(50 days)
Not Found
No
The summary describes a mechanical surgical device with a specific technology ("OPTIVIEW Technology") to reduce lens smudging. There is no mention of AI, ML, image processing, or data-driven algorithms. The performance studies focus on functional and biocompatibility testing, not AI/ML performance metrics.
No.
The device is described as a surgical tool (trocar) used to create an access port for other instruments during minimally invasive procedures. It is not intended for treating a disease or condition itself, but rather facilitates surgical access.
No
Explanation: The device description and intended use clearly state that this is a surgical instrument (trocar) used to create an access port for other endoscopic instruments during minimally invasive procedures. Its function is not to diagnose conditions or diseases.
No
The device description clearly outlines physical components like seals, a stopcock valve, and the trocar itself, indicating it is a hardware device used in surgical procedures.
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" in surgical procedures. This is a surgical tool used during a procedure, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a physical device used for creating access and maintaining insufflation during surgery. It doesn't mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the trocar (seal leakage, drag, smudge, etc.), cleaning, biocompatibility, sterilization, and packaging. These are typical evaluations for surgical instruments, not IVDs which would involve analytical performance studies (sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
N/A
Intended Use / Indications for Use
The Medline ReNewal Reprocessed ENDOPATH XCEL Bladeless Trocar with OPTWIEW 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 Medline ReNewal Reprocessed 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)
NLM
Device Description
The Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology devices are sterile, single-patient use endoscopic devices used to create an access port to the inside of the body cavity to perform endoscopic surgery. The trocars accommodate instruments that are 5-mm in diameter. The trocars contain two seals, an outer integrated removable self-adjusting seal and an integrated 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal, thoracic and gynecologic minimally invasive surgical procedures.
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)
The functional characteristics of the proposed device have been evaluated and were found to be substantially equivalent to the predicate device based on the following tests: Simulated use and artificial soiling; Functional performance studies: seal leakage; seal drag; surface roughness; endoscope smudge; and Visualization. Cleaning: protein and carbohydrates; visual inspection; and cleaning performance qualification. Biocompatibility: cytotoxicity (direct and indirect); irritation (whole device); sensitization (whole device) pyrogenicity (direct and indirect); and acute systemic toxicity (direct and indirect). Sterilization and packaging validations: bioburden enumeration testing; and ethylene oxide and ethylene chlorohydrin residuals testing. Product stability.
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.
K122511 ENDOPATH XCEL Trocar with OPTIVIEW Technology
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
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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 6, 2016
Surgical Instrument Service and Savings Inc. Ms. Brandi J. Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756
Re: K160740
Trade/Device Name: Medline Renewal Reprocessed Endopath Xcel Trocar with Optiview Technology Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NLM Dated: March 14, 2016 Received: March 17, 2016
Dear Ms. Panteleon:
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 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 - A
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
Reprocessed Single-Use Device Models Included in Clearance:
2
| Device Model | Device Name | Original
Manufacturer |
|--------------|-------------------------------------------------------------|--------------------------|
| 2B5ST | ENDOPATH XCEL® Bladeless Trocar with
OPTIVIEW Technology | Ethicon |
| 2B5LT | ENDOPATH XCEL® Bladeless Trocar with
OPTIVIEW Technology | Ethicon |
| 2B5XT | ENDOPATH XCEL® Bladeless Trocar with
OPTIVIEW Technology | Ethicon |
| 2CB5ST | ENDOPATH XCEL® Universal Sleeve with
OPTIVIEW Technology | Ethicon |
| 2CB5LT | ENDOPATH XCEL® Universal Sleeve with
OPTIVIEW Technology | Ethicon |
3
Image /page/3/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters. The Renewal logo is in green and blue letters, and the words "Full Circle Reprocessing" are below the Renewal logo.
