The Intuitive Surgical SureForm 45 Stapler, SureForm 45 Reloads and other stapler accessories are intended to be used with a compatible da Vinci Surgical System for resection, 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 45 and SureForm 45 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 45 Stapler Instrument is a disposable, fully wristed articulating device. The SureForm 45 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife. As described in Table 1, the reloads are available in four configurations (White, Blue, Green and Black) to accommodate tissues of various thicknesses (e.g., lung, stomach, and bowel).

AI/ML Overview

The information provided describes the SureForm 45 and SureForm 45 Reloads surgical stapler system. The study focuses on demonstrating substantial equivalence to a predicate device, the SureForm 60, through various performance tests.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided text describes the outcomes of the studies rather than explicit numerical acceptance criteria. However, the outcomes confirm that the device met these implicit criteria.

Study Name	Acceptance Criteria (Implicit)	Reported Device Performance
Staple Line Performance	Acceptable transection, tissue layer approximation, hemostasis, and staple formation; no effect of wrist angle.	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	Clinically acceptable tissue approximation, transection, hemostasis, and optimal staple formation when buttress material is used.	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	Similar tissue effects (approximation and hemostasis) compared to predicate; optimal staple formation (no more than three suboptimal staples per test fire).	The subject device met all acceptance criteria, exhibiting similar tissue effects (tissue approximation and hemostasis) when compared to the adjacent SureForm 60 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	Meet all design input requirements and user needs/intended uses in a clinical laboratory setting.	The subject device met all acceptance criteria.
Burst Pressure	Substantial equivalence or non-inferiority to the predicate device.	The staple lines from the subject device performed substantially equivalent to that of the predicate device. The subject device demonstrated non-inferiority to the predicate SureForm 60 and SureForm 60 Reloads.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Sizes:
- Staple Line Performance: 4 Canine, 4 Porcine
- Buttress Material Compatibility: 4 Canine, 4 Porcine
- Maximum Torque: 2 Canine, 2 Porcine
- Design Validation: 3 Porcine
- Burst Pressure: Excised jugular venous and stomach tissue from Porcine (specific number of samples not quantified)
Data Provenance: The studies were prospective acute in-vivo animal model studies using canine and porcine subjects. The country of origin is not specified but is implicitly assumed to be the location where Intuitive Surgical, Inc. conducts its preclinical research.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide details on the number or qualifications of experts used to establish ground truth for the animal studies. The evaluation appears to be based on direct observation of outcomes (e.g., transection, hemostasis, staple formation) and measurements (e.g., burst pressure) rather than subjective expert consensus on image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method as would be typical for studies involving human ratings or interpretations. The evaluations appear to be direct assessments of the surgical outcomes in the animal models.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was performed or mentioned. The device is a surgical stapler system, not an AI or imaging diagnostic tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The SureForm 45 is a surgical stapler system, a mechanical device for use with a da Vinci Surgical System, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The ground truth was established through direct physiological and physical outcomes data observed in acute in-vivo animal models, including:

Visual assessment of transection, tissue layer approximation, and hemostasis.
Evaluation of staple formation (e.g., number of suboptimal staples).
Quantitative measurements such as burst pressure.

8. The sample size for the training set

This question is not applicable. The SureForm 45 is a mechanical surgical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI. The "training" in this context refers to design and engineering work, not data-driven model learning.

9. How the ground truth for the training set was established

This question is not applicable for the same reasons as #8.

Summary

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January 18, 2019

Intuitive Surgical Nadine Nasr Regulatory Technical Lead 1266 Kifer Road Sunnyvale, California 94086

Re: K183224

Trade/Device Name: SureForm 45, SureForm 45 Reloads Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY, GDW Dated: November 19, 2018 Received: November 20, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/ofpmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to 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).

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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) K183224

Device Name SureForm 45 and SureForm 45 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

[As Required by 21 CFR 807.92(c)]

November 19, 2018

Submitter:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Official Contact:	Nadine NasrRegulatory Technical LeadPhone Number: 408-523-7093Fax Number: 408-523-8907
Trade Name:	SureForm 45
Common Name:	System, surgical, computer controlled instrument
Classification:	Class II21 CFR 876.1500, Endoscope and Accessories21 CFR 878.4750, Implantable Staple
Product Codes:	NAY (Endoscope and accessories)GDW (Implantable Staple)

Predicate Device: SureForm 60 (K173721)

Device Description: The Intuitive Surgical SureForm 45 and SureForm 45 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 45 Stapler Instrument is a disposable, fully wristed articulating device. The SureForm 45 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife. As described in Table 1, the reloads are available in four

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configurations (White, Blue, Green and Black) to accommodate tissues of various thicknesses (e.g., lung, stomach, and bowel).

