(204 days)
No
The document describes surgical instruments and accessories for a robotic surgical system, focusing on mechanical function and equivalence to a predicate device. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for surgical procedures such as manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, and suturing, all of which are therapeutic interventions.
No
Explanation: The device is indicated for surgical manipulation of tissue, grasping, cutting, dissection, approximation, clip-ligation, electrocautery, and suturing, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly details physical components such as instruments, cannulae, obturators, and a port, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for "endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, and suturing during single incision laparoscopic cholecystectomy, benign hysterectorny and salpingo- oophorectomy". This involves direct surgical intervention on the patient's body.
- Device Description: The device description details surgical instruments and accessories used for physical manipulation and access during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is used inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The Intuitive Surgical® da Vinci® Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (153000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, and suturing during single incision laparoscopic cholecystectomy, benign hysterectorny and salpingo- oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site Port.
Product codes
NAY, GCJ
Device Description
The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae sets (250 mm and 300 mm lengths), an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator (250 mm and 300 mm lengths), a rigid 10 mm Blunt Obturator, and a Single-Site Port (with insufflation adapter and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision.
The da Vinci Single-Site Instruments and Accessories include instruments to perform manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clipligation, electrocautery, and suturing. The da Vinci Single-Site Instruments and Accessories are intended to be used with the existing da Vinci Si Surgical System (IS3000).
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
trained physicians in an operating room environment
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
Bench and animal testing demonstrated that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The difference in material formulation does not raise any new issues of safety or effectiveness as compared to the predicate device.
Design verification tests were performed on the Single-Site Ports to evaluate the port requirements/specifications and also to demonstrate that it is substantially equivalent to the predicate. Verification testing included:
| Category | Test Description | Test Methods |
|---|---|---|
| Physical requirements | Configuration | Visual observation |
| Dimension | Measurements | |
| Hardness | Measurements | |
| Equipment Interface requirements | Insufflation equipment | Measurements |
Single-Site Ports were tested for reliability through the port's useful life (single use). The test evaluated the ability of the Single-Site Port to function and resist wear during a simulated clinical use. The surgical tasks were designed to simulate actual maneuvers performed with the instruments and camera during minimally invasive surgical operations throughout the expected use of the port. Specifically, the number of repetitions was determined by anticipating the maximum number of such maneuvers performed during a worst case scenario.
Design validation was performed for the subject Single-Site Port to demonstrate its ability to meet its intended use and did not raise any issues of safety or effectiveness. The Single Site Port was placed into the abdominal wall in a porcine model to evaluate the port in live tissue, specifically, the effect of the port on the skin, fascia, fat, etc., that are between the flanges.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility of the new silicone material has been evaluated by a third party lab in compliance with Good Laboratory Practices (GLP) and in accordance with the following guidance and standard:
- FDA's 510(k) Memorandum #G95-1
- ISO 10993 (Parts 1 12): Biological evaluation of medical devices.
The Single-Site Port is classified as "limited duration contact (
§ 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
Intuitive Surgical, Inc.
K133203 Page 1 of 3 Traditional 510(k)
510(k) Summary [As Required by 21 CFR 807.92(c)]
MAY 0 9 2014
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
| --------------- | -------------------------------------------------------------------- |
|---|
Official Contact: Einav Yemini Associate Regulatory Engineer 408-523-2656 (phone) 408-523-8907 (fax) einav.yemini@intusurg.com
Date Summary Prepared: May 1, 2014
| Trade Name: | Intuitive Surgical® da Vinci® Single-Site™ Instruments and
Accessories |
|--------------------|-----------------------------------------------------------------------------------|
| Common Name: | Endoscope and accessories |
| Product Code: | NAY, GCJ |
| Classification: | Endoscope and Accessories, 21 CFR 876.1500 |
| Predicate Devices: | Intuitive Surgical® da Vinci® Single-Site™ Instruments and
Accessories K130726 |
Device Description:
The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae sets (250 mm and 300 mm lengths), an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator (250 mm and 300 mm lengths), a rigid 10 mm Blunt Obturator, and a Single-Site Port (with insufflation adapter and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision.
The da Vinci Single-Site Instruments and Accessories include instruments to perform manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clipligation, electrocautery, and suturing. The da Vinci Single-Site Instruments and Accessories are intended to be used with the existing da Vinci Si Surgical System (IS3000).
1
Intuitive Surgical, Inc.
Intended Use:
i The Intuitive Surgical® da Vinciø Single-Site™ Instruments and Accessories used with the da Vincio Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingooophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site Port.
The indications for use are unchanged from the predicate (K130726).
Technological Characteristics:
The Single-Site Port that is the subject of this notification is a functionally equivalent version of the most recently cleared Single-Site Port (K 130726), which was unchanged from the original Single-Site clearance (K112208). The only change to the cleared da Vinci Single-Site Instruments and Accessories is a change in material formulation of the Single-Site Port. The port material is changing due to material availability. The supplier has changed the material composition to a chemically equivalent material with a slightly different formulation. The Single-Site Port is equivalent to the predicate Single-Site Port in terms of its technological characteristics, and the intended use is identical.
Performance Data:
Biocompatibility of the new silicone material has been evaluated by a third party lab in compliance with Good Laboratory Practices (GLP) and in accordance with the following guidance and standard:
- FDA's 510(k) Memorandum #G95-1 ●
- ISO 10993 (Parts 1 12): Biological evaluation of medical devices .
The Single-Site Port is classified as "limited duration contact ( Trade/Device Name: Single-site port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope & Accessories Regulatory Class: Class II Product Code: GCJ, NAY Dated: April 4, 2014 Received: October 21, 2013
Dear Einav Yemini:
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 and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions/Warnings/Contraindications section of the | device's labeling:
The safety and effectiveness of this device for use in the performance of general laparoscopic abdominal surgery or general gynecological surgery procedures have not been established. This device is only intended to be used for single incision laparoscopic cholecystectory, benign hysterectoriy, and salpingo-oophrectomy with the da Vinci Single Site Instruments and the da Vinci Si Surgical System (IS3000).
4
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours. Christy L. Foreman -S
Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133203
Device Name
Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories
Indications for Use (Describe)
The Intuitive Surgical® da Vinci® Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (153000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, and suturing during single incision laparoscopic cholecystectomy, benign hysterectorny and salpingo- oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site Port.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
THE ONLY BEATH OF CONTRACT OF CONFOR FOR FOR USE ONLY BEA (CAST AND THE COLLECTION COLLEGION
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.