(184 days)
No
The summary describes a mechanical surgical trocar system and does not mention any AI or ML components or functionalities.
No.
The device, a surgical trocar system, is used to create and maintain access for instruments during endoscopic procedures, but it does not directly treat a disease or condition itself.
No
The device is described as a surgical trocar system used for entry and access of endoscopic instruments in various endoscopic procedures; it does not mention any diagnostic capabilities.
No
The device description explicitly states it is a "broad range of surgical trocars and accessories" and includes physical components like cannulas, available in disposable and reposable configurations. This indicates it is a hardware medical device, not software-only.
Based on the provided information, the EntriPort Surgical Trocar System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide a means of entry and access for endoscopic instruments during surgical procedures. This is a surgical tool used in vivo (within the body), not for testing samples in vitro (outside the body).
- Device Description: The description confirms it's a surgical device for providing access during endoscopic surgery.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's condition
Therefore, the EntriPort Surgical Trocar System is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EntriPort Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of entry and access for endoscopic instruments. The Trocar may be used with or without visualization for primary and secondary insertions.
The EntriPort Mini Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of entry and access for endoscopic instruments.
Product codes
GCJ
Device Description
The EntriPort Surqical Trocar System is a broad range of surgical trocars and accessories intended for use as the means for providing surgical access for various instruments during endoscopic surgery.
The EntriPort Surgical Trocar System includes both full size and mini devices, which are available in disposable (single patient use) and reposable (at least one reusable, and one disposable component) configurations. Reusable components are limited to the Reusable Cannula and accessories of the Open Entry (Hasson) Trocar.
EntriPort Surgical Trocars:
Bladeless Optical Trocar: EntriPort Bladeless Optical Trocar consists of a Cannula Sleeve (Cannula, Stopcock, and Seal Body) and Bladeless Optical Obturator has a transparent, conical tip which accommodates an appropriately sized 0° endoscope, providing visibility of tissue layers during insertion. The Bladeless Optical Trocar is available in both disposable (single patient use), and reposable (at least one reusable, and one disposable component), configurations.
Bladed Trocar: EntriPort Bladed Trocar consists of a Cannula Sleeve (Cannula, Stopcock, and Seal Body) and a Bladed Obturator. The Bladed Obturator contains a bilateral cutting blade designed to provide a simple, linear incision that minimizes application of force to gain entry into the cavity. The Bladed Obturator is equipped with a locking, blade shield, designed to cover the blade upon entry into the cavity. The Bladed Trocar is available in both disposable (single patient use), and reposable, configurations.
Cannula Sleeve: EntriPort Cannula Sleeve (Cannula, Stopcock, and Seal Body) is a sterile, disposable (single patient use) component. When purchased separately, the Cannula Sleeve may be used in conjunction with an appropriately sized EntriPort Obturator to establish another entry port. The EntriPort Seal Body is provided attached to the Cannula and is detachable for user convenience.
Seal Body: EntriPort Seal Body seals 5mm to 12mm instruments and forms a seal when no instruments are in use. It connects to the Cannula prior to inserting either a Bladeless Optical Obturator or Bladed Obturator.
Open Entry (Hasson) Trocar: EntriPort Open Entry (Hasson) Trocar (12mm x 100mm) consists of a Cannula Sleeve (Cannula, Stopcock, and Seal Body), Open Entry (Hasson) Obturator, and Fascia Anchor Adapter"). It is designed to enter the cavity atraumatically, through the mini-laparotomy performed by the physician. The Adapter is attached to the Cannula and equipped with suture slots for site stabilization. The Open Entry (Hasson) Trocar is available in both disposable (single patient use), and reposable, configurations.
Reposable Trocar: EntriPort Reposable Trocar is comprised of the following disposable components: Seal Body, Obturator (Bladeless Optical or Bladed), and Stopcock. The Reposable Trocar is used with the 303 Stainless Steel, Reusable Cannula.
EntriPort Mini Surgical Trocars:
Bladeless Mini Trocar: EntriPort Bladeless Mini Trocar (5 mm) consists of a Mini Cannula Sleeve (Cannula, Mini Seal Cap, and optional Stopcock) and a Bladeless Mini Obturator, available in lengths of 70 mm and 100 mm. It features a conical blunt tipped obturator to gain entry through the abdominal wall. The Bladeless Mini Trocar is available in both disposable (single patient use), and reposable (at least one reusable, and one disposable component), configurations.
