The MicroPulse Phacoemulsification Console and foot switch, with third party accessories, will emulsify a cataractous lens and remove it from the eye, using the same technology that the predicate devices employ by using ultrasonic power. The MicroPulse Phacoemulsification Console modes of operation are similar to the predicate devices such as: Diathermy (Coagulation), U/S Phaco, Irrigation/Aspiration (I/A) and Vitrectomy. The component parts of the MicroPulse Phacoemulsification console include the console and foot switch. The U/S handpiece and tubing set are specified third party accessories. The Diathermy, Irrigation/ Aspiration, and Vitrectomy devices are universal type handpieces that are also considered additional third party accessories to the MicroPulse Phacoemulsification console. Trillium Medical will manufacture the console and foot switch only. Trilliums Distributers will add the third party accessories (see Exhibit B) to the console and foot switch to assemble a complete Phacoemulsification system.

AI/ML Overview

The provided 510(k) summary for the MicroPulse Phacoemulsification Console indicates that the device's acceptance criteria and performance were established through a comparison to predicate devices, rather than a standalone clinical study with specific acceptance criteria in the typical sense (e.g., sensitivity, specificity, accuracy targets).

The core of this submission relies on demonstrating substantial equivalence to legally marketed predicate devices (The Wave Digital Phaco System K981989 and Circuit Tree Phacoemulsifier K954242). This means that the acceptance criteria are implicitly that the new device performs similarly in terms of its intended use and technological characteristics to these predicates.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim, the "acceptance criteria" are the characteristics of the predicate devices. The "reported device performance" is the MicroPulse system's characteristics as compared to those predicates.

Device Characteristics	Acceptance Criteria (Predicate Device K981989 / K954242)	Reported Device Performance (MicroPulse Phacoemulsification System K051186)
Intended Use	Emulsify and remove cataractous lens from the eye	Same intended use: Emulsify and remove cataractous lens from the eye
Console
Display	LCD, Membrane switches (K981989); LED displays (K954242)	LCD, Membrane switches (Note: MicroPulse is 4 lines X 20 characters vs. Wave's 4 lines X 40, but still LCD/Membrane)
Pump	Peristaltic, no pulsation	Peristaltic, no pulsation
Pump Vacuum Range	0 to 500 mmHg	0 to 500 mmHg
Aspiration Rate	0 to 50 cc/min	0 to 50 cc/min
Fluidics	External Fluid Path	External Fluid Path
System Tubing	Disposable/Reusable Tubing cartridge (K981989); Reusable Tubing set (K954242)	Reusable Tubing set
Vent	Fluid Vent	Fluid Vent
Modes	Irrigation, Diathermy, U/S Phaco, I/A, Vitrectomy	Irrigation, Diathermy, U/S Phaco, I/A, Vitrectomy (Same)
Programmable User Parameters	Yes	Yes
Foot Switch	Operational control: Same as MicroPulse	Freeholder and 3 mode position, activates Reflux
Design	MicroPulse and WAVE are almost identical in design	MicroPulse is basically The WAVE with reduced features/Modes to lower costs for the low cost international market. All three designed by same engineers.
Hardware/Software	Shared hardware across all three; MicroPulse and WAVE almost identical hardware; WAVE has different embedded microprocessor and software than MicroPulse; Circuit Tree is hardware only.	MicroPulse and WAVE share almost identical hardware but have different embedded microprocessors and entirely different software. Circuit Tree is hardware only.
Material Specifications	No direct/indirect patient contact for console/footswitch	Console and footswitch do not have direct/indirect patient contacting materials. Patient contact only through third-party accessories.
Mechanical/Electrical Specs	Same as The WAVE Digital Phaco System	Same mechanical and electrical specifications as The WAVE. Designed to meet EN60601-1, EN60601-2, UL2601-1, CAN/CSAC22.2 No. 601.1.
Differences/Justifications	N/A (differences acknowledged and justified as not impacting substantial equivalence for intended use)	Wave has remote control, remote computer interface, larger LCD, voice annunciation. MicroPulse lacks these for cost-saving/market reasons. MicroPulse foot switch hardware added for surgeon control if microprocessor fails (improved safety feature).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable in the context of this 510(k) summary. The submission does not describe a clinical study with a "test set" of patients or data points in the conventional sense. The comparison is based on technical specifications and design similarities to predicate devices.
Data Provenance: Not applicable. No patient data or clinical study data is presented. The information provided is about the device's technical characteristics and design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There was no "ground truth" to establish in the context of a performance study on a test set. This was a substantial equivalence submission based on technical comparison.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring expert adjudication was 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 is not an AI-assisted device, nor was an MRMC study described. The device is a medical console for phacoemulsification.

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

Not applicable. This is not an algorithmic or AI-based device. The submission focuses on the performance of the physical console and its operational modes. The "software" mentioned in the document relates to embedded microprocessors controlling the device's functions, not an independent algorithm for diagnostic or prognostic purposes.

