K170084 · Fujifilm New Development U.S.A., Inc. · GCJ · Mar 10, 2017 · Gastroenterology, Urology
Device Facts
Record ID
K170084
Device Name
InterLock Trocar
Applicant
Fujifilm New Development U.S.A., Inc.
Product Code
GCJ · Gastroenterology, Urology
Decision Date
Mar 10, 2017
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
The InterLock Trocar has applications in abdominal, thoracic, and gynecological minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
Device Story
Minimally invasive surgical trocar system; includes outer sheath, inner trocar, optical obturator, and lens cleaning accessories. Provides dual-access port for simultaneous insertion of 3.8 mm laparoscope and 5 mm hand instrument. Design maintains laparoscope in direct alignment with hand instrument, enabling self-visualization without requiring assistant to hold camera. Used in OR by surgeons. Features include abdominal insufflation port and integrated lens cleaning mechanism (saline flush/aspiration) without removing scope. Benefits include reduced need for additional personnel and continuous visualization of hand instrument.
Clinical Evidence
Bench testing only. Compared InterLock Trocar to predicate (K060096) regarding insertion force, retention force, insufflation fill rate, and leak rate. Design verification testing confirmed adherence to product requirements. Biocompatibility testing per ISO 10993-1:2009. Sterilization validation per ISO 11137-2:2013. Packaging validation per ISO 11607-1.
Technological Characteristics
Single-use, sterile, gamma-irradiated trocar. Dimensions: ~18.5 mm outer diameter, ~180 mm length. Materials meet ISO 10993-1:2009. Features luer lock connectors for insufflation and lens cleaning. Mechanical design allows parallel alignment of 3.8 mm laparoscope and 5 mm hand instrument.
Indications for Use
Indicated for patients undergoing abdominal, thoracic, or gynecological minimally invasive surgical procedures requiring endoscopic instrument access.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2017 FUJIFILM New Development U.S.A., Inc. % Ms. Maureen O'Connell Regulatory Consultant O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, Massachusetts 01864
Re: K170084
Trade/Device Name: InterLock Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: January 9, 2017 Received: January 10, 2017
Dear Ms. O'Connell:
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
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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 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 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,
# Jennifer R. Stevenson -S
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
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# Indications for Use
510(k) Number (if known) K170084
Device Name InterLock Trocar
Indications for Use (Describe)
The InterLock Trocar has applications in abdominal, thoracic, and gynecological minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
| 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)
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#### 510(k) SUMMARY
## FUJIFILM New Development U.S.A. Inc. InterLock Trocar
#### 510(k) Owner
FUJIFILM New Development U.S.A, Inc. 318 Bear Hill Road Waltham, MA 02451 Phone: 781-860-2463 Contact Person: Stephen Mariano Vice President/General Manager
#### Submission Correspondent:
Maureen O'Connell Regulatory Consultant O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 978-207-1245 Phone: Maureen@oconnellregulatory.com Email:
Date Prepared: March 9, 2017
Trade Name of Device InterLock Trocar
IntelLock 110cal
Common or Usual Name Trocar
#### Classification Name
Endoscope and Accessories; 21 C.F.R. 876.1500 Class II Product Code: GCJ
#### Predicate Devices
Applied Medical Resources Corporation Applied Medical Modular Trocar System (K060096)
#### Device Description
The InterLock Trocar is comprised of a minimally invasive surgical trocar (outer sheath sleeve, inner trocar and optical obturator) and accessories (lens cleaning syringe and lens cleaning tube).
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There are two tubes with a luer lock connector attached to the InterLock Trocar. The tube connected to the Outer sheath sleeve is used for abdominal insufflation and the other attached to the Inner trocar is used for the objective lens cleaning function.