Bladed Mini Trocar: EntriPort Bladed Mini Trocar (5 mm) consists of a Mini Cannula Sleeve (Cannula, Mini Seal Cap, and optional Stopcock) and a Bladed Mini Obturator, available in lengths of 70 mm and 100 mm. The obturator features a spring-loaded plastic shield that retracts as the trocar is pushed through the abdominal tissue. The shield springs forward once the obturator enters the abdominal cavity. When the tip is located in the insufflated abdomen, CO2 gas is able to escape through the open port of the obturator handle. The Bladed Mini Trocar is available in both disposable (single patient use), and reposable, configurations.
Mini Cannula Sleeve: EntriPort Mini Cannula Sleeve (Mini Cannula, Mini Seal Cap, and optional Stopcock) is a sterile, disposable (single patient use) component. When purchased separately, the Mini Cannula Sleve may be used in conjunction with an appropriately sized EntriPort Mini Obturator to establish another entry port. The EntriPort Mini Seal Cap is provided attached to the Cannula and is detachable for user convenience.
Mini Seal Cap: The Mini Seal Cap will seal 5mm instruments and will form a seal when no instruments are in use. It connects to the Mini Cannula prior to inserting either a Bladeless Mini Obturator or Bladed Mini Obturator.
Reposable Mini Trocar: EntriPort Reposable Mini Trocar is comprised of the following disposable (single patient use) components: Mini Seal Cap, Mini Obturator (Bladeless or Bladed), and Stopcock. The reposable trocar is used with the 303 Stainless Steel, Reusable Mini Cannula. The Reusable Mini Cannula are available with, or without a stopcock port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical bench and simulated use testing demonstrated the EntriPort Surgical Trocar System is substantially equivalent to the predicate with regard to intended use, materials, technology, and performance. Product performance testing demonstrates devices comply with design specifications and applicable sections of ISO 11607-1:2006, ISO 11135-1:2007, AAMI/ANSI ST67:2011, AAMI/ANSI ST81:2004(R)2010, ISO 10993-7:2008, ISO 14971:2007, ISO 594/1:1986, and ISO 594-2:1998. Material analysis demonstrates the patient contacting materials of the EntriPort Surgical Trocar System comply with the requirements of ANSI/AAMI/ISO 10993-1:2009(R)2013. Performance testing, including blade insertion forces, entry wound defect size, instrument insertion and removal, maintenance of pneumoperitoneum, and trocar insufflation rate, demonstrates the device performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/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 a stylized graphic of three human profiles facing right, with flowing lines representing hair or fabric.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2015
Conmed Corporation Ms. Anna D'Lima Senior Specialist, Regulatory Affairs 525 French Road Utica, New York 13502
Re: K142464
Trade/Device Name: Entriport Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: February 3, 2015 Received: February 5, 2015
Dear Ms. D'Lima:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 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 yours,
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K142464
Device Name EntriPort Surgical Trocar System
Indications for Use (Describe)
The EntriPort Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of entry and access for endoscopic instruments. The Trocar may be used with or without visualization for primary and secondary insertions.
The EntriPort Mini Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of entry and access for endoscopic instruments.
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)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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510(k) Summary of Safety and Effectiveness ConMed EntriPort Surgical Trocar System
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92. ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number K142464 as of February 03, 2015.
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502 Establishment Registration: 1320894
B. Company Contact
Anna D'Lima, RAC Senior Specialist, Requlatory Affairs T: (315) 624-3371 F: (315) 624-3225
C. Device Name
Proprietary Name: EntriPort Common Name: Surgical Trocar System Classification Name: Endoscope and accessories Regulation Number: 876.1500 Product Code: GCJ Requlatory Class: . Panel: General and Plastic Surgery
D. Predicate Device
| Device Name: | ConMed OnePort Surgical Trocar System |
|---|---|
| Company Name: | ConMed Corporation |
| 510(k): | K073009 |
| Reference devices: | The follow reference devices are relevant due to their design |
| similarities: |
- · ConMed's Core Audible Trocar II (K992250)
- · ConMed's TroGARD Finesse Trocar System (K001597)
- · Ethicon's ENDOPATH XCEL Bladeless Trocar (K032676), originally submitted as ENDOPATH III Bladeless Trocar
E. Device Description
The EntriPort Surqical Trocar System is a broad range of surgical trocars and accessories intended for use as the means for providing surgical access for various instruments during endoscopic surgery.
