(59 days)
Not Found
No
The description focuses on mechanical design features for surgical access and visualization, with no mention of AI or ML.
No
The device is described as a surgical instrument used to establish a path of entry for other endoscopic instruments during minimally invasive procedures. It facilitates access for diagnostic and operative instruments but does not directly treat or diagnose a disease or condition itself.
No
The device is described as a surgical instrument used to create a path for other endoscopic instruments during minimally invasive procedures. Its functions include providing access, insufflation, and lens cleaning for a laparoscope, but it does not inherently diagnose conditions. Its purpose is procedural, not diagnostic.
No
The device description clearly details physical components like an outer sheath sleeve, inner trocar, optical obturator, and accessories, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used in surgical procedures to establish a path of entry for endoscopic instruments. This is a surgical tool used in vivo (within the body), not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a surgical trocar with components for insertion, visualization (via a laparoscope), insufflation, and instrument access. These are all functions related to performing surgery directly on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), performing tests on samples, or providing diagnostic information based on laboratory analysis.
Therefore, the InterLock Trocar is a surgical device, not an In Vitro Diagnostic device.
N/A
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.
Product codes
GCJ
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).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, thoracic, and gynecological
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
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 10-6 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.
Key Metrics
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.
0
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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
2
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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3
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).
4
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.
5
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.