What is the regulatory pathway for Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645?

Single Use Electrosurgical knife KD-655 (K171158).

Who can help prepare an FDA 510(k) submission like Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645

Q: Who is the manufacturer of Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645?

Olympus Medical Systems Corp. filed the 510(k) submission for Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 (K182408).

Q: What is the FDA product code for Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645?

KNS. It is classified under 21 CFR 876.4300 as a Class 2 device in the Gastroenterology, Urology panel.

K182408 · Olympus Medical Systems Corp. · KNS · May 15, 2019 · Gastroenterology, Urology

Device Facts

Record ID	K182408
Device Name	Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
Applicant	Olympus Medical Systems Corp.
Product Code	KNS · Gastroenterology, Urology
Decision Date	May 15, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4300
Device Class	Class 2
Attributes	Therapeutic

Intended Use

These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.

Device Story

Single-use electrosurgical knives (KD-625, KD-645) used in gastrointestinal endoscopy. Device consists of handle, insertion portion, and distal cutting knife. Operated by physician in hospital/healthcare facility. Connected to electrosurgical generator for tissue cutting and flushing pump for saline injection. Saline delivered through internal sheath channel to submucosa to lift lesions. Slider mechanism on handle extends/retracts cutting knife. Enables precise tissue dissection under direct visualization. Benefits include facilitated endoscopic mucosal resection (EMR) or similar procedures.

Clinical Evidence

Bench testing only. Performance assessed via evaluation of tissue cutting, mucosal lifting, histopathological thermal damage analysis, and perforation safety during saline feeding. Biocompatibility (ISO 10993-1), electrical safety (AAMI/ANSI ES60601-1), and EMC (IEC 60601-1-2) testing performed.

Technological Characteristics

Materials: Stainless steel, ceramics, ABS, PTFE, silicone rubber. Energy: High-frequency current. Form factor: Handle with insertion portion and distal cutting knife. Connectivity: Connects to electrosurgical unit and flushing pump. Sterilization: ETO. Standards: ASTM F1980-16 (aging), ISO 10993-1 (biocompatibility), AAMI/ANSI ES60601-1, IEC 60601-2-18, IEC 60601-1-2.

Indications for Use

Indicated for patients requiring endoscopic resection of mucosal lesions within the digestive tract. Used for tissue cutting via high-frequency current and submucosal saline injection to lift lesions under direct endoscopic visualization.

Regulatory Classification

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.

Predicate Devices

Single Use Electrosurgical knife KD-655 (K171158)

Reference Devices

KD-620LR (Single Use Electrosurgical Knife Series) (K092309)
KD-640L (Single Use Electrosurgical Knife Series) (K092309)

