(156 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of an injectable liquid composition, with no mention of AI or ML technologies.
Yes.
The device facilitates the safe excision of polyps, adenomas, and early-stage cancers, which are therapeutic interventions.
No
The device is an injectable liquid composition used to lift gastrointestinal mucosal lesions for easier and safer excision, not for diagnosis. It aids in therapeutic procedures rather than providing diagnostic information.
No
The device description clearly states it is an "injectable liquid composition in the form of an oil-in-water (o/w) emulsion" and is used as a "submucosal injection agent." This is a physical substance, not software.
Based on the provided information, the SIC 8000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for submucosal lift during endoscopic procedures to facilitate the removal of lesions. This is a therapeutic or procedural aid, not a diagnostic test performed on samples outside the body.
- Device Description: The device is an injectable liquid composition used to create a cushion in the submucosal layer. This is a physical intervention during a medical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
IVD devices are typically used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SIC 8000's function is to physically assist in a surgical procedure, not to provide diagnostic data.
N/A
Intended Use / Indications for Use
The SIC 8000 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
PLL
Device Description
SIC 8000 is an injectable liquid composition in the form of an oil-in-water (o/w) emulsion 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, such as the esophagus, the small intestine, the colon, 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. SIC 8000 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 emulsion, 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, such as the esophagus, the small intestine, the colon, the sigmoid colon, and the 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
A series of performance tests and animal studies were conducted which demonstrated the quantitative mechanical performance, tolerance and usability of SIC 8000 in endoscopic procedures.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2015
Cosmo Technologies Ltd. % Steve Kradjian Conventus Biomedical 5414 Oberlin Drive, Suite 130 San Diego, CA 92121
Re: K150852 Trade/Device Name: SIC 8000 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: PLL Dated: August 1, 2015 Received: August 3, 2015
Dear Steve Kradjian,
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (reporting of medical
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -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) To be determined K150852 Device Name
SIC 8000 Submucosal Injection Composition
Indications for Use (Describe)
The SIC 8000 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Cosmo Pharmaceuticals. The logo features a stylized human figure in blue with a yellow circle above its head, followed by the word "COSMO" in blue, and the word "Pharmaceuticals" in a smaller font below. The logo is clean and professional, and the colors are bright and inviting.
SECTION 5.0
510(k) SUMMARY
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Image /page/4/Picture/1 description: The image shows the logo for Cosmo Pharmaceuticals. The logo features a stylized figure in light blue with a yellow circle above it, followed by the word "COSMO" in dark blue, and the word "Pharmaceuticals" in a smaller font below it. The logo is clean and professional, with a focus on the company name.
510(k) Summary for the SIC 8000 5.0
5.1 Submission Sponsor:
Cosmo Technologies Ltd. 42-43 Amiens Street, Dublin 1 - Ireland Telephone: +353 (1) 8170370 Fax: +353 (1) 8230718 FDA Establishment Registration #: the facility is not currently registered
5.2 Submission Correspondent:
Steven A. Kradjian President, Conventus Biomedical Solutions, Inc. U.S. Agent and Authorized Representative for Cosmo Technologies, Ltd. 5414 Oberlin Drive, Suite 130 San Diego, CA 92121 Tel: (858) 401-2111 Email: skradjian@conventusbiomed.com
5.3 Date Prepared:
31 March 2015, Amended 03 September 2015
5.4 Device Name:
| Trade/Proprietary Name: | SIC 8000 |
|---|---|
| Common Name: | GI Endoscopic Injection Needle |
| Classification Name: | GI Endoscopic Injection Needle |
| Product Code: | TBD |
| Regulation Number: | 876.1500 |
| Device Class: | II |
| Review Panel: | Gastroenterology and Urology |
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Image /page/5/Picture/1 description: The image shows the logo for Cosmo Pharmaceuticals. The logo consists of a stylized human figure in blue with an orange circle above its head, followed by the word "COSMO" in blue, and the word "Pharmaceuticals" in a smaller font below it. The logo is clean and modern, with a focus on the company's name and its connection to the pharmaceutical industry.
5.5 Substantial Equivalence:
SIC 8000 is substantially equivalent in terms of both intended use and technological characteristics to the Cook GI Endoscopic Injection Gel Kit, which was cleared for marketing under K111495 on 19 July 2011 for sub mucosal lift of polyps or other qastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.
5.6 Device Description:
SIC 8000 is an injectable liquid composition in the form of an oil-in-water (o/w) emulsion 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, such as the esophagus, the small intestine, the colon, 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. SIC 8000 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 emulsion, 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).
5.7 Indications for Use:
SIC 8000 is intended 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.
5.8 Performance Data:
A series of performance tests and animal studies were conducted which demonstrated the quantitative mechanical performance, tolerance and usability of SIC 8000 in endoscopic procedures.