VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
K043253 · Vanguard Medical Concepts, Inc. · NLM · Apr 8, 2005 · Gastroenterology, Urology
Device Facts
Record ID
K043253
Device Name
VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
Applicant
Vanguard Medical Concepts, Inc.
Product Code
NLM · Gastroenterology, Urology
Decision Date
Apr 8, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
Reprocessed trocars are intended to provide a pathway for entry of instruments during minimally invasive surgery, with particular applications in abdominal, gynecological, urological, and thoracic procedures.
Device Story
Vanguard Reprocessed Trocars are previously used, OEM-manufactured trocars (Ethicon) that have been cleaned, inspected, packaged, and sterilized for reuse. Devices consist of a cannula (5-15mm diameter, 5-15cm length) and an obturator. Cannulae feature pressure seals for pneumoperitoneum maintenance, optional luer stopcock ports for insufflation, and stability anchors. Obturators are available in shielded (blade retracts upon cavity penetration to reduce injury risk) or non-shielded optical configurations (clear tip with video channel for visual guidance). Used in OR settings by surgeons to establish surgical access. Reprocessing restores device to original OEM specifications, ensuring safety and performance equivalent to new devices.
Clinical Evidence
Bench testing only. Validation included cleaning, sterilization, and packaging integrity testing, alongside performance and biocompatibility testing to confirm the reprocessed devices meet original OEM specifications and safety requirements.
Technological Characteristics
Materials and specifications are identical to OEM (Ethicon) devices. Components include cannulae (5-15mm diameter, 5-15cm length) with pressure seals, luer stopcock ports, and stability anchors. Obturators include shielded (retractable blade) and non-shielded optical configurations. Mechanical design utilizes standard trocar geometry for minimally invasive access. Sterilization is performed as part of the reprocessing cycle.
Indications for Use
Indicated for patients undergoing minimally invasive abdominal, gynecological, urological, or thoracic surgery requiring instrument access. Contraindicated for patients for whom endoscopic procedures are contraindicated.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
Ethicon Tristar Blunt Tip Trocar (10mm-12mm) (K020428)
Ethicon Endopath Dilating Tip Trocar (5mm-12mm) (K020428)
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# 510(k) Summary of Safety & Effectiveness
K043253/52
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Submitter | Vanguard Medical Concepts, Inc.<br>5307 Great Oak Drive<br>Lakeland, FL 33815 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Heather Crawford, RAC<br>Director of Regulatory Affairs<br>863-683-8680 [voice]<br>863-683-8703 [facsimile]<br><a href="mailto:hcrawford@safe-reuse.com">hcrawford@safe-reuse.com</a> [email] |
| Date | November 23, 2004 |
| Device | Trade Name: Vanguard Reprocessed Dilating Tip and Blunt Trocars<br><ul><li>Common Name: Dilating tip/shielded trocar, Blunt/non-shielded trocar, Adjustable stability thread</li><li>Classification Number: 21 CFR 876.1500</li><li>Classification Name: Endoscope and accessories</li><li>Product Code: NLM - Laparoscope, General & Plastic Surgery, Reprocessed - Class II</li></ul> |
| Predicate Devices | Original equipment manufacturer (OEM) Dilating Tip and Blunt Trocars are currently marketed under a variety of trade names. Trade names of legally marketed predicate devices are: <ul><li>Ethicon <sup>®</sup> Tristar <sup>™</sup> Blunt Tip Trocar (10mm-12mm)</li><li>Ethicon <sup>®</sup> Endopath <sup>®</sup> Dilating Tip Trocar (5mm-12mm)</li><li>Ethicon <sup>®</sup> Endopath <sup>®</sup> Optiview <sup>®</sup> Optical Trocar (5mm-12mm)</li><li>Ethicon <sup>®</sup> Tristar <sup>™</sup> Pyramidal Blade Trocar (5mm-12mm)</li><li>Ethicon <sup>®</sup> Endopath <sup>®</sup> Adjustable Stability Thread (5mm-12mm)</li></ul> The 510(k) Premarket Notification numbers for these devices are: <ul><li>K020428: Endopath <sup>®</sup> Dilating Tip Trocar</li><li>K011538: Endopath <sup>®</sup> Non-Bladed Solid Obturator Trocar System</li><li>K011257: Endopath <sup>®</sup> Non-Bladed Obturator Trocar System (5mm)</li><li>K990028: Endopath <sup>®</sup> Optiview <sup>®</sup> Optical Surgical Obturator and Sleeve</li><li>K971475: Shielded Surgical Trocar</li><li>K963760: Non-Shielded Surgical Trocar and Sleeve</li></ul> |
Continued on next page
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## 510(k) Summary of Safety & Effectiveness, Continued
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Indications<br>for Use | Reprocessed trocars are intended to provide a pathway for entry of<br>instruments during minimally invasive surgery, with particular applications in<br>abdominal, gynecological, urological, and thoracic procedures. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contra-<br>indications | Reprocessed trocars should not be used in patients for whom endoscopic<br>procedure is contraindicated. |
