(58 days)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. Itis intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. Itis intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
This 510(k) is for a labeling modification only, to include the following additional representative, specific procedure of "Hepatectomy/Liver Resection" under the cleared "general laparoscopic surgical procedures" Indications for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294). There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are softwarecontrolled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.
The provided text describes a 510(k) submission for a labeling modification to the da Vinci Xi Surgical System (Model IS4000) and the da Vinci X Surgical System (Model IS4200) to include "Hepatectomy/Liver Resection" as a representative specific procedure under the existing Indications for Use. The submission argues for substantial equivalence based on clinical data from published literature.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly define "acceptance criteria" in a quantitative manner (e.g., "mortality rate must be less than X%"). Instead, it presents a comparative effectiveness study showing that the da Vinci-assisted procedures for Hepatectomy/Liver Resection are "substantially equivalent" to minimally invasive/laparoscopic procedures based on several clinical endpoints. The acceptance criterion is implicitly that the robotic-assisted procedure's performance on these endpoints isnot worse than the comparator procedures.
The reported device performance is presented in Tables 1A and 1B: da Vinci vs. Minimally Invasive/Laparoscopic Hepatectomy/Liver Resection Procedures. These tables detail various clinical outcomes from 32 retrospective studies, 5 database studies, and 1 prospective study comparing robotic-assisted and laparoscopic/minimally invasive approaches for hepatectomy/liver resection.
Table of Performance Comparison (Derived from Tables 1A and 1B and supporting text):
| Clinical Endpoint | Acceptance Criteria (Implicit: Not worse than minimally invasive/laparoscopic results) | Reported Device Performance (da Vinci-assisted vs. Minimally Invasive/Laparoscopic) |
|---|---|---|
| Mortality Rates | No statistically significant increase compared to comparator. | Data in Tables 1A and 1B generally show comparable (often 0%) mortality rates for both robotic and laparoscopic groups, or small differences that are not highlighted as significant. |
| Estimated Blood Loss (EBL) Volumes | No statistically significant increase compared to comparator. | Data in Tables 1A and 1B show similar EBL ranges and means for both groups, or sometimes lower for robotic, with variations across studies. |
| Transfusion Rates | No statistically significant increase compared to comparator. | Data in Tables 1A and 1B show comparable or sometimes lower transfusion rates for robotic, with variations across studies. |
| Lengths of Hospital Stay (LOS) | No statistically significant increase compared to comparator. | Data in Tables 1A and 1B show comparable or sometimes slightly varied LOS for both groups, with no consistent trend indicating worse outcomes for robotic. |
| Post/Peri-Operative Complication Rates | No statistically significant increase compared to comparator. | Data in Tables 1A and 1B show comparable complication rates for both groups, with no consistent trend indicating worse outcomes for robotic. |
| Conversion Rates | No statistically significant increase compared to comparator. | Data in Tables 1A and 1B show comparable or sometimes lower conversion rates for robotic, with variations across studies. |
| Readmission Rates | No statistically significant increase compared to comparator. | Data in Tables 1A and 1B show comparable or sometimes lower readmission rates for robotic, with variations across studies. |
| Perforation Rates | No statistically significant increase compared to comparator. | Not explicitly detailed in the tables, but stated as an endpoint demonstrating substantial equivalence. |
| Operative Times | Acceptable, considering potential benefits or known learning curve for robotic. | Data in Tables 1A and 1B show variable operative times; in some studies robotic times are longer, in others comparable or shorter. This is often accepted for robotic procedures due to precision and benefits. |
| Biliary/Bile Leak Rates | No statistically significant increase compared to comparator. | Data in Table 1B shows comparable or low bile leak rates for both robotic and laparoscopic groups. |
| Liver Failure Rates | No statistically significant increase compared to comparator. | Data in Table 1B shows comparable or low liver failure rates for both robotic and laparoscopic groups. |
| R0 Resection Rate (Negative Margins) | No statistically significant decrease compared to comparator. | Data in Table 1B shows comparable R0 resection rates for both groups, indicating similar oncologic efficacy where applicable. |
| PSM/R1 Resection Rate (Positive Margins) | No statistically significant increase compared to comparator. | Data in Table 1B shows comparable PSM/R1 resection rates for both groups. |
2. Sample size used for the test set and the data provenance
The "test set" in this context refers to the published clinical studies analyzed.
