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 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.

AI/ML Overview

The "REVEEL ENDOSCOPIC RETRACTOR" is a medical device and therefore does not involve AI or algorithms in its operation. The provided documents focus on its substantial equivalence to predicate devices based on design, materials, and non-clinical testing.

Therefore, many of the questions related to acceptance criteria for an AI/algorithm-based device and its study are not applicable (N/A) to this product.

Here's a breakdown of the requested information based on the provided text, indicating where the information is not relevant for this type of device:

Description of the Acceptance Criteria and Study for the REVEEL ENDOSCOPIC RETRACTOR

The REVEEL ENDOSCOPIC RETRACTOR is a single-use manual device intended for mobilizing and maneuvering organs and tissue during endoscopic surgical procedures. Its acceptance criteria and supporting studies are based on demonstrating substantial equivalence to legally marketed predicate devices, focusing on design, functional performance through bench and pre-clinical testing, and safety aspects like biocompatibility and sterilization.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (Summary)
Substantial Equivalence to Predicates	Demonstrate substantial equivalence to PRETZELFLEX (K123110), AUTO SUTURE ENDO RETRACT II (K914190), and NATHANSON (K942002) in terms of: - Sterilization method - Packaging - Product architecture - Retraction surface - Patient contact materials - Mechanism of operation - Method of insertion - Incision site and size	The REVEEL ENDOSCOPIC RETRACTOR is stated to be substantially equivalent to the identified predicate devices across all these characteristics.
Bench Testing	- Ensure device performs as intended - Evaluate mechanical integrity and functionality	Bench testing was performed to ensure the device performs as intended. Specific performance metrics are not detailed but imply successful completion of these tests.
Simulated Transportation & Shelf Life	- Validate packaging integrity post-transport - Confirm device integrity over shelf life	Simulated transportation and shelf life testing were conducted, implying successful validation. Specific results are not detailed.
Sterilization Validation	- Ensure device sterility	Sterilization validation was performed, implying successful validation. Specific methods or results are not detailed.
Biocompatibility Testing	- Confirm patient contact materials are safe - Comply with ISO 10993 standards	Biocompatibility testing was performed, indicating compliance with safety standards for patient contact. Specific results are not detailed.
Pre-Clinical Testing (Functional Performance)	- Demonstrate functionality in real-life simulation (insertion, actuation, device mobilization and retraction, visualization of gastroesophageal junction, de-actuation and removal)	Use of porcine and cadaveric models demonstrated that the device is capable of functioning as intended for all listed aspects. This confirms the device's ability to perform its intended use.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Specific sample sizes for bench tests, simulated transportation, shelf life, sterilization, and biocompatibility are not provided in the summary. For pre-clinical testing, "porcine and cadaveric models" were used, but the exact number of models is not specified.
Data Provenance: The studies were conducted by RETRACTION LIMITED, located in Hong Kong. The data provenance (country, retrospective/prospective) related to the specific test execution is not explicitly detailed beyond the company's location. The studies are by nature prospective as they are part of a premarket notification for a new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is Not Applicable (N/A). The device is a manual surgical retractor, not an AI/diagnostic device that requires expert-established ground truth for performance evaluation in the context of image interpretation or similar tasks. The "ground truth" for this device's performance is its physical functionality and safety as demonstrated through engineering tests and pre-clinical simulations. The "experts" involved would be engineering and medical professionals conducting the tests, but their specific roles and qualifications are not detailed as they would be for ground-truthing diagnostic AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are typically used in studies where a panel of experts review and reach consensus on diagnostic outcomes (e.g., in medical imaging). This is not relevant for the physical and functional testing of a surgical retractor.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is Not Applicable (N/A). MRMC studies are used for evaluating the performance of diagnostic imaging systems, often involving human readers and AI. The REVEEL ENDOSCOPIC RETRACTOR is a manual surgical tool and does not involve AI, human readers, or diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is Not Applicable (N/A). The device is a manual tool and does not employ any algorithms or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device primarily relies on:

Engineering specifications and standards: For bench testing, mechanical properties, and material safety.
Performance as "intended": In pre-clinical models (porcine and cadaveric), the "ground truth" for functionality is the observable success of the device in performing retraction, mobilization, and providing visualization, as determined by the surgical operators/evaluators participating in the simulation. This is essentially functional verification against its stated intended use.
Regulatory compliance: For sterilization and biocompatibility.

8. The sample size for the training set

This question is Not Applicable (N/A). The REVEEL ENDOSCOPIC RETRACTOR is a physical medical device, not an AI algorithm, and therefore does not have a "training set."

9. How the ground truth for the training set was established

This question is Not Applicable (N/A). As there is no training set for an AI algorithm, no ground truth needed to be established for it.

Summary

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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,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 MoranChief 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 PlasticSurgery: Endoscope and accessories(21 CFR 876.1500, Product Code GCJ)
3.	IDENTIFICATION OF PREDICATE DEVICES
	PRETZELFLEX	Surgical InnovationsLimited(K123110)"PRETZELFLEX"

AUTO SUTURE ENDORETRACT II	United States Surgical(Covidien)(K914190)	"ENDO RETRACT II"
RETRACTOR	Automated MedicalProducts Corp.(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

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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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 (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

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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)

per -S ua C. Nir

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Regulation Number and Section

§ 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.