8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads
Device Facts
| Record ID | K211997 |
|---|---|
| Device Name | 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads |
| Applicant | Intuitive Surgical, Inc. |
| Product Code | NAY · Gastroenterology, Urology |
| Decision Date | Dec 10, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Intended Use
The Intuitive Surgical 8 mm SureForm 30 staplers and reloads and accessories are intended to be used with a compatible da Vinci Surgical system for resection of vasculature and tissue and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
Device Story
Disposable, fully wristed, articulating surgical staplers; designed for use with da Vinci Xi and X Surgical Systems (IS4000/IS4200). Surgeon controls device via Surgeon Console. Device places multiple staggered rows of titanium alloy (Ti3Al2.5V) staples into target tissue; cuts tissue along middle of staple line. Reloads available in three configurations (gray, white, blue) for varying tissue thicknesses. Used in OR by surgeons for resection, transection, and anastomosis. Provides consistent staple formation and tissue transection; benefits include reduced manual effort and precise control during robotic-assisted procedures.
Clinical Evidence
No human clinical data. Bench testing verified physical, mechanical, electrical, and user interface requirements. Animal validation (acute and chronic) included staple line performance, hemostasis, leak onset pressure, and torque evaluation in canine and porcine models. Chronic studies (lung lobectomy, lung wedge resection, gastrectomy, small bowel anastomosis, nephrectomy) demonstrated well-healed staple lines and no intra-operative leaks or bleeding at terminal procedures, confirming performance equivalent to predicate.
Technological Characteristics
Disposable, wristed, articulating stapler; titanium alloy (Ti3Al2.5V) staples; EO sterilization. Compatible with da Vinci Xi/X systems. Reloads feature 4 staggered rows (2 per side of cut line). Dimensions: 8 mm diameter. Software-controlled via robotic system interface.
Indications for Use
Indicated for resection and transection of vasculature and tissue and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery using a compatible da Vinci Surgical system.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- SureForm 45 Staplers and Reloads (K190999)
Related Devices
- K173721 — SureForm 60 and SureForm 60 Reloads · Intuitive Surgical · Jul 5, 2018
- K152421 — IS4000 Stapler 30 Instrument and Stapler 30 Reloads · Intuitive Surgical, Inc. · Mar 4, 2016
- K222839 — EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System · Intuitive Surgical, Inc. · Mar 16, 2023
- K140553 — ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS · Intuitive Surgical, Inc. · Jul 25, 2014
- K190999 — SureForm 45 Curved Tip, SureForm 45 Gray Reload · Intuitive Surgical, Inc. · Jul 12, 2019
Submission Summary (Full Text)
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December 10, 2021
Intuitive Surgical, Inc. Amrit Jaggi Senior Regulatory Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K211997
Trade/Device Name: 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY, GDW Dated: November 5, 2021 Received: November 10, 2021
Dear Amrit Jaggi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mark Trumbore, Ph.D. Assistant Director THT4A1: Robotically-assissted Surgical Devices Team DHT4A: Division of Sugical Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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#### Form FDA 3881 – Indications for Use statement 6
There is 1 page in this section following this cover sheet.
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# Indications for Use
510(k) Number (if known) New device
Device Name
8 mm SureForm 30 Curved-Tip Stapler 8 mm SureForm 30 Stapler 8 mm SureForm 30 Reloads
#### Indications for Use (Describe)
The Intuitive Surgical 8 mm SureForm 30 staplers and reloads and accessories are intended to be used with a compatible da Vinci Surgical system for resection of vasculature and tissue and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;"><b> Prescription Use (Part 21 CER 801 Subpart D) </b></span> | Over-The-Counter Use (21 CER 801 Subpart C) |
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510(k) Summary
#### [As Required by 21 CFR 807.92(c)]
| Submitter: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
|-------------------|-------------------------------------------------------------------------------------------------------|
| Official Contact: | Amrit Jaggi<br>Senior Regulatory Specialist<br>Phone Number: 949-690-8799<br>Fax Number: 408-523-8907 |
| Date Prepared: | June 25, 2021 |
| Trade Name: | 8 mm SureForm™ 30 Curved-Tip Stapler, 8 mm SureForm 30<br>Stapler, 8 mm SureForm 30 Reloads |
| Common Name: | System, surgical, computer controlled instrument |
| Classification: | Class II<br>21 CFR 876.1500, Endoscope and Accessories<br>21 CFR 878.4750, Implantable Staple |
| Product Codes: | NAY (Endoscope and accessories)<br>GDW (Implantable Staple) |
Predicate Device: SureForm 45 Staplers and Reloads (K190999)
## Device Description
The Intuitive Surgical 8 mm SureForm 30 Curved-Tip Stapler and the 8 mm SureForm 30 Stapler are disposable, fully wristed, articulating, surgical staplers and are designed for use exclusively with the Intuitive Surgical da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200 Systems). The staplers are controlled by the surgeon using the Surgeon Console of the IS4000/IS4200 Systems. They are intended for resection, transection and/or creation of anastomoses in surgery. The staplers achieve their intended use by placing multiple staggered rows of implantable staples in the target tissue (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The 8 mm SureForm 30 Reloads consist of a single-use cartridge that contains four staggered rows of implantable titanium alloy (Ti3A12.5V) staples. The reloads are offered in three configurations (gray, white, and blue). 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.
