Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the electrosurgical mechanism and physical components, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is indicated for medical procedures such as resection, ablation, and coagulation of soft tissue, as well as hemostasis of blood vessels, all of which are therapeutic interventions.

Diagnostic

No
The device description and intended use clearly state that it is for surgical procedures (resection, ablation, coagulation) and not for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a bipolar, sterile, single-use, high frequency electrosurgical device with physical components like an electrode tip, shaft, tubing, and handle. This is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

No, 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. This testing is done outside of the body (in vitro).
Device Function: The Ambient TurboFlash 90 IFS Wand is an electrosurgical device used for surgical procedures inside the body (in vivo). It directly interacts with and modifies soft tissue and blood vessels during surgery.
Intended Use: The intended use clearly describes surgical procedures like resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. This is a surgical tool, not a diagnostic test performed on a sample.

The description and intended use of the Ambient TurboFlash 90 IFS Wand align with a surgical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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
• 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
• Wrist Tendons	Wrist

Product codes

GEI

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ankle, elbow, hip, knee, shoulder, and wrist joints.

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 Ambient TurboFlash 90 IFS was successfully evaluated using a variety of bench tests to simulate clinical use including:

Ablation and coagulation testing;
Electrical safety testing including Hipot, continuity, and IEC 60601-2-2:2009;
Tip strength testing;
Suction rate testing;
Ex vivo performance testing; and
Ambient temperature measurement testing.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K083306

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

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 |

1

:

the state of the state of the states of the states

:

,

:

· · ·

2

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 90
IFS
(Subject Device) | Ambient Super TurboVac
IFS, K083306
(Predicate Device) | Rationale for Change |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| One-piece spacer-cap
design manufactured from
alumina. | Two-piece spacer-cap
manufactured from alumina
and stainless steel,
respectively. | Facilitates the
manufacturability of a
smaller profile tip which
provides the surgeon better
access to tight joint spaces |
| Screen is secured to the
spacer-cap with two
tungsten raised staples. The
screen and staples are
energized via a titanium
electrode leg which passes
through the spacer-cap via
an internal pathway and
conducts power from the
Quantum 2 Controller to
the screen. | Screen is energized and
secured to the spacer with
four tungsten ball wires
which pass through the
spacer and cap via an
internal pathway and
conduct power from the
Quantum 2 Controller to
the screen. | These design changes are
being proposed to provide:
• more efficient
manufacturability; and
• a smaller profile tip to
provide surgical access
to tight joint spaces. |
| Resistor in the connector of
the wand cable allows for a
maximum ablation set point
of 10. | Resistor in the connector of
the wand cable allows for a
maximum ablation set point
of 9. | Provides the surgeon more
flexibility in delivering
therapy. |

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.

3

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.

4

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

5

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

6

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 Joints (ankle, elbow,
hip, knee, shoulder, and
wrist) |
|----------------------- | 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 and Orthopedic Procedures | Joint Specific or All
-----------------|--------------------------------------------------------------------------------------|
| |
| Knee |
| Shoulder |
| All Joints |
| All Joints |
| All Joints |
| All Joints |
| All Joints |
| Knee |
| All Joints |
| All Joints |
| Shoulder |
| All Joints |
| All Joints |
| |
| Hip |
| All Joints |
| All Joints |
| Knee |
| Knee |
| All Joints |
| Knee |
| Shoulder |
| Shoulder |
| Knee |
| All Joints |
| All Joints |
| Knee |

Page 1 of 2

7

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_