(13 days)
Not Found
No
The description focuses on radiofrequency energy delivery and hardware/software validation without mentioning AI or ML capabilities.
Yes
The device is intended to ablate soft tissue during general surgery using radiofrequency energy, which is a therapeutic intervention aimed at treating medical conditions.
No
Explanation: The device is described as an ablation system intended to ablate soft tissue during general surgery using radiofrequency energy, indicating a therapeutic rather than diagnostic function.
No
The device description explicitly mentions a "reusable, non-sterile radiofrequency generator" and a "hand-held, sterile, single-use device" (Surgical Ablation Device), indicating significant hardware components. The performance studies also include "hardware qualification."
Based on the provided information, the Medtronic Cardioblate® System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "ablate soft tissue during general surgery using radiofrequency energy." This describes a therapeutic procedure performed on a patient's body, not a test performed on a sample taken from a patient's body.
- Device Description: The device is a radiofrequency generator and a surgical ablation device. These are tools used for surgical intervention, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cardioblate System's function is to surgically modify tissue, which is a therapeutic action, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Medtronic Cardioblate® System is intended to ablate soft tissue during general surgery using radiofrequency energy.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Medtronic Cardioblate® 68000 Generator is a reusable, non-Device Description: sterile radiofrequency generator. In bipolar mode, the generator is attached to a bipolar Surgical Ablation Device (e.g. Model 60831 or 60841), which is the hand-held, sterile, single-use device that applies radiofrequency energy to the selected tissue. The Cardioblate® 68000 Generator is capable of delivering a controlled amount of radiofrequency energy for both Monopolar and Bipolar surgical ablation techniques. The generator delivers up to 50 Watts energy in either the bipolar or monopolar mode.
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)
Verification and validation testing confirms that the functional characteristics of the Cardioblate Surgical Ablation System with the Cardioblate® 68000 Generator are substantially equivalent to the predicate devices cited. This included software validation, hardware qualification, electromagnetic compatibility and safety testing on the generator, and lesion equivalence and transmurality equivalence tests on tissue with the entire system.
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
§ 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
FEB 2 8 2006 KD60400
Page 1 of 2
510(k) SUMMARY of Safety and Effectiveness
(In accordance with SMDA of 1990 and pursuant with 21 CFR 807.92)
I. Applicant Information:
| Date Prepared:
Submitter: | February 3, 2006
Medtronic, Inc. |
|-----------------------------------|-----------------------------------------------------------------------|
| Address: | 710 Medtronic Parkway, NE
Minneapolis, MN 55432-5604 |
| Establishment
Registration No. | 2135394 |
| Contact Person: | David D. Cox, Ph.D.
Senior Principal Regulatory Affairs Specialist |
| Telephone Number: | (763) 391-9251 |
| Fax Number: | (763) 391-9279 |
II. Device Information:
| Trade Name: | Cardioblate® 68000 Generator |
|---|---|
| Common Name: | Cardioblate® Surgical Ablation System, which consists of: |
| • Cardioblate® 68000 Generator | |
| Which can be used with: | |
| • Cardioblate® BP2 Surgical Ablation Device, model 60831 | |
| • Cardioblate® LP Surgical Ablation Device, model 60841 | |
| • Cardioblate® Monopolar Pens (K013392) | |
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification: | Class II, 21 CFR 878.4400 |
| Product Code: | GEI |
| Predicate Device: | Cardioblate® Bipolar Radiofrequency Ablation System |
| 510(k) No. K031247, Reg. No. 878.4400; Product Code: GEI | |
| Predicate Device Intended Use: The Medtronic Cardioblate | |
| System is intended to ablate soft tissue during general surgery | |
| using radiofrequency energy. |
1
K060 400
Page 2 of 2
-
The Medtronic Cardioblate® 68000 Generator is a reusable, non-Device Description: sterile radiofrequency generator. In bipolar mode, the generator is attached to a bipolar Surgical Ablation Device (e.g. Model 60831 or 60841), which is the hand-held, sterile, single-use device that applies radiofrequency energy to the selected tissue.
The Cardioblate® 68000 Generator is capable of delivering a controlled amount of radiofrequency energy for both Monopolar and Bipolar surgical ablation techniques. The generator delivers up to 50 Watts energy in either the bipolar or monopolar mode. -
The Cardioblate® Surgical Ablation System is intended to ablate Intended Use: soft tissue during general surgery using radiofrequency energy.
-
The Cardioblate® Surgical Ablation System is contraindicated for Contraindications: patients that have active endocarditis at the time of surgery.
-
The Cardioblate® Surgical Ablation System with the model 68000 Predicate Device: Generator is substantially equivalent to the Cardioblate" Surgical Ablation System with the Model 60890 Generator cleared by K031247. The Generator uses the same energy source to deliver the same amount of radiofrequency energy to ablate tissues, and uses the same surgical ablation devices. Although both generators use the same algorithms to operate, the Model 68000 Generator is updated to include a touchscreen interface, an updated microprocessor and a molded, ergonomic case.
-
Verification and validation testing confirms that the functional Test Data: characteristics of the Cardioblate Surgical Ablation System with the Cardioblate® 68000 Generator are substantially equivalent to the predicate devices cited. This included software validation, hardware qualification, electromagnetic compatibility and safety testing on the generator, and lesion equivalence and transmurality equivalence tests on tissue with the entire system.
-
Based on the technical information, intended use, laboratory Summary: verification tests and in vitro performance information provided, the system which includes the Cardioblate® 68000 in substantially equivalent to the currently marketed predicate device.
Comparison to
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2006
Medtronic, Inc. c/o Ms. Silvia Ankova Senior Project Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062
Re: K060400
Trade/Device Name: Medtronic Cardioblate® 68000 Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 10, 2006 Received: February 15, 2006
Dear Ms. Ankova:
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 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.
3
Page 2 - Ms. Ankova
This letter will allow you to begin marketing your device as described in your Section 510(k) This icticle will anow you to begin manieting of substantial equivalence of your device to a legally premarket nonifeddom "Te 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 If you desire specific at no 10-10-10-115. Also, please note the regulation entitled, Comation of Ornec of Compilance and Ert notification" (21 CFR Part 807.97). You may obtain Whisoranding of Torerence to promesponsibilities under the Act from the Division of Small other general mionnational and Consumer Assistance at its toll-free number (800) 638-2041 or Mandracturers, International and ddress http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
fa Mark N. Melkerson, M.S.
Acting Director
Division of General, Restorative and
Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number:
K 060400
Device Name: Medtronic Cardioblate® 68000 Generator
Indications for use:
The Medtronic Cardioblate® System is intended to ablate soft tissue during general surgery using radiofrequency energy.
Prescription Use X (Part 21 CFR 801 Subpart D) OR Over-The-Counter-Use (Part 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)
Q.MDL
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
长060400 510(k) Number_
Medtronic Cardioblate® 68000 Generator 510(k) Premarket Notification
Section 4 - Page 1