(14 days)
Not Found
No
The description focuses on mechanical features for anchoring the trocar and does not mention any computational or data-driven components.
No.
The device is a Fixation Trocar, used to establish a path of entry for endoscopic instruments during minimally invasive surgical procedures, not to treat a disease or condition.
No
The provided text describes the Fixation Trocar as a device intended to establish a path of entry for endoscopic instruments during surgical procedures and to anchor the cannula in tissue. Its purpose is mechanical access and surgical support, not to diagnose or detect medical conditions.
No
The device description clearly states it is a physical medical device (trocar) with structural features for anchoring, and the performance studies involve physical force measurements. There is no mention of software as a component or the primary function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for establishing a path of entry for endoscopic instruments during surgical procedures. This is a surgical access device, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description focuses on the mechanical function of the trocar in anchoring to tissue during surgery.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, the Fixation Trocar is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fixation Trocar is a sterile, single-use device, intended for use in conjunction with APPLIED's currently marketed trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal, gynecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments. The Fixation Trocar may be used with an optical tissue separator or a bladed obturator, and with or without visualization for primary and secondary insertions.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
This filing addresses a line extension to the Modular Trocar System approved in K060096.
A typical trocar access system consists of a seal, a cannula and an obturator. The obturator is used to place the cannula (with seal attached) through the patient's abdomen, then it's discarded. To function properly, the cannula must not shift from its location in the abdomen as the surgery proceeds. For that reason, many cannulas have structural features that help anchor the cannula in the tissue. These features may range from a textured surface to ridges on the outer diameter of the cannula. The line extension that is the topic of this filing offers trocar models that have an alternate method of anchoring the cannula to abdominal tissue. For descriptive purposes in this document, these trocar models may at times be referred to as "Fixation Trocars".
Sincc the seal and the obturator of the Fixation Trocar are unchanged from the predicate device approved in K060096, this filing primarily addresses the cannula and the features that allow the new anchoring method. A technical description of those features is in "SUMMARY OF TECHNOLOGICAL CHARACTERISTICS" on page 2-2.
The Fixation Trocar will be available in cannula diamcters ranging from 5mm to 15mm and lengths ranging from 55mm to 150mm. These dimensions match the trocars approved in K060096.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, gynecological and thoracic minimally invasive procedures
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)
DISCUSSION OF NONCLINICAL TESTS SUBMITTED: There arc no currently recognized standards that specify anchoring security of trocar cannulas. For that reason, APPLIED created a test protocol designed to confirm safety and efficacy of the Fixation Trocar relative to the predicate device of K060096. These tests include a determination of:
- Insertion force the force required to insert the trocar cannula and obturator through . abdominal tissue.
- Post-insertion migration/slippage force the force required to dislodge the trocar cannula . from its position in tissue before the anchoring feature is activated.
- Retention force the force required to dislodge the cannula from tissue after deployment . of the balloon.
- Removal force the force required to remove the trocar from tissue after collapse of the . balloon.
These tests were performed on the subject device as well as predicate devices. For a discussion of the test method and results, see section 15.
CONCLUSIONS DRAWN FROM TESTING: APPLIED's performance and functional testing demonstrated that the Fixation Trocar is substantially equivalent or superior to its predicate devices and introduces no new safety and effectiveness issucs when used as instructed. The Fixation Trocar's anchoring feature porforms particularly well in its most important characteristic, retention of the cannula in the patient's abdomen.
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.
Applied Medical Modular Trocar System (K060096)
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
083638
Image /page/0/Picture/1 description: The image shows the words "Page" and "of" written in cursive, with the numbers "1" and "2" written in circles next to them. The words and numbers are written in black ink on a white background. The image appears to be a page number from a book or document.
510(k) SUMMARY
OEC 2 3 2008
| SUBMITTED BY: | Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita, CA-92688
(949) 713-8000
(949) 713-8205 (FAX) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Frans VandenBroek
Vice President, Regulatory Affairs
fvandenbroek@appliedmedical.com |
| DATE OF PREPARATION: | November 6, 2008 |
| TRADE NAME: | To be determined |
| COMMON NAME: | Trocars, Trocar Systems, Access Systems |
| CLASSIFICATION NAME: | Laparoscope, General & Plastic Surgery
(21CFR 876.1500, product code GCJ) |
| PREDICATE DEVICE: | Applied Medical Modular Trocar System (K060096) |
DEVICE DESCRIPTION: This filing addresses a line extension to the Modular Trocar System approved in K060096.
A typical trocar access system consists of a seal, a cannula and an obturator. The obturator is used to place the cannula (with seal attached) through the patient's abdomen, then it's discarded. To function properly, the cannula must not shift from its location in the abdomen as the surgery proceeds. For that reason, many cannulas have structural features that help anchor the cannula in the tissue. These features may range from a textured surface to ridges on the outer diameter of the cannula. The line extension that is the topic of this filing offers trocar models that have an alternate method of anchoring the cannula to abdominal tissue. For descriptive purposes in this document, these trocar models may at times be referred to as "Fixation Trocars".
