(24 days)
The Guidant FLEX 10® MIS Ablation Probe is indicated for the surgical ablation of soft tissue and striated, cardiac, and smooth muscles. The system is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis.
The FLEX 10® MIS Ablation Probe is designed for use in conjunction with the Guidant 1000 Series Microwave Generator. The Ablation Probe is an intraoperative, sterile, single-use, hand-held device that applies microwave energy to tissue. The Ablation Probe is comprised of a 24-cm-long, rigid handle with position indicators, a metallic shaft, a proximal control tube, a flexible sheath featuring black numbered markings together with right and left hand side markings, a detachable distal control tube, and a guide lead with sutures. The Ablation Probe further includes a 2-m-long insulated coaxial cable, which attaches to the generator output cable connector. The Microwave Generator's output (2450 MHz) is conducted through the output cable connector, into the cabling of the Ablation Probe, and out the antenna at the distal section of the Ablation Probe. The emitted microwave energy is directed toward the target tissue from the active surface opposite the corresponding numbered marking (segment), and creates a continuous lesion approximately 26 mm long. The black side-markings indicate the sides of the sheath. The numbered markings designate each numbered segment of the sheath and correspond to the position indicators on the handle. The ablations are created by independently activating the microwave ablation element at one or more of the corresponding numbered segments, which are selected by moving the sliding ring on the handle.
The Guidant FLEX 10® MIS Ablation Probe is indicated for the surgical ablation of soft tissue and striated, cardiac, and smooth muscles. The system is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis.
Here's an analysis of the provided text regarding the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list specific numerical acceptance criteria for the device's performance. Instead, it states a general conclusion about meeting established criteria.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| General Performance: Device meets established acceptance criteria and performs in a manner substantially equivalent to the predicate device. | "The results of the verification testing demonstrate that the Guidant FLEX 10® MIS Ablation Probe meets the established acceptance criteria and performs in a manner substantially equivalent to the predicate device." |
| Technological Characteristics: Incorporates the same fundamental scientific technology as the predicate device. | "The Guidant FLEX 10® MIS Ablation Probe incorporates the same fundamental scientific technology as the predicate device." |
2. Sample Size and Data Provenance
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "verification testing."
3. Number and Qualifications of Experts for Ground Truth
The document does not mention the use of experts to establish ground truth for a test set. This type of information would typically be relevant for studies involving subjective assessment (e.g., image interpretation), which is not explicitly described here.
4. Adjudication Method
The document does not describe any adjudication method. This is generally relevant when multiple experts are involved in assessing data for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. There is no mention of human readers or "AI vs. without AI assistance." The device is a medical probe, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
The document does not refer to a standalone performance study in the context of an algorithm. The device described is a physical medical device (ablation probe), not a software algorithm or AI. The "verification testing" would likely refer to engineering and functional tests of the physical device.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used. Given the nature of the device (an ablation probe), the "verification testing" would likely involve objective measurements of the ablation lesion's characteristics (size, temperature, tissue necrosis) rather than subjective assessments requiring expert consensus, pathology, or outcomes data in the usual sense of a diagnostic device. The ground truth would likely be established through physical measurements and observations in a laboratory or preclinical setting.
8. Sample Size for the Training Set
The document does not mention a training set sample size. Training sets are typically associated with algorithmic development (e.g., machine learning), and this device is a physical medical instrument.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set, the document does not provide information on how its ground truth was established.
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Guidant Corporation
Guidant FLEX 100 MIS Ablat Special 510(k)
JUL 2 7 2006
KO61865 APPENDIX A: 510(K) SUMMARY
Submitter Guidant Corporation, Cardiac Surgery Submitter's 3200 Lakeside Drive Address Santa Clara, CA 95054 Telephone (408) 845-1813 Fax (408) 845-2077 Contact Person Christina L. Rowe Date Prepared June 29, 2005 Device Trade Guidant FLEX 108 MIS Ablation Probe Name Device System, ablation, microwave and accessories Common Name Device System, ablation, microwave and accessories Classification Name Class II Device Classification Summary of The design, materials, method of delivery, features, and intended use of the substantial Guidant FLEX 100 MIS Ablation Probe are substantially equivalent to the equivalence predicate device: FLEX 10® Ablation Probe for the Guidant Microwave Ablation System (K013946, February 27, 2002 and K041340, July 28, 2004) The FLEX 10® MIS Ablation Probe is designed for use in conjunction with the Device Guidant 1000 Series Microwave Generator. The Ablation Probe is an description intraoperative, sterile, single-use, hand-held device that applies microwave energy to tissue. The Ablation Probe is comprised of a 24-cm-long, rigid handle with position indicators, a metallic shaft, a proximal control tube, a flexible sheath featuring black numbered markings together with right and left hand side markings, a detachable distal control tube, and a guide lead with sutures. The Ablation Probe further includes a 2-m-long insulated coaxial cable, which attaches to the generator output cable connector. The Microwave Generator's output (2450 MHz) is conducted through the output cable connector, into the cabling of the Ablation Probe, and out the antenna at the distal section of the Ablation Probe. The emitted microwave energy is directed toward the target tissue from the active surface opposite the corresponding numbered marking (segment), and creates a continuous lesion approximately 26 mm long. The black side-markings indicate the sides of the sheath. The numbered markings designate each numbered segment of the sheath and correspond to the position indicators on the handle. The ablations are created by independently activating the microwave ablation element at one or more of the corresponding numbered segments, which are selected by moving the sliding ring on the handle.
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Guidant Corporation
. . . . . . .
:
| Indications forUse | The Guidant FLEX 10® MIS Ablation Probe is indicated for the surgicalablation of soft tissue and striated, cardiac, and smooth muscles. The system is adevice indicated for use, under direct visualization, in surgical procedures,including minimally invasive cardiac surgery procedures. The probes ablate thetarget tissue by creating an inflammatory response, or thermal necrosis. | |
|---|---|---|
| Technologicalcharacteristics | The Guidant FLEX 10® MIS Ablation Probe incorporates the same fundamentalscientific technology as the predicate device. | |
| Performancedata | The results of the verification testing demonstrate that the Guidant FLEX 10®MIS Ablation Probe meets the established acceptance criteria and performs in amanner substantially equivalent to the predicate device. |
K 061 865
:
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Guidant Corporation c/o Ms. Christina L. Rowe Principal Regulatory Affairs Associate 3200 Lakeside Drive
Re: K061865
Santa Clara, CA 95054-2807
Trade/Device Name: Guidant FLEX 108 MIS Ablation Probe Regulatory Number: 21 CFR 878.4400 Regulatory Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL, NEY Dated: June 30, 2006 Received: July 11 2006
FEB 2 1 2008
Dear Ms. Rowe:
This letter corrects our substantially equivalent letter of July 27, 2006.
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 (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 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.
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Page 2 - Ms. Christina L. Rowe
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.
This letter will allow you to continue 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) 276-0120. 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/dsma/dsmamain.html
Sincerely vours.
e2gmaell
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX B: INDICATIONS FOR USE STATEMENT
| 510(k) number (if known) | K061865 |
|---|---|
| Device name | Guidant FLEX 10® MIS Ablation Probe |
| Indications for Use | The Guidant FLEX 10® MIS Ablation Probe is indicated for the surgical ablation of soft tissue and striated, cardiac, and smooth muscles. The system is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis. |
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
| Qoncurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number Kob1865
§ 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.