The ERBELIFT Hand Pump in conjunction with an ERBELIFT Flexible Probe is indicated for the induction of sterile normal saline into the submucosa to lift polyps or other mucosal lesions using direct visualization through a flexible endoscope.

Device Description

The ERBELIFT™ Hand Pump and Flexible Probe are used for the delivery of pressurized sterile normal saline to the submucosa to lift polyps or other mucosal lesions. A control syringe is filled with sterile normal saline. The filled syringe is attached to the Flexible Probe via a hub with a standard luer lock and loaded into the Hand Pump. The Flexible Probe is primed with the saline and then the distal end of the Probe is placed down the working channel of the endoscope. Under direct visualization, the Probe's tip is placed against the target tissue without puncturing the mucosa. Then, the trigger of the Hand Pump is squeezed to produce the pressurized saline from the control syringe and through the Probe into the bed of the polyp or lesion to achieve a desired tissue lift.

The Hand Pump is made of nylon and stainless steel. It is 8-3/4" (22 cm) long, 6" (15 cm) wide, and having a thickness of 2-1/2" (6 cm). The Pump per squeeze of the handle delivers approximately 0.75 ml of normal saline. The Flexible Probe is made of Polyetheretherketone (PEEK) and nylon (Note: Medical grade inks and reducer are used to imprint logos on the device.). It has a 1.3 mm Outer Diameter and length of 260 cm. The distal tip is tapered to approximately 0.005" and delivers a jet stream of 120 um. The Hand Pump with the Flexible Probe can generate pressures in the approximate range of 145 to 650 psi which correlates to flow rates of 17 to 38 ml/minute.

The Hand Pump is reusable with the Flexible Probe being provided as sterile and single use.

AI/ML Overview

The provided 510(k) summary for the Byrne Medical Incorporated ERBELIFT™ Hand Pump and Flexible Probe does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance with quantitative metrics. The document focuses on demonstrating substantial equivalence to predicate devices through similarities in intended use, materials, and form, and briefly mentions functional bench and animal lab testing. However, it does not provide specific acceptance criteria or performance metrics from these tests.

Therefore, the following sections will indicate where the information is not available in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document states that "Functional bench and animal lab testing has demonstrated that the ERBELIFT Hand Pump and Flexible Probe lifts the submucosa safely and effectively," but it does not provide specific acceptance criteria or quantitative performance results for these tests. Therefore, this table cannot be fully completed from the given text.

Performance Metric	Acceptance Criteria	Reported Device Performance
Mechanical Performance
Pressure Range (Hand Pump)	Not explicitly stated as acceptance criteria, but described as a characteristic	Approximately 145 to 650 psi
Flow Rate (Hand Pump)	Not explicitly stated as acceptance criteria, but described as a characteristic	17 to 38 ml/minute
Volume per squeeze (Hand Pump)	Not explicitly stated as acceptance criteria, but described as a characteristic	Approximately 0.75 ml
Delivery method to submucosa	Safe and effective lifting of submucosa	Demonstrated in functional bench and animal lab testing
Tissue trauma	Demonstrate less penetration tissue damage compared to predicates	Smaller diameter and fluid stream with no mechanical needle injection causes less penetration tissue damage. Easier to find tissue plane and create a lift.
Biocompatibility
Probe materials biocompatibility	Demonstrate biocompatibility of specific materials	Demonstrated for the specific materials of the Flexible Probe (due to slight differences from predicates)
Sterilization
Sterility (Flexible Probe)	Sterile	Provided as sterile (Ethylene Oxide)
Material/Design Characteristics
Outer Diameter (Flexible Probe)	Not explicitly stated as acceptance criteria, but described as a characteristic	1.3 mm
Length (Flexible Probe)	Not explicitly stated as acceptance criteria, but described as a characteristic	260 cm
Distal tip taper (Flexible Probe)	Not explicitly stated as acceptance criteria, but described as a characteristic	Approximately 0.005"
Jet stream size (Flexible Probe)	Not explicitly stated as acceptance criteria, but described as a characteristic	120 um

2. Sample size 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: Not specified in the provided document. The document mentions "Functional bench and animal lab testing" but does not give details on the number of samples, animals, or tests conducted.
Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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 information is not available in the provided 510(k) summary. The document mentions "Functional bench and animal lab testing" but does not detail how ground truth or performance assessment was established, nor does it refer to human expert involvement in establishing ground truth for the device's functional performance.

