(212 days)
Not Found
No
The summary describes a mechanical surgical stapler system and its reloads. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies. The performance studies focus on mechanical and functional verification, animal studies, and human factors, which are typical for a mechanical surgical device.
No
Explanation: The device is a surgical stapler system intended for resection, transection, and creation of anastomoses, which are surgical procedures, not therapeutic treatments.
No
Explanation: The device is a surgical stapler system intended for resection, transection, and the creation of anastomoses by placing staples and cutting tissue. Its function is to perform a surgical procedure, not to diagnose a condition.
No
The device description clearly states it is a disposable surgical stapler system with physical components like staples, a knife, and a wristed articulating device. The performance studies also involve bench testing of physical specifications and mechanical requirements, as well as animal studies using simulated clinical models. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical stapler system used for resection, transection, and creation of anastomoses in various surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The device description details a surgical instrument that places staples and cuts tissue. This is a mechanical action performed during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. The description of this device does not involve any such testing or analysis of specimens.
- Performance Studies: The performance studies focus on the mechanical and functional performance of the stapler during simulated and actual surgical procedures (bench testing, animal studies, human factors evaluation). They do not involve the analysis of biological samples.
Therefore, the Intuitive Surgical Stapler SureForm 60 and its reloads are a surgical device used in vivo (within the living body) and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
NAY, GDW
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. Table 1 outlines the specifications of the reloads. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
- Animal Survival Study: Lobectomy. Type/Number of animals: Canine (8 animals).
- Animal Survival Study: Lung Wedge Resection. Type/Number of animals: Canine (8 animals).
- Animal Survival Study: Gastrectomy – canine. Type/Number of animals: Canine (8 animals).
- Animal Survival Study: Gastrectomy – porcine. Type/Number of animals: Porcine (8 animals).
- Animal Survival Study: Small bowel anastomosis. Type/Number of animals: Porcine (8 animals).
- Animal Survival Study: Nephrectomy. Type/Number of animals: Porcine (8 animals).
- Staple Line Performance. Type/Number of animals: Canine and Porcine (4 Canine and 7 Porcine).
- Buttress Material Compatibility (Gore and Cook). Type/Number of animals: Canine and Porcine (1 Canine, 1 Porcine).
- Maximum Torque. Type/Number of animals: Porcine (2 animals).
- Design Validation. Type/Number of animals: Porcine (2 animals).
- Burst Pressure. Type/Number of animals: Porcine (Excised tissue and in-vivo model - 1 animal).
- Venous Burst Pressure. Type/Number of animals: Excised Porcine Jugular Veins.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- Animal Survival Study: Lobectomy (8 Canine). 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 (8 Canine). 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 (8 Canine). 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 (8 Porcine). 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 (8 Porcine). All staple lines passed visual assessment intra-operatively. Early death of one of the animals enrolled in the study 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.
- Animal Survival Study: Nephrectomy (8 Porcine). 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 Line Performance (4 Canine and 7 Porcine). 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 (Gore and Cook) (1 Canine, 1 Porcine). 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 (2 Porcine). 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 (2 Porcine). The subject device met all acceptance criteria.
- Burst Pressure (Excised tissue and in-vivo model - 1 animal). 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 (Excised Porcine Jugular Veins). 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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)
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).
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 Road
Sunnyvale, CA 94086 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nadine Nasr
Sr. Regulatory Affairs Specialist
Phone Number: 408-523-7093
Fax Number: 408-523-8907
Email: 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 and
implantable staples |
| Classification: | Class II
21 CFR 876.1500, Endoscope and Accessories
21 CRF 878.4750, Implantable Staple |
| Product Codes: | NAY (Endoscope and accessories)
GDW (Implantable Staple) |
| Classification Advisory
Committee: | General and Plastic Surgery |
| Predicate Device: | 1. Primary: IS4000 EndoWrist® Stapler 45 and Stapler 45
Reloads - K170508
2. Secondary: Echelon Flex 60 Powered Plus Articulating
Endoscopic Linear Cutter, Echelon 60 mm Endoscopic
Linear Cutter Reload, PSEE60A (Stapler) GST60X
(Reloads) - K140560 |
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
4
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 staple | ||||
| rows and | ||||
| staple line | ||||
| configuration | 6 rows total; | |||
| 3 on each side | ||||
| of transection; | ||||
| 90 staples total | 6 rows total; | |||
| 3 on each side | ||||
| of transection; | ||||
| 90 staples total | 6 rows total; | |||
| 3 on each side | ||||
| of transection; | ||||
| 90 staples total | 6 rows total; | |||
| 3 on each side of | ||||
| transection; | ||||
| 90 staples total | ||||
| Unformed | ||||
| staple leg | ||||
| length | 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.
Image /page/6/Picture/11 description: The image contains 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 to the right of the word.
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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 |
| Animal | |||
| Survival Study: | |||
| Nephrectomy | Assess subject device | ||
| performance as compared to the | |||
| Echelon Flex 60 Powered Plus | |||
| in 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 Line | |||
| Performance | Assess staple line performance | ||
| and staple formation of the | |||
| subject device compared to the | |||
| Echelon Flex 60 Powered Plus. | Canine and Porcine | ||
| (4 Canine and 7 | |||
| Porcine) | 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 | |||
| (Gore and | |||
| Cook) | Confirm the ability of the | ||
| subject device to produce well-formed staples in-vivo as well | |||
| as a staple line which exhibits | |||
| clinically acceptable tissue | |||
| approximation, transection, and | |||
| hemostasis and not be affected | |||
| when Gore Seamguard | |||
| Bioabsorbable Staple Line | |||
| Reinforcement (510(k) cleared | |||
| under 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 in | |||
| a statistically significant manner when buttress material was used in | |||
| accordance with the manufacturer's Instructions for Use. | |||
| Study Name | Study Purpose | Type/Number of animals | Study Outcome |
| Biodesign Staple Line | |||
| Reinforcement (510(k) cleared | |||
| under K170945) were used in | |||
| accordance with the | |||
| manufacturer's Instructions for | |||
| Use. | |||
| Maximum | |||
| Torque | Evaluate staple line | ||
| performance at maximum | |||
| SmartFire torque limits of the | |||
| subject device as compared to | |||
| the Echelon Flex 60 Powered | |||
| Plus. | Porcine | ||
| (2 animals) | 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 | Design validation testing of the | ||
| subject device was performed | |||
| in a clinical laboratory setting | |||
| closely approximating an | |||
| intraoperative use situation. | Porcine | ||
| (2 animals) | The subject device met all acceptance criteria. | ||
| Burst Pressure | Assess burst pressure of the | ||
| subject device as compared to | |||
| the Echelon Flex 60 Powered | |||
| Plus. | Porcine | ||
| (Excised tissue and | |||
| in-vivo model - 1 | |||
| animal) | 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. |
Table 2: Summary of Animal Validation Studies
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| Study Name | Study Purpose | Type/Number of animals | Study Outcome |
|---|---|---|---|
| Venous Burst | |||
| Pressure | Assess jugular porcine venous | ||
| staple line burst pressure of the | |||
| subject device as compared to | |||
| the Echelon Flex 60 Powered | |||
| Plus. | Excised Porcine | ||
| Jugular Veins | 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. |
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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).
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