← Product Code LFL · K021989 # SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 (K021989) _Integra Neurosciences · LFL · Sep 13, 2002 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K021989 ## Device Facts - **Applicant:** Integra Neurosciences - **Product Code:** LFL - **Decision Date:** Sep 13, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## 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. ## Device Story Ultrasonic surgical aspirator system for soft tissue fragmentation and aspiration; preserves elastic structures like nerves/vessels. System comprises console, handpieces, and footswitch. Console controls aspiration, irrigation, and ultrasonic power. Handpieces feature titanium tips; irrigation flue delivers saline to surgical site. Surgeon operates via footswitch (proportional ultrasonic power and irrigation flow). Used in hospital surgical suites (including MRI suites). Provides surgeon with precise tissue ablation; clear view of operating site due to integrated irrigation/aspiration. Benefits include selective tissue removal, reduced damage to vital structures, and ergonomic handpiece design. ## Clinical Evidence Bench testing only. Device conforms to CSA22.2 No. 601-1, EN 60601-1, EN60601-1-2, FCC 18, JIS T 1001/1002, and UL 2601-1. Biocompatibility testing performed per ISO 10993-1. Sterilization validation performed per ISO 11135:1994. ## Technological Characteristics Ultrasonic surgical aspirator; piezo-electric vibration system. Materials: TiAl6V4 titanium alloy tips. Dimensions: tip diameters 1.95-2.5 mm. Power: 100-240V, 50/60Hz. Connectivity: standalone console with footswitch. Sterilization: steam autoclaving or Ethylene Oxide. Safety: IPX 2.7 rated footswitch. ## Predicate Devices - CUSA Excel Ultrasonic Surgical Aspirator System ([K981262](/device/K981262.md)) - Sonotom 110 Ultrasonic Aspirator System ([K010637](/device/K010637.md)) - Sonopet UST 2001 Ultrasonic Surgical Aspirator System ([K010309](/device/K010309.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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-<10 ml/min | 10-50 ml/min | 0-50 ml/min | | •
Aspiration
Vacuum | 0-660 mmHg | 0-500 mmHg | -20 to -90 kPa | 0-600 mmHg | | • Tip Amplitudes | Max 23 kHz:355µm
Max 36 kHz:210µm | Max 350µm | Max 350µm | Max 24 kHz:305µm
Max 35 kHz:215µm | | • Materials in
contact with
tissue | TiAl6V4
Titanium Alloy | Not known | Titanium | TiAl6V4
Titanium Alloy | | • Power Source | 110V
60Hz | 100-200V
50/60Hz | 110-130V 50/60Hz
or
220-260V 50/60Hz | 100-240V
50/60Hz | | • Sterility | Steam | Steam
EtO | Steam
Eto | Steam
Eto | | • Electrical Safety
• Standards Met | IEC 601-1
601-2-2
60601-1-2
CSA 22.2 | Not known | EN 60601 | CSA 22.2 No. 601-
1
60601-1
60601-1-2
FCC 18
JIS T1001/1002
UL2601-1 | | • Tip External
Diameters | 1.93 to 3.98 mm | Not known | 3.2 to 4.5 mm | 1.95 to 2.5 mm | | • Handpiece
Cooling | 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. {4}------------------------------------------------ ### 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. {5}------------------------------------------------ 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 {6}------------------------------------------------ ### INDICATIONS FOR USE Page 1 of 1 # 510(K) Number: K 021989 #### SELECTOR® Integra Ultrasonic Surgical Aspirator Device Name: ## 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. ## (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) | |------------------------------------------|----|--------------------------------------------------| |------------------------------------------|----|--------------------------------------------------| (Division Sign-Off) Division of General, Restorative and Neurological Devices | 510(k) Number | 31 021989 | |---------------|----------------------| |---------------|----------------------| --- **Source:** [https://fda.innolitics.com/device/K021989](https://fda.innolitics.com/device/K021989) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com