(180 days)
Not Found
No
The description focuses on the mechanical function of folding and inserting intraocular lenses and does not mention any computational or data-driven aspects indicative of AI/ML.
No
The device is used to fold and insert lenses for surgical placement, which is a delivery mechanism, not a therapeutic action itself.
No
The device is described as an injector system designed to fold and insert intraocular lenses for surgical placement in the eye, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details physical components (injector system, cartridges made of polypropylene and GMS) and their function in physically manipulating and delivering an intraocular lens. This is a hardware device with mechanical functions, not a software-only device.
Based on the provided information, the MicrSTAAR™ MSI Injector System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "fold and insert STAAR™ Surgical Company Collamer phakic and aphakic one-piece and three-piece Collamer® intraocular lenses for surgical placement in the eye." This describes a surgical tool used during a procedure on a patient, not a device used to test samples outside of the body to diagnose a condition.
- Device Description: The description details a mechanical system for handling and delivering an intraocular lens. It doesn't mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or assays.
- Measuring biomarkers.
Therefore, the MicrSTAAR™ MSI Injector System is a surgical device, specifically an injector system for intraocular lenses, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MicroSTAAR MSI Injector System is intended to fold and insert STAAR Surgical Company Collamer phakic and aphakic 1-piece and 3-piece Collamer® intraocular lenses for surgical placement in the human eye. The MSI Cartridges in this submission are just one component of the MicroSTAAR MSI Injector System.
The intended use of the MSI Cartridges in this submission are substantially equivalent to the intended use of the predicate devices K940593 (CQ cartridge FP), K980696 (SFC-45 FP), and K073586 (SFC-25 FP). Please refer to Attachment 1 for a copy of the Directions for Use for the predicate devices which will be the same for the MSI Cartridges.
The MicrSTAAR™ MSI Injector System is a device intended to fold and insert STAAR™ Surgical Company Collamer phakic and aphakic one-piece and three-piece Collamer® intraocular lenses for surgical placement in the eye.
Product codes (comma separated list FDA assigned to the subject device)
MSS
Device Description
The injector system is designed to facilitate the loading, folding and delivery of an intraocular lens (IOL) into the human eye through a small incision. The MicroSTAAR™ MSI injector System Cartridge utilizes three different cartridges for the insertion of an IOL lens. The three cartridges; CQ cartridge, SFC-45 cartridge and the SFC-25 cartridge are designed to facilitate a folded IOL lens for delivery. Each cartridge has a loading area which tapers down to a small tip, for the SFC-45 and SFC-25 cartridges, the lens loading area is flat and for the CQ cartridge the loading area is hinged. It is a component that is fabricated from polypropylene mixed with Glycerol Monostearate (GMS). Currently, the cartridge is cleared for fabrication from polypropylene mixed with GMS and is supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human eye, 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)
Not Found
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.
K090161, K073586, K940593, K980696
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
MicroSTAAR™ (MSI) INJECTOR SYSTEM CARTRIDGES
510(k) SUMMARY
| Submitter Information | STAAR Surgical Company
Contact: Jack Coggan
Director of Regulatory Affairs
1911 Walker Avenue
Monrovia, California 91016
Phone: 626.303.7902 ext 2616
Fax: 626.303.2962 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Registration Number | 2023826 |
| Submission Correspondent | STAAR Surgical Company
Contact: Jack Coggan
Director of Regulatory Affairs
1911 Walker Avenue
Monrovia, California 91016
Phone: 626.303.7902 ext 2616
Fax: 626.303.2962 |
| Date Summary Prepared | January 4, 2011 |
| Classification Name | Lens, Guide, Intraocular
(Class I) - KYB 21 CFR 886.4300
Folders and Injectors, Intraocular Lens (IOL)
(Class I) - MSS 21 CFR 886.4300 |
| Common/Usual Name | Intraocular Lens Injector Cartridge |
| Device Trade Name | MicroSTAAR™ MSI Injector System
Models: CQ, SFC 25, SFC 45 |
The primary devices used for comparison in this summary are: Epiphany Injector System (K090161) and MicroSTAAR™ Indigo Injector System (K073586).
Intended Use
The MicroSTAAR MSI Injector System is intended to fold and insert STAAR Surgical Company Collamer phakic and aphakic 1-piece and 3-piece Collamer® intraocular lenses for surgical placement in the human eye. The MSI Cartridges in this submission are just one component of the MicroSTAAR MSI Injector System.
The intended use of the MSI Cartridges in this submission are substantially equivalent to the intended use of the predicate devices K940593 (CQ cartridge FP), K980696 (SFC-45 FP), and K073586 (SFC-25 FP). Please refer to Attachment 1 for a copy of the Directions for Use for the predicate devices which will be the same for the MSI Cartridges.
