(28 days)
No
The summary describes a surgical robotic system that provides instrument control and stereo vision, but there is no mention of AI or ML being used for image processing, decision support, or any other function. The focus is on the mechanical and visual aspects of the system.
Yes
The device is described as assisting in surgical procedures such as cutting, electrocautery, and suturing during general laparoscopic and thoracoscopic surgical procedures, which are therapeutic interventions. Additionally, the Harmonic Curved Shears Instruments are used for soft tissue incisions for bleeding control, which is also a therapeutic function.
No
Explanation: This device is described as an Endoscopic Instrument Control System intended to assist in the accurate control of surgical instruments for various surgical procedures (e.g., grasping, cutting, suturing). It is a surgical tool, not a device used for diagnosis.
No
The device description clearly outlines a system comprised of hardware components (Surgeon Console, Patient Side Cart, manipulators, endoscope, camera, light source, etc.) in addition to software control. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system and instruments for surgical procedures involving manipulation, cutting, and other actions on tissue within the body. This is the definition of an in vivo device.
- Device Description: The description details a surgical system with a surgeon console, patient side cart, manipulators, and an endoscopic vision system. These are all components used for performing surgery directly on a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
Therefore, the Intuitive Surgical® Endoscopic Instrument Control System and associated instruments are surgical devices, not IVDs.
N/A
Intended Use / Indications for 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, scissors, scalpels, ultrasonic shears, forceps/pickups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, blunt and sharp dissection, approximation, ligation. cutting. electrocautery and suturing during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
Intuitive Surgical® Harmonic Curved Shears Instruments are designed to be used in conjunction with the da Vinci® Surgical System and with the Ethicon Endo-Surgery UltraCision® Harmonic Scalpel® Hand Piece (HP054) and UltraCision® Harmonic Scalpel® Generator Model 300 (GEN04), and is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. This instrument is not intended for use on cartilage, bone or hard objects, or for contraceptive tubal occlusion.
Product codes (comma separated list FDA assigned to the subject device)
NA Y
Device Description
This special 510(k) is being submitted for a modification of Intuitive Surgical® Ultrasonic Shears. The subject device is similar to the Ultrasonic Shears instrument cleared by FDA in 2001 (K011281) and UltraCision® Harmonic Scalpel® LCS & CS Curved Shears instrument cleared by FDA in 2001 for Ethicon Endo-Surgery, Inc. (K993054). The Harmonic Curved Shears Instruments are to be used with the Intuitive Surgical® Endoscopic Instrument Control System, known as the da Vinci® Surgical System.
The da Vinci® Surgical System consists of two integrated sub-systems as follows:
Intuitive Surgical® Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC. which is located immediately adjacent to the patient, via cables. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.
Intuitive Surgical® Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci® Surgical System, also known as Intuitive Surgical Insite™ Vision System, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite™ Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.
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)
Design analysis and comparison, as well as bench testing confirm that basic functional characteristics are substantially equivalent to the predicate devices cited, and that design output meets the design input 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.
K990144 / K002489 / K011002 / K021036 / K022574 / K040237
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
K042855 1/2
NOV 1 2 2004
Section II
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance I ms summary of 91 ST (1) santy said 21 CFR 807.92.
