(43 days)
Not Found
No
The device description and summary of performance studies focus on the mechanical and functional aspects of a surgical trocar system, with no mention of AI or ML capabilities.
No
The device, a surgical trocar system, is used to create access for instruments during endoscopic procedures, but it does not directly treat a disease or condition itself.
No
This device is a surgical trocar system used to provide access for surgical instruments during endoscopic procedures, not to diagnose a condition.
No
The device description clearly outlines physical components like trocars, cannulas, and seals, indicating it is a hardware medical device.
No, 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 provide abdominal entry and access for endoscopic instruments during surgical procedures. This is a surgical device used in vivo (within the body), not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details surgical trocars and accessories used for laparoscopic and thoracoscopic surgery. This aligns with surgical tools, not diagnostic tests performed on samples.
- Lack of Diagnostic Information: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The OnePort® Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of abdominal entry and access for endoscopic instruments.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The OnePort® Surgical Trocar System is a range of surgical trocars and accessories intended for use as a means of providing abdominal access for various instruments during laparoscopic, and thoracoscopic surgery. The OnePort® Surgical Trocar System is available in four configurations:
- . Fully disposable with Bladed Trocar
- Fully disposable with Dilating Trocar .
- Reposable Cannula with Bladed Trocar (reusable cannula, disposable . trocar and seal)
- Reposable Cannula with Dilating Trocar (reusable cannula & obturator, . disposable seal)
Each configuration is made available in numerous diameters and lengths with either smooth or ribbed cannula for additional abdominal retention. Reusable cannulae and dilating obturators are supplied non-sterile and must be sterilized prior to use (Refer to "Reprocessing of Multi-use Components" in the Directions for Use). Also, see OnePort® Surgical Trocar System sales literature for a complete list of available sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The OnePort® Surgical Trocar System was tested and passed all required functional and biocompatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K924761, K933456, K952977, K001697
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary of Safety and Effectiveness
DEC 0 7 2007
OnePort® Surgical Trocar System
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter
ConMed Corporation (Registration # 1320894) 525 French Road Utica, NY 13502 USA
Contact Person
Brian Killoran Manager, Regulatory Affairs ConMed Corporation 525 French Road Utica, NY 13502 USA
Phone: 315-624-3219 Fax: 315-624-3225 e-mail: brian_killoran@mail.conmed.com
Date Prepared
August 31, 2007
Name of Device
OnePort® Surgical Trocar System
Classification Names
Endoscope and accessories
Device Classification
| Regulatory Class: | Class II |
|---|---|
| Product Code: | GCJ |
| Classification Panel: | General & Plastic Surgery |
| Obstetrics/Gynecology | |
| Regulation Number: | 21 CFR 876.1500 |
Predicate Devices
| K924761 | Reflex STR Trocar
System | Richard-Allan Medical Industries |
|---------|--------------------------------------------|----------------------------------|
| K933456 | ConMed TroGard™ Blunt
Tip Trocar System | ConMed Corporation |
| K952977 | SABRE™ Multi-Use Trocar
System | Endoscopic Concepts, Inc. |
| K001697 | ConMed TroGARD®
Finesse™ Trocar System | ConMed Corporation |
1
Description of Device
The OnePort® Surgical Trocar System is a range of surgical trocars and accessories intended for use as a means of providing abdominal access for various instruments during laparoscopic, and thoracoscopic surgery. The OnePort® Surgical Trocar System is available in four configurations:
- . Fully disposable with Bladed Trocar
- Fully disposable with Dilating Trocar .
- Reposable Cannula with Bladed Trocar (reusable cannula, disposable . trocar and seal)
- Reposable Cannula with Dilating Trocar (reusable cannula & obturator, . disposable seal)
Each configuration is made available in numerous diameters and lengths with either smooth or ribbed cannula for additional abdominal retention. Reusable cannulae and dilating obturators are supplied non-sterile and must be sterilized prior to use (Refer to "Reprocessing of Multi-use Components" in the Directions for Use). Also, see OnePort® Surgical Trocar System sales literature for a complete list of available sizes.
Indications for Use
The OnePort® Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of abdominal entry and access for endoscopic instruments.
Nonclinical Performance
The OnePort® Surgical Trocar System was tested and passed all required functional and biocompatibility testing.
Conclusion
The OnePort® Surgical Trocar System is substantially equivalent to the following 510(k) cleared devices:
| K924761 | Reflex STR Trocar
System | Richard-Allan Medical Industries |
|---------|--------------------------------------------|----------------------------------|
| K933456 | ConMed TroGard™ Blunt
Tip Trocar System | ConMed Corporation |
| K952977 | SABRE™ Multi-Use Trocar
System | Endoscopic Concepts, Inc. |
| K001697 | ConMed TroGARD®
Finesse™ Trocar System | ConMed Corporation |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ConMed Corporation % Intertek Testing Services Mr. Jay Y. Kogoma Senior Staff Engineer 2307 East Aurora Road Twinsburg, Ohio 44087
DEC - 7 2007
Re: K073009
Trade/Device Name: ConMed OnePort® Surgical Trocar System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: November 16, 2007 Received: November 19, 2007
Dear Mr. Kogoma:
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. Jay Y. Kogoma
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilitics 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.
Mark N. Mullens
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) _ _ _ _ " _ _ _ _ " _ _
Device Name: _________________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Indications for use:
The CONMED OnePort® Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of abdominal entry and access for endoscopic instruments.
Prescription Use_ X (per 21 CFR 801.109)
and/or
Over-the-counter Use _________________________________________________________________________________________________________________________________________________________
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) N