(61 days)
The Habib™ VesCoag is a catheter intended to be used for the coagulation of blood vessels during general surgery.
The Habib™ VesCoag is a bipolar radiofrequency (RF) device that consists of a catheter, wire connections, hub, Y connector and two ring electrodes are configured with two rings creating proximal and distal heating zones. The Habib™ VesCoag has an attached cable which connects the device to an RF Generator. The catheter is inserted into the vessel and the tissue is coagulated using the RF power. The Habib™ VesCoag is designed for use in surgery and in imaging/radiological procedures and is a single use sterile device.
The provided text is a Fragment of a 510(k) summary for the Habib™ VesCoag. This type of regulatory document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study with specific acceptance criteria and performance metrics.
Based solely on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state predefined acceptance criteria for specific performance metrics of the Habib™ VesCoag in a quantifiable way (e.g., "coagulation time < X seconds"). Instead, it states a broader goal:
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Functions as intended | "Sufficient data was obtained to show that the device... meets safety and effectiveness criteria." |
| Meets design specifications | "Sufficient data was obtained to show that the device... meets safety and effectiveness criteria." |
| Substantially equivalent to predicate device | "Sufficient data was obtained to show that the device is substantially equivalent to the predicate device..." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide any information on:
- Sample size used for any test set.
- Data provenance (country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided text. The document refers to "Performance testing" but does not detail the methodology or the involvement of experts in establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This document describes an electrosurgical device for blood vessel coagulation, not an AI-assisted diagnostic tool. Therefore, a MRMC study related to human readers and AI assistance would not be applicable or relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to an electrosurgical device that requires human operation, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify the type of "ground truth" used. Given the nature of the device (coagulation), performance data would likely involve direct measurements of coagulation effectiveness (e.g., vessel occlusion, burst pressure, histological analysis of tissue damage, etc.), but these details are not provided. The phrase "meets design specifications" implies internal, defined performance targets.
8. The sample size for the training set
The concept of a "training set" is relevant to machine learning algorithms. This document describes a physical medical device, not an AI system. Therefore, the concept of a "training set" is not applicable here. The performance data section refers to "performance testing" to ensure the device functions as intended and meets specifications, not an algorithmic training process.
9. How the ground truth for the training set was established
As explained above, the concept of a "training set" and its associated ground truth is not applicable to the type of device described in this document.
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Summary of Safety and Effectiveness
| Sponsor: | EMcision, Ltd. |
|---|---|
| Contact Person: | Nagy Habib, MD |
| Chief Executive Officer | |
| Liver Surgery Section, Hammersmith Hospital | |
| Du Cane Road | |
| London, W12 0NN | |
| United Kingdom |
Page 1 of 2
OCT 2 2007
| Summary Prepared: | 2007-08-21 |
|---|---|
| Trade Name: | Habib TM VesCoag |
| Common Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification: | Class II per 21 CFR 878.4400 |
| Product Code: | GEI |
VNUS Closure™ System catheter manufactured by VNUS Medical Predicate Devices: Technologies Inc., San Jose, California, USA (K974521)
Intended Use:
The Habib™ VesCoag is a catheter intended to be used for the coagulation of blood vessels during general surgery.
Description:
The Habib™ VesCoag is a bipolar radiofrequency (RF) device that consists of a catheter, wire connections, hub, Y connector and two ring electrodes are configured with two rings creating proximal and distal heating zones. The Habib™ VesCoag has an attached cable which connects the device to an RF Generator. The catheter is inserted into the vessel and the tissue is coagulated using the RF power. The Habib™ VesCoag is designed for use in surgery and in imaging/radiological procedures and is a single use sterile device.
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Image /page/1/Picture/1 description: The image shows the text "Page 2 of 2". The word "Page" is written in cursive. The numbers are handwritten, and the last number 2 is circled.
Technological Differences:
The Habib™ VesCoag has the same basic technological characteristics as the VNUS Closure™ System. Both devices use bipolar RF energy through a number of electrodes to coagulate vessels from the inside.
Performance Data:
Performance testing was undertaken to ensure that the Habib™ VesCoag 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract shapes resembling birds in flight, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EMcision, Ltd. % Underwriters Laboratories, Inc. Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator 455 E. Trimble Road San Jose, California 95131
OCT 2 2007
Re: K072126 Trade/Device Name: Habib" VesCoag Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 18, 2007 Received: September 20, 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
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Page 2 - Mr. Morten Simon Christensen
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
David Kramer
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)
Not yet Allocated
Device Name
Habib™ VesCoag
The Habib™ VesCoag is a catheter intended to be used for the coagulation of blood vessels during general surgery.
Prescription Use __ OR Over the Counter Use X
(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)
David Krause
(Division Sign-Of (Division of General, Restorative, and Neurological Devices
510(k) Number K07215
Habib™ VesCoag 510(k) Revision 1 2007-08-21 Habib
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.