(190 days)
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Not Found
No
The summary describes a standard electrosurgical wand for arthroscopic procedures and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended for resection, ablation, coagulation, and hemostasis of tissues during arthroscopic procedures, which are therapeutic interventions.
No
The device is described as an arthroscopic wand electrode intended for resection, ablation, coagulation, and hemostasis of soft tissues, which are therapeutic functions, not diagnostic ones.
No
The description focuses on a physical "arthroscopic wand electrode" and its intended use with an "electrosurgical unit," which are hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a surgical procedure (arthroscopy) for direct tissue manipulation (resection, ablation, coagulation, hemostasis). This is an in vivo application, meaning it's used within a living organism.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health.
The description of the arthroscopic wand electrode's function is entirely focused on surgical intervention within the body, not on analyzing biological samples.
N/A
Intended Use / Indications for Use
When coupled with a compatible electrosurgical unit, an arthroscopic wand electrode is intended for resection, ablation and coagulation of soft tissues and for hemostasis of blood vessels during arthroscopic procedures (of the knee, shoulder, ankle, elbow, and wrist) that utilize a conductive irrigant.
Product codes
NUJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
knee, shoulder, ankle, elbow, and wrist
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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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.
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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).
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other.
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a simple, sans-serif font. The logo is black and white.
MAY 1 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ascent Healthcare Solutions % Ms. Moira Barton-Varty Senior Director, Regulatory Affairs 10232 South 51st Street Phoenix, Arizona 85044
Re: K043198- Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NUJ Dated: November 17, 2004 Received: November 18, 2004
Dear Ms. Barton-Varty:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on May 27, 2005. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices 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 devices comply 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 applicable requirements, including, but not limited to: registration and
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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.
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K043198
Vanguard Reprocessed Arthroscopic Wands Device Name:
Indications for Use:
Prescription Use _____________________________________________________________________________________________________________________________________________________________
When coupled with a compatible electrosurgical unit, an arthroscopic wand electrode is intended for resection, ablation and coagulation of soft tissues and for hemostasis of blood vessels during arthroscopic procedures (of the knee, shoulder, ankle, elbow, and wrist) that utilize a conductive irrigant.
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K043198 |
|---|---|
| Page 1 of |
AND / OR
Over-The-Counter Use
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Page 4 - Ms. Moira Barton-Varty
Reprocessed Arthroscopic Wand or Soft Tissue Ablators found to be substantially equivalent:
ArthroWand®, TurboVac® 90, ASC 1335-01 ArthroWand®, CoVac 50®, ASC 2530-01 ArthroWand®, TriStar 50®, ASC 4630-01 ArthroWand®, Eliminator™, AC 1345-01 ArthroWand®, Sabre 30, AC 4335-01