(46 days)
No
The summary describes a standard electrosurgical generator and disposable wands for arthroscopic procedures, with no mention of AI or ML capabilities.
Yes
The device is indicated for medical procedures such as resection, ablation, and coagulation of soft tissue, as well as hemostasis of blood vessels, which are therapeutic interventions.
No
The device is described as an electrosurgical generator used for resection, ablation, and coagulation of soft tissue, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is a "bipolar, high frequency, electrosurgical generator called the Controller that is intended to be used with a family of disposable, bipolar, single use Wands," indicating it is a hardware device with associated disposable components.
Based on the provided information, the ArthroCare System 12000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures." This describes a surgical intervention performed directly on the patient's body.
- Device Description: The device is described as a "bipolar, high frequency, electrosurgical generator" used with "disposable, bipolar, single use Wands." This is consistent with surgical equipment used for tissue manipulation and hemostasis.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body. The ArthroCare System 12000 is used on the human body during surgical procedures.
N/A
Intended Use / Indications for Use
The ArthroCare System 12000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist) |
|---|---|
| Ablation and Debridement | |
| • ACL/PCL | Knee |
| • Acromioplasty | Shoulder |
| • Articular Cartilage | All Joints |
| • Bursectomy | All Joints |
| • Chondroplasty | All Joints |
| • Fascia | All Joints |
| • Ligament | All Joints |
| • Notchplasty | Knee |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Subacromial Decompression | Shoulder |
| • Synovectomy | All Joints |
| • Tendon | All Joints |
| Excision and Resection | |
| • Acetabular Labrum | Hip |
| • Articular Labrum | All Joints |
| • Capsule | All Joints |
| • Capsular Release | Knee |
| • Cartilage Flaps | Knee |
| • Cysts | All Joints |
| • Discoid Meniscus | Knee |
| • Frozen Shoulder Release | Shoulder |
| • Glenoidale Labrum | Shoulder |
| • Lateral Release | Knee |
| • Ligament | All Joints |
| • Loose Bodies | All Joints |
| • Meniscal Cystectomy | Knee |
| • Plica Removal | All Joints |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Synovial Membrane | All Joints |
| • Tendon | All Joints |
| • Triangular Fibrocartilage (TFCC) | Wrist |
| • Villusectomy | Knee |
| Coagulation | |
| • ACL/PCL | Knee |
| • Articular Cartilage | All Joints |
| • Carpal Ligaments | Wrist |
| • Glenohumeral Capsule | Shoulder |
| • Ligament | All Joints |
| • Medial Retinaculum | Knee |
| • Rotator Cuff | Shoulder |
| • Tendon | All Joints |
| • Wrist Tendons | Wrist |
Product codes
GEI
Device Description
The ArthroCare System 12000 is a bipolar, high frequency, electrosurgical generator called the Controller that is intended to be used with a family of disposable, bipolar, single use Wands.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, elbow, hip, knee, shoulder, wrist
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)
Performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare System 12000 to the predicate device. The performance testing and device comparison demonstrated that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use.
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
K071709
510(k) Summary
Page 1 of (3)
ArthroCare Corporation ArthroCare® System 12000
AUG - 7 2007
General Information
| Submitter Name/Address: | ArthroCare Corporation
680 Vaqueros Avenue
Sunnyvale, CA 94085-3523 |
|------------------------------------|---------------------------------------------------------------------------|
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng
Director, Regulatory Affairs |
| Date Prepared: | June 20, 2007 |
Device Description
| Trade Name: | ArthroCare® System 12000 |
|---|---|
| Generic/Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation |
| Device and Accessories (Class II, 21 CFR | |
| 878.4400, Product Code GEI) |
Predicate Devices
| ArthroCare® System | K032504 |
|---|---|
| -------------------- | --------- |
Product Description
The ArthroCare System 12000 is a bipolar, high frequency, electrosurgical generator called the Controller that is intended to be used with a family of disposable, bipolar, single use Wands.
