(90 days)
The reprocessed endoscopic trocars are intended to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecological or other minimally invasive surgical procedures.
Reprocessed endoscopic trocars are devices that provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures such as observation, dissecting, cutting, repairing, and removal or manipulation of internal tissues and/or organs. Reprocessed endoscopic trocars are of varying lengths and diameters, and may have either a blunt or bladed obturator tip.
The provided text is a 510(k) premarket notification letter and summary for reprocessed endoscopic trocars. It discusses the substantial equivalence of the reprocessed devices to legally marketed predicate devices. However, it does not contain a detailed study with specific acceptance criteria, reported device performance metrics, sample sizes for test or training sets, ground truth establishment, or expert information as requested in the prompt.
The document mentions "Functional and Safety Testing" and "Process validation testing" were done, but it does not provide the results, specific acceptance criteria, or methodology of these tests in a format that lends itself to answering the detailed questions about a study comparing AI performance or standalone algorithm performance.
Therefore, I cannot fulfill the request for information on acceptance criteria and a study that proves the device meets them based on the provided text. The text primarily focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a detailed performance study with quantifiable results against specific criteria.
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Public Health Service
1 2004 NOV
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Bruce Lester Vice President, Research and Development SterilMed, Inc. 11400 73rd Ave. North Minneapolis, Minnesota 55369
Re: K012578 - Supplemental Validation Submission Trade/Device Name: Reprocessed Laparoscope General and Plastic Surgery (See enclosed list)
Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: NLM Dated: August 7, 2001 Received: August 9, 2001
Dear Dr. Lester:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on November 7, 2001. 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.
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Page 2 - Dr. Bruce Lester
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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Misiane C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Reprocessed Laparoscope General and Plastic Surgery (Trocar) Models found to be Substantially Equivalent:
-
- Ethicon, 355RT
- Ethicon, 35LRT 2.
- Ethicon, 35LRL 3.
-
- Ethicon, 511RT
- Ethicon, 511RL 5.
- Ethicon, 512RT 6.
-
- Ethicon, 512RL
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Indications for Use
510(k) Number (if known):
Device Name:
Reprocessed Endoscopic Trocars
Indications For Use:
The reprocessed endoscopic trocars are intended to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecological or other minimally invasive surgical procedures.
Prescription Use _ × (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)
Miriam C. Provost
Division Sign Off
Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K012578
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NOV 0 7 2001
SECTION 2. SUMMARY AND CERTIFICATION
510(k) Summary A.
SterilMed, Inc. - -
August 7, 2001
GCJ
, ·
Contact Person:
Submitter:
Patrick Fleischhacker SterilMed, Inc. 11400 73rd Avenue North Minneapolis, MN 55369 Ph: 763-488-3400 Fax: 763-488-3350
Date Prepared:
Trade Name:
Classification Name: and Number:
Trocar and Cannula Class II, 21 CFR 876.1500
Product Code:
Predicate Device(s):
Device Description:
Intended Use:
The reprocessed endoscopic trocar is substantially equivalent to the Endopath EP Disposable Surgical Trocar (K922608), manufactured by Ethicon; AutoSuture Surgiport® Endoscopic Trocar (K925860), manufactured by US Surgical; and the counterpart devices from the original manufacturer.
Reprocessed endoscopic trocars are devices that provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures such as observation, dissecting, cutting, repairing, and removal or manipulation of internal tissues and/or organs. Reprocessed endoscopic trocars are of varying lengths and diameters, and may have either a blunt or bladed obturator tip.
This device is designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures.
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Functional and Safety Testing:
Representative samples of reprocessed endoscopic trocars underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
Conclusion:
The reprocessed endoscopictrocars are substantially equivalent to the Endopath EP Disposable surgical Trocar (K922608), manufactured by Ethicon; AutoSuture Surgiport® Endoscopic Trocar (K925860), manufactured by US Surgical; and the counterpart devices from the original manufacturer. This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction.
§ 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.