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

This information is not available in the provided 510(k) summary. Given that the testing mentioned is "functional bench and animal lab testing" for a medical device's physical performance, an adjudication method for human interpretation is unlikely to be applicable or described here.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The ERBELIFT™ Hand Pump and Flexible Probe is a physical medical device for injecting saline, not an AI-powered diagnostic or interpretive tool. Therefore, a study comparing human readers with and without AI assistance is not relevant to this device and is not mentioned.

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

No, standalone algorithm performance testing is not applicable as this device is a physical medical instrument, not a software algorithm. The device's operation involves a human user (endoscopist) directly.

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

The term "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For this physical device, the "truth" would be objective measurements and observations from the "Functional bench and animal lab testing." This would likely involve:
- Bench Testing: Direct physical measurements (e.g., pressure, flow rate, volume delivered, jet stream characteristics) and visual inspection of fluid delivery.
- Animal Lab Testing: Direct visualization of submucosal lift, potentially histological analysis of tissue for damage, and observation of overall safety and effectiveness in an in-vivo model.
The document implies that the "truth" for safety and effectiveness was derived from these direct experimental observations rather than expert consensus on interpretation of data.

8. The sample size for the training set

Not applicable / Not available. The ERBELIFT™ Hand Pump and Flexible Probe is a physical medical device, not a machine learning model, so there is no "training set" in the context of data used for algorithm development. The development process would have involved design, prototyping, and testing, but not training data for an algorithm.

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

Not applicable / Not available. As explained in item 8, there is no "training set" for this physical medical device.

Summary

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K092090

Byrne Medical Incorporated

Traditional 510(k): ERBELIFT™ Hand Pump and Flexible Probe

510(k) SUMMARY

Submitted By:

Byrne Medical Incorporated 3150 Pollock Drive Conroe, TX 77303 Tel: 936-539-0391 Fax: 936-539-2381

NOV 3 0 2009

Chris Hierholzer Contact Person: Quality Control Manager

April 22, 2009 Date Prepared:

Common Name: Iniector

ERBELIFT™ Hand Pump and Flexible Probe Trade/Proprietary Name:

Classification Name:

Product Code:

FBK

Endoscopic Injection Needle (21 CFR Part 876.1500)

Legally Marketed Predicate Device:

Endoscopic Injection Needle 510(k) Number: K924102 and Endoscopic Injection Needle/Snare 510(k) Number: K040961

Device Description:

The ERBELIFT™ Hand Pump and Flexible Probe are used for the delivery of pressurized sterile normal saline to the submucosa to lift polyps or other mucosal lesions. A control svringe is filled with sterile normal saline. The filled svringe is attached to the Flexible Probe via a hub with a standard luer lock and loaded into the Hand Pump. The Flexible Probe is primed with the saline and then the distal end of the Probe is placed down the working channel of the endoscope. Under direct visualization, the Probe's tip is placed against the target tissue without puncturing Then, the trigger of the Hand Pump is squeezed to produce the mucosa. pressurized saline from the control syringe and through the Probe into the bed of the polyp or lesion to achieve a desired tissue lift.

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Kogzogo

Byrne Medical Incorporated Traditional 510(k): ERBELIFT™ Hand Pump and Flexible Probe

The Hand Pump is reusable with the Flexible Probe being provided as sterile and single use.

Intended Use:

The ERBELIFT™ Hand Pump in conjunction with an ERBELIFT Flexible Probe is indicated for the induction of sterile normal saline into the submucosa to lift polyps or other mucosal lesions using direct visualization through a flexible endoscope.

Similarities and Differences of the Proposed Device to the Current Devices (Predicate Comparison/Substantial Equivalence):

Similarities

The ERBELIFT Hand Pump and Flexible Probe have an intended use that is within the intended uses of the predicates. Also, like the predicates, the purpose is the same in that the devices are for the injection of fluids into tissue for endoscopic purposes. The lifting medium (i.e. sterile normal saline) is also a part of the types of solutions identified for use with the predicates. The materials used for the proposed device are also similar to the predicates. Additionally for accompanying various types and sizes of endoscopes, the working length of the Flexible Probe is comparable (260 cm) to the predicates (230 cm). Both predicates also require the need for a syringe connected via standard luer lock like the proposed device (Note: A designated control syringe is used to ensure sufficiency in regards to strength and The control syringe is identified in the Instructions For Use for the durabilitv. proposed device.). Furthermore, the Flexible Probe is sterilized via Ethylene Oxide, single use, and disposable as are the predicates.