- Sample size: The study identified 38 publications. Within these publications, individual study sizes (N) for both Robotic and Laparoscopic cohorts vary widely, as shown in Tables 1A and 1B. For example, some studies have N as low as 9 (Berber 2010 Robotic) or 10, while others are significantly larger, such as Lap 6186 (Stewart 2019) or Robotic 354 (Stewart 2019). The total number of patients across all 38 studies is not aggregated but is certainly substantial.
- Data provenance: The data is retrospective and prospective clinical data from published literature.
- One (1) prospective study (LOE 2b)
- Five (5) database studies (LOE 2c)
- Thirty-two (32) retrospective studies (LOE 3b)
The country of origin is not specified in the provided text, but it's international clinical literature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for the outcomes reported in the individual studies (e.g., mortality, complications, EBL) would have been established by the clinical teams involved in those primary studies. This submission is a literature review, not a primary clinical study establishing new ground truth. Therefore, the "ground truth" here is derived from the aggregated findings of numerous published studies conducted by various clinical experts worldwide. The submission itself doesn't mention specific experts establishing a ground truth for its own analysis, but rather synthesizes existing expert-derived clinical data.
4. Adjudication method for the test set
Not applicable in the conventional sense. This is a review of published literature. The outcomes of the individual studies would have been adjudicated according to the methods of those respective studies. The selection of the studies for this submission was based on specific search criteria and filters as outlined in Figure A, implying a systematic review process rather than expert adjudication of individual cases for ground truth.
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
No. This is not an AI/imaging device. It's a surgical system where human surgeons directly control the robotic instruments. The comparative effectiveness study referenced is between human surgeons using the da Vinci system versus human surgeons using traditional minimally invasive/laparoscopic techniques. There is no mention of "human readers" or "AI assistance" in the context of improving diagnostic/interpretive tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The da Vinci system is a robotically-assisted surgical tool that requires a human surgeon in the loop. It is not an autonomous algorithm.
7. The type of ground truth used
The "ground truth" in this context is the clinical outcome data (e.g., mortality, complications, blood loss, length of stay, resection margins) reported in published peer-reviewed clinical studies. These outcomes are established through standard clinical practice, surgical records, patient follow-up, and, where applicable, pathology reports for resection margins.
8. The sample size for the training set
Not applicable. This device is a surgical system, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "training" for this device is the training of surgeons to use the system, which is mentioned in the Indications for Use: "It is intended to be used by trained physicians."
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set" in the context of an AI algorithm. The training of surgeons involves established surgical curricula, proctoring, and credentialing processes within medical institutions, based on clinical experience and outcomes.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.
Intuitive Surgical, Inc. % Cindy Domecus Principal, Domecus Consulting Services, LLC/ISI Chief Regulatory Advisor Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010
Re: K211784
Trade/Device Name: da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: June 4, 2021 Received: June 9, 2021
Dear Cindy Domecus:
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 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
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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,
Mark Trumbore Ph.D.. GWCPM Acting Assistant Director THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K211784
Device Name
Intuitive Surgical® da Vinci® X Endoscopic Instrument Control System (da Vinci X System, Model IS4200) and Endoscopic Instruments and Accessories
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. Itis intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
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.
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*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
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Indications for Use
510(k) Number (if known)
Device Name
Intuitive Surgical® da Vinci® Xi Endoscopic Instrument Control System (da Vinci Xi System, Model IS4000) and Endoscopic Instruments and Accessories
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. Itis intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
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."
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510(k) Summary (21 CFR § 807.92(c))
I. SUBMITTER INFORMATION
| Submitter: | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 |
|---|---|
| Contact: | Cindy Domecus, R.A.C. (US & EU)Principal, Domecus Consulting Services LLCChief Regulatory Advisor to Intuitive Surgical, Inc.Telephone: 650.343.4813Fax: 650.343.7822Email: Cindy@DomecusConsulting.com |
| Date Summary Prepared: | June 4, 2021 |
| II. SUBJECT DEVICE INFORMATION | |
| Device Trade Name: | da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200 |
| Common Name: | System, Surgical, Computer Controlled Instrument |
| Device Trade Name: | da Vinci Xi and Xi Surgical Systems, Model IS4300 and Model IS4200 |
|---|---|
| Common Name: | System, Surgical, Computer Controlled Instrument |
| Classification Name: | Endoscope and Accessories (21 CFR §876.1500) |
| Regulatory Class: | II |
| Product Code: | NAY |
| Submission Type: | Traditional 510(k) |
III. PREDICATE DEVICE INFORMATION:
Intuitive Surgical da Vinci Xi and X Surgical Systems, Models IS4000 and Predicate Devices: IS4200 (K131861, K152578, K153276, K161178, K170713, K171632, K171294 K172643, K173842, K173585, K182140, K183086, K202834) Intuitive Surgical da Vinci Si Surgical System, Model IS3000 (K081137, K123463, K090993)
IV. DEVICE DESCRIPTION:
This 510(k) is for a labeling modification only, to include the following additional representative, specific procedure of "Hepatectomy/Liver Resection" under the cleared "general laparoscopic surgical procedures" Indications for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294). There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are softwarecontrolled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.
