(41 days)
Not Found
No
The device is a prefilled syringe containing a liquid lifting agent for mechanical submucosal elevation, with no mention of software, algorithms, or data processing.
No
The device aids a surgical procedure (resection) by creating a cushion. It does not directly provide therapy or treatment for a condition.
No
Explanation: The device is an injectable lifting agent used during endoscopic procedures to create a cushion for easier and safer resection of lesions. It does not analyze patient data or provide diagnostic information.
No
The device description clearly states it is a prefilled plastic syringe containing a liquid lifting agent, which are physical components, not software.
Based on the provided information, the EverLift™ Submucosal Lifting Agent is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for in vivo procedures (within the body) during gastrointestinal endoscopy to lift tissue for surgical removal. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue samples to diagnose diseases or conditions.
- Device Description: The device is an injectable liquid composition used directly on the patient's tissue during a procedure. This is consistent with a surgical or procedural aid, not an IVD.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic purposes, or the use of reagents typically associated with IVDs.
Therefore, the EverLift™ Submucosal Lifting Agent is a medical device used in a surgical/procedural context, not an in vitro diagnostic device.
N/A
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 with a snare or other appropriate endoscopic device.
Product codes (comma separated list FDA assigned to the subject device)
PLL
Device Description
The GI Supply EverLift™ Submucosal Lifting Agent (10mL) is a prefilled plastic syringe with attached plunger rod containing 10mL of lifting agent. The syringe has a luer lock connection capable of interfacing with a standard, commercially available endoscopic injection needle.
EverLift™ Submucosal Lifting Agent is an injectable liguid 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 layer, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD, or polypectomy).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract, esophagus, stomach, small intestine, sigmoid colon, rectum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital / Clinic
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)
A series of non-clinical performance testing was conducted on the subject device.
- Syringe Tip Cap Removal Force Testing: Results confirmed that the syringe tip cap removal force is equivalent between the subject and predicate devices, thereby demonstrating substantial equivalence.
- Product Color Testing: Results confirmed that product color is identical between the two devices, thereby demonstrating substantial equivalence.
- Injection Flow Rate Testing: Results confirmed that the injection flow rate is equivalent between the subject and predicate devices, thereby demonstrating substantial equivalence.
- Graduation Marking Tolerance: Results confirmed that the marking tolerance meets the acceptance criteria defined in ISO 7886-1, thereby demonstrating substantial equivalence.
- Container Closure Integrity Testing: Results confirmed that the container closure integrity is identical between the subject and predicate devices, thereby demonstrating substantial equivalence.
- Tray Lid Peel Force Testing: Results post-distribution simulation met acceptance criteria, confirming that the differences in secondary packaging do not raise different questions of safety or effectiveness.
- Sterility Assurance Level: Validation results confirmed that the Sterility Assurance Level (SAL) is identical for both devices (10-6), thereby demonstrating substantial equivalence.
- LAL Testing: Results confirmed that the LAL level is identical between the subject and predicate devices, thereby demonstrating substantial equivalence. Additionally, LAL testing will be performed on each lot prior to final product release.
- Distribution and Post-Distribution Testing: Results confirmed that package integrity is identical between the subject and predicate devices, thereby demonstrating substantial equivalence.
- Accelerated and Post-Accelerated Aging Studies: Results of the testing was identical between the subject and predicate devices, thereby demonstrating substantial equivalence.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 30, 2020
Gi Supply, Inc. Erika Parry Manager, Quality and Regulatory 5069 Ritter Road Suite 104 Mechanicsburg, Pennsylvania 17055
Re: K202376
Trade/Device Name: EverLift Submucosal Lifting Agent Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: PLL Dated: September 1, 2020 Received: September 2, 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. You must comply with all the Act's
1
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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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) K202376
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 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) |
||X| Prescription Use (Part 21 CFR 801 Subpart D)
_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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 and Regulatory Phone: (717)-562-7580 Email: e.parry@gi-supply.com
Date Prepared
August 19, 2020 Amended September 29, 2020
II. DEVICE [Per 807.92(a)(2)]
| Device Trade/Proprietary Name | EverLift™ Submucosal Lifting Agent |
|---|---|
| Device Common or Usual Name | Submucosal Injection Agent |
| Regulation Number | 21 CFR 876.1500 |
| Regulation Name | Endoscope and Accessories |
| Regulatory Class | Class II |
| Submission Type | Special 510(k) |
| Product Code | PLL |
| Classification Panel | Gastroenterology/Urology |
III. PREDICATE DEVICE [Per 807.92(a)(3)]
The EverLift™ Submucosal Lifting Agent (10mL) [subject device] is substantially equivalent in terms of its intended use to the claimed predicate device, the 5mL EverLift™ Submucosal Lifting Agent (5mL) (K191923) with respect to device design, fundamental technology, physical characteristics, performance and intended use.
