(84 days)
Not Found
No
The device description and summary of performance studies describe a mechanical trocar with a balloon and seals, with no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is described as a port of access for surgical instruments, not for providing therapy like healing or pain relief.
No
Explanation: The device description states its purpose is to provide a "port of access for insertion of endoscopic instruments into an incision site." This describes a surgical tool used for access during procedures, not for diagnosing conditions or diseases.
No
The device description clearly outlines physical components such as a main body, balloon, inflation port, seals, and a syringe, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures to establish a port of entry for endoscopic instruments in the saphenous vein or radial artery. This is a surgical tool used directly on a patient's body.
- Device Description: The description details a surgical instrument with components like a balloon, inflation port, seals, and a one-way valve for gas insufflation. These are all features of a surgical access device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease. IVDs are used for diagnostic purposes on samples, not for direct surgical intervention.
Therefore, this device falls under the category of a surgical instrument, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This product has applications for surgery in the saphenous vein, or radial artery for establishment of a port of entry for endoscopic instruments.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, GEI
Device Description
The Short Port Blunt Tip Trocar (BTT) is used to provide a port of access for insertion of endoscopic instruments into an incision site. The device consists of a main body with a Balloon on the distal end, a Balloon inflation port, an Endoscope seal on the proximal end, and an external port with a one-way valve for gas insufflation. It also includes a Cannula seal to allow insertion of the Harvesting Cannula. The balloon minimizes leakage and secures the port. A 30 cc syringe is provided for inflation/deflation of the Balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
saphenous vein, radial artery
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)
Performance testing
Biocompatibility testing
Sterility testing
Shelf life testing
The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed Short Port BTT.
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
MAQUET Cardiovascular Premarket Notification Traditional 510(k) ﮯ Short Port Blunt Tip Trocar (BTT)
GETINGE GROUP
.
APR 1 1 2013
· Short Port Blunt Tip Trocar 510(k) Summary
Prepared in accordance with 21 CFR Part 807.92
510(k) Number: | K130121 |
---|---|
Date Prepared: | 8 April 2013 |
Device Owner: | MAQUET Cardiovascular LLC |
45 Barbour Pond Drive | |
Wayne, New Jersey 07470 | |
Contact Personnel: | |
Title: | |
Email: | |
Phone: | Mark Dinger |
Regulatory Affairs Specialist II | |
mark.dinger@maquet.com | |
973-709-7691 | |
Fax: 973-807-1658 | |
Trade Name: | Short Port Blunt Tip Trocar |
Device Generic Name: | Trocar Port |
Primary Classification: | According to 21 CFR 876.1500 of the Federal Food, Drug |
and Cosmetic Act, the device classification is Class II, | |
Primary Product Code GCJ, and Secondary Product Code | |
GEI. | |
Predicate Device: | K992353 Blunt Tip Trocar Port (SE: 30 July 1999) |
Device Description: | The Short Port Blunt Tip Trocar (BTT) is used to provide a |
port of access for insertion of endoscopic instruments into | |
an incision site. The device consists of a main body with a | |
Balloon on the distal end, a Balloon inflation port, an | |
Endoscope seal on the proximal end, and an external port | |
with a one-way valve for gas insufflation. It also includes a | |
Cannula seal to allow insertion of the Harvesting Cannula. | |
The balloon minimizes leakage and secures the port. A 30 | |
cc syringe is provided for inflation/deflation of the Balloon. | |
Indications for Use: | This product has applications for surgery in the saphenous |
vein, or radial artery for establishment of a port of entry for | |
endoscopic instruments. |
ત્ત્વનું
1
ETINGE GRO
Technological Characteristics
The Proposed Short Port Blunt Tip Trocar and the predicate devices have the following similarities:
- the same intended use. 0
- the same operating principles. O
- sterilized using the same materials and processes, O
- has same packaging. O
The Proposed Short Port Blunt Tip Trocar and the predicate devices have the following differences:
- Material change: From Latex balloon. o
- Labeling change: Revision of Latex content o statement.
- Change converter door to Cannula Seal and 7mm O Seal.
This difference is not considered a technological difference and is substantially equivalent to the predicate devices.
MAQUET Cardiovascular's development process required that the following activities be completed during the development of the Short Port BTT:
- . Performance testing
- . Biocompatibility testing
- Sterility testing .
- Shelf life testing .
The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed Short Port BTT.
Based upon the information submitted in this Traditional 510(k) premarket notification. MAOUET's Short Port BTT is substantially equivalent to the currently marketed Short Port BTT. The Short Port BTT is similar to the predicate devices in the intended use and the fundamental scientific technology of the device. The design verification and validation testing established that the Short Port BTT is substantially equivalent as the predicate device.
Safety and Performance:
Conclusion:
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 11, 2013
MAQUET Cardiovascular LLC % Mr. Mark Dinger Regulatory Affairs Specialist II 45 Barbour Pond Drive Wayne, New Jersey 07470
Re: K130121
Trade/Device Name: Short Port Blunt Tip Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: March 21, 2013 Received: March 27, 2013
Dear Mr. Dinger:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Mr. Mark Dinger
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, FOR
Peter Dikumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K130121
Device Name: Short Port Blunt Tip Trocar (BTT)
Indications For Use:
This product has applications for surgery in the saphenous vein, or radial artery for establishment of a port of entry for endoscopic instruments.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joshua C. Nipper -S
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
For
(Division Sign-Off)
Division of Surgical Devices
K130121 510(k) Number