(49 days)
No
The summary describes a reprocessed surgical ablation wand and its intended uses and performance testing. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes.
The device is used for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures, which are therapeutic interventions.
No
Explanation: The provided text describes the device's indications for use as "resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures." These are all therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is an "ablation wand" and is powered by a separate generator, indicating it is a physical hardware device used in surgical procedures.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the device is used for "resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures." This involves direct interaction with tissue within the body during a surgical procedure.
- Intended Use: The intended use lists various surgical procedures performed on joints, all of which are invasive and involve working directly on the patient's anatomy.
- Lack of Specimen Analysis: There is no mention of analyzing samples taken from the body.
Therefore, this device is a surgical instrument used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes
NUJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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).
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).
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
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
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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
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
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. |