CARDIOVATIONS RETRACTOR

K031847 · ETHICON, Inc. · GCJ · Jul 21, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031847
• Device Name: CARDIOVATIONS RETRACTOR
• Applicant: ETHICON, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CardioVations Retractor has application for use in the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal, and subcutaneous areas. The device may be used in surgical procedures requiring dissection and retraction of tissue.

Device Story

Single-patient use surgical retractor; used for soft tissue dissection and retraction to maintain operative space under endoscope visualization. Features blunt, spoon-shaped (hood) distal tip for creating working cavities and wide shaft for retraction. Transparent tip enables visualization during insertion, tunneling, and dissection. Includes vein retractor feature; compatible with CardioVations Optical Bipolar Device. Operated by surgeons in clinical/surgical settings. Facilitates instrument passage beneath retractor shaft during vessel harvesting and other procedures; improves surgical access and visualization.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Manual surgical instrument; blunt, spoon-shaped distal tip; wide shaft; transparent tip material. Compatible with endoscopic visualization systems. No electronic components or software.

Indications for Use

Indicated for patients undergoing surgical procedures requiring dissection and retraction of tissue in extraperitoneal spaces, including retroperitoneal, preperitoneal, and subcutaneous areas.

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

• CardioVations Ultra-Retractor

Submission Summary (Full Text)

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## 510(k) SUMMARY K031847

| Statement | Information supporting claims of substantial equivalence, as<br>defined under the Federal Food, Drug, and Cosmetic Act,<br>respecting safety and effectiveness is summarized below. For the<br>convenience of the Reviewer, this summary is formatted in<br>accordance with the Agency's final rule ".... 510(k) Summaries<br>and 510(k) Statements ...." (21 CFR 807) and can be used to<br>provide a substantial equivalence summary to anyone requesting it<br>from the Agency. | | |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|--|
| | MODIFIED DEVICE NAME: | CardioVations Retractor | |
| | PREDICATE DEVICE NAME: | CardioVations Ultra-<br>Retractor | |
| Device Description | The CardioVations Retractor is a single patient use device<br>for dissection and retraction of soft tissue to maintain space while<br>under endoscope visualization. For example, like the predicate<br>device, the retractor will be used to dissect and retract tissue<br>surrounding a vessel to allow for instrument passage beneath the<br>shaft of the retractor in vessel harvesting procedures. The blunt,<br>spoon (hood) distal tip functions to dissect and create a working<br>cavity for instrument passage. The wide shaft provides for<br>retraction and maintenance of the operative working space. The<br>transparent tip allows visualization during insertion, tunneling and<br>dissection. A vein retractor feature has been added. The device is<br>compatible with the CardioVations Optical Bipolar Device<br>(included in the vessel harvesting package tray). | | |
| Intended Use | The CardioVations Retractor has application for use in the creation<br>and maintenance of an operative cavity in the extraperitoneal<br>spaces such as the retroperitoneal, preperitoneal, and subcutaneous<br>areas. The device may be used in surgical procedures requiring<br>dissection and retraction of tissue. | | |

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| Indications Statement | The CardioVations Retractor has application for use in the creation<br>and maintenance of an operative cavity in the extraperitoneal<br>spaces such as the retroperitoneal, preperitoneal and subcutaneous<br>areas. The device may be used in surgical procedures requiring<br>dissection and retraction of tissue. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The modified device has the same technological characteristics as<br>the predicate device. The form, fit, function and method of<br>operation are similar. |
| Performance Data | Results of verification testing indicates that the product meets the<br>established performance requirements. |
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR<br>807) and the information provided herein, we conclude that the<br>subject device is substantially equivalent to the predicate devices<br>under the Federal Food, Drug and Cosmetic Act. |
| Contact | Peter Cecchini<br>Manager<br>Regulatory Affairs<br>ETHICON, Inc.<br>Rt. 22 West<br>Somerville, NJ 08876-0151 |
| Date | June 13, 2003 |

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JUL 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Peter Cecchini Manager, Regulatory Affairs Ethicon, Inc. Route 22 West Somerville, New Jersey 08876-0151

Re: K031847

Trade/Device Name: CardioVations Retractor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: June 13, 2003 Received: June 26, 2003

Dear Mr. Cecchini :

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. Peter Cecchini

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

(Celia M. Witten, Ph.D., M.D. 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): | K031847 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | CardioVations Retractor |
| Indications for Use: | The CardioVations Retractor has application for use in the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in surgical procedures requiring dissection and retraction of tissue. |

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div>✓</div> |
|---------------------------------------|--------------|
|---------------------------------------|--------------|

OR

Over-The Counter Use

(Optional Format 1-2-9G)

| | <div>Miriam C. Provost</div> <div>(Division Sign-Off)</div> <div>Division of General, Restorative and Neurological Devices</div> |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| CardioVations Retractor ETHICON, Inc. | |
| 510(k) Number. | K031847 |

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