I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN

K990292 · Ophthalmic Consultants, Inc. · HQE · Nov 19, 1999 · Ophthalmic

Device Facts

• Record ID: K990292
• Device Name: I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN
• Applicant: Ophthalmic Consultants, Inc.
• Product Code: HQE · Ophthalmic
• Decision Date: Nov 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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: - 01. Phaco Emulsifier Pack: Provides the irrigation and aspiration tubing/ administration sets and equipment covers/drapes used in anterior, e.g., cataract, surgical procedures; - 02. 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; - 03. Anterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic anterior surgical procedures; - 04. 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; - 05. Posterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic posterior surgical procedures. - 06. 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 Story

Ophthalmic surgical kits/packs containing single-use components for irrigation, aspiration, vitrectomy, phacoemulsification, and fluid administration. Kits include tubing, administration sets, drapes, vitrector, surgical blades, scleral plugs, syringes, and collection cassettes. Used in clinical settings by certified clinicians in conjunction with existing compatible ophthalmic surgical equipment. Components facilitate fluid management and surgical access during anterior and posterior segment procedures. Kits provide convenience by consolidating necessary disposables for specific surgical workflows.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity, hemolysis) performed by independent lab with no issues noted. Quality control procedures applied during and after manufacture.

Technological Characteristics

Single-use ophthalmic surgical kits. Components include tubing, drapes, vitrector, blades, plugs, syringes, and cassettes. Sterilized. No active electronic components; passive mechanical accessories for use with existing surgical equipment.

Indications for Use

Indicated for patients undergoing ophthalmic surgical procedures, including anterior segment (e.g., cataract) and posterior segment (e.g., retinal) surgeries. Used by certified clinicians in clinical settings.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• K980100
• K962131
• K961874
• K961831
• K955901
• K953575
• K913504

Submission Summary (Full Text)

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K990292 NOV 1 9 1999 halmic Consultants, Inc.

Post Office Box 2728 Kirkland WA 98083-2728 Phone [phone] [phone] 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 (and<br>specification<br>developer): | Ophthalmic Consultants, Inc.<br>P O Box 2728 (10815 106th Avenue Northeast<br>Kirkland WA 98083-2728 |
|--|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Kit Packer: | Medical Techniques, LC<br>125 N. 400 West<br>North Salt Lake UT 84054 |
| | Sterilizer: | Griffith Micro Science - Salt Lake City facility<br>5725 W. Harold Gatty Road<br>Salt Lake City UT 84116 |
| | 02. Contact Person: | Timothy Barker<br>President/CEO, Director of Sales/Marketing |
| | Telephone: | 425-803-6868 |
| | 03. Trade names: | Phacoemulsification Pack<br>Anterior Vitrector Pack<br>Anterior Collection Cassette<br>Posterior Vitrector Pack<br>Posterior Collection Cassette<br>Filtered Irrigation Administration Set |
| | 04. Common names: | Phacoemulsification Pack<br>Anterior Vitrector Pack<br>Anterior Collection Cassette<br>Posterior Vitrector Pack<br>Posterior Collection Cassette<br>Filtered 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 aspiration<br>and 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 the<br>FDA. |
| 08. Predicate Devices: | The above packs are substantially equivalent to K980100,<br>K962131, K961874, K961831, K955901, K953575, and<br>K913504, et al, all of which were determined to be SE. |
| 09. Description: | Ophthalmic surgical kits/packs containing components used<br>for irrigation/aspiration, anterior and posterior vitrectomies,<br>phacoemulsification, and or administration of fluids. |
| 10. Intended Use: | To provide single-use components to be used in conjunction with a facility's existing<br>compatable equipment, in one convenient kit/pack, for ophthalmic surgical procedures,<br>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.
- 11. 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.

- 12. 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.

- 13. 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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:

- 01. Phaco Emulsifier Pack: Provides the irrigation and aspiration tubing/ administration sets and equipment covers/drapes used in anterior, e.g., cataract, surgical procedures;
- 02. 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;
- 03. Anterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic anterior surgical procedures;
- 04. 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;
- 05. Posterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic posterior surgical procedures.
- 06. 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.

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## 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)