REVEEL ENDOSCOPIC RETRACTOR

K133345 · Retraction Limited · GCJ · Apr 11, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133345
• Device Name: REVEEL ENDOSCOPIC RETRACTOR
• Applicant: Retraction Limited
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

REVEEL is designed as an organ and tissue retractor for the use in endoscopic surgical procedures to elevate organs and tissue to provide better access as well as visualization of surgical sites

Device Story

REVEEL is a single-use endoscopic retractor used to mobilize and maneuver organs and tissue. The device consists of a proximal handle, a rigid shaft, and a distal retraction surface. It is operated by a surgeon during endoscopic procedures to elevate tissue, thereby improving surgical site access and visualization. The device functions through manual actuation of the retraction surface. It is intended for clinical use in an operating room environment.

Clinical Evidence

No clinical data. Evidence consists of bench testing (simulated transportation, shelf life, sterilization validation, biocompatibility) and pre-clinical testing using porcine and cadaveric models to demonstrate functional performance including insertion, actuation, mobilization, retraction, and removal.

Technological Characteristics

Single-use endoscopic retractor; rigid shaft with distal retraction surface; manual actuation mechanism. Materials are biocompatible. Sterilization method is validated. Device is a standalone mechanical instrument.

Indications for Use

Indicated for use in endoscopic surgical procedures to elevate organs and tissue to provide access and visualization of surgical sites.

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

• PRETZELFLEX (K123110)
• ENDO RETRACT II (K914190)
• NATHANSON (K942002)

Submission Summary (Full Text)

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510(k) Premarket Notification REVEEL ENDOSCOPIC RETRACTOR PP 5-2

APR 1 1 2014

RETRACTION LIMITED March, 2014

## 510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of CFR 807.92

| 1. | SUBMITTER INFORMATION | |
|----|-------------------------------------|---------------------------------------------------------------------------------------------------------------|
| | a. Company Name: | RETRACTION LIMITED |
| | b. Company Address: | Unit F, 2/F,<br>Hong Kong Industrial Building,<br>444-452 Des Voeux Road West,<br>Hong Kong |
| | c. Telephone:<br>Fax: | [phone]<br>[phone] |
| | d. Contact Person: | Stuart Moran<br>Chief Executive Officer |
| | e. Date Summary Prepared: | 2013-10-28 |
| 2. | DEVICE IDENTIFICATION | |
| | a. Trade/Proprietary Name: | REVEEL ENDOSCOPIC RETRACTOR |
| | b. Common Name: | Retractor |
| | c. Classification Name: | Laparoscope, General and Plastic<br>Surgery: Endoscope and accessories<br>(21 CFR 876.1500, Product Code GCJ) |
| 3. | IDENTIFICATION OF PREDICATE DEVICES | |
| | PRETZELFLEX | Surgical Innovations<br>Limited<br>(K123110)<br>"PRETZELFLEX" |

| AUTO SUTURE ENDO<br>RETRACT II | United States Surgical<br>(Covidien)<br>(K914190) | "ENDO RETRACT II" |
|--------------------------------|---------------------------------------------------|-------------------|
| RETRACTOR | Automated Medical<br>Products Corp.<br>(K942002) | "NATHANSON" |

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RETRACTION LIMITED March, 2014

510(k) Premarket Notification REVEEL ENDOSCOPIC RETRACTOR PP 5-3

#### 4. DESCRIPTION OF THE DEVICE

REVEEL is a single use device intended for mobilizing and maneuvering organs and tissue during endoscopic surgical procedures. It is comprised of a proximal handle, a rigid shaft, and a distal retraction surface.

#### ഗ STATEMENT OF INTENDED USE

REVEEL is designed as an organ and tissue retractor for the use in endoscopic surgical procedures to elevate organs and tissue to provide better access as well as visualization of surgical sites

#### 6. TECHNOLOGICAL CHARACTERISTICS COMPARISON WITH PREDICATE DEVICES

The REVEEL ENDOSCOPIC RETRACTOR is substantially equivalent to the PRETZELFLEX, ENDO RETRACT II, and NATHANSON in terms of the sterilization method, packaging, product architecture, retraction surface, patient contact materials, mechanism of operation, method of insertion, incision site and incision size.

#### 7. NON CLINICAL TESTS SUMMARY

The device has been subjected to bench testing; simulated transportation simulated shelf life testing; sterilization validation; and testing; biocompatibility testing, in order to ensure that the device performs as intended when used in accordance with its instructions for use.

#### 8 PRE-CLINICAL TESTS SUMMARY

The use of porcine and cadaveric models demonstrates through real life simulation that the REVEEL ENDOSCOPIC RETRACTOR is capable of functioning as intended; such as insertion, actuation, device mobilization and retraction, visualization of gastroesophageal junction, device de-actuation and removal.

#### 9 CONCLUSION

The results of bench and pre clinical testing demonstrate that the REVEEL ENDOSCOPIC RETRACTOR is as safe and effective as the identified legally marketed predicate devices for its intended use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 11, 2014

RETRACTION LIMITED Mr. Stuart Moran Chief Executive Officer Unit F, 2/F, Hong Kong Industrial Building 444-452 Des Voeux Road West Sai Wan, 999077 HONG KONG

Re: K133345

Trade/Device Name: REVEEL ENDOSCOPIC RETRACTOR Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: February 19, 2014 Received: February 24, 2014

### Dear Mr. Moran:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any i vith all the Act's requirements, including, but not limited to: registration and listing (2 l

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Page 2 - Mr. Stuart Moran

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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RETRACTION LIMITED February, 2014

510(k) Premarket Notification REVEEL ENDOSCOPIC RETRACTOR PP 4-2

## Indications for Use

K133345 510(k) Number (if known): Not known

Device Name: REVEEL ENDOSCOPIC RETRACTOR

Indications For Use:

REVEEL is designed as an organ and tissue retractor for the use in endoscopic surgical procedures to elevate organs and tissue to provide better access as well as visualization of surgical sites.

AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ · (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ (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)

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