The LumenR Tissue Retractor System is indicated for use in conjunction with an endoscope for tissue or foreign body manipulation and/or where multiple removal and reinsertions of the endoscope are required.

Device Description

The LumenR Tissue Retractor System (LRS) is an intra-luminal surgical device facilitating tissue manipulations inside the lumen.. It is a non-powered, handmanipulated device. The LumenR Tissue Retractor System includes a LumenR Instrument Guide (LIG) and LumenR Cannula Retractor (LCR). The LIG and LCR are single use devices that are provided non-sterile. LumenR Cannula Retractor (LCR) is provided in various Lengths and Diameters in order to accommodate individually variable natural body lumens. The LumenR Cannula Retractor (LCR) comprises of (1) Handle (proximal end located outside of a patient), (2) Retractor (chamber-like expandable retractor located at the device's distal end), and (3) flexible Shaft (located in between the handle and a Retractor). LumenR Instrument Guide (LIG) is an instrument guide or a hollow conduit for existing flexible endoscopic instruments, for example, tissue forceps, which helps guide the instrument towards the target tissue, but doesn't directly interact with the tissues.

AI/ML Overview

This document is a 510(k) premarket notification for the LumenR Tissue Retractor System, a medical device. It does not contain the structured information about acceptance criteria and a study proving device performance as typically expected for an AI/ML-based medical device.

The document focuses on demonstrating substantial equivalence to a predicate device (Megachannel Endoscopic Overtube - K080550) rather than proving performance against specific acceptance criteria with detailed statistical analysis.

However, I can extract information related to performance testing that was conducted to support the claim of substantial equivalence.

Here's an analysis based on the provided text, outlining why a complete answer to your request regarding acceptance criteria and a "study that proves the device meets the acceptance criteria" cannot be fully provided from this document:

Missing Information & Why it's Not Present:

Acceptance Criteria for Performance: The document does not explicitly state quantitative acceptance criteria (e.g., "Device must achieve a minimum seal strength of X N/mm"). Instead, it lists standards followed (e.g., ASTM F088/ASTM F088M-09 Standard Test Method for Seal Strength of Flexible Materials) and types of tests performed. The results are used to show similarity to the predicate or compliance with general safety/performance aspects, not to meet pre-defined "acceptance criteria" in the context of device accuracy or specific performance metrics in clinical use.
Reported Device Performance against Criteria: Since specific acceptance criteria are not detailed in a quantitative manner, direct "reported device performance" against such criteria is also not present in the format you requested.
AI/ML Specifics: This device, the LumenR Tissue Retractor System, is a mechanical surgical instrument. It is not an AI/ML-based device. Therefore, questions 2, 3, 4, 5, 8, and 9 from your prompt (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, training set GT) are not applicable to this document.
"Study that proves the device meets the acceptance criteria": The document describes "Performance Testing / Shelf Life Study" and "Comparison Testing to Predicate Device." These are studies conducted, but they are aimed at demonstrating substantial equivalence and general safety/efficacy per regulations for this type of mechanical device, rather than a specific validation study against an AI/ML model's performance criteria.

Based on the available information, here's an attempt to answer your request, focusing on the types of performance testing and standards used, as actual acceptance criteria and corresponding quantitative performance metrics are not explicitly detailed:

The provided document describes the LumenR Tissue Retractor System, a mechanical intra-luminal surgical device used in conjunction with an endoscope for tissue or foreign body manipulation. It is not an AI/ML-based device, therefore many sections of your request regarding AI/ML performance metrics are not applicable.

The "study" referenced in this document is a series of performance tests and comparison testing to a predicate device conducted to demonstrate substantial equivalence, safety, and efficacy for its intended use.

1. Table of "Acceptance Criteria" and Reported Device Performance

As mentioned, explicit quantitative acceptance criteria for device performance (e.g., "Seal Strength > X N/mm") are not provided in this 510(k) summary. Instead, the document lists standards and types of tests performed. The "reported performance" is implicitly that the device met the requirements of these standards and performed comparably to the predicate where applicable, supporting the claim of substantial equivalence.

