(86 days)
Not Found
No
The description focuses on direct thermal energy and pressure for cutting and coagulation, with no mention of AI, ML, or related concepts.
Yes.
The device is used to cut and coagulate body tissue, directly interacting with and affecting the body for a medical purpose.
No
The device description clearly states its purpose is to "cut and coagulate body tissue," which is a therapeutic function, not a diagnostic one. It generates thermal energy and applies pressure to treat tissue, rather than to identify or assess a condition.
No
The device description explicitly states the system consists of a generator, handpiece, and foot switch, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut and coagulate body tissue" during surgery. This is a direct surgical intervention on the patient's body.
- Device Description: The description reinforces that the system is used to "cut and coagulate tissue for general (open) abdominal surgery." It describes a physical process of applying thermal energy and pressure to tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, not to directly treat or alter the body itself. This device is clearly a surgical tool.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body tissue, abdominal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
-
- Heat scissors generator set
-
- Device Name:
-
- Common/Usual Name:
-
- Classification:
- Heat scissors handpiece
-
- Device Name:
-
- Common/Usual Name:
-
- 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
1
C. Predicate Devices :
| Model | Device Description &
510(k)#/ Date of Cleared | Manufacturer |
|------------------------------------|--------------------------------------------------|-----------------------------|
| HPU-20 | #K982289 | Olympus Optical Co., Ltd. |
| Shaw II SURGERY SYSTEM | #K902307 | HENOSTATIC
SURGERY CORP. |
| THERMAL CAUTERY DEVICE,
FORCEPS | #K990728 | STARION
INSTRUMENTS |
D. Summary Description of the Device
1. Summary
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.
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.
2
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.
3
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
4
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)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(
(Optional Format 1-2-96)