4.0 Indications for Use
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | TBD | K160740 |
| Device Name | Medline ReNewal Reprocessed ENDOPATH YCEL Trocars with OPTIVIEW Technology | |
| Submitter/
Owner | Medline ReNewal
2747 SW 6th St.
Redmond, OR 97756 | |
| Contact Name | Brandi Panteleon
Director, Quality Assurance and Regulatory Affairs
P: 541-516-4180
F: 541-923-3375
E: bpanteleon@medline.com | |
| Prepared by | Stephanie Boyle Mays
Technical Writer
P: 541-516-4205
F: 541-923-3375
E: smays@medline.com | |
| Date Prepared | March 11, 2016 | |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed ENDOPATH XCEL
Trocar with OPTIVIEW Technology
Common Name: Surgical Trocar
Model No.: 2B5ST, 2B5LT and 2B5XT ENDOPATH XCEL Bladeless Trocar
with OPTIVIEW Technology and 2CB5ST and 2CB5LT ENDOPATH XCEL
Universal Sleeve with OPTIVIEW Technology | |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed
Product code: NLM
Class: Class II, non-exempt
Regulation: Part 876.1500 of Title 21 of the Code of Federal Regulations | |
| Predicate
Device | K122511 ENDOPATH XCEL Trocar with OPTIVIEW Technology | |
| Device
Description | The Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with
OPTIVIEW Technology devices are sterile, single-patient use endoscopic
devices used to create an access port to the inside of the body cavity to
perform endoscopic surgery. The trocars accommodate instruments that
are 5-mm in diameter. The trocars contain two seals, an outer integrated
removable self-adjusting seal and an integrated 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 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 Medline ReNewal Reprocessed ENDOPATH XCEL Bladeless Trocar
with OPTIVIEW 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 Medline ReNewal Reprocessed 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 | The technological characteristics and the fundamental scientific technology
of the subject device are identical to the predicate device. The proposed
device is a reprocessed version of the predicate device. | |
| Performance
Testing | The functional characteristics of the proposed device have been evaluated
and were found to be substantially equivalent to the predicate device based
on the following tests:
Simulated use and artificial soiling; Functional performance studies: seal leakage; seal drag; surface roughness; endoscope smudge; and Visualization. Cleaning: protein and carbohydrates; visual inspection; and cleaning performance qualification. Biocompatibility: cytotoxicity (direct and indirect); irritation (whole device); sensitization (whole device) pyrogenicity (direct and indirect); and acute systemic toxicity (direct and indirect). Sterilization and packaging validations: bioburden enumeration testing; and ethylene oxide and ethylene chlorohydrin residuals testing. Product stability. | |
| Conclusion | In accordance with 21 CFR Part 807, and based on a comparison of
Indications for Use, technological characteristics and performance data,
Medline ReNewal concludes that the proposed Medline ReNewal
Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology is
substantially equivalent to the predicate device. | |
Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
Indications for Use (Describe)
The Medline ReNewal Reprocessed ENDOPATH XCEL Bladeless Trocar with OPTWIEW 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 Medline ReNewal Reprocessed 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|
| -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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FORM FDA 3881 (8/14)
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Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters next to it. The Renewal logo is in green and blue letters, and below it is the phrase "Full Circle Reprocessing" in smaller letters.
5.0 510(k) Summary
5
Image /page/5/Picture/0 description: The image shows the Medline Renewal logo. The word "MEDLINE" is in blue, with a blue star-like symbol to the left. To the right of "MEDLINE" is the word "Renewal" in green and blue, with the words "Full Circle Reprocessing" in smaller blue font below it.
6
Image /page/6/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters next to it. The Renewal logo is in green and blue letters, and below it is the phrase "Full Circle Reprocessing".