Performance Aspect / Test Type	Governed by Standard(s) / Test Objective	Implied Acceptance Criteria (based on standards/objectives)	Reported Device Performance
Seal Strength	ASTM F088/ASTM F088M-09	Compliance with ASTM F088 for flexible materials seal strength.	Testing performed, results implicitly met standard / acceptable for intended use.
Bag Leak Test	ASTM D3078-02	Compliance with ASTM D3078 for determination of leaks in flexible packaging.	Testing performed, results implicitly met standard / acceptable for intended use.
Biocompatibility	ISO 10993-5: 2009, ISO 10993-10	Absence of in vitro cytotoxicity, irritation, and skin sensitization.	Testing performed, device found biocompatible (implicitly met ISO standards).
Shipping & Packaging Integrity	ASTM D4169-09	Packaging integrity maintained after simulated distribution; box integrity maintained.	Testing performed (simulated distribution, box integrity study), results implicitly met standard / acceptable for shipping and storage.
Predesignate Device Comparability	(Direct comparison)	Performance comparable to predicate (Megachannel Endoscopic Overtube K080550) regarding insertion/removal force, dimensions, and material.	Similar insertion and removal force profiles during testing. Dimensional similarities (OD, length, endoscope size compatibility). Similar material composition (wire reinforced PVC, smooth thermoplastic).
Microbial Limits	(Microbial Enumeration, Specified Microorganisms)	Acceptable levels of microbial contamination.	Testing performed, results implicitly met acceptable limits.
Tensile Strength	(Shelf Life Study)	Device components (e.g., shaft, retractor) maintain structural integrity over shelf life.	Testing performed as part of shelf life study, results implicitly acceptable.
Reliability (Cyclic, Bending, Stress)	(Shelf Life Study)	Device functions reliably through expected use cycles and bending; tip withstands stress.	Testing performed as part of shelf life study, results implicitly acceptable for intended use and shelf life.
Break Strength	(Shelf Life Study)	Device components withstand specified forces without breaking.	Testing performed as part of shelf life study, results implicitly acceptable.
Leak Testing (seal around endoscope)	(Performance Testing)	Seal around endoscope prevents significant gas leakage from the lumen.	Testing performed, results implicitly acceptable.

Regarding your specific numbered points:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the summary. For mechanical devices, testing typically involves a statistically relevant number of manufactured units, but the specific quantity is not disclosed here. As it's a mechanical device verification, "data provenance" like country of origin or retrospective/prospective is not applicable in the same way it would be for clinical data or AI model training data.
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):
- Not applicable as this is a mechanical device, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or diagnosis.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for a mechanical device.
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:
- Not applicable as this is a mechanical device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable as this is a mechanical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the mechanical tests, the "ground truth" is adherence to engineering specifications, national/international standards (e.g., ASTM, ISO), and performance comparable to a legally marketed predicate device. There isn't a "ground truth" derived from clinical experts or patient outcomes in the way you'd apply it to a diagnostic AI.
The sample size for the training set:
- Not applicable as this is a mechanical device, not an AI/ML model that requires a training set.
How the ground truth for the training set was established:
- Not applicable as this is a mechanical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing right, resembling a bird in flight.

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

April 19, 2016

LumenR., LLC % Joseph Azary Consultant Joseph Azary 543 Long Hill Avenue Shelton, CT 06484

Re: K153698

Trade/Device Name: LumenR Tissue Retractor System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: ODB, FED, GAD Dated: March 8, 2016 Received: March 16, 2016

Dear Joseph Azary,

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No	0910-0120
Expiration Date:	January 31, 2017
	See PRA Statement below

510(k) Number (if known)	K153698
Device Name	LumenR Tissue Retractor System

Indications for Use (Describe)	The LumenR Tissue Retractor System is indicated for use in conjunction with an endoscope for tissue or foreign body manipulation and/or where multiple removal and reinsertions of the endoscope are required.
--------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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FORM FDA 3881 (8/14) Page 1 of 1

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510(k) Summary for LumenR, LLC LumenR Tissue Retractor System

1. SUBMITTER/510(K) HOLDER

LumenR, LLC 253 Main Street, Suite 270 Matawan, NJ 07747

Contact Name: Joseph Azary Email: jazary@erols.com Telephone: (203) 242-6670

Date Prepared: December 21, 2015

Date Revised: April 19, 2016

FDA Registration# 3009540718

2. DEVICE NAME

Classification Name:	Endoscopic Contamination Prevention SheathRetractor, Manual Surgical Instrument
Classification Regulation:	21 CFR 876.1500, 21 CFR 878.4800
Product code:	ODBGADFED
Classification:	Class 2
Medical Specialty (Panel):	General Surgery Devices, Gastro-enterology

3. PREDICATE DEVICES

Megachannel Endoscopic Overtube - K080550

4. DEVICE DESCRIPTION

The LumenR Tissue Retractor System (LRS) is an intra-luminal surgical device facilitating tissue manipulations inside the lumen.. It is a non-powered, handmanipulated device.

