(87 days)
The Disposable MicroSTAAR™ Injector (Model MSI-P1) is a device used to fold and insert STAAR Surgical UV-ELASTICT™ silicone lenses for surgical placement in the human eye.
The Disposable MicroSTAAR™ Injector is a device used to fold and insert STAAR Surgical Company UV-ELASTIC™ single-piece silicone lenses for surgical placement in the human eye.
The Disposable MicroSTAART™ Injector (Model MSI-P1) is used to fold and insert STAAR Surgical UV-ELASTICTM silicone intraocular lenses for surgical placement in the human eye. Like other MicroSTAAR injectors it provides a sterile tubular pathway through a surgical incision, over the iris and into either the ciliary sulcus or the capsular bag of the eye. The Disposable MicroSTAART™ Injector (Model MSI-P1) is made from plastic and the inner dimensions of the delivery pathway, as well as the outer dimensions of the portion that contacts the eye tissues are identical to STAAR Surgical Company's currently marketed injection systems. The Disposable MicroSTAART™Injector (Model MSI-P1) is provided sterile and is designed for single use.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Premarket Notification [510(K)] Summary for the Disposable MicroSTAAR™ Injector System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Functional Testing) | Reported Device Performance |
|---|---|
| No optic zone lens tears for properly loaded lenses. | No lens tears were observed. |
| All post-ejected lenses to meet a minimum resolution > 3.6. | All post-ejected lenses met the minimum resolution requirements. |
| Acceptance Criterion (Accelerated Aging Study - Microbial Challenge Dust Drum) | Reported Device Performance |
|---|---|
| All samples and negative controls to be "NEGATIVE". | All samples and negative controls were "NEGATIVE". |
| Positive controls to be "POSITIVE". | Positive controls were "POSITIVE". |
| Acceptance Criterion (Accelerated Aging Study - Dye Penetration) | Reported Device Performance |
|---|---|
| All samples to "Pass". | All samples "Passed". |
| Acceptance Criterion (Accelerated Aging Study - Peel Strength) | Reported Device Performance |
|---|---|
| Sample means and variances for baseline and one-year accelerated samples to be statistically similar (T-test and F-test). | Results indicate sample means and variances are statistically similar. |
| Acceptance Criterion (Accelerated Aging Study - Burst) | Reported Device Performance |
|---|---|
| For large pouch, sample means and variances for baseline and one-year accelerated samples to be statistically similar (T-test and F-test). | Results indicate sample means and variances for the large pouch are statistically similar. |
| For small pouch, no failures. | No failures observed. |
2. Sample Size Used for the Test Set and Data Provenance
- Functional Testing:
- Sample Size: Thirty (30) sterile Disposable MicroSTAAR™ Injectors (Model MSI-P1).
- Data Provenance: Not explicitly stated but implies laboratory testing done by the manufacturer (STAAR Surgical Company) as part of their validation. It is a prospective test, as it's a validation performed for the device.
- Accelerated Aging Study:
- Sample Size: "Baseline (zero time) and one year accelerated samples" were used. The exact number of samples for each specific test (Microbial Challenge, Dye Penetration, Peel Strength, Burst) is not explicitly stated, but it would have been a subset of the manufactured devices.
- Data Provenance: Similar to functional testing, this was likely a prospective laboratory study conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to mechanical device testing like an IOL injector. The "ground truth" here is objective physical measurements and performance thresholds (e.g., absence of tears, resolution measurements, integrity assessments). No human experts were used to establish a ground truth in the sense of image interpretation or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. The tests involve objective measurements against predefined criteria, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
Not applicable. This device is a mechanical injector, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a mechanical injector, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these tests was based on objective, measurable physical characteristics and performance criteria for the device and its packaging. This includes:
- Absence of physical damage: Lens tears.
- Performance metrics: Optical resolution post-ejection.
- Sterility integrity: Microbial challenge results, dye penetration, peel strength, burst strength.
- Statistical similarity: For aging studies, comparing mechanical properties of new vs. aged samples.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a mechanical device.
