(162 days)
Not Found
No
The summary describes a mechanical delivery system for intraocular lenses and does not mention any AI or ML components or functions.
No
This device is a delivery system for an intraocular lens, which is a therapeutic device. The delivery system itself is not directly therapeutic; it is a surgical instrument used to implant a therapeutic device.
No
The device is described as a delivery system for intraocular lenses during surgical procedures, not a tool for diagnosing medical conditions. Its function is to facilitate the insertion of an IOL, which is a therapeutic rather than diagnostic action.
No
The device description explicitly states it is a "sterile, single-use device used to fold and insert an intraocular lens through surgical procedure into a human eye," indicating it is a physical 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 and other intraocular lenses... into a human eye." This is a surgical procedure involving the insertion of a medical device into the body.
- Device Description: The device is described as a "sterile, single-use device used to fold and insert an intraocular lens through surgical procedure into a human eye." This further reinforces its role in a surgical intervention.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The Crystalsert Delivery System is a surgical instrument used to facilitate the implantation of an intraocular lens.
N/A
Intended Use / Indications for Use
The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert Delivery System in their approved labeling.
Product codes
MSS
Device Description
The Crystalsert Delivery System is a sterile, single-use device used to fold and insert an intraocular lens through surgical procedure into a human eye. The system provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human 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)
Functional/Safety Testing: The Crystalsert Delivery System has successfully undergone functional testing and was found to deliver IOLs in conformance with the requirements set forth in ISO 11979-3, section 5.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K082944 Crystalsert Crystalens Delivery System
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.
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BAUSCH+LOMB
5
Pg. 1 of 2
30 Enterprise, Suite 450
www.bausch.com
| 510(k) Summary | ||
|---|---|---|
| Submitter: | Bausch & Lomb, Inc. | |
| 30 Enterprise, Suite 450 | ||
| Aliso Viejo, CA 92656 | K123736 | |
| Contact Person: | Jason Smith | |
| Global Regulatory Affairs Manager | ||
| Phone: 949-521-7804 | ||
| Fax: 949-521-7760 | ||
| Email: jason.smith@bausch.com | MAY 1 6 2013 | |
| Date Prepared: | December 4, 2012 | |
| Trade name: | Crystalsert Delivery System | |
| Classification | ||
| Name: | Intraocular lens guide (21 CFR 886.4300) | |
| Predicate | ||
| Devices: | K082944 Crystalsert Crystalens Delivery System | |
| Device | ||
| Description: | The Crystalsert Delivery System is a sterile, single-use | |
| device used to fold and insert an intraocular lens through | ||
| surgical procedure into a human eye. The system | ||
| provides a tubular pathway through an incision over the | ||
| iris, allowing delivery of an IOL into the capsular bag. | ||
| Indications for | ||
| Use: | The Crystalsert Delivery System is intended to be used to | |
| fold and deliver the Crystalens accommodating | ||
| intraocular lens and other intraocular lenses identifying | ||
| the Crystalsert Delivery System in their approved labeling. | ||
| Comparative | ||
| Analysis: | The Crystalsert Delivery System has been demonstrated | |
| to be equivalent to the predicate device for its intended | ||
| use. | ||
| Functional/Safety | ||
| Testing: | The Crystalsert Delivery System has successfully | |
| undergone functional testing and was found to deliver | ||
| IOLs in conformance with the requirements set forth in | ||
| ISO 11979-3, section 5. | ||
| Conclusion: | The Crystalsert Delivery System is substantially | |
| equivalent to the predicate device. |
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BAUSCH+LOMB
Pg. 2 of 2
30 Enterprise, Suite 450
Aliso Viejo, CA 92656 800.393.6642 www.bausch.com
| Characteristic | Predicate K082944
Crystalsert Crystalens Delivery
System | Crystalens Delivery System
(Proposed Device) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Crystalsert Crystalens delivery
system is intended to fold and deliver
the Crystalens (AT-52SE, AT-50SE,
HD520 and HD500) accommodating
intraocular lens into the capsular bag. | The Crystalsert delivery system is
intended to be used to fold and deliver
the Crystalens accommodating
intraocular lens and other intraocular
lenses identifying the Crystalsert
delivery system in their approved
labeling. |
| Contraindications | None | None |
| Materials | Body, drawer, plunger: polypropylene
Spring: stainless steel | Body, drawer, plunger: polypropylene
Spring: stainless steel |
| Single use? | Single use | Single use |
| Sterile? | Sterile | Sterile |
| How sterilized | Ethylene oxide | Ethylene oxide |
| Sterility assurance
level | 10-6 | 10-6 |
| Shelf life | 12 months | 12 months |
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of an eagle with three wing-like shapes extending from its body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
May 16, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Bausch & Lomb Inc. % Mr. Jason Smith Global Regulatory Affairs Manager 30 Enterprise, Suite 450 Aliso Viejo, CA 92656
Re: K123736
Trade/Device Name: Crystalsert Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I (reserved) Product Code: MSS Dated: April 4, 2013 Received: April 5, 2013
Dear Mr. Smith:
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.
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 (reporting of medical
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Page 2 - Mr. Jason Smith
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ReportalProblem/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/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
4
BAUSCHELO
30 Enterprise, Suite 450 Aliso Viejo, CA 92656 800.393.6642 www.bausch.com
Indications for Use Statement
510(k) Number (if known):
Device Name: Crystalsert Delivery System
Indications for Use:
The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert delivery system in their approved labeling.
Prescription Use X_ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/4/Picture/11 description: The image shows the name "Tieuvi-H-Nguyen" at the top. Below the name, the date and time "2013:05:07 19:01:48" are displayed. The timezone offset "-04'00'" is located below the date and time. The text appears to be extracted from a document or a photograph.
(Division Sign-Off)
Division of Ophthalmic and Ear, Nose
and Throat Devices
510(k) Number K123736