(76 days)
Not Found
No
The description focuses on the mechanical and material properties of a surgical trocar and cannula, with no mention of AI, ML, image processing, or data-driven functionalities.
No
The device is a surgical instrument used to create and maintain a port of entry for other endoscopic instruments, not to directly treat a disease or condition. Its purpose is to facilitate a surgical procedure, similar to how a scalpel or forceps are tools rather than therapeutic devices.
No
The provided text describes a surgical trocar and cannula, which is a tool used to create a path for instruments during surgery. Its intended use is to establish and maintain a port of entry. There is no mention of it being used to diagnose conditions, analyze medical data, or provide diagnostic information.
No
The device description clearly states it is a surgical trocar and cannula composed of biosafe materials, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that this device is a surgical trocar and cannula used to establish a path of entry for endoscopic instruments during minimally invasive surgical procedures. It is used within the body during surgery.
- Lack of IVD Characteristics: The description does not mention any testing of samples, analysis of biological markers, or any other activity typically associated with IVD devices.
This device is a surgical instrument used for accessing the body during surgery, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The SurgiQuest™ Elastomeric Optical Trocar and Cannula has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The subject is a surgical trocar and cannula composed of biosafe materials. The device incorporates an expandable elastomer sheath, which serves to hold the cannula vertically in place during endoscopic surgery. The device is used to create and maintain a port of entry during endoscopic surgery. It is fully disposable and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal and thoracic
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 device has been tested to show its ability to adequately maintain its position within the abdominal wall during laparoscopic surgery. Also, bench top and animal testing has confirmed that insertion and removal forces are substantially equivalent to the predicate devices.
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
SurgiQuest, Inc.
510(k) Notification for SurgiQuest™ Elastomeric Optical Trocar & Cannula
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| SUBMITTER | SurgiQuest, Inc.
12 Cascade Boulevard, Suite 2B
Orange, CT 06477 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Kourosh Azarbarzin
Founder & C.E.O. - SurgiQuest, Inc.
MAR 14 2007 |
| DATE PREPARED | December 29, 2006 |
| CLASSIFICATION | Laparoscopic trocar, GCJ
Class: II |
| COMMON NAME | Disposable Endoscopic Optical Trocar & Cannula |
| PROPRIETARY NAME | SurgiQuest™ Elastomeric Optical Trocar & Cannula
(Trademark name to be determined) |
| PREDICATE DEVICE | Surgiport™ Blunt Tip Trocar
U.S. Surgical Corp. (Norwalk, CT)
K903419
EndoPath III™ Trocar System
Ethicon Endo-Surgery, Inc. (Cincinnati, OH)
K032676 |
| DEVICE DESCRIPTION | The subject is a surgical trocar and cannula composed of
biosafe materials. The device incorporates an expandable
elastomer sheath, which serves to hold the cannula vertically in
place during endoscopic surgery. The device is used to create
and maintain a port of entry during endoscopic surgery. It is
fully disposable and is intended for single use only. |
| TESTING | The device has been tested to show its ability to adequately
maintain its position within the abdominal wall during
laparoscopic surgery. Also, bench top and animal testing has
confirmed that insertion and removal forces are substantially
equivalent to the predicate devices. |
. .
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an abstract eagle or bird-like figure with three curved lines forming its body and wings. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SurgiQuest, Inc. % Kourosh Azarbarzin Founder & CEO 12 Cascade Boulevard, Suite 2B Orange, Connecticut 06477
MAR 1 4 2807
Re: K063859
Trade/Device Name: SurgiQuest™ Elastomeric Optical Trocar & Cannula (Trademark name to be determined)
Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: March 5, 2007 Received: March 5, 2007
Dear Kourosh Azarbarzin:
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
2
Page 2 - Kourosh Azarbarzin
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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mell
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SurgiQuest, Inc.
510(k) Notification for SurgiQuest144 Elastomeric Optical Trocar & Cannula
STATEMENT FOR INDICATIONS FOR USE
510(k) Number:
Device Name: SurgiQuest™ Elastomeric Optical Trocar & Cannula (Trademark name to be determined)
Indications for Use: The SurgiQuest™ Elastomeric Optical Trocar and Cannula has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
Prescription Use: Yes
DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number L063859