(88 days)
No reference devices were used in this submission.
No
The document describes a radiofrequency surgical device and its reprocessed versions. There is no mention of AI, ML, image processing, or any software that would typically incorporate such technologies. The performance studies focus on physical and electrical characteristics, not algorithmic performance.
Yes
The device is used for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures, directly treating medical conditions.
No
The device is described as a radiofrequency surgical device for resection, ablation, coagulation, and hemostasis of soft tissue and blood vessels. These are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a radiofrequency surgical device with physical components like handles, shafts, electrodes, and tips. The performance studies include testing of physical attributes and electrical safety, and the software verification and validation testing is marked as "Not applicable."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use 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 a "radiofrequency surgical device" used for surgical procedures.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are designed to perform tests on these types of samples.
Therefore, the Reprocessed ArthroCare Ablation Wands are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessed ArthroCare Ablation Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Product codes
NUJ
Device Description
Reprocessed ArthroCare Ablation Wands are radiofrequency surgical devices intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Ablation wands are powered by a radiofrequency generator or controller. The device variations include various diameters, lengths, or electrode configurations. The materials of construction are generally polycarbonate handles, stainless steel shafts, PET insulation, tungsten electrodes, alumina ceramic tips and PVC suction lines. The electrode design contributes to the performance differences across different model devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Joint Specific or All Joints (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 data provided in support of the substantial equivalence determination included:
- Performance Testing:
- Cleaning (Residual Protein and Carbohydrates, Visual Inspection, Cleaning Performance Qualification)
- Functional (Thermal Effects Performance Testing, Probe Bending Performance Testing, Probe Drop Performance Testing)
- Sterilization and Packaging (EtO Sterilization Testing, EtO Residuals Testing, Simulated Shipment Testing)
- Product Stability (Shelf Life Testing 1-year Accelerated Aging, Real-Time Shelf Life studies are on-going and are not complete for inclusion in this submission.)
- Biocompatibility Testing: (Cytotoxicity, Irritation, Acute Systemic, Material Mediated Pyrogenicity, Sensitization)
- Electrical Safety and Electromagnetic Compatibility (EMC): (IEC 60601-1-2 EMC Testing, IEC 60601-2-2 Electrical Safety Testing (high frequency equipment/accessories))
- Software Verification and Validation Testing: Not applicable, device does not contain software or firmware.
- Mechanical and Acoustic Testing: Not required.
- Animal Study: Not required.
- Clinical Studies: Not required. Substantial equivalence is based upon benchtop performance testing.
Key results: The subject device performed equivalent to the predicate in thermal effects, probe bending, and probe drop performance tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K083306, K082980, K082323, K072865, K071963, K070958, K052686, K033584, K032504, K030551, K020557, K011083
Reference Device(s)
No reference devices were used in this submission.
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and 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 text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 5, 2018
ReNovo, Inc. % Mr. Robert Packard Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, Vermont 05738
Re: K173741
Trade/Device Name: Reprocessed ArthoCare Ablation Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NUJ Dated: December 15, 2018 Received: February 16, 2018
Dear Mr. Packard:
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 (OS) 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).
Sincerelv. 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
2
Indications for Use
510(k) Number (if known) K173741
Device Name
Reprocessed ArthroCare Ablation Wands
Indications for Use (Describe)
The Reprocessed ArthroCare Ablation Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
| 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."