The LumenR Tissue Retractor System includes a LumenR Instrument Guide

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(LIG) and LumenR Cannula Retractor (LCR).

The LIG and LCR are single use devices that are provided non-sterile.

LumenR Cannula Retractor (LCR) is provided in various Lengths and Diameters in order to accommodate individually variable natural body lumens.

The LumenR Cannula Retractor (LCR) comprises of (1) Handle (proximal end located outside of a patient), (2) Retractor (chamber-like expandable retractor located at the device's distal end), and (3) flexible Shaft (located in between the handle and a Retractor).

(1) LCR Handle is a substantially cylindrical structure, interfacing operator's hands and located outside of a patient. The Handle has:

a- Retractor Slider, which slides forward and backward to correspondingly either expand (retract more) or collapse (retract less) the distally located LCR Retractor. The Retractor facilitates tissue retraction and tissue manipulations inside the gastro-intestinal lumen. The Retractor Slider is activated by the operator's hand.
b- Insufflation port for attachment to an insufflation tubing, allowing to use additional insufflation during the procedure.
c- Ancillary port openings one or two openings where the LumenR Instument Guides (LIGs) can be inserted into the LCR to reach the working space formed by the LCR Retractor. The seal, located inside the Ancillary port, reduces the gas leakage from the lumen around the LIG.
d- Endoscope channel opening is an opening for a standard endoscope. Endoscope is inserted into the LCR Endoscopic channel - via Endoscopic channel opening - to reach the working space formed by the LCR Retractor. Endoscopic channel opening has a seal reducing the gas leakage from the lumen around the endoscope.

(2) LCR Retractor is located at the distal end of the LCR Shaft, which is inserted inside a gastrointestinal lumen, during the procedure The Retractor includes:

a- Retractor wire structure is actuated at the LCR Handle by moving Retractor Slider forward (Retractor expands) or backward (Retractors collapses) to adjust the working space inside the Retractor.. When Retractor Slider is moved forward on the LCR Handle, the two top retractor wires of the Retractor wire structure are arched laterally, thus expanding the LCR Retractor and the associated working space.

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b- Plastic cover or "Basket" is the outer plastic layer, which forms a translucent cover around the Retractor wire structure. The main purpose of the Plastic cover is to provide a protective layer around the Retractor wire structure during the device delivery and to minimize the protrusion of the luminal walls into the working space during procedure. In addition, the Plastic cover helps protect the luminal walls during the procedure from the accidental injury by the conventional instruments. Furthermore, the plastic cover can facilitate the specimen containment and retrieval.
c- Distal Cap is located at the distal aspect of the LCR Retractor, which contains the distal ends of the Retractor wire structure. The Distal Cap has a central opening for the endoscope, enabling the over-the-scope delivery of the device to the target site.
d- Proximal Cap is located at the proximal aspect of the LCR Retractor, which contains the proximal ends of the Retractor wire structure. It also has an opening for the endoscope as well as 1 or 2 additional openings for the LIGs.

(3) LCR Shaft is a flexible conduit, having Endoscopic channel (a channel for the endoscope) and 1 or 2 Ancillary (LIG) channel(s).

The LCR Shaft is designed to provide:

a- Support to the LCR Retractor,

b- Flexibility to improve pass-ability

c- Torsional stiffness for rotation positioning of the LCR Retractor within the

lumen,

d- Column strength for advancing the LCR Retractor over the endoscope,

e- Tensile strength for removal of the LCR Retractor over the endoscope.

LumenR Instrument Guide (LIG) is an instrument guide or a hollow conduit for existing flexible endoscopic instruments, for example, tissue forceps, which helps guide the instrument towards the target tissue, but doesn't directly interact with the tissues.

The LIG is inserted into the Ancillary (LIG) Port and advanced inside LCR Shaft until it reaches the working space formed by the LCR Retractor. The LIG has two primary degrees of freedom: longitudinal (forward-backward) and rotational movements.

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LumenR Instrument Guide (LIG) is provided in different diameters, lengths, and angles in order to accommodate individual anatomical variations. For example, for a narrower lumen, an operator may select to use LIG with a smaller - 45 degrees - angle to better maneuver inside the working space.

The LIG comprises of: (1) Tip structure, (2) Shaft, and (3) Handle.

