LogoFDA 510(k) Search
K Number
K993885
Device Name
ULTRABLATOR ELECTRODE
Manufacturer
LINVATEC CORP.
Date Cleared
2000-02-10

(86 days)

Product Code
JOS
Regulation Number
878.4400
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
K791137,K954633,K983652
Predicate For
K050923,K101711
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The UltrAblator™ Electrode is intended to be used in arthroscopic applications of resection, ablation, tissue modification, 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
  8. Fracture Debridement
  9. Excision of Scar Tissue
  10. Synovectomy
  11. Chondroplasty
    Wrist
  12. Synovectomy
  13. Cartilage Debridement
  14. Fracture Debridement
    Shoulder
  15. Labral Tear Resection
  16. Synovectomy
  17. Excision of Scar Tissue
  18. Acromioplasty
  19. Bursectomy
  20. Subacromial Decompression
  21. Chondroplasty
    Elbow
  22. Synovectomy
  23. Tendon Debridement
  24. Chondroplasty
Device Description

The UltrAblator™ Electrode is a monopolar electrode which will be packaged individually or in a kit containing an UltrAblator™ Electrode, ConMed electrosurgical pencil, and a ConMed electrosurgical dispersive pad. The electrode is connected to an electrosurgical generator via the ConMed electrosurgical pencil. The device is inserted into the joint. Upon activation of the generator, the tip of the device electrosurgically ablates and coagulates tissue.
The UltrAblator™ Electrode is a modification of Linvatec's Ablator Electrode which received FDA clearance under 510(k)# K983652 on March 23, 1999. The electrode will be made available in a range of sizes from 2.4" to 6.3" inches in working length, and in three angles, 0°, 30°, & 90°. The insulating material will be changed from polyolefin shrink to Vitek powder coat.

AI/ML Overview

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets specific performance criteria.

The document is a 510(k) premarket notification for a medical device (UltrAblator™ Electrode) seeking clearance from the FDA based on substantial equivalence to a predicate device. This type of submission typically focuses on ensuring safety and efficacy through comparison to an already marketed device, rather than through a detailed study proving performance against explicit acceptance criteria.

Here's what the document does provide and why the requested information is absent:

  1. Acceptance Criteria and Reported Device Performance: Not present. The document describes the device, its intended use, materials, manufacturing processes (sterilization, packaging), and identifies a predicate device (Linvatec's Ablator Electrode, K983652). It also mentions "Engineering testing will be performed per ANSI/AAMI American National Standard for Electrosurgical Devices HF-18/1993" for tests like Dielectric Withstand, Voltage Withstand, Run Test, and Resection Effectiveness Test, but it does not provide the acceptance criteria for these tests nor the results that demonstrate the new device meets them. It merely states that the protocols are included in an exhibit (which is not provided in the input text).

  2. Sample size used for the test set and the data provenance: Not present. Since no performance study is detailed, there's no mention of a test set, its sample size, or data provenance.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. This information would be relevant for clinical performance studies, which are explicitly stated as "not required" for this submission.

  4. Adjudication method: Not present, for the same reasons as point 3.

  5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not present. This type of study is more common for diagnostic imaging AI systems to assess human reader improvement with AI assistance, which is not applicable to this electrosurgical electrode.

  6. Standalone (algorithm only without human-in-the-loop performance) study: Not present. This is a physical electrosurgical device, not an algorithm.

  7. Type of ground truth used: Not applicable, as there's no clinical performance study involving ground truth.

  8. Sample size for the training set: Not applicable, as there's no AI/algorithm being trained.

  9. How the ground truth for the training set was established: Not applicable, as there's no AI/algorithm being trained.

In summary, the provided document is a 510(k) notification focused on demonstrating substantial equivalence, not a detailed performance study with explicit acceptance criteria and results for the device's functional performance. It references engineering tests and biocompatibility tests but does not include the results or specific acceptance criteria within the provided text.

{0}------------------------------------------------

FEB 1 0 2000

Summary

The following information is supplied in accordance with Public Law 94-295, "Medical Device Amendment", Section 510(k) requiring premarket notification.

Linvatec manufactures all its products and maintains such records as it considers necessary to satisfy the known requirements of the Act. Linvatec Corporation, hereby notifies the Food and Drug Administration of its intent to market the following:

    1. Manufacturer Identification:
      Linvatec Corporation 11311 Concept Boulevard Largo, FL 33773-4908 Registration No. 1017294
Contact Person:Laura Seneff, RACManager, Regulatory Affairs
Phone Number:727-399-5234
Fax Number:727-399-5264
    1. Device Identification:
Proprietary Name:UltrAblator™ Electrode
Common Name:Electrode
ClassificationName/Reference:Electrosurgical cutting and coagulation device andaccessories, 878.4400
Proposed Class/Device Product Code:Class II, 79 JOS, Electrode, Electrosurgical
    1. Intended Use:
      The UltrAblator™ Electrode is intended to be used in arthroscopic applications of resection, ablation, tissue modification, 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

{1}------------------------------------------------

Intended Use (Continued)

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

Elbow

    1. Synovectomy
    1. Tendon Debridement
    1. Chondroplasty
    1. Device Description:

The UltrAblator™ Electrode is a monopolar electrode which will be packaged individually or in a kit containing an UltrAblator™ Electrode, ConMed electrosurgical pencil, and a ConMed electrosurgical dispersive pad. The electrode is connected to an electrosurgical generator via the ConMed electrosurgical pencil. The device is inserted into the joint. Upon activation of the generator, the tip of the device electrosurgically ablates and coagulates tissue.

