(193 days)
Not Found
No
The document describes a surgical robotic system and its instruments, focusing on mechanical control, reprocessing instructions, and performance studies related to cleaning, disinfection, and human factors. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as assisting in the accurate control of surgical instruments for various procedures, including manipulation of tissue, cutting, suturing, and delivery of ablation probes. It is also explicitly stated in the "Intended Use / Indications for Use" that the Intuitive Surgical Endoscopic Instrument Control System is intended to assist in various surgical procedures, which directly relate to the treatment or mitigation of disease.
No
Explanation: The device description and intended use focus on assisting surgical procedures (e.g., grasping, cutting, suturing, ablation) and providing control for instruments. There is no mention of the device performing any diagnostic functions like analyzing patient data, görüntüleme for diagnosis, or providing diagnostic interpretations.
No
The device description explicitly details hardware components such as instruments, accessories, cannulae, obturators, and the surgical system itself (IS2000/IS3000), indicating it is not a software-only device. The 510(k) is for changes to reprocessing instructions for these reusable hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The descriptions clearly state that this system is used for surgical procedures involving the manipulation of tissue within the body (in vivo). It assists surgeons in performing tasks like cutting, grasping, suturing, and delivering probes.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens outside of the body.
The device is a surgical system designed for performing procedures directly on a patient.
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/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, lisation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiae revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The Intuitive Surgical da Vinci Harmonic ACE™ Device is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the da Vinci Surgical Systems (Model IS1200, IS2000 and IS3000) and the Ethicon Endo-Surgery Generator 300 (Model GEN04) and Hand Piece (Model HP054).
The Flared Cannulae are intended to be used with the da Vinci Surgical System (da Vinci S (Model 1S2000) or da Vinci Si (Model 1S3000) to serve as a port of entry during da Vinci procedures that do not require maintenance of insufflation.
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, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic surgical procedures, general noncardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiarization. The system is indicated for adult and pediatric use. 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.
The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical® da Vinci Si Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps(pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping. cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system is indicated for adult and pediatric use. 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.
Product codes (comma separated list FDA assigned to the subject device)
NAY
Device Description
The da Vinci IS2000 (S) and IS3000 (Si) Surgical Systems are used in conjunction with reusable Instruments and Accessories to achieve their intended use. This 510(k) is submitted for changes to Reprocessing Instructions for all reusable da Vinci S and da Vinci Si Instruments and Accessories.
da Vinci S/ Si EndoWrist Instruments (5mm & 8mm): IS2000/IS3000 5mm and 8mm Instruments can be used only with the da Vinci S (IS2000) and Si (IS3000) Surgical Systems. Most instruments have a unique articulating design at their distal tips that mimics the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips.
Harmonic ACE Curved Shears (5mm & 8mm): The Harmonic ACE Curved Shears Instrument (5mm/8mm) consists of a proximal reusable instrument housing and a distal disposable insert. The reusable instrument housing, when assembled with the disposable insert, is attached to the da Vinci IS2000/IS3000 System and delivers ultrasonic energy for transection (cutting) and coagulation of tissue.
Endowrist Stabilizer: The Endowrist Stabilizer is a reusable instrument similar to the da Vinci S/ Si EndoWrist Instruments. It is mounted on a PSM arm and is positioned, controlled, and held in place by the da Vinci IS2000/IS3000 System.
da Vinci S/ Si Accessories: da Vinci S/ Si Accessories mainly consist of: Cannulae, which are essentially hollow tubes that provide a path for instruments to access the surgical site; Obturators, which provide a means of initially inserting the seal and cannula assemblies through the body wall by providing a fitted tip that extends beyond the cannula's most distal point. "Other" Accessories include PK Cables, instrument release kit (IRK), Blade Protectors and Insertion tools (used with the Snap-FitTM Scalpel Instrument), a Blank Cartridge (used with the Endopass Delivery instrument), cannula mounts, light guide cable and cannula gage pins. These accessories have simple geometries with no long narrow lumens.
