(77 days)
Not Found
No
The device description and performance studies focus on mechanical insertion of an IOL and do not mention any computational or analytical functions that would suggest AI/ML.
Yes.
The device is used to assist in the insertion of intraocular lenses into the eye for cataract extraction, which directly addresses a medical condition (cataract) and is intended to restore or improve physiological function (vision).
No
The device is an insertion system for intraocular lenses, used to fold and implant lenses into the eye after cataract extraction. It does not perform any diagnostic function.
No
The device description explicitly lists physical components (Handpiece, Soft Tip, Soft tip holder, Cartridge) and describes a mechanical process (folding and inserting an IOL), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fold and insert an intraocular lens into the eye. This is a surgical procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is an insertion system for an intraocular lens, which is an implantable medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The AMO®PhacoFlex® II Insertion System is used to fold and assist in inserting the AMO®PhacoFlex® II (SLM-2/UV) family of intraocular lenses, specifically the SI-30NB and SI-40NB, into the eye.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The AMO®PhacoFlex® II Insertion System is used to fold and assist in the insertion of an AMO®PhacoFlex® II (SLM-2/UV) silicone intraocular lens (IOL) into the eye following cataract extraction. The materials used in the AMO®PhacoFlex® II Insertion System are similar to the materials used in predicate devices.
The AMO®PhacoFlex® II Insertion System is a Bartell-type injector system comprised of the following components:
AMO®PhacoSert™ Handpiece (Model #PSH-ST)
All handpiece components are composed of titanium, a material commonly used for reusable surgical instruments. The handpiece rod is designed to accept a single-use silicone rubber soft tip. This handpiece is reusable and is designed to withstand conventional inoffice steam autoclaving. The titanium handpiece is provided to the customer in a plastic box in a non-sterile state.
AMO®PhacoSert™ Soft Tip
The soft tip is a single-use component composed of medical grade silicone which contains blue pigment to enhance its visibility during tip application and IOL implantation. The tip is provided sterile in the single-use soft tip holder.
Single-use soft tip holder
This component is composed of an optically clear version of acrylic resin. The tip holder facilitates application of the soft tip to the handpiece rod and eliminates direct handling of the soft tip during application. The tip holder is discarded following application of the soft tip to the titanium rod and does not directly contact either the IOL or the patient. The tip holder is provided sterile.
AMO® PhacoSert™ Cartridge (Model #PSC-ST)
The cartridge is a single-use component composed of lubricated polypropylene and is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 in vitro performance testing conducted on the AMO®PhacoFlex® II Insertion System evaluated the following variables:
- Impact on IOL dioptric power .
- IOL resolution return/fold recovery ●
- Overall lens diameter and haptic angle
- IOL decentration, tilt and compression force testing
- IOL haptic pull strength
- Force required to advance the IOL
- IOL release characteristics
- Streaks on IOL
- . IOL optic body marks/damage
All test results indicate that like the predicate device, the AMO®PhacoFlex® II Insertion System reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting lens optical performance, lens dimensions, or cosmetic appearance.
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.
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
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
0
510(k) Notification AMO®PhacoFlex® II Insertion System
JUN 17 1996
Page 170
510(k) Summary
In accordance with 21 CFR 807.92, Allergan is providing this 510(k) summary.
1. Submitter's name, address, and telephone number, a contact person, and the date the summary was prepared:
Allergan, Inc. 2525 Dupont Drive Irvine, California 92713-9534 (714) 246-2281
Contact person: Maureen Weiner Regulatory Affairs Analyst
Date summary prepared: March 29, 1996
Name of the device, including trade or proprietary name, common or usual 2. name, and classification name:
Trade/proprietary name: AMO®PhacoFlex® II Insertion System
Common/usual name: lens insertion guide
Classification name: intraocular lens guide
3. Identification of the predicate device or legally marketed device to which substantial equivalence is claimed:
510(k) K941603, cleared on 7/6/94, filed by Allergan Medical Optics, AMO PhacoFlex® Inserter Disposable Cartridge
510(k) K930320, cleared on 4/7/94, filed by Allergan Medical Optics, AMO®PhacoFlex® Inserter
1
4. Description of the device that is the subject of the premarket notification submission, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device such as device design, material used, and physical properties:
The AMO®PhacoFlex® II Insertion System is used to fold and assist in the insertion of an AMO®PhacoFlex® II (SLM-2/UV) silicone intraocular lens (IOL) into the eye following cataract extraction. The materials used in the AMO®PhacoFlex® II Insertion System are similar to the materials used in predicate devices.
