(148 days)
MEDISISS Reprocessed ENT Ablation Wands (Coblators) are indicated for coagulation, ablation, resection, of soft tissue and hemostasis of blood vessels in otoloaryngology (ENT) procedures including: tonsillectomy/adenoidectomy and soft tissue reduction.
The device is a high frequency, bipolar ablation wand with suction capability that contains an integrated electrical cable and integrated saline delivery system.
The provided text is a 510(k) notification for MEDISISS Reprocessed ENT Ablation Wands (Coblators). This document is for a medical device (an ablation wand) and not for an AI/ML powered medical device. Therefore, the information requested such as "acceptance criteria and the study that proves the device meets the acceptance criteria", "sample size used for the test set and the data provenance", "number of experts used to establish the ground truth", "adjudication method", "multi reader multi case (MRMC) comparative effectiveness study", "standalone (i.e. algorithm only without human-in-the-loop performance)", "type of ground truth used", "sample size for the training set", and "how the ground truth for the training set was established" are not applicable to this document. These questions are typically relevant for discussing studies related to the performance of AI/ML algorithms.
The document focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and performance specifications for regulatory clearance, rather than presenting a study with acceptance criteria in the manner requested for an AI/ML device.
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510(k) Notification: MEDISISS Reprocessed ENT Ablation Wands (Coblators)
Section 5: 510(K) Summary of Safety & Effectiveness
100595
| Submitted By | MEDISISS2747 SW 6th St.Redmond, OR 97756 | JUL 23 2010 |
|---|---|---|
| Contact Names | Brandi JamesSr. Director Quality Assurance/Regulatory AffairsP: 541-923-3310F: 541-923-3375E: bjames@MEDISISS.com | |
| Date Prepared | February 22, 2010 | |
| Proprietary Device Name | MEDISISS Reprocessed ENT Ablation Wands (Coblators) | |
| Classification | Electrosurgical Electrodes, Class II, Electrosurgical cutting and coagulationdevice and accessories, General and plastic surgery (21 CFR 878.4400), GEI | |
| Predicate Devices | K070374 ArthroCare ENT® Plasma Wands™K014290 ArthroCare ENTec® Plasma Wands™K063538 ArthroCare ENT® Plasma Wands™K013463 ArthroCare ArthroWands®, ENTec® EVac™ Plasma Wand™K012669 MEDISISS Reprocessed Soft Tissue Ablators | |
| Intended Use | MEDISISS Reprocessed ENT Ablation Wands (Coblators) are indicated forcoagulation, ablation, resection, of soft tissue and hemostasis of blood vessels inotoloaryngology (ENT) procedures including: tonsillectomy/adenoidectomy andsoft tissue reduction. | |
| Device Description | The device is a high frequency, bipolar ablation wand with suction capabilitythat contains an integrated electrical cable and integrated saline delivery system. | |
| Substantial Equivalence | The indications for use, technological characteristics, and performancespecifications are substantially equivalent to the predicate devices. |
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MEDISISS % Ms. Brandi J. James Sr. Director, Quality Assurance/
JUL 2 3 2010
Regulatory Affairs 2747 SW 6th Street Redmond, Oregon 97756
Re: K100543
Trade/Device Name: Medisiss Reprocessed ENT Ablation Wands Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical cutting and coagulation device
and accessories
Regulatory Class: Class II Product Code: GEI Dated: February 22, 2010 Received: February 25, 2010
Dear Ms. James:
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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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 - Ms. Brandi J. James
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millan
Mark N. Melkerson Director Division of Surgical. Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use
510(k) Number: TBD
Device Name: MEDISISS Reprocessed ENT Ablation Wands (Coblators)
Indications For Use:
MEDISISS Reprocessed ENT Ablation Wands (Coblators) are indicated for coagulation, resection, of soft tissue and hemostasis of blood vessels in otoloaryngology (ENT) procedures including: tonsillectomy/adenoidectomy and soft tissue reduction.
Prescription Use X (Part 21 CFR 801.109)
AND/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 Evaluation (ODE)
Mark A. Mchum
(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Division of Suices
ાડિત્ત્વે ત્વે સ
510(k) Number .
Page 1 of
§ 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.