(59 days)
SureForm 60 (K173721)
No
The summary describes a mechanical surgical stapler and its reloads, focusing on its function, compatibility with a robotic surgical system, and performance in bench and animal testing. There is no mention of AI, ML, image processing, or any data-driven decision-making components within the device itself.
No.
The device is a surgical stapler used 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 creation of anastomoses, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "disposable surgical stapler system" and a "disposable, fully wristed articulating device," which are hardware components. The testing also involves bench testing and animal models, indicating evaluation of physical performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "resection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "disposable surgical stapler system" that "places 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)." This is a surgical instrument used during an operation.
- Lack of In Vitro Activity: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition or provide information about a patient's health status.
IVD devices are specifically designed to be used in vitro (in glass, or outside the body) to examine specimens from the human body. This device is clearly designed for in vivo (in the living body) surgical use.
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 (comma separated list FDA assigned to the subject device)
NAY, GDW
Device Description
The Intuitive Surgical SureForm 45 and SureForm 45 Reloads is a disposable surgical stapler system designed for use exclusively with the Intuitive da Vinci Surgical Systems (Models IS4000 and IS4200). It is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The SureForm 45 Stapler Instrument is a disposable, fully wristed articulating device. The SureForm 45 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife. As described in Table 1, the reloads are available in four configurations (White, Blue, Green and Black) to accommodate tissues of various thicknesses (e.g., lung, stomach, and bowel).
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
Pediatric
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)
The SureForm 45 was evaluated using bench testing and acute in-vivo testing (animal model) to demonstrate that the design output meets the input requirements and the device performed as intended.
Design Verification (bench): The subject device, SureForm 45, was subjected to series of bench tests equivalent to those for the predicate device to evaluate performance and to demonstrate that the design outputs meet the design input requirements. Testing was performed with a compatible da Vinci surgical system. The design verification testing included confirmation that the device meets the:
- Physical Specifications
- Mechanical Requirements
- Electrical Requirements
- User Interface Requirements
- Equipment Interface Requirements
Design Validation (animal): A series of acute clinical validation studies were performed using simulated clinical models (animal) to evaluate the performance of the subject device, SureForm 45 and SureForm 45 Reloads. This included Staple Line Performance, Buttress Material Compatibility Testing, Maximum Torque Evaluation, Design Validation Testing and Burst Pressure Testing. A side-by-side comparison between the subject and predicate device (SureForm 60 and SureForm 60 Reloads) was performed in the Staple Line Performance, Maximum Torque and Burst Pressure Testing to demonstrate substantial equivalence between the subject and predicate device. Buttress Material Compatibility Testing and Design Validation Testing demonstrated that the design outputs of the subject device fulfill the design input requirements and that user needs and intended uses are met.
Summary of Animal Validation Studies:
- Staple Line Performance: Assess staple line performance and staple formation of the subject device compared to the predicate SureForm 60 and SureForm 60 Reloads. Type/Number of animals: Canine and Porcine (4 Canine, 4 Porcine). 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. Wrist angle also had no effect on the quality of 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. Type/Number of animals: Canine and Porcine (4 Canine, 4 Porcine). 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.
- Maximum Torque: Evaluate staple line performance at maximum SmartFire torque limits of the subject device as compared to the predicate SureForm 60 and SureForm 60 Reloads. Type/Number of animals: Canine and Porcine (2 canine, 2 porcine). 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.
- Design Validation: 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 (3 animals). Study Outcome: The subject device met all acceptance criteria.
- Burst Pressure (Jugular venous and Stomach): Assess burst pressure of the subject device as compared to the predicate SureForm 60 and SureForm 60 Reloads. Type/Number of animals: Porcine (Excised jugular venous and stomach 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 SureForm 60 and SureForm 60 Reloads.
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.
SureForm 60 (K173721)
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.
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 18, 2019
Intuitive Surgical Nadine Nasr Regulatory Technical Lead 1266 Kifer Road Sunnyvale, California 94086
Re: K183224
Trade/Device Name: SureForm 45, SureForm 45 Reloads Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY, GDW Dated: November 19, 2018 Received: November 20, 2018
Dear Nadine Nasr:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/ofpmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Image /page/1/Picture/6 description: The image shows a signature block. It starts with the word "Sincerely,", followed by the name "Jennifer R. Stevenson -S3". The signature block ends with "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) K183224
Device Name SureForm 45 and SureForm 45 Reloads
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)]
November 19, 2018
| 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 |
| 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 60 (K173721)
Device Description: The Intuitive Surgical SureForm 45 and SureForm 45 Reloads is a disposable surgical stapler system designed for use exclusively with the Intuitive da Vinci Surgical Systems (Models IS4000 and IS4200). It is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The SureForm 45 Stapler Instrument is a disposable, fully wristed articulating device. The SureForm 45 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife. As described in Table 1, the reloads are available in four
4
configurations (White, Blue, Green and Black) to accommodate tissues of various thicknesses (e.g., lung, stomach, and bowel).
