The Intuitive Surgical Endoscopic Instrument Control System, Model IS4000) is intended to 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, 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 laparosopic 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.

Device Description

This 510(k) is for a labeling modification only, to include the following additional representative, specific procedures under the cleared "thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" general indication for the da Vinci Xi Surgical System (K131861): Lobectomy, Mediastinal Mass Resection, Thymectomy, Segmentectomy, Wedge Resection and Lymphadenectomy. There are no changes to the technological characteristics of the cleared da Vinci Xi Surgical System proposed in this submission. The da Vinci Xi Surgical System, Model IS4000 is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model IS4000 Surgical System consists of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and is used with an Endoscope, EndoWrist Instruments, and Accessories.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Da Vinci Xi Surgical System, focusing on a labeling modification to include additional specific procedures under existing general indications for use. This involves demonstrating substantial equivalence to predicate devices, rather than establishing entirely new performance criteria for a novel device. Therefore, the information typically requested regarding acceptance criteria and a study proving a new device meets those criteria is not directly applicable in this context as new performance metrics are not being established.

However, I can extract and structure the available information about the demonstration of suitability for the expanded indications, which functions as the system's "acceptance" for these new procedures.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly demonstrating that the da Vinci Xi Surgical System, when used for the expanded "umbrella" and "covered" procedures, shows comparable or improved patient outcomes (mortality, complications, blood loss, length of stay, operative time) compared to established surgical methods (Open and VATS procedures).

Acceptance Criteria (Comparable to Predicate or Established Methods)	Reported Device Performance (da Vinci-assisted procedures)
Lobectomy	- Mortality Rates: Comparable or lower. - Complications: Comparable. - Blood Transfusion Rates: Comparable or lower. - Length of Hospital Stay: Comparable or shorter. - Operative Times: Comparable or shorter (5 studies), or increased (13 studies) (but no correlation with increased mortality). - Conversion Rates: Comparable or lower compared to VATS.
Mediastinal Mass Resection	- Mortality Rates: Comparable. - Operative Times: Comparable. - Complication Rates: Comparable or lower. - Length of Hospital Stay: Comparable or shorter compared to open surgical procedures. - Single-arm studies: No reports of mortality, low complication rates (intraoperative <1%, postoperative <=14%), low conversion rates (0.65-4.3%), low transfusion rates (0-1.4%).
Thymectomy	- Mortality Rates: Comparable. - Complication Rates: Comparable or lower. - Length of Hospital Stay: Comparable or shorter. - Transfusion Rates/EBL: Comparable or lower compared to open and VATS. - Operative Times: Comparable or longer (but no correlation with higher mortality rates). - Single-arm studies: No reports of mortality, low complication rates (intraoperative 1.3-15.4%, postoperative 3.6-15.4%), conversion rates 0-15.4%.
Segmentectomy, Wedge Resection, Lymphadenectomy	- The published data on the "umbrella" procedures (Lobectomy, Mediastinal Mass Resection, Thymectomy) were deemed sufficient to support the clearance of these "covered" procedures, implying similar expected performance based on the general surgical context and the device's technological characteristics remaining unchanged.

2. Sample Size Used for the Test Set and Data Provenance

Pre-Clinical Animal Study Data:
- Sample Size: A total of 20 animals were used in three evaluations.
- Provenance: This was a preclinical study. Specific country of origin is not mentioned but it's an internal study supporting the submission.
Clinical Study Data (Human Data):
- Sample Size: The clinical data relies on published retrospective, comparative, and single-arm studies.
  - Lobectomy: The provided table (Table 1) lists 18 publications with varying sample sizes per study group (ranging from N=22 to N=20,238 for comparison groups and N=22 to N=2,498 for da Vinci groups). The total number of patients across all studies is not explicitly summed, but it is substantial.
  - Mediastinal Mass Resection: Table 2 lists 7 publications with sample sizes ranging from N=14 to N=75 (da Vinci groups).
  - Thymectomy: Table 3 lists 15 publications with sample sizes ranging from N=6 to N=125 (da Vinci groups).
- Provenance: These are published clinical data. The specific countries of origin are not detailed in this summary but are derived from a global body of medical literature. These studies are retrospective, comparative, and single-arm.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of independent experts being used to establish a "ground truth" for a test set in the traditional sense of an AI/ML device evaluating images or signals. The "ground truth" or clinical outcome data in this context comes from the published clinical studies themselves, where the outcomes (e.g., mortality, complications, operative time) were determined and reported by the treating physicians and study authors. The qualifications of these physicians are implicitly high, as they are authors of peer-reviewed clinical publications performing complex surgical procedures.