1
1990085840 M 11252 JUTO HVA H8M 473 Home Ho
ារ
::
'557' 등' 2402 문제 12
. ಅಂದಿಭಾರತದಿಗಳು ಇವರಿಗಳು ಸ
មានប្រទេសនាក់នោះ និងប្រទេសស្រី ប្រពន្ធមានប្រ
n abdury, on 2007 and 14:00 p
breage for asteradosmil
on Holly Produced is
orenić fora Tarmardio O
ara 21 aberti server :
унеото 3 врімай УЗАДУ -ா ஏர்தித்தும், மேற்கும் ation recinion 14 lociolorio trafi ported in to 1,30 | 11 | 1 6 lot Replace":[1]2] [stabuse 4 6181.128 1997 2005.01 61 611511000 1700 107 510 113
0232011
villa 30 Jan 2017 SAATR स्विमा को मिलते ही बात के ridio () voorhali/" he modern 9119 8 255, 157 177 Amar Christill Onliner M of of 145 for 1. Ha rollers 1 1 1971. 08:30 14 1
1991 de resulted.
ക്കാരങ്ങിനു പ്രധാന 用具体的角度(C) LE 器内液 - (Smart) a Kazama leritoorial ,216 meint hao ze bloži 요 11 310 300 2009 11 28M = 4 38000 1
์ ที่ยังสามารถเลือก และไทเป็นต้อมาใหม
n te vel prisojni le M M An | Potar | 21.012 21.0 02.00 : 0.0 : Malais
makayi takayi yandigitý li na gumunias zím zi pokinájace něklávana v Libben mag odl (882E502) aparea2 marajid andan2 mintal2 handaris is to (1846) . 2.)
145 between to
þaðgrófu á 1.5.7.0.1.2017 hann bast er húsinari af merevit 10:41 Hr.hljóð 11.1.1.12.10.11.201 ാറിക്കുന്നത് നിന്നും അത്തിന് അമിന്റെ പ്രിമ്പിച്ച് കന്സിന്റെ മലയാളിക്കുന്നത്. എന്നും വാഹിത്യ പ്രവ eno salipas egisa arina aidi di sempluraD (715) will neks minumbed, di new contributorio pasterji sabajal 1914 11:44 11 14 12 14 11 10 10 1000 1000
diff of terdesciapS gibilitassegon son occusarity of that call letter and Arcan edi to a min the high a bhaile a than and the should was the same on the soule of the security of ത്തിക്കി ഉപയോഗ്യിന്റെ ഇരാഹരി 1 അക്കാപക്ഷിച്ചു 1- 21,4 വരെ വേഴ് ැනුම් සිට විවිධිය වේ. මේ හෝ කොට පෙන් හිට අතර විය. මෙය විය. අධිරි වූ
2
Description
The injector system is designed to facilitate the loading, folding and delivery of an intraocular lens (IOL) into the human eye through a small incision. The MicroSTAAR™ MSI injector System Cartridge utilizes three different cartridges for the insertion of an IOL lens. The three cartridges; CQ cartridge, SFC-45 cartridge and the SFC-25 cartridge are designed to facilitate a folded IOL lens for delivery. Each cartridge has a loading area which tapers down to a small tip, for the SFC-45 and SFC-25 cartridges, the lens loading area is flat and for the CQ cartridge the loading area is hinged. It is a component that is fabricated from polypropylene mixed with Glycerol Monostearate (GMS). Currently, the cartridge is cleared for fabrication from polypropylene mixed with GMS and is supplied sterile.
Technological Characteristics
The MicroSTAAR™ MSI injector System Cartridge has substantially equivalent technological characteristics to the predicate device. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, specifications and materials.
