(277 days)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, 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. 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. 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 da Vinci Surgical System, Model IS4000 is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model IS4000 Surgical System consists of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and is used with an Endoscope, EndoWrist Instruments, and Accessories. The surgeon seated at the Surgeon Console controls all movement of the EndoWrist Instruments and Endoscope by using two Master Controls and a set of foot pedals. The surgeon views the three-dimensional endoscopic image on a High Resolution Stereo Viewer (3D Viewer), which provides him/her a view of patient anatomy and instrumentation, along with icons and other user interface features. The VSC includes the supporting electronic and video processing equipment for the system. The PSC is positioned at the operating room table and has four endoscope/instrument arms that are positioned over the target patient anatomy. An endoscope attaches onto one arm and provides the surgeon a high resolution, three-dimensional view of the patient anatomy. A suite of EndoWrist Instruments are attached/detached from the arms, enabling the surgeon to perform various surgical tasks. Accessories such as cannulas, obturators, seals, and drapes are also needed to perform procedures with the system.
Here's a breakdown of the acceptance criteria and the studies that support the performance of the Intuitive Surgical da Vinci Surgical System, Model IS4000, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary doesn't present a single, consolidated table of specific quantitative acceptance criteria with corresponding performance metrics like a typical clinical trial. Instead, the "acceptance criteria" are embedded within the descriptions of various verification and validation studies as "objective pass/fail criteria," "success criteria," and "ability to perform procedure safely and effectively." The Reported Device Performance generally indicates that these criteria were met.
Due to the nature of the primary evidence presented (bench testing, animal/cadaver models, and human factors assessment for substantial equivalence to a predicate device), the "performance metrics" are largely qualitative affirmations of functionality, safety, and clinical utility.
| Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|
| Bench Verification: | |
| Physical, mechanical, electrical, and system level requirements and design specifications met for PSC sub-components. | Tests verified that requirements and specifications were met. |
| VSC sub-components met functional requirements as defined in Functional Specification Documents. | Tests verified that functional requirements were met. |
| IS4000 instruments met physical, mechanical, and electrical requirements and specifications; compatible with software parameters and user interface. | Tests verified that requirements and specifications were met for all instrument types, including electrical testing, load handling, and grip force comparison. |
| Reusable instruments met projected life (5 clinical uses) after life testing (8 life cycles). | Confirmed that 9 representative instrument types met projected life. |
| Drapes with sterile adapters maintained sterility. | Evaluations confirmed drapes met specifications and requirements for maintenance of sterility. |
| Reusable trocars met physical, mechanical, and interface requirements. | Tests confirmed trocars met requirements. |
| Pre-Clinical Verification (Cadaver & Animal Models): | |
| Ability of IS4000 system to safely and effectively: maneuver PSC and USMs, reach/attach USMs, maintain adequate external clearance, reach internal surgical targets, maximize patient access. | The IS4000 system demonstrated the ability to safely and effectively perform all listed actions across various procedures (Low Anterior Resection, Gastric Bypass, Hysterectomy, Mitral Valve Repair, Cardiac Revascularization, Nephrectomy, Pediatric) in cadaver and porcine models. |
| Representative Surgical Procedures in Live Animal Models - Safety: Ability to perform procedure without intraoperative adverse events; normal vital signs & absence of device-related adverse events post-op. | Right Colectomy (Canine): Procedure performed without intraoperative adverse events (except for one non-device-related splenic injury during port placement, repaired). All animals survived 26 days with normal vital signs and no device-related adverse events. Nissen Fundoplication (Canine): Procedure performed without intraoperative adverse events (except for one non-device-related splenic injury, controlled). All animals survived with normal vital signs and no device-related adverse events. Pyeloplasty (Porcine): Procedure performed without intraoperative adverse events. All animals survived 26 days with normal vital signs and no device-related adverse events. Radical Nephrectomy (Porcine): Procedure performed without intraoperative adverse events (except for one non-device-related splenic injury during port placement, controlled). All animals survived 25-28 days with normal vital signs and no device-related adverse events. Hysterectomy (Porcine): Procedure performed without intraoperative adverse events. All animals survived 21 days with normal vital signs and no device-related adverse events. Mitral Valve Repair (Canine): Procedure performed without intraoperative adverse events (except for one non-device-related death in IS4000 group, excluded and replaced). No device-related adverse events. |
| Representative Surgical Procedures in Live Animal Models - Effectiveness: Specific clinical endpoints appropriate for each procedure. | Right Colectomy (Canine): Ileocolic anastomosis intact and healthy at euthanasia day. Normal eating and bowel movements post-op. Findings: Surgical time 30-65 min (shorter with experience), no conversion to open, EBL 10ml, anastomoses intact and functional for all 4 animals. Nissen Fundoplication (Canine): Fundoplication wrap intact and healthy at euthanasia day. Normal eating post-op. Findings: Surgical time 48-68 min, no conversion to open, EBL 13.8ml average, all wraps intact and no abnormalities. Pyeloplasty (Porcine): Normal urine passage, normal ureter peristalsis & no stricture at euthanasia. Normal eating/bowel movements post-op. Findings: Surgical time 50-62 min, no conversion to open, EBL 15ml average, ureteral anastomoses intact/functional, no stricture. Radical Nephrectomy (Porcine): Successful organ removal. Normal eating/bowel movements post-op. Findings: Surgical time 35-42 min, no conversion to open, EBL 12.5ml average, successful kidney removal for all 4 animals. Hysterectomy (Porcine): Successful organ removal. Normal eating/bowel movements post-op. Findings: Surgical time 29-55 min (shorter with experience), no conversion to open, EBL 10ml average, successful uterus removal for all 4 animals, vaginal cuffs intact, no leaks. Mitral Valve Repair (Canine): Cardioplegia catheter placement, pacemaker lead simulation, leaflet defect closure, annuloplasty with flexible band, intra-operative valve leak test. Findings: Surgical times comparable between IS3000 and IS4000 for various steps. All animals had mitral valve regurgitation measures equal to pre-op measures, acceptable to surgeons. |
| Human Factors: Intended users could perform essential and high-risk tasks safely and effectively; use-related risks mitigated; overall ease of use/usability assessed; no previously unknown use-related risks introduced. | Found to be safe and effective for its intended uses, by intended users, in intended environment. Use-related risks identified and mitigated, ensuring residual risk at acceptable levels and no diminished use-safety compared to IS3000. |
2. Sample Sizes and Data Provenance
-
Test Set (Verification/Validation Studies):
- Bench Verification:
- PSC: 1 to 6 units (depending on test case).
