(89 days)
Not Found
Not Found
No
The summary describes a surgical electrode for coagulation and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is indicated for surgical procedures involving coagulation to control small bleeding vessels, which is a treatment and not a therapeutic function.
No
The device is used for surgical procedures to control bleeding, which is a treatment or intervention, not a diagnostic purpose.
No
The intended use describes a physical electrode insert for surgical procedures, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "laparoscopic surgical procedures where controlling small bleeding vessels with coagulation would be advantageous." This describes a surgical tool used in vivo (within the body) during a procedure.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.
The description points to a surgical instrument used for coagulation during a laparoscopic procedure, which falls under the category of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Christoudias Slim Tip Electrode Insert is indicated for laparoscopic surgical procedures where controlling small bleeding vessels with coagulation would be advantageous.
Product codes
GEI
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines above and below them, creating a sense of movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1999
Mr. Frank M. Lewis President InnerVision, Inc. 6258 Shady Grove Road East Memphis, Tennesee 38120
Re: K992345
Trade Name: Christoudias Slim Tip Electrode Insert Regulatory Class: II Product Code: GEI Dated: June 9, 1999 Received: June 13, 1999
Dear Mr. Lewis:
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 your 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Frank. M. Lewis
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 your 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
2
510[K] Number (if known): __ K992 345
Device Name: Christoudias Slim Tip Electrode Insert
Indications for Use:
The Christoudias Slim Tip Electrode Insert is indicated for laparoscopic surgical procedures where controlling small bleeding vessels with coagulation would be advantageous.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pcotele
(Division Sign-Off)
Division of General Restorative Devices K992345
510(k) Number
.............................................................................................................................................................................
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use (Optional Format 1-2-96)