(109 days)
No
The summary describes a surgical stapler and its reloads, focusing on mechanical function and performance in bench and animal testing. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
No.
The device is a surgical stapler used for resection, transection, and creating anastomoses, which are surgical procedures, not therapeutic actions.
No
The device is a surgical stapler intended for "resection, transection, and/or creation of anastomoses." This describes a therapeutic, not a diagnostic, function.
No
The device description clearly states it is a disposable, fully wristed articulating device that places implantable staples and cuts tissue, indicating it is a physical hardware device.
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, transection, and/or creation of anastomoses in Urologic, Thoracic, and Colorectal surgery." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical stapler and reloads that place staples and cut tissue. This is a surgical instrument, not a device used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The Intuitive Surgical da Vinci SP SureForm 45 Stapler, SP SureForm 45 Curved-Tip Stapler, and SureForm 45 Reloads and other accessories are intended to be used with the da Vinci SP Surgical System for resection, transection, and/or creation of anastomoses in Urologic, Thoracic, and Colorectal surgery.
Product codes
NAY, GDW, GAG
Device Description
The da Vinci SP SureForm 45 Curved Tip Stapler and da Vinci SP SureForm 45 Stapler, with the existing SureForm 45 Reloads (cleared via K183224 and K190999) are designed for use exclusively with compatible Intuitive da Vinci SP Surgical Systems (Model SP1098). 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 SP SureForm 45 Curved Tip Stapler and SP SureForm 45 Stapler Instruments are disposable, fully wristed articulating devices and are compatible with the existing, Intuitive manufactured SureForm 45 mm Gray, White, Blue, Green, and Black reloads (hereinafter referred to as SureForm 45 Reloads). The SP SureForm 45 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless-steel knife. The specifications for the SureForm 45 Reloads are provided in Table 1. The SureForm 45 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 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 SP SureForm 45 Stapler instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urologic, Thoracic, and Colorectal
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
Performance test data (bench and animal tests) for the SP SureForm 45 Staplers and Reloads demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements, user needs, and intended use.
Design Verification (Bench): The SP SureForm 45 Staplers and Reloads were subjected to full design verification testing including:
- Physical Specifications
- Mechanical Requirements
- Electrical Requirements
- User Interface Requirements
- Equipment Interface Requirements
- Reliability
- Packaging and labeling
The SP SureForm 45 Staplers and Reloads met all of the bench testing acceptance criteria, demonstrating that that the design output meets the design input requirements.
Design Validation (Animal): A series of acute validation studies were performed using simulated clinical models (animal) to evaluate the performance of the subject device. Acute clinical validation studies included Staple Line Performance, Leak Onset Testing, Buttress Compatibility, and Design Validation Testing. A side-by-side comparison between the subject and predicate device was performed in the Staple Line Performance and Leak Onset Testing to demonstrate substantial equivalence between the subject and predicate devices. Design Validation Testing demonstrated that the design outputs of the subject device fulfill the design input requirements and that user needs and intended uses are met.
The subject devices, SP SureForm 45 Staplers and Reloads, have similar technology and risk profiles and maintain identical tip geometry and utilize the same reloads as the predicate SureForm 45 Staplers and Reloads (cleared via K183224 and K190999). Hence animal survival studies were not conducted on the subject devices. The survival studies performed on predicate SureForm 45 Staplers and Reloads are used to support the safety of the subject SP SureForm 45 Staplers and Reloads.
Summary of Animal Validation Studies:
- Study Name: Staple Line Performance
- Study Purpose: Assess staple line performance and staple formation of the subject device compared to the predicate
- Animal Model: 5 Canine models, 8 Porcine models
- 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: Leak Onset Pressure
- Study Purpose: Assess leak onset pressure performance on ex vivo tissue of the subject device as compared to the predicate device.
- Animal Model: Ex-vivo porcine tissue
- Study Outcome: All staple lines met all acceptance criteria and exhibited acceptable pass rates in leak onset pressure on thick (stomach) tissue and thin (vein) tissue.
- 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.
- Animal Model: 1 Canine model, 3 Porcine models, 2 Cadaveric models
- Study Outcome: The subject device met all acceptance criteria.
Human Factors Evaluation: Human Factors process conducted for the subject devices included the following activities:
- Known use-related issues for predicate devices similar to the subject devices were analyzed using post-market data and the MAUDE database. All identified userelated issues that are relevant to the use of the subject devices were documented in the risk analysis.
- A Comparative Task Analysis (CTA) was conducted to describe all aspects of the user-device interaction, through the breakdown of steps into user tasks, and to provide an analysis of comparison to the predicate for each task.
