(41 days)
The da Vinci Xi Hasson Cone has applications in laparoscopic surgery to establish a port of entry for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, or compatible accessories.
The da Vinci Xi Hasson Cone is a cone-shaped device which is intended to be used in endoscopic surgery to anchor a port of entry (i.e., cannula) to the patient. During Hasson, or open, surgical techniques, the user places a Hasson Cone in the opening of the body wall. The cannula shaft is inserted into the cone, effectively increasing the diameter of the cannula to the contour of the incision made in the body wall.
The Hasson Cone will be offered in two sizes; 8 mm and 12 mm & Stapler.
The provided document is a 510(k) premarket notification for the Intuitive Surgical da Vinci Xi Hasson Cone. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets specific performance criteria in the format requested.
The document states that "Performance data (bench and animal testing) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements." It lists the types of testing conducted but does not provide specific numerical acceptance criteria or the reported device performance against those criteria.
Therefore, I cannot populate the table or provide detailed answers to many of the questions as the information is not present in the provided text. I will indicate where the information is not available.
Description of the Acceptance Criteria and Study:
The document broadly states that performance data (bench and animal testing) demonstrated that the da Vinci Xi Hasson Cone is substantially equivalent to a predicate device and that its design output meets design input requirements. The testing included:
- Dimensional measurements
- Mechanical and functional verification
- Simulated use in animal models
- Human factors assessment
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Example) | Reported Device Performance (Example) |
|---|---|
| Specific criteria not provided in document | Specific performance data not provided in document |
| Bench Testing Categories: | |
| Physical Specifications | Demonstrated to meet input requirements |
| Mechanical Requirements | Demonstrated to meet input requirements |
| User Interface Requirements | Demonstrated to meet input requirements |
| Functional Requirements | Demonstrated to meet input requirements |
| Animal Validation Categories: | |
| General Requirements | Validated |
| Functional Requirements | Validated |
| Use and Misuse-Related Requirements | Validated |
| Interaction (Compatibility) Requirements | Validated |
| Human Factors Evaluation: | |
| All risks assessed as "Tolerable" or "Broadly Acceptable" | All risks assessed as "Tolerable" or "Broadly Acceptable" pre-mitigated |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified in the document. The document mentions "animal and cadaveric models" for design validation testing but does not provide quantities.
- Data provenance: Not specified. Testing was described as "bench" and "animal and cadaveric models," suggesting prospective
testing, but detailed provenance (e.g., country of origin) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. The context of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus on images) does not directly apply to the mechanical and functional device testing described. The "experts" would likely be the engineers and perhaps surgeons involved in the animal validation, but their number and specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. This is typically relevant for studies involving human interpretation of data where consensus is needed to establish ground truth. For device performance testing, the "adjudication" would be based on meeting predefined engineering specifications and functional outcomes.
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. The document describes a medical device (Hasson cone) used in laparoscopic surgery, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical surgical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this type of device testing is adherence to engineering specifications, functional performance in simulated environments (bench testing), and successful operation within animal/cadaveric models. It's based on objective measurements and observed physical outcomes rather than expert interpretation of diagnostic data or pathology.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not an AI model.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9, 2015
Intuitive Surgical Incorporated Vishal Kanani Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K153126
Trade/Device Name: da Vinci Xi Hasson Cone Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: October 26, 2015 Received: October 29, 2015
Dear Mr. Kanani:
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 of medical devicerelated 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.
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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" (21 CFR 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,
Joshua C. Nipper -S
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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for Use
510(k) Number (if known) K153126
Device Name da Vinci Xi Hasson Cone
Indications for Use (Describe)
The da Vinci Xi Hasson Cone has applications in laparoscopic surgery to establish a port of entry for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, or compatible accessories.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/14)
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Image /page/2/Picture/21 description: The image shows the logo for Intuitive Surgical. The logo is in a light gray color. The word "INTUITIVE" is in all caps and is above the word "SURGICAL", which is also in all caps but in a smaller font size. There is a small yellow circle above the "I" in "INTUITIVE".
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| 510(k) Owner: | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 |
|---|---|
| Contact: | Vishal KananiSr. Regulatory Affairs SpecialistPhone Number: 408-523-2035Fax Number: 408-523-8907Email: vishal.kanani@intusurg.com |
| Date Summary Prepared: | October 27, 2015 |
| Trade Name: | da Vinci Xi Hasson Cone |
| Common Name: | Endoscope and Accessories |
| Classification: | Class II21 CFR 876.1500, Endoscope and Accessories |
| Product Code: | GCJ |
| Classification Advisory Committee: | General and Plastic Surgery |
| Predicate Device: | Hybrid Trocar System (K101937) |
Device Description:
The da Vinci Xi Hasson Cone is a cone-shaped device which is intended to be used in endoscopic surgery to anchor a port of entry (i.e., cannula) to the patient. During Hasson, or open, surgical techniques, the user places a Hasson Cone in the opening of the body wall. The cannula shaft is inserted into the cone, effectively increasing the diameter of the cannula to the contour of the incision made in the body wall.
The Hasson Cone will be offered in two sizes; 8 mm and 12 mm & Stapler.
Intended Use:
The da Vinci Xi Hasson Cone is intended to be used in laparoscopic surgery to anchor a port of entry (i.e., cannula) to the patient.
Indications for Use:
The da Vinci Xi Hasson Cone has applications in laparoscopic surgery to establish a port of entry for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, or compatible accessories.
INTUITIVE SURGICAL®
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Technological Characteristics:
The subject device, da Vinci Xi Hasson Cone, is technologically very similar to the predicate device, Aesculap 10 mm Stability Cone for Trocar Sleeve (cleared under K101937). It has the same intended use, same fundamental scientific technology, and similar technological characteristics as the predicate device.
Performance Data:
Performance data (bench and animal testing) demonstrate that the subject device is substantially equivalent to the predicate device 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 da Vinci Xi Hasson Cone, was subjected to a series of bench tests to evaluate performance and to demonstrate that the design outputs meet the input requirements. The design verification testing included:
- Physical Specifications
- Mechanical Requirements .
- User Interface Requirements
- Functional Requirements ●
Animal Validation Testing:
Design Validation Testing was performed using animal and cadaveric models to evaluate the performance of the da Vinci Xi Hasson Cone in a simulated clinical setting. The testing summarized in this submission validated general, functional, use and misuserelated, and interaction (compatibility) requirements for the subject device.
Human Factors Evaluation:
As part of the Usability Engineering Process for the da Vinci Xi Hasson Cone, a Usability Risk Analysis was created 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 device.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the da Vinci Xi Hasson Cone is substantially equivalent to its predicate device.
Image /page/4/Picture/18 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".
§ 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.