(38 days)
Not Found
No
The description focuses on the mechanical design and materials of a surgical access device and does not mention any computational or analytical capabilities, let alone AI/ML.
No
The device is described as an "access device" that "creates and maintains a passageway for laparoscopic instruments." It is a tool used during procedures, not a device that directly treats a medical condition or ailment.
No
The device is described as an "access device for laparoscopic procedures" that creates and maintains a passageway for instruments. This function is interventional, not diagnostic.
No
The device description explicitly states it is fabricated from surgical grade stainless steel and biocompatible medical grade polymers, indicating it is a physical hardware device.
Based on the provided information, the Funnel Trocar™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's an "access device for laparoscopic procedures" used to "create and maintain a passageway for laparoscopic instruments." This describes a surgical tool used in vivo (within the body) during a procedure.
- Device Description: The description details a physical instrument made of stainless steel and polymers, designed for surgical access and insufflation. This aligns with a surgical device, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on testing samples outside the body.
Therefore, the Funnel Trocar™ is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Funnel Trocar™ is an access device for laparoscopic procedures. The new instrument creates and maintains a passageway for laparoscopic instruments during a variety of general, gynecologic, thoracic, and urological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Funnel Trocar™ is a disposable single patient use device fabricated from surgical grade stainless steel, and biocompatible medical grade polymers. The device is available in a variety of diameters (5mm. 7/8mm. 12mm) and lengths (55mm. 70mm, and 100mm). The Funnel Trocar™ is supplied with either a shielded cutting obturator (trocar). The cannula is equipped with a luer fitting to provide access for insufflation of the operative area. The cannula is available with or without stability threads.
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.
K943976, K901407, K911813, K950457, K953409, K953903
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
. G 19 1999
99324
510(k) Summarv as required by 807.92(c) for Funnel Trocar™ Prepared July 9, 1999
| Submitted by: | Patton Medical Corporation
1000 Westbank Drive, Suite 5A200
Austin, Texas 78746
512 916-4880 Fax 512 916-4881 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael T. Patton
President |
| Device Trade Name: | Funnel Trocar™ |
| Common Name: | Disposable Surgical Trocar/Cannula |
| Classification: | Laparoscope, General & Plastic Surgery, § 876.1500, Class II |
| Predicate Devices: | Sabre Ultimate Shielded Trocar System (K943976), manufactured
by Endoscopic Concepts Incorporated, 11 Forest Park Drive, Mendon,
MA 01756.
Laparoscopic Trocar (K901407, K911813, K950457, K953409,
K953903), manufactured by Core Dynamics, Inc., P.O. Box 16351,
Jacksonville, FL 32245. |
Description of Device:
The Funnel Trocar™ is a disposable single patient use device fabricated from surgical grade stainless steel, and biocompatible medical grade polymers. The device is available in a variety of diameters (5mm. 7/8mm. 12mm) and lengths (55mm. 70mm, and 100mm). The Funnel Trocar™ is supplied with either a shielded cutting obturator (trocar). The cannula is equipped with a luer fitting to provide access for insufflation of the operative area. The cannula is available with or without stability threads.
Intended Use of Device:
The Funnel Trocar™ is an access device for laparoscopic procedures. The new instrument creates and maintains a passageway for laparoscopic instruments during a variety of general, gynecologic, thoracic, and urological procedures.
Substantial Equivalence to Predicate Device:
The Funnel Trocar™ shielded version is substantially equivalent to the Sabre Ultimate Shielded Trocar System (K943976), manufactured by Endoscopic Concepts Incorporated, 11 Forest Park Drive, Mendon, MA 01756. The Funnel Trocar™ non-shielded version is substantially equivalent to the Laparoscopic Trocar (K901407, K911813, K950457, K953409, K953903), manufactured by Core Dynamics, Inc., P.O. Box 16351, Jacksonville, FL 32245.
1
Image /page/1/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 an abstract symbol resembling an eagle or bird with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 1999
Mr. Michael T. Patton President Patton Medical Corporation 1000 Westbank Drive Suite 5A200 Austin, Texas 78746
Re: K992324
Trade Name: Funnel Trocar™ Regulatory Class: II Product Code: GCJ Dated: July 9, 1999 Received: July 12, 1999
Dear Mr. Patton:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Michael T. Patton
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Russell Jayson
Celia M. Witten, Ph.D., M.D. lice Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page
510(k) NUMBER (IF KNOWN): K992324
DEVICE NAME: FUNNEL TROCAR
TM
INDICATIONS FOR USE:
Intended Use of Device:
The Funnel Trocar™ is an access device for laparoscopic procedures. The new instrument creates and maintains a passageway for laparoscopic instruments during a variety of general, gynecologic, thoracic, and urological procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER I IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR ·
Over-The-Counter-(Optional Forma
Russell S. Pagan. 801,255
(Division Sign-Off) Division of General Restorative Devices 510(k) Number_1_9523