(143 days)
The Intuitive Surgical EndoWrist Introducer, 5Fr is intended to be used as a conduit through which compatible surgical laser fibers may be held and directed in conjunction with da Vinci and da Vinci S surgical systems. At this time, only the following surgical laser systems are compatible for use with the da Vinci S systems: Lisa Laser Revolix Jr. and Laserscope Aura -XP systems. It may also be used to perform blunt dissection when the laser fiber is retracted or not within the instrument.
This 510(k) is being submitted for a modified EndoWrist® instrument, the EndoWrist Introducer, 5Fr, to be utilized with surgical lasers delivering energy through flexible laser fibers. This submission also includes the product labeling for the new instrument. There are no changes in the design, technology, materials, manufacturing, performance, specifications or method of use for the da Vinci Surgical System or the other predicate devices listed.
The Introducer, 5Fr is used with the da Vinci Surgical Systems to hold and position compatible laser fibers used in conjunction with surgical laser systems such as the Laserscope Aura XP or Lisa Laser RevoLix Jr. Laser Systems during indicated surgical procedures. The instrument will also facilitate blunt tissue dissection when the fiber is not present or is retracted into the instrument. The "Introducer, 5Fr" instrument may herein be referred to as the "Introducer" or the "Introducer Instrument".
Similar to currently used minimally invasive endoscopic or laparoscopic surgical instruments, the Introducer Instrument will only hold and position surgical laser fibers and will not directly conduct laser energy.
This Intuitive Surgical instrument is compatible with the previously cleared da Vinci and da Vinci S Endoscopic Instrument Control Systems Models IS1200 and IS2000. To address use of the Introducer Instrument with surgical laser systems, a supplemental Instructions for Use sheet is included with each Introducer instrument.
The provided text describes the 510(k) submission for the Intuitive Surgical® EndoWrist® Introducer, 5Fr Instrument. However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the way a clinical trial or performance study would typically be described with quantitative metrics.
Instead, this submission focuses on establishing substantial equivalence to predicate devices through design analysis, comparison, and bench testing, rather than a clinical performance study with specific quantitative acceptance criteria for the device's function.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in the available information and explicitly state when information is not present.
Acceptance Criteria and Device Performance Study for Intuitive Surgical® EndoWrist® Introducer, 5Fr
The provided document, a 510(k) summary (K072627), does not detail specific quantitative acceptance criteria or a clinical study proving the device meets performance metrics in the format typically used for direct measurement of diagnostic or therapeutic efficacy. Instead, it establishes substantial equivalence to predicate devices.
The "Performance Data" section states: "Design analysis and comparison, as well as bench testing, have been conducted to confirm that basic functional characteristics of the subject devices are substantially equivalent to the predicate devices cited, and that design output meets the design input requirements." This implies that the 'acceptance criteria' were related to maintaining the functional characteristics of the predicate device and meeting internal design input requirements through engineering verification.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain functional characteristics of predicate devices (e.g., proper manipulation, holding, and positioning of instruments). | "Design analysis and comparison, as well as bench testing, have been conducted to confirm that basic functional characteristics of the subject devices are substantially equivalent to the predicate devices cited..." The device functions as an "Introducer, 5Fr" to hold and position compatible laser fibers and facilitate blunt tissue dissection. The "distal tip lumen was modified to accept a laser fiber and a laser fiber sheath, and the distal tip will no longer accept the cautery accessories, but is now shaped to facilitate blunt dissection of tissue when the laser is not activated." It is compatible with the da Vinci and da Vinci S Endoscopic Instrument Control Systems. |
| Meet design input requirements. | "...and that design output meets the design input requirements." |
| Compatibility with da Vinci Surgical Systems. | "This Intuitive Surgical instrument is compatible with the previously cleared da Vinci and da Vinci S Endoscopic Instrument Control Systems Models IS1200 and IS2000." |
| Retention of manufacturing, material, and sterilization processes. | "There is no change in the instrument technology, materials, manufacturing or sterilization processes, common instrument requirements or compatibility with the da Vinci Surgical Systems." |
| Elimination of cautery function components. | "The cautery function has been removed, as the Introducer Instrument is intended to only hold and position compatible laser fibers. Consequently, all electrical contacts, wiring and other components related to the cautery function have been removed." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "bench testing" but does not specify a quantitative sample size for any test set.
