-Heat scissors generator set
The Heat scissors generator set has been designed to generate electrical energy to the Heat scissors handpiece to cut and coagulate body tissue.

-Heat scissors handpiece (XRF-940-M)
The Heat scissors handpiece has been designed to cut and coagulate body tissue in general (open) abdominal surgery.

Device Description

The Heat scissors system has been designed to cut and coagulate tissue for general (open) abdominal surgery. This system consists of the Heat scissors generator, Heat scissors handpiece and foot switch. This system uses direct thermal energy and simultaneous pressure to cut and coagulate tissue. The thermal energy is generated at the Heat-generating section of the blade, on the Heat scissors handpiece. It is conveyed via a non-stick coating on the blade to the tissue.

AI/ML Overview

This 510(k) summary for the Olympus Heat scissors generator set and Heat scissors handpiece does not contain the information required to populate the acceptance criteria table or describe a study proving the device meets acceptance criteria.

The document states: "When compared to the predicate devices, 'Heat scissors system' does not incorporate any significant difference for safety and efficacy to the predicate devices. Therefore, clinical data is not necessary for its evaluation of its safety and efficacy." This explicitly indicates that no clinical study was performed to establish new acceptance criteria or demonstrate performance against such criteria.

Instead, the submission relies on substantial equivalence to predicate devices. This means that Olympus is claiming their Heat Scissors system is as safe and effective as existing legally marketed devices, rather than providing new performance metrics from a dedicated study.

Here's what can be extracted from the document regarding the device's design and testing, which are not the same as acceptance criteria and a study proving performance against them in the clinical sense:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as performance metrics in this document. The "acceptance criteria" here are implicitly linked to meeting the safety and efficacy profiles of the predicate devices.
Reported Device Performance: Not reported in terms of specific clinical or measured performance metrics. The document instead states that the "Heat scissors system" has been designed, manufactured, and tested in compliance with voluntary safety standards IEC 60601-1 and IEC60601-1-2. It also notes that biocompatibility test reports show materials comply with ISO 10993-1. These are compliance statements, not performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable as no clinical or comparative performance study with a test set is described. The tests mentioned (IEC standards, biocompatibility) are likely bench or material tests, not clinical performance tests on humans.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set is described.

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

Not applicable. No adjudication method is described.

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

Not applicable. This device is a surgical cutting and coagulation tool, not an AI-assisted diagnostic tool or system that would involve human readers.

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

Not applicable. This device is not an algorithm.

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

Not applicable. No clinical ground truth is described as being established for a performance study.

8. The sample size for the training set

Not applicable. This document describes a medical device, not an AI/ML algorithm that would have a training set.

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

Not applicable. No training set or ground truth for it is described.

In summary: The provided 510(k) summary for the Olympus Heat Scissors system does not describe a study to prove acceptance criteria in the way envisioned by the prompt. It focuses on demonstrating substantial equivalence to predicate devices through compliance with safety standards and biocompatibility, negating the need for new clinical performance data.

Summary

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510(k) SUMMARY

K024138

OLYMPUS Heat scissors generator set and Heat scissors handpiece

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section807.92.

A. Submitter's Name, Address, Phone and Fax Number

1. Manufacturer of the subject device

Name & Address of Manufacturer;

Registration No: Address, Phone and Fax Number of R&D Department Endoscope Division

Name of Contact Person

Name :

Address, Phone and Fax

Olympus Optic-Electronics Co., Ltd. Aomori Plant 248-1 Okkonoki 2-chome Kuroishi-shi Aomori, Japan, 036-0367 9614641 2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507 Japan TEL 81-426-42-2891 FAX 81-426-46-2291

Ms.Laura Storms-Tyler Director. Requlatory Affairs Olympus America Inc. Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL (631) 844-5688 FAX (631) 844-5416

B. Device Name, Common Name

1. Heat scissors generator set
1. Device Name:
1. Common/Usual Name:
1. Classification:

Heat scissors handpiece

1. Device Name:
1. Common/Usual Name:
1. Classification:

Heat scissors generator Heat scissors generator Electrosurgical Cutting & Coagulation Device & Accessories 21 CFR 878.4400

Heat scissors handpiece (XRF-940-M) Heat scissors handpiece Electrosurgical Cutting & Coagulation Device & Accessories 21 CFR 878.4400

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C. Predicate Devices :

Model	Device Description &510(k)#/ Date of Cleared	Manufacturer
HPU-20	#K982289	Olympus Optical Co., Ltd.
Shaw II SURGERY SYSTEM	#K902307	HENOSTATICSURGERY CORP.
THERMAL CAUTERY DEVICE,FORCEPS	#K990728	STARIONINSTRUMENTS

D. Summary Description of the Device

1. Summary

2. Design

"Heat scissors system" has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirements of IEC 60601-1 and IEC60601-1-2.

3. Materials

The biocompatibility test reports of the above new materials show that such materials complies with ISO 10993-1.

E. Intended Use of the device

Heat scissors generator set
Heat scissors generator has been designed to generate electrical energy to the Heat scissors handpiece to cut and coagulate body tissue.
Heat scissors handpiece (XRF-940-M)
The Heat scissors handpiece has been designed to cut and coaqulate body tissue in general(open) abdominal surgery.

F. Reason for not requiring clinical data

When compared to the predicate devices, "Heat scissors system " does not incorporate any significant difference for safety and efficacy to the predicate devices.

Therefore, clinical data is not necessary for its evaluation of its safety and efficacy.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. To the left of the profiles, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profiles.

MAR 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus Optic-Electronics Company, Ltd c/o Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157

Re: K024138

Trade/Device Name: Heat Scissors System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 13, 2002 Received: December 16, 2002

Dear Ms. Storms-Tyler:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Ms. Laura Storms-Tyler

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number(if known): _Not assigned yet_K() 24 138

Device Name: Heat scissors system

(Heat scissors generator set and Heat scissors handpiece)

Indications for Use:

-Heat scissors generator set

The Heat scissors generator set has been designed to generate electrical energy to the Heat scissors handpiece to cut and coagulate body tissue.

-Heat scissors handpiece (XRF-940-M)

The Heat scissors handpiece has been designed to cut and coagulate body tissue in general (open) abdominal surgery.

Miriam C Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

K 024138 510(k) Number _

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(

(Optional Format 1-2-96)

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.