Related Devices

K250351 — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) · Olympus Medical Systems Corporation · Oct 10, 2025
K171158 — Single Use Electrosurgical knife · Olympus Medical Systems Corp. · Nov 17, 2017
K220053 — Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI · Fujifilm Corporation · Feb 4, 2022
K193601 — Single Use Electrosurgical Knife · Micro-Tech (Nanjing) Co., Ltd. · Jul 24, 2020
K212999 — Multi-Functional Electrosurgical Knife · Anrei Medical (Hangzhou) Co., Ltd. · Mar 21, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. May 15, 2019 Olympus Medical Systems Corp. Daphney Germain-Kolawole Senior Proiect Manager, Regulatory Affairs Olympus Surgical Technologies America 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 Re: K182408 > Trade/Device Name: Single Use Electrosurgical Knife KD-625, Single Use Electrosurgical Knife KD-645 Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: KNS Dated: March 25, 2019 Received: March 26, 2019 Dear Daphney Germain-Kolawole: This letter corrects our substantially equivalent letter of May 15, 2019. 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 {1}------------------------------------------------ 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Shani Haugen Acting Assistant Division 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) K182408 #### Device Name Single Use Electrosurgical Knife KD-625, Single Use Electrosurgical Knife KD-645 #### Indications for Use (Describe) KD-625 These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. #### KD-645 This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using highfrequency current within the digestive tract. This instrument is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. A thin, horizontal, yellow line is located directly beneath the word. The word and line are centered in the image. Traditional 510(k) Notification Single Use Electrosurgical Knife KD-625LR/QR/UR, KD-645L, K182408 Date Prepared: March 25, 2019 # 510(k) Summary # 5.1 GENERAL INFORMATION | ■ 510(k) Submitter: | OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ■ Contact Person: | Daphney Germain-Kolawole Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5691 Fax: 484-896-7128 Email: daphney.germain-kolawole@olympus.com | | ■ Manufacturing site: | 2-248-1 Okkonoki, Kuroishi-shi, Aomori 036-0357, Japan | ## 5.2 DEVICE IDENTIFICATION | ■ Device Name | Single Use Electrosurgical knife KD-625 Single Use Electrosurgical knife KD-645 | |---------------------|------------------------------------------------------------------------------------| | ■ Common Name | Single Use Electrosurgical knife | | ■ Regulation Number | 876.4300 | | ■ Regulation Name | Endoscopic electrosurgical unit and accessories | | ■ Regulatory Class | II | | ■ Product Code | KNS | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. A thin, horizontal, yellow line is located directly below the word. The logo is simple and clean, with a focus on the brand name. KD-625LR/QR/UR, KD-645L, K182408 K182408 #### 5.3 PREDICATE DEVICE #### 1) Predicate device | Device name | 510(k) Submitter | 510(k) No. | |--------------------------------------------|----------------------------------|------------| | Single Use Electrosurgical knife KD-655 | OLYMPUS MEDICAL SYSTEMS CORP. | K171158 | #### 2) Reference device | Device name | 510(k) Submitter | 510(k) No. | |-------------------------------------------------------|----------------------------------|------------| | KD-620LR (Single Use Electrosurgical Knife Series) | OLYMPUS MEDICAL SYSTEMS CORP. | K092309 | #### Table 12-2 Reference device on KD-625 | Device name | 510(k) Submitter | 510(k) No. | |------------------------------------------------------|----------------------------------|------------| | KD-640L (Single Use Electrosurgical Knife Series) | OLYMPUS MEDICAL SYSTEMS CORP. | K092309 | ## 5.4 DEVICE DESCRIPTION #### 1) General Description of the subject device These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. This system consists of the electrosurgical knives (subject devices), flushing pump, and water tubes (accessories). The subject devices are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. They will be marketed as sterilized (ETO) devices for single use. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. A thin, horizontal, yellow line is located directly below the word. The logo is simple and clean, with a focus on the company name. # 2) Principle of Operation The subject devices are used in combination with an endoscope and electrosurgical generator to resect a lesion in the gastrointestinal tract using high frequency current. The KD-625 and KD-645 are composed of a handle and insertion portion. The insertion portion is inserted into the gastrointestinal organ via an endoscope. The subject devices are connected to an electrosurgical unit through the electrode on the handle and the A cord. The electrode is electrically connected with the cutting knife through a wire, which allows cutting using electricity supplied from the electrosurgical unit. Pushing the slider of the handle allows the insertion portion to follow the slider movement and allows the cutting knife at the distal end to extend. Holding the extended cutting knife against the target tissue enables dissection of the tissue. In addition, the subject devices can supply fluid into the submucosa in combination with a flushing device. Saline solution is supplied, via the channel inside the sheath, from the nozzle at the distal end through a water tube or flushing device connected to the accessory port on the handle. ## 5.5 INDICATIONS FOR USE ## 5.5.1 INDICATIONS FOR USE for KD-625 These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. ## 