(109 days)
No
The device description and performance studies focus on the mechanical function of folding and inserting an IOL, with no mention of AI/ML terms or capabilities.
No
This is a surgical tool used to insert a therapeutic device (IOL), not a therapeutic device itself.
No
The device is described as an injector system designed to fold and insert intraocular lenses for surgical placement, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components (syringe type injector, cartridge tip, loading block) and describes a mechanical function (folding and inserting a lens). There is no mention of software as a component or its function.
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 insert STAAR Surgical Collamer® Phakic One Piece Intraocular Lenses... for surgical placement in the human eye." This describes a surgical tool used during a procedure on a patient, not a device used to test samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a mechanical system for handling and delivering an intraocular lens into the eye. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of providing diagnostic results or information about a patient's health status based on testing.
Therefore, the Visian® nanoPOINT™ 2.0 Injector System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Visian® nanoPOINT™ 2.0 Injector System is a device intended to fold and insert STAAR Surgical Collamer® Phakic One Piece Intraocular Lenses, Model Visian® ICL, for surgical placement in the human eye.
Product codes
MSS
Device Description
The Visian® nanoPOINT™2.0 Injector System is a sterile, single-use device intended to fold and insert a STAAR Surgical Collamer® Phakic One Piece Intraocular Leas. Model Visian® ICL through surgical procedure in a human eye. The system provides, a tubular pathway through a corneal incision allowing delivery of a phakic IOL into the human eye.
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)
- Non Clinical Tests: All materials have been tested for biocompatibility. These (1) tests were performed in the previously cleared device, the K070669 injector set, which was substantially equivalent to K092023 and therefore equivalent to the newly submitted 510(k) device. These tests were all acceptable. The validation (non-clinical) tests for the previously cleared K092023. Naviject Sub2-1P IOL Injector Set, are the same for this newly submitted device, the Visian® nanoPOINT™ 2.0 Injector System, since it is the anne injector and it is intended for the folding and insertion of the same lens.
-
- Clinical Tests: (Not required)
-
- Conclusions: In conclusion the newly submitted device is as safe, as effective and performs as safely and effectively as the legally marketed device as it is the same device and there were no changes to the technological characteristics of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Medicel AG
Visian® nanoPOINT™ 2.0 Injector System
KIO1134
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 Wolfhaden CH 9427 Switzerland Phone: 41-71-727-1057 Fax: 41-71-727-1055
FDA Registration Number: 9681862
Medicel AG Contact: John Coggan (Official Correspondent) STAAR Surgical 1911 Walker Ave Monrovia, CA 91016 USA
Date Summary Prepared:
Submission Correspondent:
Classification Name:
Common/Usual Name:
April 5, 2010
Folders and Injectors, Intraocular Lens (IOL) (Class I) - MSS 21 CFR 886.4300
Intraocular Lens Guide
Device Trade Name:
Visian® nanoPOINT™ 2.0 Injector System
Equivalent legally-marketed devices: K092023, IOL Intraocular Injector Set,
Medicel AG (Naviject Sub2-1P Injector Set)
1. Intended Use:
The Visian® nanoPOINT™ 2.0 Injector System is a device intended to fold and insert STAAR Surgical Collamer® Phakic One Piece Intraocular Lenses, Model Visian® ICL, for surgical placement in the human eve.
- Description:
AUG - 9 2010
1
The Visian® nanoPOINT™2.0 Injector System is a sterile, single-use device intended to fold and insert a STAAR Surgical Collamer® Phakic One Piece Intraocular Leas. Model Visian® ICL through surgical procedure in a human eye. The system provides, a tubular pathway through a corneal incision allowing delivery of a phakic IOL into the human eye.
3. Technological Characteristics:
nanoPOINT™ 2.0 Injector System has substantially equivalent The Visian® 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. There are no differences in any of the technological characteristics of this device as compared to the cleared predicate device and therefore the safety and effectiveness of this device are not compromised.
4. Comparison Analysis:
The overall design of this Visian® nanoPOINT™ 2.0 Injector System is the same as the predicate device since it is the same injector. The indications for use and labeling were modified to clearly specify the lens model for which it is intended.
Performance Data
- Non Clinical Tests: All materials have been tested for biocompatibility. These (1) tests were performed in the previously cleared device, the K070669 injector set, which was substantially equivalent to K092023 and therefore equivalent to the newly submitted 510(k) device. These tests were all acceptable.
