(177 days)
Not Found
No
The document describes a surgical stapler instrument used with a robotic surgical system. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the mechanical function of stapling and cutting tissue.
Yes.
The device is described as "fully wristed, articulating, surgical staplers" intended for "resection, transection and/or creation of anastomoses in surgery," which are therapeutic actions.
No
The device is a surgical stapler intended for resection and/or creation of anastomoses, which are therapeutic actions rather than diagnostic ones.
No
The device description explicitly states it is a "fully wristed, articulating, surgical stapler" and describes physical components like "implantable titanium alloy (Ti3A12.5V) staples" and "single-use cartridge". This indicates it is a hardware device with mechanical components, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a "fully wristed, articulating, surgical stapler" used for "resection, transection and/or creation of anastomoses in surgery." It physically manipulates tissue within the body.
- Intended Use: The intended use is for surgical procedures involving cutting and joining tissue. It does not involve testing samples outside the body.
Therefore, this device falls under the category of a surgical instrument used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with a compatible da Vinci Surgical System for resection and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The Intuitive Surgical EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with a compatible da Vinci Surgical System for resection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediativ use. The device can be used with staple line or tissue buttressing material.
The Intuitive Surgical SureForm 60 Reloads and accessories are intended to be used with a compatible da Vinci System for resection, transection 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).
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).
The Intuitive Surgical 8 mm SureForm 30 Curved-Tip and 8 mm SureForm 30 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.
The EndoWrist Stapler 30 Staplers and Reloads, EndoWrist Stapler 45 Staplers and Reloads, SureForm 45 Staplers and Reloads, SureForm 60 Stapler and Reloads, and 8 mm SureForm 30 Staplers and Reloads all have the identical intended use to resect, transect and/or create anastomoses in surgery.
Product codes (comma separated list FDA assigned to the subject device)
NAY, GDW, GAG
Device Description
The Intuitive Surgical EndoWrist Stapler 30 Staplers, EndoWrist Stapler 45 Staplers, SureForm 45 Staplers, SureForm 60 Stapler, and 8 mm SureForm Staplers are fully wristed, articulating, surgical staplers and are designed for use exclusively with the Intuitive Surgical da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200 Systems). The staplers are controlled by the surgeon using the Surgeon Console of the IS4000/IS4200 Systems. They are intended for resection, transection and/or creation of anastomoses in surgery. The staplers achieve their 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 Reloads consist of a single-use cartridge that contains multiple staggered rows of implantable titanium alloy (Ti3A12.5V) staples. The reloads are sterile, single use devices that are offered in various configurations by product family. Each color represents a different staple leg height and tissue gap for use with various tissue thicknesses. Table 1Reload Specifications outlines the specifications of the reloads.
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
adult and pediatric use
Intended User / Care Setting
Surgeon, General, Thoracic, Gynecologic, Urologic, and Pediatric surgery
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)
Usability testing was conducted to demonstrate that surgeons can correctly select and safely use the device, according to the revised labeling. Testing met all acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K170508, K183224, K190999, K173721, K211997
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 16, 2023
Intuitive Surgical Inc Amrit Jaggi Senior Regulatory Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K222839
Trade/Device Name: EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY, GDW, GAG Dated: February 22, 2023 Received: February 22, 2023
Dear Amrit Jaggi:
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.
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
1
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 (OS) 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 mediation-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,
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.03.16
15:07:08 -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
2
Indications for Use
510(k) Number (if known)
Device Name
Endo Wrist Stapler 45 System, Endo Wrist Stapler 30 System, SureForm 45 System, 8 mm SureForm 30 System
Indications for Use (Describe)
The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with a compatible da Vinci Surgical System for resection and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The Intuitive Surgical EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with a compatible da Vinci Surgical System for resection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediativ use. The device can be used with staple line or tissue buttressing material.
The Intuitive Surgical SureForm 60 Reloads and accessories are intended to be used with a compatible da Vinci System for resection, transection 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).
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).