- VSC: 1 unit (except Endoscope and Endoscope adapter: 4-5 units).
- Instruments: Up to 5 units for all 24 instruments (specific numbers for load handling/grip forces not given, but mentioned "worst case representative instruments").
- Instrument Reliability/Life Testing: 9 instrument types, 4 units each.
- Accessories Testing: 5 units of each drape type; 4 units of each reusable trocar type.
- Pre-Clinical Verification (Cadaver and Animal Models):
- 10 human cadavers (2 male, 8 female).
- One 20 kg porcine model.
- Representative Surgical Procedures in Live Animal Models:
- Right Colectomy (Canine): N=4
- Nissen Fundoplication (Canine): N=4
- Pyeloplasty (Porcine): N=4
- Radical Nephrectomy (Porcine): N=4
- Hysterectomy (Porcine): N=4
- Mitral Valve Repair (Canine): N=9 (one IS4000 animal excluded due to non-device related death, replaced by another)
- Human Factors:
- 15 teams of users (includes 15 surgeons and 15 OR staff: 5 circulating nurses, 9 scrub nurse/tech, 1 physician's assistant).
- Bench Verification:
-
Data Provenance: The document does not specify the country of origin for the cadaver or animal models. The human factors study involved US-based participants (surgeons and OR staff) in a simulated OR environment. All studies appear to be prospective verification and validation studies designed specifically for this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth for Test Set
- Bench Verification: "Objective pass/fail criteria are defined and used." No specific number of experts mentioned, implies internal engineering/design team.
- Pre-Clinical Verification (Cadaver and Animal Models): No specific experts were used to "establish ground truth" in the diagnostic sense, rather, the performance was observed and evaluated against predefined functional/access requirements by the study team.
- Representative Surgical Procedures in Live Animal Models:
- One investigator (surgeon) for Right Colectomy, Nissen Fundoplication, Pyeloplasty, Radical Nephrectomy, Hysterectomy studies.
- Two board-certified cardio-thoracic surgeons for Mitral Valve Repair.
- Veterinary Pathologist for histopathology "if needed on abnormal tissue" for postmortem assessment (impartial expert for specific findings).
- Human Factors:
- 15 surgeons from different specialties (urology, gynecology, general surgery, thoracic) with varied experience from novice (<20 cases) to very experienced (>200 cases).
- 15 OR staff (5 circulating nurses, 9 scrub nurse/tech, 1 physician's assistant).
- These participants serve as the "ground truth" for usability and human factors, as their ability to safely and effectively use the device is what's being evaluated. Their qualifications are stated as their professional roles and experience levels.
4. Adjudication Method for the Test Set
- Bench Verification: "Objective pass/fail criteria are defined and used." This implies a clear binary assessment against predetermined standards, likely without subjective adjudication.
- Pre-Clinical Verification (Cadaver and Animal Models): Not explicitly stated, but the "safely and effectively" assessment likely involved the study investigators/team evaluating against pre-defined success metrics.
- Representative Surgical Procedures in Live Animal Models:
- For safety (adverse events) and effectiveness (clinical endpoints), the investigator(s) performing the surgery and the veterinary pathologist for postmortem assessment made the determinations. The presence of a single investigator for most studies suggests a direct observation without explicit multi-reader adjudication committees.
- In the Mitral Valve Repair study, with two surgeons performing the procedures, there's no mention of a formal adjudication process beyond their individual assessments within the study protocol.
- Human Factors: "Objective performance data included observations of users' ability to complete tasks, use-errors, close calls, and any difficulties encountered." "Subjective feedback included open-ended questions about risks and safety, multiple choice ratings, and follow-up interviews." This suggests data collection by human factors specialists who then analyze the findings, rather than an adjudication method typically seen in diagnostic accuracy studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly conducted to assess human reader improvement with AI vs. without AI assistance.
