(539 days)
Not Found
No
The summary describes a robotic surgical system for controlling standard endoscopic instruments. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the mechanical control of instruments.
No
The device is intended to assist in the accurate control of endoscopic instruments during laparoscopic surgical procedures, performing actions like grasping, cutting, and suturing. It is a surgical tool, but it does not directly treat or diagnose a disease state, nor does it restore a bodily function.
No
Explanation: The da Vinci™ System is described as a control system for surgical instruments used during laparoscopic procedures. Its purpose is to assist in the "accurate control" of instruments for actions like "grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing." These are therapeutic actions, not diagnostic ones. The text does not mention any function for detecting, identifying, or monitoring diseases or health conditions.
No
The device description explicitly states it includes "working ends and elements" of surgical instruments, which are physical hardware components. The system is also described as an "Endoscopic Instrument Control System," implying control over physical instruments.
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 da Vinci System and its instruments are used to assist in the control of endoscopic instruments and for endoscopic manipulation of tissue during laparoscopic surgical procedures. This describes a device used in vivo (within the body) for surgical intervention.
- 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. The da Vinci system does not perform such tests.
- Device Description: The description focuses on the surgical tools and their modification for use with the control system, not on any diagnostic testing components.
The information provided consistently points to a surgical device used for performing procedures on a patient, not a device used for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Intuitive Surgical™ Endoscopic Instrument Control System (hcreinafter referred to as the "da Vinci™ System") is intended to assist in the accurate control of Intuitive Surgical™ endoscopic instruments including: rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps / pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories during laparoscopic surgical procedures such as cholecystectomy or Nissen fundoplication. It is intended for use by trained physicians in an operating room environment.
Intuitive Surgical™ Endoscopic Instruments including scissors, scalpels, forceps/pickups, needle holders, clip appliers, and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.
Product codes (comma separated list FDA assigned to the subject device)
NAY
Device Description
The working ends and elements of the Intuitive Surgical™ Endoscopic Instruments and Accessories are essentially identical in size and shape to the predicate devices referenced and represent standard embodiments of standard surgical tools modified for use with the Intuitive Surgical™ Endoscopic Instrument Control 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
It is intended to be used by professionals in operating room environments.
It is intended for use by 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
An extensive prospectively randomized and concurrently controlled clinical study was performed to demonstrate substantial equivalence to the predicate devices cited in trans of safety and effectiveness.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design analysis and comparison as well as in vitro testing confirm that basic functional characteristics are substantially equivalent to the predicate devices cited.
An extensive prospectively randomized and concurrently controlled clinical study was performed to demonstrate substantial equivalence to the predicate devices cited in trans of safety and effectiveness.
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).
Any future design changes that affect the operating surgeons ability to personally and immediately intervene in the surgical procedure being to performed will be considered to have a major impact on the device's intended use. Therefore, any design changes that remove the operating surgeon from the immediate vicinity of the patient will require the submission of a traditional or abbreviated 510(k) submission.
§ 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
510(k) SUMMARY -- Intuitive Surgical, Inc.
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: TBD
Applicant Information:
| Date Prepared: | January 15, 1999 |
|---|---|
| Name: | Intuitive Surgical, Inc. |
| Address: | 1340 W. Middlefield Road |
| Mountain View, California 94043 | |
| Contact Person: | Michael A. Daniel |
| Phone Number: | (650) 237-7036 |
| Facsimile Number: | (650) 526-2060 |
Device Information:
| Classification: | Class I / II Gynecologic Laparoscope and Accessories
Electrocautery, Endoscope and Accessories |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Intuitive Surgical™ Instruments / Accessories:
"Resposable" (limited reuse) Endoscopic Instruments
including: Scissors, Scalpels, Forceps, Clip Applier,
Electrocautery and accessories, Pick-ups and Needle
Drivers / Holders for use with:
The Intuitive Surgical™ Endoscopic Instrument Control System |
| Common Name: | Endoscopic Instruments and Accessories |
| Classification Name: | Endoscope and Accessories, 21 CFR 876.1500
Gynecologic laparoscope and Acces. 21 CFR 884.1720 |
.
