The Intuitive Surgical Stapler SureForm 60 reloads, and other stapler accessories are intended to be used with a compatible da Vinci Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

Device Description

The Intuitive Surgical SureForm 60 and SureForm 60 Reloads is a disposable surgical stapler system designed for use exclusively with the Intuitive da Vinci Surgical Systems (Models IS4000 and IS4200). It is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The SureForm 60 is a disposable, fully wristed articulating device. The SureForm 60 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife. The reloads are available in four configurations (White, Blue, Green and Black) to accommodate tissues of various thicknesses (e.g., lung, stomach, and bowel). Each color represents a different staple leg height and tissue gap for use with various tissue thicknesses.

AI/ML Overview

The provided text describes the performance data for the Intuitive Surgical SureForm 60 and SureForm 60 Reloads, which are surgical staplers. The studies described are primarily animal validation studies, bench testing, and human factors evaluation, aiming to demonstrate substantial equivalence to predicate devices rather than proving a novel AI algorithm's performance. Therefore, many of the requested categories related to AI performance metrics, sample sizes for training/test sets, expert adjudication, and MRMC studies are not applicable or not present in the provided document.

However, I can extract the relevant information regarding acceptance criteria and study outcomes for the device's performance, focusing on the animal validation studies as they contain explicit "study outcomes" which can be interpreted as demonstrating the device meets the underlying acceptance criteria for safety and effectiveness.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a single table for all tests. Instead, the "Study Outcome" column in Table 2 (and the Venous Burst Pressure study) acts as the fulfillment of implied acceptance criteria by confirming successful operation, equivalence to predicate devices, and lack of adverse events. I will synthesize these based on the study outcomes.

Study Name	Implied Acceptance Criteria (Based on Study Outcome)	Reported Device Performance
Animal Survival Study: Lobectomy	- No intra-operative leaks - 28-day survival - No bleeding/leakage at staple lines post-survival period - Well-healed staple lines	All staple lines passed assessment for leaks intra-operatively. All animals survived through the 28-day survival period. During terminal procedures, no signs of bleeding or leakage at staple lines. Staple lines were well-healed for both subject and predicate devices.
Animal Survival Study: Lung Wedge Resection	- No intra-operative leaks - 7-day survival - No bleeding/leakage at staple lines post-survival period - Well-healed staple lines	All staple lines passed assessment for leaks intra-operatively. All animals survived through the 7-day survival period. During terminal procedures, no signs of bleeding or leakage at staple lines. Staple lines were well-healed for both test and control devices.
Animal Survival Study: Gastrectomy – canine	- No intra-operative leaks - 14-day survival - No bleeding/leakage at staple lines post-survival period - Well-healed staple lines	All subject staple lines passed intra-operative leak tests. All animals survived through the 14-day survival period. During terminal procedures, no signs of bleeding or leakage at staple lines. Staple lines were well-healed for both subject and predicate devices (1 predicate staple line needed oversewing for leak test).
Animal Survival Study: Gastrectomy – porcine	- No intra-operative leaks - 14-day survival - No bleeding/leakage at staple lines post-survival period - Well-healed staple lines	All staple lines passed intra-operative leak tests. All animals survived through the 14-day survival period. During terminal procedures, no signs of bleeding or leakage at staple lines. Staple lines were well-healed for both subject and predicate devices.
Animal Survival Study: Small bowel anastomosis	- Passed visual assessment intra-operatively - No involvement of anastomosis sites in cause of death if early death occurs - Normal tissue healing at anastomosis sites	All staple lines passed visual assessment intra-operatively. Early death of one animal due to peritonitis, not involving anastomosis sites (confirmed by histopathology). Another animal expired due to strangulation of small intestine (containing predicate anastomosis site) through a mesenteric defect; predicate anastomosis site uninvolved with cause of death, exhibited normal tissue healing. Staple lines in remaining animals passed leak testing after 14-day survival period. No active bleeding or leakage. Staple lines well-healed.
Staple Line Performance	- Met all acceptance criteria for transection, tissue layer approximation, hemostasis, and staple formation - Wrist angle has no effect on staple formation quality	The subject device met all acceptance criteria and exhibited acceptable pass rates in the areas of transection, tissue layer approximation, hemostasis, and staple formation. Wrist angle also had no effect on the quality of staple formation.
Buttress Material Compatibility	- Well-formed staples in-vivo - Clinically acceptable tissue approximation, transection, and hemostasis - Not adversely affected by buttress materials when used as instructed	Pass rates in the areas of transection, tissue layer approximation, hemostasis, and optimal staple formation were not adversely affected in a statistically significant manner when buttress material was used in accordance with the manufacturer's Instructions for Use.
Maximum Torque	- Met all acceptance criteria - Similar or superior tissue effects (tissue approximation and hemostasis) compared to predicate - Met staple formation acceptance criteria (no more than three sub-optimal staples within each test fire)	The subject device met all acceptance criteria, exhibiting similar or superior tissue effects (tissue approximation and hemostasis) when compared to the adjacent Echelon Flex 60 Powered Plus staple lines. The subject device also met the staple formation acceptance criteria with no more than three sub-optimal staples within each test fire.
Design Validation	- Met all acceptance criteria	The subject device met all acceptance criteria.
Burst Pressure (General)	- Substantially equivalent to predicate device with no statistically significant difference in staple line burst pressures	The staple lines from the subject device performed substantially equivalent to that of the predicate device as there was no statistically significant difference in staple line burst pressures.
Venous Burst Pressure	- All jugular vein seals passed 45mmHg for 10 seconds pressure acceptance criteria - Demonstrated non-inferiority to predicate device	All jugular vein seals that were burst pressure tested passed the 45mmHg for 10 seconds pressure acceptance criteria with both the subject and predicate devices. The subject device demonstrated non-inferiority to the Echelon Flex 60 Powered Plus.

