(266 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 function aimed at treating or alleviating a condition.
No
Explanation: The device is described as an "Electrosurgical Knife" designed to "cut tissue within the digestive tract using high-frequency current." Its purpose is surgical intervention, not diagnosis.
No
The device description explicitly states "has no software".
Based on the provided information, the SB Knife™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "cut tissue within the digestive tract using high-frequency current." This is a surgical procedure performed directly on a living patient.
- Device Description: The device is a "single-patient use EtO-sterilized hand-held device that connects to an external high frequency (HF) generator." It is used for surgical capabilities like "tissue ablation, resection, incision, cauterization, hemostasis, coagulation, vaporization and dissection of tissues." These are all actions performed on living tissue within the body.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
The SB Knife™ is clearly designed for surgical intervention within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The SB Knife™ is a single-use sterile Electrosurgical Knife (Model Numbers: 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 within the digestive tract using high-frequency current.
Product codes
KNS
Device Description
The SB Knife™ is a single-patient use EtO-sterilized 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 within the digestive tract using high-frequency current. Varying generator power, cycle and duration results in a control of these surgical capabilities. The SB Knives are designed to connect with Olympus and ERBE connectors and use the disposable or reusable Olympus or ERBE grounding plates and connecting cables intended for the generators.
The 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 and IEC 60601-2-2 and IEC 60601-2-18 by UL Japan
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
Surgeon's/Physician's
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
Comparative bench and animal tissue testing was performed for tissue ablation, resection, incision, cauterization, hemostasis, coagulation, vaporization and dissection of tissues using Olympus and ERBE monopolar HF generators. Testing resulted in equivalent performance to the predicate Olympus surgical knife.
Accelerated Aging and Actual Aging of Sterile Package Seal and product efficacy was completed and resulted in determination of a three-year product shelf life.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2016
Sumitomo Bakelite Co., Ltd. % Michael Beeltje Engineering Manager Vaupell Corp. 101 HP Almgren Dr. Agawam, MA 01001
Re: K152771
Trade/Device Name: SB Knife Jr Type, SB Knife Short Type, SB Knife Standard Type, SB Knife Jr Type - Long Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: KNS Dated: May 2, 2016 Received: May 6, 2016
Dear Michael Beeltje,
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. 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 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152771
Device Name
SB Knife Jr Type, SB Knife Short Type, SB Knife Standard Type, SB Knife Jr Type - Long
Indications for Use (Describe)
The SB Knife™ is a single-use sterile Electrosurgical Knife (Model Numbers: 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 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) |
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3
005_ 510(k) Summary for SB Knife™
1. Submission Sponsor
Sumitomo Bakelite Co., Ltd. Medical Products Business Division 5-8, Higashi-Shinagawa 2-chome, Shinagawa-ku, Tokyo 140-0002, JAPAN
2. Date Prepared
May 2, 2016
3. Device Name
| Trade/Proprietary Name: | SB Knife Jr Type, SB Knife Short Type, SB Knife Standard Type,
SB Knife Jr Type - Long |
|-----------------------------------|-------------------------------------------------------------------------------------------|
| Common/Usual Name: | Endoscopic Electrosurgical Knife |
| Classification Name: | Endoscopic electrosurgical unit and accessories |
| Classification Regulation: | 876.4300 |
| Classification Panel: | Gastroenterology – Urology Devices |
| Product Code: | KNS |
| Device Class: | II |
| FDA Establishment Registration #: | Not Available at time of Submission |
4. Predicate Devices
Olympus Medical Systems, Corp. IT Knife 2/ Hook Knife/ Flex Knife/ Triangle Tip Knife Electrosurgical Knife (K092309)
5. Device Description
The SB Knife™ is a single-patient use EtO-sterilized 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 within the digestive tract using high-frequency current. Varying generator power, cycle and duration results in a control of these surgical capabilities. The SB Knives are designed to connect with Olympus and ERBE connectors and use the disposable or reusable Olympus or ERBE grounding plates and connecting cables intended for the generators.
The 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 and IEC 60601-2-2 and IEC 60601-2-18 by UL Japan
4
6. Indications for Use/Intended Use
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 within the digestive tract using high-frequency current.
7. Technological Characteristics and Substantial Equivalence
The SB Knife™ consists of four configurations:
- 7.1 SB Knife™ Standard (MD-47706), which has grasping forceps and standard length blade;
- 7.2 SB Knife™ Short (MD-47704), which has grasping forceps and shorter length blade;
- 7.3 SB Knife™ Jr (MD 47703W), which has crossing forceps and standard effective length;
- 7.4 SB Knife™ Jr Long (MD 47703L), which has crossing forceps and longer effective length.
Choice of SB Knives' configurations is depend on Surgeon's/Physician's strategy for procedure, and length of endoscope used with, etc.
The SB Knife™ is substantially equivalent to the Olympus Systems, Inc. FlexKnife (K092309), having similar design, materials and configurations, intended use, indications for use. The SB Knife™ has demonstrated equivalency of use and results in side-by-side bench testing completed to defined test protocols on animal tissue, and been in use in Japan since 2009.
8. Non-Clinical Testing
The following testing has been performed to support substantial equivalence:
Comparative bench and animal tissue testing was performed for tissue ablation, resection, incision, cauterization, hemostasis, coagulation, vaporization and dissection of tissues using Olympus and ERBE monopolar HF generators. Testing resulted in equivalent performance to the predicate Olympus surgical knife.
Accelerated Aging and Actual Aging of Sterile Package Seal and product efficacy was completed and resulted in determination of a three-year product shelf life.
9. Clinical Testing
Clinical testing was not performed for this medical device.
10. Conclusion
The SB Knife™, as designed and manufactured, is substantially equivalent to the referenced predicate devices.