5.5.2 INDICATIONS FOR USE for KD-645 This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. This instrument is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. A thin, horizontal, yellow line is located directly underneath the word. The font is sans-serif and the letters are evenly spaced. The background is white. # 5.6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE The Single Use Electrosurgical Knife KD-625 and KD-645 have the same technological characteristics and design as the predicate device except for the following new features: - Material and shape of the cutting knife - Shape of the water outlet Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device. A side-by-side comparison of the subject devices and the predicate device is provided below. | Item | <Subject Device> KD-625 | <Subject Device> KD-645 | <Predicate Device> KD-655 (#171158) | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. | This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. This instrument is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. | These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract and using high-frequency current. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. | | Common name | Single Use Electrosurgical knife | Single Use Electrosurgical knife | Single Use Electrosurgical knife | | Regulation number | 876.4300 | 876.4300 | 876.4300 | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly rounded and have a glossy appearance. Below the word is a thin, horizontal stripe in a gradient of yellow and orange. | Item | <Subject Device> KD-625 | <Subject Device> KD-645 | <Predicate Device> KD-655 (#171158) | |----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation name | Endoscopic electrosurgical unit and accessories | Endoscopic electrosurgical unit and accessories | Endoscopic electrosurgical unit and accessories | | Regulatory class | II | II | II | | Classification panel | Gastroenterology and urology | Gastroenterology and urology | Gastroenterology and urology | | Product code | KNS | KNS | KNS | | Environment of use | Healthcare facility/hospital | Healthcare facility/hospital | Healthcare facility/hospital | | Single/repeat use | Single-use | Single-use | Single-use | | Sterile/non-sterile | Marketed as a sterilized device | Marketed as a sterilized device | Marketed as a sterilized device | | Sterilization method | ETO sterile | ETO sterile | ETO sterile | | Energy source | High-frequency current | High-frequency current | High-frequency current | | Material composition of main patient-contact parts | Stainless steel Ceramics ABS PTFE Silicone Rubber | Stainless steel Ceramics ABS PTFE Silicone Rubber | Stainless steel Ceramics ABS PTFE Silicone Rubber | | Duration and type of contact | Surface-contacting device in contact with mucosal membranes. The contact duration is limited exposure (i.e. contact is up to 24 hours). | Surface-contacting device in contact with mucosal membranes. The contact duration is limited exposure (i.e. contact is up to 24 hours). | Surface-contacting device in contact with mucosal membranes. The contact duration is limited exposure (i.e. contact is up to 24 hours). | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. A thin, horizontal, yellow line is located directly underneath the word. The font is sans-serif and the letters are closely spaced together. ## 5.7 PERFORMANCE DATA The following performance data are being provided in support of the substantial equivalence determination. #### 1) Sterilization/Shelf-life testing Sterilization/shelf-life testing for the Single Use Electrosurgical Knife KD-625 and KD-645 were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Accelerated aging test for the subject devices were conducted in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. The real-time aging test for three years will be performed to demonstrate longer stability and support the results of the accelerated aging test. #### 2) Biocompatibility testing Biocompatibility testing for the subject devices were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests: - Cytotoxicity Study Using the Colony Assay - - Intracutaneous Study in Rabbits । - Guinea Pig Maximization Sensitization Test i - Systemic Toxicity Study in Mice i - USP Rabbit Pyrogen Study, Material Mediated #### 3) Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted on the subject devices. The system complies with the AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2 Edition 3: 2007 standards for EMC. #### 4) Performance testing - Bench Bench testing for the subject devices as listed below was conducted to ensure that the subject device performs as intended and meet design specifications. Device performance was assessed according to the design requirements and included process verification, design verification, and design validation. - Evaluation Test for Performance to Cut Digestive Tract Mucosa । - Evaluation Test for Lifting of Digestive Tract Mucosa । - Histopathological Evaluation Test of Thermal Damage on Digestive Tract i - Evaluation Test for safety against perforation by saline feeding function i {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. A thin, horizontal, yellow line is located directly below the word. The background is white. The logo is simple and clean. Traditional 510(k) Notification Single Use Electrosurgical Knife KD-625LR/QR/UR, KD-645L, K182408 # 5) Risk analysis Risk analysis for the subject devices were conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment. # 5.8 CONCLUSIONS Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the subject devices raise no new issue of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, efficacy and performance.