Flared Cannula (5mm & 8mm): The Flared Cannula consists of a tapered hollow tubular shaft with a flared distal tip and a bowl with an integral electrical receptacle. The hollow shaft serves as the port of entry, the bowl is used to attach the cannula to the da Vinci S/Si Surgical System and the receptacle allows for attachment of commercially available dispersive electrode grounding pad via a 2-pin grounding connector.
8.5 mm Endoscope Cannula and 8.5 mm Endoscope Alignment Target: The 8.5 mm Endoscope Cannula is made of stainless steel components and is used to establish a port of entry for the 8.5mm Endoscope and provide an outlet for insufflation and/or smoke evacuation. The Endoscope Alignment Target is used during stereo endoscope set-up to align the left and right images from the endoscope to provide a stereo image to the console surgeon. It does not have any long narrow lumens.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urologic, general laparoscopic, gynecologic laparoscopic, transoral otolaryngology, general thoracoscopic, thoracoscopically assisted cardiotomy, cardiac revascularization.
Indicated Patient Age Range
Adult and pediatric use (except for transoral otolaryngology surgical procedures).
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 test data demonstrates 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 Cleaning Validations, Thermal Disinfection Validation and Human Factors Validation studies. Verification, design validation and biocompatibility testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate devices.
Cleaning Validation: The cleaning validation testing validates the efficacy of the cleaning process in the Reprocessing Instructions. Testing was performed using devices within the product family that represent the greatest challenge for the cleaning process. The Cleaning Efficacy test evaluated the cleaning process using qualitative visual inspection and quantitative endpoints.
Thermal Disinfection Validation: The disinfection validation testing validates the efficacy of the disinfection process in the Reprocessing Instructions. Efficacy of the thermal disinfection process was performed using devices within the product family that represent significant challenges to the disinfection step within the scope of the intended use. The thermal disinfection efficacy testing evaluated the efficacy of the disinfection process in the Reprocessing Instructions using a quantitative endpoint i.e., 6-log10 reduction of typical vegetative organisms, such as Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, and representatives of the Klebsiella-Enterobacter group.
Human Factors Testing: The Reprocessing Instructions underwent a Human Factors testing process including:
- Preliminary Evaluation: To better understand the users, uses, and use environment.
- Usability Risk Analysis (URA): Task and Use Error analysis was conducted for Reprocessing, including the process and Reprocessing Instructions.
- Design Team Participation: Human Factors Engineers participated in design meetings and played a significant role in the visual design and content development.
- Formative Testing: Completed during the development of the new Reprocessing Instructions.
- Validation Testing: Validation test of representative Reprocessing Instructions was completed with representative end users.
This validation study assessed the usability, effectiveness, and use safety of the Reprocessing Instructions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Quantitative endpoint for thermal disinfection: 6-log10 reduction of typical vegetative organisms.
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.
K050369, K081137, K090993, K123329, K093217, K060391, K101743, K080155
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.
0
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2017
Intuitive Surgical, Inc. Kunal Gunjal Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K170644
Trade/Device Name: Da Vinci S/Si Endowrist Instruments and Accessories, Harmonic Ace Curved Shears (5mm & 8mm) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: August 14, 2017 Received: August 15, 2017
Dear Kunal Gunjal:
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 Actinclude 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) 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" (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 Industry and Consumer Education (DICE) 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.
