(60 days)
No
Artificial intelligence, deep neural networks, or machine learning are not mentioned in the document.
No
The device is described as an "adjunct imaging system" intended to provide real-time endoscopic visible and near-infrared fluorescence imaging, enabling visual assessment for surgeons. It does not directly perform or facilitate therapeutic actions.
No
The device is described as an "adjunct imaging system" that "enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion". Its purpose is to provide "real-time endoscopic visible and near-infrared fluorescence imaging" during surgery, which is primarily for guidance and visualization during an intervention, not for diagnosing a condition from scratch.
No
The device description clearly identifies hardware components like the Endoscope Controller (light source) and the SP Endoscope, which are integral parts of the imaging system.
No
The device is an imaging system used during surgery to visualize tissue within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The da Vinci SP Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci SP Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, using near-infrared imaging.
The SP Endoscope, 0° is intended to provide stereoscopic imaging enabling surgeons to perform minimally invasive endoscopic surgery with the da Vinci SP system. The endoscope supports standard visible light color imaging and near-infrared fluorescence imaging.
Product codes
NAY
Device Description
The da Vinci SP Firefly Imaging System is a fully integrated, adjunct imaging system for the da Vinci SP Surgical System. The da Vinci SP Surgical System is a robotic-assisted surgical device (RASD) that is designed to enable complex surgery using a minimally invasive approach. The system consists of three major subsystems: the Surgeon Console, the Vision Cart, and the Patient Cart.
The da Vinci SP Firefly Imaging System consists of the following components of the da Vinci SP Surgical System:
- the Endoscope Controller (light source) on the Vision Cart
- the SP Endoscope, 0° (subject device), which is installed on the Patient Cart
The Endoscope Controller provides a light source, either visible light or a near-infrared (NIR) excitation laser.
The Endoscope transmits visible light or NIR light from the Endoscope Controller via optical fibers to illuminate the surgical site. The stereoscopic camera at the Endoscope tip images the surgical site in either visible light mode or fluorescence imaging mode.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic visible light, Near-infrared imaging
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons / Hospital
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)
The subject device (SP Endoscope, PN 430600) underwent a series of tests to evaluate the impact of the modifications made to the device. Testing included design verification, reliability testing, cleaning validation, transit verification, biocompatibility, design validation, and Electromagnetic Compatibility (EMC) testing. The successful completion of testing demonstrated that the subject device (SP Endoscope, PN 430600) design outputs meet the design inputs, and the design validation validated that the user needs are met. The subject device is substantially equivalent to the predicate device and does not raise different questions of safety and effectiveness than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
FDA Clearance Letter - SP Endoscope, 0° (430600)
Page 1
May 13, 2025
Intuitive Surgical, Inc.
Kunal Gunjal
Sr. Regulatory Affairs Specialist
1266 Kifer Road
Sunnyvale, California 94086
Re: K250786
Trade/Device Name: SP Endoscope, 0 (430600)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: NAY
Dated: March 13, 2025
Received: March 14, 2025
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 (the 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. Although this letter refers to your product as a device, please be aware that some
cleared products may instead be combination products. The 510(k) Premarket Notification Database
available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.
Page 2
K250786 - Kunal Gunjal Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA
guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part
820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a
change requires premarket review, the QS regulation requires device manufacturers to review and approve
changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and
approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for
devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart
A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections
531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent
parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule").
The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label
and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the
dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR
830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device
Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these
requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-
comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K250786 - Kunal Gunjal Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark Trumbore -
S
Digitally signed by Mark
Trumbore -S
Date: 2025.05.13 11:19:17 -04'00'
Mark Trumbore Ph.D.
Assistant Director, THT4A1: Robotically-Assisted Surgical
Devices Team
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Indications for Use
Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions.
Please provide the device trade name(s).
SP Endoscope, 0° (430600)
Please provide your Indications for Use below.
The da Vinci SP Firefly Imaging System is intended to provide real-time endoscopic visible and
near-infrared fluorescence imaging. The da Vinci SP Firefly Imaging System enables surgeons
to perform minimally invasive surgery using standard endoscopic visible light as well as visual
assessment of vessels, blood flow and related tissue perfusion, using near-infrared imaging.
Please select the types of uses (select one or both, as applicable).
- Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
SP Endoscope, 0° Page 9 of 39
Page 5
510(k) Summary
510(k) Owner: Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086
Contact: Kunal Gunjal
Senior Regulatory Affairs Specialist
Email: Kunal.Gunjal@intusurg.com
Date Summary Prepared: March 12, 2025
Trade Name: SP Endoscope, 0°
Common Name: Endoscope and accessories
Classification: Class II
21 CFR 876.1500, Endoscope and Accessories
Product Codes: NAY (System, Surgical, Computer Controlled Instrument)
Classification Advisory
Committee: General and Plastic Surgery
Predicate Device: K212101 (EndoWrist SP Camera, 0°, PN 430077)
Page 6
510(k) Summary
510(k) Owner: Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086
Contact: Kunal Gunjal
Senior Regulatory Affairs Specialist
Email: Kunal.Gunjal@intusurg.com
Date Summary Prepared: March 12, 2025
Trade Name: SP Endoscope, 0°
Common Name: Endoscope and accessories
Classification: Class II
21 CFR 876.1500, Endoscope and Accessories
Product Codes: NAY (System, Surgical, Computer Controlled Instrument)
Classification Advisory
Committee: General and Plastic Surgery
Predicate Device: K212101 (EndoWrist SP Camera, 0°, PN 430077)
Page 7
Device Description
The da Vinci SP Firefly Imaging System is a fully integrated, adjunct imaging system for the da Vinci SP Surgical System. The da Vinci SP Surgical System is a robotic-assisted surgical device (RASD) that is designed to enable complex surgery using a minimally invasive approach. The system consists of three major subsystems: the Surgeon Console, the Vision Cart, and the Patient Cart.
The da Vinci SP Firefly Imaging System consists of the following components of the da Vinci SP Surgical System (refer to Figure 1):
o the Endoscope Controller (light source) on the Vision Cart
o the SP Endoscope, 0° (subject device), which is installed on the Patient Cart
The Endoscope Controller provides a light source, either visible light or a near-infrared (NIR) excitation laser.
The Endoscope transmits visible light or NIR light from the Endoscope Controller via optical fibers to illuminate the surgical site. The stereoscopic camera at the Endoscope tip images the surgical site in either visible light mode or fluorescence imaging mode.
![Figure 1.: Components of the da Vinci SP Firefly Imaging System within the da Vinci SP Surgical System]
Page 8
Indications for Use:
The da Vinci SP Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci SP Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, using near-infrared imaging.
Intended Use:
The SP Endoscope, 0° is intended to provide stereoscopic imaging enabling surgeons to perform minimally invasive endoscopic surgery with the da Vinci SP system. The endoscope supports standard visible light color imaging and near-infrared fluorescence imaging.
Comparison of Predicate and Subject Device (SP Endoscope, 0°)
Table 2 below includes a comparison of the subject device (SP Endoscope, 0°, PN 430600) and the predicate device (EndoWrist SP Camera, 0°, PN 430077, cleared via K212101).
Design changes were made to the subject SP Endoscope (PN 430600) relative to the predicate EndoWrist SP Camera, 0° (PN 430077, cleared via K212101), to support increased number of lives (clinical uses).
Differences in the Characteristics as noted in this substantial equivalence comparison table is marked by GREYING OUT the specific rows. Additionally, any differences in the specific characteristics within these rows are BOLDED.
Page 9
Table 2: Comparison of Predicate and Subject Device (da Vinci SP Endoscope)
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| SP Endoscope, 0° | EndoWrist SP Camera, 0° (K212101) | |
| Manufacturer | Intuitive Surgical, Inc. | IDENTICAL to the subject device |
| Trade Name | SP Endoscope, 0° | EndoWrist SP Camera, 0° |
| Model # | 430600 | 430077 |
| Common Name | Endoscope and accessories | IDENTICAL to the subject device |
| Regulation Number | 21 CFR 876.1500 | IDENTICAL to the subject device |
| Product Code | NAY | IDENTICAL to the subject device |
| Device Classification | Class II | IDENTICAL to the subject device |
| Classification Advisory Committee | General and Plastic Surgery | IDENTICAL to the subject device |
Page 10
Table 2: Comparison of Predicate and Subject Device (da Vinci SP Endoscope)
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| SP Endoscope, 0° | EndoWrist SP Camera, 0° (K212101) | |
| System Compatibility | Compatible with the SP1098 system | IDENTICAL to the subject device |
| Indications for Use | The da Vinci SP Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci SP Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, using near-infrared imaging. | IDENTICAL to the subject device |
| Intended Use | The SP Endoscope, 0° is intended to provide stereoscopic imaging enabling surgeons to perform minimally invasive endoscopic surgery with the da Vinci SP system. The endoscope supports standard visible light color imaging and near-infrared fluorescence imaging. | The EndoWrist SP Endoscope, 0° is intended to provide stereoscopic imaging enabling surgeons to perform minimally invasive endoscopic surgery with the da Vinci SP system. The endoscope supports standard visible light color imaging and near-infrared fluorescence imaging. |
| Prescription use | Prescription/Physician use only | IDENTICAL to the subject device |
Page 11