- Data provenance is not mentioned, but given the nature of a 510(k) submission for a medical device manufacturer based in Sunnyvale, California (USA), it is highly likely that testing was conducted internally or by contractors within the USA. The testing appears to be prospective (new tests performed for this submission) rather than retrospective analysis of existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not mentioned. The study described is an engineering and comparative analysis, not one involving expert review for ground truth establishment in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. This type of adjudication is typically used in studies involving subjective interpretation (e.g., image reading), which is not the nature of the "design analysis and bench testing" described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is an surgical instrument (an "Introducer"), not an AI or diagnostic imaging device that would typically involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical surgical instrument, not an algorithm. The "da Vinci Surgical Systems" themselves are computer-controlled, but this submission is for a specific instrument attachment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this engineering assessment appears to be the established functional performance and design specifications of the predicate devices, along with internal engineering design input requirements.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI-based device that would typically have a "training set."
9. How the ground truth for the training set was established
- Not applicable. (See #8)
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Section II
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: K072627
| Date | January 30, 2008 |
|---|---|
| Submitter | Intuitive Surgical, Inc.950 Kifer RoadSunnyvale, CA 94086 |
| ER Number | 2955842 |
| Contact | Michael YramateguiSr. Director, Regulatory AffairsTelephone: (408) 523 - 2145Fax: (408) 523 - 1390E-mail: mike.yramategui@intusurg.com |
| SubjectDevice | Trade Name(s):Intuitive Surgical® EndoWrist® Introducer, 5Fr InstrumentClassification Name:System, Surgical, Computer Controlled Instrument (21 CFR 876.1500)Common Name:Endoscopic Instrument Control System, Endoscopic Instruments and AccessoriesDevice Class:Intuitive Surgical® da Vinci® Surgical System and Endoscopic Instruments: Class II, NAY, System, Surgical, Computer Controlled Instrument |
11:
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| PredicateDevices | Intuitive Surgical da Vinci® and da Vinci® S™ Surgical System andEndoscopic Instruments(legally marketed under K990144, K002489, K011002,K013416, K021036, K022574, K040237, K43153, K043288,K050404, K050369, K050802 and K063220) |
|---|---|
| Intuitive Surgical EndoWrist® Monopolar Cautery Instrument(legally marketed under K990144, K013416, K021036, andK050369) | |
| Laserscope Aura XP™ Series Surgical Laser System & Accessories(legally marketed under K024206) | |
| Lisa Laser RevoLix™ Family of Laser Systems including theRevoLix and RevoLix Jr.(legally marketed under K051167) | |
| DeviceDescription | This 510(k) is being submitted for a modified EndoWrist®instrument, the EndoWrist Introducer, 5Fr, to be utilized withsurgical lasers delivering energy through flexible laser fibers. This |
submission also includes the product labeling for the new instrument. There are no changes in the design, technology, materials, manufacturing, performance, specifications or method of use for the da Vinci Surgical System or the other predicate devices listed.
EndoWrist® Introducer, 5Fr
The Introducer, 5Fr is used with the da Vinci Surgical Systems to hold and position compatible laser fibers used in conjunction with surgical laser systems such as the Laserscope Aura XP or Lisa Laser RevoLix Jr. Laser Systems during indicated surgical procedures. The instrument will also facilitate blunt tissue dissection when the fiber is not present or is retracted into the instrument. The "Introducer, 5Fr" instrument may herein be referred to as the "Introducer" or the "Introducer Instrument".
Similar to currently used minimally invasive endoscopic or laparoscopic surgical instruments, the Introducer Instrument will only hold and position surgical laser fibers and will not directly conduct laser energy.