The AMO®PhacoFlex® II Insertion System is a Bartell-type injector system comprised of the following components:
AMO®PhacoSert™ Handpiece (Model #PSH-ST)
All handpiece components are composed of titanium, a material commonly used for reusable surgical instruments. The handpiece rod is designed to accept a single-use silicone rubber soft tip. This handpiece is reusable and is designed to withstand conventional inoffice steam autoclaving. The titanium handpiece is provided to the customer in a plastic box in a non-sterile state.
AMO®PhacoSert™ Soft Tip
The soft tip is a single-use component composed of medical grade silicone which contains blue pigment to enhance its visibility during tip application and IOL implantation. The tip is provided sterile in the single-use soft tip holder.
Single-use soft tip holder
This component is composed of an optically clear version of acrylic resin. The tip holder facilitates application of the soft tip to the handpiece rod and eliminates direct handling of the soft tip during application. The tip holder is discarded following application of the soft tip to the titanium rod and does not directly contact either the IOL or the patient. The tip holder is provided sterile.
AMO® PhacoSert™ Cartridge (Model #PSC-ST)
The cartridge is a single-use component composed of lubricated polypropylene and is provided sterile.
ડ. . Statement of intended use:
The AMO®PhacoFlex® II Insertion System is used to fold and assist in inserting the AMO®PhacoFlex® II (SLM-2/UV) family of intraocular lenses, specifically the SI-30NB and SI-40NB, into the eye.
2
Statement of how the technological characteristics (i.e., design, material, ર્ . chemical composition, energy source) compare to the predicate device:
| Technological
Characteristic | AMO®PhacoFlex® II
Insertion System | Predicate
Devices* |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To fold and assist in inserting
the AMO®PhacoFlex® II
(SLM-2/UV) family of intraocular
lenses, specifically the SI-30NB and
SI-40NB, into the eye | To fold and insert a foldable IOL
(AMO®PhacoFlex® II) into the
eye during normal small incision
cataract surgery |
| Operating
Principle | IOL is loaded into the cartridge
and the IOL is pushed through
the cartridge and delivered into
the eye | same operating principle |
| Materials: | | |
| handpiece | titanium | titanium or medical-grade stainless
steel |
| cartridge | lubricated polypropylene | lubricated polypropylene |
| soft tip | silicone | N/A |
| soft tip holder | acrylic | N/A |
| Design: | | |
| handpiece | reusable | reusable |
| cartridge | 1 piece (insertion chamber)
disposable, single use only | 1 piece (insertion chamber)
disposable, single use only |
| soft tip | disposable, single use only | N/A |
| soft tip holder | disposable, single use only | N/A |
| Sterilization
Method | handpiece is provided non-sterile
cartridge, soft tip, and soft tip
applicator are EtO sterilized | handpiece is provided non-sterile
cartridge is EtO sterilized |
| Portion of Device
that Contacts the
Eye | tip of cartridge and soft tip | tip of cartridge |
PhacoFlex® Inserter Disposable Cartridge and the AMOª
Allergan, Inc. - Strictly Private
3
7. Brief summary of nonclinical tests and results:
The in vitro performance testing conducted on the AMO®PhacoFlex® II Insertion System evaluated the following variables:
- Impact on IOL dioptric power .
- IOL resolution return/fold recovery ●
- Overall lens diameter and haptic angle
- IOL decentration, tilt and compression force testing
- IOL haptic pull strength
- Force required to advance the IOL
- IOL release characteristics
- Streaks on IOL
- . IOL optic body marks/damage
All test results indicate that like the predicate device, the AMO®PhacoFlex® II Insertion System reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting lens optical performance, lens dimensions, or cosmetic appearance.
The following biocompatiblity testing has been conducted by a qualified independent testing laboratory on the AMO@PhacoFlex® II Insertion System:
- Cytotoxicity Test -- ISO Agarose Overlay Method (soft tip) .
- Cytotoxicity Test -- ISO Elution Method (soft tip) .
- In Vitro Inhibition of Cell Growth (ICG, One-Point Assay) (soft tip) .
- . Ocular Irritation Study (soft tip)
- Delayed Contact Sensitization Study (soft tip)
- Cytotoxicity Test -- USP Agar Diffusion (soft tip holder) .
- . Cytotoxicity Test -- ISO Elution Method (soft tip holder)
The test results indicate that the materials are non-toxic, non-irritating, noninhibitory, and non-sensitizing. Please note that biocompatibility for the carridge was established in the predicate device 510(k) #K941603. No new materials have been added to the cartridge since this 510(k) was cleared.
Based on the performance and biocompatibility testing, we conclude that this system is a safe and effective device for delivering the AMO®PhacoFlex® II (SLM-2/UV) family of intraocular lenses, specifically the SI-30NB and SI-40NB, into the eve.