(310 days)
Not Found
No
The summary describes a mechanical injector for intraocular lenses and makes no mention of AI or ML technology.
No
The device is described as an "intraocular lens guide" or "injector," used to insert lenses. It does not directly treat a disease or condition; rather, it is an instrument used during a surgical procedure for implantation.
No
Explanation: The device is described as an intraocular lens injector used to insert lenses following cataract extraction, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is made of titanium alloy and is a physical injector, indicating 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 "ford and into the capsular bag or ciliary sulcus following cataract extraction." This describes a surgical instrument used in vivo (within the living body) to implant a medical device (an intraocular lens).
- Device Description: The description confirms it's a "titanium alloy designed for inserting intraocular lenses into the human eye." This further supports its use as a surgical tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information. IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
Therefore, the Collamer 3 Piece IOL Injector is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Collamer 3 Piece Injector is an intraocular lens guide used to fold and insert STAAR Surgical's 3 Piece Collamer intraocular lenses for surgical placement in the human eye.
The Collamer 3 Piece IOL Injector, is an intraocular lens guide used to fold and insert STAAR Surgical 3 Piece Collamer intraocular lenses into the capsular bag or ciliary sulcus following cataract extraction.
Product codes
KYB
Device Description
The Collamer 3 Piece Injector is made of titanium alloy designed for inserting intraocular lenses into the human eye following cataract extraction. The Collamer 3 Piece Injector materials and mechanical behavior are similar to those used with the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human eye, capsular bag or ciliary sulcus
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 Collamer 3 Piece Injector was found to perform equivalently to the predicate device, the MS1-P Elastic Lens Injector with respect to mechanical performance and mechanical behavior.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K032 4/2
Section 15
Summary of Safety and Effectiveness
The 510(K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 1. Submitter's name, address, telephone number, contact person, and date
| summary prepared: | |
|---|---|
| a. | Submitter: STAAR Surgical Company |
| 1911 Walker Avenue | |
| Monrovia, CA 91016 | |
| (626) 303-7902 |
| b. Contact Person: | Helene Lamielle |
|---|---|
| c. Date Summary Prepared | May 14, 2004 |
2. Name of device, including trade name and classification name:
| a. | Trade/Proprietary Name: | Collamer 3 Piece Injector |
|---|---|---|
| b. | Classification Name: | Intraocular Lens Guide |
-
- Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed.
| a. | Company: | STAAR Surgical Company |
|---|---|---|
| b. | Device: | MS1-P Elastic Lens Injector |
| c. | 510(K): | K861085 |
| d. | Date Cleared: | 5/28/1986 |
1
-
- A description of the device that is the subject of the 510(K) including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The Collamer 3 Piece Injector is made of titanium alloy designed for inserting intraocular lenses into the human eye following cataract extraction. The Collamer 3 Piece Injector materials and mechanical behavior are similar to those used with the predicate device.
- A description of the device that is the subject of the 510(K) including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
5. Statement of intended use:
The Collamer 3 Piece Injector is an intraocular lens guide used to fold and insert STAAR Surgical's 3 Piece Collamer intraocular lenses for surgical placement in the human eye. " ------------------------------------------------------------------------------------------------------------------------------------------------
-
- Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.
| CHARACTERISTICS | Collamer 3 Piece Injector | MS1-P Elastic
Lens Injector |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Intended Use | For Surgical placement of an intraocular
lens in the human eye | Same |
| Material | Titanium, 6-Aluminum, 4-Venadium, and
PEEK (polyetheretherketone) | Titanium |
| Sterilization | Provided non-sterile, may be steam
sterilized | Provided non-sterile;
may be steam sterilized |
| Mode of Operation | Intraocular lenses are folded and placed
inside a lens cartridge made from
polypropylene. The lens is then pushed
down via a plunger and plunger rod and
expelled from the lens cartridge into the
human eye. | Same |
| Single Use or Re-useable | Re-usable | Same |
Comparative Technological Characteristics
7. Brief summary of non-clinical tests and results:
The Collamer 3 Piece Injector has been designed and tested in accordance with applicable safety standards. In addition, the Collamer 3 Piece Injector was found to perform equivalently to the predicate device, the MS1-P Elastic Lens Injector with respect to mechanical performance and mechanical behavior.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2004
STAAR Surgical Company c/o Helene Lamielle, M.D. 1911 Walker Ave. Monrovia, CA 91016
Re: K032412
Trade/Device Name: Collamer 3 Piece Injector Regulation Number: 21 CFR 886.4300 Regulation Name: Ophthalmic lens guide Regulatory Class: Class I Product Code: KYB Dated: May 14, 2004 Received: May 17, 2004
Dear Dr. Lamielle:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosal of togally to togens the Medical Device Amendments, or to commerce prof to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices may have been recuire approval of a premarket approval application (PMA). and Cosmetic Ace (71ct) that as novice, subject to the general controls provisions of the Act. The r ou may, dicterore, market the Act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and 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 (600 a00 70) als. Existing major regulations affecting your device can may be subject to sater additions, Title 21, Parts 800 to 898. In addition, FDA may or found in the Overning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri 3 ibsualled by our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I cacrates and regulations and limited to: registration and listing (21 Comply with an the Act 31equirements, 01); good manufacturing practice requirements as set CTK in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality !!)Stems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – K032412
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincercly yours,
Akeiji Korentthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 3 - K032412
Indications for Use
510(k) Number (if known):_K032412
Device Name: STAAR Surgical Collamer 3 Piece Injector
:
Indications For Use:
The Collamer 3 Piece IOL Injector, is an intraocular lens guide The Collamer 3 I a man Surgical 3 Piece Collamer used to ford and into the capsular bag or ciliary sulcus following cataract extraction.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Copc@rrenee-of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| - Division of Ophthalmic Ear. | |
| Nose and Throat Devises | |
| 510(k) Number_KO32412 | Page 1 of |