The device design and fundamental technology of the subject device are nearly identical to that of the predicate device. The formulation and composition of the primary packaging materials are identical. There are slight differences in the dimensions of the subject device and predicate device which do not impact safety or effectiveness. Both the subject and predicate devices are delivered sterile and are indicated for single-use only. The Sterilization Method and Shelf Life for the subject device are identical as that for the predicate device.
| Predicate
Device | The EverLift™ Submucosal Lifting Agent (10mL) [subject device] is substantially equivalent to
the following predicate device manufactured by GI Supply:
• EverLift™ Submucosal Lifting Agent (5mL) (K191923) |
| --------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
4
IV. DEVICE DESCRIPTION [Per 807.92(a)(4)]
The GI Supply EverLift™ Submucosal Lifting Agent (10mL) is a prefilled plastic syringe with attached plunger rod containing 10mL of lifting agent. The syringe has a luer lock connection capable of interfacing with a standard, commercially available endoscopic injection needle.
EverLift™ Submucosal Lifting Agent is an injectable liguid 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 layer, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD, or polypectomy).
V. 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [Per 807.92(a)(6)]
The EverLift™ Submucosal Lifting Agent (10mL) [subject device] is substantially equivalent to the Gl Supply EverLift™ Submucosal Lifting Agent (5mL) (K191923) [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.
The detailed substantial equivalence comparison of the similarities and differences between the Gl Supply EverLift™ Submucosal Lifting Agent (10ml) [subject device] and the GI Supply EverLift™ Submucosal Lifting Agent (5mL) (K191923) [predicate device] is provided in the table below.
| Regulatory
Information | [Subject Device] | [Predicate Device] | Similarities /
Differences |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | GI Supply | GI Supply | Same |
| Device Trade
or
Proprietary
Name | EverLift™ Submucosal Lifting Agent
(10mL) | EverLift™ Submucosal Lifting Agent
(5mL) | --- |
| Regulatory
Information | [Subject Device] | [Predicate Device] | Similarities /
Differences |
| 510(k)
Number | K202376 | K191923 | --- |
| Device Class | Class II | Class II | Same |
| Device
Classification
Name | Endoscope and Accessories | Endoscope and Accessories | Same |
| Device
Common
Name | Submucosal Injection Agent | Submucosal Injection Agent | Same |
| Product Code | PLL | PLL | Same |
| Regulation
Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Design Features and Capabilities of the Device | | | |
| 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. | 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. | Same |
| Intended Use | Same as Indications for Use | Same as Indications for Use | Same |
| Prescription
or Over-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 |
| Design Features | | | |
| Packaging | Each individual 10mL COC syringe is
packed inside a thermoformed tray.
The tray is sealed with a labeled lid
stock with three (3) patient labels
affixed to the lid stock. Ten (10) of
the sealed trays are packed into a
shelf box with a copy of the IFU
placed between the trays and the
shelf box wall. The shelf box is
shipped in a regular die cut and
scored 200-pound B-flute kraft
shipper box sealed with a shipper
box label. | Each individual 5mL COC syringe is
packed along with three (3) patient
labels inside a propionate tube with
a friction fit press on closure. Ten
(10) tubes are packed into a shelf
box on top of a copy of the IFU. The
shelf box is shipped in a regular die
cut and scored 200-pound B-flute
kraft shipper box sealed with a
shipper box label. | Different. The
differences in
packaging do
not raise
different
questions of
safety or
effectiveness.
A Distribution
Study was
performed on
the new
packaging
configuration. |
| Regulatory
Information | [Subject Device] | [Predicate Device] | Similarities /
Differences |
| Images
of Device | Image: Subject Device | Image: Predicate Device | --- |
| Sterilization
Method | Sterilized by moist-heat (steam)
sterilization | Sterilized by moist-heat (steam)
sterilization | Same |
| Shelf Life | 2-Year Shelf Life | 2-Year Shelf Life | Same |
| Composition | Each steam sterilized syringe
contains 10mL of lifting agent with
the following ingredients:
• Water
• Hydroxyethyl Cellulose
• Glycerin
• Methylene Blue
• Benzyl Alcohol
• Sodium Phosphate
• Potassium phosphate | Each steam sterilized syringe
contains 5mL of lifting agent with
the following ingredients:
• Water
• Hydroxyethyl Cellulose
• Glycerin
• Methylene Blue
• Benzyl Alcohol
• Sodium Phosphate
• Potassium phosphate | Same
concentration;
however,
volume of
lifting agent
provided
differs. |
5
6
VII. 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 EverLift™ Submucosal Lifting Agent (10mL) underwent performance testing. Biocompatibility testing was performed only on the 5mL variant as it represented worst-case surface area to volume ratio.
