(14 days)
Not Found
No
The summary describes a standard RF coagulation device and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as coagulating and ablating tissue during surgical procedures, which is a surgical intervention rather than a therapeutic treatment in the sense of directly treating a disease condition.
No
The device is described as a coagulation/ablation device used in surgical procedures, not for diagnosis. Its intended use is to "coagulate tissue," which is a treatment, not a diagnostic act.
No
The device description explicitly states it is a "hand-held Radiofrequency (RF) Device" and a "single use, sterile, bipolar" device, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "coagulate tissue during laparoscopic and intraoperative surgical procedures." This is a direct surgical intervention on the patient's body.
- Device Description: The device is a "hand-held Radiofrequency (RF) Device that is used to coagulate/ablate tissue." This describes a surgical tool used for treatment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
The device is clearly a surgical instrument used for therapeutic purposes (tissue coagulation/ablation) directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The Intine™ Bi-Polar RF Linear Coagulation Device is intended to coaqulate tissue during laparoscopic and intraoperative surgical procedures.
Product codes
GEI
Device Description
The InLine™ Bi-Polar RF Linear Coagulation Device is a single use, sterile, bipolar, hand-held Radiofrequency (RF) Device that is used to coagulate/ablate tissue. The device is designed for use in intraoperative surgical procedures or used through a non-conductive hand-port during laparoscopic surgical procedures.
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)
Bench testing/functional testing was performed on the InLine™ Bi-Polar RF Linear Coagulation Device to ensure that the product is substantially equivalent to the predicate device and to ensure that the new device does not raise new questions of safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KO40763 APPENDIX A. 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Name, Address, Phone and Fax Number of Applicant A.
Resect Medical, Inc. 40874 Calido Place Fremont, CA 94539, USA Telephone: (650) 776-4804 Fax: (510) 573-3343
Contact Person B.
Nancy Lincé
Regulatory Affairs Consultant
Telephone: (650) 759-6186 Fax: (510) 885-9935
C. Date Prepared
February 20, 2004
D. Device Name
Trade Name: InLine™ Bi-Polar RF Linear Coagulation Device
Classification Name: Electrosurgical cutting and coagulation device and accessories
E. Device Description
The InLine™ Bi-Polar RF Linear Coagulation Device is a single use, sterile, bipolar, hand-held Radiofrequency (RF) Device that is used to coagulate/ablate tissue. The device is designed for use in intraoperative surgical procedures or used through a non-conductive hand-port during laparoscopic surgical procedures.
ட். Intended Use Statement:
The Intine™ Bi-Polar RF Linear Coagulation Device is intended to coaqulate tissue during laparoscopic and intraoperative surgical procedures.
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Substantial Equivalence G.
The InLine Bi-Polar RF Linear Coagulation Device is substantially equivalent to the Radionics Cool-tip RF Electrode (K984552). It has the same intended use, similar materials of construction, and principles of operation as the predicate device. Both devices are designed to coagulate tissue by delivering RF energy with the use of electrodes.
Summary of Data: H.
Bench testing/functional testing was performed on the InLine™ Bi-Polar RF Linear Coagulation Device to ensure that the product is substantially equivalent to the predicate device and to ensure that the new device does not raise new questions of safety and efficacy.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 8 2004
Resect Medical, Inc. c/o Mr. J.A. van Vugt KEMA Quality B.V. P.O. Box 5185 6802 Ed Arnhem Arnhem Netherlands
Re: K040763
Trade/Device Name: InLine™ Bi-Polar RF Linear Coagulation Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 24, 2004 Received: March 25, 2004
Dear Mr. van Vugt:
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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. J.A. van Vugt
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: InLine™ Bi-Polar RF Linear Coagulation Device
Indications For Use:
The InLine™ Bi-Polar RF Linear Coagulation Device is intended to coagulate tissue during laparoscopic and intraoperative surgical procedures.
Prescription Use -(Part 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Wilkerson
Division of General, Restorative, and Neurological Devices
510(k) Number K040763
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