The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, 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, and general thoracoscopic surgical procedures. The system is also indicated for selected thoracoscopically-assisted cardiac surgical procedures using the non-force feedback instruments. The system is indicated for adult use.

Device Description

The da Vinci Surgical System (IS5000) is a software-controlled, electromechanical system designed for surgeons to perform minimally invasive surgery. It consists of a Surgeon Side Console (Console), a Patient Side Cart (Robot), and a Vision System Cart (Tower) and is used with an Endoscope, EndoWrist Instruments, and Accessories.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - da Vinci Surgical System (IS5000)

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.02

January 16, 2026

Intuitive Surgical, Inc.
Emily Hovick
Sr. Regulatory Affairs Specialist
1266 Kifer Road
Sunnyvale, California 94086

Re: K251739
Trade/Device Name: da Vinci Surgical System (IS5000)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: NAY
Dated: December 18, 2025
Received: December 19, 2025

Dear Emily Hovick:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/medical-device-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-advice-comprehensive-regulatory-

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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,

Mark Trumbore Ph.D.
Assistant Director
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

Digitally signed by Mark Trumbore -S
Date: 2026.01.16 11:21:00 -05'00'

Enclosure

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FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known): K251739

Device Name: da Vinci Surgical System (IS5000)

Indications for Use (Describe)

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.

Contraindication: Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

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

510(k) Owner: Intuitive Surgical
1266 Kifer Road
Sunnyvale, CA 94085

Contact Person: Emily Hovick
Senior Regulatory Affairs Specialist
Phone: 314-359-8534
Email: Emily.hovick@intusurg.com

Date Summary Prepared: January 16, 2026

II. Subject Device Information

Trade Name: da Vinci Surgical System (IS5000)
Common Name: System, surgical, computer-controlled instrument
Classification: Class II
Regulation: 21 CFR § 876.1500, Endoscope and Accessories
Product Code: NAY

III. Predicate Device Information

Predicate Device: da Vinci Surgical System (IS5000), K232610
Reference Device: da Vinci Xi Surgical System (IS4000), K131861

IV. Device Description

V. Indications for 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.

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VI. Technological Characteristics

The da Vinci Surgical System (IS5000) is technologically equivalent to the predicate device, with no changes to its operational principles. This 510(k) pertains exclusively to software and labeling modifications which include the following:

• Instrument compatibility:

Atrial Retractor Short Right (PN 470246)
Cardiac Probe Grasper (PN 470215)

• Revised indications for use to include:
"The system is also indicated for selected thoracoscopically-assisted cardiac surgical procedures using the non-force feedback instruments."

• Addition of specific, representative uses:

Mitral valve repair
IMA mobilization for cardiac revascularization
Patent foramen ovale closure
Atrial septal defect repair
Left atrial appendage closure/occlusion
Atrial myxoma excision
Mitral valve replacement
Tricuspid valve repair
Epicardial pacing lead placement

VII. Performance Data

Software Testing

Software verification and validation have been conducted at the unit, integration, and system level to confirm that the subject device continues to meet design requirements and user needs. Software documentation has been provided in accordance with FDA Guidance, "Content of Premarket Submissions for Device Software Functions," issued on June 14, 2023.

Cadaver and Animal Non-Clinical Testing

Equivalence studies were conducted to compare the surgical performance and safety of the da Vinci Surgical System (IS5000) to the reference da Vinci Xi Surgical System (IS4000) during mitral valve repair and IMA mobilization for cardiac revascularization procedures. The studies involved testing in both cadaveric and live canine models.

Systematic Literature Reviews

Systematic literature reviews were conducted to evaluate clinical outcomes of robotic-assisted procedures performed with a da Vinci Surgical System, including mitral valve repair, coronary artery bypass grafting (CABG), atrial septal defect repair, left atrial appendage closure/occlusion, patent foramen ovale closure, atrial myxoma excision, mitral valve replacement, and tricuspid valve repair.

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Findings from these systematic literature reviews demonstrate that the clinical outcomes of robotic-assisted procedures performed with the da Vinci Surgical System are comparable to those of traditional non-robotic approaches, supporting their efficacy and safety across a range of cardiac interventions. Summary data are presented in Table 1 through Table 10.

Real World Data from the Premier Health Database

A retrospective cohort study using the Premier Healthcare Database compared clinical outcomes of robotic and non-robotic mitral valve repair and CABG performed in the United States between 2016 and 2023. The propensity score matched analysis included 1,507 robotic mitral valve repair procedures and 1,507 non-robotic mitral valve repair procedures and 3,893 robotic CABG procedures and 3,893 non-robotic CABG procedures. Results indicate that robotic mitral valve repair and CABG are substantially equivalent to non-robotic procedures. Primary and secondary surgical outcomes are presented in Table 11 through Table 16.

