(43 days)
The Intuitive Surgical® Stereo View Endoscopic System is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with the Intuitive Surgical® Endoscopic Instrument Control system during laparoscopic and thoracoscopic surgical procedures.
This Special 510(k) is being submitted to include an additional 8.5mm sized 3D Stereo Endoscope as an additional accessory model to the currently cleared 12mm 3D Stereo Endoscope. Both endoscopic models are for use with the Intuitive Surgical® Stereo View Endoscopic System and Intuitive Surgical da Vinci® and da VinciS™ Surgical Systems.
The 8.5mm 3D Stereo Endoscope was developed to provide an option for use of a smaller patient access port than the currently cleared 12mm 3D Stereo Endoscope, while maintaining stereo view capabilities.
There are no changes in the basic design, technology, materials or manufacturing processes for the 8.5mm Endoscope. The intended use for the subject device in conjunction with the Intuitive Surgical® Stereo View Endoscopic System (i.e., cameras, illumination sources, video processing equipment) is identical to the previously cleared intended use for the 12mm Endoscope in conjunction with the Intuitive Surgical® Stereo View Endoscopic System.
The provided 510(k) summary (K080155) describes the clearance of an 8.5mm 3D Stereo Endoscope as an additional accessory model to an already cleared 12mm 3D Stereo Endoscope. This submission is a Special 510(k), which is typically used for modifications to a cleared device that do not significantly alter its fundamental scientific technology or intended use. Consequently, the performance testing focuses on demonstrating substantial equivalence to the predicate device, rather than establishing entirely new performance criteria.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Device Performance (Result and comparison to predicate) |
|---|---|
| Basic functional characteristics equivalent to predicate device (e.g., image quality, illumination, stereo view capability, mechanical integrity, compatibility with existing systems) | "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." The document explicitly states: "The basic design and function of the subject 8.5mm Endoscope in conjunction with the Intuitive Surgical® Stereo View Endoscopic System is identical to the predicate system, except that an 8.5mm Endoscope is an available option to the 12mm Endoscope currently cleared." "There are no changes in the basic design, technology, materials or manufacturing processes for the 8.5mm Endoscope." "The technological characteristics of the subject device are identical to the predicate device." |
| Meeting design input requirements | "Design analysis and comparison, as well as bench testing, have been conducted...that design output meets the design input requirements." (Specific design input requirements are not detailed in this summary.) |
| Reduced diameter and shorter length impact on performance | The document states "The reduced diameter shaft of the endoscope is also shorter in length, but there are no changes in the compatibility of the 8.5mm Endoscope with the cameras, illumination sources or other components of the video processing system." This implies that the reduction in size did not adversely affect compatibility or functional performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the test set used in "bench testing" and "design analysis and comparison." Given the nature of a Special 510(k) for an accessory with similar technology, the testing likely involved a limited number of units to verify manufacturing consistency and functional equivalence.
- Data Provenance: Not explicitly stated. However, "bench testing" typically occurs in a lab setting, and "design analysis" is internal. This is not a clinical study, so patient data provenance is not applicable. The testing would be prospective in nature, referring to new tests conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. For this type of submission (modification to a device, demonstrating substantial equivalence through bench testing), expert consensus on a "ground truth" for a test set, as might be seen in AI/diagnostic device submissions, is not described. The evaluation relies on engineering and functional equivalence.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since this is not a diagnostic device involving human interpretation of results against a gold standard, an adjudication method for a test set is not relevant.
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
- MRMC Study: No. This is not an AI-assisted diagnostic device, nor is it a comparative effectiveness study involving human readers. It is a hardware component (endoscope) that is part of a larger surgical system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is an endoscope, a sensing and imaging component, not an algorithm. Its performance is intrinsically linked to its use by a human operator within the surgical system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the "bench testing" and "design analysis," the "ground truth" would be the design specifications and functional performance characteristics of the predicate 12mm 3D Stereo Endoscope. The testing aimed to show that the new 8.5mm endoscope met these established performance criteria or demonstrated equivalence across relevant parameters. This is an engineering/performance-based "ground truth."
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a hardware component. It does not employ machine learning or AI algorithms that would require a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device.
