These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract 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.

Device Description

The subject device is an endoscopic electrosurgical knife incorporating the saline feeding function for Endoscopic Submucosal Dissection (ESD).

AI/ML Overview

The provided document is limited to the summary of non-clinical testing for the Olympus Single Use Electrosurgical knife (K171158) in comparison to its predicate devices. It describes tests performed to establish substantial equivalence but does not provide detailed acceptance criteria or numerical reported device performance for these specific tests in a table format, nor does it detail a study that explicitly proves the device "meets" acceptance criteria with quantifiable metrics. Instead, it states that the results were "evaluated as substantially equivalent."

Therefore, I cannot fully complete the requested table or answer all questions with specific numerical data from the given text. However, I can extract the available information and indicate where details are missing.

1. Table of Acceptance Criteria and Reported Device Performance

Device Performance Aspect	Acceptance Criteria	Reported Device Performance
Cutting Performance (Test A)	Equivalency to primary predicate device 1 (KD-620LR, K092309) in cutting ex-vivo porcine digestive tract mucosa.	Evaluated as substantially equivalent to the primary predicate device.
Lifting Performance (Test B)	Equivalency to predicate device 3 (Hybridknife, K083608) in lifting ex-vivo porcine digestive tract mucosa.	Evaluated as substantially equivalent to predicate device 3.
Thermal Damage (Test C)	Equivalency to predicate device 3 (Hybridknife, K083608) in the degree of thermal damage on ex-vivo porcine digestive tract.	Evaluated as substantially equivalent to predicate device 3.
Knife Operation	Works as intended with compatible endoscopes.	Confirmed to work as intended.
Dimensions	Specific dimensional requirements.	Confirmed to meet requirements.
General Durability	Specific durability requirements.	Confirmed to meet requirements.
Risk Analysis	In accordance with established in-house acceptance criteria based on ISO 14971:2007.	Risk analysis carried out, and design verification tests identified and performed.
Shelf-life	Demonstrated stability for 3 years (accelerated aging). Ongoing 3-year aging test will be performed for longer stability.	Accelerated aging test performed in accordance with ASTM F1980-16. Results support stability.
Sterilization	Sterilization in accordance with ISO 11135:2014.	Validation carried out with Half-cycle approach.
Biocompatibility	In accordance with FDA Guidance, ISO-10993.	Testing performed.
EMC, Electrical, Thermal Safety	Compliance with relevant IEC standards (implied by "confirmed").	Confirmed.

Missing Information:

Specific numerical values or quantitative metrics for "equivalency" in cutting, lifting, and thermal damage.
The exact acceptance criteria thresholds (e.g., "within X% of predicate," "no statistically significant difference at alpha=0.05").
Futher details on "performance" for knife operation, dimensions, and general durability.

Study Details:

The document describes several non-clinical tests rather than a single unifying "study" with a single test set. The information below is a synthesis based on the provided text.

2. Sample size used for the test set and the data provenance:

Test Sets (Ex-vivo porcine digestive tract mucosa): Used for cutting, lifting, and thermal damage tests (Tests A, B, C).
- Sample Size: Not explicitly stated (e.g., number of tissue samples or repetitions per test).
- Data Provenance: Ex-vivo porcine (pig) digestive tract mucosa (esophagus, stomach, and colon). The specific country of origin for the porcine tissue is not mentioned. These are in-vitro or ex-vivo laboratory tests, not human data.
Other Performance Testing: No specific sample sizes mentioned for knife operation, dimensions, general durability, risk analysis, shelf-life, sterilization, biocompatibility, or safety tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as these are non-clinical, ex-vivo tests comparing device performance metrics, not diagnostic or clinical accuracy involving human expert interpretation. For histological evaluation (Test C), a pathologist would typically establish ground truth, but the number or specific qualifications are not mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable for these non-clinical, ex-vivo performance tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This device is an electrosurgical knife, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical electrosurgical knife, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For Cutting (Test A) and Lifting (Test B): The "ground truth" for comparison was the performance demonstrated by the predicate devices (KD-620LR for cutting, Hybridknife for lifting). The comparison aimed for "equivalency" in direct physical performance metrics.
For Thermal Damage (Test C): Histological study was carried out to evaluate the degree of thermal damage. The ground truth here would be the pathological assessment of tissue changes attributed to thermal damage, again benchmarked against the predicate device's performance.
For Other Tests: Engineering specifications, functional requirements, and adherence to recognized standards (e.g., ISO, ASTM, IEC).

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable (no training set for a physical device).

