(126 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties of a surgical trocar, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an instrument for establishing a path of entry for other endoscopic instruments, not for directly treating a disease or condition. Its function is to facilitate minimally invasive procedures.
No
Explanation: The device is described as an instrument for establishing a path of entry for endoscopic instruments in minimally invasive procedures, not for identifying a disease or condition. Its function is procedural (access), not diagnostic.
No
The device description clearly outlines physical components made of plastic and includes performance studies related to mechanical properties and sterilization, 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 to "establish 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 to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical instrument (trocar) used to create an opening and maintain access during surgery. It does not describe reagents, calibrators, control materials, kits, instruments, apparatus, equipment, or systems intended for use in the in vitro examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the TC Endo Port is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TC Endo Port has applications in abdominal, thoracic, laparoscopic and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
Product codes
GCJ
Device Description
TC Endoport trocars are sterile single patient use instruments consisting of a sleeve and obturator in sizes ranging from 5-12 mm in diameter. The TC Endoport obturator is made from plastic, and has a dilator tip which gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall.
The trocar sleeve contains two seals, an outer annular seal that accommodates instruments from 5-12 mm in diameter, and an internal seal. Together these seals minimize gas or fluid leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve, or valved luer are provided with standard luer lock fittings, to provide for gas insufflation, desufflation, or infusion and aspiration of fluids.
The TC Endo port and components are packaged in industry-standard, EtO gaspermeable sterile barrier materials using industry-standard package sealing processes. The packaging is an inner tray containing the port, and introducer components sealed with a Tyvek lid within an outer tray that is also sealed with a Tyvek lid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, 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
The following non-clinical tests were performed as the basis for establishing substantial equivalence to the predicate device, as well as safety and effectiveness of the indication for use:
- Sterilization Exposure, Sample Size: All, Test Description: The samples are exposed to a 2X sterilization cycle., Required Results: All samples must be capable of withstanding a 2Xsterilization cycle.
- Simulated implant, Sample Size: 30 1 Pred, Test Description: Simulate placing the device using an implant simulator. Measure insertion forces and compare to predicate device, Required Results: All samples must be capable of being implanted in simulated conditions using the instructions for use. Insertion forces must be equal to or less than predicate device
- Valve tool pass verification, Sample Size: 30, Test Description: Pass tools of various size through the distal valve and verify that tools can be accommodated without damage or excessive leakage, Required Results: Must pass the range of recommended tools through the valve without damaging the valve or causing the loss of more than 10ml of fluid
- Valve cyclic test, Sample Size: 30, Test Description: Pass tools through the valves repeatedly until failure occurs or maximum number of tool passes requirement is reached, Required Results: Must pass the maximum sized tool through the valve ten times without damaging the valve or causing the loss of more than 10ml of fluid
- Valve pressure withstand, Sample Size: 30, Test Description: Determine that valves meet the minimum pressure requirement without failure. Compare to predicate device, Required Results: Must withstand a fluid pressure of 450mmHg without leaking
- Balloon diameter verification, Sample Size: 30, Test Description: Measure the inflated diameter and length of the distal and proximal balloons when fully inflated, Required Results: Profile of balloons must be within 15%-25% of expected values from design
- Balloon volume loss, Sample Size: 30, Test Description: Determine that volume loss of balloons over time is within specification, Required Results: Balloons cannot lose more than 0.5ml over one hour
- Balloon inflation/deflation time, Sample Size: 30, Test Description: Measure time required to inflate and deflate balloons, Required Results: Balloons must inflate and deflate in under 15 seconds
- Balloon cyclic test, Sample Size: 30, Test Description: Repeatedly inflate/deflate balloons until failure occurs or minimum number of cycles required is reached, Required Results: Balloons and inflation lumens must withstand 40 inflation/deflation cycles to 1 atm without failure.
