(126 days)
The TC Endo Port has applications in abdominal, thoracic, laparoscopic and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
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 Together these seals minimize gas or fluid leakage when instruments are inserted or withdrawn through the trocar.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 provided document describes the acceptance criteria and performance of the "TC Endo Port" device, a surgical trocar. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Exposure | All samples must be capable of withstanding a 2X sterilization cycle. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." The device is also mentioned to be "EtO gas-permeable sterile." |
| Simulated Implant | 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. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Valve Tool Pass Verification | Must pass the range of recommended tools through the valve without damaging the valve or causing the loss of more than 10ml of fluid. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Valve Cyclic Test | 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. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Valve Pressure Withstand | Must withstand a fluid pressure of 450mmHg without leaking. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Balloon Diameter Verification | Profile of balloons must be within 15%-25% of expected values from design. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Balloon Volume Loss | Balloons cannot lose more than 0.5ml over one hour. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Balloon Inflation/Deflation Time | Balloons must inflate and deflate in under 15 seconds. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Balloon Cyclic Test | Balloons and inflation lumens must withstand 40 inflation/deflation cycles to 1 atm without failure. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Balloon Minimum Burst Strength | Balloon should withstand 2X SF over 1 atm. | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Cannula to Hub Strength | Material interface should resist a tensile force of up to 3.4 lb (15 N). | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Inflation Lumen to Hub Strength | Material interface should resist a tensile force of up to 3.4 lb (15 N). | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Valve Body to Cannula Strength | Material interface should resist a tensile force of up to 3.4 lb (15 N). | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
| Dilator Insertion/Removal Force | Material interface should resist a tensile force of up to 3.4 lb (15 N). | Implied to meet the criteria, as no failures are reported and the conclusion states "No new questions of safety or effectiveness were raised during the performance testing of the device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- For "Sterilization Exposure" test: "All" samples.
- For "Simulated Implant" test: 30 new devices + 1 Predicate device.
- For all other listed tests: 30 samples each.
- Data Provenance: The document does not specify the origin (e.g., country) of the data, nor does it explicitly state if the study was retrospective or prospective. Given that these are non-clinical, in-vitro performance tests for a new device, they are inherently prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests described are non-clinical performance evaluations of the device's physical properties and functionality, not diagnostic or clinical assessments requiring expert human interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of data where consensus is needed to establish ground truth. The tests performed for this device are objective measurements of physical and functional properties.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi Reader Multi Case comparative effectiveness study was not done. The document explicitly states: "No clinical tests were conducted as part of this products development." This device is a surgical instrument, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is an endoscope and accessories, a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, expert consensus) does not directly apply here. For these non-clinical performance tests, "ground truth" is defined by the objective physical and functional parameters measured against pre-defined engineering specifications and direct comparison to a predicate device. For example, "withstanding a 2X sterilization cycle" or "not losing more than 10ml of fluid" are the objective criteria that act as the standard.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. This is a physical medical device being evaluated through non-clinical performance testing against a predicate, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical medical device.
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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
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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.
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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 | SampleSize | Test Description | RequiredResults |
|---|---|---|---|
| SterilizationExposure | All | The samples are exposedto a 2X sterilization cycle. | All samples mustbe capable ofwithstanding a2Xsterilizationcycle. |
| Simulatedimplant | 301 Pred | Simulate placing the deviceusing an implant simulator.Measure insertion forcesand compare to predicatedevice | All samples mustbe capable of beingimplanted insimulatedconditions usingthe instructions foruse. Insertionforces must beequal to or lessthan predicatedevice |
| Valve tool passverification | 30 | Pass tools of various sizethrough the distal valve andverify that tools can beaccommodated withoutdamage or excessiveleakage | Must pass therange ofrecommended toolsthrough the valvewithout damagingthe valve orcausing the loss ofmore than 10ml offluid |
| Valve cyclictest | 30 | Pass tools through thevalves repeatedly untilfailure occurs or maximumnumber of tool passesrequirement is reached | Must pass themaximum sizedtool through thevalve ten timeswithout damagingthe valve orcausing the loss of |
| more than 10ml offluid | |||
| Valve pressurewithstand | 30 | Determine that valves meetthe minimum pressurerequirement without failure.Compare to predicatedevice | Must withstand afluid pressure of450mmHg withoutleaking |
| Balloondiameterverification | 30 | Measure the inflateddiameter and length of thedistal and proximal balloonswhen fully inflated | Profile of balloonsmust be within15%-25% ofexpected valuesfrom design |
| Balloon volumeloss | 30 | Determine that volume lossof balloons over time iswithin specification | Balloons cannotlose more than0.5ml over onehour |
| Ballooninflation/deflation time | 30 | Measure time required toinflate and deflate balloons | Balloons mustinflate and deflatein under 15seconds |
| Balloon cyclictest | 30 | Repeatedly inflate/deflateballoons until failure occursor minimum number ofcycles required is reached | Balloons andinflation lumensmust withstand 40inflation/deflationcycles to 1 atmwithout failure. |
| Balloonminimum burststrength | 30 | Measure burst pressure andvolume. Verify thatminimum is achieved | Balloon shouldwithstand 2X SFover 1 atm |
| Cannula to hubstrength | 30 | Measure tensile forces.Verify that minimum isachieved | Material interfaceshould resist atensile force of up to3.4 lb (15 N). |
| Inflation lumento hub strength | 30 | Measure tensile forces.Verify that minimum isachieved | Material interfaceshould resist atensile force of up to3.4 lb (15 N). |
| Valve body tocannulastrength | 30 | Measure tensile forces.Verify that minimum isachieved | Material interfaceshould resist atensile force of up to3.4 lb (15 N). |
| Dilatorinsertion/removal force | 30 | Measure insertion removalforces, verify that forces areless than tensile forces | Material interfaceshould resist atensile force of up to3.4 lb (15 N). |
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K083218 pg4 ofs
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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
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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.
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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
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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
14
§ 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.