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
2
7 510(k) Summary (K170644)
This 510(k) applies to multiple instruments and accessories that have been cleared through a number of 510(k) Premarket Notifications. It concerns the Reprocessing Instructions provided to users for reprocessing of instruments and accessories intended for multiple usage. For ease of review, the subject devices have been listed in Tables 7.1 and 7.2 (which is structured based on the device and the da Vinci Surgical System with which it is used). No changes have been made in the design or materials of the subject devices.
| 510(k) Owner | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 | | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Contact | Kunal Gunjal
Regulatory Affairs Specialist, Regulatory Affairs
Phone Number: 408-523-8017
Fax Number: 408-523-8907
Email: Kunal.Gunjal@intusurg.com | | |
| Date Summary Prepared | August 14, 2017 | | |
| Trade Name | da Vinci S/ Si
EndoWrist
Instruments
(5mm & 8mm) | Harmonic ACE
Curved Shears
(5mm & 8mm) | Endowrist
Stabilizer |
| Common Name | Endoscope and
accessories | Endoscope and
accessories | Cardiovascular Surgical
Instrument |
| Classification | Class II,
21 CFR
876.1500 | Class II,
21 CFR
876.1500 | Class II,
21 CFR 876.1500 |
| Product Codes | NAY | NAY | NAY |
| Classification
Advisory
Committee: | General and
Plastic Surgery | General and
Plastic Surgery | General and Plastic Surgery |
| Predicate
Devices | K050369 (use
with IS2000
Surgical
System), with
additional
indications
under K081137
(use with
IS3000
System),
K090993
(TORS
indication) and
K123329
(updated TORS
indication) | K093217 (use
with IS2000 and
IS3000 Surgical
Systems) | K060391 (use with IS2000
Surgical System
K081137 (use with IS3000
System) |
| Table 7.1: Reusable Instruments used with the da Vinci S/Si (IS2000/IS3000) System | ||
|---|---|---|
Image /page/2/Picture/8 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.
3
Changes to Reprocessing Instructions
| 510(k) Owner | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 | | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Kunal Gunjal
Regulatory Affairs Specialist, Regulatory Affairs
Phone Number: 408-523-8017
Fax Number: 408-523-8907
Email: Kunal.Gunjal@intusurg.com | | |
| Date Summary Prepared | August 14, 2017 | | |
| Trade Name | da Vinci S/ Si Accessories | Flared Cannula (5mm & 8mm) | 8.5 mm Endoscope Cannula
and 8.5 mm Endoscope
Alignment Target |
| Common Name | Endoscope and accessories | Endoscope and accessories | Endoscope and accessories |
| Classification | Class II, 21 CFR 876.1500 | Class II, 21 CFR 876.1500 | Class II, 21 CFR 876.1500 |
| Product Codes | NAY | NAY | NAY |
| Classification Advisory Committee: | General and Plastic Surgery | General and Plastic Surgery | General and Plastic Surgery |
| Predicate Devices | K050369 (use with IS2000 Surgical System), with additional indications under K081137 (use with IS3000 System), K090993 (TORS indication) and K123329 (updated TORS indication) | K101743 (use with IS2000 and IS3000 Surgical Systems) | K080155 (use with IS2000 Surgical System), with additional indications under K081137 (use with IS3000 System), K090993 (TORS indication) and K123329 (updated TORS indication) |
Table 7.2: Reusable Accessories used with the da Vinci S/Si (IS2000/IS3000) System
Device Description
The da Vinci IS2000 (S) and IS3000 (Si) Surgical Systems are used in conjunction with reusable Instruments and Accessories to achieve their intended use. This 510(k) is submitted for changes to Reprocessing Instructions for all reusable da Vinci S and da Vinci Si Instruments and Accessories. Tables 7.3 and 7.4 list the device descriptions for the subject devices impacted by the changes to the reprocessing instructions.
Image /page/3/Picture/7 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with a registered trademark symbol.
4
| Trade Name | da Vinci S/ Si EndoWrist
Instruments (5mm & 8mm) | Harmonic ACE Curved Shears
(5mm & 8mm) | Endowrist Stabilizer |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | S2000/IS3000 5mm and 8mm
Instruments can be used only
with the da Vinci S (IS2000)
and Si (IS3000) Surgical
Systems. Most instruments
have a unique articulating
design at their distal tips that
mimics the human wrist.