4. Adjudication Method for the Test Set

Not applicable. This submission relies on aggregated and summarized outcomes from published clinical literature, not on a new test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission is not for an AI-assisted diagnostic or interpretative device where human readers interact with AI. It's for a surgical system where the performance is measured by patient outcomes.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The da Vinci Xi Surgical System is a tool used by human surgeons; it is not a standalone AI device performing tasks without human intervention. Its performance is measured in the context of human surgeons using the system.

7. The Type of Ground Truth Used

The "ground truth" used is outcomes data (e.g., mortality, complication rates, operative times, length of stay, blood loss) as reported in published clinical studies. This data represents real-world clinical results rather than an independent expert consensus on a test set or pathology reports for specific diagnoses.

8. The Sample Size for the Training Set

Not applicable. The da Vinci Xi Surgical System is an electro-mechanical system controlled by software, not a machine learning algorithm that undergoes a "training phase" to learn from a specific dataset in the way an AI diagnostic tool would. Its development and refinement are based on engineering principles and clinical experience, not a "training set" for an algorithm in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for an algorithm in the context of this device. The system's design and functionality are established through engineering, preclinical testing, and clinical experience, not algorithmic training.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three human profiles incorporated into the design. The profiles are arranged in a row, facing to the right. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 7, 2016

Intuitive Surgical, Inc. % Ms. Cindy Domecus Chief Regulatory Advisor, Intuitive Surgical Domecus Consulting Services, LLC 1171 Barroilhet Drive Hillsborough, California 94010

Re: K153276

Trade/Device Name: Da Vinci Xi Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: July 15, 2016 Received: July 18, 2016

Dear Ms. 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Christopher J. Ronk -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153276

Device Name

da Vinci Surgical System, Model IS4000, and EndoWrist Instruments and Accessories

Indications for Use (Describe)

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)

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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 SurgicalTelephone: 650.343.4813Fax: 650.343.7822Email: domecusconsulting@comcast.net
Date Summary Prepared:	August 1, 2016
II. SUBJECT DEVICE INFORMATION
Device Trade Name:	da Vinci® Surgical System, Model IS4000
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 Surgical System, Model IS4000 (K131861, Predicate Device:

K152578) Intuitive Surgical da Vinci Surgical System, Model IS3000 (K081137, K123463, K090993)

IV. DEVICE DESCRIPTION:

V. INDICATIONS FOR USE

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci 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

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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 was based on evaluation of the device as a surgical tool and 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 TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

There are no changes to the technological characteristics of the cleared do Vinci Xi Surgical System (IS4000) proposed in this submission.

VII. PERFORMANCE DATA

Pre-Clinical Animal Study Data

Animal performance data were provided in this premarket notification, including the results from three (3) evaluations in a total of twenty (20) animals demonstrating use of da Vinci Xi Surgical System in Lung Resection and Lobectomy procedures. These data were also submitted in support of clearance of two (2) Xi EndoWrist Staplers (K140553 and K152421).

Clinical Study Data

Published clinical data support use of the da Vinci Xi Surgical System for the representative, specific procedures that fall under the cleared "thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" Indication for Use. Clinical data were not provided for all of the representative, specific procedures. Instead, clinical data were provided only for the more complex/higher risk representative, specific procedures (referred to as "umbrella" procedures). The published data on these "umbrella" procedures were deemed sufficient to cover the less complex/lower risk procedures (referred to as "covered" procedures), so published clinical data on the covered procedures were not provided.

Umbrella Procedures

Published clinical data were provided for the following umbrella procedures: Lobectomy, Mediastinal Mass Resection and Thymectomy. Forty (40) publications were identified for these umbrella procedures based on specific search criteria and filters. These publications included retrospective, comparative and single arm studies. A detailed summary of the published clinical data on these procedures is provided in Tables 1-3 below.

The findings from the Lobectomy publications show that da Vinci-assisted procedures are associated with comparable or lower mortality rates; comparable complications; comparable or lower blood transfusion rates; and comparable or shorter lengths of hospital stay as compared to both open and VATS surgical procedures. Five (5) studies reported comparable or shorter operative times for da Vinci

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assisted procedures as compared to VATS procedures. Thirteen (13) publications noted increased operative times in the da Vinci-assisted procedures as compared to open and VATS procedures; however, this increase did not correlate with an increase in the reported mortality rates. Lastly, these publications report comparable or lower conversion rates for da Vinci-assisted procedures as compared to VATS procedures.

