(78 days)
Not Found
No
The summary describes a mechanical device for inserting intraocular lenses and makes no mention of AI or ML.
No
The device is an injector for intraocular lenses, which is a surgical tool used to insert the lenses. It does not directly treat or cure a disease or condition itself.
No
This device is designed to insert intraocular lenses, which is a therapeutic action, not a diagnostic one. It does not gather information about a patient's condition for diagnosis.
No
The device description explicitly states it has two physical components: a reusable injector made of titanium and a disposable cartridge made of lubricated polypropylene. This indicates a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to insert foldable intraocular lenses into the eye. This is a surgical procedure performed directly on a patient.
- Device Description: The device is an injector and a cartridge used for delivering a medical implant (intraocular lens).
- Anatomical Site: The anatomical site is intraocular (within the eye).
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 biological specimens. It is a surgical tool used for implantation.
N/A
Intended Use / Indications for Use
The Medicel MultiJect injector for intraocular lenses is intended to insert foldable intraocular lenses CeeOn JI 3A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridge.
The Medicel MultiJect injector for intraocular lenses is indicated for the insertion of foldable intraocular lenses "Inc. Medicer Manason Mysetting when used in conjunction with the MicroGlide cartridge.
Product codes
MSS
Device Description
The Medicel MultiJect injector for intraocular lenses is intended to insert foldable intraocular Jenses CeeOn 913A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridge. The injector is reusable and can be autoclaved. The cartridge is single-use and is provided sterile. Two types of injectors are provided: a syringe type and a screw type. The MultiJect is designed to be used with the Pharmacia Tecnis Z9000 lenses and the Pharmacia CeeOn 913A lenses.
The device has two components: a reusable injector and a disposable cartridge, sold sterile. The injector is made of titanium. The injector can be autoclaved. The cartridge is made of lubricated polypropylene.
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 MultiJect injector and MicroGlide cartridge are equivalent in safety and efficacy to the legally varketed predicate devices.
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
Page A2
K04-0837
JUN 1 7 2004
Medicel A.G. 510(k) Submission MultiJect Reusable Injector For Intraocular lenses 510(K) Summary March 19, 2004
(1) Submitter Information
Name: Medicel AG
Address: Noellenstrasse 15a CH - 9443 Widnau Switzerland
Telephone Number: 41-71-727-1050 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: December 12, 2003??
(2) Name of Device:
Trade Name: MultiJect Injector for IOLs and MicroGlide Cartridge Common Name: Intraocular lens guide. Classification Name: Folders and injectors, intraocular lens (IOL) (MSS, 886.4300)
(3) Equivalent legally-marketed devices:
Allergan Phacoflex K961242 Alcon Monarch K003768
(4) Description
The Medicel MultiJect injector for intraocular lenses is intended to insert foldable intraocular Jenses CeeOn 913A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridge. The injector is reusable and can be autoclaved. The cartridge is single-use and is provided sterile. Two types of injectors are provided: a syringe type and a screw type. The MultiJect is designed to be used with the Pharmacia Tecnis Z9000 lenses and the Pharmacia CeeOn 913A lenses.
) Intended Use ·
1
e Medicel MultiJect injector for intraocular lenses is intended to insert foldable intraocular lenses CeeOn JI 3A and Tecnis Z9000 made by Pharmacia when used in conjunction with the MicroGlide cartridge.
(6) Technological characteristics
The device has two components: a reusable injector and a disposable cartridge, sold sterile. The injector is made of titanium. The injector 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 MultiJect injector and MicroGlide cartridge are equivalent in safety and efficacy to the legally varketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
Medicel AG c/o Dr. George Myers Medsys Inc. 377 Rt. 17S Hasbrouck Heights, NJ 07604
Re: K040837
Trade/Device Name: MultiJet Injector and MicroGlide Cartridge Regulation Number: 21 CFR 886.1850 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: March 23, 2004 Received: March 31, 2004
Dear Dr. Myers:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector of the device is substantially equivalent (for the indications ferenced above and nave determined I marketed predicate devices marketed in interstate for use stated in the encrosure) to regars chemic date of the Medical Device American of to commerce price to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alla Cosmetic Act (1101) market the device, subject to the general controls provisions of the Act. The r ou may, merelore, market are a et include requirements for annual registration, listing of general controls provisions of cactice, 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 onastined (600 world). Existing major regulations affecting your device can may or subject to basil acaderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may ou louic in the overnments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean ITCase oc advised that I Dris a lossantes verour device complies with other requirements of the Act that I DT has made a assumations administered by other Federal agencies. You must of any I edelul statutes the soguirements, including, but not limited to: registration and listing Confire will and the Hot req21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), laceming (21 CFR Part 820); and if applicable, the electronic rorth in the quant) bytvol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Dr. George Myers
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 promatics noticated 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
Sincerely yours,
A Kalgi Rosenthal
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
. age _______ of______________________________________________________________________________________________________________________________________________________________
Indications for Use
510(k) Number (if known): K 040837
Device Namc: MultiJect Injector and MicroGlide Cartridge
Indications for Use:
The Medicel MultiJect injector for intraocular lenses is indicated for the insertion of foldable intraocular lenses " Inc. Medicer Manason Mysetting when used in conjunction with the MicroGlide cartridge.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dos Calogero
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K040837