The outer diameter of the insertion portion of the outer sheath is approximately 18.5 mm and the overall length of the trocar is approximately 180 mm. The trocar provides two instruments (a 3.8 mm laparoscope and a 5 mm standard, currently marketed hand instrument) with access to the abdominal cavity at the same time. The design of the trocar allows the laparoscope to be in direct alignment with and to follow the hand instrument. This feature provides a surgeon with self-visualization control, meaning that the camera is in direct alignment or parallel to the hand instrument. Therefore, the hand instrument is always in the field of view of the laparoscope. The laparoscope does not need to be held by a surgeon. The trocar holds the laparoscope and no additional surgeon or assistant is required to control operation of the laparoscope. The trocar also provides features for insufflating the peritoneal cavity and cleaning the 3.8 mm laparoscope lens without removing it from the trocar. The InterLock Trocar is for exclusive use with a 3.8 mm laparoscope.
#### Intended Use / Indications for Use
The InterLock Trocar has applications in abdominal, thoracic, and gynecological minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
#### Substantial Equivalence
The predicate device is Applied Medical Resources Corporation's Modular Trocar System cleared in K060096. The intended use of the InterLock Trocar and the Applied Medical Modular Trocar System are the same. Both devices are trocars which have applications in abdominal, thoracic, and gynecological minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. Both trocars may be used with or without visualization for primary and secondary insertions. Both devices are prescription devices used by healthcare professionals.
There are many technological characteristics that are equivalent between the InterLock Trocar and the Applied Medical Modular Trocar System. There are however two minor differences in the technological characteristics between the InterLock Trocar and the predicate device: each difference is detailed below. The InterLock Trocar's design has two ports, allowing for simultaneous passage of a 3.8mm low profile laparoscope and a 5mm endoscopic hand instrument, whereas the predicate Applied Medical Modular Trocar System consists of a single port for either a laparoscope or a hand instrument. Despite this technological difference, bench testing established substantially equivalent performance for the InterLock Trocar to the predicate device.
The InterLock Trocar design includes a technological characteristic that allows the user to clean (i.e. flush with saline and aspirate) the laparoscope tip while it is in the trocar. Bench testing established that the lens cleaning technological characteristic is effective.
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Therefore, the InterLock Trocar and the Applied Medical Modular Trocar System are substantially equivalent.
### Performance Data
Biocompatibility testing was performed to show that all patient contacting materials meet applicable biocompatibility standards per:
- . ISO 10993-1:2009 Biological evaluation of medical devices. Evaluation and testing within a risk management process.
The InterLock Trocar is provided sterile and is intended to be single-use. The InterLock Trocar is sterilized using Gamma Irradiation Sterilization. The ANSI/AAMI/ISO 11137-2:2013 (VDmax25) Sterilization of health care products-Radiation- Part 2: Establishing the sterilization dose will be followed to achieve a Sterility Assurance Level of 10 ° for the InterLock Trocar.
In accordance with ISO 11607-1 Packaging for Terminally Sterilized Medical Devices, qualification and validation of the InterLock Trocar packaging design was performed to document that the packaging material meets the established performance requirements and specifications. The shelf life for the InterLock Trocar is 6 months. In accordance with ISO 11607-1 Packaging for Terminally Sterilized Medical Devices, shelf life of the InterLock Trocar was substantiated by verifying product and package performance following aging.
Bench testing was performed which compared the InterLock Trocar to the Applied Medical Modular Trocar System (predicate device) which was cleared in K060096. The testing provides documented evidence of substantially equivalent performance for the Interlock Trocar when evaluated against the Applied Medical Modular Trocar System (predicate device). Testing performed included insertion force, retention force, insufflation fill rate, and insufflation leak rate.
Additionally, design verification testing was performed to demonstrate that the InterLock Trocar predictably met all product requirements and design inputs when tested under nominal conditions. Testing included physical measurements/tests, obturator performance, trocar performance and destructive tests.
## Conclusion
The performance data provided in the 510(k) included bench testing comparing the InterLock Trocar to the predicate device, testing to demonstrate compliance with consensus standards, and design verification testing which demonstrated that the device met all product requirements and design inputs. The performance data supports that the InterLock Trocar is as safe and effective as the predicate device and therefore, substantially equivalent to the predicate device.
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Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
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Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
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Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
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Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
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Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
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Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
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Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
