(87 days)
No
The summary does not mention AI, ML, or any related concepts like training data, test data, or specific algorithms. The description focuses on the mechanical function of the stapler and its use with a robotic surgical system.
No
The device is a surgical stapler used for resection, transection, and creation of anastomoses, which are surgical procedures, not therapeutic treatments.
No
Explanation: This device is a surgical stapler used for resection, transection, and creation of anastomoses, which are therapeutic and operative procedures, not diagnostic ones.
No
The device description explicitly details physical components like a disposable, fully wristed articulating device, a single-use cartridge containing staples, and a stainless steel knife. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "resection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a surgical stapler and reload, designed to place staples and cut tissue. This is a mechanical surgical instrument.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are used to diagnose, monitor, or screen for diseases or conditions by analyzing samples.
- Performance Studies: The performance studies described involve bench testing and in-vivo animal testing, focusing on the mechanical performance of the stapler (staple line integrity, hemostasis, burst pressure, healing). These are typical evaluations for surgical devices, not IVDs.
In summary, the Intuitive Surgical SureForm 45 Stapler and its accessories are surgical instruments used directly on a patient during surgery, not devices used to perform tests on samples outside the body for diagnostic purposes.
N/A
Intended Use / 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, 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
NAY, GDW
Device Description
The Intuitive Surgical SureForm 45 Curved Tip and SureForm 45 Gray Reload are an addition to the existing SureForm 45 Stapling System (SureForm 45 and SureForm 45 Reloads - White, Blue, Green and Black) cleared January 18, 2019, K183224) and are designed for use exclusively with compatible 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 (transection). line The SureForm 45 Curved Tip Stapler Instrument is a disposable, fully wristed articulating device. The SureForm 45 Gray Reload consists of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: The SureForm 45 Curved Tip and Gray Reload were evaluated using bench testing, acute and chronic 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 Curved Tip and Gray Reload, 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 and chronic clinical validation studies were performed using simulated clinical models (animal) to evaluate the performance of the subject device, SureForm 45 Curved Tip and SureForm 45 Gray Reload. 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 devices (SureForm 45 and EndoWrist 30 Gray Reload) was performed in the Staple Line Performance, Maximum Torque and Burst Pressure Testing to demonstrate substantial equivalence between the subject and predicate devices. 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.
Acute Testing:
Study Name: Staple Line Performance
Study Purpose: Assess staple line performance and staple formation of the subject device compared to the predicate EndoWrist 30 Gray Reload.
Type/Number of animals: Porcine (1 animal)
Study Outcome: The subject device met all acceptance criteria and exhibited acceptable pass rates in the areas of transection, tissue layer approximation, hemostasis, and staple formation.
Study Name: Buttress Material Compatibility (Gore, Baxter and Cook)
Study Purpose: 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), Baxter PeriStrip Dry with Veritas Collagen Matrix Staple Line Reinforcement (510(k) cleared under K041669) and Cook Biodesign Staple Line Reinforcement (510(k) cleared under K170945) were used in accordance with the manufacturer's Instructions for Use.
Type/Number of animals: Porcine (1 animal)
Study Outcome: 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: Maximum Torque
Study Purpose: Evaluate staple line performance at maximum SmartFire torque limits of the subject device as compared to the SureForm 60 and SureForm 60 White Reloads
Type/Number of animals: Porcine (1 animal)
Study Outcome: 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.
Study Name: Design Validation
Study Purpose: Design validation testing of the subject device was performed in a clinical laboratory setting closely approximating an intraoperative use situation.
Type/Number of animals: Porcine (1 animal)
Study Outcome: The subject device met all acceptance criteria.
Study Name: Burst Pressure (Juglar venous)
Study Purpose: Assess burst pressure of the subject device as compared to the predicate EndoWrist 30 Gray Reload.
Type/Number of animals: Porcine (Excised jugular venous tissue)
Study Outcome: 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 EndoWrist 30 Gray Reload.
Chronic Testing:
Study Name: Lung Lobectomy
Study Purpose: Assess subject device performance as compared to the EndoWrist 30 Gray Reload in a lung lobectomy procedure.
