(95 days)
Not Found
No
The summary describes a mechanical surgical stapler controlled by a surgeon, with no mention of AI or ML in the device description, intended use, or performance studies.
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 described as a surgical stapler intended for resection, transection, and creation of anastomoses, which are surgical interventions, not diagnostic procedures.
No
The device description clearly states it is a surgical stapler and reload, which are physical hardware components containing implantable staples. The summary also details bench testing, transit testing, biocompatibility testing, and simulated clinical use testing, all of which are associated with hardware devices.
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 of vasculature and tissue 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 "fully wristed, articulating, surgical stapler" used with a robotic surgical system. It physically manipulates and cuts tissue within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health. This device does not perform any such analysis of specimens.
The device is clearly a surgical instrument used for performing procedures in vivo (within a living organism), not in vitro (in glass, or outside the body).
N/A
Intended Use / Indications for Use
The Intuitive Surgical 8mm SureForm 30 staplers and reloads and accessories are intended to be used with a compatible da Vinci Surgical system for resection of vasculature and tissue and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
Product codes
NAY, GDW, GAG
Device Description
The 8mm SureForm 30 Staplers are fully wristed, articulating, surgical staplers which are designed for use exclusively with a compatible da Vinci Surgical System (herein referred to as "system"). The staplers are controlled by the surgeon using the Surgeon Console of the system. They are intended for resection, transection and/or creation of anastomoses in surgery and achieves its intended use by placing multiple staggered rows of implantable staples in the target tissue (stapling) followed by cutting of the target tissue along the middle of the staple line (transection).
The 8mm SureForm 30 Reloads consist of a single-use cartridge that contains four staggered rows of implantable titanium alloy (Ti3Al2.5V) staples. The implantable staples are provided in various staple leg lengths (Gray, White, Blue) to accommodate various tissue types.
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)
The subject 8mm SureForm 30 Staplers and 8mm SureForm 30 Reloads underwent a series of tests to evaluate the impact of the modifications made to the predicate devices. Testing was performed with a compatible da Vinci surgical system. Testing included design verification, compatibility verification, transit verification, biocompatibility, design validation, and human factors. The successful completion of testing demonstrated that the subject 8mm SureForm 30 Staplers and 8mm SureForm 30 Reloads design outputs continue to meet design inputs.
Design Verification
Bench testing was performed to verify functional design outputs met the functional design inputs. The design verification in this section addressed the following:
- Mechanical properties such as critical dimensions, mass, materials, and finish
- Mechanical requirements such as range of motion, friction and offset
- Force limits
- Reliability
Transit Verification
Transit testing was performed in accordance with ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems.
Biocompatibility
Biocompatibility testing was completed in accordance with the following standards and guidance documents:
- . FDA Guidance: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", issued September 2020
- . ISO 10993-1:2018 Biological evaluation of medical devices
Design Validation
Simulated clinical use testing was performed to validate that the product specifications continue to meet the user's needs and intended use.
Human Factors
A summative usability study was conducted to assess the use-related risks associated with the device user interface of the 8mm SureForm 30 Staplers and 8mm SureForm 30 Reloads.
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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Image /page/0/Picture/0 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.
September 10, 2024
Intuitive Surgical, Inc. Kristy Ann Darling Regulatory Affairs Lead 1266 Kifer Road Sunnyvale, California 94086
Re: K241638
Trade/Device Name: 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY, GDW, GAG Dated: June 7, 2024 Received: August 13, 2024
Dear Kristy Ann Darling:
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 (OS) 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,
Digitally signed by Tek Tek N. N. Lamichhane -S Lamichhane -S Date: 2024.09.10 17:11:03 -04'00' Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control
and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
Enclosure
4
Indications for Use
510(k) Number (if known) K241638
Device Name 8mm SureForm 30 Curved-Tip Stapler 8mm SureForm 30 Stapler 8mm SureForm 30 Reloads
Indications for Use (Describe)
The Intuitive Surgical 8mm SureForm 30 staplers and reloads and accessories are intended to be used with a compatible da Vinci Surgical system for resection of vasculature and tissue and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary (21 CFR § 807.92)
I. Submitter Information
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|------------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristy Ann Darling, RAC
Regulatory Affairs Lead
kristyann.darling@intusurg.com
+1 (408) 528-2644 |
| Date Summary Prepared: | September 05, 2024 |
| II.
Subject Device | |
| Trade Name: | 8mm SureForm 30 Curved-Tip Stapler
8mm SureForm 30 Stapler
8mm SureForm 30 Reloads |
| Common Name: | Stapler, surgical
Stapler, implantable
System, surgical, computer controlled instrument |
| Classification: | II |
| Regulation: | 21 CFR 876.1500 Endoscope and Accessories
21 CFR 878.4740 Surgical Stapler
21 CFR 878.4750 Implantable Staple |
| Product Code: | NAY, Endoscope and Accessories
GAG, Stapler, Surgical
GDW, Implantable Staple |
III. Predicate Device Information
| Predicate Devices: | 8mm SureForm 30 Curved-Tip Stapler, K211997 & K222839
8mm SureForm 30 Stapler, K211997 & K222839
8mm SureForm 30 Reloads, K211997 & K222839 |
| -------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Image /page/5/Picture/7 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the "I" in the word. The font is sans-serif and the letters are evenly spaced.
6
IV. Device Description
The 8mm SureForm 30 Staplers are fully wristed, articulating, surgical staplers which are designed for use exclusively with a compatible da Vinci Surgical System (herein referred to as "system"). The staplers are controlled by the surgeon using the Surgeon Console of the system. They are intended for resection, transection and/or creation of anastomoses in surgery and achieves its intended use by placing multiple staggered rows of implantable staples in the target tissue (stapling) followed by cutting of the target tissue along the middle of the staple line (transection).
