(29 days)
Not Found
No
The summary describes a standard electrosurgical device with temperature monitoring and control features, but there is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
This device is a surgical instrument used for resection, ablation, and coagulation of soft tissue, which are therapeutic interventions.
No
The device is an electrosurgical device for resection, ablation, and coagulation, and its performance studies focus on these functions, not on diagnosing medical conditions.
No
The device description clearly states it is a "bipolar, high frequency electrosurgical device" and a "Wand," indicating it is a physical hardware device used in surgical procedures. It also mentions performance bench testing related to hardware function (e.g., Ambient accuracy, ablation performance, coagulation testing).
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 for surgical procedures (resection, ablation, coagulation, hemostasis) on soft tissue and blood vessels within the body during arthroscopic and orthopedic procedures. This is an in vivo application.
- Device Description: The description confirms it's a bipolar, high-frequency electrosurgical device used for surgical interventions.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not for direct surgical intervention within the body.
N/A
Intended Use / Indications for Use
The AMBIENT™ Super MULTIVAC™ 50 Wand with Integrated Finger Switches is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures.
Product codes
GEI
Device Description
The AMBIENT Super MULTIVAC° 50 Wand with Integrated Finger Switches ("Wand") is a bipolar, high frequency electrosurgical device used for specific indications in orthopedic and arthroscopic surgeries. The AMBIENT feature provides accurate (± 3° C) real-time temperature monitoring of the circulating irrigating fluid between 20° C and includes a user adjustable alarm set point. The Wand is designed for use up to five minutes of cumulative active ablation time at the default set point of 7 and is to be used only with the QUANTUM® 2 Controller ("Controller").
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
All Joints (Hip, Knee, Shoulder, Wrist, 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 bench testing, including functional testing, Ambient accuracy, ablation performance, use-limiting and coagulation testing was performed on the subject device which demonstrates that the subject device continues to meet the design requirements and supports substantial equivalence with the predicate device. The tests are listed below:
- . Transit Conditioning
- . Visual Inspection Post-Transit
- . IEC Testing
- Ambient Accuracy Testing .
- Ablation Performance Testing at Default Set Point and Suction ●
- . Coagulation Testing
- Ablation Performance Testing at Default Set Point & Suction & Use Limiting Feature .
- . Use-Limiting Feature
All devices used for verification testing were sent to an ArthroCare approved supplier for sterilization.
All testing demonstrates that the AMBIENT® Super MULTIVAC° 50 Wand with Integrated Finger Switches performs as intended and has acceptable performance when used in accordance with its labeling. As the indications for use, contraindications, principle of operation and technology are unchanged from the predicate device, except for the Integrated Cable, the subject device, AMBIENT^ Super MULTIVAC° 50 Wand with Integrated Finger Switches, is substantially equivalent to the predicate device.
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.
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).
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 1, 2018
ArthroCare Corporation Ms. Shruthi Bhat Regulatory Affairs Specialist II 7000 West William Cannon Drive Austin, Texas 78735
Re: K180848
Trade/Device Name: AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: March 30, 2018 Received: April 2, 2018
Dear Ms. Bhat:
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, 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.
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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
AMBIENT™ Super MULITVAC™ 50 Wand with Integrated Finger Switches
Indications for Use (Describe) See attached below
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a red circular design on the left and the word "ArthroCare" in gray on the right. The circular design is made up of several curved lines that create a sense of movement. The word "ArthroCare" is written in a sans-serif font, and there is a registered trademark symbol next to the word.
