(30 days)
Not Found
No
The document describes a mechanical device for inserting intraocular lenses and makes no mention of AI or ML.
No
The device is used to facilitate the insertion of an intraocular lens, but it does not directly treat a disease or condition itself. It's a delivery system for a therapeutic device (the IOL).
No
Explanation: The device is intended to fold and insert intraocular lenses for surgical placement in the eye, which is a procedural/surgical function rather than a diagnostic one.
No
The device description clearly states it is a physical cartridge made of polypropylene, intended to fold and insert intraocular lenses, and is used with a reusable injector. This indicates it is a hardware device, not software only.
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 STAAR Surgical Company Collamer® aphakic 3-piece Intraocular Lenses for surgical placement in the eye." This describes a surgical tool used during a procedure on the human body.
- Device Description: The description reinforces its role as a device to "facilitate the loading, folding and insertion of the STAAR Surgical Collamer® 3-piece Intraocular Lens (IOL) into the human eye following cataract extraction."
- Anatomical Site: The anatomical site is "The human eye," indicating direct interaction with the body.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on bodily specimens. It is a surgical instrument.
N/A
Intended Use / Indications for Use
The MicroSTAAR® Injector System Cartridge, Model CQ is a device intended to fold and insert STAAR Surgical Company Collamer® aphakic 3-piece Intraocular Lenses for surgical placement in the eye.
Product codes (comma separated list FDA assigned to the subject device)
MSS
Device Description
The MicroSTAAR Injector System Cartridge, Model CQ (also referred as "MicroSTAAR Injector CQ Cartridge" or "CQ Cartridge") is intended to facilitate the loading, folding and insertion of the STAAR Surgical Collamer® 3-piece Intraocular Lens (IOL) into the human eye following cataract extraction. The model CQ Cartridge is a single use device designed specifically to be used with the reusable MicroSTAAR MSI-PM or MSI-TM injector to deliver the STAAR Surgical Collamer® 3-piece (IOL). The CQ Cartridge is composed of polypropylene and is terminally sterilized using Ethylene Oxide.
The MicroSTAAR Injector System Cartridge, Model CQ is a single use polypropylene cartridge designed to be used with the reusable MicroSTAAR MSI-PM or MSI-TM injector to fold and deliver the STAAR Surgical Collamer® 3-piece (IOL) in the human eye. It is identical in design, dimensions, processing and packaging as the predicate device. The only difference is the polypropylene formulation composing the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The human 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test and results:
Study: Recovery of Properties
Result: The change in material formulation does not impact the performance characteristics of the cartridge or lens.
Is the Subject Device as safe and effective as the Predicate Device?: Yes
Study: Shelf-Life
Result: The change in material formulation does not impact the performance characteristic of the cartridge over the stated shelf life.
Is the Subject Device as safe and effective as the Predicate Device?: Yes
Study: Biocompatibility
Result: The biocompatibility tests performed on the modified formulation model CQ cartridge met all acceptance criteria.
Is the Subject Device as safe and effective as the Predicate Device?: Yes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2017
STAAR Surgical Company Kate Ueda, JD Manager of Regulatory Affairs 1911 Walker Avenue Monrovia, CA 91016
Re: K172375
Trade/Device Name: MicroSTAAR Injector System Cartridge, Model CQ Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: August 4, 2017 Received: August 7, 2017
Dear Kate Ueda, JD:
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.
1
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) 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 (DICE) 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 yours,
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) K172375
Device Name
MicroSTAAR Injector System Cartridge, Model CQ
Indications for Use (Describe)
The MicroSTAAR® Injector System Cattridge, Model CQ is a device intended to fold and insert STAAR Surgical Company Collamer® aphakic 3-piece Intraocular Lenses for surgical placement in the eye.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 summary document has been prepared in accordance with section 21 CFR 807.92(c).
The submitter of the 510(k) is:
| Owner's Name: | STAAR Surgical Company |
|---|---|
| Address: | 1911 Walker Avenue |
| Monrovia, California 91016 | |
| Contact Person: | Kate Ueda |
| Title: | Manager of Regulatory Affairs |
| Phone: | 626.303.7902 ext. 2316 |
| Email: | kueda@Staar.com |
| Date Summary Prepared: | August 4, 2017 |
A. Subject Device:
| Trade name: | MicroSTAAR® Injector System Cartridge, Model CQ |
|---|---|
| Common Name: | Intraocular Lens Injector Cartridge |
| Classification Name: | Folders & Injectors, Intraocular Lens (IOL) |
| Class: | Class I – MSS, 21 CFR 886.4300 |
B. Predicate Device:
MicroSTAAR108 Injector System Cartridge, K101782 is used as the predicate device for this Special 510(k) Notification. There are three (3) models cleared in K101782, SFC-45, SFC-25, and the CQ Cartridge. This Special 510(k) Notification addresses a design modification of the model CQ Cartridge only.
C. Device Description:
The MicroSTAAR Injector System Cartridge, Model CQ (also referred as "MicroSTAAR Injector CQ Cartridge" or "CQ Cartridge") is intended to facilitate the loading, folding and insertion of the STAAR Surgical Collamer® 3-piece Intraocular Lens (IOL) into the human eye following cataract extraction. The model CQ Cartridge is a single use device designed specifically to be used with the reusable MicroSTAAR MSI-PM or MSI-TM injector to deliver the STAAR Surgical Collamer® 3-piece (IOL). The CQ Cartridge is composed of polypropylene and is terminally sterilized using Ethylene Oxide.
