NES REPROCESSED ENDOSCOPIC TROCAR

{0}------------------------------------------------ K060676 - : : Page 1 of 2 . | Section 2-1 | 510(k) Summary | | | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--------------| | Submitter | Northeast Scientific, Inc.<br>29 S. Commons Rd.<br>Waterbury, CT 06704 | | SEP - 7 2007 | | Contact | Craig Allmendinger<br>President & CEO<br>Phone: 203-756-2111<br>Fax: 203-757-5532<br>Email: Allmendinger@sbcglobal.net | | | | Date | August 31st, 2007 | | | | Device | Trade Name: NES Reprocessed Endoscopic Trocar<br>Common Name: Non-Bladed Trocar<br>Classification Name: Endoscope and accessories<br>Product Code: NLM<br>Device Class: Class II<br>OEM Models: Ethicon XCEL B5LT | | | | Predicate Devices | 510(k) # | Trade Name | | | | K011538: | Endopath® Non-Bladed Solid Obturator Trocar | | | | K011257: | Endopath® Non-Bladed Obturator Trocar System<br>(5mm) | | | | K990028: | Endopath® Optiview® Optical Surgical Obturator<br>and Sleeve | | | | K971738: | Ethicon Endopath® Resposable Trocar System | | | | K922608: | Endopath® EP Disposable Surgical Trocar | | | Indications for Use | NES Reprocessed Endoscopic Trocars are indicated for use to<br>establish a port of entry for endoscopic instruments in patients<br>requiring minimally invasive surgical procedures. | | | | Contraindications | NES Reprocessed Endoscopic Trocars are not intended to be used<br>on patients undergoing open surgical procedure and for whom<br>endoscopic procedure has been contraindicated. | | | | Device Description | Trocars are devices inserted into a patient in order to maintain a<br>clear pathway to facilitate the insertion of various surgical tools.<br>Trocars are designed in both bladed and non-bladed<br>configurations, however this submission is for non-bladed B5LTs.<br>Non-bladed trocars require an incision be made before insertion<br>into the patient's cavity. Trocars have a luer stopcock port for<br>insufflation and desufflation of the patient's cavity. NES | | | | K060676 | | Page 2 of 2 | | | | Reprocessed Endoscopic Trocars are sent from a user facility to be<br>cleaned, sterilized and repackaged by NES. NES Reprocessed<br>Endoscopic Trocars have the same intended use and performance<br>characteristics equivalent to Endoscopic Trocars provided by<br>Original Equipment Manufacturers (OEM). | | | | Technological<br>Characteristics | NES Reprocessed Endoscopic Trocars have identical<br>design, materials, characteristics and intended use as the<br>OEM Trocars. | | | | Test Data | NES Reprocessed Endoscopic Trocars operate as originally<br>intended and are safe, effective and sterile as demonstrated by<br>cleaning, packaging, performance, sterilization and<br>biocompatibility testing. | | | | Conclusion | Based on the information provided, NEScientific, Inc. concludes<br>that NES Reprocessed Endoscopic Trocars are safe, effective,<br>perform as intended and are substantially equivalent to the<br>predicate devices identified herein. | | | . : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : {1}------------------------------------------------ : . 100 - 100 - 1. September 2017 : : {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP - 7 2007 Northeast Scientific, Inc. % Mr. Craig Allmendinger President & CEO 29 South Commons Road Waterbury, Connecticut 06704 Re: K060676 Trade/Device Name: NES Reprocessed Endoscopic Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NLM Dated: August 8, 2007 Received: August 9, 2007 Dear Mr. Allmendinger: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 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 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); 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. {3}------------------------------------------------ Page 2 - Mr. Craig Allmendinger This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device 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/industry/support/index.html. Sincerely yours, for Mark N. Melkerson Dep. Dir. 9/16/05 Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K06.676 Pape 0/7 ## Indications for Use 510(k) Number (if known): K060676 Device Name: NES Reprocessed Endoscopic Trocar Indications For Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures. (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** C060676 Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR 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) 2 Page 1 of {5}------------------------------------------------ Page 2 of 2 ## K060676 List of Reprocessed Device(s): . | Description | Model Number | Size (ID/Length) | |---------------------------------------------|--------------|------------------------| | Ethicon XCEL Bladeless Endoscopic<br>Trocar | B5LT | 5 mm diameter x 100 mm |