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

The "test set" in this context refers to the animals used in the validation studies. There is no AI test set explicitly mentioned.

Animal Studies Sample Sizes:
- Lobectomy: 8 Canine
- Lung Wedge Resection: 8 Canine
- Gastrectomy (canine): 8 Canine
- Gastrectomy (porcine): 8 Porcine
- Small bowel anastomosis: 8 Porcine
- Nephrectomy: 8 Porcine
- Staple Line Performance: 4 Canine and 7 Porcine
- Buttress Material Compatibility: 1 Canine, 1 Porcine
- Maximum Torque: 2 Porcine
- Design Validation: 2 Porcine
- Burst Pressure (General): 1 animal (Excised tissue and in-vivo model)
- Venous Burst Pressure: Excised Porcine Jugular Veins (number not specified, but likely multiple samples from these veins)
Data Provenance: The studies are described as "animal validation studies" performed using "simulated clinical models (animal)" and "clinical laboratory setting closely approximating an intraoperative use situation." The data is thus prospective animal study data. Country of origin is not specified but is presumably where Intuitive Surgical operates or contracts its animal labs.

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

The document does not provide information on the number or qualifications of experts establishing ground truth. The "Study Outcome" is implicitly determined by the researchers conducting the animal studies and evaluating the results (e.g., assessing leaks, healing, staple formation).

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the animal study outcomes. The outcomes are presented as direct observations and assessments by the study team.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for evaluating diagnostic or interpretive AI systems in a clinical reading setting with human readers, which is not what this premarket notification describes.

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

Not applicable. This device is a surgical stapler, not an AI algorithm. The performance studies evaluate the physical device's function, not an AI algorithm's standalone performance.

7. Type of Ground Truth Used

The ground truth used here is primarily direct observation of physiological outcomes in animal models, including:

Intra-operative leak tests
Survival rates
Visual assessment of bleeding, leakage, and healing at staple lines during terminal procedures
Histopathology (for cause of death in specific cases)
Assessment of transection, tissue layer approximation, hemostasis, and staple formation
Burst pressure measurements

Essentially, it's physiological and pathological ground truth established through direct experimental observation and measurement.

8. Sample Size for the Training Set

Not applicable. There is no AI model or algorithm that would require a "training set" described in this document.

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

Not applicable. As there is no AI model or training set, this question is not relevant to the provided text.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a square and the name in a sans-serif font. The logo is simple and professional, and it is easily recognizable.