| Predicate Device | Proposed Device | ||
|---|---|---|---|
| Device | |||
| Characteristic | Ethicon ENDOPATH | ||
| XCEL Trocar with | |||
| OPTIVIEW Technology | Medline ReNewal | ||
| Reprocessed ENDOPATH | |||
| XCEL Trocar with | |||
| OPTIVIEW Technology | Comparison | ||
| Analysis | |||
| 510(k) Number | K122511 | TBD | NAa |
| Indications for | |||
| Use | The ENDOPATH XCEL | ||
| Bladeless Trocar with | |||
| OPTIVIEW 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 | |||
| 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. | The Medline ReNewal | ||
| Reprocessed ENDOPATH | |||
| XCEL Bladeless Trocar with | |||
| OPTIVIEW 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 Medline ReNewal | |||
| Reprocessed 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. | Same | ||
| Design | |||
| Configuration | |||
| and Models | ENDOPATH XCEL with | ||
| OPTIVIEW Technology | |||
| Bladeless Trocar models: | |||
| • 2B5ST Trocar, 5- x | |||
| 75-mm stability sleeve; | |||
| • 2B5LT Trocar, 5- x | |||
| 100-mm, stability sleeve; | |||
| • 2B5XT Trocar, 5- x | |||
| 150-mm, stability sleeve. | Medline ReNewal | ||
| Reprocessed ENDOPATH | |||
| XCEL with OPTIVIEW | |||
| Technology | |||
| Bladeless Trocar models: | |||
| • 2B5ST Trocar, 5- x | |||
| 75-mm stability sleeve; | |||
| • 2B5LT Trocar, 5- x | |||
| 100-mm, stability sleeve; | |||
| • 2B5XT Trocar, 5- x | |||
| 150-mm, stability sleeve. | |||
| Predicate Device | Proposed Device | ||
| Device | |||
| Characteristic | Ethicon ENDOPATH XCEL | ||
| Trocar with OPTIVIEW | |||
| Technology | Medline ReNewal | ||
| Reprocessed ENDOPATH | |||
| XCEL Trocar with | |||
| OPTIVIEW Technology | Comparison | ||
| Analysis | |||
| Design | |||
| Configuration | |||
| and Model | |||
| (concluded) | Universal Trocar Stability | ||
| Sleeve models: | |||
| • 2CB5ST 5- x 75-mm | |||
| Sleeve (cannula); | |||
| • 2CB5LT 5- x 100-mm | |||
| Sleeve (cannula) | Universal Trocar Stability | ||
| Sleeve models: | |||
| • 2CB5ST 5- x 75-mm | |||
| Sleeve (cannula); | |||
| • 2CB5LT 5- x 100-mm | |||
| Sleeve (cannula) | Same | ||
| Technological | |||
| Attributes | ENDOPATH XCEL Trocars | ||
| with OPTIVIEW Technology | |||
| 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 5-mm in | |||
| diameter and an internal | |||
| seal. Together these two | The Medline ReNewal | ||
| Reprocessed ENDOPATH | |||
| XCEL Trocars with | |||
| OPTIVIEW Technology | |||
| 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 5-mm in | |||
| diameter and an internal | |||
| seal. Together these two | Same | ||
| Device | |||
| Characteristic | Predicate Device | Proposed Device | Comparison |
| Analysis | |||
| Ethicon ENDOPATH XCEL | |||
| Trocar with OPTIVIEW | |||
| Technology | Medline ReNewal | ||
| Reprocessed ENDOPATH | |||
| XCEL Trocar with | |||
| OPTIVIEW Technology | |||
| Technological | |||
| Characteristics | |||
| (concluded) | seals minimize gas leakage | ||
| 5-mm in 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. | seals minimize gas leakage | ||
| 5-mm in 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. |
Predicate and Medline ReNewal Reprocessed ENDOPATH XCEL Trocar Table 1: with OPTIVIEW Technology comparison chart.
continued
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Image /page/7/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters. The Renewal logo is in green and blue letters, and the words "Full Circle Reprocessing" are in smaller letters below the Renewal logo.
Predicate and Medline ReNewal Reprocessed ENDOPATH XCEL Trocar Table 1: with OPTIVIEW Technology comparison chart (continued).
(continued)
8
Image /page/8/Picture/0 description: The image contains the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left, and the Renewal Full Circle Reprocessing logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters. The Renewal logo is in green and blue letters, and the Full Circle Reprocessing logo is in smaller blue letters below the Renewal logo.