(163 days)
Not Found
No
The description focuses on the mechanical function of the device as a retractor and does not mention any computational or data-driven capabilities.
No.
REVEEL is described as a surgical retractor used to elevate organs and tissue during endoscopic procedures, which is an instrumental function rather than a therapeutic one itself.
No
The device is described as an organ and tissue retractor used in endoscopic surgical procedures to elevate organs and tissue for better access and visualization. It mobilizes and maneuvers organs/tissue and does not perform any diagnostic function.
No
The device description clearly states it is comprised of a proximal handle, a rigid shaft, and a distal retraction surface, indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that REVEEL is designed as an organ and tissue retractor for use in endoscopic surgical procedures to provide better access and visualization. This is a surgical tool used during a procedure, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description confirms it's a single-use device for mobilizing and maneuvering organs and tissue during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on the mechanical function and safety of the device in a surgical context (bench testing, simulated use, biocompatibility), not on diagnostic accuracy or analytical performance.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. REVEEL does not fit this description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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, | |
| Hong Kong Industrial Building, | ||
| 444-452 Des Voeux Road West, | ||
| Hong Kong | ||
| c. Telephone: | ||
| Fax: | +852 3110 6011 | |
| +852 2168 4120 | ||
| d. Contact Person: | Stuart Moran | |
| 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 | |
| Surgery: Endoscope and accessories | ||
| (21 CFR 876.1500, Product Code GCJ) | ||
| 3. | IDENTIFICATION OF PREDICATE DEVICES | |
| PRETZELFLEX | Surgical Innovations | |
| Limited | ||
| (K123110) | ||
| "PRETZELFLEX" |
| AUTO SUTURE ENDO
RETRACT II | United States Surgical
(Covidien)
(K914190) | "ENDO RETRACT II" |
|--------------------------------|---------------------------------------------------|-------------------|
| RETRACTOR | Automated Medical
Products Corp.
(K942002) | "NATHANSON" |
1
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.
2
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
3
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
4
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)
per -S ua C. Nir
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