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

Not applicable. No "ground truth" in terms of clinical outcomes or pathology was used or needed for this type of 510(k) submission, which demonstrates substantial equivalence through technical comparison. The implicitly "ground truth" is that the predicate devices are safe and effective.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a "training set."

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

Not applicable. No training set or ground truth for such a set was part of this submission.

Summary

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8051186

AUG 1 8 2005

Trillium Medical, Inc. PO Box 2601 Poulsbo WA 98370

510(k) Summary of Safety and Effectiveness Trillium Medical, Inc. PO Box 2601 19880 Caldart Avenue NE Poulsbo, WA 98370 360 286 1341 trillium_medical@ix.netcom.com

Michael Curtis President

Contact:

510(k): K051186

Common Name:	MicroPulse Phacoemulsification Console
Device Name:	Unit, Phacofragmentation (21 CFR 886.4670)

Phacoemulsification/extraction with ultrasonic power of Indications for Use: cataractous lens from the eye.

The Wave Digital Phaco System (K981989) Predicate Devices: Circuit Tree Phacoemulsifier (K954242)

Description of Device: The MicroPulse Phacoemulsification Console and foot switch, with third party accessories, will emulsify a cataractous lens and remove it from the eye, using the same technology that the predicate devices employ by using ultrasonic power. The MicroPulse Phacoemulsification Console modes of operation are similar to the predicate devices such as: Diathermy (Coagulation), U/S Phaco, Irrigation/Aspiration (I/A) and Vitrectomy. The component parts of the MicroPulse Phacoemulsification console include the console and foot switch. The U/S handpiece and tubing set are specified third party accessories. The Diathermy, Irrigation/ Aspiration, and Vitrectomy devices are universal type handpieces that are also considered additional third party accessories to the

Page 1 of 2

$p_2$

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MicroPulse Phacoemulsification console. Trillium Medical will manufacture the console and foot switch only. Trilliums Distributers will add the third party accessories (see Exhibit B) to the console and foot switch to assemble a complete Phacoemulsification system.

Comparison: Sec Attachment Exhibit "A"

Conclusion: The MicroPulse Phacoemulsification Consolc and foot switch, when third party accessories are included(see Exhibit B), is comparable to the features of the predicated devices including technogical specifications, performance and intended use therefore we conclude that the subject device is substantially equivalent to the predicate devices listed above.

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Exhibit A

Comparison Chart

Device Characteristics	Subject Device	Predicate Device	Predicate Device
	K051186MicroPulse Phacoemul-sification System	K981989The Wave Digital PhacoSystem	K954242Circuit Tree Phacoemulsifier
Console
Display	LCD, Membraneswitches	LCD, Membraneswitches	LCD, Membraneswitches
Pump	Peristaltic, no pulsation	Peristaltic, no pulsation	Peristaltic, no pulsation
Pump Vacuum Range	0 to 500 mmHg	0 to 500 mmHg	0 to 500 mmHg
Aspiration Rate	0 to 50 cc/min	0 to 50 cc/min	0 to 50 cc/min
Fluidics	External Fluid Path	External Fluid Path	External Fluid Path
System Tubing	Reusable Tubing set	Disposable/Reusable Tubingcartridge	Reusable Tubing set
Vent	Fluid Vent	Fluid Vent	Fluid Vent
Modes	Irrigation,Diathermy, U/S Phaco,I/A,Vitrectomy	Same	Same
Programmable UserParameters	Yes	Yes	Yes

Foot Switch

Operational control	Freeholder and and and------------------------------------------------------------------------------------------------------------------------------------------------------------------------------3 mode position, activates	-------------l same	same
	Reflux

Subject device has the same intended use as the predicate Intended Use: devices.
All three devices were designed by the same engineers. The Design: MicroPulse and The WAVE are almost identical in design. The differences have to do mostly because of their respective target markets. The MicroPulse is basically The WAVE with reduced features/Modes, to lower its costs for the low cost

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international market.

Hardwarc/Software: All threc devices share a great deal of the same hardware. The MicroPulse and The WAVE share almost identical hardware. The Circuit Tree device is hardware only, no software. The MicroPulse and The WAVE both have different embeded microprocessors, thus entirely different software.

Material specifications:

The Console and footswitch do not have any direct or indirect (e.g. fluids) patient contacting materials. Any such patient contact, direct or indirect, would be only through the third party accessories listed in 'Exhibit B'.

Mechanical and Electrical specifications:

The MicroPulse and The WAVE share the same mechanical and electrical specifications. See the MicroPulse operators manual.