The EverLift™ Submucosal Lifting Agent was developed under GI Supply's risk management process in accordance with ISO 14971:2012 - 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 non-clinical performance testing was conducted on the subject device. Please refer to the table below for a summary of all non-clinical performance testing conducted on the subject device in support of substantial equivalence.
| Test Description | Conforming Standard(s) | Conclusion in Support of Substantial Equivalence |
|---|---|---|
| Syringe Tip Cap | ||
| Removal Force | ||
| Testing | None | Syringe tip cap removal force testing was performed on |
| the subject device using the same method and | ||
| acceptance criteria as the predicate device. Results of | ||
| the testing confirmed that the syringe tip cap removal | ||
| force is equivalent between the subject and predicate | ||
| devices, thereby demonstrating substantial equivalence. | ||
| Test Description | Conforming Standard(s) | Conclusion in Support of Substantial Equivalence |
| Product Color | ||
| Testing | None | Product color testing was performed on the subject device using the same method and acceptance criteria as the predicate device. Results of the testing confirmed that product color is identical between the two devices, thereby demonstrating substantial equivalence. |
| Injection Flow | ||
| Rate Testing | None | Injection flow rate testing was performed on the subject device using the same method and acceptance criteria as the predicate device. Results of the testing confirmed that the injection flow rate is equivalent between the subject and predicate devices, thereby demonstrating substantial equivalence. |
| Graduation | ||
| Marking | ||
| Tolerance | ISO 7886-1:2017, Sterile | |
| hypodermic needles for single | ||
| use – Part 1: Syringes for manual | ||
| use | Graduation mark tolerance testing was performed on the subject device using the same method as the predicate device, and acceptance criteria as defined in ISO 7886-1. Results of the testing confirmed that the marking tolerance meets the acceptance criteria defined in ISO 7886-1, thereby demonstrating substantial equivalence. | |
| Container | ||
| Closure | ||
| Integrity Testing | None | Container closure integrity testing was performed on the subject device using the same method and acceptance criteria as the predicate device. Results of the testing confirmed that the container closure integrity is identical between the subject and predicate devices, thereby demonstrating substantial equivalence. |
| Tray Lid Peel | ||
| Force Testing | None | The secondary packaging of the subject device required a minor design change to accommodate the larger 10mL syringe. Tray lid peel force test results post-distribution simulation met acceptance criteria, confirming that the differences in secondary packaging do not raise different questions of safety or effectiveness. |
| Sterility | ||
| Assurance Level | ISO 17665-1, Sterilization of | |
| healthcare products – Moist | ||
| heat – Part 1: Requirements for | ||
| the development, validation and | ||
| routine control of a sterilization | ||
| process for medical devices | A sterilization validation was performed on the subject device using the same sterilization process and sterilization parameters as the predicate device. Validation results confirmed that the Sterility Assurance Level (SAL) is identical for both devices (10-6), thereby demonstrating substantial equivalence. | |
| LAL Testing | USP , Bacterial Endotoxins |
USP , Transfusion and
Infusion Assemblies and Similar
Medical Devices | LAL testing was performed on the subject device using the same method and acceptance criteria as the predicate device. Results of the testing confirmed that the LAL level is identical between the subject and predicate devices, thereby demonstrating substantial equivalence. Additionally, LAL testing will be performed on each lot prior to final product release. |
| Distribution and
Post-
Distribution
Testing | D7386-16, ASTM Standard
Practice for Performance Testing
of Packages for Single Parcel
Delivery Systems | Post-distribution testing was performed on the subject device using the same method and acceptance criteria as the predicate device. Results of the testing confirmed that package integrity is identical between the subject and predicate devices, thereby demonstrating substantial equivalence. |
| Test Description | Conforming Standard(s) | Conclusion in Support of Substantial Equivalence |
| Accelerated and
Post-
Accelerated
Aging Studies | F1980-16, ASTM Standard Guide
for Accelerated Aging of Sterile
Barrier Systems for Medical
Devices | Post-accelerated aging testing was performed on the
subject device using the same method and acceptance
criteria as the predicate device. Results of the testing
was identical between the subject and predicate devices,
thereby demonstrating substantial equivalence. |
7
8
VIII. CONCLUSIONS
Based on the results of the non-clinical performance testing conducted on the subject device, it has been concluded that the proposed EverLift™ Submucosal Lifting Agent is as safe and effective and performs as well as the legally marketed predicate device (K191923). The similar indications for use, intended use, technological characteristics, and performance characteristics for the proposed EverLift™ Submucosal Lifting Agent have been assessed to be substantially equivalent to the predicate device, and any differences do not raise different issues of safety and effectiveness when compared to the predicate device. Therefore, the EverLift™ Submucosal Lifting Agent is substantially equivalent to the predicate device.