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Section II
MAR - 6 2008
କ୍ଷରୁ
5
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 | January 21, 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):8.5mm 3D Stereo EndoscopeClassification Name:Endoscope and Accessories (21 CFR 876.1500)Rigid Endoscope (21 CFR 876.1500)Gynecologic Laparoscope / Accessories (21 CFR 884.1720)Common Name:3-D Endoscope and AccessoriesDevice Class:Class II, GCJ, Laparoscope, General & Plastic Surgery |
| PredicateDevices | 12mm 3D Stereo Endoscope(FDA clearance under K001666) |
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K080155 Pg 2 of 3
9
| DeviceDescription | This Special 510(k) is being submitted to include an additional8.5mm sized 3D Stereo Endoscope as an additional accessorymodel to the currently cleared 12mm 3D Stereo Endoscope. Bothendoscopic models are for use with the Intuitive Surgical® StereoView Endoscopic System and Intuitive Surgical da Vinci® and daVinciS™ Surgical Systems. |
|---|---|
| The 8.5mm 3D Stereo Endoscope was developed to provide anoption for use of a smaller patient access port than the currentlycleared 12mm 3D Stereo Endoscope, while maintaining stereo viewcapabilities. | |
| There are no changes in the basic design, technology, materials ormanufacturing processes for the 8.5mm Endoscope. The intendeduse for the subject device in conjunction with the IntuitiveSurgical®Stereo View Endoscopic System (i.e., cameras,illumination sources, video processing equipment) is identical tothe previously cleared intended use for the 12mm Endoscope inconjunction with the Intuitive Surgical® Stereo View EndoscopicSystem. | |
| IntendedUse | The Intuitive Surgical® Stereo View Endoscopic System is intendedfor endoscopic viewing of internal surgery sites during minimallyinvasive surgery in the peritoneal cavity, thoracic cavity, andperitoneum. It is designed for use with the Intuitive Surgical®Endoscopic Instrument Control system during laparoscopic andthoracoscopic surgical procedures. |
| Comparison toPredicateDevice | The basic design and function of the subject 8.5mm Endoscope inconjunction with the Intuitive Surgical® Stereo View EndoscopicSystem is identical to the predicate system, except that an 8.5mmEndoscope is an available option to the 12mm Endoscope currentlycleared. The reduced diameter shaft of the endoscope is alsoshorter in length, but there are no changes in the compatibility ofthe 8.5mm Endoscope with the cameras, illumination sources orother components of the video processing system. It is built by thesame manufacturer as the 12mm endoscope, with the samematerials and manufacturing processes. |
| TechnologicalCharacteristics | The technological characteristics of the subject device are identicalto the predicate device. |
| PerformanceData | Design analysis and comparison, as well as bench testing, havebeen conducted to confirm that basic functional characteristics ofthe subject device are substantially equivalent to the predicatedevice cited, and that design output meets the design inputrequirements. |
| Conclusion | Based upon the technical information, intended use andperformance information provided in this Special 510(k), the8.5mm 3D Stereo Endoscope) described herein has been shown tobe substantially equivalent to current legally marketed predicatedevices. |
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K080155 PG 3 of 3
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Image /page/3/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Intuitive Surgical, Inc. % Mr. Michael H. Yramategui VP of Clinical and Regulatory Affairs 950 Kifer Road Sunnyvale, California 94086
MAR - 6 2008
Re: K080155
Trade/Device Name: Intuitive Sugical® Stereo View Endoscopic System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: February 21, 2008 Received: February 22, 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
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Page 2 - Mr. Michael H. Yramategui
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Postmarket 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 vours.
Mark M. Wilkerson
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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K080155 pg 1 of 11
Section III
Indications for Use
510(k) Number (if known):
Intuitive Surgical® Stereo View Endoscopic System Device Name:
Indications For Use:
The Intuitive Surgical® Stereo View Endoscopic System is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with the Intuitive Surgical® Endoscopic Instrument Control system during laparoscopic and thoracoscopic surgical procedures.
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)
Page 1 of 1
Neil Re. Oehl for mxm
Division of General, Restorative and Neurological Devices
510(k) Number K080155
Intuitive Surgical® 8.5mm 3D Stereo Endoscope
§ 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.