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.

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.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called "Blue Eye" (model TS-910), a submucosal injection agent used in gastrointestinal endoscopic procedures. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, "Blue Eye" (model TS-905) (K220434), manufactured by the same company.

The provided document describes physical and performance characteristics, but does not include any clinical study data or acceptance criteria relating to device performance for diagnostic accuracy or clinical effectiveness.

The document states that the substantial equivalence determination is based on an assessment of non-clinical performance data. Therefore, the information requested regarding acceptance criteria and a study proving device meets these criteria in a clinical context cannot be fully provided from the given text.

However, I can extract the relevant information from the provided text regarding the non-clinical performance studies conducted:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state specific numerical acceptance criteria for each non-clinical test, nor does it provide detailed quantitative performance results. It generally states that "The tests were performed on the subject device using the same method as the predicate device, and acceptance criteria," and that based on the results, the device is "as safe and effective and performs as well as the legally marketed predicate device."

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Syringe performance	Meets standards of ISO 11040-6, ISO 80369-7 and ISO 7886-1	Conforms to standards (implied by conclusion of equivalence)
Transportation Validation & Shipping	Meets standards of ASTM D 4169: 2022	Conforms to standards (implied by conclusion of equivalence)
Steam Sterilization Validation	Meets standards of ISO 17655-1, ISO 11737-1, ISO 11737-2	Conforms to standards (implied by conclusion of equivalence)
Packaging Validation	Meets standards of ASTM F 88/ F88M-23 and ASTM F 1929-15	Conforms to standards (implied by conclusion of equivalence)
Shelf-life test	Meets standards of ASTM F 1980-21	Conforms to standards (implied by conclusion of equivalence)

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for any of the non-clinical performance tests. There is no information about data provenance because these are non-clinical (laboratory/engineering) tests, not involving human subjects or real-world data collection in a clinical setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The studies described are non-clinical engineering and laboratory tests, not clinical studies requiring expert consensus for ground truth establishment.

4. Adjudication method for the test set

This question is not applicable for the same reason as above.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a submucosal injection agent, not an AI-powered diagnostic or assistive tool, so such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the specific parameters and requirements outlined in the referenced ISO and ASTM standards (e.g., sterilization effectiveness, packaging integrity, syringe function). The tests simply confirm whether the device meets these established engineering and safety standards.

8. The sample size for the training set

This is not applicable. There is no "training set" as this device is not a machine learning model.

9. How the ground truth for the training set was established

This is not applicable as there is no training set.

Summary

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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.

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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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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

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Indications for Use

Submission Number (if known)

K241591

Device Name

Blue Eye

Indications for Use (Describe)

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

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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
ClassificationName	Endoscope and accessories	Endoscope and accessories	Same
Device CommonName	Submucosal Injection Agent	Submucosal Injection Agent	Same
RegulationNumber	21 CFR 876.1500	21 CFR 876.1500	Same
Indication for Use	The Blue Eye is indicated for use ingastrointestinal endoscopicprocedures for submucosal lift ofpolyps, adenomas, early-stagecancers or other gastrointestinalmucosal lesions prior to excisionwith a snare or endoscopic device.	The Blue Eye is indicated for use ingastrointestinal endoscopicprocedures for submucosal lift ofpolyps, adenomas, early-stagecancers or other gastrointestinalmucosal lesions prior to excisionwith a snare or endoscopic device.	Same
Prescription orOver-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 lactatingwomen or children under 18 years ofage)	Regular Adults(exclusion for pregnant or lactatingwomen or children under 18 years ofage)	Same
Sterilizationmethod	Steam sterilization	Steam sterilization	Same

5. Summary of the technical characteristics between the new device and the predicate:

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	Subject Device	Predicate Device	Differences
Packaging	Provided in 10 mL single-useprefilled syringe packed inside aTyvek paper and tray. Ten (5) of thesealed trays are packed into a paperbox.Image: [Paper box]	Provided in 5 mL single-useprefilled syringe packed inside aTyvek paper and tray. Ten (10) ofthe sealed trays are packed into acanister.Image: [Canister]	Different.The secondarypackagingmaterial andcapacity aredifferent.
Composition	Each steam sterilized syringecontains 10mL of lifting agent withthe following ingredients:• Water• Hydroxyethyl Cellulose• Glycerin• Methylene Blue• Benzyl Alcohol• Sodium Phosphate• Potassium phosphate	Each steam sterilized syringeContains 5mL of lifting agent withthe following ingredients:• Water• Hydroxyethyl Cellulose• Glycerin• Methylene Blue• Benzyl Alcohol• Sodium Phosphate• Potassium phosphate	Sameconcentration;however,Capacity oflifting agentprovideddiffers.

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.

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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.

Regulation Number and Section

§ 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.