- The only comparative study mentioned is the "Mitral Valve Repair" study in canine models, which compared the performance of the IS4000 system to the predicate IS3000 system, using two surgeons for each model. This was a direct comparison of the devices themselves, not an assessment of human reader performance with or without AI assistance. The da Vinci system is not an AI-assisted diagnostic tool; it is a surgical robotics platform. Thus, the concept of "improving human readers with AI" is not directly applicable to this device's function.
6. Standalone (Algorithm Only) Performance
- Not applicable. The da Vinci Surgical System is an electro-mechanical system with a human surgeon in the loop at all times, controlling the instruments. It does not operate as a standalone algorithm without human interaction. Its "performance" is inherently tied to the interaction between the surgeon and the machine.
7. Type of Ground Truth Used
The "ground truth" for the performance of the da Vinci Surgical System, Model IS4000, is established through a combination of:
- Engineering Specifications and Bench Test Results: For physical, mechanical, and electrical properties, and instrument durability.
- Functional Success in Cadaveric and Live Animal Models: The ability to achieve surgical access, reach targets, maintain clearance, and successfully complete representative surgical procedures (e.g., intact anastomoses, successful organ removal, absence of stricture). This is based on direct observation and postmortem assessment by surgical investigators and veterinary pathologists.
- Human Factors Assessment: Demonstrating that intended users can perform tasks safely and effectively, with identified use-related risks mitigated, as assessed through observation and feedback from surgeons and OR staff.
- Substantial Equivalence: The ultimate ground truth for regulatory approval here is demonstrating substantial equivalence to the predicate device (IS3000), meaning the new device is as safe and effective as the already marketed predicate.
8. Sample Size for the Training Set
- The document describes verification and validation for a new surgical system, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI/ML is not applicable. The device's "training" in a functional sense comes through its design, engineering, and iterative development processes, not through data input in the same way an AI model is trained.
9. How the Ground Truth for the Training Set Was Established
- As the concept of a "training set" for an AI/ML algorithm is not applicable here, this question is not relevant to the information provided about the da Vinci Surgical System.
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510(k) Summary
| MAR 28 2014 | ||
|---|---|---|
| 510(k) Owner: | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 | |
| Contact: | Brandon HansenSenior Regulatory ManagerPhone Number: 408-523-7485Fax Number: 408-523-8907Email: Brandon.Hansen@intusurg.com | |
| Date Summary Prepared: | March 26, 2014 | |
| Trade Name: | da Vinci ® Surgical System, Model IS4000 | |
| Common Name: | Endoscopic instrument control system, endoscopicinstruments and accessories | |
| Classification: | Class II21 CFR 876.1500, Endoscope and Accessories | |
| Product Codes: | NAY (System, Surgical, Computer Controlled Instrument)GCJ (Laparoscope, General & Plastic Surgery) | |
| Classification AdvisoryCommittee: | General and Plastic Surgery | |
| Predicate Device: | Intuitive Surgical da Vinci ® Si Surgical System, ModelIS3000 (K081137, K090993, K123463) |
Device Description
The da Vinci Surgical System, Model IS4000 is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model IS4000 Surgical System consists of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and is used with an Endoscope, EndoWrist Instruments, and Accessories.
The surgeon seated at the Surgeon Console controls all movement of the EndoWrist Instruments and Endoscope by using two Master Controls and a set of foot pedals. The surgeon views the three-dimensional endoscopic image on a High Resolution Stereo
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Viewer (3D Viewer), which provides him/her a view of patient anatomy and instrumentation, along with icons and other user interface features.
Image /page/1/Picture/1 description: The image shows a robotic surgery console. The console has a 3D viewer, hand controls, an armrest, and a foot pedal panel. The console is designed to allow surgeons to perform minimally invasive surgery with greater precision and control.
IS4000 Surgeon Console
The VSC includes the supporting electronic and video processing equipment for the system.
Image /page/1/Picture/4 description: The image shows a medical device cart with several labeled components. The cart includes a touchscreen display mounted on an adjustable arm, a third-party electrosurgical generator, an illuminator, an endoscope controller, and a system core. The cart is on wheels, allowing it to be easily moved around a medical facility. The device appears to be designed for use in endoscopic surgical procedures.
IS4000 Vision Side Cart
The PSC is positioned at the operating room table and has four endoscope/instrument arms that are positioned over the target patient anatomy. An endoscope attaches onto one arm and provides the surgeon a high resolution, three-dimensional view of the patient anatomy. A suite of EndoWrist Instruments are attached/detached from the arms, enabling the surgeon to perform various surgical tasks. Accessories such as cannulas, obturators, seals, and drapes are also needed to perform procedures with the system.
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Image /page/2/Picture/0 description: The image shows an IS4000 Patient Side Cart, which is a medical device. The cart has a base, column, helm, boom, and arms. The base is the bottom part of the cart, and the column is the vertical part that supports the boom. The helm is the part that the operator uses to control the cart, and the boom is the horizontal part that extends from the column. The arms are the parts that hold the surgical instruments.
The IS4000 Endoscope is a multi-use device that comprises a 3D camera in a lightweight design (60% lighter as compared to IS3000). The Endoscope can be used laparoscopically (hand-held) at the start of a surgery and then be installed on any arm of the PSC.
