(288 days)
Not Found
No
The summary describes a standard electrosurgical knife with injection capabilities and does not mention any AI or ML components or functionalities.
Yes
The device is used to cut tissue and deliver agents within the gastrointestinal tract, which are medical interventions directly aimed at treating a condition or facilitating a procedure to improve patient health.
No
The device is an electrosurgical knife designed to cut tissue and deliver fluids, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is an "electrosurgical knife" and describes its physical components and functions related to delivering high-frequency energy and saline, indicating it is a hardware device.
Based on the provided information, the ORISE™ ProKnife is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The ORISE™ ProKnife is used within the gastrointestinal tract to cut tissue and deliver substances directly to the tissue. It does not analyze samples taken from the body.
- The intended use and device description clearly state its function is for surgical procedures within the body. It's an electrosurgical knife for cutting tissue and injecting fluids during endoscopic procedures.
- There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the ORISE™ ProKnife is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ORISE™ ProKnife has been designed to be used with endoscopes and electrosurgical units to cut tissue within the gastrointestinal tract using high-frequency current. The electrosurgical knife also has the capability of delivering saline/ submucosal lifting agent into submucosal tissue layers under direct visualization through an endoscope.
Product codes
KNS
Device Description
The ORISE™ ProKnife is an electrosurgical knife intended for use in Endoluminal surgery procedures, including but not limited to Endoscopic Submucosal Dissection (ESD). The ProKnife can deliver high frequency monopolar energy to facilitate incision of tissue. The ORISE™ ProKnife also has the capability of delivering saline/submucosal lifting agent through the electrode to maintain a submucosal fluid cushion without the need for a device exchange.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests, which included bench-top and ex-vivo testing, electrical, and biocompatibility were conducted to demonstrate the performance and usability of the ORISE™ ProKnife in endoscopic procedures
Bench Testing:
Functional and performance tests were performed on the proposed ORISE™ ProKnife to satisfy all design verification requirements. The ORISE™ ProKnife passed all tests.
The following performance tests were performed to satisfy design verification requirements.
- Knife operation with the compatible endoscopes
- o Dimension of each part of the knife
- . General durability
- . Injection capability
All results were passing and demonstrate that the proposed device meets its pre-defined performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
December 3, 2020
Boston Scientific Corporation Jennifer Edouard Senior Regulatory Affairs Specialist 300 Boston Scientific Way Marlborough, Massachusetts 01752
Re: K200404
Trade/Device Name: ORISE ProKnife Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit And Accessories Regulatory Class: Class II Product Code: KNS Dated: October 9, 2020 Received: October 13, 2020
Dear Jennifer Edouard:
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. 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 located 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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.
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
2
Indications for Use
510(k) Number (if known) K200404
Device Name ORISE™ ProKnife
Indications for Use (Describe)
The ORISE™ ProKnife has been designed to be used with endoscopes and electrosurgical units to cut tissue within the gastrointestinal tract using high-frequency current. The electrosurgical knife also has the capability of delivering saline/ submucosal lifting agent into submucosal tissue layers under direct visualization through an endoscope.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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."