Type/Number of animals: Canine (8 animals)
Study Outcome: 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.
Study Name: Nephrectomy
Study Purpose: Assess subject device performance as compared to the EndoWrist 30 Gray Reload in a nephrectomy procedure.
Type/Number of animals: Porcine (8 animals)
Study Outcome: All staple lines passed assessment for leaks intra-operatively. All animals survived through the 28 day survival period. During the terminal procedure, there were no signs of bleeding at the staple lines, and staple lines were well-healed at the end of the survival period for both the subject and predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Build Correspondence
Image /page/0/Picture/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 12, 2019
Intuitive Surgical, Inc. Nadine Nasr Regulatory Technical Lead 1266 Kifer Road Sunnyvale, California 94086
Re: K190999
Trade/Device Name: SureForm 45 Curved Tip, SureForm 45 Gray Reload Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY, GDW Dated: April 15, 2019 Received: April 16, 2019
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/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.
1
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 medical devices and radiation-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,
Long Chen, Ph. D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190999
Device Name
SureForm 45 Curved Tip and SureForm 45 Gray Reload
Indications for Use (Describe)
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).
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)]
July 12, 2019
| Submitter: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|-------------------|----------------------------------------------------------------------------------------------------|
| Official Contact: | Nadine Nasr
Regulatory Technical Lead
Phone Number: 408-523-7093
Fax Number: 408-523-8907 |
| Trade Name: | SureForm 45 Curved Tip and SureForm 45 Gray Reload |
| Common Name: | System, surgical, computer controlled instrument |
| Classification: | Class II
21 CFR 876.1500, Endoscope and Accessories
21 CFR 878.4750, Implantable Staple |
| Product Codes: | NAY (Endoscope and accessories)
GDW (Implantable Staple) |
Predicate Device: SureForm 45 (K183224) - primary
EndoWrist 30 Gray Reload (K170508) - secondary
Device Description: The Intuitive Surgical SureForm 45 Curved Tip and SureForm 45 Gray Reload are an addition to the existing SureForm 45 Stapling System (SureForm 45 and SureForm 45 Reloads - White, Blue, Green and Black) cleared January 18, 2019, K183224) and are designed for use exclusively with compatible 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 (transection). line The
4
SureForm 45 Curved Tip Stapler Instrument is a disposable, fully wristed articulating device. The SureForm 45 Gray Reload consists of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife. The specifications for the SureForm 45 Gray Reload are provided in Table 1.
| Attribute | Gray Reload |
|---|---|
| No. of staple rows and staple line | |
| configuration | 6 rows total; |
| 3 on each side of transection; | |
| 66 staples total | |
| Unformed staple leg length | 2.0 mm |
| Pictures | Image: Gray Reload |
Table 1: SureForm 45 Gray Reload Specifications
The Gray Reload is a single use device and is shipped sterile to the surgeon with a retainer that protects the staples during shipping and transportation. The SureForm 45 Gray reloads, as well as the SureForm 45 White, Blue, Green and Black reloads, are compatible with the SureForm 45 and SureForm 45 Curved Tip instruments. The SureForm 45 Gray, White. Blue, Green and Black 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 and SureForm 45 Curved Tip instruments.
Image /page/4/Picture/7 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 the registered trademark symbol to the right of it. There is a yellow dot above the word "INTUITIVE".
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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 Curved Tip and SureForm 45 Gray Reload are an addition to the predicate SureForm 45 Stapler System (SureForm 45 and SureForm 45 White, Blue, Green and Black Reloads, K183224, cleared January 18, 2019). The SureForm 45 Curved Tip is equivalent to the predicate device (SureForm 45) in terms of the indications for use, design, materials, technology, and performance specifications. Modifications from the predicate are based on a change in the distal tip. The subject SureForm 45 Curved Tip is the same as the predicate SureForm 45 from a design perspective with the exception of the of the curved anvil tip feature. The curved anvil tip feature allows the surgeon to better visualize the tip of the instrument and facilitates access around and behind tissues.