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V. INDICATIONS FOR USE
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Precaution for Representative Uses
The demonstration of safety and effectiveness for the representative specific procedures did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient's underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.
VI. COMPARISON OF INTENDED USE, INDICATIONS FOR USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
There are no changes to the technological characteristics for the subject devices compared to the cleared predicate devices, da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294). This 510(k) is for a labeling modification to include the representative, specific procedure of "Hepatectomy/Liver Resection" as a labeled use under the cleared "general laparoscopic surgical procedures" Indications for Use of the cleared predicate devices, da Vinci Xi Surgical System, Model IS4000 and the da Vinci X Surgical System, Model IS4200. The subject devices differ from the predicate devices by this modification to the labeling. Results of clinical data from the literature demonstrated that the subject devices have the same intended use as the predicate devices.
VII. PERFORMANCE DATA
There were no technological changes to the subject devices, thus no bench testing, electromagnetic compatibility testing, sterilization testing or biocompatibility testing was required.
Clinical Study Data
Published clinical data were provided to support use of the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) in the subject representative, specific procedure of "Hepatectomy/Liver Resection" that falls under the cleared "general laparoscopic surgical procedures" Indication for Use. Thirty-eight (38) publications were identified for the subject procedure based on specific search criteria and filters used in three (3) databases: PubMed, Scopus and Embase. The search terms, inclusion/exclusion criteria and a flowchart depicting the results from these searches is Figure A. These publications included: one (1) prospective study (LOE 2b); five (5) database studies (LOE 2c) and thirty-two (32)
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retrospective studies (LOE 3b) comparing da Vinci-assisted procedures with minimally invasive/ laparoscopic cohorts. Detailed summaries of the published clinical data on these procedures are provided in Tables 1A and 1B.
The findings from the Hepatectomy/Liver Resection publications demonstrate that da Vinci-assisted procedures as compared to minimally invasive/laparoscopic procedures are found to be substantially equivalent based on the following endpoints:
- . Mortality Rates
- . Estimated Blood Loss (EBL) Volumes
- Transfusion Rates
- Lengths of Hospital Stay (LOS)
- Post/Peri-Operative Complication Rates
- Conversion Rates
- Readmission Rates
- Perforation Rates
- Operative Times
- Biliary/Bile Leak Rates
- . Liver Failure Rates
VIII. CONCLUSION
The da Vinci Xi and X Surgical Systems (models IS4000 and IS4200) have the same intended use as the predicate devices, as demonstrated by the clinical data from the literature to support the safety and effectiveness for the new labeled use of the representative, specific procedure of: "Hepatectomy/Liver Resection" under the "general laparoscopic surgical procedure" Indications for Use as compared to the predicate devices. In addition, the subject devices have technological characteristics as the predicate devices. Therefore, the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) are substantially equivalent to the cleared predicate devices.
