(27 days)
Not Found
No
The document describes a simple irrigation pump accessory for electrosurgery systems, with no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device description clearly states that the ArthroCare Irrigation Pump is an "accessory" designed to automate the flow of conductive media and does not directly perform therapeutic functions such as ablation, resection, coagulation, or hemostasis, which are indicated for the associated Electrosurgery Systems.
No
Explanation: The device description states that the ArthroCare Irrigation Pump is "designed to automate the flow of conductive media during soft tissue ablation and coagulation where conductive media must be delivered to the treatment site." Its intended use is described in conjunction with electrosurgery systems for ablation, resection, coagulation, and hemostasis of soft tissue and blood vessels. These are all therapeutic and surgical functions, not diagnostic. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description explicitly states it consists of a physical "Irrigation Pump and Flow Control Cable," indicating it is a hardware device with potential software control, not a software-only device.
Based on the provided information, the ArthroCare Irrigation Pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- ArthroCare Irrigation Pump's Function: The description clearly states the Irrigation Pump is an accessory used with electrosurgery systems to automate the flow of conductive media during surgical procedures (ablation, resection, coagulation, hemostasis). It is used on the patient during surgery, not for analyzing specimens outside the body.
- Intended Use: The intended use is for facilitating surgical procedures in specific anatomical areas (ENT, orthopedic, etc.), not for diagnostic testing of bodily fluids or tissues.
Therefore, the ArthroCare Irrigation Pump falls under the category of a surgical accessory or device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ArthroCare Irrigation Pump is an accessory, supplied separately, that can be used with the following Electrosurgery Systems for the referenced indications:
- The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and . coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
- The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, • and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
Product codes
GEI, GXI
Device Description
The Irrigation Pump is an accessory that may be used with ArthroCare's Electrosurgery Systems. The Irrigation Pump consists of the Irrigation Pump and Flow Control Cable. The ArthroCare Irrigation Pump is designed to automate the flow of conductive media during soft tissue ablation and coagulation where conductive media must be delivered to the treatment site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, blood vessels
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
MAR 2 0 2008
2482 510(k) Summary
ArtroCare Corporation ArthroCare Irrigation Pump
Page 1 of ②
| Manufacturer: | ArthroCare Corporation |
|---|---|
| 680 Vaqueros Avenue | |
| Sunnyvale, CA 94085-2936 | |
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng |
| Director, Regulatory Affairs | |
| Date Prepared: | February 21, 2008 |
| Device Description | |
| Classification Name: | Electrosurgical Cutting and Coagulation |
| Device and Accessories | |
| (21 CFR 878.4400) | |
| Trade Name: | ArthroCare Irrigation Pump |
| Generic/Common Name: | Electrosurgical Device and Accessories |
Predicate Devices
| · ArthroCare Flow Control Unit | K001904; cleared July 17, 2000 |
|---|---|
| -------------------------------- | -------------------------------- |
Intended Use
The ArthroCare Irrigation Pump is an accessory, supplied separately, that can be used with the following Electrosurgery Systems for the referenced indications:
- The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and . coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
- The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, • and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
1
Product Description
Page 2 of ②
The Irrigation Pump is an accessory that may be used with ArthroCare's Electrosurgery Systems. The Irrigation Pump consists of the Irrigation Pump and Flow Control Cable. The ArthroCare Irrigation Pump is designed to automate the flow of conductive media during soft tissue ablation and coagulation where conductive media must be delivered to the treatment site.
Substantial Equivalence
This Special 510(k) proposes a modification in the preformance specifications, ergonomic user interface, and labeling for the ArthroCare Flow Control Unit which was previoulsy cleared under K001904 on July 17, 2000. The indications for use and principal of operation remain the same as in the originally cleared 510(k).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of curved lines and shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2008
ArthroCare Corporation % Ms. Valerie DeFiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523
Re: K080482
Trade/Device Name: ArthroCare Irrigation Pump Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, GXI Dated: February 21, 2008 Received: February 22, 2008
Dear Ms. DeFiesta-Ng:
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.
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/industry/support/index.html.
Sincerely vours.
Mark M. Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications Statement
Device Name: ArthroCare Irrigation Pump
K_080482 510(k) Number:
Indications for use:
The ArthroCare Irrigation Pump is an accessory, supplied separately, that can be used with the following Electrosurgery Systems for the referenced indications:
- The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and . coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
- The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Imita
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
X
510(k) Number