(195 days)
Not Found
No
The summary describes surgical instruments and accessories for a robotic surgical system, focusing on mechanical function and compatibility. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a set of surgical instruments and accessories used for endoscopic manipulation of tissue during specific surgical procedures, not for treating a disease or condition itself. It's a tool for surgery, which is a therapeutic intervention, but not a therapeutic device by its own function.
No
This device is described as an instrument used for surgical procedures such as tissue manipulation, grasping, cutting, and suturing, not for diagnosing medical conditions.
No
The device description and performance studies clearly indicate the device includes physical instruments and accessories used in surgical procedures, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the da Vinci Xi Single-Site Instruments and Accessories are used for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, suction/irrigation and suturing during surgical procedures. These are actions performed directly on the patient's body during surgery, not on samples taken from the body.
- Intended Use/Indications for Use: The indications are for specific surgical procedures (cholecystectomy, hysterectomy, salpingo oophorectomy).
- Device Description: The description focuses on the instruments used for surgical manipulation.
- Performance Studies: The performance studies involve bench testing and simulated clinical settings using tissue models, not testing of patient samples.
The device is a surgical instrument system used for minimally invasive surgery, which falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Intuitive Surgical da Vinci Xi Single-Site Instruments and Accessories used with the da Vinci Xi Surgical System (154000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clectrocautery, suction irrigation and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo ophorectory with the da Vinci Xi Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, bipolar cautery, clip appliers, 5 mm and 10 mm straight cannulae, 8mm endoscope cannula, flexible and rigid blunt obturators, cannula seal, and the Single-Site Port.
Product codes (comma separated list FDA assigned to the subject device)
NAY, GCJ
Device Description
The da Vinci Xi Single-Site Instruments and Accessories are a set of devices developed by Intuitive Surgical to enable single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo oophorectomy using the da Vinci Xi (IS4000) Surgical System.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: In accordance with Intuitive Surgical's Design Control process, risk analyses were conducted to evaluate the impact of modifications to the predicate instruments. Design verification and design validation testing were conducted on the subject instruments to confirm that the design outputs meet the design input requirements and that each instrument is safe and effective for its intended use.
Design Verification: The bench testing with the subject da Vinci Xi Single-Site Instruments and Accessories was performed with an IS4000 da Vinci Surgical System. The general and device-specific design verification summarized in this submission verifies mechanical and labeling requirements for the subject device, such as:
- Instruments:
- Physical specifications (size, weight, shape);
- Mechanical requirements (axes torques, loading, range of motion, accuracy, grip forces, needle handling, tip alignment);
- Electrical requirements;
- User interface;
- Equipment interfaces (cannula, sterile adapter, RFID, Universal Surgical Manipulator, Patient Side Manipulator).
- Accessories:
- Physical specifications (size, shape, finish, materials);
- Mechanical requirements (forces, loading, insufflation, flow rate, cannula insertion, port insertion/removal);
- Compatibility (instruments, seals, cannulae);
- Markings;
- System Recognition (magnets).
Other verification included software compatibility testing and instrument data verification testing to confirm the subject da Vinci Xi Single-Site Instruments and Accessories function as intended.
Design Validation: The design validation summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject da Vinci Xi Single-Site Instruments and Accessories. Design validations for each subject da Vinci Xi Single-Site Instrument and Accessory address how the features of each device meet the user needs and intended use as documented in the product requirements documents. The safety and efficacy of the instruments was assessed in representative simulated clinical settings that utilized porcine (in vivo) and cadaveric tissue models to evaluate applicable requirements through normal and expected worst case clinical use. Representative tissue types were used, as appropriate, for evaluating applicable requirements.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of a human figure, represented by three profiles facing to the right, with a symbolic design above them that resembles an eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2016
Intuitive Surgical, Inc. Ms. Melissa Gonzales Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, CA 94086
Re: K152448
Trade/Device Name: da Vinci Xi Single-Site Instruments and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: February 5, 2016 Received: February 8, 2016
Dear Ms. Gonzales:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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" (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 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.
