(271 days)
The Ambient TurboFlash 90 IFS Wand is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures including: Ablation and Debridement (ACL/PCL, Acromioplasty, Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Notchplasty, Scar Tissue, Soft Tissue, Subacromial Decompression, Synovectomy, Tendon), Excision and Resection (Acetabular Labrum, Articular Labrum, Capsule, Capsular Release, Cartilage Flaps, Cysts, Discoid Meniscus, Frozen Shoulder Release, Glenoid Labrum, Lateral Release, Ligament, Loose Bodies, Meniscal Cystectomy, Meniscectomy, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon, Triangular Fibrocartilage (TFCC), Villusectomy), and Coagulation (ACL/PCL, Articular Cartilage, Carpal Ligaments, Glenohumeral Capsule, Ligament, Medial Retinaculum, Rotator Cuff, Tendon, Wrist Tendons). These procedures are applicable to specific joints or all joints (ankle, elbow, hip, knee, shoulder, and wrist).
The Ambient TurboFlash 90 IFS Wand is a bipolar, sterile, single-use, high frequency electrosurgical device which consists of a distal electrode tip composed of tungsten and titanium, a ceramic spacer-cap, a stainless steel shaft, internal suction tubing, and a molded handle with integrated finger switches. The Ambient TurboFlash 90 IFS is only compatible with the Quantum™ 2 Controller which incorporates a "Use Limiting" feature that prevents the re-use of the device.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ArthroCare Ambient® TurboFlash™ 90 IFS Wand:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes modifications to an existing predicate device and focuses on establishing substantial equivalence through non-clinical performance testing. It does not explicitly define quantitative "acceptance criteria" in the traditional sense (e.g., "sensitivity must be > X%") or report quantitative "device performance" metrics against such criteria in a table format. Instead, the "acceptance criteria" are implied by successful completion of various tests demonstrating equivalence or improved characteristics without adverse effects.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Ablation and Coagulation Performance Equivalence | "Ablation and coagulation testing" successfully evaluated the device, demonstrating that proposed modifications "do not affect the safety or efficacy of the device." The rationale for design changes (e.g., smaller profile tip) also implies that performance in these areas should be maintained or improved for surgical access. |
| Electrical Safety Compliance | "Electrical safety testing including Hipot, continuity, and IEC 60601-2-2:2009" was successfully conducted, indicating compliance with relevant standards. |
| Tip Strength | "I Tip strength testing" was performed successfully. |
| Suction Rate | "Suction rate testing" was successfully performed. |
| Ex Vivo Performance | "Ex vivo performance testing" was successfully conducted. While specific metrics aren't provided, the conclusion is that the modifications "do not affect the safety or efficacy." |
| Ambient Temperature Measurement | "Ambient temperature measurement testing" was successfully performed. |
| Manufacturing Efficiency and Surgical Access (Improved) | The one-piece spacer-cap and revised screen securing method were proposed to "Facilitates the manufacturability of a smaller profile tip which provides the surgeon better access to tight joint spaces" and "more efficient manufacturability; and a smaller profile tip to provide surgical access to tight joint spaces." This is an improvement over the predicate, not a maintained criterion. |
| Therapy Delivery Flexibility (Improved) | The resistor change allowing a maximum ablation set point of 10 (vs. 9 in predicate) "Provides the surgeon more flexibility in delivering therapy." This is an improvement over the predicate, not a maintained criterion. |
| Substantial Equivalence to Predicate Device (Overall) | The overall conclusion of the non-clinical performance testing is that "This testing demonstrated that the proposed modifications for the Ambient TurboFlash 90 IFS are substantially equivalent and do not affect the safety or efficacy of the device" and that it "is substantially equivalent to the Ambient Super TurboVac 90 IFS cleared via K083306. Both the subject and the predicate devices have the same indications for use and utilize the same fundamental scientific technology. The proposed modifications are not substantial and do not significantly affect the safety or efficacy of the device." |
2. Sample Size Used for the Test Set and the Data Provenance:
The document describes non-clinical bench testing and ex vivo performance testing. It does not mention a "test set" in the context of human subjects or clinical data. Therefore, the concepts of "sample size used for the test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable to this type of submission. The data provenance would be laboratory testing conducted by the manufacturer, ArthroCare Corporation, based in Austin, Texas.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable as the submission is based on non-clinical bench and ex vivo testing, not on clinical data requiring expert review for ground truth establishment.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set:
This information is not applicable for the same reasons as #3.
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:
This information is not applicable. This submission is for an electrosurgical device, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies or AI assistance for human readers are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is not an algorithmic or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this submission is established through objective engineering and performance testing standards and measurements. This includes:
- Engineering specifications and design verification.
- Conformity to recognized electrical safety standards (e.g., IEC 60601-2-2:2009).
- Quantitative measurements in ablation, coagulation, tip strength, suction rate, and temperature.
- Ex vivo performance assessments against expected functional outcomes.
8. The Sample Size for the Training Set:
This information is not applicable. This is not an AI/machine learning device that requires a training set. The device design and performance are based on engineering principles and established medical device development processes, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this type of device.