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| 6of0ರPag- |
|---|
| , Summary |
| 10(k)ഥ |
| Author | Study Size (N) | Operation Time (minutes) | Conversion to Open Rate (%) | Peri / Postoperative Complication Rate (%) | EBL (ml) | Transfusion Rate (%) | Mortality Rate (%)(in-hospital, 30, 90 days) | Length of Stay (days) | Reoperation Rate (%) | Readmission Rate (%) |
|---|---|---|---|---|---|---|---|---|---|---|
| Efanov 2017 | Robotic 40 | 407 (85-980) | 5% | 20% | 465 (0-2000) | 8% | 0%^ | 11 (6-30) | 2.5% | Not Reported |
| Lim 2019 | Lap 91 | 296 (70-605) | 4% | 17% | 302 (0-2200) | 4% | 0%/1.1%^ | 9 (4-90) | 1.1% | Not Reported |
| Lim 2019 | Robotic 61 | 277 ± 156 | 3.2% | 25% | 14.8% | 0% | 9 ± 12 | 1.6% | 0% | |
| matched | Lap 111 | 263 ± 109 | 11.2% | 15% | Not Reported | 1.8% | 0% | 7±6 | 0% | 0.9% |
| Robotic 55 | 254 ± 143 | Not Reported | 22% | 10.9% | 0% | 9 ± 13 | 1.8% | 0% | ||
| Lap 55 | 257 ± 102 | 13% | 3.6% | 0% | 7 ± 5 | 0% | 0% | |||
| Spampinato 2014 | Robotic 25 | 430 (240-725) | 4.0% | 16% | 250 (100-1900) | 44% | 0%^ | 8 (4-22) | 4.0% | 0%^ |
| Lap 25 | 360 (180-600) | 4.0% | 36% | 400 (50-1200) | 16% | 4%^ | 7 (5-22) | 4.0% | 4%^ | |
| Berber 2010 | Robotic 9 | 258.5 ± 27.9 | 11.1% | 11.1% | 136 ± 61 | |||||
| Lap 23 | 233.6 ± 16.4 | 0.0% | 17.4% | 155 ± 54 | Not Reported | |||||
| Chong 2019 | Robotic 91 | 259.3 ± 127.0 | 7.7% | 9.9% | 274.6 ± 568.1 | 4.8 ± 1.8 | Not Reported | |||
| Lap 92 | 216.8 ± 79.2 | 12.0% | 5.4% | 212.4±313.3 | Not Reported | 4.9 ± 2.0 | Not Reported | |||
| Croner 2016 | Robotic 10 | 321 (138-458) | Not Reported | 10% | 306 | Not Reported | 0% | 7 (5-13) | 0% | |
| Lap 19 | 242 (80-478) | 16% | 356 | Reported | 5.0% | 8 (4–33) | 0% | Not Reported | ||
| Fruscione 2019 | Robotic 57 | 194 (152-255) | Not Reported | 28.1% | 250 (125-600) | Not Reported | 0% | 4 (3—5) | 1.8% | 7.0%^ |
| Lap 116 | 204 (149-280) | Reported | 35.3% | 400 (150–750) | Reported | 0% | 5 (3-6) | 0.9% | 28.4%^ | |
| Hu 2019 | Robotic 58 | 107.0 ± 45.2 | 0% | 2% | 80.1 ± 144.4 | 5.2% | 0% | 4.3 ± 1.8 | Not Reported | |
| Lap 54 | 95.7 ± 47.5 | 1.9% | 4% | 108.9 ± 180.8 | 1.9% | 0% | 4.4 ± 1.8 | Not Reported | ||
| Lai 2016 | Robotic 100 | 207.4 ± 77.1 | 4.0% | 14% | 334.6 (5-3500) | 9.0% | 0% | 7.3 ± 5.3 | Not Reported | |
| Lap 35 | 134.2 ± 41.7 | 5.7% | 20% | 336.0 (5-2000) | 11.4% | 0% | 7.1 ± 2.6 | |||
| D. Lee KF 2016 | Robotic 70 | 251.5 (97-620) | 5.7% | 11.4% | 100 (2-2500) | 4.3% | 0% | 5 (2-22) | 0% | Not Reported |
| Lap 66 | 215 (90-420) | 12.1% | 4.5% | 100 (5-1610) | 1.5% | 0% | 5 (2-15) | 0% | ||
| I. Lee JS 2019 | Robotic 13 | LH: 248.6 ± 37.5LLS: 160.8 ± 33.6 | 0% | 7.7% | 320.3 ± 331.9 | 0% | 0% | 7.0 ± 2.4 | 0% | Not Reported |
| Lap 10 | LH: 226.7 ± 26.6LLS: 116.3 ± 8.7 | 10% | 10% | 392.8 ± 374.5 | 0% | 0% | 7.3 ± 2.9 | 0% | Not Reported | |
| 2. Marino 2018 | Robotic 14 | 425 ± 139 | 14.3% | 21.4% | 335.15 ± 139.8 | 0% | 0% | 9 ± 1.4 | 0% | |
| Lap 20 | 565.18 ± 183.73 | 25.0% | 15.0% | 423.95 ± 205.15 | 0% | 0% | 8.6 ± 1.5 | 5.0% | Not Reported | |