| Device<br>Description | Vanguard Reprocessed Trocar is a previously used device that has been<br>cleaned, inspected, packaged and sterilized by Vanguard Medical Concepts,<br>Inc. |
| | Trocar Cannulae is available with smooth or threaded sleeve in sizes 5-15mm<br>inner diameter and 5-15cm length. Cannulae are equipped with a pressure<br>seal for maintenance of pneumopertineum during insertion and withdrawal of<br>instruments. Some models are equipped with a luer stopcock port for<br>insufflation and desufflation of the operative cavity. Some models are<br>provided with stability anchors inserted over the cannula sleeve to help seal<br>the incision site and maintain cavity pressure. |
| | Trocar Obturator is available in shielded and non-shielded configurations<br>sized 5-15mm. Models equipped with a safety shield are designed to expose<br>the blade during insertion but to retract over the tip once the operative cavity<br>has been penetrated, so as to reduce the risk for vascular or visceral injury.<br>Non-shielded optical obturators are equipped with a clear tip and an 11-12mm<br>video laparoscopy channel to allow trocar insertion under direct visual<br>guidance and minimize the risk for internal injury. |
| Technological<br>Characteristics | Vanguard Reprocessed Dilating and Blunt Tip Trocars are essentially<br>identical to the Original Equipment Manufacturer (i.e., Ethicon®) devices.<br>No changes are made to the device materials or specifications and the<br>reprocessed trocars possess identical technological characteristics. |
| Test Data | Cleaning, sterilization, packaging validations, and performance and<br>biocompatibility testing demonstrate that the reprocessed devices perform as<br>intended and are safe and effective. |
| | Continued on next page |
ENDOPATH®, OPTIVIEW®, and TRISTAR™ are registered trademarks of Ethicon Endo-Surgery, Inc.
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### 510(k) Summary of Safety & Effectiveness, Continued
Based upon the information provided herein and the 510(k) "Substantial Conclusion Equivalence" Decision Making Process Chart, we conclude that Vanguard Reprocessed Dilating Tip and Blunt Trocars are substantially equivalent to their predicate devices under the Federal Food, Drug and Cosmetic Act.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
NOV 2 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ascent Healthcare Solutions % Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, Arizona 85044
Re: K043253 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CRF 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NLM Dated: March 7, 2005 Received: March 9, 2005
Dear Ms. Barton:
This letter corrects our substantially equivalent letter of April 8, 2005. The above-referenced premarket notification (510(k)) was cleared by the Office Evaluation (ODE) on March 31, 2005. We have received your supplemental validation data as required for reprocessed singleuse devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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.
If your devices are classified (see above) into either class II (Special Controls) or class III (PMA) they may be subject to such 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 devices 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 devices comply 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 applicable requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements
{4}------------------------------------------------
Page 2 - Ms. Moira Barton
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.
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely wours.
Pur Salla
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 - Ms. Moira Barton
### Indications for Use
510 (k) Number (if known) : ___K043253
Vanguard Reprocessed Bladed and Non-Bladed Trocars Device Name:
Indications For Use:
Reprocessed trocars are intended to provide a pathway for entry neproorments during minimally invasive surgery, with particular applications in abdominal, gynecological, urological, and thoracic procedures.
AND / OR Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED |
Concurrence of CDRH, Office of Device Evaluation (ODE)
K043253
Division of General, Restorative and Neurological Devices
Page 1 of
510(k) Number L043253
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# Page 4 -- Ms. Moira Barton Page 4 – Ms. Moira Barton
| Device | Model Numbers |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Ethicon® Endopath® Endopath Dilating Tip<br>Trocar, 5 mm-12 mm | 355LD, 355LM, 355SD, 355SM, 355TM, 511SD,<br>511SM, 512SD, 512SM, 578SD |
| Ethicon® Endopath® Optiview Optical<br>Trocar 5 mm-12 mm | 35HS, 35HL, 35HST, 35HLT, 511H, 511HT,<br>512HN, 512HT, 35NST, 35NLT, 35OS, 35OL,<br>511NT, 511O, 512NT, 512ON |
| Ethicon® TristarTM Pyramidal Blade Trocar,<br>5 mm-12 mm | 355L, 355S, 355T, 511S, 512S |
| Ethicon® TristarTM Blunt Tip Trocar,<br>10 mm-12 mm | 512B |
| Ethicon® Endopath® Adjustable Stability<br>Thread , 5 mm-12 mm | T355, T511, T512 |
100 - 100 - 100
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