(69 days)
The Habib Hexablate is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
The Habib Hexablate is a bipolar radiofrequency (RF) device that consists of a handle and an array of seven parallel electrodes which extend out from the handle. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Hexablate has an attached cable which connects the device to the Habib Hexablate Switch Unit and then to an RF Generator. The electrodes are inserted into tissue is coagulated using RF power. The Habib Hexablate is designed for use in surgery and is a single use device.
The provided text describes the Habib Hexablate device and its 510(k) submission (K071103) for market clearance. However, it does not contain the detailed information required to fill out the table describing acceptance criteria and a study proving the device meets those criteria, or all the associated study design parameters.
The document is a summary of safety and effectiveness, a 510(k) clearance letter, and an indications for use statement. It provides a high-level statement about performance data but no specifics on acceptance criteria or the study methodology used.
Here's a breakdown of what can be extracted and what is missing:
Information that can be extracted:
- Device Name: Habib Hexablate
- Intended Use/Indications For Use: To assist in coagulation of tissue during intraoperative surgical procedures.
- Predicate Device: Habib 4X (K051420)
- Description of Technological Differences: The Habib Hexablate has the same basic technological characteristics as the Habib 4X, both using bipolar RF energy through electrodes to create a volume of coagulated tissue. The primary difference is the size and shape of the coagulation zone and the Hexablate's aspiration feature through the center electrode to remove fluids and gases.
- Statement on Performance Data: "Performance testing was done to ensure that the Habib Hexablate 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."
Information that is missing from the provided text and cannot be generated:
- A table of acceptance criteria and the reported device performance: Explicit acceptance criteria and specific performance results are not detailed. The document only states "meets design specifications" and "meets safety and effectiveness criteria."
- Sample size used for the test set and data provenance: No information on the number of cases, patients, or origin of data.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. This type of study is more common for imaging/diagnostic devices, not typically for electrosurgical coagulation devices focused on tissue effect.
- If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
- The type of ground truth used: Not explicitly stated, though for a coagulation device, ground truth would likely involve measurements of coagulation zone size/shape, tissue histology post-coagulation, or animal model observations.
- The sample size for the training set: Not applicable for this type of device and study as described.
- How the ground truth for the training set was established: Not applicable.
Conclusion based on provided text:
The provided document (a 510(k) summary and clearance letter) confirms that performance testing was conducted and data were found sufficient to establish substantial equivalence to a predicate device (Habib 4X, K051420) and meet safety and effectiveness criteria for tissue coagulation during intraoperative surgical procedures. However, the specific details of these performance tests, including explicit acceptance criteria, performance metrics, study design (sample sizes, ground truth establishment, expert involvement), and results, are not present in this summary. These details would typically be found in the full 510(k) submission or associated test reports, which are not included here.
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| SECTION 3 | |
|---|---|
| Summary of Safety and Effectiveness | |
| Sponsor: | EMcision, Ltd. |
| K071103 | |
| Contact Person: | Nagy Habib, MDChief Executive OfficerLiver Surgery Section, Hammersmith HospitalDu Cane RoadLondon, W12 0NNUnited Kingdom |
| Summary Prepared: | April 10, 2006 |
| JUN 27 2007 | |
| Trade Name: | Habib Hexablate |
| Common Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification: | Class II per 21 CFR 878.4400 |
| Product Code: | GEI |
| Predicate Devices: | Habib 4X (K051420) |
Page 1 of 2Intended Use:
The Habib Hexablate is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
Description:
The Habib Hexablate is a bipolar radiofrequency (RF) device that consists of a handle and an array of seven parallel electrodes which extend out from the handle. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Hexablate has an attached cable which connects the device to the Habib Hexablate Switch Unit and then to an RF Generator. The electrodes are inserted into tissue is coagulated using RF power. The Habib Hexablate is designed for use in surgery and is a single use device.
Technological Differences:
The Habib Hexablate has the same basic technological characteristics as the Habib 4X. Both devices use bipolar RF energy through a number of electrodes to create a volume of coagulated tissue. The primary difference is in the size and shape of the coagulation zone created by each
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K071103
SECTION 3
Page 2 of 2
Summary of Safety and Effectiveness
device. The Habib Hexablate also uses aspiration through the center electrode to remove fluids and gases from the center of the coagulation zone.
Performance Data:
Performance testing was done to ensure that the Habib Hexablate 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.
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Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EMcision, Ltd. % Underwriters Laboratories, Inc. Mr. Morten Simon Christensen 455 East Trimble Road San Jose, California 95131-1230
JUN 2 7 2007
Re: K071103
Trade/Device Name: Habib Hexablate Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 7, 2007 Received: June 12, 2007
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. Iisting 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 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.
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Page 2 - Mr. Morten Simon Christensen
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
For Peter Rummell
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 2 Indications for Use Statement
Indications For Use Statement
510(K) Number (if known) K071103
Habib Hexablate Device Name
The Habib Hexablate is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures
Prescription Use OR Over the Counter Use (per 21 CFR 801.109)
PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | |
|---|---|
| --------------- | -- |
Habib Hexablate 510(k) Section 2, Indications for Use Statement EMcision, Ltd. Page 2-1
§ 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.