| 3. Mejia 2019 | Robotic 35 | 121 [107-178] | 0% | 0% | 150 [100-200] | 8.6% | 0% | 2 [2-4] | Not Reported | |
| Minor | Lap 85 | 148 [113-180] | 1.2% | 4.7% | 135 [50-275] | 4.7% | 0% | 3 [2-3] | Not Reported | |
| Major | Robotic 8 | 222 [168.5-240.5] | 0% | 0% | 500 [225-780] | 25.0% | 0% | 3 [2.5-5.5] | ||
| Lap 13 | 195 [180-210] | 7.7% | 23.1% | 250 [100-300] | 7.7% | 0% | 3 [3-5] | Not Reported | ||
| 4. Montali 2015 | Robotic 36 | 306 ± 182 | 13.9% | 19.4% | 415 ± 414 | Not Reported | 2.8% | 6 ± 2.9 | ||
| Lap 72 | 295 ± 107 | 9.7% | 19.4% | 437 ± 523 | Reported | 0% | 4.9 ± 2.95 | Not Reported | ||
| 5. Packiam 2012) | Robotic 11 | 175 (156-253) | 0% | 27% | 30 (30-50) | 0% | 0% | 4 (3-5) | 0% | 9.1% |
| Lap 18 | 188 (156-222) | 0% | 0% | 30 (30-30) | 0% | 0% | 3 (2-3) | 0% | 0% | |
| Author | Study Size (N) | Operation Time (minutes) | Conversion to Open Rate (%) | Peri / Postoperative Complication Rate (%) | EBL (ml) | Transfusion Rate (%) (in-hospital, 30, 90 days) | Mortality Rate (%) (in-hospital, 30, 90 days) | Length of Stay (days) | Reoperation Rate (%) | Readmission Rate (%) |
| 16. Tranchart 2014 | Robotic 28 | 210 (45-480) | 14.3% | 17.9% | 200 (0-1,800) | 14.3% | 0% | 6 (1-15) | Not Reported | Not Reported |
| Lap 28 | 176 (30-420) | 7.1% | 17.9% | 150 (0-1,000) | 3.6% | 3.6% | 5.5 (1-50) | |||
| 17. Troisi 2013 | Robotic 40 | 271 ± 100 | 20% | 12.5% | 330 ± 303 | Not Reported | 0% | 6.1 ± 2.6 | ||
| Lap 223 | 262 ± 111 | 7.6% | 12.6% | 174 ± 133 | 0% | 5.9 ± 3.8 | ||||
| 18. Tsung 2013 | Robotic 57 | 253 (180-355) | 7% | 19.3% | 200 (50-337.5) | 3.8% | 0%^ | 4.0 (3.0-5.5) | Not Reported | |
| Lap 114 | 198.5 (138-262) | 8.8% | 26% | 100 (50-350) | 7.4% | 0.9%/1.8%^ | 4.0 (3.0-5.0) | |||
| 19. Wang 2019 | Robotic 92 | 195.53 ± 67.00 | 1.1% | 13% | 243.04 ± 171.87 | 0% | 7.41 ± 2.64 | 0% | Not Reported | |
| Lap 48 | 198.98 ± 72.94 | 10.4% | 10.4% | 346.04 ± 234.17 | 0% | 7.06 ± 3.35 | 0% | |||
| 20. Wu 2014 | Robotic 38 | 380 ± 166 | 5.3% | 8% | 325 ± 480 | Not Reported | 0% | 7.9 ± 4.7 | Not Reported | |
| Lap 41 | 227 ± 80 | 12.2% | 9.8% | 173 ± 165 | 0% | 7.2 ± 4.4 | ||||
| 21. Yu 2014 | Robotic 13 | 291.5 ± 85.1 | 0% | 0% | 388.5 ± 65.0 | 0% | 7.8 ± 2.3 | Not Reported | ||
| Lap 17 | 240.9 ± 68.6 | 0% | 11.8% | 342.6 ± 84.7 | 0% | 9.5 ± 3.0 | ||||
| 22. Beard 2019 | Robotic 115 | 272 ± 115 | 5.2% | Not Reported | 9.6% | 0.9% | 5 (IQR: 3-6) | 0.9% | 7.0% | |
| unmatched | Lap 514 | 253 ± 118 | 63 (12.1%) | 32.5% | 0.9% | 4 (IQR: 2-6) | 3.5% | 7.0% | ||
| matched | Robotic 115 | 31.3% | ||||||||
| Lap 115 | 27.8% | |||||||||
| 23. Cortolillo 2018 | Robotic 204 | Not Reported | 0.5% | 4.5 ± 3.8 | 7.9% | |||||
| Lap 520 | 2.1% | 6.8 ± 6.0 | 13.0% | |||||||
| 24. Di Sandro 2014 | Robotic 10 | 236 (140-360) | 0% | Not Reported | 220 (50-450) | Not Reported | 0% | 6.8 (5-9) | 0% | Not Reported |
| Lap 10 | 185 (85-310) | NR | 350 (50-1,200) | 0% | 6.5 (4-10) | 0% | ||||
