(139 days)
Not Found
No
The device description focuses on mechanical components (hand pump, flexible probe, syringe) and their function in delivering saline. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
A therapeutic device is one that treats or alleviates a disease or condition. This device is indicated for the induction of normal saline to lift polyps or other mucosal lesions, which is a preparatory step for removal, not the treatment itself.
No
The device is described as a hand pump and a flexible probe used for delivering pressurized normal saline to lift polyps or other mucosal lesions, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details physical hardware components: a Hand Pump made of nylon and stainless steel, and a Flexible Probe made of PEEK and nylon. It describes their dimensions, materials, and mechanical function (delivering pressurized saline). This is not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The ERBELIFT Hand Pump and Flexible Probe are used to deliver saline into the body (submucosa) to lift tissue. They do not analyze or test any bodily fluids or tissues outside the body.
- The intended use is for a surgical/procedural application. The device is used during an endoscopic procedure to facilitate the removal of polyps or lesions. This is a direct intervention on the patient, not a diagnostic test performed on a sample.
The device is a surgical instrument used for a specific procedure, not a diagnostic tool.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FBK
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 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
submucosa
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)
Functional bench and animal lab testing has demonstrated that the ERBELIFT Hand Pump and Flexible Probe lifts the submucosa safely and effectively.
Biocompatibility of the specific materials for the Probe was demonstrated.
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
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.
1
Kogzogo
Byrne Medical Incorporated Traditional 510(k): ERBELIFT™ Hand Pump and Flexible Probe
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.
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.
2
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.
3
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
4
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.
:
5
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
6
Indications for Use
510(k) Number (if known):
Device Name: Byrne Medical, Inc.'s ERBELIFT™ Hand Pump and Flexible Probe
Indications For 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.
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_
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