(227 days)
Not Found
No
The summary describes a passive surgical cannula and does not mention any computational or analytical capabilities, let alone AI/ML.
No
The device is described as a "port of entry" for surgical instruments during da Vinci procedures, which is a supportive function and not a direct therapeutic action on a disease or condition.
No
Explanation: The device is described as a port of entry for surgical procedures and not for diagnosing any condition. Its function is to facilitate the use of a surgical system, not to provide diagnostic information.
No
The device description clearly details physical components (tapered hollow tubular shaft, flared distal tip, bowl, receptacle) and mentions bench and animal lab tests, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Flared Cannulae are used during da Vinci surgical procedures as a port of entry. This is an in vivo application (within a living organism).
- Device Description: The description details a physical device used for surgical access, not for analyzing biological samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely for surgical access during a procedure.
N/A
Intended Use / Indications for Use
The Flared Cannulae are intended to be used with the da Vinci Surgical System (da Vinci S (Model IS2000) or da Vinci Si (Model IS3000)) to serve as a port of entry during da Vinci procedures that do not require maintenance of insufflation.
Product codes (comma separated list FDA assigned to the subject device)
NAY
Device Description
The Intuitive Surgical Flared Cannula consists of a tapered hollow tubular shaft with a flared distal tip and a bowl with an Integral receptacle. The hollow shaft serves as the port of entry, the bowl is used to attach the cannula to the da Vinci Surgical System and the receptacle allows for attachment of commercially available dispersive electrode grounding pad via a 2-Pin grounding connector
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)
Performance tests (bench and animal lab tests) were conducted to demonstrate that the 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 Issues of safety or efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K101743, Intuitive Surgical 5 mm and 8 mm Flared Cannula
FEB - 4 2011
510(k) Summary
(As Required by 21 CFR 807.92(c))
| Date: | 09/10/2010 | |
|---|---|---|
| Submitter: | Intuitive Surgical, Inc. | |
| 1266 Kifer Road | ||
| Sunnyvale, CA 94086 | ||
| Official Contact: | Meghna Sridharan | |
| Sr. Regulatory Engineer | ||
| Ph: (408) 523- 2487 | ||
| Fax: (408) 523-1390 | ||
| Meghna.sridharan@intusurg.com | ||
| Trade Name: | Intuitive Surgical Flared Cannula | |
| • Model # 420262: 5mm Flared Cannula | ||
| • Model # 420319: 8mm Flared Cannula | ||
| Common Name: | Endoscopic Instrument and Accessories | |
| Classification: | Endoscope and Accessories, | |
| 21 CFR 876.1500, NAY(LFL) | ||
| Predicate Device: | Intuitive Surgical, Inc. | |
| K990144, da Vinci Endoscopic Instrument | ||
| Control System (Model IS1000) and Endoscopic | ||
| Instruments | ||
| Device Description: | The Intuitive Surgical Flared Cannula consists of | |
| a tapered hollow tubular shaft with a flared | ||
| distal tip and a bowl with an Integral | ||
| receptacle. The hollow shaft serves as the port | ||
| of entry, the bowl is used to attach the | ||
| cannula to the da Vinci Surgical System and | ||
| the receptacle allows for attachment of | ||
| commercially available dispersive electrode | ||
| grounding pad via a 2-Pin grounding | ||
| connector | ||
| Intended Use: | The Flared Cannulae are Intended to be used | |
| with the da Vinci Surgical System (da Vinci S | ||
| (Model IS2000) or da Vinci SI (Model IS3000)) to | ||
| serve as a port of entry during da Vinci | ||
| Intuitive Surgical, Inc. | Confidential | Page 3-2 |
P. 1 of 2
1
K101743, Intuitive Surgical 5 mm and 8 mm Flared Cannula
procedures that do not require maintenance of Insufflation.
Technological Characteristics: The subject device is equivalent in Intended use, design and technology as compared to the predicate device.
Performance Data: Performance tests (bench and animal lab tests) were conducted to demonstrate that the 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 Issues of safety or efficacy.
Summary: on the technical characteristics, Based Intended use and performance test data, the Intuitive Surgical 5mm and 8mm Flared Cannula have been determined to be equivalent in in safety, efficacy, and performance to the predicate device.
Intuitive Surgical, inc.
2
Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609. Silver Spring, MD 20993-0002
Intuitive Surgical, Inc. % Ms. Meghna Sridharan Senior Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086
FEB - 4 2011
Re: K101743
Trade/Device Name: Intuitive Surgical® Flared Cannula Regulation Number: 21 CFR 876-1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NA Y Dated: January 27, 2011 Received: January 28, 2011
Dear Ms. Sridharan:
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 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
3
Page 2 - Ms. Meghna Sridharan
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours.
AZ
VS
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K101743, Intuitive Surgical 5 mm and 8 mm Flared Cannula
Indications for Use
510(k) Number if known: K101743
Device Name: Intuitive Surgical Flared Cannula
INDICATION FOR USE:
The Flared Cannuiae are intended to be used with the da Vinci Surgical System (da Vinci S (Model IS2000) or da Vinci Si (Model IS3000)) to serve as a port of entry during da Vinci procedures that do not require maintenance of insufflation.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use _ (Per 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)
Neil R.P. Osdoba for mkm
Division Sign-O (Division Sign of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101743