The EndoWrist Instruments come in various configurations such as Graspers, Scissors, and Needle-drivers. A total of 24 8 mm EndoWrist Instruments for the IS4000 are listed in Table 1:
| Monopolar Curved Scissors | Permanent MonopolarCautery Hook | Permanent MonopolarCautery Spatula |
|---|---|---|
| Maryland Bipolar Forceps | Fenestrated Bipolar Forceps | Curved Bipolar Dissector |
| Micro Bipolar Forceps | Large Needle Driver | Mega SutureCut NeedleDriver |
| Black Diamond MicroForceps | ProGrasp Forceps | Tenaculum Forceps |
| Tip-Up Fenestrated Grasper | Resano Forceps | Small Grasping Retractor |
| Long Tip Forceps | Cardiac Probe Grasper | Large Hem-O-Lok ClipApplier |
| Medium Hem-O-Lok ClipApplier | Small Clip Applier | Dual Blade Retractor |
| Table 1: EndoWrist Instruments for the IS4000 | |||
|---|---|---|---|
| ----------------------------------------------- | -- | -- | -- |
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| Atrial Retractor Short Right | Snap-Fit Instrument | Potts Scissors |
|---|---|---|
| ------------------------------ | --------------------- | ---------------- |
The EndoWrist instruments have a unique articulating design at the distal tip that mimics the human wrist. Each instrument is used to perform a specific surgical task such as grasping, suturing, tissue manipulation and electrocautery. The IS4000 EndoWrist Instruments can only be used with the IS4000 Surgical System. The instruments are reusable. They are programmed with a maximum number of surgical procedures based upon life testing. This is identical to the IS3000 instruments.
A number of accessories are required to perform minimally invasive surgery with the IS4000 System including cannulas, obturators, and sterile drapes. Some accessories are modified to interface with the updated IS4000 System and instruments, while others are identical to the accessories used with the predicate IS3000 System. The complete list of IS4000 accessories is listed in Table 2:
| 8 mm Cannula (standard and long) | 8 mm Flared Cannula |
|---|---|
| 8 mm Blunt Obturator (standard and long) | 8 mm Instrument Introducer |
| Arm and Column Drape | Instrument Release Kit |
| Endoscope Sterilization Tray | Tip Cover Accessory (for MonopolarCurved Scissors) |
| SnapFit Scalpel Blade and Paddle Blade | SnapFit Insertion Tool (reusable) |
| 5-8 mm Cannula Seal | Gage Pin |
Table 2: IS4000 Accessories
Intended Use:
To assist in the accurate control of endoscopic instruments in minimally invasive surgery.
Indications for Use:
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, 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,
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gynecologic laparoscopic surgical 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. 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.
Technological Characteristics:
The Intuitive Surgical da Vinci Surgical System, Model IS4000 is equivalent to the predicate device, Model IS3000, in terms of technological characteristics and intended use. Modifications to the IS3000 include an updated Patient Side Cart architecture, design and dimensional changes to the EndoWrist Instruments and endoscope, and updated user interfaces.
Performance Data:
Performance test data to support substantial equivalence to the predicate device and that the design output meets the design input requirements consist of bench testing, animal/cadaver validation, simulated clinical procedures in live animal, and Human Factor assessment.
Bench Verification
The bench testing conducted consisted of dimensional measurements, mechanical and functional verification, electrical safety, and reliability. For the IS4000, the Surgeon Console was not subjected to any bench testing since there was no change made to the hardware. Changes were made to the software, graphical user interface, and cosmetic changes that were tested as part of the overall system. The suites of bench tests are:
| Test | Summary |
|---|---|
| Design Verification - PSC | The purpose of these tests was to verify that the physical,mechanical, electrical, and system level requirements anddesign specifications were met for each sub-component ofthe PSC. Sample size varied from 1 to 6 units depending onthe test case. Test methods were based on pre-defined testprocedures. Objective pass/fail criteria are defined andused. The following PSC sub-components were tested:• Cart Drive• Set-up Structure (SUS)• Set-up Joint (SUJ)• Universal Surgical Manipulator (USM)• PSC Overload Testing |
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| Test | Summary |
|---|---|
| Audio Intercom Hardware | |
| Design Verification - VSC | The purpose of these tests was to verify the sub-components of the VSC met the functional requirements as defined in the applicable Functional Specification Documents. Sample size was 1 unit except for the Endoscope and Endoscope adapter where 4 to 5 units were tested. Test methods were based on pre-defined test procedures. Objective pass/fail criteria were defined and used. The following VSC sub-components were tested: Video Processor hardware Endoscope Controller hardware 8.5 mm Endoscope Endoscope adapter |
