(350 days)
Reprocessed Trocars and Cannulas are intended to open and maintain a port of entry during endoscopic procedures.
Not Found
I am sorry, but the provided text does not contain information about explicit acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA, confirming that certain reprocessed endoscopic/laparoscopic trocars and cannulas are substantially equivalent to legally marketed predicate devices.
While the letter mentions "supplemental validation data" was reviewed, it does not describe the specific acceptance criteria for that validation or the details of the study itself. It primarily focuses on the regulatory outcome (substantial equivalence) rather than the technical performance data.
Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, or study design based on the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is simple and recognizable, conveying a sense of authority and purpose.
Public Health Service
MAY - 2 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MediSISS % Ms. Brandi J. James Director of Technical Services 2747 SW 6th Street Redmond, Oregon 97756
Re: K012644 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NLM Dated: August 10, 2006 Received: August 14, 2006
Dear Ms. James:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on July 29, 2002. We have received your supplemental validation data as required for reprocessed single-use 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
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Page 2 - Ms. Brandi J. James
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 yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Nef
Osseser
Enclosure
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Page 3 - Ms. Brandi J. James
Indications for Use
510 (k) Number (if known) : K012644
Device Name:
Reprocessed Endoscopic/Laparoscopic Trocars and Cannulas
Indications for Use:
Reprocessed Trocars and Cannulas are intended to open and maintain a port of entry during endoscopic procedures.
Prescription Use AND/OR AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number: ko 12644
Page 1 of __
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Page 4 - Ms. Brandi J. James
| Manufacturer | Model | Description | DiameterSize | Tip Configuration |
|---|---|---|---|---|
| AutoSuture | 179094 | VERSAPORT™ RPF* V2 RPF* V2 TrocarSystem, w/Radiolucent Sleeve | 5mm | Bladed w/Shield |
| AutoSuture | 179095P | VERSAPORT™ Plus V2 Trocar,w/Radiolucent Sleeve | 11mm | Bladed w/Shield |
| Ethicon | 355L | ENDOPATH TRISTAR Trocar w/StabilitySleeve | 5mm | Bladed w/Shield |
| Ethicon | 512B | ENDOPATH TRISTAR Blunt TipBladeless Trocar | 12mm | Blunt |
| Ethicon | 355LD | ENDOPATH Dilating Tip Trocar,w/Stability Sleeve | 5mm | Bladed w/Shield |
| Ethicon | 355SD | ENDOPATH Dilating Tip Trocarw/Stability Sleeve | 5mm | Bladed w/Shield |
| Ethicon | 512SD | ENDOPATH Dilating Tip Trocar withStability Sleeve | 12mm | Bladed w/Shield |
| Ethicon | 578SD | ENDOPATH Dilating Tip Trocarw/Stability Sleeve | 7-8mm | Bladed w/Shield |
| Ethicon | 511SD | ENDOPATH Dilating Tip Trocarw/Stability Sleeve | 11mm | Bladed w/Shield |
| Ethicon | 35HL | ENDOPATH Bladeless Trocar w/SmoothSleeve, Handled | 5mm | Blunt |
| Ethicon | 35LNA | ENDOPATH Resposable Bladeless Trocarwith Housing | 5mm | Blunt |
| Ethicon | 35NLT | ENDOPATH Bladeless Trocar withStability Sleeve | 5mm | Blunt |
| Ethicon | 511H | ENDOPATH Bladeless Trocar w/SmoothSleeve, Handled | 11mm | Blunt |
| Ethicon | 511NT | ENDOPATH, Bladeless Trocar w/StabilitySleeve | 11mm | Blunt |
| Ethicon | 511O | ENDOPATH, Bladeless Trocar, w/SmoothSleeve | 11mm | Blunt |
| Ethicon | 512HA | ENDOPATH Resposable BladelessObturator and Housing, Handled | 12mm | Blunt |
| Ethicon | 35LST | ENDOPATH, Integrated Stability TrocarSleeve | 5mm | Cannula Only |
.
Reprocessed Endoscopic/Laparoscopic Trocars and Cannulas found to be substantially equivalent:
§ 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.