3
| Arthroscopic and Orthopedic
Procedures | Joint Specific or All Joints
(ankle, elbow, hip, knee,
shoulder, wrist) |
|-------------------------------------------|-------------------------------------------------------------------------------|
| Ablation and Debridement | |
| ACL/PCL | Knee |
| Acromioplasty | Shoulder |
| Articular Cartilage | All Joints |
| Bursectomy | All Joints |
| Chondroplasty | All Joints |
| Facia | 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 | |
| Accetabular 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 |
| Menisccotmy | Knee |
| Pilca Removal | All Joints |
| Scar Tissue | All Joints |
| Soft Tissue | All Joints |
| Synovial Membrane | All Joints |
| Tendon | All Joints |
| Triangular Fibrocarilage (TFCC) | Wrist |
| Villusectomy | Knee |
| Coagulation | |
| ACL/PCL | Knee |
| Articular Cartilage | All Joints |
| Carpal Ligaments | Wrist |
| Glenohumoral Capsule | Shoulder |
| Ligament | All Joints |
| Medial Retinaculum | Knee |
| Rotator Cuff | Shoulder |
| Tendon | All Joints |
| Wrist Tendons | Wrist |
4
| K173741 Reprocessed ArthroCare Ablation Wands - Device Models Subject to Clearance | |
|---|---|
| ------------------------------------------------------------------------------------ | -- |
| OEM Model
| Number | Description | Shaft Diameter, description | Picture | OEM 510(k) |
|---|---|---|---|---|
| ASC4251-01 | STARVAC | 5.5mm tip diameter, 3.5MM SHAFT | ||
| SIZE, 90° Tip Angle, 1 screen and 4 ball | ||||
| electrodes, | Image: STARVAC | K083306 | ||
| ASH4830-01 | SUPER MULTIVAC | |||
| 50 with Integrated | ||||
| Finger Switches (IFS) | 3.0mm Tip Diameter, 3.75mm Shaft | |||
| Diameter, Flat electrode, 50° tip angle | Image: SUPER MULTIVAC | K082980 | ||
| ASC4830-01 | SUPER MULTIVAC | |||
| 50 | 3.0mm Tip Diameter, 3.75mm Shaft | |||
| Diameter, Flat electrode, 50° tip angle | Image: SUPER MULTIVAC 50 | K082323 | ||
| ASH4250-01 | SUPER TURBOVAC | |||
| 90 with integrated | ||||
| finger switches (IFS) | 5.25mm Tip diameter, 3.75 shaft | |||
| diameter, screen shape electrode, | ||||
| 9050° tip angle | Image: SUPER TURBOVAC | K072865 | ||
| AS1335-01 | TurboVac 90 | 3.75mm shaft diameter, 90° Tip Angle | Image: TurboVac 90 | K071963 |
| ASC1335-01 | TurboVac ™ 90 | |||
| Integrated Cable | ||||
| Wand | 3.75mm shaft diameter, 90° Tip Angle | Image: TurboVac 90 Integrated Cable Wand | K070958 | |
| AS1336-01 | TurboVac 90 XL | 3.75mm shaft diameter, 90° Tip Angle | Image: TurboVac 90 XL | K052686 |
| ASC1336-01 | TurboVac 90 XL | |||
| Integrated Cable | ||||
| Wand | 3.75mm shaft diameter, 90° Tip Angle | Image: TurboVac 90 XL Integrated Cable Wand | ||
| AS1337-01 | TuboVac 90 HP | 3.75 shaft diameter, 90° Tip Angle | K033584 | |
| AS4360-01 | TriStar 50 | 3.0mm shaft diameter, 50° Tip Angle | Image: TriStar 50 | K032504 |
| ASC4630-01 | TriStar 50 Integrated | |||
| Cable Wand | 3.0mm shaft diameter, 50° Tip Angle | K030551 | ||
| AS4730-01 | MultiVac 50 XL | 3.0mm shaft diameter, 50° Tip Angle | K020557 | |
| ASC4730-01 | MultiVac 50 XL | |||
| Integrated Cable | ||||
| Wand | 3.0mm shaft diameter, 50° Tip Angle | Image: MultiVac 50 XL Integrated Cable Wand | K011083 |
5
K173741 - 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
- SUBMITTER l. ReNovo, Inc. Mark K. Wells 340 SW Columbia St. Bend OR, 97702 USA Tel: +1.541.422.8880 Fax: +1.541.422.8881
- II. CONTACT PERSON Mary Vater, BS Medical Device Academy 345 Lincoln Hill Rd. Shrewsbury, VT 05738 USA Tel: +1.913.274-9899 Email: mary@fdaecopy.com
- lll. DEVICE
| Name of Device: | Reprocessed ArthroCare Ablation Wand |
|---|---|
| Classification Name: | Electrosurgical Cutting and Coagulation Device and Accessories |
| Regulation: | 21 CFR §878.4400 |
| Regulatory Class: | Class II |
| Product Classification Code: | NUJ |
PREDICATE DEVICE IV.
