(338 days)
EverLift™ Submucosal Lifting Agent is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal lesions prior to excision with a snare or other appropriate endoscopic device.
The GI Supply EverLift™ Submucosal Lifting Agent is a prefilled plastic syringe with attached plunger rod containing 5mL of lifting agent. The syringe has a luer lock connection capable of interfacing with a standard, commercially available, endoscopic injection needle.
The EverLift™ Submucosal Lifting Agent is an injectable liquid composition for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD) and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, including the esophagus, the stomach, the small intestine, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers and other pathological lesions by EMR, ESD or polypectomy.
EverLift™ Submucosal Lifting Agent is injected into the submucosal layer by means of a standard, commercially available, endoscopic injection needle, which is inserted into the working channel of the endoscope. The composition, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal laver, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD or polypectomy).
The provided document is a 510(k) premarket notification for the EverLift Submucosal Lifting Agent, describing its substantial equivalence to a predicate device. It details non-clinical performance testing but does not include information about AI/ML device performance or clinical studies involving human readers or AI assistance. Therefore, I cannot fulfill all parts of your request related to AI/ML device acceptance criteria and studies.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document speaks to "functional and performance requirements" and various "functional performance tests" but does not explicitly list quantified acceptance criteria with corresponding performance metrics in a clear table format that would be typical for an AI/ML device. Instead, it states that tests were conducted to "demonstrate substantial equivalence."
Acceptance Criteria and Reported Device Performance (as inferred and specified in the document):
| Acceptance Criteria Category | Specific Criterion (Inferred from testing mention) | Reported Device Performance (Summary from text) |
|---|---|---|
| Functional Performance | Container Closure Integrity | Testing performed. Conclusion: "device meets its functional and performance requirements." |
| Syringe Tip Cap Removal Force | Testing performed. Conclusion: "device meets its functional and performance requirements." | |
| Tube Cap Removal Force | Testing performed. Conclusion: "device meets its functional and performance requirements." | |
| pH Testing | Testing performed. Conclusion: "device meets its functional and performance requirements." | |
| Product Color Evaluation | Testing performed. Conclusion: "device meets its functional and performance requirements." | |
| Lift Duration Testing | Testing performed. Conclusion: "device meets its functional and performance requirements." | |
| Flow Rate Testing | Testing performed. Conclusion: "device meets its functional and performance requirements." | |
| Comparative Bench Testing | Viscosity (vs. predicate) | Comparative bench testing conducted against predicate (Eleview® K150852). Conclusion: "The data generated... demonstrate that the device is as safe, as effective, and performs as well as the predicate device." Implicitly, viscosity was within acceptable comparative range. |
| Osmolality (vs. predicate) | Comparative bench testing conducted against predicate (Eleview® K150852). Conclusion: "The data generated... demonstrate that the device is as safe, as effective, and performs as well as the predicate device." Implicitly, osmolality was within acceptable comparative range. | |
| Density (vs. predicate) | Comparative bench testing conducted against predicate (Eleview® K150852). Conclusion: "The data generated... demonstrate that the device is as safe, as effective, and performs as well as the predicate device." Implicitly, density was within acceptable comparative range. | |
| Preclinical (Animal) Study | Performance in Porcine Model (vs. predicate) | Preclinical testing in a porcine model conducted against predicate (Eleview® K150852). Conclusion: "The data generated... demonstrate that the device is as safe, as effective, and performs as well as the predicate device." Implicitly, performance in the porcine model was comparable. |
| Biocompatibility | Meets ISO 10993-1 requirements | Biocompatibility testing conducted in accordance with ISO 10993-1. Conclusion: "The data generated... demonstrate that the device is as safe, as effective, and performs as well as the predicate device." This indicates successful biocompatibility. |
| Sterility & Endotoxin | Bacterial Endotoxin and Pyrogen Testing | Testing performed. Conclusion: "The data generated... demonstrate that the device is as safe, as effective, and performs as well as the predicate device." This indicates satisfactory results. |
| Chemical Characterization Testing | Testing performed. Conclusion: "The data generated... demonstrate that the device is as safe, as effective, and performs as well as the predicate device." This indicates satisfactory results. | |
| Shelf Life | Maintain physical/functional requirements for 2 years | An accelerated aging study was performed to confirm that the device meets "all physical and functional requirements throughout a 2-Year Shelf Life." |
| Risk Management | Risks adequately mitigated | Developed under GI Supply's risk management process in accordance with ISO 14971:2007. "The identified risks were adequately mitigated and verified by means of non-clinical performance testing." |
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: The document mentions "a series of functional performance tests, animal studies, biocompatibility tests, and sterility tests" but does not provide specific sample sizes (e.g., number of devices tested, number of animals in the preclinical study).