Outcomes reported in the Mediastinal Mass Resection comparative publications demonstrate that da Vinci-assisted procedures are associated with comparable mortality rates and operative times, comparable or lower complication rates and comparable or shorter lengths of hospital stay as compared to open surgical procedures. Data from five (5) publications reporting on single-arm studies using the da Vinci System for mediastinal mass resection procedures demonstrate that use of the da Vinci System can be accomplished with no reports of mortality and low complication rates. Intraoperative complications were < 1% in two (2) of the single-arm publications and post operative complication rates were ≤ 14% in all five (5) publications. Two (2) of the single-arm publications reported on conversion rates (0.65% and 4.3%) and three (3) publications reported low transfusion rates (0 – 1.4%). Operative times in the singlearm publications ranged from 85.9 minutes to 210.0 minutes and length of stay ranged from 1.0 to 12.8 days.

The data provided in the Thymectomy comparative publications show that da Vinci-assisted procedures are associated with comparable mortality rates; comparable or lower complication rates; comparable or shorter lengths of hospital stay; and comparable or lower transfusion rates/estimated blood loss as compared to both open and VATS surgical procedures. Operative times were comparable or longer in the do Vinci-assisted procedures as compared to open and VATS procedures, however, this increase did not correlate with higher mortality rates. Data from ten (10) publications reporting on single-arm studies using the da Vinci System for thymectomy procedures demonstrate that use of the da Vinci System in such procedures can be accomplished with no reports of mortality and low complication rates. No intraoperative complication rates were reported in eight (8) of the single-arm publications; two (2) of the publications reported intraoperative complication rates of 1.3% and 15.4%. Postoperative complication rates in the single-arm publications ranged from 3.6% - 15.4% and conversion rates ranged from 0% - 15.4%. Operative times in the single-arm publications ranged from 85.2 minutes to 155 minutes and length of stay ranged from 2.0 to 5.0 days.

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Publications	Sample Size (N)	Operative Time (minutes)~	Transfusions (%) and/or EBL (ml)	Length of Stay (days)~	Complications (%)
1. Cerfolio (2011)	da Vinci	106	132.0	30 ml	2.0	26.4
	Open	318	90.0	90 ml	4.0	37.8
2.Veronesi (2010)	da Vinci	54	236.0	0	5.0	20.4
	Open	54	154.0	6.0	6.0	20.4
3. Kent (2013)	da Vinci	430	NR	NR	4.0	44.4
	Open	20,238	NR	NR	6.0	55.1
	VATS	12,427	NR	NR	5.0	43.6
4. Oh (2013)	da Vinci	43	217.0	100 ml	4.0	28.0* / 2.0^
	Open	88	168.0	200 ml	10.0	24.0* /3.0^
5. Adams (2014)	da Vinci	120	241.5	0.9 / 0.9#	4.7	5.2** / 0.9^^
	Open	5,913	175.5	5.0 / 7.8#	7.3	10.8** / 1.1^^
	VATS	4,612	179.8	1.4 / 3.8#	5.3	8.9** / 1.0^^
6. Deen (2014)	da Vinci	57	223.0	NR	4.6	32.0
	Open	69	180.0	NR	5.5	30.0
	VATS	58	202.0	NR	4.8	31.0
7. Farivar (2014)	da Vinci	181	199.2	0 / 0#	3.2	6.1**
	Open	5,913	243.7	4.8 / 7.8#	7.3	10.7**
	VATS	4,612	239.0	1.3 /3.7#	5.3	8.9**
8. Augustin (2013)	da Vinci	26	215.0	NR	11.0	42.3
	VATS	26	183.0	NR	9.0	38.4
9. Bodner (2011)	da Vinci	26	228.0	NR	11.0	11.5
	VATS	114	183.0	NR	9.5	7.0
10. Jang (2011)	da Vinci	40	240.0	219.0 ml	6.0	10.0
	VATS	40	257.0	374.0 ml	9.0	32.5
11. B. Lee (2012)	da Vinci	100	209.0	NR	6.3	9.0
	VATS	100	157.0	NR	8.9	21.0
12. Louie (2012)	da Vinci	45	213.0	154.0 ml	4.0	43.5
	VATS	35	207.0	134.0 ml	4.5	35.3
13. B. Lee (2014)	da Vinci	35	161.0	0	3.0	11.0
	VATS	34	128.0	0	3.0	18.0
14. Swanson (2013)	da Vinci	295	269.4	NR	6.1	16.95++/ 36.95++
	VATS	295	253.8	NR	5.8	18.98++/ 38.31++
15. Paul (2014)	da Vinci	2,498	NR	NR	5.0	50.1~
	VATS	37,595	NR	NR	5.0	45.2~
16. Spillane (2014)	da Vinci	22	261.0	143 ml	4.4	9.0
	VATS	22	159.0	223 ml	5.5	22.0
17. B Lee (2015)	da Vinci	53	161.0	NR	3.0	11.0
	VATS	158	123.0	NR	3.0	24.0
18. Mahieu (2015)	da Vinci	28	190.0	100 ml	6.0	50.0
	VATS	28	185.0	200 ml	7.0	42.8
Publications	Sample Size (N)	Operative Time (minutes)*	Transfusions (%) and /or EBL (ml)	Length of Stay (days)*	Complications (%)
1. Balduyck (2011) da Vinci	14	224.2	NR	9.6	21.4
Open	22	243.8	NR	11.8	22.5
2. Seong (2014) da Vinci	34	157.2	NR	2.7	0
Open	34	139.3	NR	5.5	14.7
3. Cerfolio (2012) da Vinci	75	95.0	NR	1.0	12.0
4. Huang (2014) da Vinci	48	85.9	NR	3.9	2.0
5. Melfi (2012) da Vinci	69	124.3	1.4	4.3	7.2
6. Nakamura (2014) da Vinci	52	142.6 – 184.3	0	7.7 – 12.8	5.8
7. Seder (2013) da Vinci	19	210.0	0	2.0	14.0

