(30 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterility of an injection agent, with no mention of AI or ML.
No.
The device facilitates the excision of lesions by lifting them, but it does not directly treat a disease or condition itself.
No
The device, "Blue Eye," is a submucosal injection agent used for lifting lesions prior to excision, not for diagnosing them. It is an aid in a therapeutic procedure.
No
The device description clearly states it is a solution provided in a prefilled syringe, which is a physical medical device, not software.
Based on the provided information, the Blue Eye device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a procedure performed on the patient (submucosal lift during endoscopy) to facilitate the removal of tissue. This is a therapeutic/procedural use, not a diagnostic test performed on a sample from the patient.
- Device Description: The device is a solution injected into the body. IVDs are typically reagents, instruments, or systems used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis.
- No mention of analyzing samples: The description focuses on the physical action of lifting tissue, not on analyzing any biological sample.
Therefore, the Blue Eye device falls under the category of 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 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.
Product codes
PLL
Device Description
Blue Eye, 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 gastrointestinal 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
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
The determination of substantial equivalence is based on an assessment of non-clinical performance data. To verify that the device design modifications meet the functional and performance requirements, the Blue Eye (TS-910) underwent the following performance testing. The tests were performed on the subject device using the same method as the predicate device, and acceptance criteria.
- Syringe performance / ISO 11040-6, ISO 80369-7 and ISO 7886-1 .
- Transportation Validation and Shipping test / ASTM D 4169: 2022 ●
- . Steam Sterilization Validation in heat distribution test, heat penetration test, BI test, Bioburden test and sterility test / ISO 17655-1, ISO 11737-1 and ISO 11737-2
- . Packaging Validation / ASTM F 88/ F88M-23 and ASTM F 1929-15
- . Shelf-life test ASTM F 1980-21
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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July 3, 2024
The Standard Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine, California 92612
Re: K241591
Trade/Device Name: Blue Eye Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: PLL Dated: June 3, 2024 Received: June 3, 2024
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 (the 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 available 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.
1
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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3
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,
Sivakami Venkatachalam -S
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
3
Indications for Use
Submission Number (if known)
Device Name
Blue Eye
Indications for Use (Describe)
The Blue Eye 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.
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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510(k) Summary
Date: June 1, 2024
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR 807.92.
1. Submitter:
| Name | The Standard Co., Ltd. |
|---|---|
| Address | 120, Gunpocheomdansaneop 2-ro, Gunpo-si, |
| Gyeonggido, 15880, Republic of Korea | |
| Phone | +82 2 838-5533 |
| Fax | +82 2 838-5523 |
| Contact | Mr. Sang-wook, Yang / QMR |
| Date prepared | May 10, 2024 |
2. Device Information:
- . Trade name: Blue Eye
- Common name: Submucosal injection agent ●
- Classification name: Endoscope and Accessories (21CFR 876.1500, Product code: PLL) .
3. Predicate Device:
- Blue Eye (K220434) manufactured by The Standard Co., Ltd. .
Blue Eye (TS-910) [subject device] is substantially equivalent in terms of its intended use to the claimed predicate device, the 5mL Blue Eye (TS-905) (K220434) 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.
4. Device Description:
Blue Eye, 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
5
endoscopic device in gastrointestinal 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.
Blue Eye 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.
| Subject Device | Predicate Device | Differences | |
|---|---|---|---|
| Manufacturer | The Standard Co., Ltd. | The Standard Co., Ltd. | - |
| Device Name | Blue Eye (TS-910) | Blue Eye (TS-905) | - |
| 510(k) numbear | - | K220434 | - |
| Product Code | PLL | PLL | Same |
| Device Class | Class II | Class II | Same |
| 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 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 Blue Eye 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 | ||
| Sterilization | |||
| method | Steam sterilization | Steam sterilization | Same |
5. Summary of the technical characteristics between the new device and the predicate:
6
| Subject Device | Predicate Device | Differences | |
|---|---|---|---|
| Packaging | Provided in 10 mL single-use | ||
| prefilled syringe packed inside a | |||
| Tyvek paper and tray. Ten (5) of the | |||
| sealed trays are packed into a paper | |||
| box. |
Image: [Paper box] | Provided in 5 mL single-use
prefilled syringe packed inside a
Tyvek paper and tray. Ten (10) of
the sealed trays are packed into a
canister.
Image: [Canister] | Different.
The secondary
packaging
material and
capacity are
different. |
| 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,
Capacity of
lifting agent
provided
differs. |
Blue Eye (TS-910) described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device.
The subject device and the unmodified device are substantially equivalent, having the same indications for use and raw materials including chemical compositions.
The modifications are in volume and secondary packaging material to meet customer needs.
Based on the test results submitted in this 510K, we conclude that the subject device is substantially equivalent to the predicate device.
7
6. Summary of Performance data
The determination of substantial equivalence is based on an assessment of non-clinical performance data. To verify that the device design modifications meet the functional and performance requirements, the Blue Eye (TS-910) underwent the following performance testing.
The tests were performed on the subject device using the same method as the predicate device, and acceptance criteria.
- Syringe performance / ISO 11040-6, ISO 80369-7 and ISO 7886-1 .
- Transportation Validation and Shipping test / ASTM D 4169: 2022 ●
- . Steam Sterilization Validation in heat distribution test, heat penetration test, BI test, Bioburden test and sterility test / ISO 17655-1, ISO 11737-1 and ISO 11737-2
- . Packaging Validation / ASTM F 88/ F88M-23 and ASTM F 1929-15
- . Shelf-life test ASTM F 1980-21
7. Conclusions:
Based on the results of the non-clinical performance testing conducted on the subject device, it has been concluded that the proposed Blue Eye (TS-910) is as safe and effective and performs as well as the legally marketed predicate device(K220434). The same indications for use, intended use, technological characteristics, and performance characteristics for the proposed Blue Eye (TS-910) 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, Blue Eye (TS-910) is substantially equivalent to the predicate device.