510(k) Number:
| Date | October 12, 2004 |
|---|---|
| Submitter | Intuitive Surgical, Inc. |
| 950 Kifer Road | |
| Sunnyvale, CA 94086 | |
| ER Number | 2955842 |
| Contact | Mike Yramategui |
| Director, Regulatory Affairs | |
| Telephone: (408) 523 - 2145 | |
| Fax: (408) 523 - 1390 | |
| e-mail: mike.yramategui@intusurg.com | |
| New Device | Name: Harmonic Curved Shears Instrument |
| Classification Name: System, Surgical, Computer Controlled Instrument | |
| Common Name: Endoscopic Instrument, Harmonic Curved Shears | |
| Predicate | |
| Devices | Intuitive Surgical® Endoscopic Instrument Control System and Intuitive |
| Surgical® Endoscopic Instruments and accessories (legally marketed | |
| under K990144 / K002489 / K011002 / K021036 / K022574 / K040237), | |
| Intuitive Surgical® Ultrasonic Shears (K011281) and Ethicon Endo- | |
| Surgery, Inc., UltraCision® Harmonic Scalpel® LCS & CS Curved Shears | |
| (K993054). | |
| Device | |
| Description | This special 510(k) is being submitted for a modification of Intuitive |
| Surgical® Ultrasonic Shears. The subject device is similar to the | |
| Ultrasonic Shears instrument cleared by FDA in 2001 (K011281) and | |
| UltraCision® Harmonic Scalpel® LCS & CS Curved Shears instrument | |
| cleared by FDA in 2001 for Ethicon Endo-Surgery, Inc. (K993054). The | |
| Harmonic Curved Shears Instruments are to be used with the Intuitive | |
| Surgical® Endoscopic Instrument Control System, known as the da | |
| Vinci® Surgical System. |
1
2042855 2/2
The da Vinci® Surgical System consists of two integrated sub-systems as follows:
Device Description (continued)
Intuitive Surgical® Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC. which is located immediately adjacent to the patient, via cables. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.
Intuitive Surgical® Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci® Surgical System, also known as Intuitive Surgical Insite™ Vision System, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite™ Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.
- The Intuitive Surgical® Endoscopic Instrument Control System Intended Use is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pickups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, blunt and sharp dissection, approximation, ligation. cutting. electrocautery and suturing during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
2
| Intended Use
(continued) | Intuitive Surgical® Harmonic Curved Shears Instruments are designed to
be used in conjunction with the da Vinci® Surgical System and with the
Ethicon Endo-Surgery UltraCision® Harmonic Scalpel® Hand Piece
(HP054) and UltraCision® Harmonic Scalpel® Generator Model 300
(GEN04), and is intended for soft tissue incisions when bleeding control
and minimal thermal injury are desired. This instrument is not intended
for use on cartilage, bone or hard objects, or for contraceptive tubal
occlusion. |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to
Predicate
Device | The Intuitive Surgical® Harmonic Curved Shears Instruments described
herein is essentially identical in terms of shape, function, activation, and
use to the predicate Class II endoscopic instrument cited. The primary
difference is that the Ethicon Endo-Surgery predicate device is a hand-
held instrument, and the subject device is to be used in conjunction with
the Intuitive Surgical® da Vinci Surgical System. |
| Technological
Characteristics | The technological characteristics of the subject devices are the same as
for the predicate devices. |
| Performance
Data | Design analysis and comparison, as well as bench testing confirm that
basic functional characteristics are substantially equivalent to the
predicate devices cited, and that design output meets the design input
requirements. |
| Conclusion | Based upon the product technical information, intended use, and
performance information provided in this pre-market notification, the
Intuitive Surgical® Harmonic Curved Shears Instruments described
herein has been shown to be substantially equivalent to current legally
marketed predicate devices, and the results of the design control process
confirm that the design output meets the design input requirements. |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with its wings spread. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 2004
Mr. Michael H. Yramategui Director, Regulatory Affairs Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, California 94086
Re: K042855
Trade/Device Name: Intuitive Surgical® Endoscopic Instrument Control System Regulation Number: 21 CFR 876. 1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NA Y Dated: October 13, 2004 Received: October 15, 2004
Dear Mr. Yramategui:
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 such 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); 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.
4
Page 2 - Mr. Michael H. Yramategui
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provoost
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
Enclosure
5
Indications for Use
510(k) Number (if known):
Intuitive Surgical® Endoscopic Instrument Control System Device Name:
Indications For Use:
The Intuitive Surgical® Endoscopic Instrument Control System is intended to assist in the The Minine Surgical "Endoscopic Instruments including rigid endoscopes, accurate control of nonomic dissectors, scalpels, ultrasonic shears, forceps/pickups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for ups, neoule norders, choos tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing during general laparoscopic surgical approximation, neation, on-cardiovascular thoracoscopic surgical procedures, and procedures, general cardiotomy procedures. The system can also be employed, with mediastinotomy to perform coronary anastomosis during cardiac adjunctive adjunctive mediabline intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Miriam C. Provost
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K042855
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Intuitive Surgical® Harmonic Curved Shears Instruments
SPECIAL 510(k) Section III, Page 1 of 1