(88 days)
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.
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.
This document is a 510(k) summary for a reprocessed medical device, specifically "Reprocessed ArthroCare Ablation Wands." It does not contain information about an AI/ML-driven device or study that uses acceptance criteria in the typical sense of measuring algorithm performance against ground truth in a clinical or diagnostic context.
Instead, the "acceptance criteria" and "study" mentioned here refer to the validation of the reprocessing process to demonstrate that the reprocessed device is substantially equivalent to the original, new device. The "performance" being reported is related to the physical and functional integrity of the reprocessed wands.
Therefore, many of the requested fields are not applicable in this context (e.g., sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI, etc.) because this is not an AI/ML device.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated by Testing) | Reported Device Performance |
|---|---|
| Cleaning: Residual Protein, Carbohydrates, Visual Inspection, Cleaning Performance Qualification meet predetermined standards. | Cleaning tests confirmed devices meet established safety and cleanliness standards for reprocessing. |
| Functional: Thermal Effects, Probe Bending, Probe Drop Performance are equivalent to the predicate (new) device. | The subject (reprocessed) devices performed equivalently to the predicate (new) devices in thermal effects, probe bending, and probe drop tests. |
| Sterilization & Packaging: EtO Sterilization, EtO Residuals, Simulated Shipment Testing meet safety and effectiveness requirements. | Tests confirmed effective sterilization, acceptable EtO residuals, and packaging integrity after simulated shipment. |
| Product Stability: Accelerated aging demonstrates 1-year shelf life. (Real-time studies ongoing.) | Accelerated aging demonstrated a 1-year shelf life. Real-time studies are ongoing. |
| Biocompatibility: Cytotoxicity, Irritation, Acute Systemic, Material Mediated Pyrogenicity, Sensitization meet ISO 10993 standards. | Biocompatibility tests (cytotoxicity, irritation, acute systemic, pyrogenicity, sensitization) confirmed material safety. |
| Electrical Safety & EMC: IEC 60601-1-2 EMC Testing and IEC 60601-2-2 Electrical Safety Testing (high frequency equipment/accessories) are met. | Electrical safety and EMC tests confirmed compliance with relevant IEC standards. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample sizes for each type of benchtop performance test (e.g., how many wands were subjected to thermal effects testing, how many for bending, etc.). It generally refers to "the subject devices" and "predicate devices" being tested.
- Data Provenance: The data is from benchtop performance testing conducted by ReNovo, Inc. (the submitter), comparing their reprocessed devices against the predicate (OEM) devices. This is prospective testing for the 510(k) submission. No country of origin is explicitly stated for the "data," but the submitter is based in Bend, OR, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not an AI/ML device, and "ground truth" in the diagnostic context is not relevant here. The "ground truth" for these tests are objective, measurable physical and chemical properties and functional performance characteristics, often against established industry standards. These are not established by human experts in a subjective manner.
4. Adjudication method for the test set:
- Not Applicable. As this is not an AI/ML device, there's no diagnostic output requiring expert adjudication. Performance is measured against predefined, objective pass/fail criteria or equivalence to a predicate device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI/ML device. No human-in-the-loop studies or MRMC studies were performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/ML device. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is the established physical, chemical, and functional performance characteristics of the original, new (predicate) medical device and compliance with relevant engineering and biocompatibility standards (e.g., ISO 10993, IEC 60601). The "ground truth" for cleaning effectively would be specific limits on residual protein/carbohydrates, for example. For functional performance, it would be the performance of the new device.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device. No training set was used.
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML device. No training set was used.
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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);
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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
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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) |
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| Arthroscopic and OrthopedicProcedures | 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 |
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| K173741 Reprocessed ArthroCare Ablation Wands - Device Models Subject to Clearance | |
|---|---|
| ------------------------------------------------------------------------------------ | -- |
| OEM ModelNumber | Description | Shaft Diameter, description | Picture | OEM 510(k) |
|---|---|---|---|---|
| ASC4251-01 | STARVAC | 5.5mm tip diameter, 3.5MM SHAFTSIZE, 90° Tip Angle, 1 screen and 4 ballelectrodes, | Image: STARVAC | K083306 |
| ASH4830-01 | SUPER MULTIVAC50 with IntegratedFinger Switches (IFS) | 3.0mm Tip Diameter, 3.75mm ShaftDiameter, Flat electrode, 50° tip angle | Image: SUPER MULTIVAC | K082980 |
| ASC4830-01 | SUPER MULTIVAC50 | 3.0mm Tip Diameter, 3.75mm ShaftDiameter, Flat electrode, 50° tip angle | Image: SUPER MULTIVAC 50 | K082323 |
| ASH4250-01 | SUPER TURBOVAC90 with integratedfinger switches (IFS) | 5.25mm Tip diameter, 3.75 shaftdiameter, 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 ™ 90Integrated CableWand | 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 XLIntegrated CableWand | 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 IntegratedCable 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 XLIntegrated CableWand | 3.0mm shaft diameter, 50° Tip Angle | Image: MultiVac 50 XL Integrated Cable Wand | K011083 |
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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.
| PredicateManufacturer | 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
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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 OrthopedicProcedures | Joint Specific or AllJoints (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 |
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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
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- · 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.
§ 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.