I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN by OPHTHALMIC CONSULTANTS, INC.

To provide single-use components to be used in conjunction with a facility's existing compatable equipment, in one convenient kit/pack, for ophthalmic surgical procedures, used in accordance with the equipment manufacturer's instructions, performed by a certified clinician in a clinical setting, as follows:

(1) Phaco Emulsifier Pack: Provides the irrigation and aspiration tubing/ administration sets and equipment covers/drapes used in anterior, e.g., cataract, surgical procedures;
(2) Anterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs for incision patency, and 10 cc syringe and fluid irrigation and aspiration tubing/administration sets, and equipment covers/drapes, used in anterior surgical procedures;
(3) Anterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic anterior surgical procedures:
(4) Posterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs for incision patency, and 10 cc syringe and fluid irrigation and aspiration tubing/administration sets, and equipment covers/drapes, used in posterior segment, e.g., retinal, surgical procedures;
(5) Posterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic posterior surgical procedures.
(6) Filtered Irrigation Administration Set: Provides commonly used tubing sets for the filtering and administration of fluids for flushing/irrigating a surgical site during either posterior or anterior ophthalmic procedures.

Device Description

Ophthalmic surgical kits/packs containing components used for irrigation/aspiration, anterior and posterior vitrectomies, phacoemulsification, and or administration of fluids.

AI/ML Overview

The provided document describes a 510(k) premarket notification for ophthalmic surgical kits/packs, not an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies or human-in-the-loop performance) is not applicable or cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving a device meets specific performance acceptance criteria through a clinical study in the way an AI/ML device would.

Here's what can be extracted, adapting to the context of a traditional medical device submission for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the typical sense for this submission. The "acceptance criteria" here is implicitly demonstrating substantial equivalence to predicate devices. The "performance" is primarily described by the device's technological characteristics and intended use being similar to existing (predicate) devices.

Acceptance Criteria Category	Description (as inferred from the document)	Reported Device Performance / Assessment
Technological Characteristics	No substantive changes in materials, basic components, or manufacturing/sterilization methods compared to predicates.	"There are no substantive changes in materials, basic components (the majority of which have their own 510(k)'s, or method of manufacture or sterilization between these devices and their predicates."
Biocompatibility	Components must be biocompatible (cytotoxicity, hemolysis).	"The packs' components have been tested by an independent lab for biocompatability (cyctotoxicity, hemolysis) with no problems noted."
Function and Use	Intended function and use must be similar to predicate and pre-amendment devices.	"The function and use of these packs and their components are no different than that of the predicates, as well as other similar devices, packs as well as individual components, marketed since pre-amendment."
Safety and Effectiveness	Device is as safe and effective as substantially equivalent predicate devices.	The FDA's letter of "substantial equivalence" determination implies this criterion was met.

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

This document does not describe a "test set" in the context of evaluating an AI/ML algorithm's performance on cases. The "testing" mentioned is for biocompatibility of components.

Sample size for biocompatibility testing: Not specified, but stated to be done by an independent lab.
Data provenance: Not applicable for performance evaluation of an AI/ML device. Biocompatibility testing results come from laboratory tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts

Not applicable. This submission doesn't involve establishing "ground truth" through expert review of medical images or data for an AI algorithm.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" or diagnostic performance evaluation described.

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

No. This is a traditional medical device submission for ophthalmic surgical kits/packs, not an AI/ML device. MRMC studies are used to evaluate human reader performance with and without AI assistance.

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

No. This is a traditional medical device.

7. The Type of Ground Truth Used

Not applicable. There's no diagnostic or prognostic output from these surgical kits that would require "ground truth" for performance evaluation in the AI/ML context. The closest concept might be conformance to manufacturing specifications or sterility, but that's not what "ground truth" typically refers to in AI/ML performance evaluation.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no AI/ML algorithm or training set.

Summary

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K990292 NOV 1 9 1999 halmic Consultants, Inc.

Post Office Box 2728 Kirkland WA 98083-2728 Phone (425) 803-6868 (425) 803-1881 Fax

10815 106th Avenue Northeast Kirkland WA 98033

PREMARKET NOTIFICATION 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [As Required by21 CFR 807.92(c)]

Date prepared: August 11, 1999

	01. Submitter (andspecificationdeveloper):	Ophthalmic Consultants, Inc.P O Box 2728 (10815 106th Avenue NortheastKirkland WA 98083-2728
	Kit Packer:	Medical Techniques, LC125 N. 400 WestNorth Salt Lake UT 84054
	Sterilizer:	Griffith Micro Science - Salt Lake City facility5725 W. Harold Gatty RoadSalt Lake City UT 84116
	02. Contact Person:	Timothy BarkerPresident/CEO, Director of Sales/Marketing
	Telephone:	425-803-6868
	03. Trade names:	Phacoemulsification PackAnterior Vitrector PackAnterior Collection CassettePosterior Vitrector PackPosterior Collection CassetteFiltered Irrigation Administration Set
	04. Common names:	Phacoemulsification PackAnterior Vitrector PackAnterior Collection CassettePosterior Vitrector PackPosterior Collection CassetteFiltered Irrigation Administration Set

