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.

Device Description

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.

AI/ML Overview

This document describes the premarket notification for the Olympus Single Use Electrosurgical Knives KD-625 and KD-645. It does not contain information about an AI/ML device. Therefore, I cannot provide details on acceptance criteria and study designs related to an AI/ML device from this document.

However, I can extract the general performance data and acceptance criteria mentioned for these electrosurgical knives:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML Device):

Performance Test Category	Acceptance Criteria / Standard	Reported Device Performance
Sterilization/Shelf-life	FDA's Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" & ASTM F1980-16 for accelerated aging.	Sterilization/shelf-life testing was conducted in accordance with the specified FDA guidance and ASTM F1980-16. Accelerated aging tests were completed. Real-time aging tests for three years will be performed to further support stability.
Biocompatibility	FDA's Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'."	Biocompatibility testing included: Cytotoxicity Study (Colony Assay), Intracutaneous Study (Rabbits), Guinea Pig Maximization Sensitization Test, Systemic Toxicity Study (Mice), and USP Rabbit Pyrogen Study (Material Mediated). These tests were conducted in accordance with ISO 10993-1.
Electrical Safety & EMC	AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Safety) & IEC 60601-2-18:2009 (Safety) & IEC 60601-1-2 Edition 3: 2007 (EMC).	The device system complies with the specified AAMI/ANSI and IEC standards for electrical safety and electromagnetic compatibility.
Performance Testing (Bench)	Established in-house acceptance criteria based on design requirements and risk analysis (ISO 14971:2007).	Bench testing was conducted to ensure the device performs as intended and meets design specifications. This included: 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, and Evaluation Test for safety against perforation by saline feeding function. All tests assessed according to design requirements.
Risk Analysis	Established in-house acceptance criteria based on ISO 14971:2007.	Risk analysis was conducted, and the design verification tests and acceptance criteria were identified and performed as a result of this assessment.

Since this document is for a traditional electrosurgical knife and not an AI/ML device, the following points are not applicable or cannot be extracted from the provided text:

Sample size used for the test set and the data provenance: Not applicable for this type of device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML models typically involves expert annotation of data.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for an electrosurgical tool, not an interpretive diagnostic aid.
Standalone (algorithm only without human-in-the loop performance) performance: Not applicable.
Type of ground truth used: Not applicable for an AI/ML device; for this device, ground truth established by physical and functional testing.
Sample size for the training set: Not applicable (no AI/ML model for training).
How the ground truth for the training set was established: Not applicable.

Summary

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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

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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

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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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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, Japan192-8507
■ Contact Person:	Daphney Germain-KolawoleOlympus Corporation of the Americas3500 Corporate Parkway PO Box 610Center Valley, PA 18034-0610, USAPhone: 484-896-5691Fax: 484-896-7128Email: 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-625Single 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

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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 knifeKD-655	OLYMPUS MEDICALSYSTEMS CORP.	K171158

2) Reference device

Device name	510(k) Submitter	510(k) No.
KD-620LR (Single UseElectrosurgical Knife Series)	OLYMPUS MEDICALSYSTEMS CORP.	K092309

Table 12-2 Reference device on KD-625

Device name	510(k) Submitter	510(k) No.
KD-640L (Single Use ElectrosurgicalKnife Series)	OLYMPUS MEDICALSYSTEMS CORP.	K092309

5.4 DEVICE DESCRIPTION

1) General Description of the subject device

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.

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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

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.

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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	KD-625	KD-645	KD-655 (#171158)
Indications for use	These instrumentshave been designedto be used withOlympusendoscopes andelectrosurgical unitsto cut tissue usinghigh-frequencycurrent within thedigestive tract.These instrumentsare indicated for theinduction of sterilenormal saline intothe submucosa to liftmucosal lesionsusing directvisualizationthrough anendoscope.	This instrumenthas been designedto be used withOlympusendoscopes andelectrosurgical unitsto cut tissue usinghigh-frequencycurrent within thedigestive tract.This instrument isindicated for theinduction of sterilenormal saline intothe submucosa tolift mucosal lesionsusing directvisualizationthrough anendoscope.	These instrumentshave been designedto be used withOlympusendoscopes andelectrosurgical unitsto cut tissue withinthe digestive tractand usinghigh-frequencycurrent. Theseinstruments areindicated for theinduction of sterilenormal saline intothe submucosa tolift mucosal lesionsusing directvisualizationthrough anendoscope.
Common name	Single UseElectrosurgicalknife	Single UseElectrosurgicalknife	Single UseElectrosurgicalknife
Regulationnumber	876.4300	876.4300	876.4300

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Item	KD-625	KD-645	KD-655 (#171158)
Regulation name	Endoscopicelectrosurgical unitand accessories	Endoscopicelectrosurgical unitand accessories	Endoscopicelectrosurgical unitand accessories
Regulatory class	II	II	II
Classificationpanel	Gastroenterologyand urology	Gastroenterologyand urology	Gastroenterologyand urology
Product code	KNS	KNS	KNS
Environment ofuse	Healthcarefacility/hospital	Healthcarefacility/hospital	Healthcarefacility/hospital
Single/repeat use	Single-use	Single-use	Single-use
Sterile/non-sterile	Marketed as asterilized device	Marketed as asterilized device	Marketed as asterilized device
Sterilizationmethod	ETO sterile	ETO sterile	ETO sterile
Energy source	High-frequencycurrent	High-frequencycurrent	High-frequencycurrent
Materialcomposition ofmainpatient-contactparts	Stainless steelCeramicsABSPTFESilicone Rubber	Stainless steelCeramicsABSPTFESilicone Rubber	Stainless steelCeramicsABSPTFESilicone Rubber
Duration and typeof contact	Surface-contactingdevice in contactwith mucosalmembranes. Thecontact duration islimited exposure(i.e. contact is up to24 hours).	Surface-contactingdevice in contactwith mucosalmembranes. Thecontact duration islimited exposure(i.e. contact is up to24 hours).	Surface-contactingdevice in contactwith mucosalmembranes. Thecontact duration islimited exposure(i.e. contact is up to24 hours).

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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

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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.

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).