| 25. Hu 2020 | Robotic 19 | 256.3 ± 57.7 | Not Reported | 5.3% | 319.5 ± 206.0 | 26.3% | 0% | 5.5 ± 2.1 | ||
| Lap 13 | 268.4 ± 93.6 | Reported | 7.7% | 476.9 ± 210.8 | 30.8% | 0% | 4.7 ± 1.7 | |||
| 26. Kim 2016 | Robotic 12 | 403.8 ± 139.0 | 0% | 25% | 225 (125-275) | 8.3% | 0% | 7 (7-8) | 8.3% | Not Reported |
| Lap 31 | 245.9 ± 100.7 | 3.2% | 22.6% | 150 (50-425) | 3.2% | 0% | 7 (5-8) | 6.5% | ||
| 27. O'Connor 2017 | Robotic 39 | 216 (80-300) | 7.7% | 18.0% | 298 (5-1650) | 5% | 3.0 (1-9) | Not Reported | Not Reported | |
| Lap 50 | 216 (120-330) | 28.0% | 34.0% | 306 (5-3000) | 6% | 3.3 (1-12) | ||||
| 28. Aziz 2021 | Robotic 109 | 3.7%-7.3% | 0%^^ | 4.5 ± 3.8 | 6.6%^* /18.3%^^ | Not Reported | ||||
| unmatched | Lap 343 | 9.8%-13.1% | 2.2%^^ | 6.1 ± 2.7 | 12.7%^* /26.7%^^ | Not Reported | ||||
| matched | Robotic 101 | 7.3% | 0%^^ | 1.5% | 14.3%^^ | Not Reported | ||||
| Lap 202 | 9.1% | 1.7%^^ | 1.9% | 16.5%^^ | ||||||
| 29. Chen 2017 | Robotic 81 | 343 (140-715) | 0% | 4.9% | 282 (50-2200) | Not Reported | 0%^^ | 7.5 (3-26) | 0% | Not Reported |
| Lap 41 | 228 (83-391) | 12.2% | 9.8% | 191 (50-600) | Reported | 0% | 6.3 (2-16) | 0% | ||
| 30. Han 2016 | Robotic 16 | 0% | Not Reported | 0% | Not Reported | Not Reported | ||||
| Lap 83 | 9.6% | 0% | ||||||||
| 31. Lin 2015 | Robotic 25 | 318.8 ± 44.1 | 0% | 24% | 270.8 ± 161.6 | 0% | 7.5 ± 1.7 | Not Reported | ||
| Lap 11 | 314.6 ± 56.3 | 0% | 27.3% | 294.6 ± 205.1 | Reported | 0% | 7.0 ± 1.3 | |||
| 32. Lorenz 2021 | Robotic 41 | 330.5 ± 132.2 | Not Reported | 19.5%** | 439.8 ± 346.3 | 17% | 0% | 13.4 ± 12.5 | 4.9% | Not Reported |
ABLE 1A: da Vinci vs. Minimally Invasive/Laparoscopic Hepatectomy/Liver Resection Procedures
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| Author | Study Size (N) | Operation Time (minutes) | Conversion to Open Rate (%) | Peri / Postoperative Complication Rate (%) | EBL (ml) | Transfusion Rate (%) | Mortality Rate (%) (in-hospital, 30, 90 days) | Length of Stay (days) | Reoperation Rate (%) | Readmission Rate (%) |
|---|---|---|---|---|---|---|---|---|---|---|
| . Magistri 2016 | Robotic22 | 318 ± 113.5 | 0% | 100% | 400 (50-1500) | 4.5% | 0% | 5.1 ± 2.4 | 0% | Not Reported |
| Lap24 | 211 ± 78.13 | 16.7% | 68.2% | 328 (100-1100) | 4.2% | 0% | 6.2 ± 2.57 | 4.2% | 8.80% | |
| 4. Miller 2021 | Robotic227 | 217 ± 101 | Not Reported | 10.6% | 0.90% | 4 ± 4 | 0.9% | 8.80% | ||
| Lap227 | 175 ± 92 | 4.8% | 0% | 3 ± NR | 1.3% | 5.30% | ||||
| 5. Salloum 2017 | Robotic16 | 190 ± 87 | 12.5% | 12.5% | 247 ± 239 | 6.3% | 0% | 6 ± 4 | Not Reported | |
| matched | Lap80 | 162 ± 51 | 2.5% | 11.3% | 206 ± 205 | 2.5% | 1.30% | 7 ± 8 | ||
| atched | Robotic14 | 203 ± 87 | 14.3% | 7.1% | 265 ± 253 | 7.1% | 0% | 6 ± 3 | Not Reported | |
| Lap14 | 140 ± 33 | 0% | 7.1% | 121 ± 99 | 0% | 0% | 6 ± 2 | |||
| 5. Stewart 2019 | Robotic354 | 21% | Not Reported | |||||||
| Lap6186 | 19% | Not Reported | ||||||||
| '. Stiles 2017 | Robotic73 | 6.8% | Not Reported | |||||||
| Lap989 | 20.0% | Not Reported | ||||||||