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

certified clinician in a clinical setting, as follows:

05. Classification nme(s):	Ophthalmic Kits Accessories to Vitreous aspirationand cutting Instruments
06. Product Code:	Unclassified, 86-series 86 HQE accessories
Device Class:	Class II
07. Performance Standards:	No performance standards have been officially adopted by theFDA.
08. Predicate Devices:	The above packs are substantially equivalent to K980100,K962131, K961874, K961831, K955901, K953575, andK913504, et al, all of which were determined to be SE.
09. Description:	Ophthalmic surgical kits/packs containing components usedfor irrigation/aspiration, anterior and posterior vitrectomies,phacoemulsification, and or administration of fluids.
10. Intended Use:	To provide single-use components to be used in conjunction with a facility's existingcompatable equipment, in one convenient kit/pack, for ophthalmic surgical procedures,used in accordance with the equipment manufacturer's instructions, performed by a

(1) Phaco Emulsifier Pack: Provides the irrigation and aspiration tubing/ administration sets and equipment covers/drapes used in anterior, e.g., cataract, surgical procedures;
(2) Anterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs for incision patency, and 10 cc syringe and fluid irrigation and aspiration tubing/administration sets, and equipment covers/drapes, used in anterior surgical procedures;
(3) Anterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic anterior surgical procedures:
(4) Posterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs for incision patency, and 10 cc syringe and fluid irrigation and aspiration tubing/administration sets, and equipment covers/drapes, used in posterior segment, e.g., retinal, surgical procedures;
(5) Posterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic posterior surgical procedures.
(6) Filtered Irrigation Administration Set: Provides commonly used tubing sets for the filtering and administration of fluids for flushing/irrigating a surgical site during either posterior or anterior ophthalmic procedures.
1. Summary of Technological Characteristics of These Packs Compared to the Predicates:

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There are no substantive changes in materials, basic components (the majority of which have their own 510(k)'s, or method of manufacture or sterilization between these devices and their predicates.

1. Summary of Nonclinical Tests and Results:
  The packs' components have been tested by an independent lab for biocompatability (cyctotoxicity, hemolysis) with no problems noted. Both components and packs will be subjected to QC upon receipt, during/after manufacture, and prior to release.
1. Conclusion:
  The function and use of these packs and their components are no different than that of the predicates, as well as other similar devices, packs as well as individual components, marketed since pre-amendment.

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Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body or wings.

Mr. John E. Lincoln Consultant to Ophthalmic Consultants, Inc. I.E. Lincoln and Associates 65 North Main Suite 101 P.O. Box 154 Toole, UT 84074

Re: K990292

Trade Name:Ophthalmic Consultants, Incorporated's Phacoemulsification Pack Posterior Collection Cassette Pack Anterior Collection Cassette Pack Posterior Vitrectomy Pack Anterior Vitrectomy Pack Administration Disposable Pack Regulatory Class: II

Product Code: 86 HQE Dated: August 19, 1999 Received: August 23, 1999

Dear Mr. Lincoln:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Nov 1 9 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Mr. Lincoln

· This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_K990292

Device Name:_0phthalmic Kits/Packs

Indications For Use:

1. Phaco Emulsifier Pack: Provides the irrigation and aspiration tubing/ administration sets and equipment covers/drapes used in anterior, e.g., cataract, surgical procedures;
1. Anterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs for incision patency, and 10 cc syringe and fluid irrigation and aspiration tubing/administration sets, and equipment covers/drapes, used in anterior surgical procedures;
1. Anterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic anterior surgical procedures;
1. Posterior Vitrectomy Pack: Provides the vitrector, surgical blade, scleral plugs for incision patency, and 10 cc syringe and fluid irrigation and aspiration tubing/administration sets, and equipment covers/drapes, used in posterior segment, e.g., retinal, surgical procedures;
1. Posterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic posterior surgical procedures.
1. Filtered Irrigation Administration Set: Provides commonly used tubing sets for the filtering and administration of fluids for flushing/irrigating a surgical site during either posterior or anterior ophthalmic procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

hi R.B. kicholas

ision of Ophthalmic Devices 510(k) Number Kyg D29

XX Prescription Jose_ (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Formal 1-2-96)

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.