VIII. Conclusion

The subject da Vinci Surgical System (IS5000) has the same intended use as the predicate device, with the addition of more specific indications for use, which includes selected thoracoscopically-assisted cardiac surgical procedures, with new specific, representative uses defined in the Professional Instructions for Use. Additionally, the IS5000 system has the same technological characteristics other than a minor software update to enable compatibility with two existing 510(k)-cleared cardiac instruments.

Performance data confirmed that these software and labeling modifications do not raise new or different questions of safety or effectiveness. Therefore, the subject da Vinci Surgical System (IS5000) is substantially equivalent to the cleared predicate device.

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Table 1: da Vinci vs. Mini-thoracotomy or Sternotomy MVr Procedure Main Clinical Outcomes

Author / Year	Study Arms	Study Size (N)	Operating time (minutes)	Conversion to sternotomy (%)	Blood transfusion (%)	Number of transfused units (N)	ICU LOS (hours)	Readmission to ICU (%)	LOS (days)	Postop. complications 30-d (%)	Mortality 30-day (%)	Readmission 30-d (%)	Reoperation for bleeding 30-d (%)	Reoperation for any reason 30-d (%)
1. Albano (2024)	Robotic	98	Median: 259	NR	21	NR	Median: 41	NR	Median: 10	ISI calc. 49	In-hospital: 0	NR	3	NR
	Mini-Thoracotomy	98	Median: 235		15		Median: 45		Median: 11	ISI calc. 47	In-hospital: 0		2
2. Baccanelli (2024)	Robotic	111		NR							In-hospital: 0			NR
	Mini-Thoracotomy	205									In-hospital: 0
3. Barac (2021)	Robotic	128		NR	1.6			NR	5	NR	0	NR	3	NR
	Mini-Thoracotomy	249			1.2				5		0.4		1
4. Chemtob (2022)	Robotic	605		NR	0	10	NR	Median: 25	NR	5.2 ± 2.9	NR	In-hospital: 0	NR	1.3
	Sternotomy	395			NA	17		Median: 27		5.9 ± 2.3		In-hospital: 0		0.51

[Table continues with additional rows...]

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[Table 1 continued with additional entries for authors 5-10]

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[Table 1 continued with additional entries for authors 11-22]

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[Table 1 continued with final entries]

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Table 2: da Vinci vs. Mini-thoracotomy or Sternotomy MVr Procedure Secondary Clinical Outcomes

Author	Study Arms	Study Size (N)	CPB time (minutes)	XC time (minutes)	Ventilation time (hours)	Prolonged mechanical ventilation (%)	Pulmonary complications (%)	Atrial fibrillation (%)	MI 30-day (%)	Cardiac arrest 30-day (%)	Stroke 30-day (%)	Renal failure 30-day (%)	Discharge to nursing facility / rehab (%)
1. Albano (2024)	Robotic	98	Median: 165	Median: 91	Median: 3	9	NR	22	NR		Dialysis: 0	10
	Mini-Thoracotomy	98	Median: 137	Median: 99	Median: 6	21		12			Dialysis: 0	41

[Table continues with additional rows...]

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[Table 2 continued]

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[Table 2 continued]

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Table 3: da Vinci vs. Non Robotic-Assisted CABG Main Clinical Outcomes

Author	Study Arms	Study Size (N)	Operating Time (minutes)	Conversion to Sternotomy (%)	Blood Transfusion (%)	Number of Transfused Units (n)	ICU Stay (days)	LOS (days)	Postoperative Complications 30-d (%)	Mortality 30-d (%)	Readmission 30-d (%)	Reoperation for bleeding 30-d (%)	Reoperation for any reason 30-d (%)	Reoperation for revascularization 30-d (%)
1. Algoet (2024)	Robotic	54	364.0 ± 71.0	NR	In-hospital: 16.7	NR	0.78 ± 1.70	6.78 ± 2.4	NR	0	0	NR	3.7	TVR: 1.9
	Open	54	286.1 ± 45.8		In-hospital: 38.9		1.91 ± 1.01	8.01 ± 2.5		0	0		9.3	TVR: 1.9

[Table continues with additional rows...]