(1) LIG Tip is a flexible pre-bent (angled) distal end of the LIG, allowing LIG to be delivered to the LCR Retractor space via substantially straight LIG channel of the LCR. When the LIG Tip enters the working space of the LCR Retractor from the LIG channel, it returns to its originally angled shape. A flexible endoscopic instrument, for example, a tissue forceps, when inserted into the LIG with a described angled tip, can be better controlled and guided towards the target site.
(2) LIG Handle is a cylindrical structure for handling the LIG during the procedure. It has a proximal opening with a valve preventing an air leak from the working space. This opening can receive a standard endoscopic instrument, for example a tissue forceps, of the appropriate size.
(3) LIG Shaft is a flexible conduit connecting the LIG Tip and the LIG Handle. The shaft is longitudinally flexible and torsionally stiff, allowing an operator to control the LIG Tip inside a working space. The LIG Shaft also has LIG Marking indicating the position of the LIG Tip within the LCR.

Model	Diameter	Retractor	Working Length	# LCR Channels	LIG Channel Instrument Size Compatibility
LCR-60	25mm	Length 8cmMax height 6cmMax width 4.5cm	60cm	3	2.8mm
LCR-75S	18mm	Length 8cmMax height 6cmMax width 4.5cm	75cm	2	1.8mm
LCR-95	25mm	Length 8cmMax height 6cmMax width 4.5cm	95cm	3	2.8mm

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5. INTENDED USE

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Megachannel (510k K080550) and LumenR Tissue Retractor System are substantially equivalent based on the following:

. Equivalent indications for use.
Both devices are non-sterile. .
Both devices can accommodate an endoscope and instruments. ●
Both devices are used in natural orifices for access to colon and esophagus.
. Dimensional similarities: LumenR LCR is available in OD between 18mm to 25mm OD, and length between 60cm - 95cm; Megachannel has OD of 22mm and length between 80cm - 100cm.
. The devices can accommodate similarly sized endoscopes: LumenR can accommodate 12.7mm OD endoscope. Megachannel can accommodate 12.8mm OD endoscope.
The LumenR and Megachannel have similar insertion and removal force ● profiles during testing.
Material Composition is similar. Both devices are composed of wire ● reinforced PVC and the guides/introducers are both composed of smooth thermoplastic.
. The LumenR devices are available with 2 and 3 small channels, whereas the Megachannel has 1 large channel. The Megachannel allows both a scope and instruments to be inserted together into a single larger channel.

One of the main differences between the LumenR and Megachannel is that

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LumenR has a retractor function, which helps retract the target tissue, facilitating the access and visibility of the endoscopic instruments to the surgical site. In addition, the LumenR has 2 or 3 small channels inside the main shaft for an endoscope and accessory instruments, allowing them to operate independently from each other. Since Megachannel has only one large channel, the endoscope and the accessory instruments may interfere with each other during a procedure.

7. PERFORMANCE TESTING

The subject device conforms to the following standards:

ASTM F088/ASTM F088M-09 Standard Test Method for Seal Strength of ● Flexible Materials
ASTM D3078-02 Standard Test Method for Determination for Leaks in ● Flexible Packaging by Bubble Emission
ASTM F1980-02 Standard Guide for Accelerated Aging of Sterile Medical Device Packaging
ASTM D4169-09 Standard Practice for Performance Testing of Shipping ● Containers and Systems
ISO 10993-5: 2009 Biological Evaluation of Medical Devices, Part 5: Test for In Vitro Cytoxicity
ISO 10993-10 Biological Evaluation of Medical Devices. Part 10: Tests for . Irritation and Skin Sensitization

8. SAFETY AND EFFICACY

The subject device was subjected to testing including:

Biocompatibility Testing
. Shipping and Packaging Testing
- o Simulated distribution
- o Box integrity study
- Bag leak test o
- Product integrity testing o
- 0 Seal Peel Strength
Comparison Testing to Predicate Device ●
Microbial Limits Testing
- o Microbial Enumeration Test
- Test for Specified Microorganisms o
Performance Testing / Shelf Life Study including: ●
- Tensile Strength O
- o Reliability Cyclic

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Bending Reliability O
Break Strength O
Reliability Stress Testing of the Tip O
Leak Testing (seal around endoscope) O

9. CONCLUSION

LumenR, LLC believes that based on the indications for use, technological characteristics, and comparison to predicate devices the LumenR Tissue Retractor System has been shown to be substantially equivalent to the predicate and is safe and effective for its intended use.

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.