(272 days)
No
The device description explicitly states that the device "has no software". AI/ML capabilities are typically implemented through software.
Yes
The device is designed to "cut tissue" within the digestive tract, which is a therapeutic intervention.
No
Explanation: The device is an electrosurgical knife designed to cut tissue, not to diagnose conditions. Its intended use is therapeutic, involving surgical capabilities.
No
The device description explicitly states "has no software".
Based on the provided text, the SB Knife Jr2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current." This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "single-patient use EtO-sterilized hand-held device that connects to an external high frequency (HF) generator." This is consistent with a surgical instrument.
- Lack of Diagnostic Function: The device's function is to cut tissue, not to diagnose a condition or provide information about a patient's health status based on analysis of a sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The SB Knife Jr2 does not perform this type of function.
N/A
Intended Use / Indications for Use
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.
Product codes
KNS
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
digestive tract
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
Non-Clinical Testing:
- 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
Key Results: All testing confirmed that the subject device performs as intended. Performance testing confirmed equivalent performance for "Type, Shape and Structure" differences between the subject device and predicate. The function of the rotation prevention part was confirmed under Performance testing. The safety of changing materials has been confirmed by biocompatibility testing.
Clinical testing was not performed for the Subject Device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K073207, K103032, K083452, K080715
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below that.
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"
1
(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).
2
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
3
Indications for Use
Submission Number (if known)
Device Name
SB Knife Jr2 (MD-47702 and MD-47702L)
Indications for Use (Describe)
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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 |
5
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
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:
Working Length: 1970 mm MD-47702
MD-47702L Working Length: 2320 mm
6
g. Indications for Use
Indications for Use Statement
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.
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.
7
| Feature | Subject Device | SB Knife (Predicate device)
(K190621) | Note |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Indications
for use | 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. | The SB Knife® is a single-use
sterile Electrosurgical Knife
(Model Numbers: MD-47703W,
MD-47704, MD-47706 and MD-
47703L). 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. | Identical |
| Type | Jr: MD-47702
Jr (Long): MD-47702L | Short: MD-47704
Standard: MD-47706
Jr: MD-47703W
Jr (Long): MD-47703L | Similar (*1) |
| Shape and
Structure | Overall shape
Image: Overall shape of subject device | Overall shape
Image: Overall shape of SB Knife | Similar (*1) |
| | Enlarged View of Distal End
Jr / Jr (Long)
Image: Enlarged view of distal end of Jr/Jr(Long) subject device | Enlarged View of Distal End
Short / Standard
Image: Enlarged view of distal end of Short/Standard SB Knife
Jr / Jr (Long)
Image: Enlarged view of distal end of Jr/Jr(Long) SB Knife | |
| Feature | Subject Device | SB Knife (Predicate device)
(K190621) | Note |
| Working
Length | Model:
MD-47702:
1970 mm
MD-47702L:
2320 mm | Model:
MD-47704:
1800 mm
MD-47706:
1800 mm
MD-47703:
1950 mm
MD-47703L:
2300 mm | Similar |
| Opening
Width | Model:
MD-47702:
4.5 mm
MD-47702L:
4.5 mm | Model:
MD-47704:
6 mm
MD-47706:
7 mm
MD-47703:
4.5mm
MD-47703L:
4.5 mm | Identical |
| Knife
Length | Model:
MD-47702:
3.5 mm
MD-47702L:
3.5 mm | Model:
MD-47704:
6 mm
MD-47706:
7 mm
MD-47703:
3.5mm
MD-47703L:
3.5 mm | Identical |
| Rotating
Operation
Portion | Yes | No | Different (*2) |
| Materials | Forceps, Supporting Frame
(Direct Body Contact)
Base Material: Stainless Steel
Coating Material:
Polysiloxane
Handle, Slider:
Polycarbonate
Rotating Operation Portion:
Polycarbonate | Forceps, Supporting Frame
(Direct Body Contact)
Base Material: Stainless Steel
Coating Material:
Polytetrafluoroethylene
Handle, Slider:
Polyphenylsulfone | Different (*3)
(Materials other
than left are
identical) |
Table 1 Comparison table for technological characteristics
8
Table 1 Comparison table for technological characteristics (continued)
9
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
-
- 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
-
- Akihiro Maruyama et al. Water pressure method for endoscopic submucosal dissection using SB Knife Jr2 Digestive Endoscopy 2023; 35: e129-e130
-
- 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
10
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).