The 8mm SureForm 30 Reloads consist of a single-use cartridge that contains four staggered rows of implantable titanium alloy (Ti3Al2.5V) staples. The implantable staples are provided in various staple leg lengths (Gray, White, Blue) to accommodate various tissue types. Table 1 outlines the specifications of the reloads.
| Table 1: Reload Specifications | |||
|---|---|---|---|
| Reloads | No. of rows | No. of Staples | Unformed Staple Leg |
| Length (mm) | |||
| 8mm SureForm 30 Gray Reload | 4 | 34 | 2.0 |
| 8mm SureForm 30 White Reload | 4 | 34 | 2.5 |
| 8mm SureForm 30 Blue Reload | 4 | 34 | 3.5 |
V. Indication for Use
The Intuitive Surgical 8mm SureForm 30 staplers and reloads and accessories are intended to be used with a compatible da Vinci Surgical system for resection of vasculature and tissue and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
VI. Technological Characteristics
The subject 8mm SureForm 30 Staplers and 8mm SureForm 30 Reloads are very similar to their predicate devices. They have the same intended use, same indication for use, same fundamental scientific technology, and similar technological characteristics as the predicate device. The modifications consist of a new alternate supplier for Tungsten material and corrective actions related to recall number Z-0340-2023. Results from performance data indicate that the 8mm SureForm 30 Staplers and 8mm SureForm 30 Reloads are substantially equivalent to their predicate devices.
Image /page/6/Picture/10 description: The image shows the word "INTUITIVE" in blue font. There is a small 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.
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| 8mm SureForm 30 Staplers | ||
|---|---|---|
| Attributes | Subject Device | |
| 8mm SureForm 30 Curved-Tip | ||
| Stapler, 8mm SureForm 30 Stapler | Predicate Device | |
| 8mm SureForm 30 Curved-Tip | ||
| Stapler, 8mm SureForm 30 Stapler | ||
| (K211997 & K222839) | ||
| Design | The subject staplers consist of | |
| Distal Jaw Assembly, Middle Shaft | ||
| and Proximal End. | ||
| Distal Jaw Assembly - modified | ||
| driver design to improve | ||
| robustness. | SIMILAR to subject device. | |
| Patient Contacting | ||
| Material | The subject device consists of the | |
| same patient contact material, with | ||
| the exception of the Tungsten | ||
| material sub-supplier | SIMILAR to subject device |
| 8mm SureForm 30 Reloads | ||
|---|---|---|
| Attributes | Subject Device | |
| 8mm SureForm 30 Reloads | Predicate Device | |
| 8mm SureForm 30 Reloads | ||
| (K211997 & K222839) | ||
| Retainer and Bottom | ||
| Cover | The Retainer and Bottom Cover | |
| were redesigned and repurposed | ||
| into Installation and Removal tools. | The Retainer and Bottom Cover | |
| protect the staples during shipping | ||
| and transportation. | ||
| Left: Image of | ||
| Installation Tool (shown | ||
| in orange) and Removal | ||
| Tool (shown in yellow) |
Right: Image of Retainer
(shown in orange) and
Bottom Cover (shown in
yellow) | Image: Installation Tool and Retainer for Subject Device | Image: Installation Tool and Retainer for Predicate Device |
| Reload Design | The reload cartridge contains
pushers, multiple staggered rows of
implantable staples and a stainless-
steel component called the switch.
Modified switch to reduce friction
and improve alignment during
reload installation. | SIMILAR to subject device. |
| Packaging | Modified primary packaging
dimensions to accommodate new
installation and removal tools. | SIMILAR to subject device. |
INTUITIVE
8
| 8mm SureForm 30 Reloads | ||
|---|---|---|
| Attributes | Subject Device | |
| 8mm SureForm 30 Reloads | Predicate Device | |
| 8mm SureForm 30 Reloads | ||
| (K211997 & K222839) | ||
| Instruction For Use | Added instructions on reload | |
| installation and removal. | SIMILAR to subject device | |
| Updated references to align with | ||
| redesigned and repurposed | ||
| components: Installation Tool | ||
| (previously a Retainer) and | ||
| Removal Tool (previously a Bottom | ||
| Cover) | ||
| New and modified warnings |
VII. Performance Data
The subject 8mm SureForm 30 Staplers and 8mm SureForm 30 Reloads underwent a series of tests to evaluate the impact of the modifications made to the predicate devices. Testing was performed with a compatible da Vinci surgical system. Testing included design verification, compatibility verification, transit verification, biocompatibility, design validation, and human factors. The successful completion of testing demonstrated that the subject 8mm SureForm 30 Staplers and 8mm SureForm 30 Reloads design outputs continue to meet design inputs.
Design Verification
Bench testing was performed to verify functional design outputs met the functional design inputs. The design verification in this section addressed the following:
- Mechanical properties such as critical dimensions, mass, materials, and finish
- Mechanical requirements such as range of motion, friction and offset
- Force limits
- Reliability
Transit Verification
Transit testing was performed in accordance with ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems.
Biocompatibility
Biocompatibility testing was completed in accordance with the following standards and guidance documents:
- . FDA Guidance: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", issued September 2020
- . ISO 10993-1:2018 Biological evaluation of medical devices
9
Design Validation
Simulated clinical use testing was performed to validate that the product specifications continue to meet the user's needs and intended use.
Human Factors
A summative usability study was conducted to assess the use-related risks associated with the device user interface of the 8mm SureForm 30 Staplers and 8mm SureForm 30 Reloads.
VIII. Conclusion
Based on the intended use, technological characteristics, and performance data, the subject 8mm SureForm 30 Staplers and 8mm SureForm 30 Reloads are substantially equivalent to the predicate devices.
Image /page/9/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.