(84 days)
K984185, Unknown
Not Found
No
The summary describes a standard electrosurgical electrode and does not mention any AI or ML components or functionalities.
Yes
The device is used for electro-coagulation of soft tissue, which is a therapeutic procedure aimed at treating a medical condition (e.g., stopping bleeding, removing abnormal tissue).
No
The device is an electrode used for electro-coagulation of soft tissue, which is a therapeutic rather than a diagnostic procedure. Its stated purpose is treatment (coagulation), not the identification or assessment of a medical condition.
No
The device description clearly states it is a sterile, single-use, monopolar electrode, which is a physical hardware component. It is also designed to be used with an electrosurgical generator, pencil, and dispersive pad, all of which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a surgical electrode used in conjunction with an electrosurgical generator and dispersive pad. This is consistent with a surgical device, not an IVD.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the HeatWave Electrode is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
JOS
Device Description
The HeatWave™ Electrode is a sterile, single-use, monopolar electrode designed to be used in conjunction with an electrosurgical generator via an electrosurgical pencil and a dispersive pad. The HeatWave Electrode will be sold individually and/or in a kit containing an electrode, electrosurgical pencil and an electrosurgical dispersive pad.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, ankle, wrist, elbow and knee
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)
Testing has been done to prove safety and effectiveness of the devices.
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.
K984185, Unknown
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
、元 20 103
August 5, 1999
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the HeatWave™ Electrode, 510(k) Number K991830.
A. Submitter
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Company Contact B.
Laura Seneff Manager, Regulatory Affairs
C. Device Name
| Trade Name: | HeatWave™ Electrode |
|---|---|
| Common Name: | Electrode |
| Classification Names: | Electrosurgical cutting and coagulation device |
| and accessories, 878.4400 | |
| Proposed Class/Device: | |
| Product Code | Class II, 79 JOS, Electrode, |
| Electrosurgical |
D. Predicate/Legally Marketed Devices
TAC™ Probes ORATEC Interventions, Inc.
ArthoWand CAPS ArthroCare Corporation
1
Summary of Safety and Effectiveness HeatWave Electrode 510(k) # K991830 August 5, 1999 Page 2 of 3
E. Device Description
The HeatWave™ Electrode is a sterile, single-use, monopolar electrode designed to be used in conjunction with an electrosurgical generator via an electrosurgical pencil and a dispersive pad. The HeatWave Electrode will be sold individually and/or in a kit containing an electrode, electrosurgical pencil and an electrosurgical dispersive pad.
F. Intended Use
The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.
G. Substantial Equivalence
The HeatWave Electrode is substantially equivalent in design, function and intended use to the TAC™ Probes (ORATEC Interventions, Inc.)and the ArthoWand CAPS (ArthroCare Corporation).
Testing has been done to prove safety and effectiveness of the devices.
The similarities/dissimilarities to the predicates are shown in the attached table.
2
Summary of Safety and Effectiveness HeatWave Electrode 510(k) # K991830 August 5, 1999 Page 3 of 3
CHART OF SIMILARITIES AND DISSIMILARITIES
| Company | Device Name | Intended Use | Material | Single-Use
Reusable
Method of
Sterilization | Design/Dimensions |
|------------------------------------------------------------------|---------------------------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------|----------------------------------------------------------------------------------|
| NEW PRODUCT
Linvatec | HeatWaveTM
Electrode | Electro-coagulation of soft
tissue in shoulder, ankle,
wrist, elbow and knee
arthroscopic procedures | Tip/Shaft: 303 Stainless Steel
Shrink Tube: Kynar
Hub: Polystyrene | Single-Use
ETO | Diameter: 2.3mm
3.0mm
4.0mm
Working length: 4-8½in.
Monopolar |
| PREDICATE
ORATEC
Interventions, Inc.
510(k)#
K984185 | TAC-STM
Monopolar
Cautery Probe | Electro-coagulation of soft
tissue in shoulder, ankle,
wrist, elbow and knee
arthroscopic procedures | Tip/Shaft: 303 Stainless Steel
Shrink Tube: Teflon
Hub/Connector: ABS Plastic | Single Use
Sterilization
Method Unknown | Diameter: 2.0mm
Working Length: 6 in.
Monopolar |
| PREDICATE
ArthroCare
Corporation
510(K) #
Unknown | ARTHROWAND
CAPS | Electro-coagulation of soft
tissue during arthroscopic
procedures | Shaft: 300 Series Stainless Steel
Tip: Ceramic
Hub/Connector: ABS Plastic | Single-Use
Sterilization
Method Unknown | Degree/Diameter:
25°/3.0mm
35°/3.0mm
Working length: 5.0 in.
Bipolar |
3
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 20 1999
Ms. Laura Seneff Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773
K991830 Re: Trade Name: HeatWave™ Electrode Regulatory Class: II Product Code: JOS Dated: August 5, 1999 Received: August 10, 1999
Dear Ms. Seneff:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Ms. Laura Seneff
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
Ser
Plumell J. Rayer
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
August 5, 1999
Page 1 of 1
510(k) Number (if known): K991830
Device Name: HeatWave™ Electrode
Indications for Use:
The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the-Counter Use
(Per 21 CFR 801.109)
Thunell V. Hagen for Jas
(Division Sign-Off Division of General Res 510lk) Number
(Optional Format 1-2-96)