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DEC 4 1998
:
PREMARKET NOTIFICATION [510(K)] SUMMARY FOR THE DISPOSABLE MicroSTAAR™ INJECTOR SYSTEM
| Trade/Proprietary Name: | Disposable MicroSTAART™ Injector (Model MSI-P1) |
|---|---|
| Common/Usual Name: | Disposable IOL Injector |
| Classification Name: | Foldable Intraocular Lens Injector |
| Submitted by: | STAAR Surgical Company1911 Walker AvenueMonrovia, CA 91016Phone: (626) 303-7902FAX: (626) 930-1423 |
| Contact Person: | Steven L. ZiembaVice-President, Regulatory AffairsPhone: (626) 303-7902 ext. 2308 |
| Date Summary Prepared: | September 4, 1998 |
| Legally MarketedPredicate Device: | MicroSTAART™ Injector System (reusable and disposable) manufacturedby STAAR Surgical Company. |
| Intended Use ofthe Device:: | The Disposable MicroSTAART™ Injector (Model MSI-P1) is a device usedto fold and insert STAAR Surgical UV-ELASTICT™ silicone lenses forsurgical placement in the human eye. |
| Device Description: | The Disposable MicroSTAART™ Injector (Model MSI-P1) is used to foldand insert STAAR Surgical UV-ELASTICTM silicone intraocular lensesfor surgical placement in the human eye. Like other MicroSTAARinjectors it provides a sterile tubular pathway through a surgical incision,over the iris and into either the ciliary sulcus or the capsular bag of the eye.The Disposable MicroSTAART™ Injector (Model MSI-P1) is made fromplastic and the inner dimensions of the delivery pathway, as well as theouter dimensions of the portion that contacts the eye tissues are identical toSTAAR Surgical Company's currently marketed injection systems. TheDisposable MicroSTAART™Injector (Model MSI-P1) is provided sterileand is designed for single use. |
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1983129
Nonclinical Performance Testing:
Functional Testing: A functional validation was performed using thirty sterile Disposable MicroSTAAR™ Injectors (Model MSI-P1) to eject thirty UV-ELASTIC™ lenses. The acceptance criteria for the lens ejection test included the following:
- No optic zone lens tears for properly loaded lenses. -
- All post-eiected lenses to meet a minimum resolution > 3.6. -
The lens eiection test results showed no lens tears in addition to meeting the minimum resolution requirements.
Accelerated Aging Study: The following tests were performed on baseline (zero time) and one year accelerated samples as part of the validation:
- Microbial Challenge Dust Drum -
- Dye Penetration -
- -Peel Strength
- Burst
The Microbial Challenge - Dust Drum test reports indicate all samples and negative controls to be "NEGATIVE" and the positive controls to be "POSITIVE" which are acceptable results.
The Dye Penetration test reports indicate all samples as "Pass".
The Peel Strength tests compared the mean maximum seal strength for the baseline and one-year accelerated age samples using the T-test and F-test analysis. The results indicate that the sample means and variances are statistically similar.
The Burst tests compared the baseline and one-year accelerated age samples using the T-test and F-test analysis. The results of the analysis of the large pouch indicate that the sample means and variances are statistically similar. No statistical analysis was required for the small pouch as there were no failures.
Overall, the non-clinical test results demonstrate that the sterilized Disposable MicroSTAAR™ Injector (Model MSI-P1) successfully ejects lenses and the packaging maintains adequate integrity to ensure product sterility for a period of one year.
110 G
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1998 DEC ব
Steven L. Ziemba Vice President, Regulatory Affairs STAAR Surgical Company 1911 Walker Avenue Monrovia, CA 91016
Re: K983129 Trade Name: Disposable MicroSTAAR™ Injector (Model MSI-P1) Regulatory Class: I Product Code: 86 KYB Dated: September 4, 1998 Received: September 8, 1998
Dear Mr. Ziemba:
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 OS 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.
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Page 2 -- Mr. Steven L. Ziemba
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. Roerl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS STATEMENT
1983129 510(k) Number:
Disposable MicroSTAAR™ Injector Device Name:
The Disposable MicroSTAAR™ Injector is a device used to fold and insert Indications For Use: STAAR Surgical Company UV-ELASTIC™ single-piece silicone lenses for surgical placement in the human eye.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ما (per 21 CFR 801.109)
OR
Over-The-Counter Use _ (Optional Format 1/2/96)
Carlisle Bucklew for DEL
(Division Sign-Off)
Division of Ophthalmic Devices 510(k) Number_k 98 3
§ 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.