(63 days)
Not Found
No
The device description and performance studies focus on mechanical and functional aspects of a surgical trocar, with no mention of AI or ML.
No.
The device is a trocar used to create a port of entry for surgical instruments; it does not directly treat or cure a disease or medical condition.
No
The device is a surgical instrument (trocar) used to provide a port of entry for other endoscopic instruments during surgical procedures. Its function is to facilitate access and aid in surgery, not to diagnose medical conditions by capturing, processing, or analyzing data.
No
The device description explicitly details physical components (cannula, obturator, universal cannula seal) and performance studies involve bench, animal, and cadaver tests, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a port of entry for endoscopic instruments during surgical procedures, typically through the abdominal or chest wall. This is a surgical tool used in vivo (within the living body).
- Device Description: The description details a physical device (cannula, obturator, seal) used for surgical access.
- Anatomical Site: The device is used on the patient's body (abdominal or chest wall).
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests.
The information clearly describes a surgical access device, not a device used for testing biological samples in vitro.
N/A
Intended Use / Indications for Use
The 8 mm Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
Product codes
GCJ
Device Description
The 8 mm Trocar consists of a cannula, an obturator, and a universal cannula seal. It provides a port of entry for endoscopic instruments typically through the abdominal or chest wall of the patient during endoscopic surgery. It is available in standard and long versions. The universal seal contains a valve and stopcock to allow for insufflation and the cannula has a fin for attachment to the da Vinci Surgical System and markings for placing the remote center in the body wall. The three components are packaged as a kit, and the obturator and cannula seal also packaged individually.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal or chest wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons and operating room staff; simulated operating room
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
Performance test data (bench, animal and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of dimensional measurements, functional verification, and simulated use in animal and cadaver models.
A summative usability validation study was conducted with users (surgeons and operating room staff) for the 8 mm Trocar. This study was conducted in a simulated operating room and involved typical workflow scenarios as well as certain troubleshooting scenarios related to safety-critical tasks. Results of the validation study and the other elements of the human factors engineering program provide evidence that the 8 mm Trocar is safe and effective when used by the intended users in the intended use environment.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-0002
DEPA
February 19, 2014
Intuitive Surgical. Inc. Mr. Brandon Hansen Project Manager, Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086
Re: K133845
Trade/Device Name: 8mm trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Disposable Surgical Trocar/Cannula Regulatory Class: Class II Product Code: GCJ Dated: January 24, 2014 Received: January 27, 2014
Dear Mr. Hansen:
We have reviewed vour 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 [OIR/IVD OPTION] and Part 809); 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
1
Page 2 - Mr. Brandon Hansen
·
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 [OIR/IVD OFTION] and Part 809), please contact 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. 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 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,
Felipe Aguel
for
Binita S. Ashar. M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
......................... Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133845
Device Name S mm Tricar
Indications for Use (Describe)
The 8 mm Trocar has application in a variety of endoscopic provide a port of entry for endoscopic instruments.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpan D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | |
|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| Long H. Chen-A | for BSA |
| (Division Sign-off) | |
| Division of Surgical Devices | 510(k) Number: K133845 |
| FORM FDA 3881 (1/14) | Page 1 of 2 |
3
K133845
Page 1 of 2
510(k) Summary
FEB 1 9 2014
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Brandon Hansen
Project Manager, Regulatory Affairs
Phone Number: 408-523-7485
Fax Number: 408-523-8907
Email: Brandon.Hansen@intusurg.com |
| Date Summary Prepared: | January 24, 2014 |
| Trade Name: | 8 mm Trocar |
| Common Name: | Disposable Surgical Trocar/Cannula |
| Classification: | Class II
21 CFR 876.1500, Laparoscope, General & Plastic Surgery |
| Product Code: | GCJ |
| Classification Advisory
Committee: | General and Plastic Surgery |
| Predicate Device: | Unimax Trocar System (K112358) |
Device Description:
The 8 mm Trocar consists of a cannula, an obturator, and a universal cannula seal. It provides a port of entry for endoscopic instruments typically through the abdominal or chest wall of the patient during endoscopic surgery. It is available in standard and long versions. The universal seal contains a valve and stopcock to allow for insufflation and the cannula has a fin for attachment to the da Vinci Surgical System and markings for placing the remote center in the body wall. The three components are packaged as a kit, and the obturator and cannula seal also packaged individually.
4
Intended Use:
To provide a port of entry for endoscopic instruments.
Indications for Use:
The 8 mm Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
Technological Characteristics:
The 8 mm Trocar is substantially equivalent to the Unimax Medical Systems, Inc., Trocar System (K112358) in terms of design, materials, technological characteristics and intended use.
Performance Data:
Performance test data (bench, animal and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of dimensional measurements, functional verification, and simulated use in animal and cadaver models.
Human Factors and Usability Testing:
A summative usability validation study was conducted with users (surgeons and operating room staff) for the 8 mm Trocar. This study was conducted in a simulated operating room and involved typical workflow scenarios as well as certain troubleshooting scenarios related to safety-critical tasks. Results of the validation study and the other elements of the human factors engineering program provide evidence that the 8 mm Trocar is safe and effective when used by the intended users in the intended use environment.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the 8 mm Trocar is substantially equivalent to the Unimax Medical Systems, Inc., Trocar System (K112358)
INTUITIVE SURGICAL®