(120 days)
Not Found
No
The summary describes a surgical system with various tools and functionalities but makes no mention of AI, ML, or image processing capabilities.
Yes
The device is indicated for various medical procedures, including the removal of cataracts, retinal photocoagulation for various abnormalities, and treatment of glaucoma, all of which aim to treat or alleviate a disease or condition.
No
Explanation: The CONSTELLATION® Vision System is described as an ophthalmic microsurgical system, indicated for surgical procedures such as phacoemulsification, cataract removal, intraocular lens injection, and vitreoretinal surgery. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a "microsurgical system" designed for various ophthalmic procedures requiring infusion, cutting, aspiration, illumination, emulsification, fragmentation, cautery, diathermy, and IOL insertion. This indicates a complex hardware system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The CONSTELLATION® Vision System and its components are described as ophthalmic microsurgical systems and instruments used during surgical procedures on the eye. They are used for tasks like phacoemulsification, vitreous cutting, laser photocoagulation, and IOL insertion.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient. Its function is entirely focused on performing surgical interventions within the eye.
Therefore, the CONSTELLATION® Vision System falls under the category of surgical or therapeutic devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification, removal of cataracts, and intraocular lens injection) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. The AutoSert® IOL Injector Handpiece is intended to deliver qualified ACRYSOF® intraocular lenses into the eye following cataract removal.
The AutoSert® IOL Injector Handpiece achieves the functionality of intraocular lenses. The AutoSert® is indicated for use with ACRYSOF lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySoft® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
Flex-Tip Laser Probes
- Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Proliferative and nonproliferative retinopathy (including diabetic);
- Choroidal neovascularization secondary to age-related macular degeneration;
- Retinal tears and detachments;
- Macular edema;
- Retinopathy of prematurity;
- Choroidal neovascularization;
- Leaking microaneurysms.
- Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma.
- Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma.
- And other laser treatments including:
- Internal sclerostomy;
- Lattice degeneration;
- Central and Branch Retinal Vein Occlusion;
- Suturelysis;
- Vascular and pigmented skin lesions.
UltraVit Probes
- Vitreous aspiration & cutting.
- Membrane cutting & aspiration.
- Lens removal.
Endoilluminator Probes
- Endoillumination
Valved Entry Systems
- Scleral incision
- Canulae for posterior segment instrument access
- Venting (of valved cannulae)
Infusion Cannulas
- Posterior segment infusion (liquid or gas)
Product codes (comma separated list FDA assigned to the subject device)
HQE
Device Description
The CONSTELLATION® Vision System is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, and illumination as well as irrigation, lens emulsification and fragmentation, cautery, diathermy, and IOL Insertion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ophthalmic
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)
Safety tests of the CONSTELLATION® Vision System have demonstrated its compliance with applicable requirements of the following standards:
EN ISO 11135-1:2007 - Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
AAMI/ANSI/ ISO or EN ISO 11137-1:2006/(R)2010 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
AAMI/ANSI/ ISO or EN ISO 11137-2:2012 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
EN ISO 14971: 2012 - Medical devices - Application of risk management to medical devices
UL 60601-1: 2003 - Medical Electrical Equipment, Part 1 - General Requirements for Safety
EN 60601-1: 2006/AC: 2010 - Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
EN 60601-1-2: 2007/AC: 2010 - Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC-60601-1-4 - Part 1-4: 2000 - General Requirements for Safety - Collateral Standard: Programmable Electric Medical Systems
IEC 60601-1-6: 2010 - Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
EN 60601-2-2: 2009 - Medical electrical equipment -- Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
EN 80601-2-58: 2009 - Medical electrical equipment -- Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
Biocompatibility evaluations of materials coming in contact with the patient fluid path have been performed to the following standards:
ISO 10993-1: 2009 - Biological Evaluation of Medical Devices -- Part 1: Evaluation and Testing within a Risk management Process
ISO 10993-5: 2009 - Biological Evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
ISO 10993-7: 2010 - Biological Evaluation of Medical Devices -- Part 7: Ethylene Oxide Sterilization Residuals
ISO 10993-10: 2006 - Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Delayed-Type Hypersensitivity
ISO 10993-11: 2006 - Biological Evaluation of Medical Devices -- Part 11: Tests for Systemic Toxicity
ISO 10993-12: 2009 - Biological Evaluation of Medical Devices --Part 12: Sample Preparation and Reference Materials
CONSTELLATION® accessories that are provided sterile and intended for single use only are EtO or Gamma sterilized. The sterilization process has been validated per ISO 11135-1: 2007: Medical Devices – Validation and Routine Control of Ethylene Oxide Sterilization or per ISO 11137-1: 2006, Sterilization of health care products - Radiation - Part1: Requirements for the development, validation and routine control of a sterilization process for medical devices. Reusable handpieces are provided non-sterile. Validated reprocessing instructions for cleaning, sterilization, and re-use of the handpieces are provided in the Directions for Use of the product.
