(51 days)
Reprocessed trocars are 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. Reprocessed trocars are single patient use devices.
Reprocessed Disposable Trocars
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for "Reprocessed Disposable Trocars," which indicates that the device has been found substantially equivalent to a legally marketed predicate device.
The letter does not include:
- A table of acceptance criteria or reported device performance.
- Details about any studies, including sample sizes, data provenance, or the number/qualifications of experts.
- Information on adjudication methods.
- Mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or how it was established for training or testing sets.
The document primarily focuses on regulatory clearance, device classification, and general controls provisions.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the words "Public Health Service" in a simple, sans-serif font. The text is horizontally aligned and appears to be part of a document or sign. The words are clearly legible and stand out against the background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ..
Medical Device Services c/o Mr. Mark W. Aldana President Adven Medical, Inc. 1001 Slaton Highway Lubbock, Texas 79404
Re: K022743
Trade/Device Name: Reprocessed Disposable Trocars Regulation Number: 870.1390 Regulation Name: Trocar Regulatory Class: II Product Code: KAB Dated: August 9, 2002 Received: August 19, 2002
Dear Mr. Aldana:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Mark W. Aldana
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 marketed 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours.
Aupt Durch
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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K022743 510(k) Number: :
Reprocessed Disposable Trocars Device Name:
Indications For Use:
Reprocessed trocars are 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.
Reprocessed trocars are single patient use devices.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Stupt. Rhodes
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K022743
Prescription Use v (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.