Table 2: Comparison of Predicate and Subject Device (da Vinci SP Endoscope)
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| SP Endoscope, 0° | EndoWrist SP Camera, 0° (K212101) | |
| Where used (hospital, home, ambulance, etc) | Hospital | IDENTICAL to the subject device |
| Number of Lives and Reprocessing Cycles | Number of Lives: 50 | |
| Number of Reprocessing Cycles: 60 | Number of Lives: 33 | |
| Number of Reprocessing Cycles: 40 | ||
| Compatible System and Accessories | Compatible with the following system and accessories: | |
| o da Vinci SP Firefly Imaging System (K212101) | ||
| o SP Camera Sheath (K173906) | IDENTICAL to the subject device | |
| Biocompatibility | All patient-contacting materials are biocompatible per ISO 10993-1 | IDENTICAL to the subject device |
| Sterilization Method | Steam Sterilization | IDENTICAL to the subject device |
| Sterility / Disposable or Multiple use | Multiple use | IDENTICAL to the subject device |
| Cleaning and Disinfection Method | Manual Cleaning Process and Thermal Disinfection | IDENTICAL to the subject device |
Page 12
Table 2: Comparison of Predicate and Subject Device (da Vinci SP Endoscope)
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| SP Endoscope, 0° | EndoWrist SP Camera, 0° (K212101) | |
| Packaging | Non-sterile packaging, reusable | IDENTICAL to the subject device |
Performance Data:
The subject device (SP Endoscope, PN 430600) underwent a series of tests to evaluate the impact of the modifications made to the device. Testing included design verification, reliability testing, cleaning validation, transit verification, biocompatibility, design validation, and Electromagnetic Compatibility (EMC) testing. The successful completion of testing demonstrated that the subject device (SP Endoscope, PN 430600) design outputs meet the design inputs, and the design validation validated that the user needs are met. The subject device is substantially equivalent to the predicate device and does not raise different questions of safety and effectiveness than the predicate device.
Design Verification
Bench testing was performed to verify that the functional design outputs met the functional design inputs. The design verification in this section addressed the following:
o Design Properties
o Range of Motion
o PSC Interaction
o Optical Performance
o Electrical Properties
o Firefly
o Mechanical requirements (Crimp Strength, Window Strength, Extended Illumination, Tip Durability, and Manifold Air Permeability)
Page 13
Reliability Testing
Reliability Testing was performed to ensure that subject device, SP Endoscope (PN 430600) is not adversely affected by the increased number of lives (uses) and reprocessing cycles.
Cleaning Validation
Cleaning Validation was performed to validate the efficacy of the manual cleaning process in accordance with the following standards and guidance documents:
o FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", document issued on: March 17, 2015 (Amended on June 9, 2017).
o AAMI ST98:2022, Cleaning validation of health care products – Requirements for development and validation of a cleaning process for medical devices.
o AAMI TIR 12:2020, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.
o AAMI TIR 30: 2011/(R)2016, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
o ISO 17664-1:2022, Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices.
The subject device (SP Endoscope, PN 430600) successfully met the acceptance criteria for all markers and the test results demonstrate that the subject device can be cleaned using the manual cleaning process.
Transit Verification Testing
Transit Verification Testing was performed in accordance with ASTM D4169-22, Standard Practice for Performance Testing of Shipping Containers and Systems. The subject device, (SP Endoscope, PN 430600) met all the acceptance criteria and the test results demonstrate that the subject device has been validated for use within the shipping and distribution environment.
Page 13
Biocompatibility
Biocompatibility testing was completed in accordance with the following standards and guidance documents:
o FDA Guidance: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", document issued on September 8th, 2023
o ISO 10993-1:2018, Biological evaluation of medical devices
The subject device, (SP Endoscope, PN 430600) met all acceptance criteria for biocompatibility testing. The Biological Safety Assessment for the device materials determined that there was negligible risk to patient safety under its intended use. Therefore, the subject device met the safety and biocompatibility requirements per ISO 10993-1.
Design Validation
Simulated clinical use testing was performed to validate that the product specifications meet the user's needs and intended use.
EMC Testing
Electromagnetic Compatibility (EMC) testing was performed on the SP1098 System (which includes the subject device, SP Endoscope PN 430600) in accordance with IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. The test results demonstrate that the subject device meets the applicable requirements within this standard.
Conclusion:
Based on the intended use, indications for use, technological characteristics and performance data, the subject device, SP Endoscope, 0° (PN 430600) is substantially equivalent to the predicate device (EndoWrist SP Camera, 0°, PN 430077, cleared via K212101).