D. Indications for Use:
The MicroSTAAR® Injector System Cartridge, Model CQ is a device intended to fold and insert STAAR Surgical Company Collamer® aphakic 3-piece Intraocular Lenses for surgical placement in the eye. These are the same indications for use as the predicate model CQ Cartridge.
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E. Summary of Technological Characteristics
The MicroSTAAR Injector System Cartridge, Model CQ is a single use polypropylene cartridge designed to be used with the reusable MicroSTAAR MSI-PM or MSI-TM injector to fold and deliver the STAAR Surgical Collamer® 3-piece (IOL) in the human eye. It is identical in design, dimensions, processing and packaging as the predicate device. The only difference is the polypropylene formulation composing the device. The following table provides a comparison to the predicate device.
| Characteristic | Predicate Device | Subject Device |
|---|---|---|
| MicroSTAARTM Injector System Cartridges | ||
| K 101782 | Proposed MicroSTAAR® | |
| Injector System Cartridge | ||
| Model CQ | ||
| Indications for use | The MicroSTAARTM Injector System Cartridges is a device | |
| intended to fold and insert STAAR Surgical Company | ||
| Collamer® phakic and aphakic one-piece and 3-piece Intraocular | ||
| Lenses for surgical placement in the eye. | Same | |
| (As modified for the model | ||
| CQ cartridge only- | ||
| The MicroSTAAR® Injector | ||
| System Cartridge, Model | ||
| CQ is a device intended to | ||
| fold and insert STAAR | ||
| Surgical Company | ||
| Collamer® aphakic 3-piece | ||
| Intraocular Lenses for | ||
| surgical placement in the | ||
| eye.) | ||
| Contraindications | Use of the MicroSTAAR Injector with other intraocular implants | |
| and cartridges that have not been tested or approved for use with | ||
| the MicroSTAAR Injector System and Cartridges | Same | |
| Anatomical site | The human eye | Same |
| Injector | ||
| configuration | ||
| (single use) | The MicroSTAAR Injector Cartridges are used in conjunction | |
| with appropriate injector systems with 1-piece and 3-piece | ||
| phakic and aphakic Collamer lenses. | Same | |
| (As modified for the model | ||
| CQ cartridge only) | ||
| How is the device | ||
| used | The lens is placed into the loading area of the cartridge and | |
| folded shut. Then the cartridge is loaded onto the injector. When | ||
| the injector is advanced, the lens is ejected from the cartridge | ||
| nozzle into the human eye. | Same | |
| Single use? | The MicroSTAAR Injector Cartridges are intended for single | |
| use only | Same | |
| Is the product | ||
| sterile? | The MicroSTAAR Injector Cartridges are supplied sterile | Same |
| How sterilized | Ethylene Oxide (EtO) | Same |
| How supplied | The MicroSTAAR Injector Cartridge is placed in a tray, sealed | |
| with a Tyvek lid and labeled. The tray is sealed in a pre-printed, | ||
| labeled Tyvek pouch and terminally sterilized. | Same |
COMPARISON OF PREDICATE DEVICE TO THE PROPOSED DEVICE
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The technological characteristics of the modified CQ Cartridge are substantially equivalent to the predicate CQ Cartridge, cleared in K101782. As demonstrated above, the modified and predicate CQ Cartridges share the same intended use, indications, operating principle, design, packaging and sterilization method.
F. Brief Summary of Nonclinical Test and Results:
Results from validation testing of the modified MicroSTAAR Injector CQ Cartridge demonstrate that the cartridge functions as intended. In accordance with applicable tests in ISO 11979-3:2012 Ophthalmic implants -- Intraocular lenses -- Part 3: Mechanical properties and test methods (i.e., Section 5, Recovery of Properties following simulated surgical manipulation), intraocular lenses recovered to specifications after being folded and deformed by the cartridge.
A shelf-life study was initiated and is on-going for the modified cartridge under real time and accelerated conditions in accordance with applicable tests in ISO 11979-6:2014, Ophthalmic implants -- Intraocular lenses -- Part 6: Shelf-life and transport stability testing.
The CQ Cartridge composed of the modified polypropylene formulation has been tested for biocompatibility to ensure that the new material formulation meets the requirements of ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, and the FDA Guidance for Industry and Food and Drug Administration Staff dated June 16, 2016, "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Conclusions Drawn from Non-clinical Studies G.
A summary of the results of the non-clinical studies is provided below.
| Study | Result | Is the Subject Device
as safe and effective as
the Predicate Device? |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Recovery of Properties | The change in material formulation does
not impact the performance characteristics
of the cartridge or lens. | Yes |
| Shelf-Life | The change in material formulation does
not impact the performance characteristic
of the cartridge over the stated shelf life. | Yes |
| Biocompatibility | The biocompatibility tests performed on the
modified formulation model CQ cartridge
met all acceptance criteria. | Yes |
Non-Clinical Study Results
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The data generated from the non-clinical studies of the modified MicroSTAAR Injector cartridge, Model CQ support the subject device substantial equivalence to the predicate device.
The comparison of technical characteristics and data generated from the non-clinical studies demonstrate the substantial equivalence of the subject device and the predicate device.