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given it's a non-AI/ML device based on physical/chemical properties and animal studies, "retrospective/prospective" in the context of clinical data isn't directly applicable here.
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 applicable and not provided as this is a medical device for submucosal lifting, not an AI/ML diagnostic or image analysis device requiring expert ground truth for image interpretation. The ground truth for this device's performance is based on physical/chemical measurements and in-vivo effects in animal models.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided as this relates to expert review and consensus for imaging or diagnostic studies, which is not relevant to this device's testing.
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 information is not applicable and not provided. The device is not an AI/ML algorithm that assists human readers. It is a physical agent used in endoscopic procedures.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established through:
- Direct physical and chemical measurements (e.g., pH, viscosity, osmolality, density, flow rate).
- Direct observation of physical effects and safety in an in vitro (container integrity) and ex vivo / in vivo (porcine model for lift duration and performance) setting.
- Results from standardized biocompatibility, sterility, and aging tests.
This is not based on expert consensus, pathology, or outcomes data in the typical sense of AI/ML diagnostic evaluation.
8. The sample size for the training set
This information is not applicable and not provided as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided as this is not an AI/ML device that requires a training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 20, 2020
GI Supply, Inc. Erika Parry Manager, Quality & Regulatory 5069 Ritter Road. Suite 104 Mechanicsburg, PA 17055
Re: K191923
Trade/Device Name: EverLift Submucosal Lifting Agent Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: PLL Dated: May 20, 2020 Received: May 22, 2020
Dear Erika Parry:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K191923
Device Name EverLift Submucosal Lifting Agent
Indications for Use (Describe)
EverLift Submucosal Lifting Agent is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal lesions prior to excision with a snare or other appropriate endoscopic device.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for GI Supply, a company that specializes in endoscopic products. The logo features a green graphic element resembling interconnected circles, followed by the text "GI Supply" in a bold, green font. Below the company name, the tagline "Specialty Endoscopic Products" is written in a smaller, gray font.
510(k) Summary
I. SUBMITTER [Per 807.92(a)(1)]
Sponsor / Manufacturer
GI Supply 5069 Ritter Road Suite 104 Mechanicsburg, PA 17055 USA Phone: (800)-451-5797
Contact Person
Erika Parry Manager, Quality & Regulatory Phone: (717)-562-7580 Email: e.parry@gi-supply.com
Date Prepared
July 19, 2019 Amended June 19, 2020
II. DEVICE [Per 807.92(a)(2)]
| Device Trade/Proprietary Name: | EverLift™ Submucosal Lifting Agent |
|---|---|
| Device Common or Usual Name: | Submucosal Injection Agent |
| Device Classification Name: | Endoscope and Accessories |
| Device Regulatory Classification: | Class II |
| Device Classification Regulation: | 21 CFR 876.1500 |
| Product Code: | PLL |
| Submission Type: | 510(k) |
| Classification Panel: | Gastroenterology/Urology |
III. PREDICATE DEVICE [Per 807.92(a)(3)]
The EverLift™ Submucosal Lifting Agent (subject device) is substantially equivalent in terms of its indications for use / intended use for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers, or other gastrointestinal lesions, prior to excision with a snare, forceps, or other appropriate endoscopic device, when compared to the predicate device, the Cosmo Technologies Ltd. SIC 8000 (Eleview Submucosal Injectable Composition) (K150852). Please refer to the table below for additional details.
