What is the regulatory pathway for Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics?

Modification to ArthroCare ArthroWands (K083306).

Who can help prepare an FDA 510(k) submission like Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics

Q: Who is the manufacturer of Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics?

Surgical Instrument Service and Savings, Inc. filed the 510(k) submission for Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics (K171324).

Q: What is the FDA product code for Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics?

NUJ. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

K171324 · Surgical Instrument Service and Savings, Inc. · NUJ · Jun 23, 2017 · General, Plastic Surgery

Device Facts

Record ID	K171324
Device Name	Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics
Applicant	Surgical Instrument Service and Savings, Inc.
Product Code	NUJ · General, Plastic Surgery
Decision Date	Jun 23, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Medline ReNewal Reprocessed ArthroCare and Smith & Nephew Dyonics Ablation Wands with integrated cables are indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

Device Story

Reprocessed electrosurgical ablation wands; used for soft tissue resection, ablation, coagulation, and hemostasis in arthroscopic/orthopedic procedures. Device connects to external RF generator (not reprocessed). Operated by surgeons in clinical settings. Reprocessing restores device to original functional specifications; includes cleaning, sterilization, and performance testing. Output is RF energy delivered to tissue via wand tip; enables precise tissue removal and vessel sealing. Benefits include cost-effective reuse of single-use surgical instruments while maintaining clinical performance equivalent to original devices.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing: sterilization validation, biocompatibility (cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity), electrical safety (IEC 60601-1, IEC 60601-2-2), electromagnetic compatibility (IEC 60601-1-2), and performance qualification (simulated use, bending, suction, thermal tissue damage, drop, and integrity testing).

Technological Characteristics

Electrosurgical ablation wands; 3.0mm to 3.75mm shaft diameters; 50° to 90° tip angles. Powered by external RF generator. Materials and design identical to predicate. Standards: IEC 60601-1 (General safety), IEC 60601-2-2 (High frequency surgical equipment), IEC 60601-1-2 (EMC). Sterilization method not specified.

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures, including knee, shoulder, ankle, hip, elbow, and wrist joints.

Regulatory Classification

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.

Predicate Devices

Modification to ArthroCare ArthroWands (K083306)

Reference Devices

ArthroCare System 1500 Controller, ArthroWands (K093165)