The EntriPort Surgical Trocar System includes both full size and mini devices, which are available in disposable (single patient use) and reposable (at least one reusable, and one disposable component) configurations. Reusable components are limited to the Reusable Cannula and accessories of the Open Entry (Hasson) Trocar.
5
EntriPort Surgical Trocars
Bladeless Optical Trocar
EntriPort Bladeless Optical Trocar consists of a Cannula Sleeve (Cannula, Stopcock, and Seal Body) and Bladeless Optical Obturator has a transparent, conical tip which accommodates an appropriately sized 0° endoscope, providing visibility of tissue layers during insertion. The Bladeless Optical Trocar is available in both disposable (single patient use), and reposable (at least one reusable, and one disposable component), configurations.
Bladed Trocar
EntriPort Bladed Trocar consists of a Cannula Sleeve (Cannula, Stopcock, and Seal Body) and a Bladed Obturator. The Bladed Obturator contains a bilateral cutting blade designed to provide a simple, linear incision that minimizes application of force to gain entry into the cavity. The Bladed Obturator is equipped with a locking, blade shield, designed to cover the blade upon entry into the cavity. The Bladed Trocar is available in both disposable (single patient use), and reposable, configurations.
Cannula Sleeve
EntriPort Cannula Sleeve (Cannula, Stopcock, and Seal Body) is a sterile, disposable (single patient use) component. When purchased separately, the Cannula Sleeve may be used in conjunction with an appropriately sized EntriPort Obturator to establish another entry port. The EntriPort Seal Body is provided attached to the Cannula and is detachable for user convenience.
Seal Bodv
EntriPort Seal Body seals 5mm to 12mm instruments and forms a seal when no instruments are in use. It connects to the Cannula prior to inserting either a Bladeless Optical Obturator or Bladed Obturator.
Open Entrv (Hasson) Trocar
EntriPort Open Entry (Hasson) Trocar (12mm x 100mm) consists of a Cannula Sleeve (Cannula, Stopcock, and Seal Body), Open Entry (Hasson) Obturator, and Fascia Anchor Adapter"). It is designed to enter the cavity atraumatically, through the mini-laparotomy performed by the physician. The Adapter is attached to the Cannula and equipped with suture slots for site stabilization. The Open Entry (Hasson) Trocar is available in both disposable (single patient use), and reposable, configurations.
Reposable Trocar
EntriPort Reposable Trocar is comprised of the following disposable components: Seal Body, Obturator (Bladeless Optical or Bladed), and Stopcock. The Reposable Trocar is used with the 303 Stainless Steel, Reusable Cannula.
EntriPort Mini Surgical Trocars
Bladeless Mini Trocar
EntriPort Bladeless Mini Trocar (5 mm) consists of a Mini Cannula Sleeve (Cannula, Mini Seal Cap, and optional Stopcock) and a Bladeless Mini Obturator, available in lengths of 70 mm and 100 mm. It features a conical blunt tipped obturator to gain entry through the abdominal wall. The Bladeless Mini Trocar is available in both disposable (single patient use), and reposable (at least one reusable, and one disposable component), configurations.
Bladed Mini Trocar
EntriPort Bladed Mini Trocar (5 mm) consists of a Mini Cannula Sleeve (Cannula, Mini Seal Cap, and optional Stopcock) and a Bladed Mini Obturator, available in lengths of 70 mm and 100 mm. The obturator features a spring-loaded plastic shield that retracts as the trocar is pushed through the abdominal tissue. The shield springs forward once the obturator enters the abdominal cavity. When the tip is located in the insufflated abdomen, CO2 gas is able to escape through the open port of the obturator handle. The Bladed Mini Trocar is available in both disposable (single patient use), and reposable, configurations.
Mini Cannula Sleeve
EntriPort Mini Cannula Sleeve (Mini Cannula, Mini Seal Cap, and optional Stopcock) is a sterile, disposable (single patient use) component. When purchased separately, the Mini Cannula Sleve may be used in conjunction with an appropriately sized EntriPort Mini Obturator to establish another entry port. The EntriPort Mini Seal Cap is provided attached to the Cannula and is detachable for user convenience.