Technological characteristics affecting clinical performance are similar to those of the predicate devices previously listed. The current CONSTELLATION® Vision System as well as the predicate systems have been developed and manufactured in compliance with 21 CFR 820 and ISO 14971: 2012. Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the modified device is equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K101285, K063583, K121555, K120912, K112425, K082845, K021566, K091777
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines representing hair or fabric. The profiles are stacked slightly offset from each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2014
Alcon Research Ltd. Mr. Robert Lundberg Vice President Regulatory Affairs, VGR 20511 Lake Forest Drive Lake Forest, CA 92630
Re: K141065
Trade/Device Name: CONSTELLATION® Vision System Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration & Cutting Instrument Regulatory Class: Class II Product Code: HQE Dated: July 23, 2014 Received: July 24, 2014
Dear Mr. Lundberg:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Eric A. Mann -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
2
Traditional 510(k) Premarket Submission
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
CONSTELLATION® Vision System
Indications for Use (Describe)
The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification, removal of cataracts, and intraocular lens injection) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. The AutoSert® IOL Injector Handpiece is intended to deliver qualified ACRYSOF® intraocular lenses into the eye following cataract removal.
The AutoSert® IOL Injector Handpiece achieves the functionality of intraocular lenses. The AutoSert® is indicated for use with ACRYSOF lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySoft® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
Flex-Tip Laser Probes
· Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
o Proliferative and nonproliferative retinopathy (including diabetic);
- o Choroidal neovascularization secondary to age-related macular degeneration;
- o Retinal tears and detachments;
- o Macular edema;
- o Retinopathy of prematurity;
- o Choroidal neovascularization;
- o Leaking microaneurysms.
- Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma.
- · Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma.
- · And other laser treatments including:
- o Internal sclerostomy;
- o Lattice degeneration;
- o Central and Branch Retinal Vein Occlusion;
- o Suturelysis;
- o Vascular and pigmented skin lesions.
UltraVit Probes
- · Vitreous aspiration & cutting.
- Membrane cutting & aspiration.
- · Lens removal.
Endoilluminator Probes
-
· Endoillumination
Valved Entry Systems -
Scleral incision
-
· Canulae for posterior segment instrument access
-
· Venting (of valved cannulae)
3
Traditional 510(k) Premarket Submission Constellation(R) Vision System
Infusion Cannulas
- Posterior segment infusion (liquid or gas)
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------- |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Eric A. Mann - S
2014.08.22 14:24:42 -04'00'
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(K) SUMMARY 5
The 510(k) Summary is provided here.
This summary is in accordance with 21 CFR 807.92(c).
The submitter of the 510(k) is:
Robert Lundberg VP, Regulatory Affairs - VGR Alcon Research Ltd. 20511 Lake Forest Drive Lake Forest, CA 92630, USA Phone: (949) 505-7817 Fax: (949) 505-6237
Date Prepared: April 23, 2014
Device Subject to this 510(k):
| Trade Name: | CONSTELLATION® Vision System |
|---|---|
| Common Name: | Vitreous Aspiration & Cutting |
| Instrument/Phacofragmentation System | |
| Classification Name: | Class II |
| Vitreous Aspiration & Cutting Instrument | |
| (21 CFR 886.4150) | |
| Phacofragmentation System | |
| (21 CFR 886.4670) |
5.1 Predicate Devices:
The legally marketed device(s) to which Alcon is claiming substantial equivalence are:
| 510(k) Number | Date Cleared | Device |
|---|---|---|
| K101285 | 11/12/2010 | CONSTELLATION® Vision System |
| K063583 | 05/09/2008 | |
| K121555 | 12/21/2012 | CENTURION® Vision System |
| K120912 | 06/15/2012 | INFINITI® Vision System |
5
| 510(k) Number | Date Cleared | Device |
|---|---|---|
| K112425 | 11/21/2011 | |
| K082845 | 02/12/2009 | |
| K021566 | 07/02/2002 | |
| K091777 | 10/20/2009 | Alcon UltraChopper |
5.2 Device Description:
The CONSTELLATION® Vision System is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, and illumination as well as irrigation, lens emulsification and fragmentation, cautery, diathermy, and IOL Insertion.
5.3 Indications for Use:
The CONSTELLATION® Vision System is indicated for the following:
The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. The AutoSert® IOL Injector Handpiece is intended to deliver qualified ACRYSOF® intraocular lenses into the eye following cataract removal.
The AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert is indicated for use with ACRYSOF® lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved ACRYSOF® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
6
| Flex-Tip Laser Probes | Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including diabetic); Choroidal neovascularization secondary to age-related macular degeneration; Retinal tears and detachments; Macular edema; Retinopathy of prematurity; Choroidal neovascularization; Leaking microaneurysms. Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma. Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma. And other laser treatments including: Internal sclerostomy; Lattice degeneration; Central and Branch Retinal Vein Occlusion; Suturelysis; Vascular and pigmented skin lesions. |
|---|---|
| UltraVit Probes | Vitreous aspiration & cutting. Membrane cutting & aspiration. Lens removal. |
| Endoilluminator Probes | Endoillumination |
| Valved Entry Systems | Scleral incision Canulae for posterior segment instrument access Venting (of valved cannulae) |
| Infusion Cannulas | Posterior segment infusion (liquid or gas) |
5.4 Brief Summary of Nonclinical Test and Results:
Safety tests of the CONSTELLATION® Vision System have demonstrated its compliance with applicable requirements of the following standards:
| Standard # | Title |
|---|---|
| EN ISO 11135-1: | |
| 2007 | Sterilization of health care products - Ethylene oxide - Part 1: |
| Requirements for development, validation and routine control | |
| of a sterilization process for medical devices |
7
| Standard # | Title |
|---|---|
| AAMI/ANSI/ ISO or | |
| EN ISO 11137-1: | |
| 2006/(R)2010 | Sterilization of health care products - Radiation - Part 1: |
| Requirements for development, validation and routine control | |
| of a sterilization process for medical devices | |
| AAMI/ANSI/ ISO or | |
| EN ISO 11137-2: | |
| 2012 | Sterilization of health care products - Radiation - Part 2: |
| Establishing the sterilization dose | |
| EN ISO 14971: 2012 | Medical devices - Application of risk management to medical |
| devices | |
| UL 60601-1: 2003 | Medical Electrical Equipment, Part 1 - General Requirements |
| for Safety | |
| EN 60601-1: | |
| 2006/AC: 2010 | Medical electrical equipment -- Part 1: General requirements |
| for basic safety and essential performance | |
| EN 60601-1-2: | |
| 2007/AC: 2010 | Medical electrical equipment -- Part 1-2: General requirements |
| for basic safety and essential performance - Collateral | |
| standard: Electromagnetic compatibility - Requirements and | |
| tests | |
| IEC-60601-1-4 - Part | |
| 1-4: 2000 | General Requirements for Safety - Collateral Standard: |
| Programmable Electric Medical Systems | |
| IEC 60601-1-6: 2010 | Medical electrical equipment -- Part 1-6: General requirements |
| for basic safety and essential performance - Collateral | |
| standard: Usability | |
| EN 60601-2-2: 2009 | Medical electrical equipment -- Part 2-2: Particular |
| requirements for the basic safety and essential performance of | |
| high frequency surgical equipment and high frequency surgical | |
| accessories | |
| EN 80601-2-58: 2009 | Medical electrical equipment -- Part 2-58: Particular |
| requirements for the basic safety and essential performance of | |
| lens removal devices and vitrectomy devices for ophthalmic | |
| surgery |
Biocompatibility evaluations of materials coming in contact with the patient fluid path have been performed to the following standards:
| Standard # | Title |
|---|---|
| ISO 10993-1: 2009 | Biological Evaluation of Medical Devices -- Part 1: Evaluation |
| and Testing within a Risk management Process | |
| ISO 10993-5: 2009 | Biological Evaluation of medical devices -- Part 5: Tests for In |
| Vitro cytotoxicity | |
| ISO 10993-7: 2010 | Biological Evaluation of Medical Devices -- Part 7: Ethylene |
| Oxide Sterilization Residuals | |
| ISO 10993-10: 2006 | Biological Evaluation of Medical Devices -- Part 10: Tests for |
| Irritation and Delayed-Type Hypersensitivity | |
| ISO 10993-11: 2006 | Biological Evaluation of Medical Devices -- Part 11: Tests for |
| Systemic Toxicity |
8
| Standard # | Title |
|---|---|
| ISO 10993-12: 2009 | Biological Evaluation of Medical Devices --Part 12: Sample |
| Preparation and Reference Materials |
CONSTELLATION® accessories that are provided sterile and intended for single use only are EtO or Gamma sterilized. The sterilization process has been validated per ISO 11135-1: 2007: Medical Devices – Validation and Routine Control of Ethylene Oxide Sterilization or per ISO 11137-1: 2006, Sterilization of health care products - Radiation - Part1: Requirements for the development, validation and routine control of a sterilization process for medical devices. Reusable handpieces are provided non-sterile. Validated reprocessing instructions for cleaning, sterilization, and re-use of the handpieces are provided in the Directions for Use of the product.
Technological characteristics affecting clinical performance are similar to those of the predicate devices previously listed. The current CONSTELLATION® Vision System as well as the predicate systems have been developed and manufactured in compliance with 21 CFR 820 and ISO 14971: 2012. Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the modified device is equivalent to the predicate devices.