3
K200404 Page 1 of 3
510(k) Summary for ORISE™ ProKnife
1. Submitter
Boston Scientific Corporation Endoscopy Division 200 Boston Scientific Way Marlborough, MA 01752
| Contact: | Jennifer Edouard
Sr. Regulatory Affairs Specialist
Phone: (508) 683-6134
E-mail: jennifer.edouard@bsci.com |
| ---------- | --------------------------------------------------------------------------------------------------------------------- |
|---|
| Secondary Contact: | Karin Desjardins |
|---|---|
| Sr. Manager Regulatory Affairs | |
| Phone: (508) 683-5748 | |
| Email: karin.desjardins@bsci.com |
Date Prepared: October 9, 2020
2. Device
| Trade Name: | ORISE™ ProKnife |
|---|---|
| Classification Name: | Endoscopic Electrosurgical Unit and Accessories |
| Product Code: | KNS |
| Device Class and Panel: | Class II, Gastroenterology/Urology |
| Classification Regulation: | 21 CFR 876.4300 |
3. Predicate Devices
| Trade Name: | Single Use Electrosurgical Knife (Dual Knife J) |
|---|---|
| Manufacturer: | Olympus Medical Systems Corp. |
| Clearance Number: | K171158 |
| Classification Name: | Endoscopic Electrosurgical Unit and Accessories |
| Product Code: | KNS |
| Device Class and Panel: | Class II, Gastroenterology/Urology |
| Classification Regulation: | 21 CFR 876.4300 |
| Trade Name: | ERBE Hybrid Knife |
|---|---|
| Manufacturer: | ERBE USA Incorporated |
| Clearance Number: | K083608 |
| Classification Name: | Jet Lavage |
| Product Code: | FQH – Lavage, Jet |
| GEI - Electrosurgical, Cutting & Coagulation & Accessories | |
| Device Class and Panel: | Class II, General & Plastic Surgery |
| Classification Regulation: | 21 CFR 880.5475 |
4
4. Proposed Device Description
The ORISE™ ProKnife is an electrosurgical knife intended for use in Endoluminal surgery procedures, including but not limited to Endoscopic Submucosal Dissection (ESD). The ProKnife can deliver high frequency monopolar energy to facilitate incision of tissue. The ORISE™ ProKnife also has the capability of delivering saline/submucosal lifting agent through the electrode to maintain a submucosal fluid cushion without the need for a device exchange.
5. Indications for Use
The ORISE™ ProKnife has been designed to be used with endoscopes and electrosurgical units to cut tissue within the gastrointestinal tract using high-frequency current. The electrosurgical knife also has the capability of delivering saline/submucosal lifting agent into submucosal tissue layers under direct visualization through an endoscope.
6. Technological Characteristics
The ORISE ProKnife, the Olympus Single Use Electrosurgical Knife, and the ERBE Hybrid Knife are all sterile, single use devices and are identical with regard to lifting agent delivery pathway, electrode length, working length, endoscope compatibility, HF Generator Compatibility, Generator Operating Frequency Range and Voltage Capability and Maximum Power.
The proposed and predicate devices share similar characteristics, including principle of operation, tip outer diameter, shaft outer diameter, generator connection. Voltage Capability and Minimum Power, and materials.
7. Substantial Equivalence
A direct comparison of key characteristics demonstrates that the ORISE™ ProKnife is substantially equivalent to the predicate devices in terms of intended use, technological characteristics, and performance characteristics.
8. Performance Data
Performance tests, which included bench-top and ex-vivo testing, electrical, and biocompatibility were conducted to demonstrate the performance and usability of the ORISE™ ProKnife in endoscopic procedures
Bench Testing:
Functional and performance tests were performed on the proposed ORISE™ ProKnife to satisfy all design verification requirements. The ORISE™ ProKnife passed all tests.
The following performance tests were performed to satisfy design verification requirements.
- Knife operation with the compatible endoscopes
- o Dimension of each part of the knife
5
- . General durability
- . Injection capability
All results were passing and demonstrate that the proposed device meets its pre-defined performance specifications.
Electrical Testing:
Electrical safety was evaluated in accordance with the following standards:
- IEC 60601-1: 2005 + A1: 2012, Third Edition Medical Electrical Equipment o General Requirements for Basic Safety and Essential Performance
- . IEC 60601-2-2: 2017, Edition 6.0 – Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- IEC 60601-2-18:2009, Ed. 3.0 Medical electrical equipment Part 2: Particular . requirements for the basic safety and essential performance of endoscopic equipment
- IEC 60601-1-6:2010, AMD1:2013 Medical electrical equipment Part 1-6 ● General requirements for safety - Collateral Standard: Usability
Biocompatibility Testing:
Biocompatibility of the ORISE™ ProKnife was evaluated in accordance with ISO 10993-1: 2018 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process and FDA Guidance Use of International Standard ISO 10993-1 (June 16, 2016) for devices categorized as limited (