Mini Seal Cap
The Mini Seal Cap will seal 5mm instruments and will form a seal when no instruments are in use. It connects to the Mini Cannula prior to inserting either a Bladeless Mini Obturator or Bladed Mini Obturator.
Reposable Mini Trocar
EntriPort Reposable Mini Trocar is comprised of the following disposable (single patient use) components: Mini Seal Cap, Mini Obturator (Bladeless or Bladed), and Stopcock. The reposable trocar is used with the 303 Stainless Steel, Reusable Mini Cannula. The Reusable Mini Cannula are available with, or without a stopcock port.
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F. Intended Use
The EntriPort Surqical Trocar System is a broad range of surgical trocars and accessories intended for use as the means for providing surgical access for various instruments during endoscopic surgery.
G. Indications for Use
EntriPort Surgical Trocar System
The EntriPort Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of entry and access for endoscopic instruments. The Trocar may be used with or without visualization for primary and secondary insertions.
EntriPort Mini Surgical Trocar System
The EntriPort Mini Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of entry and access for endoscopic instruments.
H. Non-clinical Performance Testing
Non-clinical bench and simulated use testing demonstrated the EntriPort Surgical Trocar System is substantially equivalent to the predicate with regard to intended use, materials, technology, and performance. Product performance testing demonstrates devices comply with design specifications and applicable sections of ISO 11607-1:2006, ISO 11135-1:2007, AAMI/ANSI ST67:2011, AAMI/ANSI ST81:2004(R)2010, ISO 10993-7:2008, ISO 14971:2007, ISO 594/1:1986, and ISO 594-2:1998. Material analysis demonstrates the patient contacting materials of the EntriPort Surgical Trocar System comply with the requirements of ANSI/AAMI/ISO 10993-1:2009(R)2013. Performance testing, including blade insertion forces, entry wound defect size, instrument insertion and removal, maintenance of pneumoperitoneum, and trocar insufflation rate, demonstrates the device performance is substantially equivalent to the predicate devices.
I. Substantial Equivalence
Indications for Use
EntriPort Surqical Trocar System
The difference between the indications for use statements of the EntriPort Surgical Trocar System and the identified predicate includes removal of the term "abdominal" as it limited the application of the trocar devices. This determination is based on trocars being used for a variety of endoscopic surgical procedures, as deemed appropriate by the overseeing surgeon. There is no change to the intended use of the surgical trocar system in comparison to the predicate device. Additionally, optional use of visualization for primary and secondary trocar insertions does not alter the intended use. Product performance and user acceptance testing demonstrate the safe and effective application of the EntriPort Surgical Trocar System for its indications for use.
The differences are not critical to the intended use of the device and therefore do not affect the safety and effectiveness of the device when used as labeled.
EntriPort Mini Surgical Trocar System
As listed above for the EntriPort Surgical Trocar System, the term "abdominal" was removed. Product performance and user acceptance testing demonstrate the safe and effective application of the EntriPort Mini Surgical Trocar System for its indications for use. The difference is not critical to the intended use of the device and
7
therefore does not affect the safety and effectiveness of the device when used as labeled.
Technological Characteristics
The new/different technological characteristics presented by the EntriPort Surgical Trocar System (subject of this submission) are limited to design features considered to be "customer preference" driven, including the new indication of optional visualization for primary and secondary trocar insertions. The EntriPort Surgical Trocar System is identical to the predicate in that it is made up of the same operational components such as obturators (bladeless and bladed), cannula, seals, and optional insufflation ports. Both the subject and predicate systems include disposable and reposable configurations. Materials include various polymers, stainless steel, and silicone rubber. To accommodate the visualization feature of the new design, composition of some materials were updated to allow for optical transmittance. All patient contacting materials are biocompatible per ANSI/AAMI/ISO 10993-1:2009(R)2013. Product performance and user acceptance testing demonstrate the safe and effective application of the new design features for the same intended use as the predicate device.
J. Conclusion
The differences between the predicate and the modified design do not raise any new risks of safety or efficacy. Supporting information per this premarket submission confirms that the EntriPort Surgical Trocar System is safe and effective for its intended use and is substantially equivalent to the predicate devices.