(82 days)
Not Found
No
The summary describes a simple electrosurgical electrode and makes no mention of AI or ML.
Yes
The device is used for electrosurgical cauterization or hemostasis, which are therapeutic interventions aimed at treating conditions (e.g., bleeding) in the body.
No
The device is described as being used for "electrosurgical cauterization or hemostasis," which are therapeutic actions, not diagnostic ones. It helps to treat or stop bleeding, rather than identify a condition or disease.
No
The device description clearly identifies it as a "Coagulation Electrode," which is a physical hardware component used in electrosurgery. The intended use also describes a physical action (cauterization or hemostasis) performed by this electrode. There is no mention of software as the primary or sole component.
Based on the provided information, the Olympus CD-6C-1 Coagulation Electrode is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "electrosurgical cauterization or hemostasis in upper airways and tracheobronchial tree." This is a therapeutic procedure performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description is for an electrode used in a surgical procedure.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting analytes, or providing diagnostic information.
Therefore, the Olympus CD-6C-1 Coagulation Electrode is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
Olympus CD-6C-1 Coagulation Electrode has been designed to be used with the Olympus BF-240 Bronchovideoscopes for electrosurgical cauterization or hemostasis in upper airways and tracheobronchial tree.
Product codes
FFE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper airways and tracheobronchial tree
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)
Olympus CD-1L/U Coagulation Electrode, Olympus KD Series Sphinctertomes (K955247)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4650 Water jet renal stone dislodger system.
(a)
Identification. A water jet renal stone dislodger system is a device used to dislodge stones from renal calyces (recesses of the pelvis of the kidney) by means of a pressurized stream of water through a conduit. The device is used in the surgical removal of kidney stones.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
971328
JUL - 1 1997
510 (k) SUMMARY OLYMPUS CD-6C-1 ELECTROSURGICAL SYSTEM
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.
| Device Name: | Olympus CD-6C-1 Coagulation Electrode. |
|---|---|
| Common/Usual Name: | Coagulation Electrodes |
| Classification Name: | 21 CFR 876.4300, Class II |
| Endoscopic Coagulation Electrode and Accessories. | |
| Predicate Devices: | Olympus CD-1L/U Coagulation Electrode (Preamendment) |
| Olympus KD Series Sphinctertomes (K955247) | |
| Prepared & Submitted By: | |
| (Contact Person) | Mr. Subhash Patel |
| Olympus America Inc. | |
| Endoscope Division | |
| Two Corporate Center Drive | |
| Melville, New York 11747-3157 | |
| (516) 844-5481 | |
| Summary Preparation | |
| Date: | 04/07/97 |
Statement of Intended Use:
ﻤﺴﻠﺴﺔ
Olympus CD-6C-1 Coagulation Electrode has been designed to be used with the Olympus BF-240 Bronchovideoscopes for electrosurgical cauterization or hemostasis in upper airways and tracheobronchial tree.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of three stylized human figures in profile, with their arms raised and connected, representing health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Subhash R. Patel Regulatory Affairs Associate Endoscope Division ………………… Olympus America Inc. Two Corporate Center Drive Melville, New York 11747-3157
JUL == 1 1997
Re: K971328
Trade Name: Olympus CD-6C-1 Coagulation Electrode Regulatory Class: II Product Code: FFE Dated: April 7, 1997 Received: April 10, 1997
Dear Mr. Patel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
2
Page 2 - Mr. Subhash R. Patel
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
| 510(k) Number (if known): | Not assigned yet | K971328 |
|---|---|---|
| --------------------------- | ------------------ | --------- |
Device Name:
Olympus CD-6C-1 Coagulation Electrode.
Indications for Use:
Olympus CD-6C-1 Coagulation Electrode has been designed to be used with the Olympus BF-240 Bronchovideoscopes for electrosurgical cauterization or hemostasis in upper airways and tracheobronchial tree.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21CFR 801.109) ✓ OR Over-the Counter Use
instructional videos, and other resources to help you learn more about the topic.