The SB Knife Jr2 is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47702, MD-47702L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current.

Device Description

SB Knife Jr2 under application (Hereinafter "the Subject Device" is a single-patient use EtOsterilized hand-held device that connects to an external high frequency (HF) generator and is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current. Varying generator power, cycle and duration results in a control of these surgical capabilities. The Subject Device is designed to connect with Olympus and ERBE connectors and uses the disposable or reusable Olympus or ERBE grounding plates and connecting cables intended for the generators.

The Subject Device is not life supporting or life sustaining. It is designed as a short-term limited contact device (less than 24 hours), has no software, and has been certified to comply with IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 60601-1-6 and IEC 60601 2-18 by ISO 17025 accredited laboratory.

The Subject Device consists of two models as follows:

MD-47702 Working Length: 1970 mm
MD-47702L Working Length: 2320 mm

AI/ML Overview

The provided text is a 510(k) summary for the SB Knife Jr2, a medical device. It does not contain the information typically found in a study proving a device meets specific acceptance criteria based on performance.

Specifically, the text describes:

The device and its intended use.
A comparison to a predicate device (SB Knife®).
Differences between the subject device and the predicate device, particularly regarding type, shape, structure, presence of a rotating operation portion, and materials.
Non-clinical testing performed (transportation, shelf-life, packaging, sterilization, electromagnetic compatibility, electrical safety, biocompatibility).
A statement that clinical testing was not performed.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving the device meets them from the provided text. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device through technological comparison and non-clinical performance, rather than providing a detailed study of the device's performance against pre-defined acceptance criteria for a new clinical claim or feature that requires such a study.

Summary

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March 26, 2025

Sb-Kawasumi Laboratories, Inc. % Fumiaki Kanai President MIC International 4-32-16 Ryogoku Sumida-ku. Tokyo 130-0026 Japan

Re: K241855

Trade/Device Name: SB Knife Jr2 (MD-47702 and MD-47702L) Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit And Accessories Regulatory Class: Class II Product Code: KNS Dated: February 20, 2025 Received: February 24, 2025

Dear Fumiaki Kanai:

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.

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"

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(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 OS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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.

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).

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Sincerely,

Shanil P. Haugen -S

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)

K241855

Device Name

SB Knife Jr2 (MD-47702 and MD-47702L)

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 – K241855

510(k) Summary

a. Owner/Company name, address SB-KAWASUMI LABORATORIES, INC. 3-15-4 Tonomachi Kawasaki-ku, Kawasaki-shi, Kanagawa, 210-8602, Japan Kenichi Inamura Manager, Regulatory Affairs Department Phone: +81-44-589-8070 Email: k-inamura@sb-kawasumi.jp

b. Contact/Application Correspondent

MIC International 4-32-16 Ryogoku, Sumida-ku, Tokyo, 130-0026, Japan Fumiaki Kanai President Phone: 011-81-3-6659-5482 Email: kanaif(@mici.co.jp

c. Date prepared

June 24, 2024

d. Name of device

Trade/Proprietary Name:	SB Knife Jr2 (MD-47702 and MD-47702L)
Common/Usual Name:	Endoscopic Electrosurgical Knife
Regulation Description:	Endoscopic electrosurgical unit and accessories
Regulation Number:	876.4300
Classification Panel:	Gastroenterology – Urology Devices
Product Code:	KNS
Device Class:	II

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e. Predicate devices

510(k):	K190621
Trade/Proprietary Name:	SB Knife®
Common/Usual Name:	Endoscopic Electrosurgical Knife
Regulation Description:	Endoscopic electrosurgical unit and accessories
Regulation Number:	876.4300
Classification Panel:	Gastroenterology – Urology Devices
Product Code:	KNS
Device Class:	II

f. Description of the device

The Subject Device consists of two models as follows:

Working Length: 1970 mm MD-47702

MD-47702L Working Length: 2320 mm

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g. Indications for Use

Indications for Use Statement

h. Technological Characteristics and Substantial Equivalence Discussion

Subject Device is designed to perform Endoscopic Submucosal Dissection (hereinafter ESD) of digestive tract tissues and endoscopic dissection of Zenker's diverticulum and to work with the Olympus ESG-100 (K073207), ESG-400 (K103032) and the ERBE VIO-300D (K083452), ICC-200 (K080715) monopolar high-frequency electrosurgical generators, connectors and patient grounding plates.

The intended use of the Subject Device is identical to that of the Predicate device (SB Knife® K190621).

The comparison table for technological characteristics between the two devices is shown below.