| Instrument Design Verification | The purpose of these tests was to verify the IS4000 instruments met the physical, mechanical, and electrical requirement and specifications. Instrument compatibility to software parameters and user interface specifications were also verified. Samples sizes up to 5 units for all 24 instruments were used. For load handling and grip forces verification, worst case representative instruments were tested. The following design verification tests were performed: All Instrument types (24) Instrument Electrical Testing Load Handling Grip Force Comparison for grasping instruments |
| Test | Summary |
| Instrument Reliability/LifeTesting | The purpose of this test was to confirm the instruments metthe projected life of each re-usable instrument. A sample of9 instruments types was subjected to life testingrepresenting worst case for all 24 instruments. A samplesize of 4 units of each type was tested. Test instrumentswere tested up to 8 life cycles to establish a projected life of5 clinical uses. Each life cycle consisted of cleaning,sterilizing, performance measurements, and simulatedsurgical use. Objective pass/fail criteria were defined andused. The following instruments were evaluated: |
| • Monopolar Curved Scissors | |
| • Maryland Bipolar Forceps | |
| • Large Needle Driver | |
| • Black Diamond Micro Forceps | |
| • Mega SutureCut Needle Driver | |
| • ProGrasp Forceps | |
| • Tenaculum Forceps | |
| • Permanent Cautery Hook | |
| • Small Clip Applier | |
| Accessories Testing | • The purpose of this test was to confirm that Column andInstrument Arm Drapes with sterile adapters met thespecifications and requirements for maintenance ofsterility. A sample of 5 units of each type was evaluatedper the verification protocol. Objective pass fail criteriawere defined and used. |
| • Reusable trocars were tested for physical, mechanical,and interface requirements. A sample of 4 units of eachtype of reusable trocar was tested per the verificationprotocol. Objective pass/fail criteria were defined andused. |
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Pre-Clinical Verification via cadaver and animal models
The IS4000 system was evaluated for surgical access for seven representative procedures using multiple patient positions and port locations involving 10 cadavers (2 male and 8 female) and one 20 kg porcine model. Test cases validated requirements across all system components associated with system set-up, positioning, docking, transporting and procedure specific requirements for achieving external access and internal surgical
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targets. Specifically, the protocol focused on the IS4000 system's ability to safely and effectively:
- . Maneuver the PSC and USMs into proper surgical position for the target procedure
- . Reach and attach the USMs to the ports
- Maintain adequate external clearance between the system and its surroundings at . all times (e.g., during transport, roll-up, and intraoperative use)
- Reach the internal surgical targets with the instruments and endoscope .
- Maximize patient access .
| Procedure/# of cases | PortLocation | PortSpacing | WorkVolume | Body WallType | PatientPosition | WorkingDistance |
|---|---|---|---|---|---|---|
| Low AnteriorResection/ 2(cadaver) | AnteriorTransverse/AnteriorOblique | 8-11 cm | > 3k cm³ | Abdomen | TrendelenburgRight rollLithotomy | 3-15 cm |
| Gastric Bypass/ 3(cadaver) | AnteriorTransverse | 8-11 cm | Between1-3k cm³ | ThickAbdomen | ReverseTrendelenburgLithotomy | 4-12 cm |
| Hysterectomy/ 3(cadaver) | AnteriorTransverse | 8-11 cm | > 3k cm³ | Abdomen | TrendelenburgLithotomy | 3-15 cm |
| Mitral ValveRepair/ 1(cadaver) | Lateral,Anterior,Coronal | 2-8 cm | <1k cm³ | Ribs | Supine,Left roll rightarm down | 2-8 cm |
| CardiacRevascularization/1 (cadaver) | Lateral,Anterior,Coronal | 5-8 cm | Between1-3k cm³ | Ribs | Supine, dropLeft shoulder | 2-8 cm |
| Nephrectomy w/partialUreterectomy/ 3(cadaver) | Anterior,Lateral,Sagittal | 5-11 cm | Between1-3k cm³ | Abdomen | Lateraldecubitus, flex | 2-9 cm |
| Pediatric/ 2(small porcine<20 kg) | Variable | 2-5 cm | Between1-3k cm³ | Abdomen | Variable | 2-10 cm |
The following table shows the types of procedures used to set-up and deploy the system:
Representative Surgical Procedures in Live Animal Models
A series of six evaluations in which surgeons performed complete procedures on live animal models were conducted covering the range of specialties listed in the indication statement. Each study included clinical endpoints to assess safety and effectiveness of the IS4000 system that were appropriate for the procedure being performed. The evaluations for five of the six specialties involved surviving the animal models for a minimum of 21 days.