July 5, 2018

Intuitive Surgical Nadine Nasr Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086

Re: K173721

Trade/Device Name: SureForm 60 and SureForm 60 Reloads Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: June 1, 2018 Received: June 4, 2018

Dear Nadine Nasr:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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K173721

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -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) K173721

Device Name SureForm 60 and SureForm 60 Reloads

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 7

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Nadine NasrSr. Regulatory Affairs SpecialistPhone Number: 408-523-7093Fax Number: 408-523-8907Email: nadine.nasr@intusurg.com
Date Summary Prepared:	December 4, 2017
Trade Name:	SureForm 60 and SureForm 60 Reloads
Common Name:	Endoscope and accessories; Surgical Stapler andimplantable staples
Classification:	Class II21 CFR 876.1500, Endoscope and Accessories21 CRF 878.4750, Implantable Staple
Product Codes:	NAY (Endoscope and accessories)GDW (Implantable Staple)
Classification AdvisoryCommittee:	General and Plastic Surgery
Predicate Device:	1. Primary: IS4000 EndoWrist® Stapler 45 and Stapler 45Reloads - K1705082. Secondary: Echelon Flex 60 Powered Plus ArticulatingEndoscopic Linear Cutter, Echelon 60 mm EndoscopicLinear Cutter Reload, PSEE60A (Stapler) GST60X(Reloads) - K140560

Device Description:

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staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The SureForm 60 is a disposable, fully wristed articulating device. The SureForm 60 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife. The reloads are available in four configurations (White, Blue, Green and Black) to accommodate tissues of various thicknesses (e.g., lung, stomach, and bowel). Each color represents a different staple leg height and tissue gap for use with various tissue thicknesses. Table 1 outlines the specifications of the reloads.

Attribute	SureForm 60 Reloads
	White	Blue	Green	Black
No. of staplerows andstaple lineconfiguration	6 rows total;3 on each sideof transection;90 staples total	6 rows total;3 on each sideof transection;90 staples total	6 rows total;3 on each sideof transection;90 staples total	6 rows total;3 on each side oftransection;90 staples total
Unformedstaple leglength	2.5 mm	3.5 mm	4.3 mm	4.6 mm
Pictures	Image: White Stapler	Image: Blue Stapler	Image: Green Stapler	Image: Black Stapler

Table 1: SureForm 60 Reloads Specifications

The reloads are single use devices and are shipped sterile to the surgeon with a retainer that protects the staples during shipping and transportation. The SureForm 60 reloads are not compatible with any other Intuitive Surgical stapler instruments, the IS4000 Stapler 30 and 45 instruments and the IS3000 Stapler 45 instrument, and likewise, the IS4000 Stapler 30 and 45 reloads and IS3000 Stapler 45 reloads are not compatible with the SureForm 60.

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Intended Use:

The Intuitive Surgical SureForm 60, SureForm 60 reloads, and other stapler accessories are intended to be used with a compatible da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

Indications for Use:

The Intuitive Surgical SureForm 60, SureForm 60 Reloads and Accessories are intended to be used with a compatible da Vinci Surgical Systems for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

Technological Characteristics:

The subject devices, SureForm 60 and SureForm 60 Reloads, are technologically very similar to the predicate devices, IS4000 EndoWrist® Stapler 45 and Stapler 45 Reloads (cleared under K170508) and the Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter (PSEE60A) and Echelon 60 mm Endoscopic Linear Cutter Reload (GST60X), cleared under K140560. The subject device has the same architecture design as the predicate except for differences like longer staple line length (60 mm on the subject device vs. 45 mm on the predicate), and use of a Black color reload with higher formed staple height.

Performance Data:

Performance data (bench and animal testing) demonstrate that the subject devices are substantially equivalent to the predicate devices and that the design output meets the design input requirements. The testing included dimensional measurements, mechanical and functional verification, simulated use in animal models, and human factors evaluation.

Image /page/5/Picture/10 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that is the word "SURGICAL" in a smaller font and also in light gray, with the registered trademark symbol next to it. There is a small yellow dot above the "I" in "INTUITIVE".