TABLE 1: Comparison of da Vinci vs. Open and VATS Lobectomy

~Mean or median reported; *Air leak > 24 hours; ^Return to OR; *Intraoperative values; **Air leak > 5 days; ^^Bleeding requiring reoperation; Major Complications; *Authors reported all complications which included latrogenic Complications (i.e., Intraoperative Complications)

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TABLE 2: Comparison of da Vinci vs. Open and Single Arm Mediastinal Mass Resection Procedures

*Mean or median reported

TABLE 3: Comparison of da Vinci vs. Open and VATS and Single Arm Thymectomy Procedures

Publications	Sample Size (N)	Operative Time (minutes)*	Transfusions (%) and/or EBL (ml)	Length of Stay (days)*	Complications (%)
1. Weksler (2011) da Vinci	15	130.0	41.67 ml	1.0	6.7
Open	35	NR	151.43 ml	4.0	57.1
2. Ye (2014) da Vinci	23	97.0	0% / 61.3 ml	3.7	4.3
Open	51	214.5	0% / 466.1 ml	11.6	3.9
3. Renaud (2013) da Vinci	6	189.2	<10 ml	5.0	0
Open	15	55.0	24.6 ml	8.7	15.0
4. Ye (2013) da Vinci	21	96.2	0% / 58.6 ml	3.7	4.8
VATS	25	103.6	4.0% / 86.8 ml	6.7	4.0
5. Ruckert (2010) da Vinci	75	187.0	NR	NR	2.7
VATS	79	198.0	NR	NR	2.5
6. Jun (2014) da Vinci	56	139.8	NR	7.18	10.7
VATS	60	121.07	NR	7.23	6.66
7. Freeman (2011) da Vinci	75	113.0	NR	2.2	5.3
8. Goldstein (2010) da Vinci	26	127.0	NR	2.0	15.4
9. Huang (2013) da Vinci	23	85.2	NR	3.6	4.3
10. Keijzers (2014) da Vinci	125	123.0	NR	3.0	7.2
11. Marulli (2012) da Vinci	79	155.0	1.2%	3.0	12.7
12. Marulli (2013) da Vinci	100	120.0	3.0%	3.0	6.0
13. Mussi (2011) da Vinci	14	139.0	NR	4.0	14.2
14. Rea (2011) da Vinci	108	120.0	1.8%	3.0	3.6
15. Schneiter (2013) da Vinci	20	NR	NR	5.0	10.0

*Mean or median reported

Covered Procedures

The published data on the above cited umbrella procedures were used to support clearance of the following covered procedures: Segmentectomy, Wedge Resection and Lymphadenectomy.VIII.

CONCLUSION

Based on the information provided in this premarket notification, the inclusion of the following additional representative, specific procedures under the da Vinci Xi Surgical System "thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" previously cleared Indications for Use is substantially equivalent to the predicate devices: Lobectomy, Mediastinal Mass Resection, Thymectomy, Segmentectomy, Wedge Resection and Lymphadenectomy.

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.