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[Table 3 continued]

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[Table 3 continued]

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[Table 3 continued]

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Table 4: da Vinci vs. Non Robotic-Assisted CABG Secondary Clinical Outcomes

Author	Study Arms	Study Size (N)	CPB Time (if on-pump) (min)	XC Time (min)	Ventilation Time (h)	Prolonged Ventilation Time (%)	Atrial Fibrillation (%)	MI 30-d (%)	Angina 30-d (%)	Stroke 30-d (%)	Renal Failure 30-d (%)	Ejection Fraction (%)	MACE (%)	Discharge Location (%)
1. Algoet (2024)	Robotic	54		NR			31.5	STEMI: 0 NSTEMI: 0	NR	0	NR	1.9		NR
	Open	54					20.4	STEMI: 1.9 NSTEMI: 1.9		1.9		0

[Table continues with additional rows...]

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[Table 4 continued]

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[Table 4 continued]

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Table 5: da Vinci Robotic-Assisted Defect Closure Main Clinical Outcomes

Cardiac procedure	Author	Study Arms	Study Size (N)	Operating time (minutes)	Conversion to open surgery (%)	Blood transfusion (%)	Number of transfused units, n	ICU LOS (days)	LOS (days)	Postop. complications 30-d (%)	Mortality 30-d (%)	Readmission 30-d (%)	Reoperation for bleeding 30-d (%)	Reoperation for any reason 30-d (%)	Postop. ejection fraction (%)
ASD	1. Liu (2023) Comparative retro.	Robotic	101	190.4 ± 12.68	NR	3/101	NR	18.2h ± 4.6h	8 ± 1.9	NR	1/101	NR	1/100	NR
		Sternotomy	162	181.4 ± 12.3		10/162		23.5h ± 5.6h	10 ± 1.5		0/162		2/162

[Table continues with additional rows...]

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[Table 5 continued]

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Table 6: da Vinci Robotic-Assisted Defect Closure Secondary Clinical Outcomes

Cardiac procedure name	Author	Study Arms	Study Size (N)	CPB time (minutes)	XC time (minutes)	Ventilation time (hours)	Prolonged mechanical ventilation (%)	Pulmonary complications (%)	Cardiac arrest (%)	Myocardial infarction (%)	New-onset atrial fibrillation (%)	Renal failure (%)	Stroke (%)	Discharge location (%)	Atrial septal leakage (%) or Postoperative residual flow (%)
ASD		Robotic	101	69.3 ± 7.8	0						NR				0

[Table continues with additional rows...]

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[Table 6 continued]

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[Table 6 continued]

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Table 7: da Vinci Robotic-Assisted Extirpative Main Clinical Outcomes

Cardiac Procedure	Author	Study Arms	Study Size (N)	Operating time (minutes)	Conversion to open surgery (%)	Blood transfusion (%)	Number of transfused units, n	ICU LOS (days)	LOS (days)	Postop. complications 30-d (%)	Mortality 30-d (%)	Readmission 30-d (%)	Reoperation for bleeding 30-d (%)	Reoperation for any reason 30-d (%)	Postop. Ejection Fraction (%)
Myxoma Excision	8. Kesavuori (2015) Comparative retro.	Robotic	9	226 ± 39	0	RBC: 44	RBC: 1.67 ± NR	1 (IQR 0)	5.8 ± 1	NR	0	NR			56.8 ± 8.3
		Sternotomy	18	139 ± 33	NA	RBC: 72	RBC: 2 ± NR	1 (IQR 0)	7 ± 1.6		0				50.9 ± 6.3

[Table continues with additional rows...]

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[Table 7 continued]

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Table 8: da Vinci Robotic-Assisted Extirpative Secondary Clinical Outcomes

Cardiac Procedure	Author	Study Arms	Study Size (N)	CPB time (minutes)	XC time (minutes)	Ventilation time (hours)	Prolonged mechanical ventilation (%)	Pulmonary complications (%)	Cardiac arrest (%)	Myocardial infarction (%)	New-onset atrial fibrillation (%)	Renal failure (%)	Stroke (%)	Discharge location (%)	Myxoma recurrence (%)
Myxoma Excision	8. Kesavuori (2015) Comparative retro.	Robotic	9	124 ± 30	67 ± 21	14.6 ± 5	NR	Pneumonia: 0	NR	0	NR	0	NR		0
		Sternotomy	18	54 ± 21	34 ± 15	9 ± 3		Pneumonia: 0		6		0			0

[Table continues with additional rows...]