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General laparoscopic surgical procedures
| Right Colectomy | Canine Model (N=4) with weights 25-35 kg |
|---|---|
| Prospective Study | |
| No. of Investigators: | One (trained on system 4-6 weeks prior to use) |
| Success Criteria Safety: | Ability to perform procedure without intraoperative adverse events.Normal vital signs and absence of device-related adverse eventsduring post-op period. |
| Success CriteriaEffectiveness: | Ileocolic anastomosis intact and looking healthy at day of euthanasia.Normal eating and bowel movements over post-op period. |
| Instrumentation Used: | Fenestrated Bipolar Forceps, Tip-Up Grasper, 30° down endoscope,Monopolar Curved Scissors, EndoGIA® Ultra-Universal stapler,Endopouch® specimen retrieval bag, and LigaClips. |
| Findings: | 1. Surgical time ranged from 30-65 minutes shorter times noted with each subsequent case.2. There was no conversion to open surgery.3. Estimated blood loss was 10 ml in all cases. |
| Adverse Events: | 1. Unanticipated splenic injury with placement of port. Splenic injury was repaired and procedure continued without further incident.2. There were no device-related adverse events. |
| Postmortem AssessmentProtocol: | 1. Animals were euthanized and the operative site examined grossly for intactness of the ileoclic anastomosis and tissue health.2. Blood samples collected for hematology and chemistry analysis.3. Histopathology if needed on abnormal tissue as determined by Veterinary Pathologist. |
| Postmortem findings: | 1. All four animals survived for 26 days with normal vital signs and absence of device-related adverse events intra-operatively and during the post-operative period.2. One animal presented with intermittent inappetance, moderate weight loss and clinical pathology results indicative of ongoing inflammation.3. The ileocolic anastomoses were intact and functional at the end of the survival period. In the animal with irregular clinical observations, solid feces were found distal to the anastomosis with surrounding tissue inflammation (not device-related) at the end of the survival period.4. All animals had a loop of small bowel covering the staple line, as observed during the post-survival evaluation surgery. This did not cause obstruction of the anastomosis in any of the animals. All other animals were free of clinically significant variances in observations or clinical pathology. |
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General laparoscopic surgical procedures (pediatric)
:
| Nissen Fundoplication | Canine Model (N=4) with weights 9-15 kg (representative of |
|---|---|
| Prospective Study | pediatric population) |
| No. of Investigators: | One |
| Success Criteria Safety: | Ability to perform procedure without intraoperative adverse events.Normal vital signs and absence of device-related adverse eventsduring postoperative period. |
| Success CriteriaEffectiveness: | Fundoplication wrap intact and looking healthy at day of euthanasia.Normal eating over post-op period. |
| Instrumentation Used: | Monopolar Curved Scissors, Fenestrated Bipolar Grasper, Tip-UpGrasper, 30° down endoscope, Large Needle Drivers |
| Findings: | 1. Surgery time ranged from 48-68 min. |
| 2. No animal required conversion to open surgery. | |
| 3. Estimated blood loss average was 13.8 ml. | |
| 4. Moderate weight loss occurred in all four animals during thecourse of the study, and ranged from a 1.1-1.7 kg decrease. | |
| 5. All animals retained good appetites and were clinically healthythroughout the duration of the survival period with noobservations of vomiting, regurgitation, or other Gl upset, and noreported loss of body condition. The weight loss was likely dueto decreased caloric intake as a result of the post-operativedietary change to canned food/gruel to accommodate GI tractchanges from the Nissen fundoplication. | |
| Adverse Events: | 1. One animal sustained a splenic injury during takedown of thegastro-colic ligament using the Monopolar Curved Scissors.Bleeding was controlled by applying standard surgicaltechniques of pressure to the puncture site with a 4x4 gauze andmonopolar electro-cautery. Hemostasis was achieved and thisevent had no impact on the clinical outcome for the animal. Thiswas felt to be related to surgical error rather than instrumentationas the scissor was under the command of the surgeon and not aresult of motions from the system. |
| Postmortem AssessmentProtocol: | 1. Animals were euthanized and the operative site examined grosslyfor intactness of fundal wrap and tissue health. |
| 2. Blood samples collected for hematology and chemistry analysis. | |
| 3. Histopathology if needed on abnormal tissue as determined byVeterinary Pathologist. | |
| Postmortem Findings: | 1. In the post-survival evaluation surgeries on Day 24, all wrapswere found to be intact with no abnormalities noted in thesurrounding tissue. |
| 2. One slight adhesion was noted at a port site in one animal. |
.
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General urologic surgical procedures (pediatric)
| PyeloplastyProspective Study | Porcine Model (N=4) with weights 25-30 kg |
|---|---|
| No. of Investigators: | One |
| Success Criteria Safety: | Ability to perform procedure without intraoperative adverse events.Normal vital signs and absence of device-related adverse events during intra-operative and post-op periods. |
| Success CriteriaEffectiveness: | Normal passage of urine throughout the survival period.Normal peristalsis of ureter at day of euthanasia.No stricture of ureter at day of euthanasia.Normal eating and bowel movements over post-op period. |
| Instrumentation Used: | Tip Up Grasper, Monopolar Curved Scissors, Maryland Bipolar Forceps, Large Needle Driver |
| Findings: | 1. Surgical time range from 50-62 minutes.2. There were no conversions to an open procedure.3. Estimated blood loss average was 15 ml. |
| Adverse Events: | 1. One animal was noted to have thickened port sites with some purulent material expressed. Peritoneal wounds on this animal had healed normally.2. There were no device-related adverse events. |
| Postmortem AssessmentProtocol: | 1. Animals were euthanized and the operative site examined grossly for intactness of the pyeloplasty, presence or absence of intra-peritoneal fluid, peristaltic activity.2. Blood samples collected for hematology and chemistry analysis.3. The anastomotic segment was explanted and histopathology performed by Veterinary Pathologist. |
