(116 days)
Not Found
No
The device description and intended use focus on electrosurgical functions (cauterization, coagulation, hemostasis) and tissue collection using high-frequency current. There is no mention of AI, ML, image processing, or any data-driven decision-making processes.
Yes
The device is intended to perform therapeutic functions such as cauterization, coagulation, and hemostasis within the digestive tract.
Yes
The device "FD-1L/U-1 Hot Biopsy Forceps" is used to "collect tissue," which is a diagnostic function because collected tissue is then analyzed to diagnose diseases.
No
The device description clearly indicates these are physical instruments (forceps) used with endoscopes, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that these devices are used within the digestive tract to collect tissue, cauterize, coagulate, and perform hemostasis using high-frequency current. This is a direct intervention on the patient's body, not a test performed on a sample outside the body.
The intended use and device description describe a surgical/interventional tool, not a diagnostic test.
N/A
Intended Use / Indications for Use
FD-1L/U-1 Hot Biopsy Forceps
This instrument has been designed to be used with Olympus endoscopes to collect tissue, cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.
FD-410LR Single Use Electrosurgical Hemostatic Forceps
This instrument has been designed to be used with Olympus endoscopes to cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.
Product codes (comma separated list FDA assigned to the subject device)
78 KGE
Device Description
The FD-1L/U-1 has been 510(k) cleared in K955052 for collecting tissue in the digestive tract. The subject FD-1L/U-1 has identical specification as the predicate cleared in K955052. This 510(k) submission is for the purpose of adding coagulation and hemostasis to the intended use. The FD-410LR is intended to be used for coagulation and hemostasis only. Although its cup shape is different from that of the FD-1L/U-1, coagulation and hemostasis abilities are the same.
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): 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
§ 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
DEL 9 2 2006
Ko62517
Fig. 1 of 2
August 9, 2006
510(k) SUMMARY
.
Electrosurgical Hemostatic Forceps Series
1_ General Information
| Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-850
Establishment Registration No: 8010047 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Laura Storms-Tyler
Executive Director
Regulatory Affairs & Quality Assurance
Olympus America Inc.
3500 Corporate Parkway
PO Box 610
Center Valley, PA 18034-0610, USA
Phone: 484-896-5688
FAX: 484-896-7128
Email: Laura.storms-tyler@olympus.com
Establishment Registration No: 2429304 |
| Manufacturer: | Aomori Olympus
248-1 Okkonoki 2-chome Kuroishi-shi,
Aomori, Japan, 036-0367
Establishment Registration Number: 9614641 |
| 2 Device Identification | |
| Device Trade Name: | Electrosurgical Hemostatic Forceps Series |
| Common Name: | Electrosurgical Hemostatic Forceps |
| Regulation Number: | 21 CFR 876.4300/876.1500 |
| Regulation Name: | Endoscopic electrosurgical unit and accessories
Endoscope and accessories |
| Regulatory Class: | II |
| Classification Panel: | Gastroenterology and urology
General and Plastic Surgery Devices |
| Product Code: | 78 KGE |
1
Kcb2517
Pg 2 of 2
Predicate Device Information 3
| Device Name | Common Name | 510(k) No. | Manufacturer |
|---|---|---|---|
| FD-1L/U-1 Hot Biopsy | |||
| Forceps | Hot Biopsy | ||
| Forceps | K955052 | Olympus Medical Systems Corp. | |
| LSVP International | |||
| Hot Biopsy Forceps | Hot Biopsy | ||
| Forceps | K971204 | LSVP International, Inc. |
4 Device Description
The FD-1L/U-1 has been 510(k) cleared in K955052 for collecting tissue in the digestive tract. The subject FD-1L/U-1 has identical specification as the predicate cleared in K955052. This 510(k) submission is for the purpose of adding coagulation and hemostasis to the intended use. The FD-410LR is intended to be used for coagulation and hemostasis only. Although its cup shape is different from that of the FD-1L/U-1, coagulation and hemostasis abilities are the same.
5 Indications for Use
FD-1L/U-1 Hot Biopsy Forceps
This instrument has been designed to be used with Olympus endoscopes to collect tissue, cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.
FD-410LR Single Use Electrosurgical Hemostatic Forceps
This instrument has been designed to be used with Olympus endoscopes to cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.
Comparison of Technological Characteristics 6
The FD-1L/U-1 and FD-410LR are basically identical to the predicate device in intended use, and similar in specifications except for addition of coagulation and hemostasis indications.
7 Conclusion
When compared to the predicate device, the FD-1L/U-1 and FD-410LR do not incorporate any significant changes that could affect the safety or effectiveness of the device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Laura Storms-Tyler Executive Director Regulatory Affairs & Quality Assurance Olumpus America Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610
DEC 2 2 2006
Re: K062517
Trade/Device Name: Electrosurgical Hemostatic Forceps Series Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KGE Dated: November 28, 2006 Received: December 1, 2006
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 1906-2006. The central element is the FDA acronym in a stylized font, with the word "Centennial" written below it in cursive. Three stars are arranged beneath the word "Centennial". The logo is surrounded by a circular border with text, though the text is difficult to read due to the image quality.
Protecting and Promoting Public Health
3
Page 2 -
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.
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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon 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): // (122517
Device Name: Electrosurgical Hemostatic Forceps Series Indications For Use:
FD-1L/U-1 Hot Biopsy Forceps
This instrument has been designed to be used with Olympus endoscopes to collect tissue, coagulate and perform hemostasis using high-frequency current within the digestive cauterize, tract.
FD-410LR Single Use Electrosurgical Hemostatic Forceps
This instrument has been designed to be used with Olympus endoscopes to cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.
Prescription Use V (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)
David A. Syzm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
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