(294 days)
Not Found
No
The device description and intended use focus on providing single-use surgical components and kits, with no mention of AI or ML capabilities.
No
The device provides single-use components for ophthalmic surgical procedures, rather than directly treating a condition or disease. It assists in surgical procedures by providing necessary supplies and equipment for irrigation, aspiration, vitrectomies, and phacoemulsification.
No
Explanation: The provided text describes ophthalmic surgical kits/packs that provide single-use components for surgical procedures such as irrigation/aspiration, vitrectomies, and phacoemulsification. The "Intended Use / Indications for Use" section explicitly states these components are "used in conjunction with a facility's existing compatible equipment" for "ophthalmic surgical procedures." There is no mention of the device being used to diagnose, detect, or analyze any medical condition; its function is purely to aid in surgical intervention.
No
The device description and intended use clearly describe physical components (tubing, blades, syringes, cassettes, etc.) used in ophthalmic surgical procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as providing components for surgical procedures (ophthalmic surgery). These components are used during the surgery for tasks like irrigation, aspiration, vitrectomy, and phacoemulsification.
- Device Description: The description reinforces this by stating the kits/packs contain components used for these surgical procedures.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, tissue, or other bodily fluids) in vitro to provide information for diagnosis, monitoring, or screening. The device is used directly on the patient during the surgical procedure.
- Focus on Surgical Support: The components listed (tubing, administration sets, vitrectors, blades, collection cassettes) are all tools used to facilitate the surgical process itself, not to analyze biological samples.
Therefore, the device falls under the category of a surgical device or kit, not an In Vitro Diagnostic device.
N/A
Intended Use / 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:
- (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.
Product codes (comma separated list FDA assigned to the subject device)
86 HQE
Device Description
Ophthalmic surgical kits/packs containing components used for irrigation/aspiration, anterior and posterior vitrectomies, phacoemulsification, and or administration of fluids.
(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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior (e.g., cataract) and posterior (e.g., retinal) segments of the eye.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
certified clinician in a clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K980100, K962131, K961874, K961831, K955901, K953575, K913504
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image is a black and white drawing of an eye. The eye is open, with the iris and pupil clearly visible. The eyelashes are drawn in a spiky style, adding a dramatic effect to the image. The overall style of the drawing is simple, yet detailed enough to convey the shape and features of an eye.
.
·
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 (and
specification
developer): | Ophthalmic Consultants, Inc.
P O Box 2728 (10815 106th Avenue Northeast
Kirkland WA 98083-2728 |
|--|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Kit Packer: | Medical Techniques, LC
125 N. 400 West
North Salt Lake UT 84054 |
| | Sterilizer: | Griffith Micro Science - Salt Lake City facility
5725 W. Harold Gatty Road
Salt Lake City UT 84116 |
| | 02. Contact Person: | Timothy Barker
President/CEO, Director of Sales/Marketing |
| | Telephone: | 425-803-6868 |
| | 03. Trade names: | Phacoemulsification Pack
Anterior Vitrector Pack
Anterior Collection Cassette
Posterior Vitrector Pack
Posterior Collection Cassette
Filtered Irrigation Administration Set |
| | 04. Common names: | Phacoemulsification Pack
Anterior Vitrector Pack
Anterior Collection Cassette
Posterior Vitrector Pack
Posterior Collection Cassette
Filtered Irrigation Administration Set |
1
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
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
FDA. |
| 08. Predicate Devices: | The above packs are substantially equivalent to K980100,
K962131, K961874, K961831, K955901, K953575, and
K913504, et al, all of which were determined to be SE. |
| 09. Description: | Ophthalmic surgical kits/packs containing components used
for 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 existing
compatable 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.
-
- Summary of Technological Characteristics of These Packs Compared to the Predicates:
2
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.
-
- 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.
- Summary of Nonclinical Tests and Results:
-
- 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.
- Conclusion:
3
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
4
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
5
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:
-
- Phaco Emulsifier Pack: Provides the irrigation and aspiration tubing/ administration sets and equipment covers/drapes used in anterior, e.g., cataract, surgical procedures;
-
- 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;
-
- Anterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic anterior surgical procedures;
-
- 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;
-
- Posterior Collection Cassette: Provides the fluid collection cassette and tubing for the collection and disposal of fluids during ophthalmic posterior surgical procedures.
-
- 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)