The SureForm 45 Gray Reload is a new disposable reload for use with the SureForm 45 Instruments (Straight and Curved Tip anvil configurations). It is an addition to the existing family of SureForm 45 Reloads (White, Blue, Green and Black). It is equivalent to the Endo Wrist 30 Gray Reload (K170508, cleared March 10, 2017) in terms of the indications for use, design, technology and performance specifications.
The changes to the distal tip and introduction of a new reload do not substantially change the function of the subject device relative to the function of the predicate devices.
Performance Data: The SureForm 45 Curved Tip and Gray Reload were evaluated using bench testing, acute and chronic 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 Curved Tip and Gray Reload, 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 .
INTUITIVE SURGICAL®
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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, SureForm 45 Curved Tip and SureForm 45 Gray Reload. 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 devices (SureForm 45 and EndoWrist 30 Gray Reload) was performed in the Staple Line Performance, Maximum Torque and Burst Pressure Testing to demonstrate substantial equivalence between the subject and predicate devices. 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/4 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 a registered trademark symbol next to it.
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K190999
SureForm 45 Curved Tip and Gray Reload
| Study Name | Study Purpose | Type/Number of animals | Study Outcome |
|---|---|---|---|
| Acute Testing: | |||
| Staple Line | |||
| Performance | Assess staple line performance | ||
| and staple formation of the | |||
| subject device compared to the | |||
| predicate EndoWrist 30 Gray | |||
| Reload. | Porcine (1 animal) | The subject device met all acceptance criteria and exhibited acceptable | |
| pass rates in the areas of transection, tissue layer approximation, | |||
| hemostasis, and staple formation. | |||
| Buttress | |||
| Material | |||
| Compatibility | |||
| (Gore, Baxter | |||
| 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), Baxter | |||
| PeriStrip Dry with Veritas | |||
| Collagen Matrix Staple Line | |||
| Reinforcement (510(k) cleared | |||
| under K041669) and Cook | |||
| Biodesign Staple Line | |||
| Reinforcement (510(k) cleared | |||
| under K170945) were used in | |||
| accordance with the | |||
| manufacturer's Instructions for | |||
| Use. | Porcine (1 animal) | 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 | Evaluate staple line | ||
| performance at maximum | |||
| SmartFire torque limits of the | |||
| subject device as compared to | |||
| the SureForm 60 and SureForm | |||
| 60 White Reloads | Porcine (1 animal) | 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. |
| Table 2: Summary of Animal Validation Studies | ||||
|---|---|---|---|---|
| -- | -- | -- | ----------------------------------------------- | -- |
Image /page/7/Picture/5 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 a registered trademark symbol.
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SureForm 45 Curved Tip and Gray Reload
| 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 (1 animal) | The subject device met all acceptance criteria. | |
| Burst Pressure | |||
| (Juglar venous) | Assess burst pressure of the | ||
| subject device as compared to | |||
| the predicate EndoWrist 30 | |||
| Gray Reload. | Porcine | ||
| (Excised jugular | |||
| venous 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 EndoWrist 30 Gray | |||
| Reload. | |||
| Chronic Testing: | |||
| Lung | |||
| Lobectomy | Assess subject device | ||
| performance as compared to the | |||
| EndoWrist 30 Gray Reload 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. |
| Nephrectomy | Assess subject device
performance as compared to the
EndoWrist 30 Gray Reload in a
nephrectomy procedure. | Porcine (8 animals) | All staple lines passed assessment for leaks intra-operatively.
All animals survived through the 28 day survival period. During the
terminal procedure, there were no signs of bleeding at the staple lines,
and staple lines were well-healed at the end of the survival period for
both the subject and predicate devices. |
Image /page/8/Picture/4 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.
9
SureForm 45 Curved Tip and Gray Reload
Summary: Based on the indications for use, technological characteristics, and performance data, the subject device, SureForm 45 Curved Tip and SureForm 45 Gray Reload are substantially equivalent to the predicate devices, the SureForm 45 and SureForm 45 Reloads and the EndoWrist 30 Gray Reload.
Image /page/9/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font above the word "SURGICAL" which is in a smaller font. There is a yellow dot above the word "INTUITIVE".