(251 days)
Not Found
No
The summary describes a surgical instrument (hot shears) for cutting and coagulation, focusing on its compatibility with existing robotic surgical systems and its equivalence to a predicate device. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is used to cut and coagulate tissue during surgery, which directly treats the patient.
No
The device is an endoscopic instrument used for cutting and coagulation of tissue during surgery, not for diagnosing conditions.
No
The device description explicitly states it is an "endoscopic instrument" and a "single-use disposable endoscopic tool," 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 is for "endoscopic cutting and coagulation of tissue during surgery." This describes a surgical tool used on the patient's body during a procedure.
- Device Description: The description clearly states it's an "endoscopic instrument" and a "surgical tool."
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are used to diagnose diseases or conditions, monitor treatments, or screen for health issues by examining biological samples.
This device is a surgical instrument used for performing a procedure, not for diagnosing or analyzing samples.
N/A
Intended Use / Indications for Use
The Intuitive Surgical EndoWrist One Hot Shears Instrument is intended to be used with the da Vinci and da Vinci S Surgical Systems for endoscopic cutting and coagulation of tissue during surgery.
Product codes
NAY
Device Description
This 510(k) is being submitted for an endoscopic instrument, the EndoWrist One Hot Shears Instrument, to be used with the Intuitive Surgical da Vinci and da Vinci S Surgical Systems. The Intuitive Surgical EndoWrist® instrument family currently consists of resposable endoscopic tools including the predicate EndoWrist® Monopolar Curved Scissors Instrument. The subject Hot Shears instrument has the same intended use as the Monopolar Curved Scissors but is a single-use disposable endoscopic tool.
This Intuitive Surgical instrument will be compatible with the previously cleared da Vinci and da Vinci S Endoscopic Instrument Control Systems Models IS1200 and IS2000.
The EndoWrist One Hot Shears Instrument is identical in shape, function, activation, and use as the predicate reusable Monopolar Curved Scissors instrument. Specific design and material changes were made in order to create a functionally equivalent instrument intended only for a single surgical procedure. Additionally, the trade name has been updated from EndoWrist to EndoWrist One to hight the single-use characteristic of the new instrument.
The overall scissor shape and size of the Hot Shears are essentially identical to that of the Monopolar Curved Scissors. The proximal housing and chassis have the same physical dimensions as the predicate instrument, but are provided with a different color scheme and labeling to aid in identification.
The predicate Monopolar Curved Scissors instrument uses a sterile removable and disposable Tip Cover accessory which insulates the clevis portion of the distal instrument tip. This Tip Cover is provided as an accessory sciparate from the instrument. The subject Hot Shears incorporates a Tip Cover with the same function and insulating material directly into its assembly and the user receives the sterile instrument with the tip cover already in place on the distal tip.
The single-use Hot Shears Instrument is compatible for use with all electrosurgical generators already cleared for use with the reusable Monopolar Curved Scissors instrument.
The Hot Shears instrument interfaces with the da Vinci and da Vinci S surgical systems in an identical manner to the reusable instruments. Both reusable EndoWrist instruments and the single use Hot Shears are assigned a specific number of working lives, and the lives are decremented in exactly the same manner by the da Vinci Systems. The Hot Shears are assigned only one life, and the systems will not recognize the instrument after that one life is expired, ensuring that it cannot be used again with the da Vinci This is identical to the manner in which a reusable systems. instrument expires.
The EndoWrist One Hot Shears is provided to the customer sterile and packaged in a sealed tray and outer carton. The predicate Monopolar Curved Scissors is provided non-sterile, and the user is responsible for cleaning and sterilizing the instrument prior to each use.
Labeling updates for the Hot Shears Instrument consist of new instrument housing markings, new tray and box labeling and a new Instructions For Use.
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)
Design analysis and comparison, as well as bench testing, have been conducted to confirm that basic functional characteristics of the subject device are substantially equivalent to the predicate device cited, and that design output meets the design input requirements.
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.
