(22 days)
LeVeen™ Needle Electrode
Not Found
No
The description focuses on the physical components and function of a standard RF ablation electrode, with no mention of AI or ML capabilities.
Yes
The device is used for "thermal coagulation necrosis of soft tissues," which is a medical treatment.
No
The device is described as an electrosurgical device for thermal coagulation necrosis of soft tissues, indicating a therapeutic rather than diagnostic function. It is used to ablate lesions, not to diagnose them.
No
The device description clearly states it is a "disposable, monopolar, electrosurgical device" consisting of physical components like an electrode tip, needle, handle, and cable. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Soloist™ Single Needle Electrode Function: The Soloist™ Single Needle Electrode is used directly on soft tissues within the body to perform thermal coagulation necrosis. It delivers energy to heat and destroy tissue. This is an in vivo procedure, not an in vitro test.
- Intended Use: The intended use clearly states it's for "thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions." This describes a therapeutic intervention performed on the patient's body.
Therefore, the Soloist™ Single Needle Electrode is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Soloist™ Single Needle Electrode is intended to be used in conjunction with a Boston Scientific radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
Product codes
GEI
Device Description
The Soloist™ Single Needle Electrode is a disposable, monopolar, electrosurgical device. The device consists of an electrode tip, an insulated delivery needle with handle, and cable. The Soloist™ Single Needle Electrode is connected to Boston Scientific radiofrequency (RF) generator so that energy passes into the electrode tip and heats the surrounding tissue. The device is also compatible with and may be used in conjunction with the Boston Scientific Coaccess™ Introducer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, including nonresectable liver lesions.
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)
The Soloist™ Single Needle Electrode has been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LeVeen™ Needle Electrode
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.
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NOV 3 0 2005
Special 510(k) Soloist™ Single Needle Electrode November 7, 2005
K 053128
Summary of Safety and Effectiveness
Page 1 of 2
This 510(k) sunmary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
| General Information | Submitter: Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752
508-683-4003 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Nicholas Condakes |
| General Provisions | Trade Name: Soloist™ Single Needle Electrode
Classification Name: Electrode, Electrosurgical |
| Name of Predicate Devices | LeVeen™ Needle Electrode |
| Classification | Class II |
| Performance Standards | The Soloist™ Single Needle Electrode has been designed to comply with the applicable sections of: |
| | ANSI/AAMI HF-18: 2001, Electrosurgical DevicesEN 60601-2-2: 2000, Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical EquipmentEN 60601-1:1990/Amd.1:1993/Amd.11:1993/Amd.12:1993/Amd.2: 1995/Amd 13:1996. Medical Electrical Equipment Part 1 General Requirements for SafetyEN ISO 10555-5: 1997/Amd 1: 2000, Sterile single use intravascular cathetersEN 1707: 1996, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Lock fittings. |
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Soloist™ Single Needle Electrode November 7, 2005
Soloist™ Single Needle Electrode is intended to be used in conjunction with a Intended Use Boston Scientific radiofrequency (RF) generator for the thermal coagulation and Device Description necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
The Soloist™ Single Needle Electrode is a disposable, monopolar, electrosurgical device. The device consists of an electrode tip, an insulated delivery needle with handle, and cable.
The Soloist™ Single Needle Electrode is connected to Boston Scientific radiofrequency (RF) generator so that energy passes into the electrode tip and heats the surrounding tissue. The device is also compatible with and may be used in conjunction with the Boston Scientific Coaccess™ Introducer.
Summary of Substantial Equivalence
The Soloist™ Single Needle Electrode has been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2005
Nicholas Condakes Sr. Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way Marlborough, Massachusetts 01752
Re: K053128
Trade/Device Name: Soloist™ Single Needle Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 7, 2005 Received: November 8, 2005
Dear Mr. Condakes:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated 976, the enactment date of the Medical Device Amendments, or to commerce prior to trial 2011-11-11 accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). allu Cosmetic Act (11ct) that to her request to the general controls provisions of the Act. The r ou may, dierelore, mans of the Act include requirements for annual registration, listing of general controld providering 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 If your device is clusiblined (600 a 270) als. Existing major regulations affecting your device can may be subject to satin adata a and regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oouverements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Drivisance sour device complies with other requirements of the Act that I Dr has intates and regulations administered by other Federal agencies. You must of any I carates and 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 CFN in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo lotet notification. The FDA finding of substantial equivalence of your device to a legally promateer notincted 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 If you abon't the Office of Compliance at (240) 276-0115. 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 other general mistmance in Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Naibare Bneem
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k) Soloist™ Single Needle Electrode November 7, 2005
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Indications For Use
| 510(k)
Number
| (if known) | K053128 |
|---|---|
| Device Name: | Soloist™ Single Needle Electrode |
| Indications | |
| for Use | Soloist™ Single Needle Electrode is intended to be used in conjunction with a |
| Boston Scientific radiofrequency (RF) generator for the thermal coagulation | |
| necrosis of soft tissues, including partial or complete ablation of | |
| nonresectable liver lesions. | |
| Prescription Use | |
| (Per 21 CFR 801 Subpart D) | X |
| 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 I valuation (OD) =
harlaue buens
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
ornitions! scon scientific Company of
510(k) Number K053128
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