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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Selector® Integra Ultrasonic Surgical Aspirator System. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

However, the document does not contain a study that proves the device meets specific acceptance criteria in the way typically found in a clinical trial or performance study focusing on metrics like sensitivity, specificity, accuracy, or diagnostic improvement. Instead, it relies on demonstrating substantial equivalence to already approved devices by comparing technical specifications, function, performance, and intended use.

Therefore, for many of your requested points, the information will be unavailable as the document does not present a performance study in that context.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not specify "acceptance criteria" in terms of clinical performance metrics, nor does it report specific performance data for the device against such criteria. Instead, it focuses on demonstrating that the device's technical specifications and functionality are within acceptable ranges when compared to predicate devices, and that it conforms to relevant safety standards.

Here's a table based on the information provided regarding the device's characteristics and its equivalence to predicates:

Characteristic	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (Selector® Integra)
Indications for Use	Fragmenting, emulsifying, and aspirating soft tissue in various surgeries (Neuro, GI, Uro, Plastic & Recon, General, Ortho, Gynecology, Thoracic, Laparoscopic, Thoracoscopic)	Matches predicate devices
Where Used	Hospitals	Hospitals
Basic Operating Principle	Ultrasonic action for tissue fragmentation and cavitation, irrigation, aspiration	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	Piezo (matching two predicates)	Piezo
Frequency	23-36 kHz (range of predicates)	24 kHz & 35 kHz
Irrigation Flow	1-50 ml/min (range of predicates)	0-50 ml/min
Aspiration Vacuum	0-660 mmHg (range of predicates)	0-600 mmHg
Tip Amplitudes	Max 210-350µm (range of predicates)	Max 24 kHz: 305µm, Max 35 kHz: 215µm
Materials in Contact with Tissue	TiAl6V4 / Titanium Alloy (matching predicates)	TiAl6V4 Titanium Alloy
Power Source	100-240V, 50/60Hz (range of predicates)	100-240V, 50/60Hz
Sterility	Steam, EtO (matching predicates)	Steam, EtO
Electrical Safety Standards Met	Various IEC, CSA, EN, FCC, JIS, UL standards (range of predicates)	CSA 22.2 No. 601-1, EN 60601-1, EN60601-1-2, FCC 18, JIS T1001/1002, UL2601-1 (plus IPX 2.7 for footswitch)
Tip External Diameters	1.93-4.5 mm (range of predicates)	1.95 to 2.5 mm
Handpiece Cooling	Water/Air (matching predicates)	Air (matching most predicates)
Biocompatibility	Tested and Compliant to ISO 10993-1	Confirmed

2. Sample size used for the test set and the data provenance

There is no mention of a "test set" in the context of a clinical performance study. The 510(k) submission relies on comparison to predicate devices and adherence to safety standards. No patient data (retrospective or prospective) is discussed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No test set requiring expert ground truth is described.

4. Adjudication method for the test set

Not applicable. No test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an ultrasonic surgical aspirator, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to human "readers" or AI assistance is not relevant to this submission.

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

Not applicable. This is a surgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the predicate devices. The new device proves "substantial equivalence" by meeting similar technical specifications and performance characteristics, and adhering to recognized safety and sterility standards.

8. The sample size for the training set

Not applicable. The device is not an AI model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set mentioned. The submission focuses on device design, materials, and comparison to existing, legally marketed devices.

Summary

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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 RobinsonQuality Assurance/Regulatory Affairs ManagerE-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)

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D. Intended Use

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 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

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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.

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Substantial Equivalence Table

TABLE 1	CUSA ExcelK981262	SonopetUST 2001K010309	BerchtoldSonotom 110K010637	SELECTOR®K901974 &K925129
• Indications forUse	NeuroGastroUroPlastic & Recon.GeneralOrthoGynecologyThoracicLaparoscopicThoracoscopic	NeuroGastroUroPlastic & Recon.GeneralOrthoGynecologyThoracicLaparoscopicThoracoscopic	NeuroUroGeneralGynae	NeuroGastroUroPlastic & Recon.GeneralOrthoGynecologyThoracicLaparoscopicThoracoscopic
• Where used	Hospitals	Hospitals	Medical environment	Hospitals
• Basic OperatingPrinciple	Ultrasonic action through Titanium Alloy Tip onto biological tissue causes fragmentation andcavitation 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-<10 ml/min	10-50 ml/min	0-50 ml/min
•AspirationVacuum	0-660 mmHg	0-500 mmHg	-20 to -90 kPa	0-600 mmHg
• Tip Amplitudes	Max 23 kHz:355µmMax 36 kHz:210µm	Max 350µm	Max 350µm	Max 24 kHz:305µmMax 35 kHz:215µm
• Materials incontact withtissue	TiAl6V4Titanium Alloy	Not known	Titanium	TiAl6V4Titanium Alloy
• Power Source	110V60Hz	100-200V50/60Hz	110-130V 50/60Hzor220-260V 50/60Hz	100-240V50/60Hz
• Sterility	Steam	SteamEtO	SteamEto	SteamEto
• Electrical Safety• Standards Met	IEC 601-1601-2-260601-1-2CSA 22.2	Not known	EN 60601	CSA 22.2 No. 601-160601-160601-1-2FCC 18JIS T1001/1002UL2601-1
• Tip ExternalDiameters	1.93 to 3.98 mm	Not known	3.2 to 4.5 mm	1.95 to 2.5 mm
• HandpieceCooling	Water	Air	Air	Air

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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EP 1 3 2002

Integra Neurosciences Nikki Robinson Quality Assurance/Regulatory Affairs Manager Newbury Road Andover, Hampshire, SP10 4DR United Kingdom

Re: K021989

Trade/Device Name: Selector® Integra Ultrasonic Surgical Aspirator System Regulation Number: 888.4580 Regulation Name: Sonic surgical instrument and accessories/attachments Regulatory Class: Class II Product Code: LFL Dated: June 14, 2002 Received: June 18, 2002

Dear Ms. Robinson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Nikki Robinson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,

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: K 021989

SELECTOR® Integra 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(Per 21 CFR 801.109)	Or	Over-the-Counter Use(Optional Formal 1-2-96)
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(Division Sign-Off)
Division of General, Restorative and Neurological Devices

510(k) Number	31 021989
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Regulation Number and Section

N/A