(71 days)
The MicroSTAAR® Injector System (MSI) is a device intended to fold and insert STAAR® Surgical Company Collamer® phakic and aphakic 1-piece intraocular lenses for surgical placement into the human eye.
The MicroSTAAR® Injector System Cartridge (MSI Cartridge) is designed to facilitate the loading, folding and delivery of Collamer® phakic and aphakic intraocular lenses (ICL/IOL) into the human eve through a small incision. There is one model of MSI Cartridge in this submission, SFC-45 cartridge. The SFC-45 Cartridge is designed to lock into a corresponding MicroSTAAR® Injector System. The cartridge has a loading area on one end and a tapered tip on the other. The SFC-45 has a funnel shape, with exposed flat loading areas, and was designed to work with the Collamer® 1piece lenses manufactured by STAAR Surgical.
The provided document is a 510(k) summary for the MicroSTAAR® Injector System Cartridges, specifically concerning a change in the polypropylene material used for manufacturing. The document describes several performance tests conducted to demonstrate that the device, with the new material, is substantially equivalent to its predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - Cytotoxicity Test (ISO 10993-5) | Passed. "No evidence of causing cell lysis or toxicity." |
| - Sensitization Test (ISO 10993-10) | Passed. "No evidence of causing delayed dermal contact sensitization in the guinea." |
| - Intraocular Irritation Test (ISO 10993-10) | Passed. "No differences in ocular observations between eyes treated with test article extract and those treated with the control vehicle." |
| Feasibility Test (Device Function/Integrity): | Passed. "Successfully delivered the lenses without any damage to the cartridge." Concluded to be "substantially equivalent to the cartridges manufactured using the current material." |
| Fourier-transform infrared spectroscopy (FTIR) (Material Composition): | Performed. "FTIR resulting spectra showed the typical makeup for the polypropylene copolymer material. The main difference between all materials was related to the amount of additives." (This is a characterization, not a pass/fail, but supports material identity). |
| Shelf-Life (Accelerated Aging): | Passed (1 month accelerated aging). "Comparable to the cartridges manufactured using the current material and passed within the manufacturer's specifications. The delivery of the lenses was smooth and there was no damage to the cartridges or lenses." |
| Sterilization (Sterility Assurance Level - SAL): | Achieved a minimum sterility assurance level of 1 x 10^-6 (probability of less than one non-sterile unit out of each one million units sterilized). Biological indicators indicated no bacteriostatic characteristics. EO/ECH residuals negligible. (Indicates successful sterilization, which is a required characteristic for this medical device type). |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state the sample sizes for each individual test (biocompatibility, feasibility, shelf-life, sterilization).
- Data Provenance: The biocompatibility study was performed by "Namsa Laboratory." No country of origin is explicitly mentioned for the data, but the company (STAAR Surgical) is based in the USA, and the material supplier is in Japan. The study is retrospective in the sense that these tests were performed on a device with a modified material to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable to the type of device and studies described. The tests performed are engineering and laboratory-based assessments (e.g., cytotoxicity, material analysis, mechanical function, sterility), not clinical evaluations requiring expert interpretation of diagnostic images or patient outcomes. Therefore, "ground truth" in the sense of expert consensus on clinical data is not relevant here.
4. Adjudication Method for the Test Set:
- Not applicable. As the tests are objective laboratory and functional evaluations, there is no need for an adjudication method as would be used in expert consensus for clinical image interpretation.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an intraocular lens injector cartridge, a mechanical device used in surgery, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI effect size are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For biocompatibility, the ground truth is established by standard biological assays and the absence of cytotoxic, sensitizing, or irritating effects as per ISO 10993 standards.
- For feasibility, the ground truth is successful delivery of the lenses without damage, as determined by visual inspection and functional assessment.
- For FTIR, the ground truth is the chemical fingerprint of polypropylene copolymer.
- For shelf-life, the ground truth is the continued functional performance and integrity of the cartridge after accelerated aging, meeting manufacturer's specifications.
- For sterilization, the ground truth is the achievement of the specified Sterility Assurance Level (SAL), demonstrated by biological indicators.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model that requires a training set. The "training" in this context refers to the development and manufacturing processes that establish the device's characteristics.
