(30 days)
No
The summary describes a traditional electrosurgical device and makes no mention of AI or ML.
Yes
The device is indicated for various surgical procedures to treat specific medical conditions, which aligns with the definition of a therapeutic device.
No
The document describes a surgical device used for ablation, resection, coagulation, and hemostasis, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states the device is a "bipolar, single use, high frequency electrosurgical device," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "bipolar, single use, high frequency electrosurgical device." This is a surgical tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside of the body on samples taken from the body. This device is used inside the body during surgery.
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 Wands are bipolar, single use, high frequency electrosurgical devices designed for a variety of ENT applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Otorhinolaryngology (ENT) surgery including adenoids, cysts, head, neck, oral, sinus, mastoid, middle ear, nasal airway, nasal turbinates, nasopharynx, larynx, trachea, 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)
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
MAY 3 0 2002
Image /page/0/Picture/1 description: The image shows the logo for ArthroCare Corporation. The logo features a stylized letter "A" followed by the text "rthroCare" in a serif font. Below "rthroCare" is the word "CORPORATION" in smaller, sans-serif letters.
510(k) Summary 1021364 ArthroCare Corporation Electrosurgery Wands
General Information Submitters Name/Address: ArthroCare Corporation 680 Vaqueros Ave. Sunnyvale, CA 94085-2936 2951580 Establishment Registration Number: Valerie Defiesta-Ng Contact Person: Director, Regulatory Affairs (408) 736-0224 Phone Number: April 29, 2002 Date Prepared: Device Description ENTec® Plasma Wands Trade Name: Electrosurgical Device and Accessories Generic/Common Name: Electrosurgical Cutting and Coagulation Classification Name: Device and Accessories (21 CFR 878.4400) Predicate Devices
ENTec Plasma Wands
K014290; cleared on March 28, 2002
Product Description
The Wands are bipolar, single use, high frequency electrosurgical devices designed for a variety of ENT applications.
ix
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 ■
- Cysts 로
- Head, Neck, Oral, and Sinus Surgery 로
- 미 Mastoidectomy
- Myringotomy with Effective Hemorrhage Control ■
- Nasal Airway Obstruction by Reduction of Hypertrophic 트 Nasal Turbinates
- Nasopharyngeal/Laryngeal indications including 트 Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- 에 Neck Mass
- Papilloma Keloids 트
- Submucosal Palatal Shrinkage 이
- Submucosal Tissue Shrinkage 이
- 트 Tonsillectomy
- Traditional Uvulopalatoplasty (RAUP) 트
- Tumors 트
- Tissue in the Uvula/Soft Palate for the Treatment of 비 Snoring
Substantial Equivalence
This Special 510(k) proposes a modification in labeling for the Wands, which were previously cleared under K014290 on March 28, 2002. The indications for use, technology, principle of operation, packaging, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)s.
Summary of Safety and Effectiveness
The Wands, as described in this submission, are substantially equivalent to the predicate, The proposed modification in labeling is not a substantial change or unmodified Wands. modification, and does not significantly affect the safety or efficacy of the devices.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2002
Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
Re: K021364
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: April 29, 2002 Received: April 30, 2002
Dear Ms. Defiesta-Ng:
We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave roview your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sured in the encreases)76 the enactment date of the Medical Device Amendments, or to econments that have been reclassified in accordance with the provisions of the Federal Food, Drug, de noos martie 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 r ou may , ateres, while 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Valerie Defiesta-Ng
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,
uriam C. Provost
for 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 Statement
Device Name:
ENTec® Plasma Wands
510(k) Number:
K 021364
Indications for 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 I
- 프 Cysts
- Head, Neck, Oral, and Sinus Surgery 트
- 프 Mastoidectomy
- Myringotomy with Effective Hemorrhage Control ■
- Nasal Airway Obstruction by Reduction of Hypertrophic 피 Nasal Turbinates
- Nasopharyngeal/Laryngeal indications including 프 Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- 이 Neck Mass
- 트 Papilloma Keloids
- 프 Submucosal Palatal Shrinkage
- Submucosal Tissue Shrinkage 피
- Tonsillectomy 해
- Traditional Uvulopalatoplasty (RAUP) 車
- Tumors 트
- Tissue in the Uvula/Soft Palate for the Treatment of 트 Snoring
X
(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) OR
Over-the-Counter Use
Muriam C. Provost
(Division Sign-Off) (Division of General, Restorative Division ological Devices
510(k) Number K021364