(75 days)
Not Found
None
No
The summary contains no mention of AI, ML, image processing, or any data related to training or testing of algorithms, which are typical indicators of AI/ML in medical devices.
Yes
The device is intended to assist in coagulation of tissue during intraoperative surgical procedures, which is a therapeutic intervention to control bleeding.
No
The device is intended to assist in coagulation of tissue during surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The summary describes a device intended for "coagulation of tissue during intraoperative surgical procedures." This function strongly implies a physical interaction with tissue, which would require hardware (e.g., an energy source and applicator) to achieve. The lack of a device description or mention of software-specific functions further supports this conclusion.
Based on the provided information, the Habib 4X is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "to assist in coagulation of tissue during intraoperative surgical procedures." This describes a device used on the patient's tissue during surgery, not a device used to test samples outside the body (in vitro).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
The Habib 4X appears to be a surgical device used for a therapeutic or procedural purpose (tissue coagulation) directly on the patient.
N/A
Intended Use / Indications for Use
The Habib 4X is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
Product codes
GEI
Device Description
Not Found
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 and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing right. The text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2005
Emcision Ltd c/o Ms. Chantel Carson Section Manager Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062-2096
Re: K051420
Trade/Device Name: Habib 4X Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 28, 2005 Received: August 1, 2005
Dear Ms. Carson:
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 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.
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 sct 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.
1
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 (240) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Barbara Buckner for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
1051420
Section D - Statement of Indications for Use
Indications for Use
K051420 510(k) Number (if known): Not yet allocated
Device Name: Habib 4X
Indications for Use:
The Habib 4X is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clutara Buehnd for Melleuson
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number_K 05 1420
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