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R 092090

Byrne Medical Incorporated

Traditional 510(k): ERBELIFT™ Hand Pump and Flexible Probe

Differences

The Hand Pump is an additional component for the ERBELIFT™ system as compared to the predicates. The Pump provides the force to the control syringe to induce the pressurized fluid into the submucosa as compared to the force of the needle and fluid hand pushed from a syringe to lift polyps or other mucosal lesions.

The technology employed in the ERBELIFT product has been widely used in medical devices since the 1900s. Needle-free injection devices, first called "iet injectors," were developed in the 1930s and used extensively for over 50 years in mass human vaccination programs for smallpox, polio, and measles.123 Usina mechanical compression to force fluid through a small orifice, these devices produced a high-pressure stream 76 to 360 µm in diameter (compared to 810 µm for a 21-gauge needle) that could penetrate skin and subcutaneous tissue4. These devices are used today to inject insulin, cardiovascular dves, etc. The manual fluid injectors are classified by FDA as product code. KZE.

Functional bench and animal lab testing has demonstrated that the ERBELIFT Hand Pump and Flexible Probe lifts the submucosa safely and effectively. See Section III, Product Data - Performance Testing.

The types of materials used for the Flexible Probe are similar to the predicates but specific materials are slightly different. Therefore, biocompatibility of the specific materials for the Probe was demonstrated. See Section III, Product Data -Biocompatibility Study,

Besides the use of a Hand Pump with the ERBELIFT system to provide the force needed to lift the mucosa in comparison to force of a needle and fluid pressure from the predicates. the working diameter and tip/fluid stream of the ERBELIFT Flexible Probe is much smaller (i.e. a working diameter of 1.3 mm with a tipped Inner Diameter of approximately 0.120 mm as compared to a working diameter of 2.5/3.0 mm respectively with a 25 G needle/tip of 0.508 mm Outer Diameter and 0.241 mm Inner Diameter for the predicates). For the ERBELIFT Flexible Probe the smaller diameter and fluid stream with no mechanical needle injection causes less penetration tissue damage. Also, because fluid seeks the path of least resistance it is easier to find the tissue plane and easier to create a lift, See Section III. Product Data - Performance Testing.

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Byrne Medical Incorporated

Traditional 510(k): ERBELIFT™ Hand Pump and Flexible Probe

Conclusion:

The ERBELIFT Hand Pump and Flexible Probe's intended use is a part of the predicate's indications in the previously cleared 510(k)s. The ERBELIFT system has slightly different principles of operation and technological characteristics as the predicate devices. The use of an amplified fluid force via the Hand Pump as compared to the force of a needle and pressure from pushing a syringe by hand with the predicates (i.e. mechanical trauma of a needle with less fluid pressure) was found to be less traumatic to tissue because of the penetration size being much smaller as well as it being easier to do because of fluid dynamics. The modifications of having a Hand Pump instead of a needle as well as a Flexible Probe with a smaller working diameter and tip configuration did not raise any new safety or efficacy concerns. In conclusion, all the changes were verified or validated. As a result, the ERBELIFT Hand Pump and Flexible Probe did not adverselv affect safety or effectiveness.

| Reis EC, Jacobson RM, Tarbell S, Weniger BG, Taking the sting out of shots; control of vaccination-associated pain and adverse reactions. Pediatr Ann. 1998:27:375-386.

2 Hingson RA, Davis HS, Rosen M. The historical development of jet injection and envisioned uses in mass immunization and mass therapy based upon two decades experience. Mil Med. 1963;128:516-524.

3 Chase CCL, Daniels CS, Garcia R, et al. Needle-free injection technology in swine: Progress toward vaccine efficacy and pork quality. J Swine Health Prod. 2008:16(5):254-261. (http://www.aasv.org/shap/issues/v16n5/v16n5p254.htm

4 Mitragotri S. Immunization without needles. Nat Rev Immunol, 2005;5;905-916

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Byrne Medical, Inc. % Mr. Daniel W. Lehtonen Sr. Staff Engineer - Medical Devices Intertek Testing Services 2307 East Aurora Road, Unit B7 TWINSBURG OH 44087

NOV 3 0 2009

Re: K092090

Trade/Device Name: Erbelift Hand Pump and Flexible Probe Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: September 28, 2009 Received: September 29, 2009

Dear Mr. Lehtonen:

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 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.

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Page 2 -

device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Byrne Medical, Inc.'s ERBELIFT™ Hand Pump and Flexible Probe

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Huthenie

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 092091 510(k) Number_

Page 1 of 1

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.