11
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Device This Intuitive Surgical instrument is compatible with the Description previously cleared da Vinci and da Vinci S Endoscopic (continued) Instrument Control Systems Models IS1200 and IS2000. To address use of the Introducer Instrument with surgical laser systems, a supplemental Instructions for Use sheet is included with each Introducer instrument. EndoWrist® Introducer, 5Fr Intended Use The Intuitive Surgical EndoWrist Introducer, 5Fr is intended to be used as a conduit through which compatible surgical laser fibers may be held and directed in conjunction with da Vinci and da Vinci S surgical systems. At this time, only the following surgical laser systems are compatible for use with the da Vinci and da Vinci S systems: Lisa Laser Revolix Jr. and Laserscope Aura-XP systems. It may also be used to perform blunt dissection when the laser fiber is retracted or not within the instrument. EndoWrist® Introducer, 5Fr Comparison to Predicate The predicate device, the 5mm Monopolar Cautery Instrument, Device was modified to meet the requirements of the Introducer Instrument. The cautery function has been removed, as the Introducer Instrument is intended to only hold and position compatible laser fibers. Consequently, all electrical contacts, wiring and other components related to the cautery function have been removed. The distal tip lumen was modified to accept a laser fiber and a laser fiber sheath, and the distal tip will no longer accept the cautery accessories, but is now shaped to facilitate blunt dissection of tissue when the laser is not activated. There is no change in the instrument technology, materials, manufacturing or sterilization processes, common instrument requirements or compatibility with the da Vinci Surgical Systems.
{3}------------------------------------------------
| Comparison toPredicateDevice(continued) | Labeling modification for the Introducer Instrument consists ofupdated box labeling and the addition of a supplement to theInstrument Instructions For Use which describes the use of theinstrument with surgical laser systems. |
|---|---|
| da Vinci® Surgical Systems, Laserscope Aura XP™ SeriesSurgical Laser System, Lisa Laser RevoLix Jr. Surgical LaserSystem | |
| There are no changes in the design, technology, materials,manufacturing, performance, specifications, or method of usefor the Intuitive da Vinci Surgical Systems and there are nochanges intended for surgical laser systems which utilize fiberscompatible with the Introducer Instrument, or the fibersthemselves. | |
| There will be no modifications to labeling for the surgical lasersystems or the compatible fibers. | |
| TechnologicalCharacteristics | The technological characteristics of the subject devices are identicalto the predicate devices. |
| PerformanceData | Design analysis and comparison, as well as bench testing, havebeen conducted to confirm that basic functional characteristics ofthe subject devices are substantially equivalent to the predicatedevices cited, and that design output meets the design inputrequirements. |
| Conclusion | Based upon the technical information, intended use andperformance information provided in this pre-market notification,the EndoWrist® Introducer, 5Fr has been shown to be substantiallyequivalent to the current legally marketed predicate device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
FEB -- 7 ZUUS
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Intuitive Surgical, Inc. % Mr. Michael H. Yramategui Senior Director, Regulatory Affairs 950 Kifer Road Sunnyvale, California 94086
Re: K072627
Trade/Device Name: Intuitive Surgical® Endoscopic Instrument Control System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NA Y Dated: January 10, 2008 Received: January 14, 2008
Dear Mr. Yramategui:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 – Mr. Michael H. Yramategui
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Protmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.
Mark N. Wilkinson
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section III
Indications for Use
510(k) Number (if known): K072627
Intuitive Surgical® EndoWrist Introducer, 5Fr Device Name: Indications For Use:
The Intuitive Surgical EndoWrist Introducer, 5Fr is intended to be used as a conduit through which compatible surgical laser fibers may be held and directed in conjunction with da Vinci and da Vinci S surgical systems. At this time, only the following surgical laser systems are compatible for use with the da Vinci S systems: Lisa Laser Revolix Jr. and Laserscope Aura -XP systems. It may also be used to perform blunt dissection when the laser fiber is retracted or not within the instrument.
Prescription Use X (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)
Deo Of
2/6/08
Division of Ge and Neurologica
510(k) Number
C6
Page 1 of 1
Intuitive Surgical® da Vinci® Surgical System Introducer, 5Fr Instrument
CONFIDENTIAL
510(k) Section III, Page 1 of 1
§ 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.