9. How the ground truth for the training set was established:
- Not applicable. See point 8. The "ground truth" for the device design and manufacturing is established through engineering specifications, material science principles, and adherence to quality system regulations (e.g., 21 CFR 820). The studies described here are verification and validation activities against those established specifications.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2015
STAAR Surgical Company Mr. Jack Coggan Director of Regulatory Affairs 1911 Walker Avenue Monrovia, CA 91016
Re: K152357
Trade/Device Name: MicroSTAAR® Injector System Cartridges Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS, KYB Dated: September 29, 2015 Received: September 30, 2015
Dear Mr. Coggan:
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.
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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 of medical 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 contact the Division of Industry and Consumer Education 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 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,
Kesia Y. Alexander -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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Image /page/2/Picture/0 description: The image shows the logo for STAAR Surgical. The logo consists of a star-shaped symbol on the left and the text "STAAR" on the right. Below the word STAAR is the word "SURGICAL" in a smaller font. The star symbol is a golden color, while the text is a dark blue color.
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K152357
Device Name: MicroSTAAR® Injector Cartridge
The MicroSTAAR® Injector System (MSI) is a device intended to fold and insert STAAR® Surgical Company Collamer® phakic and aphakic 1-piece intraocular lenses for surgical placement into the human eye.
Prescription Use _________________________________________________________________ (Part 21 CI-1 (801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for STAAR Surgical. The logo consists of a star-shaped symbol on the left and the text "STAAR" in a bold, sans-serif font on the right. Below "STAAR" is the word "SURGICAL" in a smaller, lighter font. The star symbol is made up of three intersecting lines that form a six-pointed star.
510 (k) SUMMARY
Submitter Information
Company Registration Number Submission Correspondent
Date Summary Prepared
Classification Name
STAAR Surgical Company Contact: Jack Coggan Director of Regulatory Affairs 1911 Walker Avenue Monrovia, California 91016 Phone: 626.303.7902 ex. 2616 Fax: 626.303.2962
2023826
STAAR Surgical Company Contact: Jack Coggan Director of Regulatory Affairs 1911 Walker Avenue Monrovia, California 91016 Phone: 626.303.7902 ex. 2616 Fax: 626.303.2962
September 16, 2015
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
Device Trade Name
Intraocular Lens Injector Cartridge
MicroSTAAR® Injector System Model: SFC 45
The primary device used for comparison in this summary is MicroSTAAR® Injector System Cartridges (K101782).
INTENDED USE
The intended use of the MSI Cartridge in this submission is substantially equivalent to the intended use of the predicate cartridges (K101782). Please refer to the Directions for Use for the predicate device, which will also be used with the proposed MSI cartridge.
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Image /page/4/Picture/0 description: The image shows the logo for STAAR Surgical. The logo features a stylized star-like symbol on the left, with the word "STAAR" in a bold, sans-serif font to the right of the symbol. Below "STAAR" is the word "SURGICAL" in a smaller, lighter font.
The intended use of the modified device, as described in its labeling has not changed as a result of this modification. The MicroSTAAR® Injector System is intended to fold and insert STAAR Surgical Company Collamer® phakic and aphakic 1-piece intraocular lenses for surgical placement in the human eye.
DESCRIPTION (Device)
The MicroSTAAR® Injector System Cartridge (MSI Cartridge) is designed to facilitate the loading, folding and delivery of Collamer® phakic and aphakic intraocular lenses (ICL/IOL) into the human eve through a small incision. There is one model of MSI Cartridge in this submission, SFC-45 cartridge. The SFC-45 Cartridge is designed to lock into a corresponding MicroSTAAR® Injector System.
The cartridge has a loading area on one end and a tapered tip on the other. The SFC-45 has a funnel shape, with exposed flat loading areas, and was designed to work with the Collamer® 1piece lenses manufactured by STAAR Surgical.
The new polypropylene material used for manufacturing the SFC-45 cartridges is substantially equivalent to that of the predicate device's polypropylene material. The proposed material will be supplied by the same supplier in Japan. The material will be shipped to STAAR Monrovia, USA, to be forwarded to a molding contractor in the USA. The molded MSI cartridge will be returned to STAAR Monrovia for the rest of the manufacturing process. There will be no changes to the in-process or the final release specifications and all manufacturing processes of the MSI Cartridges will be the same as those of the predicate cartridges.
The product description for the MSI Cartridge is substantially equivalent to that of the predicate devices.
TECHNOLOGICAL CHARACTERISTICS
The MSI Cartridge has substantially equivalent technological characteristics to the predicate device. Refer to Table 7 in the following section, entitled Device Comparison, for a summation of the technological characteristics such as design.