While seated at the Surgeon
Console of the Surgical
System, the surgeon can
precisely control movements
of the end
effectors/instrument tips. | The Harmonic ACE Curved
Shears Instrument (5mm/8mm)
consists of a proximal reusable
instrument housing and a distal
disposable insert. The reusable
instrument housing, when
assembled with the disposable
insert, is attached to the da
Vinci IS2000/IS3000 System
and delivers ultrasonic energy
for transection (cutting) and
coagulation of tissue. | The Endowrist Stabilizer is a
reusable instrument similar to the
da Vinci S/ Si EndoWrist
Instruments. It is mounted on a
PSM arm and is positioned,
controlled, and held in place by the
da Vinci IS2000/IS3000 System. |
Table 7.3: Reusable Instruments used with the da Vinci S/Si (IS2000/IS3000) System
| Table 7.4: Reusable Accessories used with the da Vinci S/Si (IS2000/IS3000) System | ||
|---|---|---|
| Trade
Name | da Vinci S/ Si Accessories | Flared Cannula (5mm &
8mm) | 8.5 mm Endoscope Cannula and 8.5 mm
Endoscope Alignment Target |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | da Vinci S/ Si Accessories mainly consist of:
Cannulae, which are essentially hollow tubes
that provide a path for instruments to access the
surgical site
Obturators, which provide a means of initially
inserting the seal and cannula assemblies
through the body wall by providing a fitted tip
that extends beyond the cannula's most distal
point.
"Other" Accessories include PK Cables,
instrument release kit (IRK), Blade Protectors
and Insertion tools (used with the Snap-FitTM
Scalpel Instrument), a Blank Cartridge (used
with the Endopass Delivery instrument),
cannula mounts, light guide cable and cannula
gage pins. These accessories have simple
geometries with no long narrow lumens. | The Flared Cannula
consists of a tapered
hollow tubular shaft with
a flared distal tip and a
bowl with an integral
electrical receptacle. The
hollow shaft serves as the
port of entry, the bowl is
used to attach the cannula
to the da Vinci S/Si
Surgical System and the
receptacle allows for
attachment of
commercially available
dispersive electrode
grounding pad via a 2-pin
grounding connector. | The 8.5 mm Endoscope Cannula is made
of stainless steel components and is used to
establish a port of entry for the 8.5mm
Endoscope and provide an outlet for
insufflation and/or smoke evacuation.
The Endoscope Alignment Target is used
during stereo endoscope set-up to align the
left and right images from the endoscope to
provide a stereo image to the console
surgeon. It does not have any long narrow
lumens. |
Indications for Use:
Tables 7.5 through 7.7 list the Indications for Use for the devices impacted by the changes to the reprocessing instructions. There is no change in the Indications for Use between the subject and predicate devices.
Image /page/4/Picture/9 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a light gray color, with the registered trademark symbol next to it. There is a yellow dot above the "I" in "INTUITIVE".
5
| Trade Name | da Vinci S/ Si EndoWrist Instruments (5mm&
8mm) and Accessories | Harmonic ACE Curved Shears (5mm& 8mm) |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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/pick-ups, needle
holders, endoscopic retractors, stabilizers,
electrocautery and accessories for endoscopic
manipulation of tissue, including grasping,
cutting, blunt and sharp dissection,
approximation, ligation, electrocautery, suturing,
and delivery and placement of microwave and
cryogenic ablation probes and accessories, during
urologic surgical procedures, general laparoscopic
surgical procedures, gynecologic laparoscopic
surgical procedures, transoral otolaryngology
surgical procedures restricted to benign and
malignant tumors classified as TI and T2, and for
benign base of tongue resection procedures,
general thoracoscopic surgical procedures, and
thoracoscopically assisted cardiotomy procedures.
