(37 days)
Not Found
No
The description focuses on the mechanical and electrical components of an ultrasonic aspirator system and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No.
The device is used for surgical fragmentation, emulsification, and aspiration of soft tissue, which is an interventional procedure rather than a therapeutic one. It facilitates the removal of tissue during surgery and does not directly treat a disease or condition.
No
The device description clearly states its purpose is for "fragmentation, emulsification and aspiration of soft tissue" during surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines hardware components including a Console, Handpieces with titanium tips, a footswitch, and an optional Service Module. It is a system with physical components, not solely software.
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 surgical device used for fragmenting, emulsifying, and aspirating soft tissue during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The description details a system that physically interacts with tissue using ultrasonic energy and aspiration. It's a surgical tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is therapeutic/surgical, not diagnostic.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SELECTOR® Quantum Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
Product codes
LFL
Device Description
The SELECTOR® Ouantum Ultrasonic Aspirator System dissects and fragments soft tissue and leaves essential elastic structures such as nerves and blood vessels relatively undamaged. It is particularly useful for the ablation of unwanted tissue adjacent or attached to vital structures.
The system consists of a Console, which provides control and display of aspiration, irrigation and ultrasonic power, and one or more Handpieces for selective tissue removal at the surgical site. The handpieces have a titanium tip and silicone irrigation flue. The tips are interchangeable which allows the surgeon to use the same handpiece for different applications. The required settings on the Console are selected by operation of up-down controls on the front panel. The Console provides power to the footswitch, which has two controls. One pedal provides proportional control of ultrasonic power, and the other the flow of irrigation fluid. An accessory Service Module may be used to provide a convenient source of suction and waste collection.
A range of handpieces are connected to the console, both electrically and by a disposable sterile tubing kit which delivers sterile saline for irrigation, and removes aspirated waste matter. A special version of the Selector system will be available for use within an MRI suite. All handpieces may be sterilized by steam autoclaving or by Ethylene Oxide.
The Selector® Quantum Ultrasonic Aspirator System described in the submission is a modification of the Selector® Integra Ultrasonic Surgical Aspirator System currently cleared to market. The main differences are that the Selector® Quantum Ultrasonic Surgical Aspirator System has:
- a software user interface on a LCD display screen ◆
- a new range of handpieces with interchangeable tips .
- pulse mode .
- a more powerful vacuum system for enhanced aspiration .
The Indications for Use and all other aspects of the device remain the same.
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
Hospitals
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
The Selector® Quantum Ultrasonic Surgical Aspirator System has been designed to conform to the following standards, as applicable:
CSA22.2 No. 601-1 EN 60601-1 EN60601-1-2 EN60601-2-2 FCC 18 JIS T 1001/1002 UL 2601-1
The footswitch is additionally rated IP2.7 for dust and moisture resistance.
The Selector® Quantum handpieces will be tested to comply to ISO 11134:1994 for steam sterilisation and ISO 11135:1994 for ethylene oxide sterilisation.
The biological safety of the Selector® Quantum handpieces has been assured through the selection of materials that demonstrate appropriate levels of biocompatibility. The material is the same used in the current Selector® Integra handpieces and the Cusa Excel predicate. This material has been tested to ISO10993-1 and confirmed.
In addition, the Selector® Quantum was subjected to extensive performance testing. Results of the testing showed that the system design was technically sound and the product safe for its intended use.
The Selector® Quantum manufacturing process complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.
Key Metrics
Not Found
Predicate Device(s)
K901974, K925129, K021989, K981262, K010309
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Selector® Quantum Ultrasonic Surgical Aspirator System
510(k) Summary
August 20, 2004
A. Submitter Information
Manufacturer
Integra NeuroSciences Ltd Newbury Road Andover Hampshire SP10 4DR England United Kingdom +44 (0) 1264 345700 Telephone: +44 (0) 1264 332113 Facsimile:
| Contact Person: | Nikki Hinton |
|---|---|
| Quality Assurance/Regulatory Affairs Manager | |
| E-Mail: nikki hinton@integra-neuro.com |
Authorized Agent in the United States
Integra NeuroSciences 5955 Pacific Center Blvd San Diego CA 92121, USA Telephone: 858 455 1115 858 455 8298 Facsimile:
Contact Person: Nancy Mathewson Director, Regulatory Affairs E-Mail: nmathewson@integra-ls.com
B. Device Identification
Selector® Quantum Ultrasonic Surgical Aspirator System Proprietary Name: Common Name: Ultrasonic Surgical Aspirator Classification Name: Instrument, Ultrasonic Surgical Code: 192 LFL Classification Panel: General and Plastic Surgery
1
C. Identification of Predicate Devices
The Selector® Quantum Ultrasonic Surgical Aspirator System is substantially equivalent to the following previously cleared and currently marketed devices:
- · Selector® Ultrasonic Surgical Aspirator System (K901974, K925129, K021989)
- · CUSA Excel Ultrasonic Surgical Aspirator System (K981262)
- · Sonopet UST 2001 Ultrasonic Surgical Aspirator System (K010309)
D. Intended Use
The SELECTOR® Quantum Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
E. Device Description
The SELECTOR® Ouantum Ultrasonic Aspirator System dissects and fragments soft tissue and leaves essential elastic structures such as nerves and blood vessels relatively undamaged. It is particularly useful for the ablation of unwanted tissue adjacent or attached to vital structures.