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Table 9: da Vinci Robotic-Assisted Valve Repair Main Clinical Outcomes

Cardiac procedure	Author	Study Arms	Study Size (N)	Operating time (minutes)	Conversion to open surgery (%)	Blood transfusion (%)	Number of transfused units, n	ICU LOS (days)	LOS (days)	Postop. complications 30-d (%)	Mortality 30-d (%)	Readmission 30-d (%)	Reoperation for bleeding 30-d (%)	Reoperation for any reason 30-d (%)	Postop. Ejection Fraction (%)
	Comparative retro.	Sternotomy	64	227.41 ± 35.88	0		3.5 (IQR 2-4)	21h (IQR 18h-41.5h)	10 (IQR 8-14)		1.6		0

[Table continues with additional rows...]

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Table 10: da Vinci Robotic-Assisted Valve Repair Secondary Clinical Outcomes

Cardiac procedure	Author	Study Arms	Study Size (N)	CPB time (minutes)	XC time (minutes)	Ventilation time (hours)	Prolonged mechanical ventilation (%)	Pulmonary complications (%)	Cardiac arrest (%)	Myocardial infarction (%)	New-onset atrial fibrillation (%)	Renal failure (%)	Stroke (%)	Discharge location (%)	Tricuspid regurgitation (%)	Mitral regurgitation (%)
MVr+TVr	3. Arslanhan (2021) Comparative retro. Not matched	Robotic MVr	226	128.4 ± 45.7	82.4 ± 31.2	NR	0.5	Pleural effusion: 2.2 Pneumonia: 0.9	NR		26/226	Acute: 0	CVE: 0.4	NR
		Robotic MVr + TVR	59	150.1 ± 38.2	99.2 ± 23.9		5.2	Pleural effusion: 1.7 Pneumonia: 0			6/59	Acute: 1.7	CVE: 1.7

[Table continues with additional rows...]

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Table 11: MVr Primary Outcomes

Variable mean (SD) [95% CI] N (%) [95% CI]	Unmatched			Matched
	Robotic N = 1,507	Not Robotic N = 19,252	P-Value	Robotic N = 1,507	Not Robotic N = 1,507	P-Value
Operating time, minutes	378.8 (72.9) [375.1, 382.5]	321.7 (84.9) [320.5, 322.9]	<0.001	378.8 (72.9) [375.1, 382.5]	321.8 (87.5) [317.4, 326.2]	<0.001
Length of hospital stay, days	5.7 (5.2) [5.5, 6.0]	7.8 (6.5) [7.7, 7.9]	<0.001	5.7 (5.2) [5.5, 6.0]	7.0 (7.1) [6.7, 7.4]	<0.001
Intensive care unit length of stay, days	2.3 (2.6) [2.2, 2.5]	2.9 (4.0) [2.9, 3.0]	<0.001	2.3 (2.6) [2.2, 2.5]	2.8 (5.1) [2.6, 3.1]	<0.001
Blood transfusion	161 (10.7%) [9.2%, 12.4%]	3,309 (17.2%) [16.7%, 17.7%]	<0.001	161 (10.7%) [9.2%, 12.4%]	208 (13.8%) [12.1%, 15.7%]	0.009
Mortality, in hospital	7 (0.5%) [0.2%, 1.0%]	120 (0.6%) [0.5%, 0.7%]	0.45	7 (0.5%) [0.2%, 1.0%]	8 (0.5%) [0.2%, 1.1%]	0.80
Mortality, within 30 days	7 (0.5%) [0.2%, 1.0%]	157 (0.8%) [0.7%, 1.0%]	0.14	7 (0.5%) [0.2%, 1.0%]	10 (0.7%) [0.3%, 1.3%]	0.47
Readmission, within 30 days	95 (6.3%) [5.2%, 7.7%]	1,443 (7.5%) [7.1%, 7.9%]	0.089	95 (6.3%) [5.2%, 7.7%]	96 (6.4%) [5.2%, 7.8%]	0.94
Reoperation for any reason, within 30 days	15 (1.0%) [0.6%, 1.7%]	275 (1.4%) [1.3%, 1.6%]	0.17	15 (1.0%) [0.6%, 1.7%]	19 (1.3%) [0.8%, 2.0%]	0.49