| 8. Ji 2011 | Robotic13 | 338 (150-720) | 0% | 7.7% | 280 | 0% | 6.7 | Not Reported | ||
| Lap20 | 130 (40-210) | 5% | 10% | 350 | 15% | Not Reported | 5.2 | Not Reported |
Major complications; ^90-day rate; ^^6month rate; ^* 45 day rate
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| Author | Study Size (N) | R0 Resection Rate (%) | PSM/R1 Resection Rate (%) | Bile leak Rate (%) | Liver failure Rate (%) | |
|---|---|---|---|---|---|---|
| 1. Efanov 2017 | Robotic | 40 | Not Reported | Not Reported | 10.0% | 0% |
| Lap | 91 | 4.4% (bile comps) | 1.1% | |||
| 2. Lim 2019unmatched | Robotic | 61 | 11.5% | |||
| matched | Lap | 111 | 15.3% | Not Reported | ||
| Robotic | 55 | Not Reported | 10.9% | |||
| Lap | 55 | 16.4% | ||||
| 3. Spampinato 2014 | Robotic | 25 | 100% | 0% | 0% | 0% (transient) |
| Lap | 25 | 91.3% | 8.7% | 8.0% | 8% (transient) | |
| 4. Berber 2010 | Robotic | 9 | Not Reported | |||
| Lap | 23 | Not Reported | ||||
| 5. Chong 2019 | Robotic | 91 | 98.9% | |||
| Lap | 92 | 98.9% | Not Reported | |||
| 6. Croner 2016 | Robotic | 10 | 100% | |||
| Lap | 19 | 100% | Not Reported | |||
| 7. Fruscione 2019 | Robotic | 57 | 91.9% | 8.1% | ||
| Lap | 116 | 92.6% | 7.4% | Not Reported | ||
| 8. Hu 2019 | Robotic | 58 | 100% | 0% | ||
| Lap | 54 | 100% | 0% | Not Reported | ||
| 9. Lai 2016 | Robotic | 100 | 96.0% | 2% | 1% | |
| Lap | 35 | 91.4% | Not Reported | 0% | 0% | |
| 10. Lee KF 2016 | Robotic | 70 | Not Reported | 1.8% | 1.40% | Not Reported |
| Lap | 66 | 1.6% | 0% | |||
| 11. Lee JS 2019 | Robotic | 13 | 100% | 0% | ||
| Lap | 10 | NR | NR | Not Reported | ||
| 12. Marino 2018 | Robotic | 14 | 91.7% | 8.3% | 7.1% | 7.1% (transient) |
| Lap | 20 | 85.0% | 10.0% | 10.0% | 5% (transient) | |
| 13. Mejia 2019minor | Robotic | 35 | Not Reported | 9.1% | 0% | Not Reported |
| major | Lap | 85 | 9.4% | 1.2% | ||
| Robotic | 8 | Not Reported | 0% | |||
| Lap | 13 | 25.0% | Not Reported | |||
| 14. Montali 2015 | Robotic | 36 | 11.1% | 2.8% | 5.6% | |
| Lap | 72 | Not Reported | 12.5% | 1.4% | 0% | |
| 15. Packiam 2012 | Robotic | 11 | Not Reported | |||
| Lap | 18 | |||||
| 16. Tranchart 2014 | Robotic | 28 | Not Reported | |||
| Lap | 28 | |||||
| 17. Troisi 2013 | Robotic | 40 | Not Reported | 7.5% | ||
| Lap | 223 | 5.4% | Not Reported | |||
| 18. Tsung 2013 | Robotic | 57 | 95% | Not Reported | 1.8%^ | Not Reported Page |
| Lap | 114 | 92% | 0% | |||
| Author | Study Size (N) | R0 Resection Rate (%) | PSM/R1 Resection Rate (%) | Bile leak Rate (%) | Liver failure Rate (%) | |
| 19. Wang 2019 | Robotic 92 | Not Reported | Not Reported | Not Reported | Not Reported | |
| 20. Wu 2014 | Lap 48 | 2.6% | Not Reported | |||
| Robotic 38 | NR | |||||
| 21. Yu 2014 | Lap 41 | Not Reported | ||||
| Robotic 13 | ||||||
| 22. Beard 2019matched | Lap 17 | 73.7% | 20.2% | Not Reported | ||
| Robotic 115 | 77.4% | 20.9% | ||||
| 23. Cortolillo 2018 | Lap 115 | Not Reported | ||||
| Robotic 204 | ||||||
| 24. Di Sandro 2014 | Lap 520 | 0% | 0% | 0% | ||
| Robotic 10 | 10.0% | 0% | ||||
