(92 days)
KD-610L, KD-611L, KD-620LR, KD-630L, KD-640L
KD-610L, KD-611L, KD-620LR, KD-630L, KD-640L
No
The description focuses on the mechanical and electrical functions of the electrosurgical knife and does not mention any AI or ML components or capabilities.
Yes
This electrosurgical knife is used with high-frequency current to cut tissue within the digestive tract, which is a therapeutic intervention.
No
The device is an electrosurgical knife designed to cut tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components (knives, tips, electrodes, wire) designed to interact directly with tissue using high-frequency current, indicating it is a hardware device, not software-only.
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 tissue within the digestive tract and using high-frequency current." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details different types of electrosurgical knives designed for cutting tissue. This aligns with a surgical instrument, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Single Use Electrosurgical Knife KD-610L/KD-611L/KD-620LR/KD-630L/KD-640L is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
Single Use Electrosurgical Knife KD-610L/KD-611L/KD-620LR/KD-630L/KD-640L
This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract and using high-frequency current.
Product codes
KGE, KNS
Device Description
The following five models of Single Use Electrosurgical Knives are the subject of this 510(k) notification: KD-610L, KD-611L, KD-620LR, KD-630L and KD-640L.
The KD-610L and KD-611L knives have isolation tips on the distal tip to prevent inadvertent deep cauterization. The KD-611L knive also has an electrode at the bottom of the isolation tip, which can also cut tissue.
The KD-620LR knive is a L-shaped knife, which cutstissue by hooking the mucous membrane. This device is rotatable so that both longitudinal and lateral dissection is possible.
The KD-630L knife consists of flexible wire, which is adjustable by the user, preventing inadvertent deep cauterization.
The KD-640L knife has a triangle tip to the distal end of the knife, which hooks mucous membrane to cut. Both longitudinal and lateral dissection is possible without rotating the instrument due to the triangle tip design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
digestive tract
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)
Preamendment Device
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K092309
pg 1 of 2
510(k) SUMMARY
Single Use Electrosurgical Knife Series
OCT 3 0 2009
General Information 1
- Applicant:
- Official Correspondent:
발 Manufacturer: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047 Stacy Abbatiello Kluesner, M.S., RAC
Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 Phone: 484-896-5405 FAX: 484-896-7128 Email: Stacy.Kluesner@olympus.com Establishment Registration No: 2429304
OLYMPUS MEDICAL SYSTEMS CORP.
Aomori Olympus 248-1 Okkonoki 2-chome Kuroishi-shi, Aomori, Japan, 036-0367 Establishment Registration Number: 9614641
Device Identification 2
- . Device Trade Name:
- 트 Common Name:
- Regulation Number:
■ Regulation Name:
■ Regulatory Class:
- 동 Classification Panel:
- Product Code: .
Single Use Electrosurgical Knife Series
Electrosurgical Knife
21 CFR 876.4300
Endoscopic electrosurgical unit and accessories
II
Gastroenterology and urology
KGE
1
K0923a
pgjofv
Predicate Device Information 3
| Device Name | Common Name | 510(k) No. | Manufacturer |
|---|---|---|---|
| KD-1L-1 | Electrosurgical | ||
| Knife | Preamendment | ||
| Device | Olympus Medical Systems Corp. |
Device Description 4
The following five models of Single Use Electrosurgical Knives are the subject of this 510(k) notification: KD-610L, KD-611L, KD-620LR, KD-630L and KD-640L.
The KD-610L and KD-611L knives have isolation tips on the distal tip to prevent inadvertent deep cauterization. The KD-611L knive also has an electrode at the bottom of the isolation tip, which can also cut tissue.
The KD-620LR knive is a L-shaped knife, which cutstissue by hooking the mucous membrane. This device is rotatable so that both longitudinal and lateral dissection is possible.
The KD-630L knife consists of flexible wire, which is adjustable by the user, preventing inadvertent deep cauterization.
The KD-640L knife has a triangle tip to the distal end of the knife, which hooks mucous membrane to cut. Both longitudinal and lateral dissection is possible without rotating the instrument due to the triangle tip design.
5 Indications for Use
Single Use Electrosurgical Knife KD-610L/KD-611L/KD-620LR/KD-630L/KD-640L This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract and using high-frequency current.
Comparison of Technological Characteristics હે
The Single Use Electrosurgical knives are basically identical to the predicate device in intended use, and similar in specifications except for cutting knife shapes.
7 Conclusion
When compared to the predicate device, the Single Use Electrosurgical Knives do not incorporate any significant changes that could affect the safety or effectiveness of the device.
2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
OLYMPUS MEDICAL SYSTEMS CORP. % Ms. Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway PO Box 610 CENTER VALLEY PA 18034-0610
OCT 3.0 2009
Re: K092309
Trade/Device Name: Single Use Electrosurgical Knife Series Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: July 30, 2009 Received: August 3, 2009
Dear Ms. Kluesner:
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 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); medical device reporting (reporting of medical
3
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K092309
Device Name: Single Use Electrosurgical Knife series
Indications For Use:
Single Use Electrosurgical Knife KD-610L/KD-611L/KD-620LR/KD-630L/KD-640L
This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arzich Wh
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
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