Table 12: MVR Secondary Outcomes, Index Hospitalization

Variable, N (%) [95% CI]	Unmatched			Matched
	Robotic N = 1,507	Not Robotic N = 19,252	P-Value	Robotic N = 1,507	Not Robotic N = 1,507	P-Value
Infection	0 (0.0%) [0.0%, 0.3%]	26 (0.1%) [0.1%, 0.2%]	0.26	0 (0.0%) [0.0%, 0.3%]	0 (0.0%) [0.0%, 0.3%]	>0.99
Respiratory failure	106 (7.0%) [5.8%, 8.5%]	1,569 (8.1%) [7.8%, 8.5%]	0.13	106 (7.0%) [5.8%, 8.5%]	99 (6.6%) [5.4%, 8.0%]	0.61
Prolonged mechanical ventilation	29 (1.9%) [1.3%, 2.8%]	663 (3.4%) [3.2%, 3.7%]	0.002	29 (1.9%) [1.3%, 2.8%]	39 (2.6%) [1.9%, 3.6%]	0.22
Dialysis	15 (1.0%) [0.6%, 1.7%]	346 (1.8%) [1.6%, 2.0%]	0.022	15 (1.0%) [0.6%, 1.7%]	17 (1.1%) [0.7%, 1.8%]	0.72
Discharge to home	1,424 (94.5%) [93.2%, 95.6%]	17,030 (88.5%) [88.0%, 88.9%]	<0.001	1,424 (94.5%) [93.2%, 95.6%]	1,372 (91.0%) [89.5%, 92.4%]	<0.001

[Table continues with additional rows...]

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Table 13: MVr Secondary Outcomes, within 30 Days Post Index Hospitalization Discharge

Variable, N (%) [95% CI]	Unmatched			Matched
	Robotic N = 1,501	Not Robotic N = 19,189	P-Value	Robotic N = 1,501	Not Robotic N = 1,501	P-Value
Acute myocardial infarction	12 (0.8%) [0.4%, 1.4%]	104 (0.5%) [0.4%, 0.7%]	0.20	12 (0.8%) [0.4%, 1.4%]	5 (0.3%) [0.1%, 0.8%]	0.089
New onset atrial fibrillation	377 (25.1%) [23.0%, 27.4%]	5,372 (28.0%) [27.4%, 28.6%]	0.016	377 (25.1%) [23.0%, 27.4%]	438 (29.2%) [26.9%, 31.6%]	0.012

[Table continues with additional rows...]

Table 14: CABG Primary Outcomes

Variable mean (SD) [95% CI] N (%) [95% CI]	Unmatched			Matched
	Robotic N = 3,893	Not Robotic N = 238,165	P-Value	Robotic N = 3,893	Not Robotic N = 3,893	P-Value
Operating time, minutes	320.6 (83.5) [318.0, 323.2]	317.0 (79.5) [316.7, 317.3]	0.77	320.6 (83.5) [318.0, 323.2]	316.6 (79.2) [314.1, 319.1]	0.81
Length of hospital stay, days	7.4 (6.1) [7.2, 7.6]	8.8 (5.9) [8.7, 8.8]	<0.001	7.4 (6.1) [7.2, 7.6]	8.3 (6.0) [8.1, 8.5]	<0.001

[Table continues with additional rows...]

Table 15: CABG Secondary Outcomes, Index Hospitalization

Variable, N (%) [95% CI]	Unmatched			Matched
	Robotic N = 3,893	Not Robotic N = 238,165	P-Value	Robotic N = 3,893	Not Robotic N = 3,893	P-Value
Infection	14 (0.4%) [0.2%, 0.6%]	873 (0.4%) [0.3%, 0.4%]	0.94	14 (0.4%) [0.2%, 0.6%]	15 (0.4%) [0.2%, 0.7%]	0.85
Respiratory failure	420 (10.8%) [9.8%, 11.8%]	27,162 (11.4%) [11.3%, 11.5%]	0.23	420 (10.8%) [9.8%, 11.8%]	439 (11.3%) [10.3%, 12.3%]	0.49

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Table 16: CABG Secondary Outcomes, within 30 Days Post Index Hospitalization Discharge

Variable, N (%) [95% CI]	Unmatched			Matched
	Robotic N = 3,893	Not Robotic N = 238,163	P-Value	Robotic N = 3,893	Not Robotic N = 3,893	P-Value
Infection	14 (0.4%) [0.2%, 0.6%]	873 (0.4%) [0.3%, 0.4%]	0.94	14 (0.4%) [0.2%, 0.6%]	14 (0.4%) [0.2%, 0.6%]	>0.99
Respiratory failure	420 (10.8%) [9.8%, 11.8%]	27,162 (11.4%) [11.3%, 11.5%]	0.23	420 (10.8%) [9.8%, 11.8%]	434 (11.1%) [10.2%, 12.2%]	0.61

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Regulation Number and Section

§ 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.