| Postmortem Findings: | 1. All four animals survived for 26 days with normal vital signs and absence of device-related adverse events intra-operatively and during the post-operative period. All animals were free of clinically significant variances in observations or clinical pathology.2. The ureteral anastomoses were intact and functional at the end of the survival period. There was no evidence of stricture as evidenced by the successful passage of a 6F dilator.3. All animals were found to have 20cc clear abdominal fluid at euthanasia. This was the same finding prior to beginning the |
Urologic surgical procedures
| Radical NephrectomyProspective Study | Female Porcine Model (N=4) with weights 50-60 kg | ||
|---|---|---|---|
| No. of Investigators: | One (trained on system 6 weeks prior to study) | ||
| Success Criteria Safety: | Ability to perform procedure without intraoperative adverse events.Normal vital signs and absence of device-related adverse eventsduring intra-operative and post-op periods. | ||
| Success CriteriaEffectiveness: | Successful organ removal.Normal eating and bowel movements over post-op period |
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| Instrumentation Used: | Tip Up Grasper, Monopolar Curved Scissors, Fenestrated BipolarForceps, Laparoscopic EndoGIA Ultra-Universal stapler, |
|---|---|
| Findings: | 1. Surgical time range from 35-42 minutes. |
| 2. There were no conversions to an open procedure. | |
| 3. Successful removal of kidney in all animals. | |
| 4. Estimated blood loss average 12.5ml. | |
| Adverse Events: | 1. One splenic injury during port placement controlled with localmeasures. |
| 2. There were no device-related adverse events. | |
| Postmortem AssessmentProtocol: | 1. Animals were sedated and the operative site palpated for painand swelling and then euthanized. All port sites healed. |
| 2. Blood samples collected for hematology and chemistry analysis. | |
| 3. Histopathology performed by Veterinary Pathologist onabnormal tissue if needed. | |
| Postmortem Findings: | 1. All four animals survived for 25-28 days with normal vital signsand absence of device-related adverse events intra-operativelyand during the post-operative period. |
| 2. No inappetance or other GI disturbances were reported, and allanimals remained in good condition throughout the duration ofthe survival period. | |
| 3. None of the animals showed any signs of pain reaction. |
Gynecologic laparoscopic surgical procedures
| HysterectomyProspective Study | Female Porcine Model (N=4) with weights 35-40 kg |
|---|---|
| No. of Investigators: | One (trained on system 2 weeks prior to study) |
| Success Criteria Safety: | Ability to perform procedure without intraoperative adverse events.Normal vital signs and absence of device-related adverse eventsduring intra-operative and post-op periods. |
| Success CriteriaEffectiveness: | Successful organ removal.Normal eating and bowel movements over post-op period. |
| Instrumentation Used: | Tip Up Grasper, Monopolar Curved Scissors, Fenestrated BipolarForceps, Mega SutureCut Needle Driver, |
| Findings: | 1. Surgical time range from 29-55 minutes; shorter time noted witheach subsequent case.2. There was no conversion to an open procedure.3. Estimated blood loss average 10ml.4. Successful removal of uterus in all animals. |
| Adverse Events: | There were no device-related adverse events. |
| Postmortem AssessmentProtocol: | 1. Animals were euthanized and the vaginal cuff closure assessed.A trans-vaginal leak test was performed.2. Blood samples collected for hematology and chemistry analysis.3. Histopathology performed by Veterinary Pathologist onabnormal tissue if needed |
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| Postmortem Findings: | 1. All four animals survived for 21 days with normal vital signs andabsence of device-related adverse events intra-operatively andduring the post-operative period.2. All vaginal cuffs were found to be intact with no abnormalitiesnoted in the surrounding tissue.3. There were no leaks observed in the trans-vaginal air leaktesting. |
|---|---|
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General thoracoscopic surgical and thoracoscopically-assisted cardiotomy procedures .
| Mitral Valve Repair | Canine Model (N=9) with weights 28-35 kg |
|---|---|
| Prospective Study | Comparative performance study of da Vinci IS3000 to theIS4000 |
| No. of Investigators: | Two board certified cardio-thoracic surgeons each performed4 procedures, 2 using the IS3000 and 2 using the IS4000. |
| Success Criteria Safety: | Ability to perform procedure without intraoperative adverse events. |
| Success CriteriaEffectiveness: | 1. Placing a cardioplegia catheter.2. Simulating pacemaker lead placement.3. Closing a leaflet defect.4. Perform an annuloplasty with a flexible band.5. Intra-operative valve leak test as surrogate for assessment ofmitral regurgitation. |
| Instrumentation Used: | Large Needle Driver, Resano Forceps, Atrial Retractor Short Right,Monopolar Curved Scissors |
| Procedural Steps: | 1. Placing a cardioplegia catheter.2. Simulating pacemaker lead placement. .3. Closing a leaflet defect.4. Perform an annuloplasty with a flexible band. |
| Findings: | 1. Total surgical time for all steps was 67-93 minutes for theIS3000 and 76-101 minutes for the IS4000.2. Time to cardioplegia catheter averaged 8.71 minutes for the1S3000 and 8.12 minutes for the IS4000.3. Time for lead placement averaged 13.25 minutes for the IS3000and 13.5 minutes for the IS4000.4. Time to completion of annuloplasty averaged 14.74 minutes forthe IS3000 and 14.57 minutes for the IS4000.5. All animals had measures for mitral valve regurgitation that wereequal to pre-operative measures. All changes were acceptable tosurgeons. |
| Adverse Events: | *One animal (D955) in the IS4000 group died intra-operatively dueto a non-device-related adverse event, an acute onset pulmonarycomplication leading to bronchial obstruction with reduced O₂exchange. This animal was excluded from the study, and anotheranimal (D999) added to the study. |
| There were no device-related adverse events. | |
| Postmortem AssessmentProtocol: | None as animals were euthanized during the procedures to simulatebypass machine. |
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The results of the animal testing demonstrate that the IS4000 Surgical System can be used to safely and effectively perform procedures from all of the specialties listed in the indications for use statement.