Indications for Use:
The AMBIENT Super MULTIVAC® 50 Wand with Integrated Finger Switches is indicated for resection,
ablation, and coagulation of soft tissue and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures.
| Ablation/Debridement | ||
|---|---|---|
| All Joints (Hip, Knee, | ||
| Shoulder, Wrist, | ||
| Ankle, Elbow) | ArticularCartilageBursectomyChondroplastyFasciaLigament | Scar TissueSoft TissueSynovectomyTendon |
| Knee | ACL/PCLNotchplasty | |
| Shoulder | AcromioplastySubacromial Decompression | |
| Excision/Resection | ||
| All Joints (Hip, Knee, | ||
| Shoulder, Wrist, | ||
| Ankle, Elbow) | ArticularLabrumCapsuleCystsLigamentLoose Bodies | Plica RemovalScar TissueSoft TissueSynovial |
| MembraneTendon | ||
| Hip | Acetabular Labrum | |
| Knee | Capsular | |
| ReleaseCartilage FlapsDiscoid | ||
| MeniscusLateral Release | Meniscal | |
| CystectomyMeniscectomyVillusectomy | ||
| Shoulder | Frozen Shoulder ReleaseGlenoidale Labrum | |
| Wrist | Triangular Fibrocartilage (TFCC) | |
| Coagulation | ||
| All Joints (Hip, Knee, | ||
| Shoulder, Wrist, | ||
| Ankle, Elbow) | Articular CartilageLigamentTendon | |
| Knee | ACL/PCLMedial Retinaculum | |
| Shoulder | Glenohumeral CapsuleRotator Cuff | |
| Wrist | Carpal LigamentsWrist Tendons |
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ۾/ 2012.391.3901 | www.arthrocare.com
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Image /page/4/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a circular design on the left, made up of several curved red lines. To the right of the design is the word "ArthroCare" in a dark gray, sans-serif font. A registered trademark symbol is located to the upper right of the word "Care".
510(k) Summary
AMBIENT® Super MULITVAC° 50 Wand with Integrated Finger Switches
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information
| Submitter Name: | ArthroCare Corporation |
|---|---|
| Address | 7000 West William Cannon Drive |
| Austin, TX 78735 | |
| Contact Person: | Mrs. Shruthi Bhat M.Sc. (Biosciences) MS (Regulatory Affairs) |
| Regulatory Affairs Specialist II | |
| ArthroCare Corporation | |
| Phone: (512) 895-1295 | |
| Fax: 512-895-1489 | |
| Email: shruthi.bhat@smith-nephew.com | |
| Address: 7000 West William Cannon Drive | |
| Austin, TX 78735 | |
| Submitter Person: | Mrs. Shruthi Bhat M.Sc. (Biosciences) MS (Regulatory Affairs) |
| Regulatory Affairs Specialist II | |
| ArthroCare Corporation | |
| Phone: (512) 895-1295 | |
| Fax: 512-895-1489 | |
| Email: shruthi.bhat@smith-nephew.com | |
| Address: 7000 West William Cannon Drive | |
| Austin, TX 78735 | |
| Date Prepared: | 30 March 2018 |
Device Name
Proprietary Name: AMBIENT Super MULTIVAC° 50 Wand with Integrated Finger Switches 7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ρέας 512.391.3901 | www.arthrocare.com
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Image /page/5/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a circular design on the left, made up of several curved red lines. To the right of the design is the word "ArthroCare" in a dark gray sans-serif font. A registered trademark symbol is located to the upper right of the word "Care".
| Common Name: | Electrosurgical devices and accessories |
|---|---|
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Device Class: | Class II |
| Product Code: | GEI |
| CFR Section: | 21 CFR 878.4400 |
Predicate Device
AMBIENT Super MULITVAC® 50 Wand with Integrated Finger Switches cleared under 510(k) K083306 (Modification to ArthroCare ArthroWands) on December 10, 2008.
Description
The AMBIENT Super MULTIVAC° 50 Wand with Integrated Finger Switches ("Wand") is a bipolar, high frequency electrosurgical device used for specific indications in orthopedic and arthroscopic surgeries. The AMBIENT feature provides accurate (± 3° C) real-time temperature monitoring of the circulating irrigating fluid between 20° C and includes a user adjustable alarm set point. The Wand is designed for use up to five minutes of cumulative active ablation time at the default set point of 7 and is to be used only with the QUANTUM® 2 Controller ("Controller").