| Predicate
| Manufacturer | Predicate Submission Name | 510(k) |
|---|---|---|
| ArthroCare Corp. | Modification To Arthrocare Arthrowands | K083306 |
| ArthroCare Corp. | Arthrocare Arthrowands | K082980 |
| ArthroCare Corp. | Arthrocare Arthrowands | K082323 |
| ArthroCare Corp. | Modification To: Arthrocare Arthrowands | K072865 |
| ArthroCare Corp. | Modification To: Arthrocare Arthrowands | K071963 |
| ArthroCare Corp. | Modification To Arthrocare Arthrowands | K070958 |
| ArthroCare Corp. | Arthrocare Arthrowands | K052686 |
| ArthroCare Corp. | Arthrocare Arthrowands | K033584 |
| ArthroCare Corp. | ArthroCare System | K032504 |
| ArthroCare Corp. | ArthroCare ArthroWands | K030551 |
| ArthroCare Corp. | ArthroCare ArthroWands | K020557 |
| ArthroCare Corp. | ArthroCare System | K011083 |
No reference devices were used in this submission.
DEVICE DESCRIPTION V.
Reprocessed ArthroCare Ablation Wands are radiofrequency surgical devices intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and
6
orthopedic procedures. Ablation wands are powered by a radiofrequency generator or controller. The device variations include various diameters, lengths, or electrode configurations. The materials of construction are generally polycarbonate handles, stainless steel shafts, PET insulation, tungsten electrodes, alumina ceramic tips and PVC suction lines. The electrode design contributes to the performance differences across different model devices.
INDICATIONS FOR USE VI.
The Reprocessed ArthroCare Ablation Wands are 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, wrist) |
|-------------------------------------------|-------------------------------------------------------------------------------|
| Ablation and Debridement | |
| ACL/PCL | Knee |
| Acromioplasty | Shoulder |
| Articular Cartilage | All Joints |
| Bursectomy | All Joints |
| Chondroplasty | All Joints |
| Facia | 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 |
| Meniscotomy | Knee |
| Pilca 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 |
| Glenohumoral Capsule | Shoulder |
| Ligament | All Joints |
| Medial Retinaculum | Knee |
| Rotator Cuff | Shoulder |
| Tendon | All Joints |
| Wrist Tendons | Wrist |
7
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE
The fundamental technological characteristics of the subject device are identical to the predicate devices. The subject devices are reprocessed versions of the predicate devices. Validation was done to ensure that the reprocessing activities did not affect the form or function of the device, and that the reprocessed device performs as well as the original, new device.
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
- . Indications for Use – The indications for use of the subject device is identical to the predicate (OEM) devices' indications for use other than the device name, and therefore are substantially equivalent. All are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
- Materials The subject devices are identical reprocessed versions of the predicate OEM ● devices, therefore the subject devices materials are identical to the predicate.
- . Design - The predicate and subject devices are identical in design changes are made during reprocessing.
- . Energy Source - The predicate and subject devices are both powered by external RF Generators.
- Performance Testing The subject devices were tested side by side with predicate devices for ● thermal effects, probe bending, and probe drop performance. The subject device performed equivalent to the predicate.
VIII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Performance Testing
- · Cleaning
- Residual Protein and Carbohydrates O
- Visual Inspection O
- Cleaning Performance Qualification O
8
- · Functional
- Thermal Effects Performance Testing O
- Probe Bending Performance Testing O
- Probe Drop Performance Testing O
- · Sterilization and Packaging
- EtO Sterilization Testing O
- EtO Residuals Testing O
- Simulated Shipment Testing O
- · Product Stability
- Shelf Life Testing 1-year Accelerated Aging O
- O Real-Time Shelf Life studies are on-going and are not complete for inclusion in this submission.
Biocompatibility Testing
The following biocompatibility tests were conducted to ensure the safety of the devices:
- · Cytotoxicity
- · Irritation
- · Acute Systemic
- · Material Mediated Pyrogenicity
- · Sensitization
Electrical Safety and Electromagnetic Compatibility (EMC)
The following electrical safety and EMC tests have been performed:
- IEC 60601-1-2 EMC Testing
- IEC 60601-2-2 Electrical Safety Testing (high frequency equipment/accessories) .
Software Verification and Validation Testing
Software Testing is not applicable, because the device does not contain software or firmware.
Mechanical and Acoustic Testing
Mechanical and acoustic performance testing was not required to demonstrate safety and effectiveness of the device.
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the Reprocessed ArthroCare Ablation Wand. Instead, substantial equivalence is based upon benchtop performance testing.
IX. CONCLUSIONS
Based on a comparison of technological characteristics, indications for use, and performance data, it can be concluded that the proposed Reprocessed ArthroCare Ablation Wand devices are substantially equivalent to the predicate (OEM) devices.