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 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.

AI/ML Overview

This 510(k) summary for the SELECTOR® Quantum Ultrasonic Surgical Aspirator System does not provide the detailed acceptance criteria and study results in the format requested, as it is a premarket notification for a medical device seeking substantial equivalence to existing devices rather than a report on a clinical trial with specific performance metrics.

However, I can extract information related to performance and safety, and how the device's characteristics compare to predicate devices. It focuses on the device's technical specifications and adherence to relevant standards rather than a study with specific performance numbers against defined acceptance criteria.

Here's an attempt to structure the available information regarding "acceptance criteria" and "device performance" based on the provided text, recognizing that these terms are interpreted within the context of a 510(k) submission for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically inferred from the technical specifications of the predicate devices and relevant performance standards. The "reported device performance" is demonstrated by the new device meeting or being comparable to these specifications and standards.

Feature/Criteria (Inferred Acceptance based on Predicate)	SELECTOR® INTEGRASpecifications (Predicate)	CUSA Excel Specifications (Predicate)	Sonopet UST 2001 Specifications (Predicate)	SELECTOR® QUANTUM Performance (Subject Device)
Indications for Use	Same as pred.	Same as pred.	Same as pred.	Neurosurgery, Gastro, Uro, Plastic & Recon, General, Ortho, Gynecology, Thoracic, Laparoscopic, Thoracoscopic
Basic Operating Principle	Ultrasonic fragmentation and cavitation of tissue, irrigation, aspiration	(Same implied)	(Same implied)	Ultrasonic fragmentation and cavitation of tissue, irrigation, aspiration
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-<10 ml/min	0-40 ml/min
Aspiration Vacuum	0-600 mmHg	0-660 mmHg	0-500 mmHg	0-700 mmHg
Tip Amplitudes	Max 24 kHz:305µm, Max 35 kHz:215µm	Max 23 kHz:355µm, Max 36 kHz:210µm	Max 350µm (unspecified freq.)	Max 24 kHz:330µm, Max 35 kHz:240µm
Materials in contact with tissue	TiAl6V4 Titanium Alloy	TiAl6V4 Titanium Alloy	Not known	TiAl6V4 Titanium Alloy
Power Source	100-240V 50/60Hz	110V 60Hz	100 - 200V 50/60Hz	100-240V 50/60Hz
Sterility	Steam, EtO	Steam	Steam, EtO	Steam, EtO (Tested to ISO 11134:1994, ISO 11135:1994)
Electrical Safety Standards	CSA 22.2 No. 601-1, 60601-1, 60601-1-2, FCC 18	IEC 601-1, 601-2-2, 60601-1-2	Not known	CSA 22.2 No. 601-1, 60601-1, 60601-1-2, FCC 18 (Footswitch IP2.7 rated)
Biocompatibility	Material tested to ISO10993-1	Material tested to ISO10993-1 (Cusa Excel predicate)	(Same implied)	Material (same as current Selector® Integra and Cusa Excel) tested to ISO10993-1 and confirmed.

Study that Proves the Device Meets Acceptance Criteria:

The provided document describes a 510(k) submission, which is a regulatory pathway to demonstrate substantial equivalence to a predicate device, not necessarily a study proving specific numerical acceptance criteria. The "study" here is primarily a comparative analysis of technical specifications and adherence to standards, reinforced by performance testing.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of this 510(k) summary. This document does not present a clinical trial or a test set of patient data. The "testing" referred to is engineering and performance verification of the device components and system.
Data Provenance: Not applicable. There is no patient data or clinical trial data referenced in this summary. The data provenance relates to the technical specifications of the device and its predicate devices, as well as the standards it was tested against (e.g., ISO, CSA, EN, FCC).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts & Qualifications: Not applicable. This document does not describe a study involving expert assessment of a test set for ground truth establishment. The assessment is primarily technical and regulatory.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no test set in the clinical or data analysis sense requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses on device characteristics and technical equivalence.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance Study: Not applicable. This device is an ultrasonic surgical aspirator, a physical medical instrument, not an algorithm or AI system. Its performance is tied to its mechanical and electrical characteristics and how it physically interacts with tissue under human control.

7. The Type of Ground Truth Used

Type of Ground Truth: For this device, "ground truth" is established through engineering principles, adherence to recognized standards (e.g., electrical safety, sterilization, biocompatibility), and comparison of technical specifications (e.g., frequency, power, amplitude, vacuum) against predicate devices that have already been cleared for marketing. The ultimate "ground truth" for a 510(k) is the demonstration of substantial equivalence to an existing legally marketed device.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This summary does not involve machine learning or AI with a training set. The "training" in the context of a medical device would refer to the development and refinement process, which would be covered by design controls and verification/validation activities, not a distinct "training set" of data.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set Establishment: Not applicable, as there is no training set in the context of AI/ML. The development and verification of the device's performance are based on engineering specifications, testing against known physical and biological principles, and comparison to the proven performance of predicate devices.

Summary

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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 +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

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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 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®INTEGRAK901974,K925129 andK021989	CUSA ExcelK981262	SonopetUST 2001K010309	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 forUse	Ortho	Ortho	Ortho	Ortho
	Gynecology	Gynecology	Gynecology	Gynecology
	Thoracic	Thoracic	Thoracic	Thoracic
	LaparoscopicThoracoscopic	LaparoscopicThoracoscopic	LaparoscopicThoracoscopic	LaparoscopicThoracoscopic
• 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
• VibrationSystem	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
• AspirationVacuum	0-600 mmHg	0-660 mmHg	0-500 mmHg	0-700 mmHg
• Tip Amplitudes	Max 24 kHz:305µmMax 35 kHz:215µm	Max 23 kHz:355µmMax 36 kHz:210µm	Max 350µm	Max 24 kHz:330µmMax 35 kHz:240µm
• Materials incontact withtissue	TiAl6V4Titanium Alloy	TiAl6V4Titanium Alloy	Not known	TiAl6V4Titanium Alloy
• Power Source	100-240V 50/60Hz	110V60Hz	100 - 200V50/60Hz	100-240V 50/60Hz
• Sterility	SteamEtO	Steam	SteamEtO	SteamEtO
• Electrical Safety	CSA 22.2 No. 601-160601-160601-1-2FCC 18	IEC 601-1601-2-260601-1-2	Not known	CSA 22.2 No. 601-160601-160601-1-2FCC 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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:

(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)

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

Miriam C. Provost

Divisio and Neurolog

510(k) Number K042277

Regulation Number and Section

N/A