(45 days)
Not Found
No
The description focuses on mechanical design enhancements (seals, stopcock valve, OPTIVIEW™ Technology for reducing lens smudging) and performance testing related to physical properties (drag force, seal durability, air leak, image quality, ergonomic force). There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as creating an access path for instruments in surgical procedures and reducing endoscope lens smudging, but it does not directly treat a disease or condition.
No
The device's intended use is to establish a path of entry for endoscopic instruments in surgical procedures, not to diagnose a condition.
No
The device description clearly describes physical components like seals, a stopcock valve, and a design enhancement for reducing lens smudging, 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 is to "establish a path of entry for endoscopic instruments" during surgical procedures. This is a surgical access device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the mechanical function of creating an access port, maintaining insufflation, and reducing endoscope smudging. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, tissue, urine, or any other bodily fluid or substance for diagnostic purposes. The performance studies focus on mechanical properties and visualization quality, not diagnostic accuracy.
Therefore, the ENDOPATH® XCEL® Trocars with OPTIVIEW™ Technology are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The ENDOPATH® XCEL® Bladeless Trocar with OPT:VIEW™ Technology has applications in abdominal, thoracic, and gynecologic 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.
The ENDOPATH® XCEL® Blunt Tip Trocar with OPTIVIEW™ Technology has application in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive instruments.
The ENDOPATH® XCEL® Dilating Tip Trocar with OPTIVIEW™ Technology has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
The ENDOPATH® XCEL®. Universal Trocar Stability Sleeve with OPTIVIEW™ Technology has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The ENDOPATH® XCEL® Trocars with OPTIVIEW™ Technology are sterile, singlepatient use endoscopic devices used to create an access port to the inside of the body cavity to perform endoscopic surgery. The trocars accommodate instruments ranging from 5 to 12 mm diameter. The trocars contain two seals, an outer integrated removable self-adjusting seal and an internal seal. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation. The trocars contain OPTIVIEW™ Technology, a design enhancement that reduces the incidence of trocar-induced endoscope lens smudging during endoscope insertion. Endoscope smudging occurs when bodily fluids and debris smear across the endoscope lens during a laparoscopic procedure. Trocar-induced smudging occurs when these bodily fluids and debris are deposited within the trocar's seal system when an endoscope or instrument has been exchanged through the trocar.
ENDOPATH® XCEL® Trocars with OPTIVIEW™ Technology have similar design, dimensions, and features as the predicate devices. The devices consist of two components: a sleeve and an obturator. The sleeve and obturator are used to create the access port. The obturator is a subsystem used to assist in the process of installing the sleeve port through the body tissue. After installation, the obturator is not required for trocar performance. The Bladeless Trocar obturators accommodate an appropriately sized 0° endoscope and provide visibility of individual tissue layers during insertion.
The sleeve has an integrated two-seal system for maintaining pneumoperitoneum. The trocar sleeves contain two seals, an outer integrated removable self-adjusting seal that accommodates instruments ranging from 5 to 12 mm in diameter and an internal seal. Together, these two seals minimize gas leakage when instruments are inserted through or completely withdrawn from the trocar. The sleeve has a welded stopcock assembly, which is compatible with standard luer lock fittings, and provides attachment for gas insufflation and desufflation of the pneumoperitoneum. The sleeve cannula contains integrated stability threads for abdominal wall retention. The ENDOPATH® XCEL® Trocars with OPTIVIEW™ Technology are equivalent to the predicate devices' indications and performance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, thoracic, gynecologic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to demonstrate that the device performs as intended and is substantially equivalent to the predicate device, ENDOPATH® XCEL® Trocars. To validate that the subject device performs as intended, the following bench testing was performed:
- . Drag Force of an Instrument within the Trocar, Peak Force
- Drag Force of an Instrument within the Trocar, Average Force .
- Trocar Seal System Durability, demonstrated by Air Leak Performance ●
- Air Leak Performance While Trocar is Under Torque .
- . Endoscope Visualization Image Quality
- Ergonomic Force to Attach and Detach Universal Seal Cap ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
K 122511
Page 1 of 3
2017
Ony
Ethicon Endo-Surgery, LLC, 510(k) Premarket Notification (Traditional) for ENDOPATH® XCEL® Trocars with OPTIVIEW™ Technology
510(k) Summary
Company
Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
Contact
Emily Kruetzkamp. Regulatory Affairs Associate Ethicon Endo-Surgery, Inc Telephone: (513) 337-1546 Fax: (513) 337-2802 Email: ekruetzk@its.inj.com
Date Prepared: August 15, 2012
Device Name
Trade Name: ENDOPATH® XCEL® Trocar with OPTIVIEW™ Technology Common Name: Trocar
Classification Names Laparoscope, General & Plastic Surgery Regulation Number 876.1500
Predicate Device
ENDOPATH® XCEL® 12mm Trocars, submitted as ENDOPATH® III Trocar System, K032676
Device Description:
The ENDOPATH® XCEL® Trocars with OPTIVIEW™ Technology are sterile, singlepatient use endoscopic devices used to create an access port to the inside of the body cavity to perform endoscopic surgery. The trocars accommodate instruments ranging from 5 to 12 mm diameter. The trocars contain two seals, an outer integrated removable self-adjusting seal and an internal seal. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation. The trocars contain OPTIVIEW™ Technology, a design enhancement that reduces the incidence of trocar-induced endoscope lens smudging during endoscope insertion. Endoscope smudging occurs when bodily fluids and debris smear across the endoscope lens during a laparoscopic procedure. Trocar-induced smudging occurs when these bodily fluids and debris are deposited within the trocar's seal system when an endoscope or instrument has been exchanged through the trocar.
