(212 days)
Not Found
No
The description focuses on the device's function as a bipolar radiofrequency coagulator and does not mention any AI/ML components or capabilities.
Yes
The device is used to assist in the coagulation of tissue during endoscopic surgical procedures, which is a therapeutic intervention.
No
The device is intended to assist in tissue coagulation during surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a bipolar radiofrequency (RF) device consisting of a catheter with electrodes and an attached cable connecting to an RF Generator. This describes physical hardware components, not a software-only device.
Based on the provided information, the Habib EndoHPB is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "assist in the coagulation of tissue during Endoscopic surgical procedures in the Gastro-intestinal Tract." This describes a therapeutic or surgical intervention performed directly on the patient's tissue in vivo.
- Device Description: The device is a bipolar radiofrequency (RF) device used to coagulate tissue. This is a physical process applied to living tissue within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening. The Habib EndoHPB does not perform any such analysis of specimens.
Therefore, the Habib EndoHPB is a surgical device used for tissue coagulation during endoscopic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to enable the Endoscopist to cauterize and coagulate tissue in the gastrointestinal tract.
The Habib EndoHPB is intended to be used to assist in the coagulation of tissue during Endoscopic surgical procedures in the Gastro-intestinal Tract.
Product codes (comma separated list FDA assigned to the subject device)
KNS
Device Description
The Habib EndoHPB is a bipolar radiofrequency (RF) device that consists of a catheter with 2 ring electrodes, introduced via an endoscope's biopsy channel and activated with bipolar RF energy.
The Habib EndoHPB has an attached cable which connects the device to an RF Generator. The catheter is inserted into the gastrointestinal tract and the tissue is coagulated using the RF power. The Habib EndoHPB is designed for use in endoscopic procedures and is a single use sterile device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract, Gastro-intestinal Tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Endoscopist, endoscopic procedures
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)
Performance testing was undertaken to ensure that the Habib EndoHPB functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.
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
K083292
SECTION 3
Summary of Safety and Effectiveness
| Sponsor: | EMcision, Ltd. | JUN 10 2009 |
|---|---|---|
| Contact Person: | Nagy Habib, MD | |
| Chief Executive Officer | ||
| Liver Surgery Section, Hammersmith Hospital | ||
| Du Cane Road | ||
| London, W12 0NN | ||
| United Kingdom | ||
| Summary Prepared: | 2007-05-01 | |
| Trade Name: | Habib EndoHPB | |
| Common Name: | Endoscopic Electrosurgical Unit | |
| Classification: | Class II per 21 CFR 876.4300 | |
| Product Code: | Gastroenterology-Urology (GU) | |
| KNS | ||
| Predicate Device: | ||
| (K072383.) | Habib Endoblate catheter manufactured by EMcision Ltd |
Intended Use:
The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to enable the Endoscopist to cauterize and coagulate tissue in the gastrointestinal tract.
Description:
The Habib EndoHPB is a bipolar radiofrequency (RF) device that consists of a catheter with 2 ring electrodes, introduced via an endoscope's biopsy channel and activated with bipolar RF energy.
1
SECTION 3
Summary of Safety and Effectiveness
The Habib EndoHPB has an attached cable which connects the device to an RF Generator. The catheter is inserted into the gastrointestinal tract and the tissue is coagulated using the RF power. The Habib EndoHPB is designed for use in endoscopic procedures and is a single use sterile device.
Technological Differences:
The Habib EndoHPB has the same basic technological characteristics as the Habib Endoblate. Both devices use bipolar RF energy through a number of electrodes to coagulate tissue.
Performance Data:
Performance testing was undertaken to ensure that the Habib EndoHPB functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2009
EMcision Ltd. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA. 95131
Re: K083292
Trade/Device Name: Habib EndoHPB
Regulation Number: 21 CFR 876.4300
Regulation Name: Endoscopic electrosurgical unit and accessories
Regulatory Class: II Product Code: KNS Dated: May 20, 2009 Received: May 26, 2009
Dear Mr. Christensen:
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.
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 (OS) regulation (21 CFR Part 820); and if avplicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) 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 892.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). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 2 Indications for Use Statement
Indications For Use Statement
510(K) Number (if known)
Not yet Allocated
Device Name
Habib EndoHPB
The Habib EndoHPB is intended to be used to assist in the coagulation of tissue during Endoscopic surgical procedures in the Gastro-intestinal Tract.
PLEASE DO NO WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ OR Over the Counter Use X
(per 21 CFR 878.4400)
Coles n Pollard
(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Habib EndoHPB 510(k) Section 2, Indications for Use Statement Revision 2 2009-06-09 EMcision, Ltd. Page 2-1