Differences:

Features:	The Wave has a remote control. The MicroPulse and Circuit Treedevices do not.
	The Wave has a remote computer interface. The MicroPulse andCircuit Tree devices do not.
	LCD Display. The Wave is 4 lines X 40 characters. TheMicroPulse is 4 lines X 20 characters. The Circuit Tree has LEDdisplays.
	The WAVE has voice annunciation upon keypress. TheMicroPulse and Circuit Tree devices do not.
Electronics:	The circuitry of the MicroPulse and The WAVE are almostidentical, with the following exceptions; They both use differentembeded microprocessors, because the one used on The Wave is no

Page 2 of 3

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longer sold. The MicroPulse does not have voice playback clectronics for cost saving reasons. The remote computer interface (serial) is too expensive for the low cost market therefore not included. In the MicroPulse the foot switch position hardware was added to replace the function that was performed in software on The WAVE. This change allows the surgeon using the MicroPulse console to have more control, such as keeping Irrigation control and the ability to continue to control the drivers if the microprocessor fails. The design in The WAVE only allowed the surgeon to shut down the drivers by taking his foot off of the foot switch if the microprocessor failed.

The major differences in software design are as follows; In the Software: MicroPulse, the microprocessor is only used for front panel user interface. This involves reading the switch matrix, displaying data on the LCD, sctting the modes, setting the driver levels, and memorizing memory presets.

The Sofware design of The WAVE does not only the above front panel user interface, but, also interfaces between the foot switch and the drivers (this is done real time in hardware on both Micropulse and Circuit Tree). Software routines in The WAVE are included for the remote computer interface (scrial) and voice playback, but, not on the MicroPulse or Circuit Tree. The Circuit Tree does not have a microprocessor, therefore, no software.

The circuits affecting electrical safety, Input power, power Electrical Safety: supplies, driver outputs and patient/doctor connections are identical in design with The WAVE. Electrical safety tests required by safety agency are identical and all devices are fully tested to the same requirements. Both the MicroPulse and The WAVE were designed to meet the following standards; EN60601-1, EN60601-2,UL2601-1, and CAN/CSAC22.2 No. 601.1.

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Exhibit B

RECOMMENDED REUSABLE ACCESSORIES

The following accessories have been tested to be compatible with the MicroPulse console and foot switch.

Phaco Handpiece and tips

Handpiece Part Number: PH-10140, Microsurgical Technology (K953959) Frequency (kHz) 37.5 to 40.5 Bandwidth (Hz) 250 to 400 Capacitance (pF) 1400 Stroke at full power (u) 69 to 96 Connector - 9 pin Fisher 104 scries sealed to facilitate autoclaving.

30 degree tip Part Number: PT-11030, Microsurgical Technology (K943672) 45 degree tip Part Number: PT-11045, Microsurgical Technology (K943672)

Diathermy Handpiece and Cable

Bi-Polar Pencil Part Number: 14-7000, Kirwan Surgical Products (K962678) Bi-Polar Cord Part Number: 10-5000, Kirwan Surgical Products (K913514) The Bipolar Diathermy Generator in the MicroPulse console is designed to use all of the currently available handpiece and cordsets designed for the phaco procedure.

Irrigation/Aspiration Handpiece and tips

Handpiece Part Number: IH-90200, Microsurgical Technology Connectors - Irrigation, Female Luer. Aspiraton, Male Luer.

Straight tip Part Number: IH-90301, Microsurgical Technology Curved tip Part Number: IH-90302, Microsurgical Technology Aspiration Port size - 0.3 mm.

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Vitrectomy Handpicce and Infusion sleeve_

Handpicce Part Number: 12-101, M. Imonti and Associates (K950799) Connectors - Pressure line, Male Luer with integral lock ring. Aspiration line, Male Luer.

Cutting speed - 50 to 600 cuts/min.

Pressure drive – 20 psi. Must operate at 10 psi with a residual pressure of 5 psi at 600 cuts/min.

Infusion Sleeve Part Number: 12-150-100, M. Imonti and Associates

Tubing set

Reusable pak Part Number: 013-0000-007, Circuit Tree Medical (K962430)

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2005

Trillium Medical, Inc. c/o Mr. Michael Curtis President PO Box 2601 19880 Caldart Avenue NE Poulsbo, WA 98370

Re: K051186

Trade/Device Name: MicroPulse Phacoemulsification Console Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation Unit Regulatory Class: Class II Product Code: HQC Dated: July 26, 2005 Received: August 2, 2005

Dear Mr. Curtis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use surve in the energene in the enactment date of the Medical Device Amendments, or to conimered processions) in accordance with the provisions of the Federal Food, Drug, de vices that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, ateres, many 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 r 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 or any I ederal barated uns 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- Mr. Michael Curtis, President

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), please contact the Office of Compliance at (301) 827-8910. 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 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/industry/support/index.html.

Sincerely yours,

David M. Whipple

Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:	K051186
Device Name:	MicroPulse Phacoemulsification Console
Indications for Use:	Phacoemulsification/extraction with ultrasonic power of cataractous lens from the eye.

Prescription Use __ كل_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use _ (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ML B hicholas

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises KOSII 86

510(k) Number _

Page 1 of 1

Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.