HyperVit™ Vitrectomy Probe (23, 25 gauge)
The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended to be used to remove vitreous and dissect tissue in the eye.

HyperVit™ Vitrectomy Probe (27 gauge)
The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended for use as follows:

Vitreous aspiration & cutting
Membrane cutting & aspiration
Lens removal
Dissect tissue in the eye

Device Description

The HyperVit" Vitrectomy Probe is an accessory to the Constellation® Vision System (K141065, K101285 and K063583). The HyperVit™ Vitrectomy Probe is a sterile, single-use pneumatically actuated device which supports aspiration and guillotine style cutting functions for the purpose of vitreous cutting and aspiration, as well as tissue dissection, in the eye during vitreoretinal or cataract surgery. The HyperVit™ Vitrectomy Probe is comprised of a pre-assembled hand piece and tubing. The tubing assembly interfaces with a Constellation® Vision System console by means of RFID tags at the proximal end of the probe. The HyperVit" Vitrectomy Probe is offered in three different sizes: 23, 25 and 27 gauge.

The HyperVit" Vitrectomy Probe is a modification of the existing UltraVit® Vitrectomy Probes currently used with the Constellation® Vision System. A port opening has been added to the cutter tip to create a second cutting edge. Thus, two cuts are made during a single operating cycle, compared to one cut for the existing UltraVit® Vitrectomy Probes. With an operating actuation speed of 10,000 cycles per minutes, the HyperVit™ Vitrectomy Probe can achieve 20,000 cuts per minute.

AI/ML Overview

This document describes the HyperVit™ Vitrectomy Probe, a device designed for vitreous aspiration and cutting, membrane cutting and aspiration, lens removal, and tissue dissection in the eye during vitreoretinal or cataract surgery.

Here's the breakdown of the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Cut Quality	The forward and return cutting surfaces must meet the same acceptance criteria for cut quality and cut reliability as the predicate device (Enhanced UltraVit® Probe K093305, 27+ UltraVit® Probe K110951).	"Results show that the probe met the acceptance criteria and, therefore, have the same cut quality as the predicate device."
Aspiration Flow	Aspiration flow characteristics at default vacuum settings should be similar to those of the predicate device, given identical fluid path dimensions.	"The aspiration flow characteristics of the HyperVit™ Vitrectomy Probe at the default vacuum settings were characterized and compared with the predicate device. The flow characteristics of the HyperVit™ Vitrectomy Probe at the default vacuum setting were similar to those of the predicate device as a result of the identical dimensions of the fluid path (e.g., cutter and aspiration tubing). Therefore, the aspiration flow is equivalent to the predicate device."
Heat Generation	Maximum temperature increase at the vitreous cutter tip should be no more than 10°C during operation, based on literature review (Ref: Wu et al., Photochemical damage of the retina. Survey of Ophthalmology, 51(5), 461–481, 2006).	"Testing showed that the maximum temperature increase was 0.8℃ throughout 30 minutes of operation; this is less than the maximum allowed temperature increase at the probe tip of no more than 10°C..."
Metal Particulates	No metal particulates should be generated by the device during operation.	"After running the test continuously for 20 minutes, the filter in the container was microscopy-examined for metal particulate and no particulates were detected, thus meeting the acceptance criteria."

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

The document does not explicitly state the sample size used for the test set for each mechanical test. For the metal particulates test, the experiment describes "The probe was actuated at the maximum 10,000 cycles per minute in a water container" and "After running the test continuously for 20 minutes." This implies a single probe was tested for this specific criterion during the specified duration.

The data provenance is from mechanical testing conducted by Alcon Research, Ltd. This is an internal developmental and validation study, not data collected from patient populations. Therefore, country of origin of data or retrospective/prospective nature is not applicable in the patient-data sense.

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

Not applicable. The tests conducted are mechanical and objective (e.g., measuring flow, temperature, presence of particulates, and comparing cut quality to a defined standard), not relying on expert interpretation of ambiguous data to establish ground truth.