Human Factors
A Human Factor (HF) engineering process was followed in accordance with FDA guidelines for medical devices:
- Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk . Management, 2000
- Draft Guidance for Industry and Food and Drug Administration Staff Applying . Human Factors and Usability Engineering to Optimize Medical Device Design, 2011
The HF process focused primarily on identifying and mitigating use-related risks to safe levels while also providing a user friendly product. For the 1S4000 system, an extensive HF process was followed documenting many user research, design iteration, and formative evaluations prior to usability validation testing. A summative usability validation study was conducted with 15 teams of users (surgeons and OR team). This study was conducted in a simulated OR and involved representative typical workflow scenarios as well as troubleshooting scenarios that involved safety-critical tasks. Training materials and user manuals were developed in concert with the product hardware and software, and were incorporated in the validation study. The study assessed the following:
- ensure intended users could perform essential and high risk tasks in the expected t use environments in a safe and effective manner;
- validate that use-related risks have been mitigated to acceptable levels of residual . risk;
- assess the overall ease of use and usability of the IS4000 Surgical System; .
- this study evaluated whether the design introduced any previously unknown use-. related risks.
Fifteen surgeons from different surgical specialties (urology, gynecology, general surgery and thoracic) from novice (<20 cases) to very experienced (>200 cases) participated in the study. In addition, fifteen OR staff (5 circulating nurses, 9 scrub nurse/tech, and 1 physician's assistant) provided OR support during the sixteen study sessions. Each participant received one-half day of hands-on training prior to conducting testing. A simulated OR environment was provided to perform pre-operation set-up tasks (e.g., docking, draping, power on), intraoperative tasks (e.g., installing and activating instruments, instrument exchange, manipulating instruments), and post-operative tasks (e.g., undocking, cleaning, sorting for reprocessing). Data collected included both
INTUITIVE SURGICAL®
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objective performance data and subjective feedback from participants. Objective performance data included observations of users' ability to complete tasks, use-errors, close calls, and any difficulties encountered. Subjective feedback included open-ended questions about risks and safety, multiple choice ratings, and follow-up interviews.
The Model 1S4000 da Vinci Surgical System has been assessed and found to be safe and effective for its intended uses, by the intended users, in its intended use environment. The Human Factor engineering process, culminating in a usability validation study, was to identify and assess the use-related risks associated with the IS4000 Surgical System. The safety and usability of the IS4000 Surgical System was assessed to ensure residual risk is at acceptable levels, and that the use-safety of the system has not diminished in comparison to the IS3000 Surgical System.
Summary:
Based on the intended use, indications for use, technological characteristics and performance data, the Intuitive Surgical da Vinci Surgical System, Model IS4000, is substantially equivalent (SE) to the predicate device, the Intuitive Surgical da Vinci Si Surgical System, Model IS3000. This SE determination is based on bench testing including reliability testing, animal/cadaver validation, simulated clinical procedures in live animals, and Human Factors assessment. The bench/reliability testing verified that the design requirements and specifications for the new and/or changed components of the system are met. The animal/cadaver validation demonstrated the users' ability to use the system to accurately control the endoscopic instruments, to reach the necessary target anatomy, and to perform surgical tasks. The simulated clinical procedures in live animals provided clinical validation that the system can safely and effectively complete representative surgical procedures encompassed by the indications for use statement. Finally, the Human Factors assessment provided further assurance that risks due to user errors are identified and mitigated.
This SE determination did not require clinical data for the following reasons:
- The indications for use are within the scope of the predicate device (da Vinci . IS3000).
- The changes to the device hardware and software were such that bench testing, . animal/cadaver validation, and simulated clinical procedures in live animals were adequate to establish SE to the predicate.
This review did not compare human clinical performance between the IS4000 System to the IS3000 System. This review did not assess user training, although a training program was described as part of the human factors assessment. Finally, because there were no human clinical data, user learning curve was not assessed for the new model.
1 N T U I T I V E SURGICAL®
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Image /page/15/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2014
Intuitive Surgical Incorporated Mr. Brandon Hansen Senior Manager, Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086
Re: K131861
Trade/Device Name: da Vinci Surgical System, Model IS4000 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: June 19, 2014 Received: June 24, 2013
Dear Mr. Hansen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Brandon Hansen
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fdagov/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Binita S. Ashar 2014.03.28 16:00:30 -04'00'
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K131861
Device Name
da Vinci Surgical System, Model IS4000, and EndoWrist® Instruments, and Accessories
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps pick-ups, needle holders, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic surgical procedures, general thoracoscopic surgical procedures and thoracoscopicallyassisted 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 to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professions 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | ||
|---|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)Long H. Chen[FDA Signature Image]for BSA | ||
| (Division Sign-Off) | 510 (k) Number: K131861 | |
| Division of Surgical Devices | ||
| FORM FDA 3881 (1/14) | Page 1 of 2 |
§ 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.