TC ENDO PORT

K083218 · Transcardiac Therapeutics, Inc. · GCJ · Mar 6, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K083218
• Device Name: TC ENDO PORT
• Applicant: Transcardiac Therapeutics, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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.

Device Story

TC Endo Port is a sterile, single-use trocar system (5-12 mm diameter) for minimally invasive surgery; consists of sleeve and plastic obturator with dilator tip. Sleeve features dual seals (annular and internal) to minimize gas/fluid leakage and a stopcock/luer valve for insufflation/desufflation or fluid management. Unlike predicate devices using barbs, TC Endo Port utilizes inflatable balloons along the shaft for securement and hemostatic sealing. Used by surgeons in OR settings to provide access for endoscopic instruments. Benefits include customizable securement for varying patient needs and maintenance of pneumoperitoneum.

Clinical Evidence

No clinical tests were conducted. Substantial equivalence is based on non-clinical bench testing, including sterilization validation, valve leak/pressure testing, balloon inflation/deflation/burst strength, and mechanical tensile strength of interfaces.

Technological Characteristics

Sterile, single-use trocar (5-12 mm). Materials: plastic obturator. Securement: inflatable balloons. Seals: dual-seal system. Connectivity: standard luer lock fittings. Sterilization: EtO gas. Mechanical testing: tensile strength (15 N), pressure withstand (450 mmHg).

Indications for Use

Indicated for patients undergoing abdominal, thoracic, laparoscopic, or gynecologic minimally invasive procedures requiring an entry path for endoscopic instruments.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Endopath Trocar System (K032676)

Submission Summary (Full Text)

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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: [phone] Ext. 105 Fax: [phone]

#### Contact Person (s):

#### Primary Contact Person

David Smith

·

Chief Technology Officer

Tel: [phone] ext 105

Fax: [phone]

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: [phone] ext 108 Fax: [phone]

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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 | Sample<br>Size | Test Description | Required<br>Results |
|-----------------------------------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization<br>Exposure | All | The samples are exposed<br>to a 2X sterilization cycle. | All samples must<br>be capable of<br>withstanding a<br>2Xsterilization<br>cycle. |
| Simulated<br>implant | 30<br>1 Pred | Simulate placing the device<br>using an implant simulator.<br>Measure insertion forces<br>and compare to predicate<br>device | All samples must<br>be capable of being<br>implanted in<br>simulated<br>conditions using<br>the instructions for<br>use. Insertion<br>forces must be<br>equal to or less<br>than predicate<br>device |
| Valve tool pass<br>verification | 30 | Pass tools of various size<br>through the distal valve and<br>verify that tools can be<br>accommodated without<br>damage or excessive<br>leakage | Must pass the<br>range of<br>recommended tools<br>through the valve<br>without damaging<br>the valve or<br>causing the loss of<br>more than 10ml of<br>fluid |
| Valve cyclic<br>test | 30 | Pass tools through the<br>valves repeatedly until<br>failure occurs or maximum<br>number of tool passes<br>requirement is reached | Must pass the<br>maximum sized<br>tool through the<br>valve ten times<br>without damaging<br>the valve or<br>causing the loss of |
| | | | more than 10ml of<br>fluid |
| Valve pressure<br>withstand | 30 | Determine that valves meet<br>the minimum pressure<br>requirement without failure.<br>Compare to predicate<br>device | Must withstand a<br>fluid pressure of<br>450mmHg without<br>leaking |
| Balloon<br>diameter<br>verification | 30 | Measure the inflated<br>diameter and length of the<br>distal and proximal balloons<br>when fully inflated | Profile of balloons<br>must be within<br>15%-25% of<br>expected values<br>from design |
| Balloon volume<br>loss | 30 | Determine that volume loss<br>of balloons over time is<br>within specification | Balloons cannot<br>lose more than<br>0.5ml over one<br>hour |
| Balloon<br>inflation/<br>deflation time | 30 | Measure time required to<br>inflate and deflate balloons | Balloons must<br>inflate and deflate<br>in under 15<br>seconds |
| Balloon cyclic<br>test | 30 | Repeatedly inflate/deflate<br>balloons until failure occurs<br>or minimum number of<br>cycles required is reached | Balloons and<br>inflation lumens<br>must withstand 40<br>inflation/deflation<br>cycles to 1 atm<br>without failure. |
| Balloon<br>minimum burst<br>strength | 30 | Measure burst pressure and<br>volume. Verify that<br>minimum is achieved | Balloon should<br>withstand 2X SF<br>over 1 atm |
| Cannula to hub<br>strength | 30 | Measure tensile forces.<br>Verify that minimum is<br>achieved | Material interface<br>should resist a<br>tensile force of up to<br>3.4 lb (15 N). |
| Inflation lumen<br>to hub strength | 30 | Measure tensile forces.<br>Verify that minimum is<br>achieved | Material interface<br>should resist a<br>tensile force of up to<br>3.4 lb (15 N). |
| Valve body to<br>cannula<br>strength | 30 | Measure tensile forces.<br>Verify that minimum is<br>achieved | Material interface<br>should resist a<br>tensile force of up to<br>3.4 lb (15 N). |
| Dilator<br>insertion/remov<br>al force | 30 | Measure insertion removal<br>forces, verify that forces are<br>less than tensile forces | Material interface<br>should resist a<br>tensile force of up to<br>3.4 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.

2) 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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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

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