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Image /page/5/Picture/0 description: The image shows the logo for STAAR Surgical. The logo features a stylized star-like symbol on the left, with the word "STAAR" in a dark blue, sans-serif font to the right of the symbol. Below "STAAR" is the word "SURGICAL" in a smaller, lighter font.
| Description | Predicate MicroSTAAR Injector SystemCartridges | New MicroSTAAR Injector System Cartridge(SFC-45) |
|---|---|---|
| 510(k) | K101782 | N/A |
| Models | SFC 45 | SFC 45 |
| ProductDescription | System is designed to facilitate theloading, folding and delivery of anintraocular lens (ICL) into the human eyethrough a small incision. | Identical |
| Intended Use | Intended to fold and insert STAARSurgical Company 1-piece Collamer®intraocular lenses for surgical placement inthe eye. | Identical |
| DesignControlActivities | Single use cartridge to be used inconjunction with appropriate injectorsystem and 1-piece Collamer® lenses forsurgical placement of lens into eye. | Identical |
| Materials | Cartridge is manufactured fromPolypropylene MG05 (which containsGMS) and polypropylene MG03 (whichdoes not contain GMS) purchased from asupplier in Japan. | Cartridge is manufactured from a newpolypropylene MG03BDS formulation (whichcontains GMS) material is purchased from thesame supplier in Japan |
| Manufacturing | Utilization of contract manufacturers forpolypropylene material and cartridgemolding. | Identical |
| OperatingPrinciple | Depending on the cartridge the ICL iseither loaded into the loadingarea and folded shut, or it is pressedforward towards the tip. | Identical |
| Packaging | Cartridge is placed in a tray, sealed withTyvek lid and label is placed on a Tyvekpouch. utilizing STAAR Monrovia's USApackaging supplier | Identical |
| Sterilization | Sterile Ethylene Oxide (EtO) | Identical |
| Manufacturer | STAAR Surgical Company | Identical |
Table 7 Device Comparison
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Image /page/6/Picture/0 description: The image shows the STAAR Surgical logo. The logo consists of a stylized star-like symbol on the left and the text "STAAR" in a larger, bolder font on the right. Below "STAAR" is the word "SURGICAL" in a smaller font. The star symbol is a golden color, while the text is a dark blue color.
PERFORMANCE DATA:
The non-clinical tests summary that was performed to validate and verify the change in the polypropylene formulation is summarized below:
Biocompatibility Study:
The SFC Cartridge manufactured using the new GMS (MG03BDS) passed the biocompatibility study that Namsa Laboratory tested for the cytotoxicity tests, sensitization test and intraocular irritation test. The cytotoxicity test article extract showed no evidence of causing cell lysis or toxicity. The sterilization test article extract showed no evidence of causing delayed dermal contact sensitization in the guinea. The intraocular irritation test showed there were no differences in ocular observations between eyes treated with test article extract and those treated with the control vehicle It is concluded that the SFC45 cartridge material used in the new GMS material (MG03BDS) is biocompatible.
Feasibility Test:
The feasibility test results of the cartridges manufactured using the new MG03BDS material were found to be substantially equivalent to the cartridges manufacture using the current material. The SFC-45 cartridge manufactured with the new MG03BDS material successfully delivered the lenses without any damage to the cartridge. Therefore, it was concluded that the MG03BDS material is an adequate replacement for the current material.
Fourier-transform infrared Fourier-transform infrared spectroscopy (FTR):
An analysis of the new polypropylene formulation change was performed using the Fouriertransform infrared spectroscopy (FTIR) The FTIR resulting spectra showed the typical makeup for the polypropylene copolymer material. The main difference between all materials was related to the amount of additives.
Shelf-life:
Shelf-life testing of the SFC-45 cartridge after 1 months accelerated aging indicated the cartridges manufactured with the new MG03BDS material are comparable to the cartridges manufactured using the current material and passed within the manufacturer's specifications. The delivery of the lenses was smooth and there was no damage to the cartriges or lenses.
Sterilization:
Sterilization study indicated that cartridges sterilization was successful and provided a minimum sterility assurance level of 1 x 10 probability of less than on non-sterile unit out of each one million units sterilized.). All biological indicators indicated that bacteriostatic characteristics were not associated with the product EO/ECH residuals were negligible.
§ 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.