0
082497
Section IV
MAY - 7 2009
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number:
| Date | August 28, 2008 |
|---|---|
| Submitter | Intuitive Surgical, Inc. |
| 950 Kifer Road | |
| Sunnyvale, CA 94086 | |
| ER Number | 2955842 |
| Contact | James Farnworth |
| Director, Regulatory Affairs | |
| Telephone: (408) 523 - 8687 | |
| Fax: (408) 523 - 1390 | |
| E-mail: james.farnworth@intusurg.com | |
| Subject Device | Trade Name(s): |
| Intuitive Surgical® EndoWrist® One Hot Shears Instrument | |
| Classification Name: | |
| System, Surgical, Computer Controlled Instrument (21 CFR 876.1500) | |
| Common Name: | |
| Endoscopic Instrument Control System, | |
| Endoscopic Instruments and Accessories | |
| Device Class: | |
| Intuitive Surgical da Vinci Surgical System and Endoscopic Instruments: Class II, NAY, System, Surgical, Computer Controlled Instrument | |
| Predicate Devices | Intuitive Surgical EndoWrist Monopolar Curved Scissors Instrument, K050005 |
| Device | This 510(k) is being submitted for an endoscopic instrument, the |
P. 1/3
1
Description
EndoWrist One Hot Shears Instrument, to be used with the Intuitive Surgical da Vinci and da Vinci S Surgical Systems. The Intuitive Surgical EndoWrist® instrument family currently consists of resposable endoscopic tools including the predicate EndoWrist® Monopolar Curved Scissors Instrument. The subject Hot Shears instrument has the same intended use as the Monopolar Curved Scissors but is a single-use disposable endoscopic tool.
This Intuitive Surgical instrument will be compatible with the previously cleared da Vinci and da Vinci S Endoscopic Instrument Control Systems Models IS1200 and IS2000.
Indications for The Intuitive Surgical EndoWrist One Hot Shears Instrument is Use intended to be used with the da Vinci and da Vinci S Surgical Systems for endoscopic cutting and coagulation of tissue during surgery.
Comparison to Predicate Device
The EndoWrist One Hot Shears Instrument is identical in shape, function, activation, and use as the predicate reusable Monopolar Curved Scissors instrument. Specific design and material changes were made in order to create a functionally equivalent instrument intended only for a single surgical procedure. Additionally, the trade name has been updated from EndoWrist to EndoWrist One to hight the single-use characteristic of the new instrument.
The overall scissor shape and size of the Hot Shears are essentially identical to that of the Monopolar Curved Scissors. The proximal housing and chassis have the same physical dimensions as the predicate instrument, but are provided with a different color scheme and labeling to aid in identification.
The predicate Monopolar Curved Scissors instrument uses a sterile removable and disposable Tip Cover accessory which insulates the clevis portion of the distal instrument tip. This Tip Cover is provided as an accessory sciparate from the instrument. The subject Hot Shears incorporates a Tip Cover with the same function and insulating material directly into its assembly and the user receives the sterile instrument with the tip cover already in place on the distal tip.
The single-use Hot Shears Instrument is compatible for use with all electrosurgical generators already cleared for use with the reusable
2
Monopolar Curved Scissors instrument.
The Hot Shears instrument interfaces with the da Vinci and da Vinci S surgical systems in an identical manner to the reusable instruments. Both reusable EndoWrist instruments and the single use Hot Shears are assigned a specific number of working lives, and the lives are decremented in exactly the same manner by the da Vinci Systems. The Hot Shears are assigned only one life, and the systems will not recognize the instrument after that one life is expired, ensuring that it cannot be used again with the da Vinci This is identical to the manner in which a reusable systems. instrument expires.
The EndoWrist One Hot Shears is provided to the customer sterile and packaged in a sealed tray and outer carton. The predicate Monopolar Curved Scissors is provided non-sterile, and the user is responsible for cleaning and sterilizing the instrument prior to each use.
Labeling updates for the Hot Shears Instrument consist of new instrument housing markings, new tray and box labeling and a new Instructions For Use.
| Technological
Characteristics | The technological characteristics of the subject devices are identical
to the predicate devices. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Data | Design analysis and comparison, as well as bench testing, have
been conducted to confirm that basic functional characteristics of
the subject device are substantially equivalent to the predicate
device cited, and that design output meets the design input
requirements. |
| Conclusion | Based upon the technical information, Indications for Use and
performance information provided in this pre-market notification,
the EndoWrist One Hot Shears Instrument described herein has
been shown to be substantially equivalent to the current legally
marketed predicate device. |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Public Health Service
MAY - 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Intuitive Surgical, Inc. % Ms. James Farnworth Director, Regulatory Affairs 950 Kifer Road Sunnyvale, California 94086
Re: K082497
Trade/Device Name: Intuitive Surgical® EndoWrist® One Hot Shears Instrument Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NAY Dated: March 26, 2009 Received: March 27, 2009
Dear Ms. Farnworth:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at
4
Page 2 - Ms. James Farnworth
(240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Daniel Keane
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K082497
Intuitive Surgical® EndoWrist® One Hot Shears Instrument Device Name:
Indications For Use:
The Intuitive Surgical EndoWrist One Hot Shears Instrument is intended to be used with the da Vinci and da Vinci S Surgical Systems for endoscopic cutting and coagulation of tissue during surgery,
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neike Oden for mkm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K082497
EndoWrist® One Hot Shears Instrument