| PredicateDevice | The EverLift™ Submucosal Lifting Agent (subject device) is substantially equivalent to the following predicate device, manufactured by Cosmo Technologies Ltd.:SIC 8000 (Eleview Submucosal Injectable Composition (K150852) |
|---|---|
| The EverLift™ Submucosal Lifting Agent (subject device) is substantially equivalent in terms of its indications for use / intended use for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers, or other |
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image contains the logo for GI Supply. The logo features a green graphic element resembling two interconnected circles on the left. To the right of the graphic is the text "GI Supply" in a bold, green font. Below the main text, in a smaller, gray font, are the words "Specialty Endoscopic Products."
gastrointestinal lesions, prior to excision with a snare, forceps, or other appropriate endoscopic device, when compared to the predicate device, the Cosmo Technologies Ltd. SIC 8000 (Eleview Submucosal Injectable Composition) (K150852). Substantial Equivalency (SE) of the subject device has also been based on substantially equivalent usability, functionality, and performance characteristics as the predicate device.
IV. DEVICE DESCRIPTION [Per 807.92(a)(4)]
The GI Supply EverLift™ Submucosal Lifting Agent is a prefilled plastic syringe with attached plunger rod containing 5mL of lifting agent. The syringe has a luer lock connection capable of interfacing with a standard, commercially available, endoscopic injection needle.
The EverLift™ Submucosal Lifting Agent is an injectable liquid composition for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD) and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, including the esophagus, the stomach, the small intestine, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers and other pathological lesions by EMR, ESD or polypectomy.
EverLift™ Submucosal Lifting Agent is injected into the submucosal layer by means of a standard, commercially available, endoscopic injection needle, which is inserted into the working channel of the endoscope. The composition, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal laver, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD or polypectomy).
IV. INTENDED USE / INDICATIONS FOR USE [Per 807.92(a)(5)]
Intended Use / Indications for Use
EverLift™ Submucosal Lifting Agent is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal lesions prior to excision with a snare or other appropriate endoscopic device.
V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [Per 807.92(a)(6)]
The EverLift™ Submucosal Lifting Agent [subject device] is substantially equivalent to the Cosmo Technologies Ltd. SIC 8000 (Eleview Submucosal Injectable Composition (K150852) [predicate device] based on the same indication for use as the predicate device, and the similar or identical functional and performance characteristics of the subject device when compared to the predicate device. The differences between the subject device and predicate device do not raise different issues of safety and effectiveness. Non-Clinical Performance Testing was conducted to demonstrate substantial equivalence.
The detailed substantial equivalence comparison of the similarities and differences between the Gl Supply EverLift™ Submucosal Lifting Agent (subject device) and the Cosmo Technologies Ltd. SIC 8000 (Eleview Submucosal Injectable Composition) (K150852) (predicate device) is provided in the table below.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for GI Supply. The logo consists of a green circular design to the left of the text "GI Supply" in green. Below the company name is the text "Specialty Endoscopic Products" in a smaller, gray font.