Intended Use/Indications for Use
The AMBIENT Super MULTIVAC* 50 Wand with Integrated Finger Switches is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures.
| Ablation/Debridement | ||
|---|---|---|
| All Joints (Hip, Knee, | ||
| Shoulder, Wrist, | ||
| Ankle, Elbow) | Articular Cartilage Bursectomy Chondroplasty Fascia | Scar Tissue Soft Tissue Synovectomy Tendon |
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | phone 512.391.3901 | www.arthrocare.com
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Image /page/6/Picture/0 description: The image contains the logo for ArthroCare. The logo consists of a circular graphic on the left, composed of several curved red lines. To the right of the graphic is the company name, "ArthroCare," in a dark gray, sans-serif font. A registered trademark symbol is present next to the word "Care".
| Ligament | ||
|---|---|---|
| Knee | ACL/PCL Notchplasty | |
| Shoulder | Acromioplasty Subacromial Decompression | |
| Excision/Resection | ||
| All Joints (Hip, Knee, | ||
| Shoulder, Wrist, | ||
| Ankle, Elbow) | Articular Labrum Capsule Cysts Ligament Loose Bodies | Plica Removal Scar Tissue Soft Tissue Synovial Membrane Tendon |
| Hip | Acetabular Labrum | |
| Knee | Capsular Release Cartilage Flaps Discoid Meniscus Lateral Release | Meniscal Cystectomy Meniscectomy Villusectomy |
| Shoulder | Frozen Shoulder Release Glenoidale Labrum | |
| Wrist | Triangular Fibrocartilage (TFCC) | |
| Coagulation | ||
| All Joints (Hip, Knee, | ||
| Shoulder, Wrist, | ||
| Ankle, Elbow) | Articular Cartilage Ligament Tendon | |
| Knee | ACL/PCL Medial Retinaculum | |
| Shoulder | Glenohumeral Capsule | |
| Rotator Cuff | ||
| Wrist | Carpal Ligaments Wrist Tendons |
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Image /page/7/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized red circular design on the left and the name "ArthroCare" in gray text on the right. The circular design is made up of several curved lines that create a sense of movement. The logo is simple and modern.
Summary of Technological Characteristics
| Parameter/ Characteristics | Predicate Device | Subject Device |
|---|---|---|
| Indications for Use | Resection, ablation, and coagulation | |
| of soft tissue and hemostasis of blood | ||
| vessels in arthroscopic and orthopedic | ||
| procedures. | Same | |
| Arthrocare Controller(s) | Quantum 2 | Same |
| Wand Materials | ||
| Materials Biocompatible | Yes | Same |
| Active Electrode | Tungsten | Same |
| Electrode Insulation | Polyolefin | Same |
| Spacer | Alumina | Same |
| Shaft (Return Electrode) | Stainless Steel | Same |
| Suction Tubing/ Saline Delivery | ||
| Tubing | PVC & Nylon | Same |
| Suction / Irrigation Line | ||
| Connector | PVC | Same |
| Adhesive | Epoxy, Cyanoacrylate, UV Adhesive | Same |
| Cable Assembly Design | The cable assembly is composed of a | |
| cable that at one end contains a unique | ||
| connector with embedded PCBA to | ||
| mate with the RF generator/controller, | ||
| and at the other end contains a PCBA | ||
| that is housed within the handle of the | Same | |
| wand. The cable contains 8 | ||
| conductors. Two (2) of the conductors | ||
| transmit the RF power from the RF | ||
| generator. Six (6) of the conductors | ||
| are used for signal transmission. The | ||
| PCBAs contain wand operating | ||
| parameters and process fingerswitch | ||
| and thermistor inputs and | ||
| communicate with the RF generator | ||
| via the 6 signal transmission | ||
| conductors. | ||
| Resistor R1 in the connector of | ||
| the Integrated Cable | 576 ohms | 1210 ohms |
| Resistor R2 in the connector of | ||
| the Integrated Cable | 1050, 1210, 1300, 1400, 1500, 1620, | |
| 1740, or 1870 Ohms. | Same | |
| External Insulation (Return | ||
| Insulation) | Polyester | Same |
| Handle Material | Polycarbonate, Polyolefin (finger | |
| switch material) | Same | |
| Handle Length | 5.75 | Same |
| Wand Temperature Sensor (non- | ||
| body contacting) | Copper, Constantan | Same |