| Attribute | SureForm 45 Reloads | |||
|---|---|---|---|---|
| White | Blue | Green | Black | |
| No. of staple | ||||
| rows and | ||||
| staple line | ||||
| configuration | 6 rows total; | |||
| 3 on each side of | ||||
| transection; | ||||
| 66 staples total | 6 rows total; | |||
| 3 on each side of | ||||
| transection; | ||||
| 66 staples total | 6 rows total; | |||
| 3 on each side of | ||||
| transection; | ||||
| 66 staples total | 6 rows total; | |||
| 3 on each side of | ||||
| transection; | ||||
| 66 staples total | ||||
| Unformed | ||||
| staple leg | ||||
| length | 2.5 mm | 3.5 mm | 4.3 mm | 4.6 mm |
| Pictures | Image: White SureForm 45 Reload | Image: Blue SureForm 45 Reload | Image: Green SureForm 45 Reload | Image: Black SureForm 45 Reload |
Table 1: SureForm 45 Reloads Specifications
The reloads are single use devices and are shipped sterile to the surgeon with a retainer that protects the staples during shipping and transportation. The SureForm 45 reloads are not compatible with any other Intuitive Surgical stapler instruments (the SureForm 60, IS4000 Stapler 30 and 45 instruments and the IS3000 Stapler 45 instrument), and likewise, the SureForm 60, IS4000 Stapler 30 and 45 reloads and IS3000 Stapler 45 reloads are not compatible with the SureForm 45 instrument.
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Indications for Use: The Intuitive Surgical SureForm 45 Stapler, SureForm 45 Reloads and other stapler accessories are intended to be used with a compatible da Vinci Surgical System for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
Technological Characteristics: The SureForm 45 System is equivalent to the predicate device (SureForm 60) in terms of its indications for use, design, technology, and performance specifications. Modifications from the predicate are based on a change in the staple line length (45 mm vs. 60 mm). The subject SureForm 45 is the same as the predicate SureForm 60 from a design perspective with the exception of the staple line length itself. The changes to the distal iaw do not substantially change the function of the subject device relative to the function of the predicate device.
Performance Data: The SureForm 45 was evaluated using bench testing and acute in-vivo testing (animal model) to demonstrate that the design output meets the input requirements and the device performed as intended.
Design Verification (bench): The subject device, SureForm 45, was subjected to series of bench tests equivalent to those for the predicate device to evaluate performance and to demonstrate that the design outputs meet the design input requirements. Testing was performed with a compatible da Vinci surgical system. The design verification testing included confirmation that the device meets the:
- Physical Specifications
- . Mechanical Requirements
- Electrical Requirements
- User Interface Requirements ●
- Equipment Interface Requirements ●
Design Validation (animal):
A series of acute clinical validation studies were performed using simulated clinical models (animal) to evaluate the performance of the subject device, SureForm 45 and SureForm 45 Reloads. This included Staple Line Performance, Buttress Material Compatibility Testing, Maximum Torque Evaluation, Design Validation Testing and Burst Pressure Testing. A side-by-side comparison between the subject and predicate device (SureForm 60 and SureForm 60 Reloads) was performed in the Staple Line Performance, Maximum Torque and Burst Pressure Testing to demonstrate substantial equivalence between the subject and predicate device. Buttress Material Compatibility Testing and Design Validation Testing demonstrated that the design outputs of the subject device fulfill the design input
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requirements and that user needs and intended uses are met. A summary of the animal validation studies is provided in Table 2 below.
Image /page/6/Picture/3 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.
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| Study Name | Study Purpose | Type/Number of
animals | Study Outcome |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Staple Line
Performance | Assess staple line performance
and staple formation of the
subject device compared to the
predicate SureForm 60 and
SureForm 60 Reloads. | Canine and Porcine
(4 Canine, 4 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, 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. | Canine and Porcine
(4 Canine, 4 Porcine) | Pass rates in the areas of transection, tissue layer approximation,
hemostasis, and optimal staple formation were not adversely affected 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 predicate SureForm 60 and
SureForm 60 Reloads. | Canine and Porcine
(2 canine, 2 porcine) | 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/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font, and is colored in gray. Above the "I" in "INTUITIVE" is a yellow dot. Below "INTUITIVE" is the word "SURGICAL" in a smaller, sans-serif font, also in gray, with a registered trademark symbol to the right.
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| Study Name | Study Purpose | Type/Number of animals | Study Outcome |
|---|---|---|---|
| Design Validation | Design validation testing of the subject device was performed in a clinical laboratory setting closely approximating an intraoperative use situation. | Porcine (3 animals) | The subject device met all acceptance criteria. |
| Burst Pressure (Juglar venous and Stomach) | Assess burst pressure of the subject device as compared to the predicate SureForm 60 and SureForm 60 Reloads. | Porcine (Excised jugular venous and stomach tissue) | The staple lines from the subject device performed substantially equivalent to that of the predicate device. The subject device demonstrated non-inferiority to the predicate SureForm 60 and SureForm 60 Reloads. |
Image /page/8/Picture/3 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in gray, with a yellow dot above the "I". Below that, the word "SURGICAL" is also in gray, with a registered trademark symbol to the right.
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Summary: Based on the indications for use, technological characteristics, and performance data, the subject device, SureForm 45 and SureForm 45 Reloads are substantially equivalent to the predicate device, the SureForm 60 and SureForm 60 Reloads.