(191 days)
Not Found
No
The summary describes a mechanical surgical stapler system and its reloads, focusing on its function, configurations, and performance testing (bench, animal, human factors). There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is used for resection and/or creation of anastomoses, which are therapeutic surgical procedures.
No
The device is a surgical stapler system used for resection and/or creating anastomoses, which are therapeutic and procedural functions, not diagnostic.
No
The device description clearly details physical components like a reusable surgical stapler instrument, single-use cartridges containing staples and a knife, and mentions mechanical and electrical requirements in performance testing, indicating it is a hardware device.
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, and Urologic surgery." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "reusable surgical stapler system" that "places multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue." This is a surgical instrument used for physical manipulation of tissue during surgery.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
The Intuitive Surgical EndoWrist® Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Surgical System (Model IS4000) for resection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatic use. The device can be used with staple line or tissue buttressing material.
Product codes (comma separated list FDA assigned to the subject device)
NAY, GDW
Device Description
The Intuitive Surgical IS4000 EndoWrist® Stapler 30 and Stapler 30 Reloads is a reusable surgical stapler system designed for use exclusively with the Intuitive da Vinci Surgical System (Model IS4000). It is intended for resection 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 Stapler 30 Instrument is a reusable, fully wristed articulating device offered in two configurations, a straight tip and a curved-tip. The Stapler 30 Reloads consist of a single use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife. The reloads are available in four configurations (Gray, White, Blue and Green) 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
adult and 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)
Performance data (bench and animal testing) demonstrate that the subject devices are substantially equivalent to the predicate devices and that the design output meets the design input requirements. The testing included dimensional measurements, mechanical and functional verification, simulated use in animal models, and human factors assessment.
Bench Testing:
The subject devices, Stapler 30 Instrument and Stapler 30 Reloads, were subjected to a series of bench tests to evaluate the performance and to demonstrate that the design outputs meet the input requirements. The design verification testing included:
- Physical Specifications
- Mechanical Requirements
- Electrical Requirements
- User Interface Requirements
- Equipment Interface Requirements
Animal Validations:
A series of tests were performed using simulated clinical models (animal) to evaluate the performance of the subject devices, IS4000 EndoWrist® Stapler 30 and Stapler 30 Reloads. This included Animal Survival Studies, Staple Line Performance and Formation, Buttress Material Compatibility Testing, Design Validation Testing, Burst Pressure Testing, and SmartClamp™ evaluation. A side-by-side comparison between the subject and predicate devices (IS4000 EndoWrist® Stapler 45 and Stapler 45 Reloads and the ENDOPATH Endocutter with Gray Cartridge was performed in the Animal Survival Studies, Staple Line Performance and Formation, and Burst Pressure Testing to demonstrate substantial equivalence between the subject and predicate devices. Buttress Material Compatibility Testing, SmartClamp evaluation, 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.
Human Factors Evaluation:
As part of the Usability Engineering Process for the Stapler 30 and Stapler 30 Reloads, the Usability Risk Analysis was updated to identify any new usability characteristics related to safety, as well as foreseeable hazards and hazardous situations. All risks were assessed as having "Tolerable" or "Broadly Acceptable" pre-mitigated risk profiles. As a result, no further usability testing was conducted to evaluate the safety and usability of the subject devices.
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.
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).
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked slightly offset from each other. The profiles are simple and abstract, with a flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2016
Intuitive Surgical, Inc. Mr. Manish Patel Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, CA 94086
Re: K152421
Trade/Device Name: IS4000 EndoWrist Stapler 30 and Stapler 30 Reloads Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, GDW Dated: February 1, 2016 Received: February 2, 2016
Dear Mr. Patel:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jennifer R. Stevenson -A
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
| 510(k) Number (if known) | K152421 |
|---|---|
| To be assigned |
Device Name
IS4000 EndoWrist® Stapler 30 and Stapler 30 Reloads
Indications for Use (Describe)
The Intuitive Surgical EndoWrist® Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Surgical System (Model IS4000) for resection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatic use. The device can be used with staple line or tissue buttressing material.
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.
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Sarvices (301) 443-6740 EF
Image /page/2/Picture/22 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font and is in all caps. Below that is the word "SURGICAL" in a smaller font with the registered trademark symbol.