| Packaging | Tyvek Lid 09570 | Same |
| Cable Wrap for Packaging | Paper | Same |
| Physical Specifications (Wands) | ||
| Total Length | 11 inches | Same |
| Distal Bend Angle | 43 degrees | Same |
| Number of Electrodes | 1 | Same |
| Number of Internal Suctions | ||
| Channels | 1 | Same |
| Wand Features | ||
| Electrode Configurations | Screen | Same |
| Electrode Articulation | 0 degrees | Same |
| Shaft Rotation | 0 degrees | Same |
| Spacer Configurations | Single Lumen | Same |
| Rigid Construction | Yes | Same |
| Suction and/ or Irrigation | Suction | Same |
| Packaged Sterile | Yes | Same |
| Single Use Disposable | Yes | Same |
| Operates in saline environment | Yes | Same |
| Bipolar/ monopolar | Bipolar | Same |
| Activation | Foot Control or Wand with Integrated | |
| Finger Switch | Same | |
| Coagulation Voltage Setting | Adjustable (3 set points), | |
| 2 Active Set Points | ||
| Use Limiting Scheme | Activation of fuse allows up to 40 | |
| minutes of use and an overall | ||
| connection time up to 8 hours | Activation of fuse allows up to 7 | |
| minutes of use and an overall | ||
| connection time up to 8 hours | ||
| Performance Specifications | ||
| Environmental Exposure | 2 hours in Normal Saline or blood | Same |
| Sterilization | Irradiation | Same |
| Wand Temperature Sensor | T-Type thermocouple with range of | |
| 20-60° C + 3 ° C | Same |
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ρέος 512.391.390 | www.arthrocare.com
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Image /page/8/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a circular design on the left, made up of several curved red lines. To the right of the design is the word "ArthroCare" in a dark gray, sans-serif font. A small registered trademark symbol is located to the upper right of the word "Care".
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | رمان 2012.391.3901 | www.arthrocare.com
9
Image /page/9/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, circular graphic on the left and the word "ArthroCare" on the right. The graphic is made up of several curved, red lines that converge towards the center, creating a sense of movement. The word "ArthroCare" is written in a bold, sans-serif font, and the registered trademark symbol is located to the right of the word.
Clinical Data
No clinical data are included in this submission.
Performance Data
Performance bench testing, including functional testing, Ambient accuracy, ablation performance, use-limiting and coagulation testing was performed on the subject device which demonstrates that the subject device continues to meet the design requirements and supports substantial equivalence with the predicate device. The tests are listed below:
- . Transit Conditioning
- . Visual Inspection Post-Transit
- . IEC Testing
- Ambient Accuracy Testing .
- Ablation Performance Testing at Default Set Point and Suction ●
- . Coagulation Testing
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ρόνο 512.391.3901 | www.arthrocare.com
10
Image /page/10/Picture/0 description: The image features the logo for "ArthroCare." To the left of the text is a circular graphic made of several curved lines. The text "ArthroCare" is in a sans-serif font and is dark gray. A registered trademark symbol is to the right of the word "Care."
- Ablation Performance Testing at Default Set Point & Suction & Use Limiting Feature .
- . Use-Limiting Feature
All devices used for verification testing were sent to an ArthroCare approved supplier for sterilization.
Conclusion
All testing demonstrates that the AMBIENT® Super MULTIVAC° 50 Wand with Integrated Finger Switches performs as intended and has acceptable performance when used in accordance with its labeling. As the indications for use, contraindications, principle of operation and technology are unchanged from the predicate device, except for the Integrated Cable, the subject device, AMBIENT^ Super MULTIVAC° 50 Wand with Integrated Finger Switches, is substantially equivalent to the predicate device.