Sincc the seal and the obturator of the Fixation Trocar are unchanged from the predicate device approved in K060096, this filing primarily addresses the cannula and the features that allow the new anchoring method. A technical description of those features is in "SUMMARY OF TECHNOLOGICAL CHARACTERISTICS" on page 2-2.
The Fixation Trocar will be available in cannula diamcters ranging from 5mm to 15mm and lengths ranging from 55mm to 150mm. These dimensions match the trocars approved in K060096.
1
08 3638
INTENDED USE: The Fixation Trocar is a sterile, single-use device, intended for use in conjunction with APPLIED's currently marketed trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal, gynecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments. The Fixation Trocar may be used with an optical tissue separator or a bladed obturator, and with or without visualization for primary and secondary insertions.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS: The objective of the line extension is to offer trocar models that provide an alternate method of anchoring the trocar cannula to the patient's abdominal wall. The Fixation Trocar design has an inflatable balloon that is mounted at the cannula tip. Oncc the cannula tip is positioned inside the patient's abdominal cavity, the balloon is inflated thus preventing the cannula from unintended movement out of the patient. To prevent unintended movement into the patient, a movable bolster located on the cannula portion outside the patient is advanced until it contacts the patient's skin. The balloon/bolster combination - in effect - anchors the cannula to the abdominal wall, thus preventing undesirable shifting as the surgery proceeds. Scc Fig 1.
Image /page/1/Figure/3 description: This image shows a diagram of a medical device. The device includes a seal module, a movable bolster, an abdominal wall, an anchoring balloon, and a cannula. The diagram shows how the device is positioned within the abdominal wall, with the seal module on one side and the anchoring balloon on the other.
Fig 1 Cutaway of Fixation Trocar in tissue
The predicate trocar cannula in K060096 also had an anchoring feature, a series of ridges on the external surface. These ridges, or threads, are designed to provide a degree of resistance to unintended cannula movement. See Fig 2.
Image /page/1/Figure/6 description: This image shows a diagram of a cannula, seal module, abdominal wall, and ridges or threads. The seal module is on the left side of the image, and the cannula is on the right side of the image. The abdominal wall is in the middle of the image, and the ridges or threads are on the cannula.
Fig 2 Trocar in tissue with threads (ridges) on cannula surface
2
Image /page/2/Picture/0 description: The image contains a sequence of handwritten digits. The digits appear to be "4083638". The numbers are written in a cursive style, and the image is in black and white.
Image /page/2/Picture/1 description: The image shows the words "Page 3 of 13" written in cursive. The word "Page" is written in cursive, followed by the number 3 in a circle. The word "of" is written in cursive, followed by the number 13 in a circle. The image appears to be a page number from a document.
DISCUSSION OF NONCLINICAL TESTS SUBMITTED: There arc no currently recognized standards that specify anchoring security of trocar cannulas. For that reason, APPLIED created a test protocol designed to confirm safety and efficacy of the Fixation Trocar relative to the predicate device of K060096. These tests include a determination of:
- Insertion force the force required to insert the trocar cannula and obturator through . abdominal tissue.
- Post-insertion migration/slippage force the force required to dislodge the trocar cannula . from its position in tissue before the anchoring feature is activated.
- Retention force the force required to dislodge the cannula from tissue after deployment . of the balloon.
- Removal force the force required to remove the trocar from tissue after collapse of the . balloon.
These tests were performed on the subject device as well as predicate devices. For a discussion of the test method and results, see section 15.
CONCLUSIONS DRAWN FROM TESTING: APPLIED's performance and functional testing demonstrated that the Fixation Trocar is substantially equivalent or superior to its predicate devices and introduces no new safety and effectiveness issucs when used as instructed. The Fixation Trocar's anchoring feature porforms particularly well in its most important characteristic, retention of the cannula in the patient's abdomen.
3
Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with outstretched wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2008
Applied Medical Resources Corporation % Underwriters Laboratorics, Inc. Mr. Morten Christensen 455 Fast Trimble Road San Jose, California 95131-1230
Re: K083638
Trade/Device Name: Fixation Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: December 8, 2008 Received: December 9, 2008
Dear Mr. Christensen:
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.
4
Page 2 - Mr. Morten Christensen
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 Presmarlect 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 Assisstance 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 M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
083638
INDICATIONS FOR USE
510(k) Number (if known): Not yet assigned.
Device Name: Modular Trocar System; trade name not yet assigned.
Indications for Use: Applied Medical Modular Trocar Systems are sterile, single-use devices consisting of an obturator, a cannula and seal. These systems are indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) Division of General, Restormative, and Neurological Devices
510(k) Number L083631