| RegulatoryInformation | EverLift™ Submucosal LiftingAgent (Subject Device) | SIC 8000 (Eleview SubmucosalInjectable Composition(K150852) (Predicate Device) | Same/Similarities/Differences |
|---|---|---|---|
| Manufacturer | GI Supply | Cosmo Technologies Ltd. | -- |
| Device Trade orProprietaryName | EverLift™ Submucosal LiftingAgent | SIC 8000(Eleview Submucosal InjectableComposition) | -- |
| 510(k) Number | K191923 | K150852 | -- |
| Device Class | Class II | Class II | Same |
| Device CommonName | Submucosal Injection Agent | Submucosal Injection Agent | Same |
| DeviceClassificationName | Endoscope and Accessories | Endoscope and Accessories | Same |
| Product Code | PLL | PLL | Same |
| RegulationNumber | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Indications forUse | EverLift™ Submucosal Lifting Agentis indicated for use ingastrointestinal endoscopicprocedures for submucosal lift ofpolyps, adenomas, early-stagecancers, or other gastrointestinallesions prior to excision with asnare or other appropriateendoscopic device. | The SIC 8000 (EleviewSubmucosal InjectableComposition) is indicated for usein gastrointestinal endoscopicprocedures for submucosal lift ofpolyps, adenomas, early-stagecancers, or other gastrointestinalmucosal lesions, prior to excisionwith a snare, or other suitableendoscopic device. | Same |
| Intended Use | Same as Indications for Use | Same as Indications for Use | Same |
| Prescription orOver-the-Counter (OTC)Use | Prescription Use | Prescription Use | Same |
| Use Environment | Hospital / Clinic | Hospital / Clinic | Same |
| Sterile | Sterile | Sterile | Same |
| Single-Use | Single-Use Only | Single-Use Only | Same |
| Shelf Life | 2-Year Shelf Life | 3-Year Shelf Life | Different. The difference inshelf life duration does notraise different questions ofsafety and effectiveness. Anaccelerated aging study wasperformed on the subjectdevice to confirm that thedevice meets all physical andfunctional requirementsthroughout a 2-Year Shelf Life. |
| SterilizationMethod | EverLift™ Submucosal Lifting Agentis sterilized by moist-heatsterilization. | SIC 8000 (Eleview) is sterilized byfiltration and aseptically filled. | Different. The difference insterilization method does notraise different questions ofsafety and effectiveness. |
| Filling Method of Primary Container | Filled into a 5mL COC (cyclic olefin copolymer) syringe in an environmentally controlled ISO Class 7 cleanroom. | Aseptically filled into a 10mL polypropylene ampoule. | Different. The difference in filling methods of the primary containers does not raise different questions of safety and effectiveness. |
| Size and Material of the Primary Container | 5mL COC (cyclic olefin copolymer) syringe | 10mL polypropylene ampoule | Similar. The minor difference in size and material of the primary container does not raise different questions of safety and effectiveness. Biocompatibility Testing and Non-Clinical Performance Testing was conducted to demonstrate SE. |
| Design Features of the Primary Container | 5mL COC pre-filled syringe (includes plunger) with Luer-lock connection that can easily be connected to a 23-gauge endoscopic injection needle with a needle length of 4 mm or less (not provided with the device). | 10mL polypropylene ampoule with a female Luer-lock closure that can easily be connected to a suitable disposable plastic or glass syringe with male Luer-lock connection fitting, to extract the emulsion, and be injected through an endoscope via a normal, commercially available endoscopic injection needle (e.g.: a 2.3 mm x 230 cm endoscopic injection needle) having a needle diameter of 23 gauge (23G) or less (not provided with the device). | Similar. Design is similar, although composition of syringe/ampoule differs. Injection method is identical. The difference does not raise different questions of safety and effectiveness. Non-Clinical Performance Testing was conducted to demonstrate SE. |
| Injection Method | Injected into the submucosal layer by means of a standard, commercially available, endoscopic injection needle, which is inserted into the working channel of the endoscope. The composition, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal layer, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD or polypectomy). | Injected into the submucosal layer by means of a standard, commercially available, endoscopic injection needle, which is inserted into the working channel of the endoscope. The composition, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal layer, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD or polypectomy). | Same |