4. Adjudication method for the test set:

Not applicable. The tests are objective mechanical performance evaluations, not diagnostic/interpretive tasks requiring adjudication.

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 a surgical instrument (vitrectomy probe), not an AI-assisted diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm, so "standalone algorithm performance" is not relevant.

7. The type of ground truth used:

The ground truth used for these tests is based on:

Predicate device performance: The HyperVit™ Probe's performance (cut quality, aspiration flow) was compared to the performance of the legally marketed predicate devices (Enhanced UltraVit® Probe K093305, 27+ UltraVit® Probe K110951).
Established engineering specifications and safety limits: For heat generation, a maximum allowed temperature increase of 10°C was derived from literature (Wu et al., 2006). For metal particulates, the absence of particulates on microscopy served as the ground truth for meeting the acceptance criteria.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 22, 2017

Alcon Research, Ltd. Karen Mudd. Ph.D. Director. Regulatory Affairs 20511 Lake Forest Drive Lake Forest, CA 92630

Re: K170520

Trade/Device Name: Hypervit Vitrectomy Probe, 23 Ga, Hypervit Vitrectomy Probe, 25+, Hypervit Vitrectomy Probe, 27+ Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration and Cutting Instrument Regulatory Class: Class II Product Code: MLZ Dated: February 16, 2017 Received: February 22, 2017

Dear Dr. Mudd:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Denise L. Hampton -S

for Malvina B. Eydelman, M.D. 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 (if known) K170520

Device Name HyperVit™ Vitrectomy Probe

Indications for Use (Describe)

HyperVit™ Vitrectomy Probe (23, 25 gauge)

The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended to be used to remove vitreous and dissect tissue in the eye.

HyperVit™ Vitrectomy Probe (27 gauge) The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended for use as follows:

· Vitreous aspiration & cutting
Membrane cutting & aspiration
· Lens removal
· Dissect tissue in the eye

Type of Use (Select one or both, as applicable)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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(510)k SUMMARY

This 510(k) summary document has been prepared in accordance with Section 21 CFR 807.92.

I. Submitter of the 510(k)

Company:	Alcon Laboratories, Inc.
	6201 South Freeway
	Fort Worth, TX 76134-2099, USA
Primary Contact Person:	Karen Mudd, Ph.D.
Phone:	949-505-7269
Fax:	949-505-6237
Email:	karen.mudd@alcon.com
Back up Contact Person:	Amy Tezel, Ph.D.
Phone:	817-363-1513
Fax:	817-551-4630
Email:	amy.tezel@alcon.com
Date Prepared:	16 February 2017

II. Devices Subject to this 510(k)

Trade Names:	HyperVit™ Vitrectomy Probe
Common Name:	Vitrectomy Device
Classification Name:	Vitreous Aspiration & Cutting Instrument (21 CFR886.4150)
Product Code:	MLZ

III. Predicate Devices

Enhanced UltraVit® Probe K093305 .
27+ UltraVit® Probe, K110951 .

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Device Description IV.

Indications for Use V.

HyperVit™ Vitrectomy Probe (23, 25 gauge)

The HyperVit" Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended to be used to remove vitreous and dissect tissue in the eye.

HyperVit™ Vitrectomy Probe (27 gauge)

The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended for use as follows:

Vitreous aspiration & cutting
Membrane cutting & aspiration
Lens removal
Dissect tissue in the eye

Comparison of Technological Characteristics with the Predicate Device VI.

The technological characteristics of the HyperVit™ Vitrectomy Probe are substantially equivalent to those of the predicate device, as shown in the table below.