Indication for Use:
The ENDOPATH® XCEL® Bladeless Trocar with OPT:VIEW™ Technology has applications in abdominal, thoracic, and gynecologic minimally invasive surgical
1
Ethicon Endo-Surgery, LLC, 510(k) Premarket Notification (Traditional) for ENDOPAT Trocars with OPTIVIEWTM Technology
procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The ENDOPATH® XCEL® Blunt Tip Trocar with OPTIVIEW™ Technology has application in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive instruments.
The ENDOPATH® XCEL® Dilating Tip Trocar with OPTIVIEW™ Technology has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
The ENDOPATH® XCEL®. Universal Trocar Stability Sleeve with OPTIVIEW™ Technology has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
Technological Characteristics:
ENDOPATH® XCEL® Trocars with OPTIVIEW™ Technology have similar design, dimensions, and features as the predicate devices. The devices consist of two components: a sleeve and an obturator. The sleeve and obturator are used to create the access port. The obturator is a subsystem used to assist in the process of installing the sleeve port through the body tissue. After installation, the obturator is not required for trocar performance. The Bladeless Trocar obturators accommodate an appropriately sized 0° endoscope and provide visibility of individual tissue layers during insertion.
The sleeve has an integrated two-seal system for maintaining pneumoperitoneum. The trocar sleeves contain two seals, an outer integrated removable self-adjusting seal that accommodates instruments ranging from 5 to 12 mm in diameter and an internal seal. Together, these two seals minimize gas leakage when instruments are inserted through or completely withdrawn from the trocar. The sleeve has a welded stopcock assembly, which is compatible with standard luer lock fittings, and provides attachment for gas insufflation and desufflation of the pneumoperitoneum. The sleeve cannula contains integrated stability threads for abdominal wall retention. The ENDOPATH® XCEL® Trocars with OPTIVIEW™ Technology are equivalent to the predicate devices' indications and performance.
Performance Data: Bench testing was performed to demonstrate that the device performs as intended and is substantially equivalent to the predicate device, ENDOPATH® XCEL® Trocars. To validate that the subject device performs as intended, the following bench testing was performed:
- . Drag Force of an Instrument within the Trocar, Peak Force
- Drag Force of an Instrument within the Trocar, Average Force .
- Trocar Seal System Durability, demonstrated by Air Leak Performance ●
- Air Leak Performance While Trocar is Under Torque .
- . Endoscope Visualization Image Quality
- Ergonomic Force to Attach and Detach Universal Seal Cap ●
2
Ethicon Endo-Surgery, LLC, 510(k) Premarket Notification (Traditional) for ENDOPATH® XCEL® Trocars with OPTIVIEW™ Technology
Please note that animal testing was not used to verify substantial equivalence of the
ENDOPATH® XCEL® Trocars with OPTIVEW™ Technology to the predicate device
ENDOPATH® XCEL®
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room --WO66-G609 Silver Spring, MD 20993-0002
Ocr
1 2012
Enthicon End-Surgery, LLC % Enthicon End-Surgery, Incorporated Ms. Emily Kruetzkamp Regulatory Affairs Associate 4545 Creek Road Cincinnati, Ohio 45242
Re: K122511
Trade/Device Name: ENDOPATH® XCEL® Bladeless Trocar with OPTIVIEW™ Technology Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 15, 2012 Received: August 17, 2012
Dear Ms. Kruetzkamp:
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
4
Page 2 - Ms. Emily Kruetzkamp
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millkevan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ethicon Endo-Surgery, LLC, 510(k) Premarket Notification (Traditional) for ENDOPATH® XCEL® Trocars with OPTIVIEW™ Technology
Indications for Use Form
Indications for Use
510(k) Number (if known): __ K | 2 2 S | | 1
Device Name: ENDOPATH® XCEL® Bladeless Trocar with OPTIVIEW™ Technology
Indications for Use:
The ENDOPATH® XCEL® Bladeless Trocar has applications in abdominal, thoracic, and gynecologic 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.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Qffice of Device Evaluation (ODE) r min
Page 1 of 4
Neil R. Ogden
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number__
(;)
6
Ethicon Endo-Surgery, LLC, 510(k) Premarket Notification (Traditional) for ENDOPATH® XCEL® Trocars with OPTIVIEWTM Technology
Indications for Use Form
Indications for Use
510(k) Number (if known): _ K 1225 l |
Device Name ENDOPATH® XCEL® Blunt Tip Trocar with OPTIVIEW™ Technology
Indications for Use:
The ENDOPATH® XCEL® Blunt Tip Trocar has application in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive instruments.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 4
Nal R.P. Doder for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122511.
7
Ethicon Endo-Surgery, LLC, 510(k) Premarket Notification (Traditional) for ENDOPATH® XCEL® Trocars with OPTIVIEWTM Technology
Indications for Use Form
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ENDOPATH® XCEL® Dilating Tip Trocar with OPTIVIEW™ Technology
Indications for Use:
The ENDOPATH® XCEL® Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 3 of 4.
Neil R.P. Ogle Ar nxn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122511
8
Ethicon Endo-Surgery, LLC, 510(k) Premarket Notification (Traditional) for ENDOPATH® XCEL® Trocars with OPTIVIEWTM Technology
Indications for Use Form
Indications for Use
510(k) Number (if known): _ | 222 5 | |
Device Name: ENDOPATH® XCEL® Universal Trocar Stability Sleeve with OPTIVIEW™ Technology
Indications for Use:
The ENDOPATH® XCEL® Universal Trocar Stability Sleeve has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart.C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 4 of 4
Neil K. Poddar for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122511
(4)