| 25. Hu 2020 | Lap 10 | Not Reported | ||||
| Robotic 19 | ||||||
| 26. Kim 2016 | Lap 13 | 8.3% | Not Reported | |||
| Robotic 12 | 6.5% | |||||
| 27. O'Connor 2017 | Lap 31 | 90% | Not Reported | |||
| Robotic 39 | 88% | Not Reported | ||||
| 28. Aziz 2021matched | Lap 50 | Not Reported | 0.8% | |||
| Robotic 101 | ||||||
| 29. Chen 2017 | Lap 202 | Not Reported | ||||
| Robotic 81 | ||||||
| 30. Han 2016 | Lap 41 | Not Reported | ||||
| Robotic 16 | ||||||
| 31. Lin 2015 | Lap 83 | 100% | 0% | 4% | Not Reported | |
| Robotic 25 | 100% | 0% | 0% | |||
| 32. Lorenz 2021 | Lap 11 | 93.8% | Not Reported | 2.4% | Not Reported | |
| Robotic 41 | 87.9% | 0% | ||||
| 33. Magistri 2016 | Lap 72 | 95.5% | 4.5% | 0% | Not Reported | |
| Robotic 22 | 95.8% | 4.2% | 4.2% | |||
| 34. Miller 2021 | Lap 24 | Not Reported | ||||
| Robotic 227 | ||||||
| 35. Salloum 2017unmatched | Lap 227 | 0% | 0% | 0% | ||
| Robotic 16 | 2.1% | 0% | 1.3% | |||
| Lap 80 | Not Reported | 0% | 0% | Not Reported | ||
| Robotic 14 | 0% | 0% | ||||
| 36. Stewart 2019 | Lap 14 | Not Reported | ||||
| Robotic 354 | ||||||
| 37. Stiles 2017 | Lap 6186 | Not Reported | ||||
| Robotic 73 | ||||||
| 38. Ji 2011 | Lap 989 | 100% | 0% | 7.7% (transient) | Not Reported Page 32 o | |
| Robotic 13 | Not Reported | Not Reported | 5% (transient) | |||
| Lap 20 |
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ABLE 1B: da Vinci vs. Minimally Invasive/Laparoscopic Hepatectomy/Liver Resection Procedure
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FIGURE A: Search Criteria & Flowchart for Identification of Hepatectomy/Liver Resection Publications
Image /page/12/Figure/2 description: This image is a flowchart that shows the process of selecting publications for a study on robotic liver resection. The flowchart starts with 4909 publications from PubMed, Scopus, and Embase searches, and then it shows the number of publications that were removed at each stage of the selection process. The inclusion criteria include publication date between 1/1/2010 & 4/21/2021, LOE ≤ 3b, and study is an RCT, meta-analysis/SLRs, independent database or comparative study reporting on robotic-assisted versus minimally invasive/laparoscopic, surgery. The exclusion criteria include not in English, paper reports on a pediatric population, and publication is an HTA that was not published in a peer reviewed journal, among others, and the flowchart ends with 38 publications that meet the above criteria.
Key Search Terms: liver cancer, hepatocellular carcinoma, liver cirrhosis, hepatic/liver hemangioma, liver adenocarcinoma, liver/hepatic cyst, focal nodular hyperplasia, gian her tumor, liver surgery, hepatic surgery, hepatic surgery, partial hepatectorny, hepatectomies, hepatectorny, segmentectomies, hepatic resection, liver resection, pericystectory, hepatic segmentectorny, hepatic sectionectomy, wedge resection, hepatic lobectomy, hepatic nodular hyperplasia, hepatic adenoma
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.