Related Devices

K173740 — Reprocessed DePuy Mitek Ablation Wand · Renovo, Inc. · Mar 19, 2018
K173741 — Reprocessed ArthoCare Ablation Wand · Renovo, Inc. · Mar 5, 2018
K012631 — REPROCESSED SOFT TISSUE ABLATORS · Alliance Medical Corp. · Dec 6, 2001
K043198 — VANGUARD REPROCESSED ARTHROSCOPIC WANDS · Vanguard Medical Concepts, Inc. · May 27, 2005
K121855 — RESPROCESSED SERFAS ENERGY PROBE · Stryker Sustainability Solutions · Aug 16, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/12 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized representation of human profiles facing right, stacked on top of each other. The profiles are silhouetted in black, and the text is also in black. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 23, 2017 Surgical Instrument Service and Savings Inc. Brandi Panteleon Director, Quality Assurance and Regulatory Affairs (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, Oregon 97756 Re: K171324 Trade/Device Name: Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics Ablation Wands Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NUJ Dated: May 4, 2017 Received: May 5, 2017 Dear Ms. Panteleon: 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. 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 {1}------------------------------------------------ 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 (reporting of medical devicerelated adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Jennifer R. Stevenson -S3 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}------------------------------------------------ | Model Number | Device Name/Description | Design | Original Manufacturer | |-----------------|--------------------------------------|--------------------------------|---------------------------| | ASHA 4250-01 | Ambient® Super TurboVac® 90° IFS | 3.75mm Shaft, 90° Tip Angle | ArthroCare | | ASH 4250- 01 | Super TurboVac 90° IFS | 3.75mm Shaft, 90° Tip Angle | ArthroCare | | ASHA 4830-01 | Ambient® Super MultiVac® 50° IFS | 3.75mm Shaft, 50° Tip Angle | ArthroCare | | ASH 4830- 01 | Super MultiVac® 50° IFS | 3.75mm Shaft, 50° Tip Angle | ArthroCare | | ASHA 3730-01 | Ambient® CoVac® 70° IFS | 3.0mm Shaft, 70° Tip Angle | ArthroCare | | ASHA 2530-01 | Ambient® CoVac® 50° IFS | 3.0mm Shaft, 50° Tip Angle | ArthroCare | | 72202140 | Dyonics RF-S Cross 50° Suction Probe | 3.0mm Shaft, 50° Tip Angle | Smith & Nephew Dyonics | # Reprocessed Single-Use Device Models Subject to Clearance: {3}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K171324 #### Device Name Medline ReNewal Reprocessed ArthroWands models ASHA 4250-01; ASH 4250-01; ASHA 2530-01; ASHA 3730-01; ASHA 4830-01; and ASH 4830-01 and Medline ReNewal Reprocessed Smith & Nephew Dyonics model 72202140 Ablation Wands #### Indications for Use (Describe) The Medline ReNewal Reprocessed ArthroWands models ASHA 4250-01; ASH 4250-01; ASHA 2530-01; ASHA 3730-01; ASHA 4830-01; and ASH 4830-01 and Medline ReNewal Reprocessed Smith & Nephew Dyonics model 72202140 ablation wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Ablation and Debridement: ACL/PCL (knee); acromioplasty (shoulder); articular cartilage (all joints); bursectomy (all joints); chondroplasty (all joints); fascia (all joints); notchplasty (knee); scar tissue (all joints); soft tissue (all joints);subacromial decompression (shoulder); synovectomy (all joints); and tendon (all joints). Excision and Resection: acetabular labrum (hip); articular labrum (all joints); capsular release (knee); cartilage flaps (knee); cysts (all joints); discoid meniscus (knee); frozen shoulder); glenoidale labrum (shoulder); lateral release (knee); ligament (all joints); loose bodies (all joints); meniscal cystectomy (knee); meniscectomy (knee); plica removal (all joints); soft tissue (all joints); synovial membrane (all joints); tendon (all joints); triangular fibrocartilage (TFCC); (wrist); and 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) and wrist tendons (wrist). Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {4}------------------------------------------------ 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." {5}------------------------------------------------ | Model Number | Device Name/Description | Design | Original Manufacturer | |-----------------|--------------------------------------|--------------------------------|---------------------------| | ASHA 4250-01 | Ambient® Super TurboVac® 90° IFS | 3.75mm Shaft, 90° Tip Angle | ArthroCare | | ASH 4250- 01 | Super TurboVac 90° IFS | 3.75mm Shaft, 90° Tip Angle | ArthroCare | | ASHA 4830-01 | Ambient® Super MultiVac® 50° IFS | 3.75mm Shaft, 50° Tip Angle | ArthroCare | | ASH 4830- 01 | Super MultiVac® 50° IFS | 3.75mm Shaft, 50° Tip Angle | ArthroCare | | ASHA 3730-01 | Ambient® CoVac® 70° IFS | 3.0mm Shaft, 70° Tip Angle | ArthroCare | | ASHA 2530-01 | Ambient® CoVac® 50° IFS | 3.0mm Shaft, 50° Tip Angle | ArthroCare | | 72202140 | Dyonics RF-S Cross 50° Suction Probe | 3.0mm Shaft, 50° Tip Angle | Smith & Nephew Dyonics | # Reprocessed Single-Use Device Models Subject to Clearance: {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the Medline Renewal Full Circle Reprocessing logo. The Medline logo is on the left, and the Renewal Full Circle Reprocessing logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters. The Renewal logo is in green and blue letters, and the Full Circle Reprocessing logo is in gray letters. Smith & Nephew Dyonics Ablation Wands # K171324 Summary | Submitter/ Owner | Surgical Instrument Service and Savings (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, OR 97756 | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Name | Brandi Panteleon Director, Quality Assurance and Regulatory Affairs P: 541-516-4180 F: 541-923-3375 E: bpanteleon@medline.com | | Prepared by | Stephanie Boyle Mays Regulatory Affairs Specialist, Regulatory Affairs P: 541-516-4205 F: 541-923-3375 E: smays@medline.com | | Date Prepared | April 14, 2017 | | Device Names | Proprietary Name: Medline ReNewal Reprocessed ArthroCare ArthroWands models ASHA 4250-01; ASH 2530-01; ASHA 3730-01; ASHA 4830-01; and ASH 4830-01 and Medline ReNewal Reprocessed Smith & Nephew Dyonics model 72202140 Ablation Wands Common Name: Electrosurgical device and accessories | | Classification | Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) Product code: NUJ | | Predicate Device | K083306 Modification to ArthroCare ArthroWands | | Reference Device | K093165 ArthroCare System 1500 Controller, ArthroWands | | Device Description | Ablation wands are indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic procedures, including knee, shoulder, ankle, hip, elbow, and wrist joints. The device is powered by a separate generator. The generator is not included in the scope of the study and will not be reprocessed. | | Intended Use | The Medline ReNewal Reprocessed ArthroCare and Smith & Nephew Dyonics Ablation Wands with integrated cables are indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | | Technological Characteristics | The technological characteristics and the fundamental scientific technology of the subject devices are identical to the predicate device. The proposed devices are a reprocessed version of the predicate K083306 Modification to ArthroCare ArthroWands. The predicate devices were used to support