Summary

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November 17, 2017

Olympus Medical Systems Corp. % Daphney Germain-Kolawole Senior Project Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway P.O. Box 610 Center Vallev. PA 18034-0610

Re: K171158

Trade/Device Name: Single Use Electrosurgical knife Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: KNS Dated: October 20, 2017 Received: October 23, 2017

Dear Daphney Germain-Kolawole:

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.

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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); 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.

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.

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,

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171158

Device Name

Single Use Electrosurgical Knife

Indications for Use (Describe)

These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Summary

April 19, 2017

I. General Information OLYMPUS MEDICAL SYSTEMS CORP. = Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047 ■ Daphney Germain-Kolawole Official Correspondent: Senior Project Manager, Regulatory Affairs 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 = Manufacturer: Aomori Olympus Co., Ltd. 248-1 Okkonoki 2-chome Kuroishi-shi, Aomori, Japan 036-0357 Establishment Registration No.: 9614641 II. Device Identification ■ Device Trade Name: Single Use Electrosurgical knife ■ Common Name: Single Use Electrosurgical knife . Regulation Number: 876.4300 ■ Regulation Name: Endoscopic electrosurgical unit and accessories ■ Regulatory Class: II ■ Classification Panel: Gastroenterology and urology

Product Code: KNS

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Single Use Electrosurgical knife
Primary Predicate Device1
Device name	Applicant	510(k)#
SINGLE USEELECTROSURGICAL KNIFESERIES	OLYMPUS MEDICALSYSTEMS CORPORATION	K092309
Additional Predicate Device2
Device name	Applicant	510(k)#
ERBE WaterJet ModelERBEJET®2 System withHybridAPC Probe	ERBE USA, INC.	K143306
Additional Predicate Device3
Device name	Applicant	510(k)#
ERBE HYBRID KNIFE	ERBE USA, INC.	K083608

III. Predicate Device and Reference Devices Information

Device Description IV.

The subject device is an endoscopic electrosurgical knife incorporating the saline feeding function for Endoscopic Submucosal Dissection (ESD). The indications for use of the subject device is a combination of predicate devices 1 and 2.

V. Indications for Use

VI. Comparison of Technological Characteristics

Compared to the primary predicate device (KD-620LR, K092309), the subject device has a different knife shape. Additionally, the subject device incorporates the saline feeding function for ESD procedures which is an equivalent function available in both predicate device 2 (HybridAPC Probe, K143306) and predicate device 3 (ERBE HYBRID KNIFE, K083608).

VII. Summary of non-clinical testing

Performance testing was conducted to demonstrate the essential performance of the subject device and confirmed that the subject device works as intended with the compatible devices. Additionally, the results of the tests below were evaluated as substantially equivalent to the cited predicate devices.

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K171158

A test to evaluate the performance to cut the digestive tract mucosa and compare the result with that of the predicate device. The subject device and the primary predicate device 1 (KD-620LR, K092309) were compared for the equivalency in cutting the ex-vivo porcine digestive tract mucosa (esophagus, stomach, and colon).

A test to evaluate the lifting of the digestive tract mucosa and compare the size of mucosal lift with that of the predicate device. The subject device and the predicate device 3 (Hybridknife, K083608) were compared for the equivalency in lifting of the ex-vivo porcine digestive tract mucosa (esophagus, stomach, and colon).

A test composed of the test items "cut the mucosa" and "lift the mucosa by induction of saline to the submucosal layer" to compare the degree of thermal damage on the ex-vivo porcine digestive tract (esophagus, stomach, and colon) wall caused by the subject device and that caused by the predicate device 3 (Hybridknife, K083608). The histological study was carried out to evaluate the degree of thermal damage.

Knife operation with the compatible endoscopes
Dimension of each part of the knife
General durability
Risk analysis was carried out 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.
Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. Three-year aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test.
Sterilization validation was carried out with Methods Half-cycle approach in accordance with ISO 11135:2014.
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process' issued on June 16, 2016.
Electromagnetic compatibility, electric safety, and thermal safety had been confirmed.

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K171158 Page 4 of 4

The following standards have been applied to the Single Use Electrosurgical knife.

ISO 11135
ASTM F1980-16
ISO 10993-1
AAMI/ANSI/ISO 10993-5
AAMI/ANSI/ISO 10993-10
ISO 10993-11
AAMI/ANSI ES60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-2-2
IEC 60601-2-18
ISO 14971

VIII. Conclusion

Compared to the predicate devices, the proposed design modifications to the Single Use Electrosurgical Knife were verified and validated and do not raise any significant issues with safety and effectiveness. Therefore, the subject device is substantially equivalent to the cited predicate devices.

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).