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| | 8 mm SureForm 30 Reloads | | |
|--------------------------------------------------------|----------------------------------------------------|----------------------------------------------------|----------------------------------------------------|
| Attribute | Gray | White | Blue |
| No. of staple rows<br>and staple line<br>configuration | 4 rows total;<br>2 on each side of the<br>cut line | 4 rows total;<br>2 on each side of the<br>cut line | 4 rows total;<br>2 on each side of the<br>cut line |
| No. of Staples | 34 staples | 34 staples | 34 staples |
| Unformed staple<br>leg length | 2.0 mm | 2.5 mm | 3.5 mm |
| Image | Image: gray stapler | Image: white stapler | Image: blue stapler |
Table 1 8 mm SureForm 30 Reloads Specifications
The reloads are single use devices and are shipped sterile to the surgeon with a retainer and bottom cover that protects the staples during shipping and transportation. The 8 mm SureForm 30 Reloads are not compatible with any other Intuitive Surgical stapler instruments and likewise, the existing Intuitive Surgical stapler reloads are not compatible with the 8 mm SureForm 30 Staplers.
## Intended Use
The 8 mm SureForm 30 Staplers and Reloads are intended to resect, transect and/or create anastomoses in surgery.
## Indications for Use
The Intuitive Surgical 8 mm SureForm 30 Staplers and Reloads and accessories are intended to be used with a compatible da Vinci Surgical system for resection and transection of vasculature and tissue and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
## Comparison of Technological Characteristics
The subject device, 8 mm SureForm 30 Staplers and the predicate device, SureForm 45 Staplers and Reloads (K190999) are regulated under the same regulation number, product code, and classification. They have the same intended use, sterility characteristics (EO sterilization), and principles of operation. The subject device, 8 mm SureForm 30 Staplers and Reloads, and the predicate SureForm 45 Staplers and Reloads
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differ in some design attributes (the subject device has a narrower diameter and shorter staple line length), indications for use (the subject device is indicated for use on vasculature and tissue), and patient-contacting materials (some same, some different).
#### Performance Data
Performance test data (bench and animal tests) for the 8 mm SureForm 30 Staplers and Reloads demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements, user needs, and intended use. The testing is summarized below.
#### Design Verification (bench):
The 8 mm SureForm 30 Staplers and Reloads were subject to full design verification testing included:
- Physical Specifications ●
- Mechanical Requirements ●
- Electrical Requirements ●
- User Interface Requirements ●
- Equipment Interface Requirements ●
- Reliability ●
- Packaging and labeling
The 8 mm SureForm 30 Staplers and Reloads met all of the bench testing acceptance criteria, demonstrating that that the design output meets the design input requirements.
