(22 days)
Not Found
No
The summary describes a mechanical device for inserting intraocular lenses and does not mention any AI or ML components or functionalities.
No
The device is an injector for intraocular lenses, facilitating the delivery of a therapeutic device (the IOL) but not itself providing a therapeutic effect on the body.
No
The device description states its intended use is to fold and insert an intraocular lens during a surgical procedure, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a "sterile, single-use device" and describes a physical mechanism for inserting an intraocular lens, 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 for the insertion of intraocular lenses into a human eye during a surgical procedure. This is a direct surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description clearly states it's a device for folding and inserting an intraocular lens through a surgical incision. This is a tool for a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Naviject Sub2-1P IOL Injector and Cartridge Set 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
MSS
Device Description
The Naviject Sub2-1P IOL Injector and Cartridge Set is a sterile, single-use device intended to fold and insert a STAAR Surgical Visian ICL phakic intraocular lens through surgical procedure in a human eye. The system provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the human eye. This device has 3 basic components: a syringe type injector with a silicone cushion tip plunger, a 33° bevel down cartridge tip and a loading block.
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)
Not Found
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
JUL 8 8 2008
510(k) SUMMARY
Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR § 807.92.
Submitter Information:
Medicel AG Contact: Volker Dockhorn Chief Operating Officer Luchten 1262 Wolfhalden CH 9427 Switzerland Phone: 41-71-727-1057 Fax: 41-71-727-1055
FDA Registration Number: 9681862
Medicel AG Contact: Volker Dockhorn (Official Correspondent)
Medsys Inc. Contact: Dr. George Myers President Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Phone: 201-727-1703 Fax: 201-727-1708
Date Summary Prepared:
Submission Correspondent:
Classification Name:
Common/Usual Name:
Device Trade Name:
Equivalent legally-marketed devices:
February 20, 2009
Folders and Injectors, Intraocular Lens (IOL) (Class I) - MSS 21 CFR 886.4300
Intraocular Lens Guide
Naviject™ Sub2-1P IOL Injector Set
K070669, IOL Intraocular Injector Set, Medicel AG
Section 1
1
1. Intended Use:
The Naviject Sub2-1P IOL Injector and Cartridge Set for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.
2. Description:
The Naviject Sub2-1P IOL Injector and Cartridge Set is a sterile, single-use device intended to fold and insert a STAAR Surgical Visian ICL phakic intraocular lens through surgical procedure in a human eye. The system provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the human eye.
3. Technological Characteristics:
The Naviject Sub2-1P IOL Injector Set has substantially equivalent technological characteristics to the predicate devices. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material.
4. Comparison Analysis:
The overall design of the Naviject Sub2-1P IOL Injector Set is substantially equivalent to the predicate device. See Table 1 for a comparison of the new Naviject Sub2-1P IOL Injector Set and the predicate device.
2
.
| Feature | Naviject Sub2-1P IOL Injector Set | K070669 | Substantially
Equivalent |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-----------------------------|
| Product
Description | This Injector and Cartridge Set is a
sterile, single-use device intended to
fold and insert a STAAR Surgical
Visian ICL phakic intraocular lens
through surgical procedure in a human
eye. The system provides a tubular
pathway through an incision over the
iris, allowing delivery of an IOL into
the human eye. | Same, except for
use with different
IOLs | Yes |
| Intended Use | The Naviject Sub2-1P IOL Injector and
Cartridge Set for intraocular lenses is
indicated for the insertion only of
models of intraocular lenses that allow
use of this injector in their approved
labeling. | Same, except for
use with different
IOLs | Yes |
| Design | This device has 3 basic components: a
syringe type injector with a silicone
cushion tip plunger, a 33° bevel down
cartridge tip and a loading block. | Same, except for
the 40° bevel up
cartridge tip | Yes |
| Materials | Plastic materials: ABS,
Polydimethilsiloxane (Silicone) and
Polypropylene with GMS additive | Same | Yes |
| Mechanical
Safety | Validated for STAAR Surgical phakic
Visian ICL intraocular lenses | Same, except
with different
IOLs | Yes |
| Manufacturing | Per internal operating procedures | Same | Yes |
| Operating
Principle | An IOL is loaded into the cartridge, then
pushed through the cartridge and
delivered into a human eye through a
2.2 mm surgical incision. | Same | Yes |
| Packaging | Labeled blister trays with Tyvek
material lids and boxes | Same | Yes |
| Sterility | Sterile (EO) | Same | Yes |
| Manufacturer | Medicel AG | Medicel AG | Yes |
Table 1: Summary of Design Comparison
.
.
:
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized, minimalist design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medicel AG c/o George Myers, M.D 377 Route 17 South Hasbrouck Heights, NJ 07604
JUL 2 8 2009
Re: K092023
Trade/Device Name: Naviject™ Sub2-1P IOL Injector Set Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: April 3, 2009 Received: July 6, 2009
Dear Dr. Myers:
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 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 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.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Jue C. Calloway for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K092023
Device Name: Naviject™ Sub2-1P IOL Injector Set
Indications For Use:
The Naviject Sub2-1P IOL Injector and Cartridge Set for intraccular 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Brad Ramsey
(Division Sign-Off). Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of
510(k) Number K092023