(90 days)
Not Found
No
The summary describes a standard electrosurgical device and makes no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
No
The device performs ablation, resection, and coagulation of tissue, as well as hemostasis, which are surgical interventions rather than therapeutic treatments.
No
The device is described for ablation, resection, coagulation, and hemostasis of soft tissue, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states that the ENTec Plasma Wands are "bipolar, high frequency electrosurgical devices," which are hardware components. They are designed to be used with a "Plasma Surgery System," also indicating a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The ENTec Plasma Wands are described as electrosurgical devices used for ablation, resection, coagulation, and hemostasis of soft tissue and blood vessels during surgical procedures. This involves direct interaction with the patient's body during surgery, not the analysis of samples taken from the body.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, diagnostic purposes, or any of the typical components or processes associated with IVD devices (e.g., reagents, assays, sample preparation).
Therefore, the ENTec Plasma Wands are surgical devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The ENTec Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- Adenoidectomy
- Cysts
- Head, Neck, Oral, and Sinus Surgery
- Mastoidectomy
- Myringotomy with Effective Hemorrhage Control
- Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
- Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- Neck Mass
- Papilloma Keloids
- Submucosal Palatal Shrinkage
- Submucosal Tissue Shrinkage
- Tonsillectomy
- Traditional Uvulopalatoplasty (RAUP)
- Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of Snoring
Product codes
GEI
Device Description
The ENTec Plasma Wands are bipolar, high frequency electrosurgical devices designed to be used in conjunction with the ENTec Coblator Plasma Surgery System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, blood vessels in otorhinolaryngology (ENT) surgery (Adenoids, Cysts, Head, Neck, Oral, Sinus, Mastoid, Nasal Turbinates, Nasopharyngeal, Laryngeal, Tracheal, Uvula/Soft Palate)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K973478, K000036, K000778, K011279, K982717, K981361, K001253, K011703, K002987
Reference Device(s)
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
ArthroCare
CORPORATION
MAR 2 8 2002
510(k) Summary ArthroCare Corporation ENTec® Plasma Wands™
KO14290
General Information
Manufacturer:
ArthroCare, Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
Establishment Registration Number:
Contact Person:
2951580
Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research
Date Prcpared:
Device Description
Trade Namc:
ENTcc® Plasma Wands™M
December xx, 2001
Generic/Common Name:
Classification Name:
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Electrosurgical Device and Accessories
Predicate Devices
| Predicate Devices | |
|---|---|
| ENTec Coblator™ Plasma Surgery System | K973478, K000036, |
| K000778, and K011279 | |
| Somnus Somnoplasty System | K982717 |
| Ethicon PowerStar Bipolar Scissors | K981361 |
| Ellman Surgitron IEC II | K001253 |
| Lumenis VersaPulse PowerSuite Holmium | |
| (Ho:YAG) and Dual Wavelength | |
| (Ho:YAG/Nd:YAC) Surgical Lasers | K011703 |
| Medtronic Xomed Monopolar Energized | |
| Blade | K002987 |
680 Vaqueros Avenue • Sunnyvale, CA 94085 • (408) 736-0224 • Fax: (408) 736-0226
1
Intended Use
The ENTec Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- Adenoidectomy 예
- 미 Cysts
- Head, Neck, Oral, and Sinus Surgery 트
- 트 Mastoidectomy
- Myringotomy with Effective Hemorrhage Control 인
- Nasal Airway Obstruction by Reduction of Hypertrophic . Nasal Turbinates
- Nasopharyngeal/Laryngeal indications including 파 Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- 트 Neck Mass
- 트 Papilloma Keloids
- Submucosal Palatal Shrinkage ■
- Submucosal Tissue Shrinkage 트
- 이 Tonsillectomy
- 프 Traditional Uvulopalatoplasty (RAUP)
- 트 Tumors
- 피 Tissue in the Uvula/Soft Palate for the Treatment of Snoring
Product Description
The ENTec Plasma Wands are bipolar, high frequency electrosurgical devices designed to be used in conjunction with the ENTec Coblator Plasma Surgery System.
Substantial Equivalence
In establishing substantial equivalence to the predicate devices, ArthroCare evaluated the indications for use, materials incorporated, product specifications, and energy requirements of those systems. The expansion of the indications to include specific ENT procedures does not raise any new issues of safety or efficacy.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol in the center, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
MAR 2 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
Re: K014290
Trade/Device Name: ENTec® Plasma Wands™ Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 27, 2001 Received: December 28, 2001
Dear Mr. Prothro:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfal to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce pror to 114) 2011-01-11 in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, alors, and controls 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 or any I vith 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 - Mr. Bruce Prothro
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). 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,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D.
Director Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
ENTec® Plasma Wands™ Device Name: K 014290 510(k) Number:
Indications for Use:
The ENTec Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- Adenoidectomy .
- Cysts 요
- Head, Neck, Oral, and Sinus Surgery 체
- 속 Mastoidectomy
- Myringotomy with Effective Hemorrhage Control 예
- Nasal Airway Obstruction by Reduction of Hypertrophic 트 Nasal Turbinates
- Nasopharyngeal/Laryngeal indications including u Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- Neck Mass 때
- Papilloma Keloids 의
- Submucosal Palatal Shrinkage 1
- Submucosal Tissue Shrinkage 속
- Tonsillectomy
- Traditional Uvulopalatoplasty (RAUP)
- Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of Snoring
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | ||
| (Per 21 CFR 801 109) | X OR | Over-the-Counter Use |
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K014290