1
071709
Page 2 of 3
Intended Uses
The ArthroCare System 12000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
| Arthroscopic and Orthopedic Procedures | Joint Specific or All
Joints (ankle, elbow,
hip, knee, shoulder, and
wrist) |
|----------------------------------------|--------------------------------------------------------------------------------------|
| Ablation and Debridement | |
| • ACL/PCL | Knee |
| • Acromioplasty | Shoulder |
| • Articular Cartilage | All Joints |
| • Bursectomy | All Joints |
| • Chondroplasty | All Joints |
| • Fascia | All Joints |
| • Ligament | All Joints |
| • Notchplasty | Knee |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Subacromial Decompression | Shoulder |
| • Synovectomy | All Joints |
| • Tendon | All Joints |
| Excision and Resection | |
| • Acetabular Labrum | Hip |
| • Articular Labrum | All Joints |
| • Capsule | All Joints |
| • Capsular Release | Knee |
| • Cartilage Flaps | Knee |
| • Cysts | All Joints |
| • Discoid Meniscus | Knee |
| • Frozen Shoulder Release | Shoulder |
| • Glenoidale Labrum | Shoulder |
| • Lateral Release | Knee |
| • Ligament | All Joints |
| • Loose Bodies | All Joints |
| • Meniscal Cystectomy | Knee |
2
Page 3 g (3)
| Continued | |
|---|---|
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist) |
| • Plica Removal | All Joints |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Synovial Membrane | All Joints |
| • Tendon | All Joints |
| • Triangular Fibrocartilage (TFCC) | Wrist |
| • Villusectomy | Knee |
| Coagulation | |
| • ACL/PCL | Knee |
| • Articular Cartilage | All Joints |
| • Carpal Ligaments | Wrist |
| • Glenohumeral Capsule | Shoulder |
| • Ligament | All Joints |
| • Medial Retinaculum | Knee |
| • Rotator Cuff | Shoulder |
| • Tendon | All Joints |
| • Wrist Tendons | Wrist |
Substantial Equivalence
In establishing substantial equivalence to the predicate device, ArthroCare compared the indications for use, dimensional specifications, and performance specifications of the subject device and the predicate device. Additionally, performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare System 12000 to the predicate device. The performance testing and device comparison demonstrated that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use.
Summary of Safety and Effectiveness
The ArthroCare System 12000, as described in this premarket notification 510(k), is substantially equivalent to the predicate device. The differences in performance specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2007
ArthroCare Corpopration % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523
Re: K071709
Trade/Device Name: ArthroCare System 12000 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 20, 2007 Received: June 22, 2007
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.
4
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 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) 633-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark H. Millikan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
Device Name
ArthroCare System 12000
510(k) Number:
K 071709
Page 1 of ②
Indications for Use:
The ArthroCare System 12000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
| | Arthroscopic and Orthopedic Procedures | Joint Specific or All
Joints (ankle, elbow,
hip, knee, shoulder, and
wrist) |
|---|----------------------------------------|--------------------------------------------------------------------------------------|
| | Ablation and Debridement | |
| • | ACL/PCL | Knee |
| • | Acromioplasty | Shoulder |
| • | Articular Cartilage | All Joints |
| • | Bursectomy | All Joints |
| • | Chondroplasty | All Joints |
| • | Fascia | All Joints |
| • | Ligament | All Joints |
| • | Notchplasty | Knee |
| • | Scar Tissue | All Joints |
| • | Soft Tissue | All Joints |
| • | Subacromial Decompression | Shoulder |
| • | Synovectomy | All Joints |
| • | Tendon | All Joints |
| | Excision and Resection | |
| • | Acetabular Labrum | Hip |
| • | Articular Labrum | All Joints |
| • | Capsule | All Joints |
| • | Capsular Release | Knee |
| • | Cartilage Flaps | Knee |
| • | Cysts | All Joints |
| • | Discoid Meniscus | Knee |
| • | Frozen Shoulder Release | Shoulder |
| • | Glenoidale Labrum | Shoulder |
| • | Lateral Release | Knee |
| • | Ligament | All Joints |
| • | Loose Bodies | All Joints |
| • | Meniscal Cystectomy | Knee |
| • | Meniscectomy | Knee |
:
Mark H. Millan
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
xi
6
071709
Page 2 of 2
| Continued |
|---|
| | Arthroscopic and Orthopedic Procedures | Joint Specific or All
Joints (ankle, elbow,
hip, knee, shoulder, and
wrist) |
|---|----------------------------------------|--------------------------------------------------------------------------------------|
| • | Plica Removal | All Joints |
| • | Scar Tissue | All Joints |
| • | Soft Tissue | All Joints |
| • | Synovial Membrane | All Joints |
| • | Tendon | All Joints |
| • | Triangular Fibrocartilage (TFCC) | Wrist |
| • | Villusectomy | Knee |
| | Coagulation | |
| • | ACL/PCL | Knee |
| • | Articular Cartilage | All Joints |
| • | Carpal Ligaments | Wrist |
| • | Glenohumeral Capsule | Shoulder |
| • | Ligament | All Joints |
| • | Medial Retinaculum | Knee |
| • | Rotator Cuff | Shoulder |
| • | Tendon | All Joints |
| • | Wrist Tendons | Wrist |
(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
Mark A. Milburn
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
X
510(k) Number K071709