(60 days)
The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci S and da Vinci Si Surgical Systems Models IS1200, IS2000, IS3000) are intended to assist in the accurate control of Intuitive Surgical Endoscopic EndoWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors; scissors, scalpels, ultrasonic/harmonic shears; forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, general thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative. specific procedures set forth in the Instructions for Use.
The Monopolar Curved Scissors Tip Cover Accessory is an electrically isolating sleeve that is placed over the distal tip of the Monopolar Curved Scissors. The Tip Cover Accessory acts to isolate the metal parts of the instrument so that only the intended electrode (the scissor blades) is exposed for surgical application.
This document is a 510(k) summary for a device modification, specifically for the Monopolar Curved Scissors Tip Cover Accessory. It states that the device is substantially equivalent to a predicate device and that performance tests were conducted to demonstrate this. However, it does not provide detailed acceptance criteria or present a formal study with statistical findings in the manner typically seen for complex AI/ML device submissions.
Here's a breakdown based on the information provided, highlighting what is missing concerning your specific questions for AI/ML device studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states: "Performance tests (bench tests) were conducted to demonstrate that the subject device is substantially equivalent to the predicate device, and that the design output meets the design input requirements. The results of the testing did not raise any new types of safety or effectiveness questions."
This is a general statement. The specific acceptance criteria (e.g., electrical isolation resistance, durability under specific conditions) and the numerical results of the reported device performance are not detailed in this summary. It only indicates that the criteria were met and no new safety/effectiveness questions arose.
2. Sample Size Used for the Test Set and Data Provenance:
This document describes a medical device accessory, not an AI/ML algorithm. Therefore, the concept of a "test set" for an algorithm's performance on data (like images or medical records) is not applicable here. The "performance tests" mentioned would have involved physical testing of the device.
- Sample Size for Test Set: Not specified in terms of units tested, but these would be physical units of the accessory.
- Data Provenance (country of origin, retrospective/prospective): Not applicable, as this is a physical device accessory and not an AI/ML diagnostic or predictive tool relying on medical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. For a physical device accessory like a tip cover, "ground truth" is typically established through engineering specifications, material properties, and physical testing against predefined standards, rather than expert interpretation of medical data.
4. Adjudication Method:
Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers on a test set's ground truth, which is not relevant for this type of device modification.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not done. This type of study is specifically designed to evaluate the impact of an AI system on human reader performance for diagnostic tasks, which is not relevant for a physical accessory like a tip cover.
6. Standalone Performance Study:
A standalone performance study for an algorithm was not done. The "performance data" refers to bench tests of the physical accessory itself, demonstrating its functional characteristics.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance would be based on engineering specifications and physical measurement standards used in bench testing (e.g., electrical resistance limits, physical dimensions, material integrity). It is not based on expert consensus, pathology, or outcomes data in the context of clinical AI/ML studies.
8. Sample Size for the Training Set:
Not applicable. This device is a physical accessory, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. (See #8)
In summary, this 510(k) pertains to a physical medical device accessory modification and does not align with the typical requirements or study designs for AI/ML medical devices. The information you're asking for, particularly regarding sample sizes for training/test sets, expert ground truth, and AI/ML specific study types (MRMC, standalone), is not provided because it's not relevant to this type of submission.
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OCT - 7 2011
Intuitive Surgical Inc.
Tip Cover Accessory Special 510(k): Device Modification
510(K) SUMMARY (per 21 CFR 807.92)
| Submitter: | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086Ph: (408) 523-2100Fax: (408) 523-1390 |
|---|---|
| Official Contact: | Brandon HansenSr. Regulatory Affairs Manager |
Date Summary Prepared: August 5, 2011
Device Name:
| Trade Name: | Monopolar Curved Scissors Tip Cover Accessory |
|---|---|
| Common Name: | Endoscopic Instrument Accessory, Tip CoverAccessory |
| ClassificationName: | Endoscope and Accessories (21 CFR 876.500,Product Code NAY) |
Predicate Device: The Monopolar Curved Scissors and Tip Cover Accessory (originally cleared under K050005, current procedures covered under K090993), currently marketed by Intuitive Surgical, Inc. (Sunnyvale, CA). Device Description: The Monopolar Curved Scissors Tip Cover Accessory is an electrically isolating sleeve that is placed over the distal tip of the Monopolar Curved Scissors. The Tip Cover Accessory acts to isolate the metal parts of the instrument so that only the intended electrode (the scissor blades) is exposed for surgical application. Indications For Use: The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, IS2000, IS3000) are intended to assist in the accurate control of Intuitive Surgical Endoscopic EndoWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation,
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Summary:
electrocautery, suturing, , delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, qynecological laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, general thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Instructions for Use.
The subject device (Monopolar Curved Scissors Tip Technological Cover Accessory) is equivalent in technological Characteristics: characteristics as compared to the predicate device.
Performance Data: Performance tests (bench tests) were conducted to demonstrate that the subject device is substantially equivalent to the predicate device, and that the design output meets the design input requirements. The results of the testing did not raise any new types of safety or effectiveness questions.
The Monopolar Curved Scissors Tip Cover Accessory is substantially equivalent in indications for use and technological characteristics as compared to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT - 7 2011
Intuitive Surgical, Inc. % Mr. Brandon Hansen Sr. Regulatory Affairs Manager 1266 Kifer Road Sunnyvale, California 94086
Re: K112263
Trade/Device Name: Monopolar Curved Scissors Tip Cover Accessory Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: August 05, 2011 Received: September 12, 2011
Dear Mr. Hansen:
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
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Page 2 - Mr. Brandon Hansen
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Intuitive Surgical Inc.
K112263 510(k) Number if known:
Device Name: Monopolar Curved Scissors Tip Cover Accessory
INDICATIONS FOR USE:
The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci S and da Vinci Si Surgical Systems Models IS1200, IS2000, IS3000) are intended to assist in the accurate control of Intuitive Surgical Endoscopic EndoWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors; scissors, scalpels, ultrasonic/harmonic shears; forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, general thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative. specific procedures set forth in the Instructions for Use.
Prescription Use × (Per 21 CFR 801 Subpart D) C)
AND/OR
Over-the-Counter Use (Per 21 CFR 807 Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
NeilklOeder for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112263
§ 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.