- A Use-Related Risk Analysis (URRA) was conducted to identify all use-related risks for each user task identified as New or Modified from the predicate in the CTA.
- Formative usability evaluations were conducted during the development process to inform the device user interface design and confirm assessment of use-related risks.
- Summative usability validations were conducted on the subject SP SureForm 45 Staplers Reloads and were found to be safe and effective for the intended users, uses, and use environments.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4740 Surgical stapler.
(a) Surgical stapler for external use.
(1)
Identification. A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.(b) Surgical stapler for internal use.
(1)
Identification. A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.(2)
Classification. Class II (special controls). The special controls for this device are:(i) Performance testing must demonstrate that the stapler, when used with compatible staples, performs as intended under anticipated conditions of use. Performance testing must include the following:
(A) Evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type;
(B) For manual staplers only, measurement of the worst-case deployment pressures on stapler firing force;
(C) Measurement of staple line strength;
(D) Confirmation of staple line integrity; and
(E) In vivo confirmation of staple line hemostasis.
(ii) For powered staplers only, appropriate analysis/testing must demonstrate the electromagnetic compatibility and electrical, thermal, and mechanical safety of the device.
(iii) For powered staplers only, appropriate software verification, validation, and hazard analysis must be performed.
(iv) Human factors testing must demonstrate that the clinician can correctly select and safely use the device, as identified in the labeling, based on reading the directions for use.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) Performance data must demonstrate the sterility of the device.
(vii) Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling.
(viii) Performance data must support the shelf life of the device by demonstrating continued device functionality, sterility, and package integrity over the identified shelf life.
(ix) Labeling of the device must include the following:
(A) Unless data demonstrates the safety of doing so, contraindications must be identified regarding use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of tissues that are necrotic, friable, or have altered integrity.
(B) Unless available information demonstrates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazards associated with device use including:
(
1 ) Avoidance of use of the stapler to staple tissue outside of the labeled limits for maximum and minimum tissue thickness;(
2 ) Avoidance of obstructions to the creation of the staple line and the unintended stapling of other anatomic structures;(
3 ) Avoidance of clamping and unclamping of delicate tissue structures to prevent tissue damage;(
4 ) Avoidance of use of the stapler on the aorta;(
5 ) Establishing proximal control of blood vessels prior to stapling where practical and methods of blood vessel control in the event of stapler failure;(
6 ) Ensuring stapler compatibility with staples; and(
7 ) Risks specifically associated with the crossing of staple lines.(C) Specific user instructions for proper device use including measures associated with the prevention of device malfunction, and evaluation of the appropriateness of the target tissue for stapling.
(D) List of staples with which the stapler has been demonstrated to be compatible.
(E) Identification of key performance parameters and technical characteristics of the stapler and the compatible staples needed for safe use of the device.
(F) Information regarding tissues on which the stapler is intended to be used.
(G) Identification of safety mechanisms of the stapler.
(H) Validated methods and instructions for reprocessing of any reusable device components.
(I) An expiration date/shelf life.
(x) Package labels must include critical information and technical characteristics necessary for proper device selection.
0
March 10, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "FDA U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".
Intuitive Surgical, Inc. Alifiya Jagmag Regulatory Affairs Project Manager 1266 Kifer Road Sunnyvale, California 94086
Re: K243596
Trade/Device Name: da Vinci SP SureForm 45 Staplers and Reloads (SP1098) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY, GDW, GAG Dated: February 5, 2025 Received: February 5, 2025
Dear Alifiya Jagmag:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark Trumbore Digitally signed by Mark
Trumbore -S Date: 2025.03.10 13:37:48 -5 -04'00' Mark Trumbore, 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
Indications for Use (Describe)
The Intuitive Surgical da Vinci SP SureForm 45 Stapler, SP SureForm 45 Curved-Tip Stapler, and SureForm 45 Reloads and other accessories are intended to be used with the da Vinci SP Surgical System for resection, transection, and/or creation of anastomoses in Urologic, Thoracic, and Colorectal surgery.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary (21 CFR § 807.92)
I. SUBMITTER INFORMATION
| Submitter: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|------------|-------------------------------------------------------------------------------------------------------------------|
| Contact: | Alifiya Jagmag
Regulatory Project Manager
Phone Number: 617-850-5688
Email: Alifiya.Jagmag@jintusurg.com |
Date Summary Prepared: March 7, 2025
II. SUBMITTER INFORMATION
| Trade Name: | da Vinci SP SureFormTM 45 Curved-Tip Stapler |
|---|---|
| da Vinci SP SureFormTM 45 Stapler | |
| SureFormTM 45 Reload, Gray | |
| SureFormTM 45 Reload, White | |
| SureFormTM 45 Reload, Blue | |
| SureFormTM 45 Reload, Green | |
| SureFormTM 45 Reload, Black | |
| Common Name: | Stapler, Surgical |
| Staple, Implantable | |
| System, Surgical, Computer Controlled Instrument | |
| Classification Name: | Surgical Stapler (21 CFR §878.4740) |
| Implantable Staple (21 CFR §878.4750) | |
| Endoscope and Accessories (21 CFR §876.1500) | |
| Regulatory Class: | Class II |
| Product Code: | NAY (System, Surgical, Computer Controlled Instrument) |
| GDW (Staple, Implantable) | |
| GAG (Stapler, Surgical) | |
| Submission Type: | Traditional 510(k) |
Image /page/4/Picture/8 description: The image shows the word "INTUITIVE" in blue font. There is a small blue circle above the letter "U". The font is sans-serif and the letters are evenly spaced. The image is simple and clean, with a white background.