The system consists of a Console, which provides control and display of aspiration, irrigation and ultrasonic power, and one or more Handpieces for selective tissue removal at the surgical site. The handpieces have a titanium tip and silicone irrigation flue. The tips are interchangeable which allows the surgeon to use the same handpiece for different applications. The required settings on the Console are selected by operation of up-down controls on the front panel. The Console provides power to the footswitch, which has two controls. One pedal provides proportional control of ultrasonic power, and the other the flow of irrigation fluid. An accessory Service Module may be used to provide a convenient source of suction and waste collection.
A range of handpieces are connected to the console, both electrically and by a disposable sterile tubing kit which delivers sterile saline for irrigation, and removes aspirated waste matter. A special version of the Selector system will be available for use within an MRI suite. All handpieces may be sterilized by steam autoclaving or by Ethylene Oxide.
2
The Selector® Quantum Ultrasonic Aspirator System described in the submission is a modification of the Selector® Integra Ultrasonic Surgical Aspirator System currently cleared to market. The main differences are that the Selector® Quantum Ultrasonic Surgical Aspirator System has:
- a software user interface on a LCD display screen ◆
- a new range of handpieces with interchangeable tips .
- pulse mode .
- a more powerful vacuum system for enhanced aspiration .
The Indications for Use and all other aspects of the device remain the same.
F. Safety and Performance Data
The Selector® Quantum Ultrasonic Surgical Aspirator System has been designed to conform to the following standards, as applicable:
CSA22.2 No. 601-1 EN 60601-1 EN60601-1-2 EN60601-2-2 FCC 18 JIS T 1001/1002 UL 2601-1
The footswitch is additionally rated IP2.7 for dust and moisture resistance.
The Selector® Quantum handpieces will be tested to comply to ISO 11134:1994 for steam sterilisation and ISO 11135:1994 for ethylene oxide sterilisation.
The biological safety of the Selector® Quantum handpieces has been assured through the selection of materials that demonstrate appropriate levels of biocompatibility. The material is the same used in the current Selector® Integra handpieces and the Cusa Excel predicate. This material has been tested to ISO10993-1 and confirmed.
In addition, the Selector® Quantum was subjected to extensive performance testing. Results of the testing showed that the system design was technically sound and the product safe for its intended use.
The Selector® Quantum manufacturing process complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.
3
G. Summary of Substantial Equivalence
The Selector Ultrasonic Surgical Aspirator System (Console, Handpieces and Accessories) is substantially equivalent in function, technical specifications, performance and intended use to the following predicates:
- Selector® Ultrasonic Surgical Aspirator System (K901974, K925129, . K021989)
- . CUSA Excel Ultrasonic Surgical Aspirator System, frequency 23kHz and 36kHz (K981262)
- . Sonopet UST2001 Ultrasonic Surgical Aspirator, frequency 25 kHz/ 34kHz (K010309)
Table 1 is a feature comparison chart regarding the subject of this Premarket Notification for the SELECTOR® Quantum Ultrasonic Aspirator (previously cleared to marked under 510(k)s K901974, K925129 and K021989) and the predicate devices.
4
| TABLE 1 | SELECTOR®
INTEGRA
K901974,
K925129 and
K021989 | CUSA Excel
K981262 | Sonopet
UST 2001
K010309 | SELECTOR®
QUANTUM |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------|------------------------------------------------------|
| | Neuro | Neuro | Neuro | Neuro |
| | Gastro | Gastro | Gastro | Gastro |
| | Uro | Uro | Uro | Uro |
| | Plastic & Recon. | Plastic & Recon. | Plastic & Recon. | Plastic & Recon. |
| | General | General | General | General |
| • Indications for
Use | Ortho | Ortho | Ortho | Ortho |
| | Gynecology | Gynecology | Gynecology | Gynecology |
| | Thoracic | Thoracic | Thoracic | Thoracic |
| | Laparoscopic
Thoracoscopic | Laparoscopic
Thoracoscopic | Laparoscopic
Thoracoscopic | Laparoscopic
Thoracoscopic |
| • Basic Operating Principle | Ultrasonic action through Titanium Alloy Tip onto biological tissue causes | | | |
| | fragmentation and cavitation of tissue. Irrigation system bathes site, aspiration removes unwanted ablated tissue. | | | |
| • Where used | Hospitals | Hospitals | Hospitals | Hospitals |
| • Vibration
System | Piezo | Magnetostrictive | Piezo | Piezo |
| • Frequency | 24 kHz & 35 kHz | 23 kHz & 36 kHz | 25 kHz & 34 kHz | 24 kHz & 35 kHz |
| • Irrigation Flow | 0-50 ml/min | 1-29 cc/min | 3-