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K Number
K960040
Device Name
SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE
Manufacturer
SHARPLAN LASERS, INC.
Date Cleared
1996-04-29

(118 days)

Product Code
LFL
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
It is indicated for use in laparoscopic surgical procedures where fragmentation, emulsification, and aspiration of soft is desirable.
Device Description
The Sharplan Ultra Model 4300 Ultrasonic Aspirator System is a surgical tool which achieves fragmentation and excision of unwanted tissue by high frequency vibration of the titanium tip housed in the handpiece. The application of the vibration tip to the unwanted tissue results in the rupture of the tissue. Irrigation and aspiration of the debris is also accomplished by the system. There accessories to the system are various handpieces, one of which can be used in laparoscopy.
More Information

K921251, K883091

Not Found

No
The description focuses on the mechanical action of ultrasonic vibration for tissue fragmentation and aspiration, with no mention of AI or ML terms or functionalities.

No
The device is described as a surgical tool used for fragmentation, emulsification, and aspiration of soft tissue during laparoscopic procedures, which are interventional rather than therapeutic. Its function is to remove unwanted tissue, not to treat a disease or condition therapeutically.

No

The device is described as a surgical tool used for fragmentation, emulsification, and aspiration of soft tissue during laparoscopic procedures, which are therapeutic actions, not diagnostic ones.

No

The device description clearly states it is a "Sharplan Ultra Model 4300 Ultrasonic Aspirator System" which is a "surgical tool" with a "titanium tip housed in the handpiece" that achieves fragmentation through "high frequency vibration". This describes a physical hardware device, not software.

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

Here's why:

  • Intended Use: The intended use clearly states it's for "laparoscopic surgical procedures where fragmentation, emulsification, and aspiration of soft is desirable." This describes a surgical tool used directly on tissue within the body during a procedure.
  • Device Description: The description details a "surgical tool" that uses "high frequency vibration of the titanium tip" to fragment and excise tissue. This is a mechanical surgical action, not a diagnostic test performed on samples outside the body.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue biopsies) or providing diagnostic information about a patient's condition. IVDs are designed to provide information about a disease or condition.

Therefore, the Sharplan Ultra Model 4300 Ultrasonic Aspirator System is a surgical device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Sharplan Ultra Model 4300 Ultrasonic Aspirator is indicated for use in laparoscopic surgical procedures where fragmentation, emulsification, and aspiration of soft [tissue] is desirable.

Product codes

Not Found

Device Description

The Sharplan Ultra Model 4300 Ultrasonic Aspirator System is a surgical tool which achieves fragmentation and excision of unwanted tissue by high frequency vibration of the titanium tip housed in the handpiece. The application of the vibration tip to the unwanted tissue results in the rupture of the tissue. Irrigation and aspiration of the debris is also accomplished by the system. There [are] accessories to the system [including] various handpieces, one of which can be used in laparoscopy.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

K921251, K883091

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

N/A

0

APR 3 0 1996

K 960040

510(k) Summary of Safety and Effectiveness Sharplan Lasers, Inc. Ultra Model 4300 Ultrasonic Aspirator System for Laparoscopic Use

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the Sharplan Model 4300 Ultrasonic Aspirator for use in Laparoscopy is based on a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the Valley Lab CUSA and the Sharplan Ultrasonic Aspirator .

  • 1 . Sharplan Lasers, Inc. 1 Pearl Court Allendale, NJ 07401 George J. Hattub, Director of Regulatory Affairs Updated: October, 1995
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2. Model: Sharplan Ultra Model 4300 Ultrasonic Aspirator system for Laparoscopy

    1. Predicate Devices: The Valley Lab CUSA Ultrasonic Aspirator for Laparoscopy and the Sharplan Ultrasonic Aspirator .
      4 . Description: The Sharplan Ultra Model 4300 Ultrasonic Aspirator System is a surgical tool which achieves fragmentation and excision of unwanted tissue by high frequency vibration of the titanium tip housed in the handpiece. The application of the vibration tip to the unwanted tissue results in the rupture of the tissue. Irrigation and aspiration of the debris is also accomplished by the system. There accessories to the system are various handpieces, one of which can be used in laparoscopy.

  • ડ . The Sharplan Ultra Model 4300 Ultrasonic Aspirator is substantially equivalent to the -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------following devices: The Valley Labs CUSA and the Sharplan Ultrasonic Aspirator (K921251 and K883091, respectively). It is indicated for use in laparoscopic surgical ...... procedures where fragmentation, emulsification, and aspiration of soft is desirable.
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510(k) Summary of Safety and Effectiveness (continued) Sharplan Lasers, Inc. Ultra Model 4300 Ultrasonic Aspirator System For Use in Laparoscopy

    1. From a technological and clinical performance perspective, the aforementioned devices while are not identical, perform the same function and are of the same technology. The modification to the candidate device involved changing the length of the probe so that it will have the ability to utilized in laparoscopic procedures. Based upon a comparison of the performance characteristics of the devices, no significant differences exist. In regards to safety or effectiveness of the Sharplan Ultra Model 4300 Ultrasonic Aspirator System for Laparoscopic Use, Sharplan Lasers, Inc.believes that this modification and expanded indication does not change the performance characteristics of the device and raises no concerns.
    • This information was prepared for the sole purpose of compliance with the Advisory: Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.