5
III. PREDICATE DEVICE INFORMATION
Predicate Device: SureForm 45 Curved-Tip Stapler (K190999) SureForm 45 Stapler (K183224) SureForm 45 Reloads (K183224 & K190999)
IV. Device Description
The da Vinci SP SureForm 45 Curved Tip Stapler and da Vinci SP SureForm 45 Stapler, with the existing SureForm 45 Reloads (cleared via K183224 and K190999) are designed for use exclusively with compatible Intuitive da Vinci SP Surgical Systems (Model SP1098). 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 SP SureForm 45 Curved Tip Stapler and SP SureForm 45 Stapler Instruments are disposable, fully wristed articulating devices and are compatible with the existing, Intuitive manufactured SureForm 45 mm Gray, White, Blue, Green, and Black reloads (hereinafter referred to as SureForm 45 Reloads). The SP SureForm 45 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless-steel knife. The specifications for the SureForm 45 Reloads are provided in Table 1.
| Attribute | SureForm 45 Reloads | ||||
|---|---|---|---|---|---|
| Gray | White | Blue | Green | Black | |
| No. of staple | |||||
| rows and | |||||
| staple line | |||||
| configuration | 6 Staggered | ||||
| staple rows | |||||
| total; |
3 on each
side of
transection; | 6 Staggered
staple rows
total;
3 on each
side of
transection; | 6 Staggered
staple rows
total;
3 on each
side of
transection; | 6 Staggered
staple rows
total;
3 on each
side of
transection; | 6 Staggered
staple rows
total;
3 on each
side of
transection; |
| No. of Staples | 66 staples
total | 66 staples
total | 66 staples
total | 66 staples
total | 66 staples
total |
Table 1: SureForm 45 Reload Specifications
6
| Attribute | SureForm 45 Reloads | ||||
|---|---|---|---|---|---|
| Gray | White | Blue | Green | Black | |
| Unformed | |||||
| staple leg | |||||
| length | 2.0 mm | 2.5 mm | 3.5 mm | 4.3 mm | 4.6 mm |
| Pictures | Image: Gray staple | Image: White staple | Image: Blue staple | Image: Green staple | Image: Black staple |
The SureForm 45 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 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 SP SureForm 45 Stapler instruments.
Intended Use
The SP SureForm 45 Staplers and Reloads are intended to resect, transect and/or create anastomoses in surgery.
Indications for Use
The Intuitive Surgical da Vinci SP SureForm 45 Stapler, SP SureForm 45 Curved-Tip Stapler, and SureForm 45 Reloads and other accessories are intended to be used with the da Vinci SP Surgical System for resection, transection, and/or creation of anastomoses in Urologic, Thoracic, and Colorectal surgery.