| Storage Conditions | Store product at room temperature (15-30°C). Store in a dark place. | Store between 2°C (35.6°F) and 25°C (77°F). Excursions permitted up to 40°C (104°F). | Similar. The differences do not raise different questions of safety and effectiveness. Aging Studies were conducted to demonstrate SE. |
| How Provided toUser | Provided in 5 mL single-use pre-filled syringes. | Provided in 10 mL single-usepolypropylene ampoulespouched in an aluminum pouchunder nitrogen, which is packedin a cardboard box. | Different. The difference in theuse of a 5mL pre-filled syringeversus a 10mL ampoule do notraise different questions ofsafety and effectiveness.Biocompatibility Testing andNon-Clinical PerformanceTesting was conducted todemonstrate SE. |
| Use of SpecialEquipment | Does not require any specialapparatus or equipment and isdesigned to be use with mostcommon endoscopic resectiondevices. | Does not require any specialapparatus or equipment and isdesigned to be used with themost common endoscopicresection devices. | Same |
| Composition | Each steam sterilized syringecontains 5mL of lifting agent withthe following ingredients:• Water• Hydroxyethyl Cellulose• Glycerin• Methylene Blue• Benzyl Alcohol• Sodium Phosphate• Potassium Phosphate | The emulsion consists of thefollowing components:• Water for injection• Medium chain triglycerides• Poloxamer 188• Polyoxyl-15Hydroxystearate• Sodium Chloride• Methylene Blue | Different. Both devices areformulated using water andmethylene blue as the baseformulation. Additives toincrease surface tension, act asviscosifying agents, etc. differslightly. The differences do notraise different questions ofsafety and effectiveness.Biocompatibility Testing andNon-Clinical PerformanceTesting was conducted todemonstrate SE. |
| Dosage andAdministration | Remove the cap from the tube andremove the syringe. Examine thesyringe to verify there is nodamage. Then, using aseptictechnique, attach the syringe tothe Luer fitting on the endoscopicinjection needle. A 23-gaugeinjection needle with a needlelength of 4 mm or less isrecommended for this procedure.Prime the needle with EverLift™prior to injection. With the needleretracted, insert the needle'scatheter through the biopsyworking channel of the endoscope.When the needle is properlypositioned, insert the tip at a 30°-45° angle to the surface into thesubmucosal space of the colon,ensuring the beveled tip of theneedle is entirely beneath themucosa. The maximum allowabledose is 50 mL per patient. | Eleview can be injected throughan endoscope via a normal,commercially availableendoscopic injection needle (e.g.:a 2.3 mm x 230 cm endoscopicinjection needle) having a needlediameter of 23-gauge (23G) orless (not provided with thedevice). The administered dose ofEleview should be determinedbased on the dimensions of thelesion to be removed. Inject intothe submucosa the amount ofEleview needed to form asubmucosal cushion of optimalheight and shape for the lesion tobe removed. During theprocedure do not exceed a totaldose of 50 mL per patient, eitherin single or in multipleadministrations. | Same |
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for GI Supply. The logo consists of a green symbol resembling two interconnected circles on the left, followed by the text "GI Supply" in green. Below the text, there is a smaller line of text that reads "Specialty Endoscopic Products" in a darker color.
Specialty Endoscopic Products
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for GI Supply. The logo consists of a green circular design on the left, followed by the text "GI Supply" in green. Below the text is the phrase "Specialty Endoscopic Products" in gray.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for GI Supply, a company that specializes in endoscopic products. The logo features a green, stylized symbol to the left of the company name, "GI Supply," which is also in green. Below the company name, in a smaller, gray font, is the tagline "Specialty Endoscopic Products."
Rationale for Substantial Equivalence
The GI Supply EverLift™ Submucosal Lifting Agent [subject device] is substantially equivalent to the SIC 8000 (Eleview Submucosal Injectable Composition (K150852) [predicate device] in terms of the same indications for use / intended use and substantially equivalent usability, functionality, and performance characteristics as the predicate device. A detailed description of the similarities shared between the subject device and the predicate device, as well as, a description of the minor differences which do not raise new or different issues of safety and effectiveness, support a determination of substantial equivalency.