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Feature	Subject Device	SB Knife (Predicate device)(K190621)	Note
Indicationsfor use	The SB Knife Jr2 is a single-use sterileElectrosurgical Knife (Model Numbers:MD-47702, MD-47702L). This deviceis designed to be used with Olympusand ERBE Electrosurgical monopolarHF generators, connectors and patientgrounding plates to cut tissue includingZenker's diverticulum within thedigestive tract using high-frequencycurrent.	The SB Knife® is a single-usesterile Electrosurgical Knife(Model Numbers: MD-47703W,MD-47704, MD-47706 and MD-47703L). This device is designedto be used with Olympus andERBE Electrosurgical monopolarHF generators, connectors andpatient grounding plates to cuttissue including Zenker'sdiverticulum within the digestivetract using high-frequency current.	Identical
Type	Jr: MD-47702Jr (Long): MD-47702L	Short: MD-47704Standard: MD-47706Jr: MD-47703WJr (Long): MD-47703L	Similar (*1)
Shape andStructure	Overall shapeImage: Overall shape of subject device	Overall shapeImage: Overall shape of SB Knife	Similar (*1)
	Enlarged View of Distal EndJr / Jr (Long)Image: Enlarged view of distal end of Jr/Jr(Long) subject device	Enlarged View of Distal EndShort / StandardImage: Enlarged view of distal end of Short/Standard SB KnifeJr / Jr (Long)Image: Enlarged view of distal end of Jr/Jr(Long) SB Knife
Feature	Subject Device	SB Knife (Predicate device)(K190621)	Note
WorkingLength	Model:MD-47702:1970 mmMD-47702L:2320 mm	Model:MD-47704:1800 mmMD-47706:1800 mmMD-47703:1950 mmMD-47703L:2300 mm	Similar
OpeningWidth	Model:MD-47702:4.5 mmMD-47702L:4.5 mm	Model:MD-47704:6 mmMD-47706:7 mmMD-47703:4.5mmMD-47703L:4.5 mm	Identical
KnifeLength	Model:MD-47702:3.5 mmMD-47702L:3.5 mm	Model:MD-47704:6 mmMD-47706:7 mmMD-47703:3.5mmMD-47703L:3.5 mm	Identical
RotatingOperationPortion	Yes	No	Different (*2)
Materials	Forceps, Supporting Frame(Direct Body Contact)Base Material: Stainless SteelCoating Material:PolysiloxaneHandle, Slider:PolycarbonateRotating Operation Portion:Polycarbonate	Forceps, Supporting Frame(Direct Body Contact)Base Material: Stainless SteelCoating Material:PolytetrafluoroethyleneHandle, Slider:Polyphenylsulfone	Different (*3)(Materials otherthan left areidentical)

Table 1 Comparison table for technological characteristics

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Table 1 Comparison table for technological characteristics (continued)

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Discussion regarding differences

(*1) Type, Shape and Structure

The Subject Device has Jr / Jr (Long) type. SB Knife (Predicate device) has not only Jr and Jr (long) type, but also Short / Standard type.

Subject Device has protrusion to restrain from slipping of the grasped tissue. Performance testing confirmed equivalent performance.

(*2) Rotating Operation Portion

Subject Device has Rotating Operation Portion, but SB Knife (Predicate device) does not have it. Forceps can be rotated in any direction by Rotating Operation Portion.

The Rotating Operation Portion is added for the purpose of improving handling. The function of the rotation prevention part was confirmed under Performance testing.

(*3) Materials
Coating material at Forceps, Supporting Frame of the Subject Device is Polysiloxane, whereas coating material at Forceps, Supporting Frame of Predicate Device is Polytetrafluoroethylene.

This part directly contacts body.

In clinical use, equivalent or better insulation and incision performance has been reported with changes in coating material. (See References)

The safety of changing materials has been confirmed by biocompatibility testing.

References

1. Yuzuru Tamaru et al. Endoscopic submucosal dissection of colorectal tumors using a novel monopolar scissor-type knife "SB Knife Jr.2" Digestive Endoscopy 2019; 31: e105—e106
1. Akihiro Maruyama et al. Water pressure method for endoscopic submucosal dissection using SB Knife Jr2 Digestive Endoscopy 2023; 35: e129-e130
1. Yasutoshi Shiratori et al.Introducing the newly developed SB Knife Jr 2: enhancing creative endoscopic submucosal dissection Article published online: 2020-11-19

Material of Handle, Slider, Rotating Operation Portion of SB Knife Jr2 (Proposed device) is Polycarbonate, whereas material of Handle, Slider of SB Knife (Proposed device) is Polyphenylsulfone. This part does not directly contact body.

510(K) SUMMARY

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i. Non-Clinical Testing

The following non-clinical testing was conducted to demonstrate the safety and efficacy of the subject device and confirmed that the subject device performs as intended.

. Transportation and Shelf life tests in accordance with ASTM D4169-22, ASTM D4332-14, ASTM F1980-21.
. Packaging test in accordance with ASTM F2096-11, ASTM F88/F88M-15.
. Sterilization validation in accordance with ISO 11135 Second edition 2014-07-15, ISO 10993-7 Second edition 2008-10-15.
. Electromagnetic compatibility test in accordance with IEC 60601-2-2 Edition 6.0 2017-03, IEC 60601-1-2 Edition 4.0 2014-02, and Electrical safety tests in accordance with IEC 60601-1 Edition 3.2 2020-08, IEC 60601-1-6 Edition 3.2 2020-07, IEC 60601-2-2 Edition 6.0 2017-03, IEC 60601-2-18: Edition 3.0 2009-08.
. Biocompatibility testing was conducted in accordance with ISO 10993-1 Fifth edition 2018-08

j. Clinical Testing

Clinical testing was not performed for the Subject Device.

k. Conclusion

Based on the above consideration, we concluded that the Subject Device is substantially equivalent to the SB Knife (Predicate device).

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).