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K 120791
DEC 1 1 2012
510(k) Summary
ARTHROCARE® CORPORATION Ambient ® TurboFlash™ 90 IFS
· General Information
| Submitter Name: | ArthroCare Corporation |
|---|---|
| Address: | 7000 West William Cannon Drive |
| Austin, TX 78735 | |
| Contact Person: | Cheryl Frederick |
| Director, Regulatory Affairs | |
| Date Prepared: | October 8, 2012 |
Device Description
| Proprietary: | Ambient ® TurboFlash™ 90 IFS Wand |
|---|---|
| Common: | Electrosurgical Cutting and Coagulation and Accessories |
| Classification: | Class II |
| Product Code: | GEI |
| CFR Section: | 21 CFR 878.4400 |
Predicate Device
Ambient Super TurboVac® 90 IFS Wand included in:
ArthroCare ArthroWand Devices, K083306
Product Description
The Ambient TurboFlash 90 IFS Wand is a bipolar, sterile, single-use, high frequency electrosurgical device which consists of a distal electrode tip composed of tungsten and titanium, a ceramic spacer-cap, a stainless steel shaft, internal suction tubing, and a molded handle with integrated finger switches. The Ambient TurboFlash 90 IFS is only compatible with the Quantum™ 2 Controller which incorporates a "Use Limiting" feature that prevents the re-use of the device..
Intended Uses/Indications for Use
The Ambient TurboFlash 90 IFS is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures including:
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints(ankle, elbow, hip, knee,shoulder, and wrist) |
|---|---|
| Ablation and Debridement | |
| • ACL/PCL | Knee |
| • Acromioplasty | Shoulder |
| • Articular Cartilage | All Joints |
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints(ankle, elbow, hip, knee,shoulder, and wrist) |
| • 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 |
| • 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 |
| • Glenoid Labrum | Shoulder |
| • Lateral Release | Knee |
| • Ligament | All Joints |
| • Loose Bodies | All Joints |
| • 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 |
| • 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 |
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:
the state of the state of the states of the states
:
,
:
· · ·
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Summary of Technological Characteristics
This Special 510(k) proposes modifications to the specifications for the Ambient Super TurboVac 90 IFS most recently cleared in K083306. The indications for use, fundamental scientific technology, principle of operation, and sterilization methodology remain the same as in previously cleared 510(k). The following table summarizes the technological differences between the subject device, the Ambient TurboFlash 90 IFS, and the predicate device, the Ambient Super TurboVac IFS 90).
| Ambient TurboFlash 90IFS(Subject Device) | Ambient Super TurboVacIFS, K083306(Predicate Device) | Rationale for Change |
|---|---|---|
| One-piece spacer-capdesign manufactured fromalumina. | Two-piece spacer-capmanufactured from aluminaand stainless steel,respectively. | Facilitates themanufacturability of asmaller profile tip whichprovides the surgeon betteraccess to tight joint spaces |
| Screen is secured to thespacer-cap with twotungsten raised staples. Thescreen and staples areenergized via a titaniumelectrode leg which passesthrough the spacer-cap viaan internal pathway andconducts power from theQuantum 2 Controller tothe screen. | Screen is energized andsecured to the spacer withfour tungsten ball wireswhich pass through thespacer and cap via aninternal pathway andconduct power from theQuantum 2 Controller tothe screen. | These design changes arebeing proposed to provide:• more efficientmanufacturability; and• a smaller profile tip toprovide surgical accessto tight joint spaces. |
| Resistor in the connector ofthe wand cable allows for amaximum ablation set pointof 10. | Resistor in the connector ofthe wand cable allows for amaximum ablation set pointof 9. | Provides the surgeon moreflexibility in deliveringtherapy. |
As a result of these modifications, the corresponding product labeling has also been updated.
Summary of Non-Clinical Performance Testing
In establishing substantial equivalence to the predicate device, ArthroCare compared the intended use, as well as features including materials, physical specifications, performance specifications and sterilization parameters. In addition, the Ambient TurboFlash 90 IFS was successfully evaluated using a variety of bench tests to simulate clinical use including:
- Ablation and coagulation testing; 트
- Electrical safety testing including Hipot, continuity, and IEC 60601-2-2:2009; ■
- I Tip strength testing;
- 트 Suction rate testing;
- 트 Ex vivo performance testing; and
- l Ambient temperature measurement testing.
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This testing demonstrated that the proposed modifications for the Ambient TurboFlash 90 IFS are substantially equivalent and do not affect the safety or efficacy of the device.
Summary of Safety and Effectiveness
The Ambient TurboFlash 90 IFS is substantially equivalent to the Ambient Super TurboVac 90 IFS cleared via K083306. Both the subject and the predicate devices have the same indications for use and utilize the same fundamental scientific technology. The proposed modifications are not substantial and do not significantly affect the safety or efficacy of the device.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved shapes that resemble a human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
December 11, 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Arthrocare Corporation % Ms. Cheryl Frederick Director, Regulatory Affairs 7000 West William Cannon Drive, Building One Austin, Texas 78735
Re: K120791
Trade/Device Name: Ambient™ TurboFlash 90 IFS Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 29, 2012 Received: November 30, 2012
Dear Ms. Frederick:
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 10 merce 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 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
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Page 2 - Ms. Cheryl Frederick
device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Peter D. Rumm -S
- Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: K120791
Device Name: Ambient® TurboFlash™ 90 IFS Wand
Indications for Use:
The Ambient TurboFlash 90 IFS Wand is 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 AllJoints (ankle, elbow,hip, knee, shoulder, andwrist) |
|---|---|
| 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 |
| • 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 |
| • Glenoid Labrum | Shoulder |
| • Lateral Release | Knee |
| • Ligament | All Joints |
| • Loose Bodies | All Joints |
| • Meniscal Cystectomy | Knee |
Page 1 of 2
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| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist) |
|---|---|
| • Menisectomy | Knee |
| • Plica 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 |
| • Glenohumeral Capsule | Shoulder |
| • Ligament | All Joints |
| • Medial Retinaculum | Knee |
| • Rotator Cuff | Shoulder |
| • Tendon | All Joints |
| • Wrist Tendons | Wrist |
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
X
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division of Orthopedic Devices , 2019 510(k) Number_
§ 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.