BASX BLADELESS TROCAR

K062209 · Ethicon Endo-Surgery, LLC · GCJ · Oct 10, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K062209
• Device Name: BASX BLADELESS TROCAR
• Applicant: Ethicon Endo-Surgery, LLC
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The BASX™ Bladeless Trocar has applications in abdominal and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.

Device Story

BASX™ Bladeless Trocar is a sterile, single-patient-use surgical instrument used to establish an entry path for endoscopic instruments during abdominal and gynecologic minimally invasive surgeries. The device consists of a radiolucent sleeve (5mm, 11mm, or 12mm diameters) and a one-piece molded obturator. The 11mm and 12mm sleeves feature an integrated two-seal system—an outer self-adjusting seal and an internal seal—to maintain pneumoperitoneum and minimize gas leakage during instrument insertion or withdrawal. A stopcock valve allows for gas insufflation and desufflation. The sleeve includes stability threads for abdominal wall retention. Operated by surgeons in an OR setting, the device facilitates access for endoscopic tools, enabling minimally invasive procedures and potentially reducing patient trauma compared to open surgery.

Clinical Evidence

Bench testing only. Performance evaluation demonstrated that the device performs as intended and meets design requirements consistent with predicate trocar devices.

Technological Characteristics

Radiolucent sleeve (5mm, 11mm, 12mm); one-piece molded obturator; integrated two-seal system for pneumoperitoneum maintenance; stopcock valve for luer lock gas insufflation/desufflation; sleeve includes stability threads for abdominal wall retention. Materials are similar to predicate devices. Non-powered, mechanical device.

Indications for Use

Indicated for use in abdominal and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. Contraindicated for thoracic applications or when minimally invasive techniques are contraindicated.

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® Optiview Optical Surgical Obturator and Sleeve
• ENDOPATH® Non-Bladed Solid Obturator (with Sleeve)
• ENDOPTH® XCEL™ Bladeless Trocar

Submission Summary (Full Text)

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## 510(k) Summary

| Company | Ethicon Endo-Surgery, LLC<br>Angora Industrial Park, Building G<br>Caguas, Puerto Rico 00725 |
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OCT 1 0 2006

Contact Dennis Hahn Director, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Phone: [phone] FAX: [phone] Email: [e-mail]

Date Prepared July 31, 2006

- Trade Name: BASX™ Bladeless Trocar Device Name Common or Usual Name: Surgical Trocar Classification Name: Laparoscope, General & Plastic Surgery
Predicate Devices ENDOPATH® Optiview Optical Surgical Obturator and Sleeve ENDOPATH® Non-Bladed Solid Obturator (with Sleeve) ENDOPTH® XCEL™ Bladeless Trocar

Device Description: The BASX™ Bladeless Trocar is a sterile single patient use instrument consisting of a radiolucent sleeve in sizes 5mm, 11mm, and 12 mm diameters. The trocar sleeve for the 11 and 12mm devices contains two seals, an outer integrated self-adjusting seal that accommodates instruments ranging from 5mm to 12mm in diameter where indicated and an internal seal. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. The 5mm trocar sleeve accommodates only 5mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation.

Indications for Use: The BASX™ Bladeless Trocar has applications in abdominal and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.

Contraindications: This device is not intended for thoracic applications or when minimally invasive techniques are contraindicated.

Technological Characteristics: The BASX™ Bladeless Trocar consists of a sleeve and housing with welded a stopcock assembly and an integrated two seal system for maintaining pneumoperitoneum. The sleeve cannula contains integrated stability threads for abdominal wall retention. The obturator is a one-piece molded design. The trocar uses materials that are similar to those used in the predicate devices.

Performance Data Bench testing evaluation was performed to demonstrate that the new device performs as intended. Design and development were predicated on use of technology currently used in Ethicon Endo-Surgery trocar devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 0 2006

Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgerv, Inc. Mr. Dennis Hahn Director, Regulatory Affairs 4545 Creek Road Cincinnati, Ohio 45242

Re: K062209

Trade/Device Name: BASX™ Bladeless Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: July 31, 2006 Received: August 1, 2006

Dear Mr. Hahn:

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. Dennis Hahn

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

> Sincerely yours. િમી 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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## Indications for Use

510(k) Number (if known): KO62209

Device Name: BASX™ Bladeless Trocar

Indications for Use:

The BASX™ Bladeless Trocar has applications in abdominal and gynecologic minimally invasive surgical procedures to establish a path 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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K062209
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