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Characteristic	Predicate DevicesK093305, Enhanced UltraVit Probe(23 and 25 gauge)K110951, 27+ UltraVit Probe (27 gauge)	HyperVit Vitrectomy Probe(23, 25 and 27 gauge)
Regulation	886.4150	Same
Intended use /Indications for use	K093305, Enhanced UltraVitProbe (23 and 25 gauge):The ALCON® Enhanced UltraVit®Probe is designed for use with theConstellation® Vision System and isintended to be used to removevitreous and dissect tissue in the eye.K110951, 27+ UltraVit Probe(27 gauge):• Vitreous aspiration & cutting• Membrane cutting & aspiration• Remove a crystalline lens• Dissect tissue in the eye(The 27 UltraVit Probe is intended tobe used with the Alcon ConstellationVision System)	23 and 25 gauge:The HyperVit™ VitrectomyProbe is designed for use withthe Constellation® Vision Systemand is intended to be used toremove vitreous and dissecttissue in the eye.27 gauge:The HyperVit™ VitrectomyProbe is designed for use withthe Constellation® Vision Systemand is intended for use asfollows:• Vitreous aspiration & cutting• Membrane cutting & aspiration• Lens removal• Dissect tissue in the eye
Power source for cutteractivation	Forward and return pneumaticpressure pulses	Same
Probe needle gauge	23, 25, 27	Same
Cutting action format	Guillotine	Same
Frequency of cutteractivation	Up to 15,000 pulses per minute	Up to 10,000 pulses per minute
Cutting port format	Side port, one	Side port, two
Cutting rate	Up to 15,000 cuts per minute	Up to 20,000 cuts per minute
Aspiration channel	Through the cutter tubing cannula	Same
Patient contact material(direct or through fluidpath)	Stainless steel	Same
Overall length of probe(nominal)	3.3"	Same
Single-use / Reusable	Single use only	Same
Shelf-life	Two years	Same
Sterile productpackaging	Tyvek pouch	Same
Sterility method	EtO-sterilized	Same
Gauge identifier	Color coded and molded in theproduct	Same
Connector	RFID (connectors for pneumatic linesand luer connectors for aspirationline)	Same

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VII. Performance Data

Testing and validations have demonstrated that the functional requirements and specifications have been met. Therefore, the HyperVit" Vitrectomy Probe is as safe and effective as the predicate device. An overview of key performance tests conducted is provided below:

Mechanical Testing

. Cut Quality: Testing was conducted on the vitreous cutting surfaces in order to verify that the forward and return cutting surfaces met the same acceptance criteria for cut quality and cut reliability as the predicate device. Results show that the probe met the acceptance criteria and, therefore, have the same cut quality as the predicate device.
Aspiration Flow: The aspiration flow characteristics of the HyperVit™ Vitrectomy Probe . at the default vacuum settings were characterized and compared with the predicate device. The flow characteristics of the HyperVit™ Vitrectomy Probe at the default vacuum setting were similar to those of the predicate device as a result of the identical dimensions of the fluid path (e.g., cutter and aspiration tubing). Therefore, the aspiration flow is equivalent to the predicate device.
Heat Generation: Testing was conducted to measure the temperature increase at the . vitreous cutter tip operated at 150% of HyperVit™ Vitrectomy Probe maximum speed. Testing showed that the maximum temperature increase was 0.8℃ throughout 30 minutes of operation; this is less than the maximum allowed temperature increase at the probe tip of no more than 10°C, based on literature review (Ref: Wu et al., Photochemical damage of the retina. Survey of Ophthalmology, 51(5), 461–481, 2006).
Metal Particulates: Testing was performed to evaluate whether metal particulates were . generated by the HyperVit™ Vitrectomy Probe during operation. The probe was actuated at the maximum 10.000 cycles per minute in a water container. After running the test continuously for 20 minutes, the filter in the container was microscopy-examined for metal particulate and no particulates were detected, thus meeting the acceptance criteria.

Safety and Effectiveness Information VIII.

A review of the indications for use and technical characteristics demonstrates that the HyperVit™ Vitrectomy Probe is substantially equivalent to the predicate devices and is safe and effective for use for the stated indications for use.

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Conclusion IX.

The HyperVit™ Vitrectomy Probe was found to be substantially equivalent to the predicate device.

The HyperVit™ Vitrectomy Probe shares identical indications for use, similar design features and functional features with the predicate device, and thus is substantially equivalent to the predicate device.

Regulation Number and Section

§ 886.4150 Vitreous aspiration and cutting instrument.

(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.