(127 days)
Not Found
No
The device description and intended use clearly describe a mechanical access device (trocar) and its accessories, with no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an "access device" that "creates and maintains a passageway for laparoscopic instruments." Its function is to facilitate surgical procedures, not to directly treat a disease or condition.
No
The device description indicates that the listed products are "access devices" or "access ports" used to create and maintain a passageway for surgical instruments during laparoscopic procedures. Their function is for access and maintenance of an opening, not for diagnosing a condition or disease.
No
The device description clearly indicates it is a physical access device (trocar) used in surgical procedures, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an "access device" used to create and maintain a passageway for surgical instruments during laparoscopic procedures. This is a surgical tool used in vivo (within the body) for a surgical intervention.
- Device Description: The description reinforces this by stating it's a "single patient device to be utilized as an access port."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The PassPort® Optical Trocar is an access device that may be used with or without visualization that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Vortex Seal functions in combination with Patton Surgical's PassPort® Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Blunt Tip Trocar is an access device that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Shielded Trocar is an access device that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Cannula Anchor functions in combination with Patton Surgical's PassPort® Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Candidate Devices are a single patient device to be utilized as an access port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
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
Section 5 510(k) Summary
Image /page/0/Picture/1 description: The image shows the date "MAY 29 2008" in bold, black font. The letters and numbers are closely spaced together. The date is likely extracted from a document or photograph.
This 510(K) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21CFR § 807.92
The assigned 510(K) number is :
K 080161
Submitted by:
Michael Patton 6300 Bridgepoint Parkway Bldg. 2, Ste. 420 Austin, Texas, 78730 Phone: 512 329 0469 Fax: 512 328 9113 Email: mpatton@pattonsurgical.com
Date Prepared:
31 October 2007
Establishment Registration Number: Patton Surgical is located at 6300 Bridgepoint Parkway, Bldg. 2, Suite 420 in Austin, Texas 78730. We are registered with the Food and Drug Administration as Establishment Number 1651380.
Classification Name:
Common/Usual Name:
Proprietary Name:
Disposable Surgical Trocar/Cannula
Laparoscope, General & Plastic Surgery
PassPort® Optical Trocar, PassPort® Vortex Seal, PassPort® Blunt Tip Trocar, PassPort® Shielded Trocar, PassPort® Cannula Anchor
Indication for Use:
The PassPort® Optical Trocar is an access device that may be used with or without visualization that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Vortex Seal functions in combination with Patton Surgical's PassPort® Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Blunt Tip Trocar is an access device that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
1
The PassPort® Shielded Trocar is an access device that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Cannula Anchor functions in combination with Patton Surgical's PassPort® Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
Device Description:
The Candidate Devices are a single patient device to be utilized as an access port.
Substantial Equivalence Claim:
The principles of operation and technology in the candidate device are similar to other devices, which the FDA has found to be substantially equivalent as outlined below:
Product:
Manufacturer: 510(K) Number:
Endopath® Bladeless Trocar, Endopath® Blunt Tip Trocar, Endopath® Dilating Tip Trocar Ethicon Endo-Surgery, Inc. K032676 Substantial Equivalence Date: 10/30/03
Product: Manufacturer: 510(K) Number: Substantial Equivalence Date: 08/19/99
Patton Surgical Corp. K992324
Funnel Trocar
Product: Manufacturer: 510(K) Number: Substantial Equivalence Date: 08/21/97
Shielded Surgical Trocar Ethicon Endo-Surgery, Inc. K971475
-End of summary-
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring an abstract design of an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2008
Patton Surgical Corporation % Mr. Michael Patton President 6300 Bridgepoint Parkway Building 2, Suite 420 Austin, Texas 78730
Re: K080161
Trade/Device Name: PassPort® Optical Trocar, PassPort® Vortex Seal, PassPort® Blunt Tip Trocar, Passport® Shielded Trocar, PassPort® Cannula Anchor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: May 22, 2008 Received: May 22, 2008
Dear Mr. Patton:
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
3
Page 2 - Mr. Michael Patton
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.
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 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/industry/support/index.html.
Sincerely yours,
Mark N Wilkerson
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 Indications for Use Statement K 080161
510(K) Number:
Device Name:
PassPort® Optical Trocar, PassPort® Vortex Seal, PassPort® Blunt Tip Trocar, PassPort® Shielded Trocar, PassPort® Cannula Anchor
Indications for Use:
The PassPort® Optical Trocar is an access device that may be used with or without visualization that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Vortex Seal functions in combination with Patton Surgical's PassPort® Shielded Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Blunt Tip Trocar is an access device that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Shielded Trocar is an access device that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Cannula Anchor functions in combination with Patton Surgical's PassPort® Shielded Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-the-Counter (Optional format 1-2-96)
Neil K. Sieler for mxa
sion Sign-Cl Division of General, Restorative, and Neurological Devices
510(k) Number K080161