(87 days)
No
The device description focuses on mechanical and electrical components for tissue fragmentation and aspiration, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used in surgical procedures for fragmentation, emulsification, and aspiration of soft tissue to treat medical conditions.
No
Explanation: The device description states its purpose is for "fragmentation, emulsification, and aspiration of soft tissue" in surgical procedures, aiming to "dissect and fragment soft tissue." There is no mention of diagnosing conditions, only of surgically removing tissue.
No
The device description clearly outlines hardware components including a console, handpieces with titanium tips, a footswitch, and an accessory service module.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used in surgical procedures for "fragmentation emulsification and aspiration of soft tissue." This is a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a system for dissecting and fragmenting tissue using ultrasonic energy and aspiration. This is a physical intervention on tissue within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on specimens.
The device is a surgical instrument used for tissue removal during surgery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SELECTOR® Integra 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 Ultrasonic Surgical 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 irrigation flue. The required settings on the console are selected by operation of up-down controls on the membrane switch 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 is available for use within an MRI suite. All handpieces can be sterilized by steam autoclaving or by Ethylene Oxide. A large number of these are in routine use.
The main features of the Selector Ultrasonic Surgical Aspirator System are as follows:
- . Console is compact and portable
- Simple to set up, use, clean and sterilise .
- Linear action footswitch places the ultrasonic power and irrigation . rate directly under the surgeon's control
- . Available for use within an MRI suite
- . Ergonomically designed Handpieces for ease of use
- . Lightweight and compact Handpieces which are extremely energy efficient
- . No external cooling system required
- Handpieces meet the tactile needs of the surgeon .
- Free from external tubing, thus providing a clear view of the ● operating site
- Irrigation fluid is delivered directly to the surgical site allowing . efficient ablation of unwanted tissue
- Variety of Handpieces specifically designed for surgery and ● surgeon preference, including laparoscopic
- Irrigation flue provides protection of the titanium surgical tip ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, including areas related to Neurosurgery, Gastrointestinal and affiliated organs, Urology, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Selector Ultrasonic Surgical Aspirator System has been designed to conform with the following standards, as applicable:
CSA22.2 No. 601-1 EN 60601-1 EN60601-1-2 FCC 18 JIS T 1001/1002 UL 2601-1
The footswitch is additionally rated IPX 2.7 for dust and moisture resistance.
The Selector® Integra Handpieces have been tested and comply to ISO 10993-1 for steam sterilisation and ISO 11135:1994 for ethylene oxide sterilisation.
Conclusion:
Valid scientific evidence through biocompatibility physical property and performance testing provide reasonable assurance that the SELECTOR® Integra Ultrasonic Aspirator System is safe and effective under the proposed conditions of use, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Selector® Integra Ultrasonic Surgical Aspirator System
510(k) Summary
A. Submitter Information
| Integra NeuroSciences Ltd | |
|---|---|
| Newbury Road | |
| Andover | |
| Hampshire SP10 4DR | |
| England | |
| United Kingdom | |
| Telephone: | +44 (0) 1264 345700 |
| Facsimile: | +44 (0) 1264 332113 |
| Contact Person: | Nikki Robinson |
| Quality Assurance/Regulatory Affairs Manager | |
| E-Mail: nikki_robinson@integra-neuro.com | |
| Date Prepared: | June 14, 2002 |
B. Device Identification
Proprietary Name: Selector® Integra Ultrasonic Surgical Aspirator System Ultrasonic Surgical Aspirator Common Name: Classification Name: Instrument, Ultrasonic Surgical Code: 192 LFL Classification Panel: General and Plastic Surgery
C. Identification of Predicate Devices
The Selector® Integra Ultrasonic Surgical Aspirator System is substantially equivalent to the following previously cleared and currently marketed devices:
- · CUSA Excel Ultrasonic Surgical Aspirator System (K981262)
- · Sonotom 110 Ultrasonic Aspirator System (K010637)
- · Sonopet UST 2001 Ultrasonic Surgical Aspirator System (K010309)
1
D. Intended Use
The SELECTOR® Integra 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 Ultrasonic Surgical 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 irrigation flue. The required settings on the console are selected by operation of up-down controls on the membrane switch 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 is available for use within an MRI suite. All handpieces can be sterilized by steam autoclaving or by Ethylene Oxide. A large number of these are in routine use.
The main features of the Selector Ultrasonic Surgical Aspirator System are as follows:
- . Console is compact and portable
- Simple to set up, use, clean and sterilise .
- Linear action footswitch places the ultrasonic power and irrigation . rate directly under the surgeon's control
- . Available for use within an MRI suite
- . Ergonomically designed Handpieces for ease of use
- . Lightweight and compact Handpieces which are extremely energy efficient
- . No external cooling system required
2
- Handpieces meet the tactile needs of the surgeon .
- Free from external tubing, thus providing a clear view of the ● operating site
- Irrigation fluid is delivered directly to the surgical site allowing . efficient ablation of unwanted tissue
- Variety of Handpieces specifically designed for surgery and ● surgeon preference, including laparoscopic
- Irrigation flue provides protection of the titanium surgical tip ●
F. Safety and Performance Data
The Selector Ultrasonic Surgical Aspirator System has been designed to conform with the following standards, as applicable:
CSA22.2 No. 601-1 EN 60601-1 EN60601-1-2 FCC 18 JIS T 1001/1002 UL 2601-1
The footswitch is additionally rated IPX 2.7 for dust and moisture resistance.
The Selector® Integra Handpieces have been tested and comply to ISO 10993-1 for steam sterilisation and ISO 11135:1994 for ethylene oxide sterilisation.
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:
- . CUSA Excel Ultrasonic Surgical Aspirator System, frequency 23kHz and 36kHz (K981262)
- Sonotom 110 Ultrasonic Aspirator, frequency 26.5 kHz (K010637)
- 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® Integra Ultrasonic Aspirator (previously cleared to marked under 510(k)s K901974 and K925129) and the predicate devices.
3
Substantial Equivalence Table
| TABLE 1 | CUSA Excel
K981262 | Sonopet
UST 2001
K010309 | Berchtold
Sonotom 110
K010637 | SELECTOR®
K901974 &
K925129 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| • Indications for
Use | Neuro
Gastro
Uro
Plastic & Recon.
General
Ortho
Gynecology
Thoracic
Laparoscopic
Thoracoscopic | Neuro
Gastro
Uro
Plastic & Recon.
General
Ortho
Gynecology
Thoracic
Laparoscopic
Thoracoscopic | Neuro
Uro
General
Gynae | Neuro
Gastro
Uro
Plastic & Recon.
General
Ortho
Gynecology
Thoracic
Laparoscopic
Thoracoscopic |
| • Where used | Hospitals | Hospitals | Medical environment | Hospitals |
| • 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. | | | |
| • Vibration System | Magnetostrictive | Piezo | Piezo | Piezo |
| •
Frequency | 23 kHz & 36 kHz | 25 kHz & 34 kHz | 26.5 kHz | 24 kHz & 35 kHz |
| • Irrigation Flow | 1-29 cc/min | 3-31 021989 |
| --------------- | ---------------------- |
|---|