intended use, technological characteristics, and functional performance specifications. | | Performance Testing | The functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices based on the following tests: sterilization validation; biocompatibility; cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity; electrical testing electromagnetic compatibility (per IEC 60601-1-2); electrical safety (per IEC 60601-1 and IEC 60601-2-2); and basic safety (per IEC 60601-1 and IEC 60601-2-2) performance qualification: simulated use; critical function bending equivalence test; critical function suction equivalence test; critical function thermal tissue damage equivalence test; critical function drop equivalence test; critical function device equivalence integrity; and product stability cleaning; protein, and hemoglobin. | | Conclusion | Based on comparisons of the indications for use, intended use, technological characteristics, and performance data to the predicate devices, the Medline ReNewal Reprocessed ArthroCare and Smith & Nephew Dyonics Ablation Wands are substantially equivalent to the predicate and reference devices. | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the text 'K171324' in a simple, sans-serif font. The text is horizontally oriented and appears to be a code or identifier. The characters are uniformly sized and spaced. Image /page/7/Picture/2 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the words "Full Circle Reprocessing" are below it. Medline ReNewal Reprocessed ArthroCare ArthroWands and {8}------------------------------------------------ Image /page/8/Picture/2 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the words "Full Circle Reprocessing" are below it. The Medline logo is a blue star. Traditional 510(k) Notification Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics Ablation Wands #### Table 1: Predicate, Reference and Medline Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics Ablation Wands comparison chart. | | Predicate | Reference | Proposed | Comparison | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Device | Modification to ArthroCare ArthroWands | ArthroCare System 1500 Controller, ArthroWandsa | Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics Ablation Wandsa | As stated | | 510(k) | K083306 | K093165 | TBD | N/A | | Model Numbers | ArthroCare ArthroWands: ASHA 4250-01; ASH 4250-01; ASHA 2530-01; ASHA 3730-01; ASHA 4830-01; and ASH 4830- 01 | Smith & Nephew Dyonics: 72202140 | ArthroCare ArthroWands: ASHA 4250-01; ASH 4250-01; ASHA 2530-011; ASHA 3730-01; ASHA 4830-01; and ASH 4830- 01 Smith & Nephew Dyonics: 72202140 | N/A | | Power Platformb | Quantum 2 Controller | Dyonics RF Generator | Quantum 2 Controller; Dyonics RF Generator | As stated | | Technological Characteristics | The ArthroCare ArthroWands and ablation wands are used to coagulate isolated vessels up to 5 mm in diameter. | The ArthroCare System 1500 Wands (Smith & Nephew Dyonics) ablation wands are used to coagulate isolated vessels up to 5 mm in diameter. | The reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics ablation wands are used to coagulate isolated vessels up to 5 mm in diameter. | Same | | Indications for Use | The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | The ArthroCare System 1500 Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | The reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics Ablation Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic | Same | {9}------------------------------------------------ K171324 Image /page/9/Picture/2 description: The image contains the logo for Medline Renewal. The Medline logo is on the left, and it features the word "MEDLINE" in a sans-serif font with a stylized blue star above it. To the right of the Medline logo is the Renewal logo, with the word "Renewal" in a combination of green and blue, with "Re" in green and "newal" in blue. Below "Renewal" is the text "Full Circle Reprocessing" in a smaller, sans-serif font. Traditional 510(k) Notification Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics Ablation Wands #### Table 1: Predicate, Reference and Medline Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics Ablation Wands comparison chart (continued). | Device | Predicate | Reference | Proposed | Comparison | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | Modification to ArthroCare ArthroWands | ArthroCare System 1500 Controller, ArthroWandsª | Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics Ablation Wandsª | As stated | | Intended Use/Indication for Use | 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); and 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); | 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); and tendon (all joints). Excision and Resection: acetabular labrum (hip); articular labrum (all joints); capsule (all joints); capsular release (knee); cartilage flaps (knee); cysts (all (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); | procedures. 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); and 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); | Same | {10}------------------------------------------------ K171324 Image /page/10/Picture/2 description: The image shows the Medline Renewal logo. The word "Renewal" is in large, bold letters, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, lighter blue font. To the left of the text is the Medline logo, which is a blue star-like shape with the word "MEDLINE" written horizontally across the center. Traditional 510(k) Notification Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics Ablation Wands #### Predicate, Reference and Medline ReNewal Reprocessed ArthroWands and Smith & Nephew Dyonics Table 1: Ablation Wands comparison chart (concluded). | Devices | Predicate | Reference | Proposed | Comparison | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | Modification to ArthroCare ArthroWands | ArthroCare System 1500 Controller, ArthroWandsa | Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics Ablation Wandsa | | | Intended Use/Indication for Use (concluded) | meniscectomy (knee); plica removal (all joints); scar tissue (all joints); soft tissue (all joints); synovial membrane (all joints); tendon (all joints); triangular fibrocartilage (TFCC), (wrist); and 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) and wrist tendons (wrist). | meniscectomy (knee); plica removal (all joints); scar tissue (all joints); soft tissue (all joints); synovial membrane (all joints); tendon (all joints); triangular fibrocartilage (TFCC), (wrist); and 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) and wrist tendons (wrist). | meniscal cystectomy (knee); meniscectomy (knee); plica removal (all joints); scar tissue (all joints); soft tissue (all joints); synovial membrane (all joints); tendon (all joints); triangular fibrocartilage (TFCC), (wrist); and 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) and wrist tendons (wrist). | As stated | | a. The ArthroCare 15000 wand model 72202140 is sold as the Smith & Nephew Dyonics ablation wand model 72202140. | | | | | | b. The ArthroCare Quantum 2 Controller and Smith & Nephew Dyonics generators are not part of this submission and will not be reprocessed by Medline ReNewal. The generators were cleared in K083306 and K093165 respectively. | | | | |