The validation (non-clinical) tests for the previously cleared K092023. Naviject Sub2-1P IOL Injector Set, are the same for this newly submitted device, the Visian® nanoPOINT™ 2.0 Injector System, since it is the anne injector and it is intended for the folding and insertion of the same lens. See Table 1 for a comparison of the new and the previous K092023, Naviject Sub2-1P IOL Injector Set.
Shelf Life for the previously submitted devices was set at three years based on tests performed on equivalent injectors. This new device will have the same shelf life. .
-
- Clinical Tests: (Not required)
-
- Conclusions: In conclusion the newly submitted device is as safe, as effective and performs as safely and effectively as the legally marketed device as it is
2
.
. .
.
the same device and there were no changes to the technological characteristics of the device.
| Feature | Visian® nanoPOINTTM 2.0 Injector
System | K092023 | Substantially
Equivalent |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Product
Description | This Injector and Cartridge System is
a sterile, single-use device intended
to fold and insert a STAAR Surgical
Collamer® phakic one piece
intraocular lens, Model Visian® ICL
through surgical procedure in a
human eye. The system provides a
tubular pathway through a corneal
incision allowing delivery of a phakic
IOL into the human eye. | Identical | Yes |
| Intended Use | The Visian® nanoPOINTTM 2.0
Injector System is a device intended
to fold and insert a STAAR Surgical
Collamer® phakic one piece
intraocular lens, Model Visian® ICL,
for surgical placement in the human
eye. | 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. | Yes, the only
difference is in
the inclusion of
the specific lens
name for which
it is intended |
| Design | This device has 3 basic components: a
syringe type injector with a silicone
cushion tip plunger, a 33º bevel down
cartridge tip and a loading block. | Identical | Yes |
| Materials | Plastic materials: ABS,
Polydimethilsiloxane (Silicone) and
Polypropylene with GMS additive | Identical | Yes |
| Mechanical
Safety | Validated for STAAR Surgical
Collamer® Phakic One Piece
Intraocular Lenses, Model Visian®
ICL (V08-138) | Identical | Yes |
| Manufacturing | Per internal operating procedures | Identical | Yes |
| Operating
Principle | A phakic IOL is loaded into the
cartridge, then pushed through the
cartridge and delivered into a human
eye through a 2.2 mm surgical
incision. | Identical | Yes |
| Packaging | Blister trays with pre-printed labeling
on Tyvek material lids and boxes | Blister trays with labeled
Tyvek material lids and labeled
boxes | Yes |
| Biocompatibility | Injector materials are the same as the
previously cleared K070669 IOL
injector. Biocompatibility tests for
that injector were acceptable. | Biocompatibility for
K092023, substantially
equivalent to K070669, shall
be identical to the newly
submitted device | Yes |
| Shelf Life | Three years | Identical | Yes |
| Sterility | Sterile (EO) | Identical | 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 seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medicel AG c/o Mr. John Coggan Director of Regulatory Affairs STAAR Surgical Company 1911 Walker Avenue Monrovia, CA 91016
AUG - S 2010
Re: K101134
Trade/Device Name: Visian® nanoPOINT™ 2.0 Injector System Regulation Number: 21 CFR 886.4300 Regulation Name: Folders and Injectors, Intraocular Lenses Regulatory Class: Class I (reserve) Product Code: MSS Dated: July 14, 2010 Received: July 16, 2010
Dear Mr. Coggan:
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.
4
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.
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/CDRH/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/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 Alexander
Image /page/4/Picture/7 description: The image shows a portion of a document with some text and a signature. The text includes the words "Malv", "Dire", "Divi", and "Office". To the left of the text is a handwritten signature, which appears to be in cursive. The document seems to be an official or formal paper, possibly related to a business or organization.
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
Visian® nanoPOINT™ 2.0 Injector System
Medicel AG
Indications for Use Statement
AUG - 9 2010
510(k) Number (if known): ___K 101134
Device Name: Visian® nanoPOINT™2.0 Injector System
The Visian® nanoPOINT™ 2.0 Injector System is a device intended to fold and insert STAAR Surgical Collamer® Phakic One Piece Intraocular Lenses, Model Visian® ICL, for surgical placement in the human eye.
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)
Signature
Page I of I
Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K101134