LogoFDA 510(k) Search
K Number
K983652
Device Name
ABLATOR ELECTRODE
Manufacturer
LINVATEC CORP.
Date Cleared
1999-03-23

(155 days)

Product Code
HRX
Regulation Number
888.1100
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ablator Electrode is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following: Knee 1. Meniscectomy 2. Lateral Release 3. Chondroplasty 4. Synovectomy 5. ACL Debridement 6. Plica Removal 7. Meniscal Cystectomy Ankle 1. Fracture Debridement 2. Excision of Scar Tissue 3. Synovectomy 4. Chondroplasty Wrist 1. Synovectomy 2. Cartiledge Debridement 3. Fracture Debridement Shoulder 1. Labral Tear Resection 2. Synovectomy 3. Excision of Scar Tissue 4. Acromioplasty 5. Bursectomy 6. Subacromial Decompression 7. Chondroplasty Elbow 1. Synovectomy 2. Tendon Debridement 3. Chondroplasty
Device Description
The Ablator Electrode is packaged in a kit containing an Electrode, pencil, and a Ablator electrosurgical dispersive pad. The electrode will also be individually. The electrode is connected sold to an electrosurgical generator via the electrosurgical pencil.
More Information

Not Found

Not Found

No
The provided text describes a standard electrosurgical electrode and its intended uses. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML. The description focuses on the physical components and surgical applications.

Yes
The device is used for surgical procedures like resection, ablation, and excision of soft tissue, directly treating conditions and performing therapeutic functions.

No

The device is described as an "Ablator Electrode" used for resection, ablation, excision, and coagulation of tissues during surgery, indicating a therapeutic function rather than a diagnostic one.

No

The device description explicitly mentions physical components like an electrode, pencil, and dispersive pad, which are hardware.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a device used during surgical procedures to directly interact with and modify tissues within the body (resection, ablation, excision, hemostasis, coagulation). This is an in vivo application.
  • Device Description: The description details a surgical electrode, pencil, and dispersive pad, all components used in electrosurgery performed on a patient.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.

IVD devices are used to perform tests on samples taken from the body, not to directly treat or modify tissues within the body during surgery.

N/A

Intended Use / Indications for Use

The Ablator Electrode is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following:

Knee

  1. Meniscectomy
  2. Lateral Release
  3. Chondroplasty
  4. Synovectomy
  5. ACL Debridement
  6. Plica Removal
  7. Meniscal Cystectomy

Ankle

  1. Fracture Debridement
  2. Excision of Scar Tissue
  3. Synovectomy
  4. Chondroplasty

Wrist

  1. Synovectomy
  2. Cartiledge Debridement
  3. Fracture Debridement

Shoulder

  1. Labral Tear Resection
  2. Synovectomy
  3. Excision of Scar Tissue
  4. Acromioplasty
  5. Bursectomy
  6. Subacromial Decompression
  7. Chondroplasty

Elbow

  1. Synovectomy
  2. Tendon Debridement
  3. Chondroplasty

Product codes (comma separated list FDA assigned to the subject device)

HRX and GEI

Device Description

The Ablator Electrode is packaged in a kit containing an Electrode, pencil, and a Ablator electrosurgical dispersive pad. The electrode will also be individually. The electrode is connected sold to an electrosurgical generator via the electrosurgical pencil.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Knee, Ankle, Wrist, Shoulder, Elbow

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)

Testing has been done to prove safety and effectiveness of the devices.

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.

ESA Electrodes (Linvatec Corporation), ArthroCare® Electrosurgery System 2000 (ArthroCare Corporation), VAPR™ (Mitek Products)

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

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.

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3/23/99

Image /page/0/Picture/1 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is a stylized diamond with three lines inside. The word "Linvatec" is in a bold, sans-serif font.

11311 Concept Boulevard Largo, Florida 33773 727 399-5334 Fax 727 399-5264

Carol A. Weideman, Ph.D.