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Bench Testing:

The subject devices, SureForm 60 and SureForm 60 Reloads, were subjected to a series of bench tests to evaluate the performance and to demonstrate that the design outputs meet the input requirements. The design verification testing included:

Physical Specifications ●
Mechanical Requirements
Electrical Requirements ●
User Interface Requirements ●
Equipment Interface Requirements

Animal Validation Studies:

A series of studies were performed using simulated clinical models (animal) to evaluate the performance of the subject devices, SureForm 60 and SureForm 60 Reloads. This included Animal Survival Studies (Lobectomy, Lung Wedge Resection, Gastrectomy (Canine), Gastrectomy (Small Porcine), Small bowel anastomosis and Nephrectomy (small and large porcine). Additional animal studies including Staple Line Performance, Buttress Material Compatibility Testing, Maximum Torque Evaluation, Design Validation Testing and Burst Pressure Testing were also performed. A side-by-side comparison between the subject and predicate device (Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter (PSEE60A) and Echelon 60 mm Endoscopic Linear Cutter Reload (GST60X)) was performed in the Animal Survival Studies, Staple Line Performance, Maximum Torque and Burst Pressure Testing to demonstrate substantial equivalence between the subject and predicate device. Buttress Material Compatibility Testing and Design Validation Testing demonstrated that the design outputs of the subject device fulfill the design input requirements and that user needs and intended uses are met. A summary of the animal validation studies is provided in Table 2 below.