| | MicroSTAAR Injector System
K940593, K980696, K073586 | Epiphany Injector System
K090161
Epiphany | MicroSTAAR MSI Injector
System Cartridges | Substantially
Equivalent |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Product
Description | System is designed to facilitate
the loading, folding and
delivery of an intraocular lens
(IOL) into the human eye
through a small incision. | System is designed to facilitate
the loading, folding and
delivery of an intraocular lens
(IOL) into the human eye
through a small incision. | System is designed to facilitate
the loading, folding and
delivery of an intraocular lens
(IOL) into the human eye
through a small incision. | Same |
| Intended Use | Intended to fold and insert
STAAR Surgical Company 1-
piece or 3-piece Collamer
intraocular lenses for surgical
placement in the eye. | Intended to fold and insert
STAAR Surgical Company 3-
piece Silicone intraocular
lenses for surgical placement in
the eye. | Intended to fold and insert
STAAR Surgical Company 1-
piece and 3-piece Collamer
intraocular lenses for surgical
placement in the eye. | Same |
| Design | Single cartridge to be used in
conjunction with appropriate
injector system and 1-piece or
3-piece Collamer lenses for
surgical placement of lens into
eye. | A single component medical
device used in conjunction with
3-piece silicone lenses for
surgical placement in the eye. | Single cartridge to be used in
conjunction with appropriate
injector system and 1-piece or
3-piece Collamer lenses for
surgical placement of lens into
eye. | Same |
| Materials | Cartridge is manufactured from
Polypropylene purchased from
US Supplier. | Cartridge is manufactured from
Polypropylene MG05 and
Polypropylene MG03
purchased from Japan Supplier. | Cartridge is manufactured from
Polypropylene MG05 and
Polypropylene MG03
purchased from Japan Supplier. | Same |
| Mechanical
Safety | | | | |
| Manufacturing | Utilization of contract
manufacturers and in-house
processing at Monrovia facility | Utilization of contract
manufacturers and in-house
processing at the STAAR Japan
facility | Utilization of contract
manufacturers and in-house
processing at the STAAR Japan
facility, while molding process
is still done by a US contractor. | Similar |
Comparison Analysis
3
MicroSTAAR™ (MSI) INJECTOR SYSTEM CARTRIDGES
| 510(k) | MicroSTAAR Injector System
K940593, K980696, K073586 | Epiphany Injector System
K090161
Epiphany | MicroSTAAR MSI Injector System Cartridges | Substantially Equivalent |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Operating
Principle | The IOL is placed into the
loading area and folded shut or
gently pressed towards tip.
Then cartridge is loaded onto
the injector. | The cartridge is part of the
Epiphany Injector. The lens is
loaded into the cartridge,
snapped shut, and pushed into
pre-operative position. | Depending on the cartridge
type, the IOL is either placed
into the loading area and folded
shut, or it is pressed forward
towards the tip. Then cartridge
is loaded onto the injector. | Same |
| Packaging | Cartridge is placed in tray,
sealed with Tyvek lid and
labeled. Tray is placed in Kraft
paper pouch and then a foil
pouch, and labeled again. US
Packaging Supplier. | The Epiphany injector is placed
into a tray, which is labeled.
This unit is placed inside a
pouch which is sealed. The
sealed pouch is then put into a
box with a package insert.
Japanese Packaging Supplier. | Cartridge is placed in tray,
sealed with Tyvek lid and
labeled. Tray is placed in Kraft
paper pouch. Japanese
Packaging supplier. | Similar |
| Sterility | Sterile Ethylene Oxide (EtO)
by Subcontractor | Sterile Ethylene Oxide (EtO)
by STAAR Japan | Sterile Ethylene Oxide (EtO)
by STAAR Japan | Same |
| Manufacturer | STAAR Surgical | STAAR Japan | STAAR Japan | Same |
8 .
Table 1 – Summary of Design comparison for 21 CFR § 807.87(f)
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
FEB - 7 2011
STAAR Surgical Company c/o Mr. Jack Coggan Director of Regulatory Affairs 1911 Walker Avenue Monrovia, CA 91016
Re: K101782
Trade/Device Name: MicroSTAAR Injector System Cartridges Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I, reserve Product Code: MSS Dated: December 2, 2010 Received: December 6, 2010
Dear Mr. Coggan:
This letter corrects our substantially equivalent letter of December 22, 2010.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocasined 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 commerce provided to May 20, 1977, the oncordance with the provisions of the Federal Food, Drug, devices that have occh require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, marker the devices subject to eno gements for annual registration, listing of devices, controls provisions of the frect merade song prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (000 as ) Existing major regulations affecting your device can be may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuated or wouldevice complies with other requirements of the Act that I DA has made a acterimansions administered by other Federal agencies. You must of any I cuthal saltutes and regulations and limited to: registration and listing (21 Comply with an the For 8 requirements (01); medical device reporting (reporting of medical
5
Page 2 - Mr. Jack Coggan
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Image /page/5/Picture/7 description: The image shows a handwritten word, "for", in cursive script. The letter "f" is elongated with a large loop extending below the baseline, and the letters "o" and "r" are connected in a fluid, continuous stroke. The writing appears to be done with a pen or marker, and the ink is dark and bold.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use
510(k) Number (if known): K101782
Device Name: MicroSTAAR™ Injector System Cartridge
Indications For Use:
The MicrSTAAR™ MSI Injector System is a device intended to fold and insert STAAR™ Surgical Company Collamer phakic and aphakic one-piece and three-piece Collamer® intraocular lenses for surgical placement in the eye.
Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jennifer Brown
Page 1 of
(Division Sign Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K101782