met required specifications | In-vitro |
| Sensitization (Biocompatibility) | Met required specifications | In-vitro |
| USP Physiochemical tests (Biocompatibility) | Met required specifications | In-vitro |
| EO residual testing | Met required specifications | In-vitro |
| Initial Tip Orientation | Met required specifications | In-vitro |
| Tip Bowing | Met required specifications | In-vitro |
| Tip Bow Holding | Met required specifications | In-vitro |
| Tip Rotation | Met required specifications | In-vitro |
| Guidewire Passage/Compatibility | Met required specifications | In-vitro |
| System Leakage | Met required specifications | In-vitro |
| Tip OD | Met required specifications | In-vitro |
| Luer to Extrusion Integrity | Met required specifications | In-vitro |
| Electrical safety (IEC 60601-1:1988 A1:1991 A2:1995) | Confirmed (met standard) | In-vitro |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each in-vitro test. It mentions that "all components, subassemblies, and/or full devices" were tested.
The data provenance is in-vitro (laboratory) testing. There is no mention of human subject data, animal data, or data from specific countries of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for these engineering and biocompatibility tests is based on established scientific principles, industry standards (e.g., AAMI/ANSI/ISO 10993-1, IEC 60601-1), and the manufacturer's internal specifications, not expert interpretation of complex clinical data.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" for these performance tests is based on objective measurements against predefined specifications, not on expert adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This 510(k) submission focuses on demonstrating substantial equivalence through non-clinical performance data (in-vitro testing) and comparison of technological characteristics to predicate devices. It does not involve human readers evaluating images or clinical outcomes that would necessitate an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. This device is a medical instrument (sphincterotome), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant here.
7. The Type of Ground Truth Used
The ground truth used for the performance tests is based on:
- Industry Standards: Such as AAMI/ANSVISO 10993-1, AAMI/ANSI/ISO 10993-7, and IEC 60601-1.
- Manufacturer's Required Specifications: Internal design and performance specifications for the device and its components.
- Engineering Principles: Applied to evaluate physical properties, electrical safety, and functional parameters.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI/ML algorithm. Therefore, 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 this type of device.
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K 122203 page 1 of 2
SECTION 5 510(k) SUMMARY
510(k) SUMMARY
AUG 1 7 2012
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4793 Fax: 508-683-5939
Contact: Laurie Pannella Regulatory Affairs Specialist Date Prepared: July 20, 2012
2. Proposed Device:
Trade Name: TRUEtome™ Sphincterotome, Classification Name: Endoscopic Electrosurgical Unit and Accessories Regulation Number: 876.4300 Product Code: KNS Classification: Class II
3. Predicate Devices:
Trade Name: Autotome TM RX Sphincterotome Manufacturer and Clearance Number: Boston Scientific Corporation, K013153 Classification Name: Endoscopic Electrosurgical Unit and Accessories Regulation Number: 876.4300 Product Code: KNS Classification: Class II
Trade Name: UltratomeTM XL Sphincterotome Manufacturer and Clearance Number: Boston Scientific Corporation, K930022 Classification Name: Endoscopic Electrosurgical Unit and Accessories Regulation Number: 876.4300 Product Code: FDI Classification: Class II
4. Proposed Device Description:
TRUEtome™ Sphincterotome when connected to a monopolar current may be used to incise the Papilla of Vater and/or the Sphincter of Oddi. The TRUEtome™ Sphincterotome is a 200 cm, triple lumen sphincterotome that tapers from 7 Fr (2.3 mm) to 5.5 Fr (1.8 mm) with an atraumatic tip. The catheter is capable of accepting a 0.035 in (0.89 mm) Boston Scientific Guidewire and a 0.025 in (0.64 mm) Boston Scientific Guidewire, while injecting and/or cutting using other lumens. The sphincterotome may be placed with or without the aid of a guidewire. When connected to a monopolar current, the sphincterotome may be used to incise the Papilla of Vater and/or the Sphincter of Oddi. The sphincterotome is designed for use with endoscopes that have a working channel of 2.8 mm and larger.
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5. Indication for Use:
The Intended Use of the proposed TRUEtomeTM Sphincterotome is identical the predicate devices, Autotome TM RX Sphincterotome and Ultratome™ XL. These devices are indicated for use in the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The Sphincterotome can also be used cannulate and to inject contrast medium.
6. Technological Characteristics:
The proposed TRUEtome™ Sphincterotomes are similar in design, materials, and manufacturing processes to the predicate, Autotome ™ RX Sphincterotome (K013153) and Ultratome™ XL Sphincterotome (K930022).
7. Performance Data:
Biocompatibility of the proposed device was confirmed via AAMI/ANSVISO 10993-1: 2009, and included Cytotoxicity, Intracutaneous Reactivitity (Irritation), Sensitization and USP Physiochemical tests.
EO residual testing was done per AAMI/ANSI/ISO 10993-7: 2008
In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications. The testing included Initial Tip Orientation, Tip Bowing, Tip Bow Holding, Tip Rotation, Guidewire Passage/Compatibility, System Leakage, Tip OD, Luer to Extrusion Integrity. Electrical safety of the device has also been confirmed via IEC 60601-1:1988 A1:1991 A2:1995.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the minor device modifications to the existing predicate Autotome ™ RX Sphincterotome (K013153) are substantially equivalent to the proposed TRUEtome™ Sphincterotome. Therefore, the proposed TRUEtome™ Sphincterotome device is as safe, as effective and performs as well as the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
AUG 1 7 2012
Ms. Laurie Pannella Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752
K122203 Re:
Trade/Device Name: TRUEtome™ Sphincterotome Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: July 24, 2012 Received: July 25, 2012
Dear Ms. Pannella:
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. 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.
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 (reporting of medical
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Page 2 -
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you doshe sportio advice 10. Jour FDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin K. Kirk
Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KIZZZO3
SECTION 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Indications For Use:
To Be Determined
TRUEtome™ Sphincterotome
The TRUEtome™ Sphincterotome devices are indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The sphincterotome can also be used to cannulate and inject contrast medium.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aonu Khan
uctive, Gastro-Rena
600.013
§ 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).