{2}------------------------------------------------

The UltrAblator™ Electrode is a modification of Linvatec's Ablator Electrode which received FDA clearance under 510(k)# K983652 on March 23, 1999. The electrode will be made available in a range of sizes from 2.4" to 6.3" inches in working length, and in three angles, 0°, 30°, & 90°. The insulating material will be changed from polyolefin shrink to Vitek powder coat.

ConMed's electrosurgical dispersive pad has received clearance for marketing under 510(K) Number K791137. ConMed's electrosurgical pencil has received clearance to market the device under 510(K) Number K954633.

Linvatec is a wholly owned subsidiary of ConMed Corporation.

Advertisement and labeling are included in Exhibit 1.

Pictures of the device are included in Exhibit 2.

Engineering drawings are included in Exhibit 3.

    1. Materials:
Tip/Shaft:304 Stainless Steel, ASTM A-908
Shrink Tube:Vitek Coating, No ASTM Reference
Insulator:Zirconia or Alumina, No ASTM Reference
Hub:Nylon, ASTM GFN2
    1. Labeling:
      Proposed labeling is included in Exhibit 1.
    1. Additional Information:
      Engineering testing will be performed per ANSI/AAMI American National Standard for Electrosurgical Devices HF-18/1993. Test protocols are included in Exhibit 4 for the following tests: 3,000 VAC Dielectric Withstand Test; 1.5 Times Maximum Voltage Withstand Test; 18 Minute Run Test, and Resection Effectiveness Test.

Biocompatibility testing was performed on the final packaged sterilized device per ISO Standard 10993-1. A Summary of Test Results is included in Exhibit 5.

    1. Clinical Data
      Clinical data are not required.

{3}------------------------------------------------

9. Sterility Information:

The UltrAblator ™ Electrode will be supplied sterile, single use, and will be sterilized using Ethylene Oxide as follows:

    1. EtO Sterilization Cycle Parameters:
      The UltrAblator™ Electrode is sterilized by using 100% Ethylene Oxide (EtO). Validation of the process will be on file at Linvatec, Largo, Florida.

Sterilization of product will be processed at Cosmed, New NOTE: Jersey. Other contract sterilization facilities and/or processes may be used in the future.

    1. Residual levels for ETO, ECH, & EG will meet the requirements per FDA Proposed Rule, page 27482, dated June 23, 1978, and ISO 10993-7-1995 "Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals".
    1. Sterility Assurance Level (SAL): 10-6
    1. Sterility Validation Method will be per ANSI/AAMI/ISO 1135-1994 Method C, Half Cycle Method.

10. Packaging

The UltrAblator™ Electrode is placed into protective mounting card fabricated from .010" High Density Polyethylene (HDPE), natural color.

The electrode is then placed into a chevron style peel pouch with one layer consisting of DuPont Tyvek®, 1073B medical grade (uncoated), and the other layer consisting of .002" thick translucent coextruded film consisting of polyethylene/polymar (.0015" polyethylene and .0005" polymer). The pouch is then heat sealed to create a sterile barrier. A label will be applied to the pouch.

Kit components ("pencil" and dispersive pad) are packed along with the pouched electrode into a folding carton, reverse tuck style, consisting of .024" thick Clay-Coated Newsback (CCN) fiberboard. A label will be applied to the Kit box.

{4}------------------------------------------------

Substantial Equivalence Information: 11.

The UltrAblator™ Electrode is substantially equivalent to:

1.Ablator ElectrodeCatalog Number                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         n
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The similarities/dissimilarities to the predicates are shown in the table on the following page.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three horizontal lines above it, representing wings or feathers.

FEB 1 0 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K993885 Trade Name: UltrAblator™ Electrode Regulatory Class: II Product Code: JOS and GEI Dated: November 15, 1999 Received: November 16, 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.

{6}------------------------------------------------

Page 2 – Ms. Laura 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,

Stipt Rhodes

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

November 15, 1999

Page 1 of 2

् ।

510(k) Number (if known): K993885

Device Name: UltrAblator™ Electrode

Indications for Use:

The UltrAblator™ Electrode is intended to be used in arthroscopic applications of resection, ablation, tissue modification, 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

{8}------------------------------------------------

Intended Use (Continued)

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)

(Division Sign-Off) Division of General Restorative Devices K993885 510(k) Number .

Prescription Use_X OR Over-the-Counter Use_

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Page 2 of 2

§ 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.