(568 days)
Not Found
No
The document describes a reprocessed surgical trocar, a mechanical device for creating entry points in minimally invasive surgery. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on reprocessing validation, not algorithmic performance.
No.
The device is used for establishing a path of entry for surgical instruments during minimally invasive procedures, not for treating a disease or condition itself.
No
Explanation: The device, a surgical trocar, is designed to create a path of entry for instruments during minimally invasive procedures. Its function is interventional, not diagnostic, as it does not gather information about the patient's health status.
No
The device description clearly outlines physical components (obturator, sleeve, stopcock valve, desufflation lever, safety shield) and mentions validation of cleaning, performance, packaging, sterilization, and biocompatibility testing, all indicative of a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "establish a path of entry for minimally invasive instruments" during surgical procedures. This is a surgical tool used in vivo (within the body), not a device used to examine specimens in vitro (outside the body) to diagnose conditions.
- Device Description: The description details the physical components of a surgical trocar (obturator, sleeve, valves, safety shield). This aligns with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with IVD devices.
Therefore, this device is a surgical instrument, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ClearMedical Reprocessed Endopath® Tristar® Blunt Tip Surgical Trocar, ClearMedical Reprocessed Endopath® Tristar® Surgical Trocar, and ClearMedical Reprocessed Endopath® Dilating Tip Trocar have application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for minimally invasive instruments.
Product codes
NLM, KBG
Device Description
Reprocessed endoscopic trocars consist of an obturator and sleeve. The trocar sleeve has a stopcock valve for gas insufflation and a desufflation lever for gas evacuation. The trocar obturator are either flat bladed, pyramidal, or blunt tip. Bladed and dilating tip obturators have a safety shield that exposes the blade during insertion and retract over the tip after the operative cavity has been penetrated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, gynecologic, abdominal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Validation of cleaning, performance, and packaging, and sterilization, as well as biocompatibility testing, demonstrate that reprocessed trocars perform as intended and are safe and effective.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUN 3 - 2005
A CLDF 3
510(k) SUMMARY
| Submitter: | ClearMedical, Inc.
1776 136th Place NE
Bellevue, WA 98005 |
|----------------------|-----------------------------------------------------------------|
| Contact: | Gene Lim
Ph: 425-460-2779
Fax: 425-401-1515 |
| Date: | June 2, 2005 |
| Trade name: | ClearMedical Reprocessed Trocars |
| Common name: | Bladed and Non-Bladed Trocars |
| Classification name: | Endoscope and Accessories (Class II, 21 CFR 876-1500) |
| Product Code: | NLM - Laparoscope, General & Plastic Surgery, Reprocessed |
Predicate Device(s):
The trade names of current legally marketed predicate devices are:
- Ethicon Endopath® Dilating Tip Trocar (5mm-12mm) .
- . Ethicon Endopath® Tristar® Trocar (5mm-12mm)
- Ethicon Endopath® Tristar® Blunt Tip Trocar (10mm-12mm) .
The 510(k) Premarket Notification numbers for these devices are:
- K020428 Endopath® Dilating Tip Trocar .
- . K011538 Endopath® Non-Bladed Solid Obturator (with sleeve)
- K011257 Endopath® Non-Bladed Obturator Trocar System (5mm) .
Device description:
Reprocessed endoscopic trocars consist of an obturator and sleeve. The trocar sleeve has a stopcock valve for gas insufflation and a desufflation lever for gas evacuation. The trocar obturator are either flat bladed, pyramidal, or blunt tip. Bladed and dilating tip obturators have a safety shield that exposes the blade during insertion and retract over the tip after the operative cavity has been penetrated.
1
Intended use:
Reprocessed trocars are used in thoracic, gynecologic, laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments.
Technological characteristics:
Reprocessed trocars are used devices that are cleaned, inspected, tested, packaged, and sterilized for an additional single patient use. The technological characteristics of design, material, and functional performance of reprocessed trocars are unchanged and remain equivalent to the predicate devices.
Test data:
Validation of cleaning, performance, and packaging, and sterilization, as well as biocompatibility testing, demonstrate that reprocessed trocars perform as intended and are safe and effective.
Conclusion:
Based on information provided in this submission. ClearMedical Reprocessed Trocars are substantially equivalent to the identified predicate devices and are safe and effective for their intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing or feather shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 - 2005
Mr. Gene Lim Director of Product Development ClearMedical Incorporated 1776 136" Place NE Bellevue, Washington 98005
Re: K033591
Trade/Device Name: Reprocessed Trocars (see additional list) Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: II Product Code: KBG Dated: April 4, 2005 Received: April 5, 2005
Dear Mr. Lim:
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. Ilsting 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.
3
Page 2 - Mr. Gene Lim
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), 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/industry/support/index.html.
Sincerely vours.
Miriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Listing of device being cleared in K033591:
| Ethicon
model | ClearMedical
Part Number |
|------------------|-----------------------------|
| 355S | 10154-S-1 |
| 355T | 10154-S-2 |
| 355L | 10154-S-3 |
| 511S | 10154-S-4 |
| 512S | 10154-S-5 |
| 355SM | 10155-S-1 |
| 355SD | 10155-S-2 |
| 355TM | 10155-S-3 |
| 355LM | 10155-S-4 |
| 355LD | 10155-S-5 |
| 578SD | 10155-S-6 |
| 511SM | 10155-S-7 |
| 511SD | 10155-S-8 |
| 512SM | 10155-S-9 |
| 512SD | 10155-S-10 |
| 512B | 10157-S |
.
:
:
5
Indications for Use
510(k) Number (if known): K033591
Device Name: Reprocessed Trocars
Indications for Use:
The ClearMedical Reprocessed Endopath® Tristar® Blunt Tip Surgical Trocar, ClearMedical Reprocessed Endopath® Tristar® Surgical Trocar, and ClearMedical Reprocessed Endopath® Dilating Tip Trocar have application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for minimally invasive instruments.
Contraindications:
These instruments are not intended for use when minimally invasive techniques are contraindicated.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Page 1 of 1
K033591 510(k) Number ________________________________________________________________________________________________________________________________________________________________