Director Compliance and Regulatory Affairs October 16, 1998

SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Ablator Electrode, 510(k) Number K 983653

A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

B. Company Contact

Carol A. Weideman, Ph.D. Director, Compliance and Regulatory Affairs

c. Device Name

Trade Name::Ablator Electrode
Common Name:Electrode
Classification Names:Electrosurgical cutting and
coagulation device and
accessories, 878.4400
Proposed Class/Device :
Product Code:Class II, 79 JOS, Electrode,
Electrosurgical

D. Predicate/Legally Marketed Devices

ESA Electrodes Linvatec Corporation

ArthroCare® Electrosurgery System 2000 ArthroCare Corporation

VAPR™ Mitek Products

1

Summary of Safety and Effectiveness Ablator Electrode 510(k) # October 16,1998 Page 2 of 3

E. Device Description

The Ablator Electrode is packaged in a kit containing an Electrode, pencil, and a Ablator electrosurgical dispersive pad. The electrode will also be individually. The electrode is connected sold to an electrosurgical generator via the electrosurgical pencil.

F. Intended Use

The Ablator Electrode is designed for general surgical use, including orthopaedic and arthroscopic applications resection, ablation, excision of soft tissue, of hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following:

Knee

    1. Meniscectomy
    1. Lateral Release
    1. Chondroplasty
    1. Synovectomy
    1. ACL Debridement
    1. Plica Removal
    1. Meniscal Cystectomy

Ankle

    1. Fracture Debridement
    1. Excision of Scar Tissue
    1. Synovectomy
    1. Chondroplasty

Wrist

    1. Synovectomy
    1. Cartiledge Debridement
    1. Fracture Debridement

2

Intended Use (cont.)

Shoulder

    1. Labral Tear Resection
    1. Synovectomy
    1. Excision of Scar Tissue
    1. Acromioplasty
    1. Bursectomy
    1. Subacromial Decompression
    1. Chondroplasty

Elbow

    1. Synovectomy
    1. Tendon Debridement
    1. Chondroplasty

G. Substantial Equivalence

The Ablator Electrode is substantially equivalent in design, function and intended use to the ESA Electrodes (Linvatec Corporation), ArthroCare® Electrosurgery System 2000 (ArthroCare Corporation), and VAPR™ (Mitek Products)

Testing has been done to prove safety and effectiveness of the devices.

The similarities/dissimilarities to the predicates are shown in the attached table.

3

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1999

Ms. Laura D. Seneff Manager, Regulatory Affairs Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K983652 Trade Name: Ablator Electrode Regulatory Class: II Product Code: HRX and GEI Dated: February 16, 1999 Received: February 17, 1999

Dear Ms. Seneff:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

4

Page 2 – Ms. Laura D. Seneff

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Sincerely, John,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

3/23/99

Image /page/5/Picture/1 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is a black diamond with three white chevrons inside. The word "Linvatec" is written in a bold, sans-serif font.

11311 Concept Boulevard Largo, Florida 33773-4908 813 392-6464

October 16, 1998

Page 1 of 2

510(k) Number (if known): K983652

Device Name: Ablator Electrode

Indications for Use:

The Ablator Electrode is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following:

Knee

    1. Meniscectomy
    1. Lateral Release
    1. Chondroplasty
    1. Synovectomy
    1. ACL Debridement
    1. Plica Removal
    1. Meniscal Cystectomy

Ankle

    1. Fracture Debridement
    1. Excision of scar tissue
    1. Synovectomy
    1. Chondroplasty

Wrist

    1. Synovectomy
    1. Cartilage Debridement
    1. Fracture Debridement

Shoulder

    1. Labral Tear Resection
    1. Synovectomy
    1. Excision of Scar Tissue
    1. Acromioplasty
    1. Bursectomy
    1. Subacromial Decompression
    1. Chondroplasty

bn Sign-Off) of General Restorative Devices

Prescription Use
(Per 21 CFR 801.109)

2

6

Intended Use (cont.)

Page 2 of 2

Elbow

    1. Synovectomy
    1. Tendon Debridement
    1. Chondroplasty

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR

Over-the-Counter Use_

(Per 21 CFR 801.109)

(Optio

(Optional Format 1-296)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983652