Comparison of Technological Characteristics
The subject device, SP SureForm 45 Staplers and Reloads, and the predicate device, SureForm 45 Staplers and Reloads (cleared under K183224 & K190999) are regulated under the same regulation number, product code, and classification. They have the same intended use, sterility characteristics (EO sterilization), and principles of operation. The subject device, SP SureForm 45 Staplers and Reloads, and the predicate SureForm 45 Staplers and Reloads differ in some design attributes (the subject device has an instrument shaft and proximal housing that allows for the instrument to mate with and be driven by the da Vinci SP Surgical System Patient Side Cart (PSC) instrument drives), indications for use (the subject device is indicated for use with the da Vinci SP Surgical system in Urology, Thoracic and Colorectal surgeries), accessory (the subject SP SureForm 45 Staplers use the da Vinci SP Advanced Access Port system for insertion into the patient anatomy), software
7
(the subject device uses the SP Software control parameters taking into account for the mechanical characteristics of the SP Patient Side Cart Instrument drive and the subject SP SureForm 45 Staplers (e.g. motor torque constants, gear ratios, friction, etc.) in order to generate the clamping and firing forces and motion profiles that achieve the same performance outcome using the same SmartFire and ForceFire features as the predicate SureForm 45 Stapler) and patient-contacting materials (most same, one different).
Performance Data
Performance test data (bench and animal tests) for the SP SureForm 45 Staplers and Reloads demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements, user needs, and intended use. The testing is summarized below.
Design Verification (Bench):
The SP SureForm 45 Staplers and Reloads were subjected to full design verification testing included:
- Physical Specifications ●
- Mechanical Requirements ●
- Electrical Requirements ●
- User Interface Requirements
- Equipment Interface Requirements ●
- Reliability ●
- Packaging and labeling ●
The SP SureForm 45 Staplers and Reloads met all of the bench testing acceptance criteria, demonstrating that that the design output meets the design input requirements.
Design Validation (Animal):
A series of acute validation studies were performed using simulated clinical models (animal) to evaluate the performance of the subject device. Acute clinical validation studies included Staple Line Performance, Leak Onset Testing, Buttress Compatibility, and Design Validation Testing. A side-by-side comparison between the subject and predicate device was performed in the Staple Line Performance and Leak Onset Testing to demonstrate substantial equivalence between the subject and predicate devices. Design Validation Testing demonstrated that the design outputs of the subject device fulfill the design input requirements and that user needs and intended uses are met.
The subject devices, SP SureForm 45 Staplers and Reloads, have similar technology and risk profiles and maintain identical tip geometry and utilize the same reloads as the predicate SureForm 45 Staplers and Reloads (cleared via K183224 and K190999). Hence animal survival studies were not conducted on the subject devices. The survival studies performed on predicate SureForm 45 Staplers and Reloads are used to support the safety of the subject SP SureForm 45 Staplers and Reloads.
8
A summary of the acute animal validation studies is provided in Table 2 below.
| Study Name | Study Purpose | Animal
Model | Study Outcome |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acute Testing: | | | |
| Staple Line
Performance | Assess staple line
performance and staple
formation of the subject
device compared to the
predicate | 5 Canine
models
8 Porcine
models | The subject device met all
acceptance criteria and
exhibited acceptable pass
rates in the areas of
transection, tissue layer
approximation, hemostasis,
and staple formation |
| Leak Onset
Pressure | Assess leak onset pressure
performance on ex vivo
tissue of the subject device
as compared to the predicate
device. | Ex-vivo
porcine
tissue | All staple lines met all
acceptance criteria and
exhibited acceptable pass
rates in leak onset pressure
on thick (stomach) tissue
and thin (vein) tissue. |
| Design
Validation | Design validation testing of
the subject device was
performed in a clinical
laboratory setting closely
approximating an
intraoperative use situation. | 1 Canine
model
3 Porcine
models
2 Cadaveric
models | The subject device met all
acceptance criteria. |
Table 2: Summary of Animal Validation Studies
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9
Human Factors Evaluation:
Human Factors process conducted for the subject devices included the following activities:
- Known use-related issues for predicate devices similar to the subject devices O were analyzed using post-market data and the MAUDE database. All identified userelated issues that are relevant to the use of the subject devices were documented in the risk analvsis.
- A Comparative Task Analysis (CTA) was conducted to describe all aspects of the user- O device interaction, through the breakdown of steps into user tasks, and to provide an analysis of comparison to the predicate for each task.
- A Use-Related Risk Analysis (URRA) was conducted to identify all use-related risks for O each user task identified as New or Modified from the predicate in the CTA.
- Formative usability evaluations were conducted during the development process to O inform the device user interface design and confirm assessment of use-related risks.
- Summative usability validations were conducted on the subject SP SureForm 45 Staplers O Reloads and were found to be safe and effective for the intended users, uses, and use environments.
Summary: Based on the indications for use, technological characteristics, and performance data, the subject device, SP SureForm 45 Staplers and Reloads are substantially equivalent to the predicate devices, the SureForm 45 Staplers Reloads.
Image /page/9/Picture/10 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "I". The font is sans-serif and the letters are evenly spaced. The word is centered in the image.