Jennifer R. Stevenson -A
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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
da Vinci Xi Single-Site Instruments and Accessories
Indications for Use (Describe)
The Intuitive Surgical da Vinci Xi Single-Site Instruments and Accessories used with the da Vinci Xi Surgical System (154000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clectrocautery, suction irrigation and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo ophorectory with the da Vinci Xi Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, bipolar cautery, clip appliers, 5 mm and 10 mm straight cannulae, 8mm endoscope cannula, flexible and rigid blunt obturators, cannula seal, 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
INTUITIV
SURGICAL
3
510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Melissa S. Gonzalez
Regulatory Affairs
Phone Number: 408-523-8684
Fax Number: 408-523-8907
Email: melissa.gonzalez@intusurg.com |
| Date Summary Prepared: | August 26, 2015 |
| Trade Name: | da Vinci® XiTM Single-Site Instruments and Accessories |
| Common Name: | Endoscope and accessories |
| Classification: | Class II - 21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | NAY, GCJ |
| Classification Advisory
Committee: | General and Plastic Surgery |
| Predicate Device: | K122532 – da Vinci® SiTM Single-Site Instruments and Accessories |
Device Description
The da Vinci Xi Single-Site Instruments and Accessories are a set of devices developed by Intuitive Surgical to enable single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo oophorectomy using the da Vinci Xi (IS4000) Surgical System.
Intended Use/Indications for Use:
The Intuitive Surgical da Vinci® Xi™ Single-Site Instruments and Accessories used with the da Vinci Xi Surgical System (IS4000) 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, suction/irrigation and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo oophorectorny with the da Vinci Xi Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, clip appliers, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, 8 mm endoscope cannula, flexible and rigid blunt obturators, cannula seal, and the Single-Site Port.
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Substantial Equivalence:
The subject da Vinci Xi Single-Site Instruments and Accessories are very similar to the predicate devices (da Vinci® SiTM Single-Site Instruments and Accessories in K122532). They have the same intended use, same fundamental scientific technology, and similar technological characteristics as the predicate device. The basic architecture of the subject devices remains unchanged from the predicate; the distal tips (jaws, blades, cautery-tips, and clevis) of the da Vinci Xi Single-Site Instruments are identical to the predicate da Vinci Si Single-Site Instruments. However, the back ends of the instruments and accessories have been modified for compatibility with the IS4000 Surgical System, incorporating elements of both the predicate da Vinci Si Single-Site Instruments and Accessories and the referenced IS4000 8mm EndoWrist Instruments and related accessories. Several previously cleared accessories, used with both the subject and the predicate devices, are unchanged from the predicate da Vinci Si Single-Site Accessories (10mm accessory cannula and obturator and 5mm flexible blunt obturators).
Performance Data:
In accordance with Intuitive Surgical's Design Control process, risk analyses were conducted to evaluate the impact of modifications to the predicate instruments. Design verification and design validation testing were conducted on the subject instruments to confirm that the design outputs meet the design input requirements and that each instrument is safe and effective for its intended use.
Design Verification:
The bench testing with the subject da Vinci Xi Single-Site Instruments and Accessories was performed with an IS4000 da Vinci Surgical System. The general and device-specific design verification summarized in this submission verifies mechanical and labeling requirements for the subject device, such as:
- . Instruments:
- Physical specifications (size, weight, shape); o
- Mechanical requirements (axes torques, loading, range of motion, accuracy, grip o forces, needle handling, tip alignment):
- Electrical requirements: o
- User interface; o
- Equipment interfaces (cannula, sterile adapter, RFID, Universal Surgical o Manipulator, Patient Side Manipulator).
- Accessories: ●
- Physical specifications (size, shape, finish, materials); o
- Mechanical requirements (forces, loading, insufflation, flow rate, cannula O insertion, port insertion/removal);
- Compatibility (instruments, seals, cannulae) O
- Markings O
- System Recognition (magnets) O
Image /page/4/Picture/20 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in all caps, with the word "SURGICAL" in smaller letters below it. There is a yellow graphic above the word "INTUITIVE".
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Other verification included software compatibility testing and instrument data verification testing to confirm the subject da Vinci Xi Single-Site Instruments and Accessories function as intended.
Design Validation:
The design validation summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject da Vinci Xi Single-Site Instruments and Accessories. Design validations for each subject da Vinci Xi Single-Site Instrument and Accessory address how the features of each device meet the user needs and intended use as documented in the product requirements documents. The safety and efficacy of the instruments was assessed in representative simulated clinical settings that utilized porcine (in vivo) and cadaveric tissue models to evaluate applicable requirements through normal and expected worst case clinical use. Representative tissue types were used, as appropriate, for evaluating applicable requirements.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, the subject da Vinci Xi Single-Site Instruments and Accessories are substantially equivalent to the predicate da Vinci Si Single-Site Instruments and Accessories cleared in K122532.
Image /page/5/Picture/7 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in large, gray, sans-serif font. Below that, the word "SURGICAL" is in a smaller font. There is a yellow dot above the "I" in Intuitive.