(178 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological compatibility of a submucosal injection agent, with no mention of AI or ML.
No.
The device is an injection agent used to lift lesions prior to excision, which is a diagnostic procedure. While it facilitates the removal of potentially diseased tissue, its primary role is to aid in the diagnostic or therapeutic procedure, rather than directly treating a disease itself.
No
The device is a submucosal injection agent used for lifting lesions prior to excision, which is a therapeutic rather than a diagnostic function. It facilitates the removal of identified lesions, rather than identifying or characterizing them.
No
The device description clearly states it is a solution provided in a prefilled syringe, indicating it is a physical substance and delivery mechanism, not software.
Based on the provided information, the Blue Eye (TS-905) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for submucosal lift of lesions during gastrointestinal endoscopic procedures. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: It's a solution injected into the body to facilitate a procedure. IVDs are typically used to examine samples outside the body (in vitro) to diagnose conditions.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect biomarkers, or provide diagnostic information. Its function is purely mechanical (creating a lift).
Therefore, the Blue Eye (TS-905) is a medical device used in a surgical/procedural context, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Blue Eye (TS-905) is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions with a snare or endoscopic device.
Product codes
PLL
Device Description
The Blue Eye (TS-905), submucosal injection agent, is a solution used for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device in gastrointenstinal endoscopic procedures. The main materials of the solution are sodium hyaluronate and saline, and it is provided in prefilled syringe. It is supplied sterile and disposable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal mucosal lesions
Indicated Patient Age Range
Regular Adults (exclusion for pregnant or lactating women or children under 18 years of age)
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The following comparison tests were performed on the subject device. The test results show that the subject device is substantially equivalent to the predicate device in effectiveness.
- Sterilization validation per ISO 17665-1
- Shelf life validation per ASTM F1980-16
- Biocompatibility tests per ISO 10993-3, 5, 6, 10, 11
- Performance test: Characterization (ISO 10993-18), packaging (ASTM F88/F88M, ASTM F1929), Shipping (ASTM D4169), Syringe Performance (ISO 7886-1, ISO 80369-7 ISO 80369-20), Osmolality, pH, Viscosity
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
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 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 12, 2022
The Standard Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine, CA 92612
Re: K220434
Trade/Device Name: Blue Eye (TS-905) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: PLL Dated: February 3, 2022 Received: February 15, 2022
Dear Priscilla Chung:
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
1
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 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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advicecomprehensive-regulatory-assistance/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,
for
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) K220434
Device Name Blue Eye (TS-905)
Indications for Use (Describe)
The Blue Eye (TS-905) is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions with a snare or endoscopic device.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| For Therapeutic Use (with OTP Marketed Drug) | For Use in a Health OTP Marketed Drug |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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K220434 Page 1 of 2
510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).
Date: Feb 03, 2022
- Company and Correspondent making the submission:
| Company | |
|---|---|
| Name | The Standard Co., Ltd. |
| Address | 120, Gunpocheomdansaneop 2-ro, Gunpo- |
| si, Gyeonggido, 15880, Republic of Korea | |
| Phone | |
| Fax | |
| Contact | +82 2 838-5533 |
| +82 2 838-5523 | |
| Mr. Seongnam Kim/ president |
2. Device:
Trade name: Blue Eye (TS-905) Common name: Submucosal injection agent Classification name: Submucosal injection agent, 21CFR 876.1500 Product code: PLL
3. Predicate Device:
SIC 8000, K150852(Product Code: PLL, 21CFR 876.1500) by Cosmo Technologies Ltd.
-
- Description:
The Blue Eye (TS-905), submucosal injection agent, is a solution used for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device in gastrointenstinal endoscopic procedures. The main materials of the solution are sodium hyaluronate and saline, and it is provided in prefilled syringe. It is supplied sterile and disposable.
- Description:
-
- Indication for use:
The Blue Eye (TS-905) 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 endoscopic device.
- Indication for use:
- Summary of the technical characteristics between the new device and the predicate:
| Subject Device | Predicate Device | Same/Similarities/Differences | |
|---|---|---|---|
| Manufacturer | The Standard Co., Ltd. | Cosmo Technologies Ltd. | --- |
4
| Device Name | Blue Eye (TS-905) | SIC8000 | --- |
|---|---|---|---|
| 510(k) # | K150852 | --- | |
| Product Code | PLL | PLL | Same |
| 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 |
| Regulation | |||
| Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Indication for | |||
| Use | The Blue Eye (TS-905) 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 endoscopic | |||
| device. | 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 endoscopic device. | Same | ||
| Prescription or | |||
| Over-the- | |||
| Counter(OTC) | |||
| Use | Prescription Use | Prescription Use | Same |
| Anatomical Site | gastrointestinal mucosal lesions | gastrointestinal mucosal lesions | Same |
| Target | |||
| Population | Regular Adults | ||
| (exclusion for pregnant or lactating | |||
| women or children under 18 years of | |||
| age) | Regular Adults | ||
| (exclusion for pregnant or lactating | |||
| women or children under 18 years of | |||
| age) | Same |
The Blue Eye (TS-905) is substantially equivalent to the predicate device, SIC 8000 (K150852) in terms of indications for use and technological characteristics. There are differences in raw materials, packaging, and shelf life, however, we conducted various tests including sterilization validation, shelf-life validation, and non-clinical performance tests and the results support that the subject device is substantially equivalent to the predicate device.
7. Brief discussion of the nonclinical tests
The following comparison tests were performed on the subject device. The test results show that the subject device is substantially equivalent to the predicate device in effectiveness.
- Sterilization validation per ISO 17665-1 ●
- Shelf life validation per ASTM F1980-16 ●
- Biocompatibility tests per ISO 10993-3, 5, 6, 10, 11
- Performance test: Characterization (ISO 10993-18), packaging (ASTM F88/F88M, ASTM ● F1929), Shipping (ASTM D4169), Syringe Performance (ISO 7886-1, ISO 80369-7 ISO 80369-20), Osmolality, pH, Viscosity
8. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, The Standard Co., Ltd. concludes that the Blue Eye (TS-905) is substantially equivalent to predicate devices as described herein.