Similarities
The GI Supply EverLift™ Submucosal Lifting Agent [subject device] shares the following same or similar characteristics as the SIC 8000 (Eleview Submucosal Injectable Composition (K150852) [predicate device]:
- . Intended Use / Indications for Use for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal mucosal lesions prior to excision with a snare or other appropriate endoscopic device: Same
- Sterile Device: Same
- Single-Use: Same
- Prescription Use: Same
- . Use Environment: Same
Additional features and functionality also shared among the subject device and the primary predicate and reference device include:
- Injection Method: Same
- Dosage and Administration: Same
Differences
There are minor differences that exist between the EverLift™ Submucosal Lifting Agent [subject device] when compared to the SIC 8000 (Eleview Submucosal Injectable) (K150852) [predicate device] which do not raise new or different questions of safety and effectiveness. Non-Clinical Performance Testing was conducted to demonstrate substantial equivalence (SE). The subject device has the following characteristics which are different from the predicate device:
- Material / Ingredient Composition: Similar. Both devices are formulated using water and methylene blue as the base formulation. Additives to increase surface tension, act as viscosifying agents, etc. differ slightly. The differences do not raise different questions of safety and effectiveness. Biocompatibility Testing and Non-Clinical Performance Testing was conducted to demonstrate substantial equivalence (SE).
- . Size of Primary Container: Different (5mL vs 10mL). The difference in size of the primary container does not raise different questions of safety and effectiveness. Non-Clinical Performance Testing was conducted to demonstrate substantial equivalence (SE).
- Filling Method of Primary Container: Different filling methods of the primary container are used. The different filling methods do not raise different questions of safety and effectiveness.
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the logo for GI Supply, a company that specializes in endoscopic products. The logo features a green graphic element resembling two interconnected circles on the left, followed by the text "GI Supply" in a matching green color. Below the company name, the words "Specialty Endoscopic Products" are written in a smaller, gray font. The overall design is clean and professional, reflecting the company's focus on medical equipment and supplies.
- 2-Year Shelf Life: Different. The differences in shelf life do not raise different questions of ● safety and effectiveness. An Accelerated Aging Study was conducted on the subject device to confirm that the device meets all physical and functional requirements throughout a 2-year shelf life.
- Sterilization Method: Different. Different sterilization methods are used. The different sterilization methods do not raise different questions of safety and effectiveness.
- . How Provided to User: Different. The difference in the use of a 5mL pre-filled syringe versus a 10mL ampoule do not raise different questions of safety and effectiveness.
- . Biocompatibility Testing and Non-Clinical Performance Testing was conducted to demonstrate SE.
VI. SUMMARY OF PERFORMANCE DATA AND PERFORMANCE TEST CONCLUSIONS [Per 807.92(b)(1)(2)(3)]
The determination of substantial equivalence is based on an assessment of Non-Clinical Performance data. To verify that the device design meets its functional and performance requirements, the subject device underwent testing in accordance with the following.
The EverLift™ Submucosal Lifting Agent is developed under GI Supply's risk management process in accordance with ISO 14971:2007 - Medical Devices-Application of Risk Management to Medical Devices. The identified risks were adequately mitigated and verified by means of non-clinical performance testing.
Summary of Performance Testing
A series of functional performance tests, animal studies, biocompatibility tests, and sterility tests were conducted on the subject device. The following functional performance tests were performed: container closure integrity testing, syringe tip cap removal force testing, tube cap removal force testing, pH testing, product color evaluation, lift duration testing, and flow rate testing.
Comparative bench testing was conducted, which compared the proposed EverLift™ device to the predicate device Eleview® (K150852) for the following performance measures: viscosity, osmolality, and density.
Preclinical testing in a porcine model was conducted which compared the proposed EverLift™ device to the predicate device Eleview® (K150852).
Biocompatibility testing was conducted on the proposed EverLift™ device in accordance with ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process.
Bacterial endotoxin and pyrogen testing, in addition to chemical characterization testing, were also performed.
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image shows the logo for GI Supply, a company that specializes in endoscopic products. The logo features a green, stylized "GI" symbol on the left, followed by the words "GI Supply" in a sans-serif font. Below the company name, the tagline "Specialty Endoscopic Products" is written in a smaller font.
VII. CONCLUSIONS
The data generated from the results of the robust functional, performance, preclinical, and biocompatibility testing conducted on the EverLift™ Submucosal Lifting Agent [subject device] demonstrate that the device is as safe, as effective, and performs as well as the predicate device. Therefore, the data results may be relied on to support a determination of substantial equivalence.
§ 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.