The Intuitive Surgical 8 mm SureForm 30 Curved-Tip and 8 mm SureForm 30 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 K222839
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- 510(K) SUMMARY K222839
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510(k) Summary As Required by 21 CFR 807.92(c))
| Submitter: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Amrit Jaggi
Senior Regulatory Specialist
Phone Number: 949-690-8799
Fax Number: 408-523-8907 |
| Date Prepared: | March 13, 2023 |
| Trade Name: | EndoWristTM Stapler 30 Curved-Tip Stapler, EndoWrist Stapler 30
Stapler, EndoWrist Stapler 30 Reloads
EndoWrist Stapler 45 Stapler, EndoWrist Stapler 45 Curved-Tip
Stapler, EndoWrist Stapler 45 Reloads
SureFormTM 45 Stapler Curved-Tip, SureForm 45 Stapler, SureForm
45 Reloads
SureForm 60 Stapler, SureForm 60 Reloads
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler,
8 mm SureForm 30 Reloads |
| Common Name: | System, surgical, computer controlled instrument |
| Classification: | Class II
21 CFR 876.1500, Endoscope and Accessories
21 CRF 878.4750, Implantable Staple
21 CFR 878.4740, Surgical Stapler |
| Product Codes: | NAY (Endoscope and accessories)
GDW (Implantable Staple)
GAG (Stapler, Surgical) |
| Predicate Device: | EndoWristTM Stapler 30 Curved-Tip Stapler, EndoWrist Stapler 30
Stapler, EndoWrist Stapler 30 Reloads (K170508)
EndoWrist Stapler 45 Stapler, EndoWrist Stapler 45 Curved-Tip
Stapler, EndoWrist Stapler 45 Reloads (K170508)
SureForm 45 Staplers and Reloads (K183224 and K190999)
SureForm 60 Stapler, SureForm 60 Reloads (K173721)
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler,
8 mm SureForm 30 Reloads (K211997) |
Device Description
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5
INTUITIVE
The Intuitive Surgical EndoWrist Stapler 30 Staplers, EndoWrist Stapler 45 Staplers, SureForm 45 Staplers, SureForm 60 Stapler, and 8 mm SureForm Staplers are fully wristed, articulating, surgical staplers and are designed for use exclusively with the Intuitive Surgical da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200 Systems). The staplers are controlled by the surgeon using the Surgeon Console of the IS4000/IS4200 Systems. They are intended for resection, transection and/or creation of anastomoses in surgery. The staplers achieve their 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 Reloads consist of a single-use cartridge that contains multiple staggered rows of implantable titanium alloy (Ti3A12.5V) staples. The reloads are sterile, single use devices that are offered in various configurations by product family. Each color represents a different staple leg height and tissue gap for use with various tissue thicknesses. Table 1Reload Specifications outlines the specifications of the reloads.
| Reloads | No. of rows | No. of Staples | Unformed
Staple Leg
Length |
|-----------------------------------|-------------|----------------|----------------------------------|
| EndoWrist Stapler 45 White Reload | 6 row | 66 staples | 2.5 mm |
| EndoWrist Stapler 45 Blue Reload | 6 row | 66 staples | 3.5 mm |
| EndoWrist Stapler 45 Green Reload | 4 row | 44 staples | 4.3 mm |
| EndoWrist Stapler 30 Gray Reload | 6 row | 48 staples | 2.0 mm |
| EndoWrist Stapler 30 White Reload | 6 row | 48 staples | 2.5 mm |
| EndoWrist Stapler 30 Green Reload | 6 row | 48 staples | 4.3 mm |
| EndoWrist Stapler 30 Blue Reload | 6 row | 48 staples | 3.5 mm |
| SureForm 60 White Reload | 6 row | 90 staples | 2.5 mm |
| SureForm 60 Blue Reload | 6 row | 90 staples | 3.5 mm |
| SureForm 60 Green Reload | 6 row | 90 staples | 4.3 mm |
| SureForm 60 Black Reload | 6 row | 90 staples | 4.6 mm |
| SureForm 45 Gray Reload | 6 row | 66 staples | 2.0 mm |
| SureForm 45 White Reload | 6 row | 66 staples | 2.5 mm |
| SureForm 45 Blue Reload | 6 row | 66 staples | 3.5 mm |
| SureForm 45 Green Reload | 6 row | 66 staples | 4.3 mm |
| SureForm 45 Black Reload | 6 row | 66 staples | 4.6 mm |
| 8 mm SureForm 30 Gray Reload | 4 row | 34 staples | 2.0 mm |
| 8 mm SureForm 30 White Reload | 4 row | 34 staples | 2.5 mm |
| 8 mm SureForm 30 Blue Reload | 4 row | 34 staples | 3.5 mm |
Table 1 Reload Specifications
Intended Use:
The EndoWrist Stapler 30 Staplers and Reloads, EndoWrist Stapler 45 Staplers and Reloads, SureForm 45 Staplers and Reloads, SureForm 60 Stapler and Reloads, and 8 mm SureForm 30 Staplers and Reloads all have the identical intended use to resect, transect and/or create anastomoses in surgery.
6
Indications for Use
The Intuitive Surgical EndoWrist Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with a compatible da Vinci Surgical System for resection, transection of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The Intuitive Surgical EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with a compatible da Vinci Surgical System for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
The Intuitive Surgical SureForm 60, SureForm 60 Reloads and accessories are intended to be used with a compatible da Vinci 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).
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).
The Intuitive Surgical 8 mm SureForm 30 Curved-Tip and 8 mm SureForm 30 Reloads and accessories are intended to be used with a compatible da Vinci Surgical System for resection, transection of vasculature and tissue, and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric Surgery.
Comparison of Technological Characteristics
The subject devices are identical to their predicate devices in terms of design, technology, and performance specifications.
Performance Data:
Usability testing was conducted to demonstrate that surgeons can correctly select and safely use the device, according to the revised labeling. Testing met all acceptance criteria.
Summary:
The subject of this 510(k) is to add a contraindication to warn users against the use of these devices on tissues that are necrotic, friable, or have altered integrity. Based on the intended
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7
INTUITIVE
use, indications for use, technological characteristics, and performance data, the subject devices EndoWrist Stapler 30 Staplers and Reloads, EndoWrist Staplers and Reloads, SureForm 45 Staplers and Reloads, SureForm 60 Staplers and Reloads, and 8 mm SureForm 30 Staplers and Reloads are substantially equivalent to the currently marketed predicate devices.