(116 days)
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.
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.
The provided text is a 510(k) summary for Electrosurgical Hemostatic Forceps Series (K062517). This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving those criteria are met.
The document discusses:
- Device Identification: Electrosurgical Hemostatic Forceps Series (FD-1L/U-1 Hot Biopsy Forceps and FD-410LR Single Use Electrosurgical Hemostatic Forceps).
- Intended Use: For FD-1L/U-1, it's for collecting tissue, cauterizing, coagulating, and performing hemostasis with Olympus endoscopes in the digestive tract. For FD-410LR, it's for cauterizing, coagulating, and performing hemostasis with Olympus endoscopes in the digestive tract. The main purpose of this 510(k) for the FD-1L/U-1 is to add coagulation and hemostasis to its intended use.
- Predicate Devices: FD-1L/U-1 Hot Biopsy Forceps (K955052) and LSVP International Hot Biopsy Forceps (K971204).
- Conclusion: The devices (FD-1L/U-1 and FD-410LR) are substantially equivalent to the predicate device and do not incorporate significant changes that could affect safety or effectiveness.
Key takeaway for your request: This is a premarket notification for substantial equivalence, which primarily relies on comparing the new device's characteristics to a legally marketed predicate. It does not typically include detailed performance study data against specific acceptance criteria in the way you've outlined for clinical studies. The FDA letter confirms substantial equivalence but does not describe a clinical study validating performance parameters.
Therefore, for your specific questions:
- A table of acceptance criteria and the reported device performance: Not provided in this document.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided.
- Adjudication method: Not applicable/provided.
- 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 not an AI/imaging diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable/provided for this type of submission.
- The sample size for the training set: Not applicable/provided.
- How the ground truth for the training set was established: Not applicable/provided.
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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 192-850Establishment Registration No: 8010047 |
|---|---|
| Official Correspondent: | Laura Storms-TylerExecutive DirectorRegulatory Affairs & Quality AssuranceOlympus America Inc.3500 Corporate ParkwayPO Box 610Center Valley, PA 18034-0610, USAPhone: 484-896-5688FAX: 484-896-7128Email: Laura.storms-tyler@olympus.comEstablishment Registration No: 2429304 |
| Manufacturer: | Aomori Olympus248-1 Okkonoki 2-chome Kuroishi-shi,Aomori, Japan, 036-0367Establishment 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 accessoriesEndoscope and accessories |
| Regulatory Class: | II |
| Classification Panel: | Gastroenterology and urologyGeneral and Plastic Surgery Devices |
| Product Code: | 78 KGE |
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Kcb2517
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Predicate Device Information 3
| Device Name | Common Name | 510(k) No. | Manufacturer |
|---|---|---|---|
| FD-1L/U-1 Hot BiopsyForceps | Hot BiopsyForceps | K955052 | Olympus Medical Systems Corp. |
| LSVP InternationalHot Biopsy Forceps | Hot BiopsyForceps | 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.
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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
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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
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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.
Page 1 of _ 1
§ 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).