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Study Name	Study Purpose	Type/Number of animals	Study Outcome
Animal Survival Study: Lobectomy	Assess subject device performance as compared to the Echelon Flex 60 Powered Plus in a lung lobectomy procedure.	Canine (8 animals)	All staple lines passed assessment for leaks intra-operatively. All animals survived through the 28 day survival period. During the terminal procedures, there were no signs of bleeding or leakage at the staple lines. Staple lines were well-healed at the end of the survival period for both subject and predicate devices.
Animal Survival Study: Lung Wedge Resection	Assess subject device performance as compared to the Echelon Flex 60 Powered Plus in a lung wedge resection procedure.	Canine (8 animals)	All staple lines passed assessment for leaks intra-operatively. All animals survived through the 7 day survival period. During the terminal procedures, there were no signs of bleeding or leakage at the staple lines. Staple lines were well-healed at the end of the survival period for both the test and control devices.
Animal Survival Study: Gastrectomy – canine	Assess subject device performance as compared to the Echelon Flex 60 Powered Plus in a gastrectomy procedure.	Canine (8 animals)	All subject staple lines passed intra-operative leak tests. 3 predicate staple lines passed intra-operative leak tests. 1 predicate staple line did not pass the intra-operative leak test until a portion of the staple line was oversewn. All animals survived through the 14 day survival period. During the terminal procedure there were no signs of bleeding or leakage at the staple lines. Staple lines were well-healed at the end of the survival period for both the subject and predicate devices.
Animal Survival Study: Gastrectomy – porcine	Assess subject device performance as compared to the Echelon Flex 60 Powered Plus in a gastrectomy procedure.	Porcine (8 animals)	All staple lines passed intra-operative leak tests. All animals survived through the 14 day survival period. During the terminal procedure there were no signs of bleeding or leakage at the staple lines. Staple lines were well-healed at the end of the survival period for both the subject and predicate devices.
Animal Survival Study: Small bowel anastomosis	Assess the performance of the subject device as compared to the Echelon Flex 60 Powered Plus in a small bowel anastomosis procedure.	Porcine (8 animals)	All staple lines passed visual assessment intra-operatively. Early death of one of the animals enrolled in the stud occurred. Gross necropsy determined cause of death to be peritonitis with no apparent involvement of the anastomosis sites, and the findings were confirmed by histopathology.
Study Name	Study Purpose	Type/Number of animals	Study Outcome
AnimalSurvival Study:Nephrectomy	Assess subject deviceperformance as compared to theEchelon Flex 60 Powered Plusin a nephrectomy procedure.	Porcine(8 animals)	Another animal also expired during the study. Gross necropsy determined cause of death to be peritonitis due to strangulation of small intestine (containing the predicate anastomosis site) through a mesenteric defect. The predicate anastomosis site was confirmed by histopathology to be uninvolved with cause of death and exhibited normal tissue healing similar to staple lines harvested during the scheduled terminal procedures. The staple lines in the remaining animals passed leak testing after the 14-day survival period. There were no signs of active bleeding or leakage at the staple lines. Staple lines were well-healed at the end of the survival period for both the subject and predicate devices.
Staple LinePerformance	Assess staple line performanceand staple formation of thesubject device compared to theEchelon Flex 60 Powered Plus.	Canine and Porcine(4 Canine and 7Porcine)	The subject device met all acceptance criteria and exhibited acceptablepass rates in the areas of transection, tissue layer approximation,hemostasis, and staple formation. Wrist angle also had no effect on thequality of staple formation.
ButtressMaterialCompatibility(Gore andCook)	Confirm the ability of thesubject device to produce well-formed staples in-vivo as wellas a staple line which exhibitsclinically acceptable tissueapproximation, transection, andhemostasis and not be affectedwhen Gore SeamguardBioabsorbable Staple LineReinforcement (510(k) clearedunder K053202) and Cook	Canine and Porcine(1 Canine, 1 Porcine)	Pass rates in the areas of transection, tissue layer approximation,hemostasis, and optimal staple formation were not adversely affected ina statistically significant manner when buttress material was used inaccordance with the manufacturer's Instructions for Use.
Study Name	Study Purpose	Type/Number of animals	Study Outcome
	Biodesign Staple LineReinforcement (510(k) clearedunder K170945) were used inaccordance with themanufacturer's Instructions forUse.
MaximumTorque	Evaluate staple lineperformance at maximumSmartFire torque limits of thesubject device as compared tothe Echelon Flex 60 PoweredPlus.	Porcine(2 animals)	The subject device met all acceptance criteria, exhibiting similar orsuperior tissue effects (tissue approximation and hemostasis) whencompared to the adjacent Echelon Flex 60 Powered Plus staple lines.The subject device also met the staple formation acceptance criteria withno more than three sub-optimal staples within each test fire.
DesignValidation	Design validation testing of thesubject device was performedin a clinical laboratory settingclosely approximating anintraoperative use situation.	Porcine(2 animals)	The subject device met all acceptance criteria.
Burst Pressure	Assess burst pressure of thesubject device as compared tothe Echelon Flex 60 PoweredPlus.	Porcine(Excised tissue andin-vivo model - 1animal)	The staple lines from the subject device performed substantiallyequivalent to that of the predicate device as there was no statisticallysignificant difference in staple line burst pressures.

Table 2: Summary of Animal Validation Studies

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Study Name	Study Purpose	Type/Number of animals	Study Outcome
Venous BurstPressure	Assess jugular porcine venousstaple line burst pressure of thesubject device as compared tothe Echelon Flex 60 PoweredPlus.	Excised PorcineJugular Veins	All jugular vein seals that were burst pressure tested passed the45mmHg for 10 seconds pressure acceptance criteria with both thesubject and predicate devices. The subject device demonstrated non-inferiority to the Echelon Flex 60 Powered Plus.

Image /page/10/Picture/3 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, with the registered trademark symbol next to it.

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Human Factors Evaluation:

As part of the Usability Engineering Process for the SureForm 60 and SureForm 60 Reloads, the Usability Risk Analysis was updated to identify any new usability characteristics related to safety, as well as foreseeable hazards and hazardous situations. Human factors evaluation was conducted on the SureForm 60 and SureForm 60 Reloads. Based on the results of those studies, the SureForm 60 has been found to be safe and effective for the intended users, uses, and use environments.

Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the subject devices, SureForm 60 and SureForm 60 Reloads are substantially equivalent to the predicate devices, the IS4000 EndoWrist® Stapler 45 and Stapler 45 Reloads and the Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter (PSEE60A) and Echelon 60 mm Endoscopic Linear Cutter Reload (GST60X).

Image /page/11/Picture/6 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is in a smaller font and also in a light gray color with a registered trademark symbol.

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.