- Balloon minimum burst strength, Sample Size: 30, Test Description: Measure burst pressure and volume. Verify that minimum is achieved, Required Results: Balloon should withstand 2X SF over 1 atm
- Cannula to hub strength, Sample Size: 30, Test Description: Measure tensile forces. Verify that minimum is achieved, Required Results: Material interface should resist a tensile force of up to 3.4 lb (15 N).
- Inflation lumen to hub strength, Sample Size: 30, Test Description: Measure tensile forces. Verify that minimum is achieved, Required Results: Material interface should resist a tensile force of up to 3.4 lb (15 N).
- Valve body to cannula strength, Sample Size: 30, Test Description: Measure tensile forces. Verify that minimum is achieved, Required Results: Material interface should resist a tensile force of up to 3.4 lb (15 N).
- Dilator insertion/removal force, Sample Size: 30, Test Description: Measure insertion removal forces, verify that forces are less than tensile forces, Required Results: Material interface should resist a tensile force of up to 3.4 lb (15 N).
No clinical tests were conducted as part of this products development.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K083218 Pg 1 of 5
510(K) SUMMARY
MAR - 6 2009
1) Submitter's Name:
TransCardiac Therapeutics Inc 3355 Lenox Road NE Suite 415 Atlanta, GA 30326 Tel: 404-816-4520 Ext. 105 Fax: 404-816-4530
Contact Person (s):
Primary Contact Person
David Smith
·
Chief Technology Officer
Tel: 404-816-4520 ext 105
Fax: 404-816-4530
Cell: 404-353-3717
Establishment registration number: TBD
Date the summary was prepared: 10-27-2008
2) Device Identification:
| Proprietary Name: | TC Endo Port |
|---|---|
| Common Name: | Endoscope and Accessories |
| Classification Name: | Endoscope and Accessories |
| Classification Number: | 21 CFR 876.1500 |
| Classification Panel: | Gastroenterology and Urology |
| Product Code: | GCJ |
Secondary Contact Person
Lina Lattouf Vice President Scientific & Regulatory Tel: 404-816-4520 ext 108 Fax: 404-816-4530
1
3) Legally marketed device to which equivalence is claimed:
| Manufacturer: | Ethicon Endo-Surgery |
|---|---|
| Device Name: | Endopath Trocar System |
| 510(K) Identification: | K032676. |
4) DEVICE DESCRIPTION
TC Endoport trocars are sterile single patient use instruments consisting of a sleeve and obturator in sizes ranging from 5-12 mm in diameter. The TC Endoport obturator is made from plastic, and has a dilator tip which gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall.
The trocar sleeve contains two seals, an outer annular seal that accommodates instruments from 5-12 mm in diameter, and an internal seal. Together these seals minimize gas or fluid leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve, or valved luer are provided with standard luer lock fittings, to provide for gas insufflation, desufflation, or infusion and aspiration of fluids.
The device depiction section provides a more detailed description of the device, and the predicate.
5) Statement of Intended Use
The TC Endo Port has applications in abdominal, thoracic, laparoscopic and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
6) Technological Characteristics
a) Summary of technological characteristics of the TC Endo Port compared to the predicate device
The technological characteristics of the new device are different from the predicate in that the trocar securement mechanism is created through the use of inflatable balloons placed along the trocar shaft instead of barbs as in the predicate device. This provides for a secure hemostatic seal, and allows for the device to be customized for different patient needs.
2
b) Assessment of Performance Data
1) Summary of the non-clinical performance data
The following non-clinical tests were performed as the basis for establishing substantial equivalence to the predicate device, as well as safety and effectiveness of the indication for use:
| Test Name | Sample
Size | Test Description | Required
Results |
|-----------------------------------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization
Exposure | All | The samples are exposed
to a 2X sterilization cycle. | All samples must
be capable of
withstanding a
2Xsterilization
cycle. |
| Simulated
implant | 30
1 Pred | Simulate placing the device
using an implant simulator.