3
510(k) Summary 7
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Manish Patel
Sr. Regulatory Affairs Specialist
Phone Number: 408-523-2185
Fax Number: 408-523-8907
Email: manish.patel@intusurg.com |
| Date Summary Prepared: | August 24, 2015 |
| Trade Name: | IS4000 EndoWrist® Stapler 30 and Stapler 30 Reloads |
| Common Name: | Endoscope and accessories; Surgical Stapler and
implantable staples |
| Classification: | Class II
21 CFR 876.1500, Endoscope and Accessories
21 CRF 878.4750, Implantable Staple |
| Product Codes: | NAY (Endoscope and accessories)
GDW (Implantable Staple) |
| Classification Advisory
Committee: | General and Plastic Surgery |
| Predicate Device: | 1. IS4000 EndoWrist® Stapler 45 and Stapler 45 Reloads
K140553 (primary) |
| | 2. ENDOPATH Endocutter with Gray Cartridge -
K033269 (secondary) |
Device Description:
The Intuitive Surgical IS4000 EndoWrist® Stapler 30 and Stapler 30 Reloads is a reusable surgical stapler system designed for use exclusively with the Intuitive da Vinci Surgical System (Model IS4000). It is intended for resection 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 Stapler 30 Instrument is a reusable, fully wristed articulating device offered in two configurations, a straight tip and a curved-tip. The Stapler 30 Reloads consist of a single
4
use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife. The reloads are available in four configurations (Gray, White, Blue and Green) to accommodate tissues of various thicknesses (e.g., lung, stomach, and bowel).
Intended Use:
The IS4000 EndoWrist® Stapler 30 and Stapler 30 Reloads are intended to resect, transect and/or create anastomoses in surgery.
Indications for Use:
The Intuitive Surgical EndoWrist® Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Surgical System (Model IS4000) 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.
Technological Characteristics:
The subject devices, IS4000 EndoWrist® Stapler 30 and Stapler 30 Reloads, are technologically very similar to the primary predicate devices, IS4000 EndoWrist" Stapler 45 and Stapler 45 Reloads (cleared under K140553). They have the same architecture design as the predicate except for differences like shorter staple line length (30 mm on the subject device vs. 45 mm on the predicate), addition of the curved-tip configuration for the instrument, and use of a Gray color reload with shorter formed staple height.
Performance Data:
Performance data (bench and animal testing) demonstrate that the subject devices are substantially equivalent to the predicate devices and that the design output meets the design input requirements. The testing included dimensional measurements, mechanical and functional verification, simulated use in animal models, and human factors assessment.
Bench Testing:
The subject devices, Stapler 30 Instrument and Stapler 30 Reloads, were subjected to a series of bench tests to evaluate the performance and to demonstrate that the design outputs meet the input requirements. The design verification testing included:
- Physical Specifications ●
- Mechanical Requirements ●
- Electrical Requirements ●
- User Interface Requirements ●
- Equipment Interface Requirements
Image /page/4/Picture/18 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in a sans-serif font, with a small yellow circle above the "I". Below "INTUITIVE" is the word "SURGICAL" in a smaller font, followed by the registered trademark symbol.
5
Animal Validations:
A series of tests were performed using simulated clinical models (animal) to evaluate the performance of the subject devices, IS4000 EndoWrist® Stapler 30 and Stapler 30 Reloads. This included Animal Survival Studies, Staple Line Performance and Formation, Buttress Material Compatibility Testing, Design Validation Testing, Burst Pressure Testing, and SmartClamp™ evaluation. A side-by-side comparison between the subject and predicate devices (IS4000 EndoWrist® Stapler 45 and Stapler 45 Reloads and the ENDOPATH Endocutter with Gray Cartridge was performed in the Animal Survival Studies, Staple Line Performance and Formation, and Burst Pressure Testing to demonstrate substantial equivalence between the subject and predicate devices. Buttress Material Compatibility Testing, SmartClamp evaluation, 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.
Human Factors Evaluation:
As part of the Usability Engineering Process for the Stapler 30 and Stapler 30 Reloads, the Usability Risk Analysis was updated to identify any new usability characteristics related to safety, as well as foreseeable hazards and hazardous situations. All risks were assessed as having "Tolerable" or "Broadly Acceptable" pre-mitigated risk profiles. As a result, no further usability testing was conducted to evaluate the safety and usability of the subject devices.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the subject devices, IS4000 EndoWrist® Stapler 30 and Stapler 30 Reloads are substantially equivalent to the predicate devices, the IS4000 EndoWrist Stapler 45 and Stapler 45 Reloads and the ENDOPATH Endocutter with Gray Cartridge.
Image /page/5/Picture/8 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, with the registered trademark symbol next to it. There is a yellow dot above the word "INTUITIVE".