Attribute	SureForm 45 Reloads
	White	Blue	Green	Black
No. of staplerows andstaple lineconfiguration	6 rows total;3 on each side oftransection;66 staples total	6 rows total;3 on each side oftransection;66 staples total	6 rows total;3 on each side oftransection;66 staples total	6 rows total;3 on each side oftransection;66 staples total
Unformedstaple leglength	2.5 mm	3.5 mm	4.3 mm	4.6 mm
Pictures	Image: White SureForm 45 Reload	Image: Blue SureForm 45 Reload	Image: Green SureForm 45 Reload	Image: Black SureForm 45 Reload

Table 1: SureForm 45 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 45 reloads are not compatible with any other Intuitive Surgical stapler instruments (the SureForm 60, IS4000 Stapler 30 and 45 instruments and the IS3000 Stapler 45 instrument), and likewise, the SureForm 60, IS4000 Stapler 30 and 45 reloads and IS3000 Stapler 45 reloads are not compatible with the SureForm 45 instrument.

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Indications for Use: The Intuitive Surgical SureForm 45 Stapler, SureForm 45 Reloads and other stapler accessories are intended to be used with a compatible da Vinci Surgical System 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 SureForm 45 System is equivalent to the predicate device (SureForm 60) in terms of its indications for use, design, technology, and performance specifications. Modifications from the predicate are based on a change in the staple line length (45 mm vs. 60 mm). The subject SureForm 45 is the same as the predicate SureForm 60 from a design perspective with the exception of the staple line length itself. The changes to the distal iaw do not substantially change the function of the subject device relative to the function of the predicate device.

Performance Data: The SureForm 45 was evaluated using bench testing and acute in-vivo testing (animal model) to demonstrate that the design output meets the input requirements and the device performed as intended.

Design Verification (bench): The subject device, SureForm 45, was subjected to series of bench tests equivalent to those for the predicate device to evaluate performance and to demonstrate that the design outputs meet the design input requirements. Testing was performed with a compatible da Vinci surgical system. The design verification testing included confirmation that the device meets the:

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

Design Validation (animal):

A series of acute clinical validation studies were performed using simulated clinical models (animal) to evaluate the performance of the subject device, SureForm 45 and SureForm 45 Reloads. This included Staple Line Performance, Buttress Material Compatibility Testing, Maximum Torque Evaluation, Design Validation Testing and Burst Pressure Testing. A side-by-side comparison between the subject and predicate device (SureForm 60 and SureForm 60 Reloads) was performed in the 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

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requirements and that user needs and intended uses are met. A summary of the animal validation studies is provided in Table 2 below.

Image /page/6/Picture/3 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.

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Study Name	Study Purpose	Type/Number ofanimals	Study Outcome
Staple LinePerformance	Assess staple line performanceand staple formation of thesubject device compared to thepredicate SureForm 60 andSureForm 60 Reloads.	Canine and Porcine(4 Canine, 4 Porcine)	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, Baxterand Cook)	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), BaxterPeriStrip Dry with VeritasCollagen Matrix Staple LineReinforcement (510(k) clearedunder K041669) and CookBiodesign Staple LineReinforcement (510(k) clearedunder K170945) were used inaccordance with themanufacturer's Instructions forUse.	Canine and Porcine(4 Canine, 4 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.
MaximumTorque	Evaluate staple lineperformance at maximumSmartFire torque limits of thesubject device as compared tothe predicate SureForm 60 andSureForm 60 Reloads.	Canine and Porcine(2 canine, 2 porcine)	The subject device met all acceptance criteria, exhibiting similar tissueeffects (tissue approximation and hemostasis) when compared to theadjacent SureForm 60 staple lines. The subject device also met the stapleformation acceptance criteria with no more than three sub-optimalstaples within each test fire.

	Table 2: Summary of Animal Validation Studies
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Image /page/7/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font, and is colored in gray. Above the "I" in "INTUITIVE" is a yellow dot. Below "INTUITIVE" is the word "SURGICAL" in a smaller, sans-serif font, also in gray, with a registered trademark symbol to the right.

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Study Name	Study Purpose	Type/Number of animals	Study Outcome
Design Validation	Design validation testing of the subject device was performed in a clinical laboratory setting closely approximating an intraoperative use situation.	Porcine (3 animals)	The subject device met all acceptance criteria.
Burst Pressure (Juglar venous and Stomach)	Assess burst pressure of the subject device as compared to the predicate SureForm 60 and SureForm 60 Reloads.	Porcine (Excised jugular venous and stomach tissue)	The staple lines from the subject device performed substantially equivalent to that of the predicate device. The subject device demonstrated non-inferiority to the predicate SureForm 60 and SureForm 60 Reloads.

Image /page/8/Picture/3 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in gray, with a yellow dot above the "I". Below that, the word "SURGICAL" is also in gray, with a registered trademark symbol to the right.

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Summary: Based on the indications for use, technological characteristics, and performance data, the subject device, SureForm 45 and SureForm 45 Reloads are substantially equivalent to the predicate device, the SureForm 60 and SureForm 60 Reloads.

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.