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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
SU
Reference & Predicate Devices
K791137,K954633,K983652
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.

§ 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.