(262 days)
Not Found
No
The device description and performance studies focus on the physical properties and performance of a gel for submucosal injection, with no mention of AI or ML capabilities.
No
The device is used to lift gastrointestinal mucosa to facilitate the excision of lesions, but it does not directly treat or cure a disease or condition itself.
No
The device is described as a viscous solution used for submucosal injection to lift gastrointestinal mucosa during endoscopic resection procedures. Its purpose is to facilitate the removal of lesions, not to diagnose them.
No
The device description clearly states it is a "viscous dyed solution which is pre-filled into a standard luer lock syringe" and describes physical performance testing (viscosity, color, pH, osmolality, injection force, etc.), indicating it is a physical substance and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "submucosal lift of polyps, adenomas, early stage cancers, or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device." This describes a procedure performed on the patient's tissue in situ (within the body), not a test performed on a sample of the patient's tissue outside the body.
- Device Description: The device is a "viscous dyed solution which is pre-filled into a standard luer lock syringe for use in submucosal injection." This is a substance injected into the body to facilitate a surgical procedure.
- Lack of Diagnostic Function: The device's purpose is to physically lift tissue, making it easier to remove. It does not analyze a sample to provide diagnostic information about the patient's health or condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
This device is indicated 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 suitable endoscopic device.
Product codes (comma separated list FDA assigned to the subject device)
PLL
Device Description
The ORISE™ Gel device is a viscous dyed solution which is pre-filled into a standard luer lock syringe for use in submucosal injection to lift gastrointestinal mucosa 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, such as 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. The Injection 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 proposed device will have a blue colorant added to provide the user with ability to visually see the raised lesion.
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
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)
A series of bench performance tests, animal studies and biocompatibility tests were conducted which demonstrated the quantitative mechanical performance, tolerance and usability of the ORISE™ Gel in endoscopic procedures. The following performance bench tests were performed; Solution Viscosity, Solution Color, Solution pH, Solution Osmolality, Injection Force, Connection Seal Integrity and Connection Separation Force. Comparative bench testing was conducted, which compared the proposed ORISE™ Gel to the predicate Cosmo Technologies Ltd. SIC-8000 (Eleview™) device (K150852) for the following performance measures; Solution Viscosity, Solution Color, Solution pH, Solution Osmolality, and Injection Force. The results demonstrated that the proposed device is substantially equivalent to the predicate device for these performance measures. Ex-Vivo testing was performed and compared directly to Eleview (the predicate) and dyed saline to evaluate initial height, and height at 5, 10, 20 and 30 minutes. Preclinical testing was conducted to support substantial equivalence claims of our final ORISE™ Gel formulation as compared to the predicate device. The objective of this study was to evaluate the efficacy and safety of Boston Scientific's ORISE Gel (compared to a dyed saline control) for submucosal life during EMR/ESD procedures in the upper and lower GI tract of a porcine model. A total of 12 EMR and 11 ESD procedures were performed using the Test Article and 12 EMR and 11 ESD procedures were performed using the Control Article. All biocompatibility tests conducted on the ORISE™ Gel passed. All device bench test results were acceptable. Animal testing demonstrated that Boston Scientific ORISE Gel (Test Article) was comparable to the use of a dyed saline Control Article (Saline with Methlylene Blue) in terms of efficacy and comparable to the use of dyed saline Control article in terms of safety endpoints for submucosal lift during EMR and ESD procedures in the upper and lower GI tract of a porcine model.
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & 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.
September 28, 2018
Boston Scientific Jennifer Edouard Senior Manager, Regulatory Affairs 100 Boston Scientific Way Marlborough, MA 01752
Re: K180068 Trade/Device Name: ORISE™ Gel Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: PLL Dated: August 23, 2018 Received: August 27, 2018
Dear Jennifer Edouard:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mark R. Kreitz -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180068
Device Name ORISE Gel
Indications for Use (Describe)
This device is indicated 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 suitable endoscopic device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 5 510(k) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-6134 Fax: 508-683-5939
| Contact: | Jennifer Edouard |
|---|---|
| Regulatory Specialist II, Regulatory Affairs | |
| Date Prepared: | August 23, 2018 |
2. Proposed Device:
| Trade Name: | ORISE™ Gel |
|---|---|
| Classification Name: | Endoscope and Accessories |
| Regulation Number: | 876.1500 |
| Product Code: | PLL |
| Common Name: | Submucosal Injection Agent |
| Classification: | Class II |
3. Predicate Device:
| Trade Name: | SIC-8000 (Eleview™) |
|---|---|
| 510(k) Number: | K150852 |
| Classification Name: | Endoscope and Accessories |
| Regulation Number: | 876.1500 |
| Product Code: | PLL |
| Common Name: | Submucosal Injection Agent |
| Classification: | Class II |
4. Proposed Device Description:
The ORISE™ Gel device is a viscous dyed solution which is pre-filled into a standard luer lock syringe for use in submucosal injection to lift gastrointestinal mucosa 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, such as 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. The Injection 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.
5. Indications for Use:
This device is indicated 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 suitable endoscopic device.
4
6. Technological Characteristics:
The ORISE™ Gel 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 solution, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal layer, allowing the endoscopist to perform a resection procedure (EMR, ESD or polypectomy). The proposed device will have a blue colorant added to provide the user with ability to visually see the raised lesion.
7. Performance Data:
A series of bench performance tests, animal studies and biocompatibility tests were conducted which demonstrated the quantitative mechanical performance, tolerance and usability of the ORISE™ Gel in endoscopic procedures. The following performance bench tests were performed; Solution Viscosity, Solution Color, Solution pH, Solution Osmolality, Injection Force, Connection Seal Integrity and Connection Separation Force.
Comparative bench testing was conducted, which compared the proposed ORISE™ Gel to the predicate Cosmo Technologies Ltd. SIC-8000 (Eleview™) device (K150852) for the following performance measures; Solution Viscosity, Solution Color, Solution pH, Solution Osmolality, and Injection Force. The results demonstrated that the proposed device is substantially equivalent to the predicate device for these performance measures.
Ex-Vivo testing was performed and compared directly to Eleview (the predicate) and dyed saline to evaluate initial height, and height at 5, 10, 20 and 30 minutes.
Preclinical testing was conducted to support substantial equivalence claims of our final ORISE™ Gel formulation as compared to the predicate device. The objective of this study was to evaluate the efficacy and safety of Boston Scientific's ORISE Gel (compared to a dyed saline control) for submucosal life during EMR/ESD procedures in the upper and lower GI tract of a porcine model. A total of 12 EMR and 11 ESD procedures were performed using the Test Article and 12 EMR and 11 ESD procedures were performed using the Control Article.
8. Conclusion:
All biocompatibility tests conducted on the ORISE™ Gel passed. Therefore, the System is considered biocompatible for its intended use.
All device bench test results were acceptable. The data demonstrate that the System sufficiently meets the design specifications and is suitable for the intended use.
Animal testing demonstrated that Boston Scientific ORISE Gel (Test Article) was comparable to the use of a dyed saline Control Article (Saline with Methlylene Blue) in terms of efficacy and comparable to the use of dyed saline Control article in terms of safety endpoints for submucosal lift during EMR and ESD procedures in the upper and lower GI tract of a porcine model.
Boston Scientific Corporation has demonstrated that the proposed ORISE™ Gel is substantially equivalent to the currently marketed SIC-8000 (Eleview™) device (K150852) and can be safely and effectively used for its proposed indication.