(26 days)
The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. The Habib EndoHPB is also intended for use to ablate malignant or benign tissue, notably to perform endoscopic biliary drainage or decompression, prior to stent placement or afterwards, to clear occluded stent.
The Habib EndoHPB is an 8F RF bipolar catheter that consists of a catheter with 2 ring electrodes, introduced via an endoscope's biopsy channel. It has an attached cable which connects the device to an RF Generator. RF is applied to the two electrodes at the top of the catheter so that heat is applied to tissue surrounding the catheter.
This document is a 510(k) Pre-market Notification from the FDA regarding the "Habib EndoHPB" device. It claims substantial equivalence to a previously cleared device of the same name (K180165). The only identified difference is "the recommended generator settings for using the Habib EndoHPB with the Erbe VIO 3 electrosurgical unit."
Therefore, the performance data presented is focused on demonstrating that these new settings maintain substantial equivalence, rather than establishing new performance criteria or proving the device meets those criteria from scratch. The document states: "The new settings have been evaluated using the same methods described in the predicate device 510(k), with additional controls, and the resulting performance data show substantial equivalence."
Based on the provided text, there is no detailed information on specific acceptance criteria or a study that rigorously proves the device meets such criteria. The document focuses on demonstrating substantial equivalence to a predicate device, specifically regarding new generator settings. As such, many of the requested details cannot be extracted from this document alone.
Here's an attempt to answer the questions based only on the provided text, with the understanding that most information regarding a standalone study proving acceptance criteria is absent:
1. A table of acceptance criteria and the reported device performance
This document does not provide specific acceptance criteria or reported device performance metrics in a typical table format as would be expected for a de novo device or a device demonstrating new performance claims. The claim is "substantial equivalence" to a predicate device for new generator settings. The "performance data" mentioned refers to showing that these new settings maintain the performance established by the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in this document. The document states, "The new settings have been evaluated using the same methods described in the predicate device 510(k), with additional controls, and the resulting performance data show substantial equivalence." Details about the specific test set size, data provenance, or study design (retrospective/prospective) for this evaluation are not included here. We would need to refer to the predicate device's 510(k) (K180165) for such information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not provided in this document. This level of detail regarding ground truth establishment would typically be found in a clinical study report, which is not present here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in this document. Information about adjudication methods is absent.
5. 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
Not applicable. The Habib EndoHPB is an RF catheter for tissue ablation, not an AI-assisted diagnostic or decision-support device that would involve human readers or AI improvement effect sizes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an RF catheter, not an algorithm. The "performance data" mentioned is likely related to the physical performance of the device (e.g., ablation efficacy, tissue damage patterns, temperature profiles) under the new generator settings, not an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not provided in this document. Given it's an ablation device, "ground truth" in the context of its performance validation would likely involve histological assessment of ablated tissue, temperature measurements, or other physical/biological markers of ablation effectiveness, rather than typical clinical "ground truth" for diagnostic devices. However, the document does not specify.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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June 21, 2023
Boston Scientific Corporation Carter Navarro Fellow, Regulatory Affairs 100 Boston Scientific Way Marlborugh, MA 01752
K231533 Re:
Trade/Device Name: Habib EndoHPB Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KNS Dated: May 26, 2023 Received: May 26, 2023
Dear Carter Navarro:
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.
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
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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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advicecomprehensive-regulatory-assistance/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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231533
Device Name Habib EndoHPB
Indications for Use (Describe)
The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.
The Habib EndoHPB is also intended for use to ablate malignant or benign tissue, notably to perform endoscopic biliary drainage or decompression, prior to stent placement or afterwards, to clear occluded stent.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
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Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way Marlborough, MA 01752 (508) 382-0356 www.bostonscientific.com
510(k) Summary for Habib EndoHPB
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Carter Navarro Contact: Fellow, Regulatory Affairs Phone: (508) 382-0356 E-mail: carter.navarro@bsci.com
Date Prepared: May 26, 2023
2. Device
| Trade Name: | Habib EndoHPB |
|---|---|
| Common Name: | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
| Product Code: | KNS |
| Device Class: | Class II |
| Device Panel: | Gastroenterology/Urology |
| Classification Regulation: | 21 CFR 876.4300, Endoscopic electrosurgical unit and accessories |
3. Predicate Device
| Trade Name: | Habib EndoHPB |
|---|---|
| 510(k) Number: | K180165 |
| Common Name: | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
| Product Code: | KNS |
| Device Class: | Class II |
| Device Panel: | Gastroenterology/Urology |
| Classification Regulation: | 21 CFR 876.4300, Endoscopic electrosurgical unit and accessories |
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4. Device Description
The Habib EndoHPB is an 8F RF bipolar catheter that consists of a catheter with 2 ring electrodes, introduced via an endoscope's biopsy channel. It has an attached cable which connects the device to an RF Generator. RF is applied to the two electrodes at the top of the catheter so that heat is applied to tissue surrounding the catheter.
5. Indications for Use
The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. The Habib EndoHPB is also intended for use to ablate malignant or benign tissue, notably to perform endoscopic biliary drainage or decompression, prior to stent placement or afterwards, to clear occluded stent.
6. Technological Characteristics
The technological characteristics of the proposed Habib EndoHPB are identical to those of the predicate device.
7. Substantial Equivalence
The proposed Habib EndoHPB is identical to the predicate device, with no changes in technology, engineering, performance, or materials. The only difference is the recommended generator settings for using the Habib EndoHPB with the Erbe VIO 3 electrosurgical unit. These settings do not raise new questions of safety or effectiveness, and the subject device is considered substantially equivalent to the predicate device.
8. Performance Data
The new settings have been evaluated using the same methods described in the predicate device 510(k), with additional controls, and the resulting performance data show substantial equivalence.
9. Conclusion
Boston Scientific has demonstrated that the proposed Habib EndoHPB is substantially equivalent to the currently marketed predicate device.
§ 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).