The system can also be employed with adjunctive
mediastinotomy to perform coronary anastomosis
during cardiac revascularization. The system is
indicated for adult and pediatric use (except for
transoral otolaryngology surgical procedures). It
is intended to be used by trained physicians in an
operating room environment in accordance with
the representative, specific procedures set forth in
the Professional Instructions for Use. | The Intuitive Surgical da Vinci Harmonic ACE™
Device is intended for soft tissue incisions when
bleeding control and minimal thermal injury are
desired. It is designed to be used in conjunction with
the da Vinci Surgical Systems (Model IS1200, IS2000
and IS3000) and the Ethicon Endo-Surgery Generator
300 (Model GEN04) and Hand Piece (Model HP054). |
Table 7.6: EndoWrist Stabilizer Instrument used with the da Vinci S/Si (IS2000/IS3000) System
| Trade Name | EndoWrist Stabilizer Instrument- For use with the da
Vinci S IS2000 System) | EndoWrist Stabilizer Instrument- For use with the da Vinci Si IS3000
System) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, cutting, blunt
and sharp dissection, approximation, ligation,
electrocautery, suturing, and delivery and placement of
microwave ablation probes and accessories during
urologic surgical procedures, general laparoscopic
surgical procedures, gynecologic laparoscopic surgical
procedures, general noncardiovascular thoracoscopic
surgical procedures and thoracoscopically assisted
cardiotomy procedures. The system can also be
employed, with adjunctive mediastinotomy to perform
coronary anastomosis during cardiac revascularization.
The system is indicated for adult and pediatric use. 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. | The Intuitive Surgical Endoscopic Instrument Control System (Intuitive
Surgical® da Vinci Si Surgical System Model IS3000) 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/pick-ups, needle holders,
endoscopic retractors, stabilizers, electrocautery and accessories for
endoscopic manipulation of tissue, including grasping, cutting, blunt and
sharp dissection, approximation, ligation, electrocautery, suturing, and
delivery and placement of microwave and cryogenic ablation probes and
accessories during urologic surgical procedures, general laparoscopic
surgical procedures, gynecological laparoscopic surgical procedures,
general cardiovascular and non-cardiovascular thoracoscopic surgical
procedures, and thoracoscopically assisted cardiotomy procedures. The
system is indicated for adult and pediatric use. 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. |
6
| Trade Name | Flared Cannula (5mm & 8mm) |
|---|---|
| Indications for Use | The Flared Cannulae are intended to be used with the da Vinci Surgical System (da Vinci S (Model |
| 1S2000) or da Vinci Si (Model 1S3000) to serve as a port of entry during da Vinci procedures that | |
| do not require maintenance of insufflation. |
Table 7.7: Flared Cannula (5mm & 8mm) used with the da Vinci S/Si (1S2000/IS3000) System
Technological Characteristics:
The technological characteristics of the subject devices are identical to the predicate devices.
Performance Data:
Performance test data demonstrates 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 Cleaning Validations, Thermal Disinfection Validation and Human Factors Validation studies. Verification, design validation and biocompatibility testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate devices.
Cleaning Validation
The cleaning validation testing summarized in this submission validates the efficacy of the cleaning process in the Reprocessing Instructions in accordance with the following standards and guidance documents:
- FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation ● Methods and Labeling", document issued on: March 17, 2015
- AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for 0 reprocessing in health care facilities: A guide for medical device manufacturers
- AAMI TIR 30: 2011 A compendium of processes, materials, test methods, and ● acceptance criteria for cleaning reusable medical devices
Cleaning validation testing was performed using devices within the product family that represent the greatest challenge for the cleaning process. The Cleaning Efficacy test evaluated the cleaning process (as described in the Reprocessing Instructions) for the devices using qualitative visual inspection and quantitative endpoints.
Thermal Disinfection Validation
The disinfection validation testing summarized in this submission validates the efficacy of the disinfection process in the Reprocessing Instructions in accordance with the following guidance documents:
Image /page/6/Picture/18 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a small yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.
7
- K170644
- FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation ● Methods and Labeling", document issued on: March 17, 2015
- FDA Guidance, "Class II Special Controls Guidance Document: Medical Washers and ● Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff", document issued on February 7, 2002.