Predicate Devices:
The Intuitive Surgical™ Endoscopic Instruments and Tools are substantially equivalent in intended use and/or method of operation to the following prodicate deviccs:
- The Intuitive Surgical™ Endoscopic Instrument Control System and selected 2. instruments (K975001).
003
136
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Device Description:
The working ends and elements of the Intuitive Surgical™ Endoscopic Instruments and Accessories are essentially identical in size and shape to the predicate devices referenced and represent standard embodiments of standard surgical tools modified for use with the Intuitive Surgical™ Endoscopic Instrument Control System.
Intended Use:
The Intuitive Surgical™ Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical™ Endoscopic Instruments including, rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps / pick-ups, needle holders, clip appliers, endoscopic retractors, stabilizers, electrocautery and accessories during laparoscopic surgical procedures. It is intended to be used by professionals in operating room environments.
Comparison to Predicate Device(s):
The Intuitive Surgical™ Instruments are essentially identical in terms of shape, size, function and tissue effect to the standard Class I and II endoscopic instruments cited. Further, the Intuitive Surgical™ Instrument Control System with the additional endoscopic instruments is substantially equivalent to the cleared Intuitive Surgical™ Instrument Control System (K975001).
In Vitro Test Data:
Design analysis and comparison as well as in vitro testing confirm that basic functional characteristics are substantially equivalent to the predicate devices cited.
Clinical Study Data:
An extensive prospectively randomized and concurrently controlled clinical study was performed to demonstrate substantial equivalence to the predicate devices cited in trans of safety and effectiveness.
Summary:
Based upon the product technical information, intended use, and performance information provided in the pre-market notification, the Intuitive Surgical Endoscopic Instrument Control System has been shown to be substantially equivalent to curvently marketed predicate devices.
Intuitive™ and Intuitive Surgical™ is a registered trademark of Intuitive Surgical, Inc.
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Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
David Casal, Ph.D. Vice President of Clinical, Regulatory and Quality Affairs Intuitive Surgical, Inc. 1340 W. Middlefield Road Mountain View, California 94043
JUL 11 2000
Re: K990144
Trade Name: Intuitive Surgical™ da Vinci Endoscopic Instrument Control System and Endoscopic Instruments Regulatory Class: II Product Code: NA Y Dated: 18 November 1999 Received: 29 November 1999
Dear Dr. Casal:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the generals controls provisions of the Act and the following limitation:
Any future design changes that affect the operating surgeons ability to personally and immediately intervene in the surgical procedure being to performed will be considered to have a major impact on the device's intended use. Therefore, any design changes that remove the operating surgeon from the immediate vicinity of the patient will require the submission of a traditional or abbreviated 510(k) submission.
The general controls of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for
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Page 2 - David Casal, Ph.D.
Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections. the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
Sincerely yours,
Ala with
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K990144
Intuitive Surgical™ da Vinci™ Endoscopic Instrument Control System Device name: and Endoscopic Instruments
Indications for Use:
The Intuitive Surgical™ Endoscopic Instrument Control System (hcreinafter referred to as the "da Vinci™ System") is intended to assist in the accurate control of Intuitive Surgical™ endoscopic instruments including: rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps / pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories during laparoscopic surgical procedures such as cholecystectomy or Nissen fundoplication. It is intended for use by trained physicians in an operating room environment.
Intuitive Surgical™ Endoscopic Instruments including scissors, scalpels, forceps/pickups, needle holders, clip appliers, and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing .
Cila with
(Division Sign-Off)
Division of General Res 510(k) Number
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use
OR
Over-the Counter Use
(per 21 CFR §801.109
(Optional Format 1-2-96)
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