(234 days)
Not Found
No
The summary describes a mechanical device for inserting intraocular lenses and does not mention any computational or data-driven features indicative of AI/ML.
No.
The device is used for inserting intraocular lenses, which is a procedural aid, not a device that provides therapy for a disease or condition.
No
Explanation: The device is an injector for intraocular lenses, which is a therapeutic function (inserting a lens), not a diagnostic one. It does not identify a disease, condition, or provide information for diagnosis.
No
The device description clearly states it is a physical injector set with reusable or single-use components made of plastic and titanium, and a disposable cartridge made of polypropylene. This indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the insertion of intraocular lenses into the eye. This is a surgical procedure performed on a living patient.
- Device Description: The device is an injector and cartridge designed to physically deliver a medical device (the intraocular lens) into the body.
- Lack of Diagnostic Function: There is no mention of this device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor a treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is purely for the physical delivery of a medical implant.
N/A
Intended Use / Indications for Use
The Medicel IOL Injector Set and Cartridge for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.
Product codes (comma separated list FDA assigned to the subject device)
KYB
Device Description
The Medicel IOL Injector Set for intraocular lenses is intended to insert foldable intraocular whose labeling specifies this injector. The injector is available as reusable or single-use. The cartridge is single-use and is provided sterile..
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraocular
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)
(1) Non-clinical tests: All contact materials have been tested for biocompatibility. The device was tested with each of the recommended intraocular lenses.
(2) Clinical tests: Not required
(3) Conclusions: The IOL Injector Set is equivalent in safety and efficacy to the legally marketed predicate devices.
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
NOV - 1 2007
Medicel A.G. 510(k) Submission IOL Injector Set For Intraocular lenses 510(K) Summary March 2, 2007
(1) Submitter Information
Name: Medicel AG
Address: Luchten 1262 Wolfhalden CH 9427 Switzerland
Telephone Number: 41-71-727-1057 Fax: 41-71-727-1055
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703
Date Prepared: March 6, 2007
(2) Name of Device:
Trade Name: IOL Injector Set Common Name: Intraocular lens guide. Classification Name: Folders and injectors, intraocular lens (IOL) (MSS, 886.4300)
(3) Equivalent legally-marketed devices:
K040837, Multiject injector, Medicel AG
(4) Description
The Medicel IOL Injector Set for intraocular lenses is intended to insert foldable intraocular whose labeling specifies this injector. The injector is available as reusable or single-use. The cartridge is single-use and is provided sterile..
(5) Intended Use
1
The Medicel IOL Injector Set for intraocular lenses is intended to insert foldable intraocular lenses for lenses specifying this injector set in their labeling.
(6) Technological characteristics
The device has two basic components: an injector (available either reusable or single use) and a disposable cartridge, sold sterile. The single-use injector is made of plastic and is sold sterile. The re-usable injector is made of titanium and can be autoclaved. The cartridge is made of lubricated polypropylene.
(b) Performance data
(1) Non-clinical tests
All contact materials have been tested for biocompatibility. The device was tested with each of the recommended intraocular lenses.
(2) Clinical tests
Not required
(3) Conclusions
The IOL Injector Set is equivalent in safety and efficacy to the legally marketed predicate devices.
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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEC - 4 2007
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medicel AG c/o George Myers, Sc.D Medsys, Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604
K070669 Re:
Trade/Device Name: Medicel AG IOL Injector Set Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: KYB Dated: October 12, 2007 Received: October 15, 2007
Dear Dr. Myers:
This letter corrects our substantially equivalent letter of November 1, 2007.
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 (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 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.
3
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,
M. B. Egleston, MD
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
Page 3 - Dr. George Myers
Indications for Use
510(k) Number (if known): K070669
Device Name: Medicel AG IOL Injector Set
Indications For Use: The Medicel IOL Injector Set and Cartridge for intraocular lenses is
indicated for the insertion only of models of intraocular lenses that allow use of this
injector in their approved labeling.
Prescription Use X (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Onhthalmic Ear, Nose and Throat Devises
KO70669 510(k) Number .
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