(384 days)
Not Found
No
The device description focuses on manual controls and standard electrical components, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for "coagulation of soft tissue," which is a direct medical intervention to treat or manage a condition, thereby performing a therapeutic function.
No
The device is intended for the coagulation of soft tissue, indicating a therapeutic or surgical function rather than a diagnostic one.
No
The device description explicitly details hardware components including an external microwave generator, probe, electric circuits, circuit boards, cooling fans, power supply, and a microwave module. It is a physical system, not software only.
Based on the provided information, the VivaWave™ Microwave System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "coagulation of soft tissue." This is a therapeutic procedure performed in vivo (within the body) on a patient.
- Device Description: The device is a microwave system with a generator and probe designed to deliver energy to tissue. This aligns with a therapeutic device, not a diagnostic one that analyzes samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VivaWave™ system's function is to directly treat tissue within the body.
N/A
Intended Use / Indications for Use
The VivaWave™ Microwave System is intended for coagulation of soft tissue
Product codes (comma separated list FDA assigned to the subject device)
NEY, GEI
Device Description
The VivaWave™ Microwave System consists of an external microwave generator and probe. The generator is manually set at the desired power levels by the operator. Procedure time is also preset by the operator. The generator is connected to the probe through a connector.
The external generator unit measures approximately ( 13"H x 17"W x 3.5"D) The exterior housing is formed of aluminum coated with plastic. The unit contains electric circuits, circuit boards, and integrated control panel. The major components of the generator are cooling fans, power supply, microwave module and the front panel/control board assembly.
The probe is a specifically designed antenna coated with Teflon (PTFE). The probe is permanently attached to a cable that carries the energy from the generator to the tip of the probe. The proximal end of the cable has a connector that fits into the generator and allows the energy to be delivered to the probe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Product testing was conducted to evaluate conformance to product specification. Biocompatibility testing was conducted in accordance with ISO 10993. All materials used in the VivaWave™ Microwave System are biocompatible and suitable for use.
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.
K864413, K861904, K981672, K962313, K962692
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
Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines that suggest the shape of a bird's head and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 9 2004
Vivant Medical, Inc. c/o Mr. Steven Kim Director, Research and Development 1916-A Old Middlefield Way Mountain View, CA 94043
Re: K011676
Trade Name: VivaWave™ Microwave System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II (two) Product Code: NEY and GEI Dated: May 8, 2002 Received: May 9, 2002
Dear Mr. Kim:
This letter corrects our substantially equivalent letter of June 18, 2002 regarding the regulation name and number for your device. The regulation number for product code NEY has been changed from 878.4350 to 878.4400.
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 - Mr. Steven Kim
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 (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 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 (301) 594-4646. 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 may be obtained 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.
B. Zimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
This application
Device Name:
VivaWave™ Microwave System
Indications for Use:
The VivaWave™ Microwave System is intended for coagulation of soft tissue
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
Hypt. Rhode
(Division Sign-Off) Division of General, Restorative and Neurological Devices
OR
. ·
510(k) Number_1 KD/1676
3
510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | VivaWave™ Microwave System |
| Submitter | Vivant Medical, Inc. |
| 1916-A Old Middlefield Way | |
| Mountain View, CA 94043 | |
| 650-694-2900 | |
| Contact | Steven Kim |
| Director of Research and Development |
Intended Use
The VivaWave™ Microwave System is intended for coagulation of soft tissue
Predicate Devices
| HSE-5M Microtaze - Cooper Lasersonics, Inc. | K864413 |
|---|---|
| HHS-15M Microtaze - Cooper Lasersonics, Inc. | K861904 |
| RF-2000 RF Generator - RadioTherapeutics Corp | K981672 |
| LeVeen Needle Electrode - RadioTherapeutics Corp | K962313 |
| Model 30-6 Multielectrode Array Probe - Zomed Intl | K962692 |
Device Description
The VivaWave™ Microwave System consists of an external microwave generator and probe. The generator is manually set at the desired power levels by the operator. Procedure time is also preset by the operator. The generator is connected to the probe through a connector.
The external generator unit measures approximately ( 13"H x 17"W x 3.5"D) The exterior housing is formed of aluminum coated with plastic.
4
The unit contains electric circuits, circuit boards, and integrated control panel. The major components of the generator are cooling fans, power supply, microwave module and the front panel/control board assembly.
The probe is a specifically designed antenna coated with Teflon (PTFE). The probe is permanently attached to a cable that carries the energy from the generator to the tip of the probe. The proximal end of the cable has a connector that fits into the generator and allows the energy to be delivered to the probe.
Materials
All patient contact materials used in the manufacture of the VivaWave™ Microwave System are suitable for this use and have been used in numerous previously cleared products.
Testing
The generator is designed to comply with electrical safety (EN60601-1) and electromagnetic compatibility (EN60601-1-2). Product testing was conducted to evaluate conformance to product specification. Biocompatibility testing was conducted in accordance with ISO 10993. All materials used in the VivaWave™ Microwave System are biocompatible and suitable for use.
Summary of Substantial Equivalence
The VivaWave™ Microwave System is equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent. Vivant Medical believes the VivaWave™ Microwave System is substantially equivalent to existing legally marketed devices.