Measure insertion forces
and compare to predicate
device | All samples must
be capable of being
implanted in
simulated
conditions using
the instructions for
use. Insertion
forces must be
equal to or less
than predicate
device |
| Valve tool pass
verification | 30 | Pass tools of various size
through the distal valve and
verify that tools can be
accommodated without
damage or excessive
leakage | Must pass the
range of
recommended tools
through the valve
without damaging
the valve or
causing the loss of
more than 10ml of
fluid |
| Valve cyclic
test | 30 | Pass tools through the
valves repeatedly until
failure occurs or maximum
number of tool passes
requirement is reached | Must pass the
maximum sized
tool through the
valve ten times
without damaging
the valve or
causing the loss of |
| | | | more than 10ml of
fluid |
| Valve pressure
withstand | 30 | Determine that valves meet
the minimum pressure
requirement without failure.
Compare to predicate
device | Must withstand a
fluid pressure of
450mmHg without
leaking |
| Balloon
diameter
verification | 30 | Measure the inflated
diameter and length of the
distal and proximal balloons
when fully inflated | Profile of balloons
must be within
15%-25% of
expected values
from design |
| Balloon volume
loss | 30 | Determine that volume loss
of balloons over time is
within specification | Balloons cannot
lose more than
0.5ml over one
hour |
| Balloon
inflation/
deflation time | 30 | Measure time required to
inflate and deflate balloons | Balloons must
inflate and deflate
in under 15
seconds |
| Balloon cyclic
test | 30 | Repeatedly inflate/deflate
balloons until failure occurs
or minimum number of
cycles required is reached | Balloons and
inflation lumens
must withstand 40
inflation/deflation
cycles to 1 atm
without failure. |
| Balloon
minimum burst
strength | 30 | Measure burst pressure and
volume. Verify that
minimum is achieved | Balloon should
withstand 2X SF
over 1 atm |
| Cannula to hub
strength | 30 | Measure tensile forces.
Verify that minimum is
achieved | Material interface
should resist a
tensile force of up to
3.4 lb (15 N). |
| Inflation lumen
to hub strength | 30 | Measure tensile forces.
Verify that minimum is
achieved | Material interface
should resist a
tensile force of up to
3.4 lb (15 N). |
| Valve body to
cannula
strength | 30 | Measure tensile forces.
Verify that minimum is
achieved | Material interface
should resist a
tensile force of up to
3.4 lb (15 N). |
| Dilator
insertion/remov
al force | 30 | Measure insertion removal
forces, verify that forces are
less than tensile forces | Material interface
should resist a
tensile force of up to
3.4 lb (15 N). |
3
K083218 pg4 ofs
・
4
The TC Endo port and components are packaged in industry-standard, EtO gaspermeable sterile barrier materials using industry-standard package sealing processes. The packaging is an inner tray containing the port, and introducer components sealed with a Tyvek lid within an outer tray that is also sealed with a Tyvek lid.
- No clinical tests were conducted as part of this products development.
3) SUMMARY OF CONCLUSIONS
The TC Endo Port and the predicate devices have identical intended uses and fundamental scientific technology. The subject and predicate devices are substantially similar in configuration, dimensions, and materials. No new questions of safety or effectiveness were raised during the performance testing of the device. The TC Endo Port has been determined to be substantially equivalent to the predicate device.
895 075
5
DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TransCardiac Therapeutics, Inc. % Mr. David Smith VP and Chief Technology Officer 3355 Lenox Road North East, Suite 415 Atlanta, Georgia 30326 - - -
MAR - 6 2009
Re: K083218
Trade/Device Name: TC Endo Port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: February 6, 2009 Received: February 9, 2009
Dear Mr. Smith:
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.
6
Page 2 - Mr. David Smith
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,
fuchti, m.D. for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K08/3218 pg 1041
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: TC Endo Port
Indications for Use:
The TC Endo Port has applications in abdominal, thoracic, laparoscopic and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
AND/OR Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart D) (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)
Niel RP Sgden for nixon
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K083218
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