Efficacy of the thermal disinfection process (as described in the Reprocessing Instructions) was performed using devices within the product family that represent significant challenges to the disinfection step within the scope of the intended use. The thermal disinfection efficacy testing evaluated the efficacy of the disinfection process in the Reprocessing Instructions using a quantitative endpoint i.e., 6-log10 reduction of typical vegetative organisms, such as Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, and representatives of the Klebsiella-Enterobacter group.
Human Factors Testing
The Reprocessing Instructions underwent a rigorous Human Factors testing process. This process included:
- Preliminary Evaluation: A preliminary evaluation was completed to better understand . the users, uses, and use environment.
- . Usability Risk Analysis (URA): Task and Use Error analysis was conducted for Reprocessing. This analysis included the process and Reprocessing Instructions.
- Design Team Participation: Human Factors Engineers participated in design meetings 0 and played a significant role in the visual design and content development.
- 0 Formative Testing: Formative tests were completed during the development of the new Reprocessing Instructions.
- . Validation Testing: Validation test of representative Reprocessing Instructions was completed with representative end users.
This validation study assessed the usability, effectiveness, and use safety of the Reprocessing Instructions.
Summary:
Based on the intended use, indications for use, technological characteristics, performance data and nonclinical tests performed, the subject device is substantially equivalent and is as safe, as effective, and performs as well as the legally marketed predicate devices listed in Tables 7.1 and 7.2.
Image /page/7/Picture/17 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.
Page | 7-6
8
Changes to Reprocessing Instructions
Traditional 510(k)
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) K170644
Device Name
da Vinci S/Si EndoWrist Instruments (5mm & 8mm) and Accessories
Indications for Use (Describe)
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/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, lisation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiae revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*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)
Page 1 of 1
600000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Image /page/8/Picture/24 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Above the "I" in Intuitive is a yellow dot. Below the word "INTUITIVE" is the word "SURGICAL" in a smaller font and also in light gray.
9
Changes to Reprocessing Instructions
DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: January 31, 2017 Indications for Use See PRA Statement below.
510(k) Number (if known)
Device Name
Harmonic ACE Curved Shears Instrument (5mm & 8mm)
Indications for Use (Describe)
The Intuitive Surgical da Vinci Harmonic ACE™ Device is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the da Vinci Surgical Systems (Model IS 1200, IS2000 and IS3000) and the Ethicon Endo-Surgery Generator 300 (Model GEN04) and Hand Piece (Model HP054).
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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)
PSC Publiching Sarvices (301)-403-4740 17
Image /page/9/Picture/23 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a light gray sans-serif font, with a yellow dot above the "I". Below that, the word "SURGICAL" is in a smaller, light gray sans-serif font, with the registered trademark symbol next to it.
10
Changes to Reprocessing Instructions
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Flared Cannula (5mm & 8mm)
Indications for Use (Describe)
The Flared Cannulae are intended to be used with the da Vinci Surgical System (da Vinci S (Model 1S2000) or da Vinci Si (Model 1S3000) to serve as a port of entry during da Vinci procedures that do not require maintenance of insufflation.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*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)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Image /page/10/Picture/23 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" followed by the registered trademark symbol. The text is light gray against a white background.
11
Changes to Reprocessing Instructions
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) K170644
Device Name
EndoWrist Stabilizer Instrument
Indications for Use (Describe)
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, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic surgical procedures, general noncardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiarization. The system is indicated for adult and pediatric use. 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.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*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)
Page 1 of 1
PSC Publishing Services (301) 443-6740
Image /page/11/Picture/24 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a light gray sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.
12
Changes to Reprocessing Instructions
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
Endowrist Stabilizer Instrument
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical® da Vinci Si Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps(pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping. cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system is indicated for adult and pediatric use. 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.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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
"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)
Page 1 of 1
EP PSC Publishing Services (301) 443-6740