(14 days)
Not Found
No
The device description and intended use focus on mechanical components for delivering an intraocular lens, with no mention of AI, ML, image processing, or data-driven functionalities.
No
Explanation: The device is a delivery system for an intraocular lens, designed to fold and deliver the lens into the capsular bag. It facilitates the implantation of a therapeutic device (the intraocular lens), but it is not itself directly therapeutic.
No
The device description states its intended use is to fold and deliver an intraocular lens into the capsular bag, which is a therapeutic or delivery function, not a diagnostic one.
No
The device description clearly outlines physical components made of medical-grade polypropylene and stainless steel, indicating it is a hardware device.
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 deliver the Crystalens® ... accommodating intraocular lens into the capsular bag." This describes a surgical delivery system for an implantable medical device, not a test performed on biological samples outside the body to diagnose a condition.
- Device Description: The description details the mechanical components of a delivery system for an intraocular lens. It does not mention any reagents, assays, or processes for analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions
Therefore, the Crystalsert™ Crystalens® Delivery System is a surgical instrument for delivering an intraocular lens, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Crystalsert™ Crystalens® Delivery System is intended to be used to fold and deliver the Crystalens® (AT-50SE, AT-52SE, HD520 and HD500) accommodating intraocular lens into the capsular bag.
Product codes (comma separated list FDA assigned to the subject device)
MSS
Device Description
The Crystalsert consists of a plunger, body, drawer and inserter tip. All of the components are manufactured with medical grade polypropylene. There is also a stainless steel spring for the plunger return. The plunger tip is 2.8 mm that requires the lens to be folded when delivered. The body has a loading dock area for placement of the lens with forceps with an additional notch to allow for correct haptic placement. Once the lens is placed in the loading dock, the drawer is pressed closed and then the plunger can be depressed to deliver the lens. Finger flanges are also built onto the body to assist in the deliver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
capsular bag
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.
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
OCT 1 6 2008
Section 15
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CRF 807.92.
Submitter's name, address, telephone number, contact person, and date 1. summary prepared
- -Bausch & Lomb Incorporated દ્યા. 1400 N. Goodman Street Rochester, N.Y. 14609 (585) 338-8467
- Contact Person: David U. Thomas, M.S., R.A.C. b. Manager, Global Regulatory Affairs
- Date Summary Prepared: September 4, 2008. C.
- Name of device, including trade name and classification name: 2.
- Crystalsert™ Crystalens® Delivery System Trade/Proprietary Name: a.
- Intraocular lens guide b. Classification Name:
-
- Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
| Company: | Chiron Vision Corporation (currently acquired by Bausch & Lomb Corporation |
|---|---|
| Device: | MPort (MP-30) |
| 510(k) | K970727 |
| Date Cleared: | December 17, 1997 |
- A description of the device that is the subject of the 510(k), including 4. explanation of how the device functions, basic scientific concepts, significant
1
Bausch & Lomb Incorporated Crystalsert™ Crystalens® Delivery System
physical and performance characteristics (design, material, physical properties):
The Crystalsert consists of a plunger, body, drawer and inserter tip. All of the components are manufactured with medical grade polypropylene. There is also a stainless steel spring for the plunger return. The plunger tip is 2.8 mm that requires the lens to be folded when delivered. The body has a loading dock area for placement of the lens with forceps with an additional notch to allow for correct haptic placement. Once the lens is placed in the loading dock, the drawer is pressed closed and then the plunger can be depressed to deliver the lens. Finger flanges are also built onto the body to assist in the deliver.
5. Statement of intended use:
The Crystalsert™ Crystalens delivery system is intended to be used to fold and deliver the Crystalens® (AT-50SE and AT-52SE) accommodating intraocular lens into the capsular bag.
6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.
| MPort (MP-30) | Crystalsert Inserter |
|---|---|
| Operating Principle | |
| Lens is loaded into inserter through | |
| loading deck and then pushed into | |
| position by closing drawer. Lens is | |
| laying flat in loading deck when | |
| drawer is closed. Haptic puller is | |
| used to place leading haptic in | |
| correct loading position. | Lens is loaded into loading dock |
| in unfolded flat state. Lens is put | |
| in proper position for loading by | |
| closing drawer. No haptic puller | |
| is necessary. | |
| Lens is delivered by direct forward | |
| motion of syringe-type plunger | same |
| Single lens is inserted through a 3 | |
| mm inserter tip. Lens is folded | |
| when pushed through tip. | Single lens is inserted through |
| 2.8 mm inserter tip. Lens is | |
| folded when pushed through tip. | |
| Design | |
| The inserter consists of plunger, | |
| inserter body, drawer and haptic puller. | The inserter consists of plunger, |
| inserter body, and drawer. A loading | |
| A loading dock is attached to the end of | |
| the inserter body. | dock is attached to end of inserter |
| body. Additional notch is cut in | |
| loading area to allow for correct | |
| haptic placement. | |
| Material | |
| The inserter is single use and consists | |
| of Medical Grade Polypropylene with | |
| PA-208 lubricant. The plunger return | |
| spring is stainless steel and the plunger | |
| O-ring consists of silicone. | The body and drawer consist Medical |
| Grade Polypropylene material | |
| ((Huntsman) with 1% by weight | |
| InCon GMB#2 Lubricant) and the | |
| Plunger is medical grade | |
| polypropylene from BP Amoco. | |
| Plunger return spring is stainless | |
| steel. No plunger O-ring is used with | |
| this plunger. | |
| Labeling | |
| Indications for Use: | Indications for Use: |
| The Mport Foldable Lens Placement | |
| system is indicated for compressing and | |
| inserting a Soflex™ series multi-piece | |
| intraocular lens into the eye during | |
| small incision cataract surgery. | The Crystalsert™ Crystalens delivery |
| system is intended to be used to fold | |
| and deliver the Crystalens® (AT- | |
| 50SE, AT-52SE, HD520 and HD500) | |
| accommodating intraocular lens into | |
| the capsular bag. | |
| Cleaning/Sterilization Information | |
| Product is EtO sterilized to a SAL of | |
| 10-6. No cleaning is necessary or | |
| recommended. |
Product is Single-Use only.
The inserter will be labeled with a 6
month shelf life. | same |
| Validations | |
| Validated for use with LI61U, LI51U,
C31UB and Silens6/Soflex 2. Bausch
& Lomb Ocucoat Viscoelastic and
Amvisc viscoelastics can used. | Validated with Crystalens models
AT-50SE or AT-52SE and validated
with Bausch & Lomb Viscoelastic
Amvisc Plus. |
Technical Comparison Matrix
2
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2008
Bausch & Lomb, Inc. c/o Jay Y. Kogoma Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K082944
Trade/Device Name: Cystalsert™ Crystalens® Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: IOL Inserter/Injector Regulatory Class: I Product Code: MSS Dated: October 1, 2008 Received: October 2, 2008
Dear Mr. Kogoma:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 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); 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.
4
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Malvina B. Edwards, und
Malvina B, Eydelman, M Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K082944 510(k) Number (if known):
Device Name: Crystalsert™ Crystalens® Delivery System
Indications For Use:
The Crystalsert™ Crystalens® Delivery System is intended to be used to fold and deliver the Crystalens® (AT-50SE, AT-52SE, HD520 and HD500) accommodating intraocular lens into the capsular bag.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kesia Hexander
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K082944
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