#### Design Validation (animal):
A series of acute and chronic clinical validation studies were performed using simulated clinical models (animal) to evaluate the performance of the subject device. Acute clinical validation studies included Staple Line Performance, Hemostasis Testing, Leak Onset Testing, Maximum Torque Evaluation, and Design Validation Testing. Chronic survival studies included Lung Lobectomy Study, Lung Wedge Resection Study, Gastrectomy Study, Small Bowel Anastomosis, and Nephrectomy Study. A side-by-side comparison between the subject and predicate device was performed in the Staple Line Performance, Hemostasis Testing, Leak Onset Testing, Maximum Torque Evaluation, and all Chronic Survival Studies to demonstrate substantial equivalence between the subject and predicate devices. 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 | Animal<br>Model | Study Outcome |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acute Testing: | | | |
| Staple Line<br>Performance | Assess staple line<br>performance and staple<br>formation of the subject<br>device compared to the<br>predicate | 3 canine<br>models<br>1 porcine<br>model | The subject device met all<br>acceptance criteria and<br>exhibited acceptable pass<br>rates in the areas of<br>transection, tissue layer<br>approximation, hemostasis,<br>and staple formation |
| Hemostasis | Assess hemostasis<br>performance for the subject<br>device as compared to the<br>predicate device. | 2 porcine<br>models | The subject device<br>demonstrated equivalent<br>hemostasis performance to<br>the predicate device. |
| Leak Onset<br>Pressure | Assess leak onset pressure<br>performance on ex vivo<br>tissue of the subject device<br>as compared to the predicate<br>device. | 1 porcine<br>model | All staple lines met all<br>acceptance criteria and<br>exhibited acceptable pass<br>rates in leak onset pressure<br>on thick (stomach) tissue<br>and thin (vein) tissue. |
| Maximum<br>Torque | Evaluate staple line<br>performance at maximum<br>SmartFire torque limits of<br>the subject device as<br>compared to the predicate<br>device. | 2 canine<br>models<br>1 porcine<br>model | The 8 mm SureForm 30<br>Stapler and Reloads<br>demonstrated clinically<br>acceptable performance and<br>met all design<br>specifications. The subject<br>device demonstrated<br>equivalent clinical<br>performance when<br>compared to the predicate<br>device in all adjacent fires.<br>No new of issues of safety<br>and efficacy were raised. |
| Design<br>Validation | Design validation testing of<br>the subject device was<br>performed in a clinical<br>laboratory setting closely<br>approximating an | 2 canine<br>models<br>2 porcine<br>models | The subject device met all<br>acceptance criteria. |
| Study Name | Study Purpose | Animal<br>Model | Study Outcome |
| | intraoperative use situation. | | |
| Chronic Testing: | | | |
| Lung<br>Lobectomy | Assess subject device<br>performance as compared to<br>the predicate device in a<br>lung lobectomy procedure. | 8 canine<br>models | All staple lines passed<br>assessments for leaks intra-<br>operatively. All animals<br>survived through the 28 day<br>+ survival period. During<br>the terminal procedures,<br>there were no signs of<br>bleeding or leakage at the<br>staple lines. Staple lines<br>were well-healed at the end<br>of the survival period for<br>both the subject and<br>predicate devices. |
| Lung Wedge<br>Resection | Assess subject device<br>performance as compared to<br>the predicate device in a<br>lung wedge resection<br>procedure. | 8 canine<br>models | All staple lines passed<br>assessments for leaks intra-<br>operatively. All animals<br>survived through the 7 day +<br>survival period. During the<br>terminal procedures, there<br>were no signs of bleeding or<br>leakage at the staple lines.<br>Staple lines were well-<br>healed at the end of the<br>survival period for both the<br>subject and predicate<br>devices. |
| Small Bowel<br>Anastomosis | Assess subject device<br>performance as compared to<br>the predicate device in a<br>small bowel anastomosis<br>procedure. | 8 porcine<br>models | All staple lines passed<br>assessments for leaks intra-<br>operatively. All animals<br>survived through the 14 day<br>+ survival period. During<br>the terminal procedures,<br>there were no signs of<br>bleeding or leakage at the<br>staple lines. Staple lines<br>were well-healed at the end<br>of the survival period for<br>both the subject and predicate devices. |
| Study Name | Study Purpose | Animal<br>Model | Study Outcome |
| Nephrectomy | Assess subject device<br>performance as compared to<br>the predicate device in a<br>nephrectomy procedure. | 8 porcine<br>models | All staple lines passed<br>assessments for leaks intra-<br>operatively. All animals<br>survived through the 28 day<br>+ survival period. During<br>the terminal procedures,<br>there were no signs of<br>bleeding or leakage at the<br>staple lines. Staple lines<br>were well-healed at the end<br>of the survival period for<br>both the subject and<br>predicate devices. |
| Gastrectomy | Assess subject device<br>performance as compared to<br>the predicate device in a<br>gastrectomy procedure. | 8 canine<br>models | All staple lines passed<br>assessments for leaks intra-<br>operatively. All animals<br>survived through the 14 day<br>+ survival period. During the terminal procedures,<br>there were no signs of<br>bleeding or leakage at the<br>staple lines. Staple lines were well-healed at the end of the survival period for both the subject and predicate devices. |
## Table 2 Summary of Animal Validation Studies
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## Human Factors Evaluation:
As part of the Usability Engineering Process for the 8 mm SureForm 30 Staplers and 8 mm SureForm 30 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 8 mm SureForm 30 Staplers and 8 mm SureForm 30 Reloads. Based on the results of those studies, the 8 mm SureForm 30 Staplers and Reloads has been found to be safe and effective for the intended users, uses, and use environments.
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Based on the indications for use, technological characteristics, and Summary: performance data, the subject device, 8 mm SureForm 30 Staplers and Reloads are substantially equivalent to the predicate devices, the SureForm 45 Staplers and SureForm Reloads.
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