SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM

K042277 · Integra Neurosciences, Ltd. · LFL · Sep 29, 2004 · SU

Device Facts

• Record ID: K042277
• Device Name: SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM
• Applicant: Integra Neurosciences, Ltd.
• Product Code: LFL · SU
• Decision Date: Sep 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

Ultrasonic surgical aspirator system for soft tissue fragmentation, emulsification, and aspiration; preserves elastic structures like nerves and blood vessels. System comprises console (controls aspiration, irrigation, ultrasonic power), handpieces with titanium tips, and footswitch. Surgeon operates console via LCD interface and footswitch (proportional power/irrigation control). Used in hospital surgical settings (OR). Provides selective tissue ablation near vital structures. Benefits include precise tissue removal with minimal collateral damage. Includes pulse mode and enhanced vacuum system.

Clinical Evidence

Bench testing only. Performance testing confirmed system design is technically sound and safe. Biocompatibility of handpiece materials confirmed per ISO 10993-1. Compliance with electrical safety (EN 60601-1, etc.) and sterilization standards (ISO 11134, ISO 11135) verified.

Technological Characteristics

Ultrasonic surgical aspirator; piezoelectric vibration system. Frequencies: 24 kHz and 35 kHz. Materials: TiAl6V4 titanium alloy tips, silicone irrigation flue. Power: 100-240V 50/60Hz. Connectivity: Standalone console. Sterilization: Steam autoclaving or Ethylene Oxide. Software: LCD user interface with pulse mode control.

Indications for Use

Indicated for patients requiring soft tissue fragmentation, emulsification, and aspiration during neurosurgical, gastrointestinal, urological, plastic/reconstructive, general, orthopedic, gynecological, thoracic, laparoscopic, and thoracoscopic surgical procedures.

Predicate Devices

• Selector® Ultrasonic Surgical Aspirator System (K901974, K925129, K021989)
• CUSA Excel Ultrasonic Surgical Aspirator System (K981262)
• Sonopet UST 2001 Ultrasonic Surgical Aspirator System (K010309)

Submission Summary (Full Text)

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K042277

# 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 [phone] Telephone: [phone] Facsimile:

| Contact Person: | Nikki Hinton |
|-----------------|----------------------------------------------|
| | Quality Assurance/Regulatory Affairs Manager |
| | E-Mail: nikki [e-mail] |

#### Authorized Agent in the United States

Integra NeuroSciences 5955 Pacific Center Blvd San Diego CA 92121, USA Telephone: [phone] 455 8298 Facsimile:

Contact Person: Nancy Mathewson Director, Regulatory Affairs E-Mail: [e-mail]

## 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

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# 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.

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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.

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# 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.

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| TABLE 1 | SELECTOR®<br>INTEGRA<br>K901974,<br>K925129 and<br>K021989 | CUSA Excel<br>K981262 | Sonopet<br>UST 2001<br>K010309 | SELECTOR®<br>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<br>Use | Ortho | Ortho | Ortho | Ortho |
| | Gynecology | Gynecology | Gynecology | Gynecology |
| | Thoracic | Thoracic | Thoracic | Thoracic |
| | Laparoscopic<br>Thoracoscopic | Laparoscopic<br>Thoracoscopic | Laparoscopic<br>Thoracoscopic | Laparoscopic<br>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<br>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-<10ml/min | 0-40 ml/min |
| • Aspiration<br>Vacuum | 0-600 mmHg | 0-660 mmHg | 0-500 mmHg | 0-700 mmHg |
| • Tip Amplitudes | Max 24 kHz:305µm<br>Max 35 kHz:215µm | Max 23 kHz:355µm<br>Max 36 kHz:210µm | Max 350µm | Max 24 kHz:330µm<br>Max 35 kHz:240µm |
| • Materials in<br>contact with<br>tissue | TiAl6V4<br>Titanium Alloy | TiAl6V4<br>Titanium Alloy | Not known | TiAl6V4<br>Titanium Alloy |
| • Power Source | 100-240V 50/60Hz | 110V<br>60Hz | 100 - 200V<br>50/60Hz | 100-240V 50/60Hz |
| • Sterility | Steam<br>EtO | Steam | Steam<br>EtO | Steam<br>EtO |
| • Electrical Safety | CSA 22.2 No. 601-1<br>60601-1<br>60601-1-2<br>FCC 18 | IEC 601-1<br>601-2-2<br>60601-1-2 | Not known | CSA 22.2 No. 601-1<br>60601-1<br>60601-1-2<br>FCC 18 |

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## Conclusion:

The SELECTOR® Quantum Ultrasonic Surgical Aspirator System is a modification of the SELECTOR® Integra Ultrasonic Surgical Aspirator System, previously cleared to market under 510(k) K901974, K925129 and K021989. It 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 Selector® Quantum Ultrasonic Surgical Aspirator System (Console, Handpieces and Accessories) is substantially equivalent in function, technical specifications, performance and intended use to the following predicate devices delineated in this submission:

- Selector® Integra Ultrasonic Surgical Aspirator System, frequency 24kHz and 35kHz, . FDA 510(k) # K901974, K925129 and K021989
- CUSA Excel Ultrasonic Surgical Aspirator System, frequency 23kHz and 36kHz, . FDA 510(k) #K981262K010309
- Sonopet UST2001 Ultrasonic Surgical Aspirator, frequency 25kHz and 34kHz, FDA . 510(k) #

All predicates are used for similar applications in the medical field to those proposed for the SELECTOR® Ouantum Ultrasonic Surgical Aspirator.

The SELECTOR® Quantum Ultrasonic Surgical Aspirator System meets the requirements for a Premarket Notification 510(k) as defined in CFR 21, Part 807.

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Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with a serpent entwined around it, topped with a set of three horizontal bars.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 2004

Ms. Nikki Hinton Quality Assurance/Regulatory Affairs Manager Integra NeuroSciences Ltd. Newbury Road Andover, Hampshire SP10 4DR UK

Re: K042277

R042277
Trade/Device Name: SELECTOR® Quantum Ultrasonic Surgical Aspirator Regulatory Class: Unclassified Product Code: LFL Dated: August 20, 2004 Received: August 23, 2004

Dear Ms. Hinton:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamined the device is substantially equivalent (for the indications felerenced above und nave astering marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to comments prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices frat have been recuire approval of a premarket approval application (PMA). allu Cosmetic Act (Tel) that do not required to the general controls provisions of the Act. The I ou may, mercerore, mance of the Act include requirements for annual registration, listing of general controls proficions of aactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is oneshired (600 a0070) als. Existing major regulations affecting your device can Inay oc subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Gode announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast of advisou that I be Court of the your device complies with other requirements of the Act that I Dri has made a cound regulations administered by other Federal agencies. You must or any I occurrents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Cl I rat 607); idoling (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualision control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Nikki Hinton

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow your to begal finding of substantial equivalence of your device to a legally premateer noticated 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), please If you atence of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gollers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE

Page 1 of 1

# 510(K) Number:

SELECTOR® Quantum Ultrasonic Surgical Aspirator Device Name:

#### 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.

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Or

Over-the-Counter Use (Optional Formal 1-2-96)

Miriam C. Provost

Divisio and Neurolog

**510(k) Number** k042277