(196 days)
The 27+ Retina Instrument Set instruments, along with the Constellation Vision System or Next Generation Laser System, are intended for the following uses:
27+ UltraVit Probe: Vitreous aspiration & cutting. Membrane cutting & aspiration. Lens removal. Dissect tissue in the eye. (The 27+ UltraVit Probe is intended to be used with the Alcon Constellation Vision System.)
27+ Flex-Tip Laser Probe: 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. (The 27+ Flex-Tip Probe is intended to be used with 532 nm laser systems such as the Alcon Constellation Vision System, or the Alcon PurePoint Laser System.)
27+ Endoilluminator Probe: Endoillumination (The 27+ Endoilluminator Probe is intended to be used with the Alcon Constellation Vision System)
27+ Valved Entry System: Scleral incision; Canulae for posterior segment instrument access; Venting (of valved cannulae)
27+ Infusion Cannula: Posterior segment infusion (liquid or gas)
The five instruments comprising the 27+ Retina Instrument Set are modified versions of approved larger gauge CONSTELLATION accessories but with smaller diameter instrument tips for less invasive surgery. All other features are exactly the same as the respective predicate devices cleared in K093305, K062624, K063583, and K101285.
The Alcon Research, Ltd. 27+ Retina Instrument Set is a set of surgical instruments intended for ophthalmic procedures, specifically vitreoretinal surgery. The devices are modified versions of existing, larger gauge instruments with smaller diameter tips for less invasive surgery. This 510(k) summary focuses on demonstrating substantial equivalence to these predicate devices rather than providing a detailed study proving performance against defined acceptance criteria.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in the format requested. Instead, the submission demonstrates equivalence through a combination of:
- Biocompatibility Standards Compliance: The materials are evaluated against a comprehensive set of ISO 10993 standards.
- Sterilization Validation: The ethylene oxide (EO) sterilization process is validated to a Sterility Assurance Level (SAL) of 10^-6, compliant with EN ISO 11135-1:2007.
- Technological Characteristics Equivalence: The claim is that the "Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed. The 27+ Retina Instrument Set has been developed and will be manufactured in compliance with 21 CFR 820 and ISO 14971:2007. Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the modified devices are equivalent to the predicate devices."
Since no specific numerical acceptance criteria or performance results are provided, a table in the requested format cannot be created. The "performance" is demonstrated by adherence to technical standards and the claim of substantial equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical testing for biocompatibility and sterilization.
- Sample Size for Test Set: Not specified. The document states that "Biocompatibility evaluations of materials coming in contact with the patient or patient fluid path have been performed" and "EO sterilized and the process has been validated." The specific number of samples for each test (e.g., cytotoxicity, irritation, systemic toxicity) is not disclosed in this summary.
- Data Provenance: The tests are non-clinical (laboratory-based) and conducted to international standards (ISO, AAMI/ANSI, EN ISO). The country of origin for the data is not explicitly stated beyond being conducted by Alcon Research, Ltd. There is no indication of retrospective or prospective patient data, as this is a pre-market submission for a surgical instrument rather than a diagnostic AI device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" in this context refers to established scientific and regulatory standards for biocompatibility and sterilization, which are inherently defined by consensus among scientific and medical experts who developed these international standards (ISO, AAMI/ANSI, EN ISO). There are no "experts" establishing ground truth for this specific device's test set in the way one would for annotating medical images for an AI algorithm. The device's materials and sterilization process are evaluated against predefined criteria outlined in the standards.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for resolving disagreements in expert labeling of ground truth data, especially in studies involving human interpretation (e.g., reading medical images). Here, the testing involves standardized laboratory methods and measurements against established criteria, not subjective expert judgment that requires adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI assistance
This is not applicable. The submission is for a surgical instrument set, not an AI or diagnostic imaging device that involves human readers or AI assistance. No MRMC study was performed or is relevant to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a set of physical surgical instruments, not an algorithm, and therefore does not have a "standalone" algorithmic performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is based on:
- Established Biocompatibility Standards: The test results are compared against the acceptance criteria defined within ISO 10993 series standards, which represent expert consensus on biological evaluation of medical devices.
- Sterilization Validation Standards: The sterilization process is validated against EN ISO 11135-1:2007, a standard for ethylene oxide sterilization, representing expert consensus on achieving sterility.
There is no "pathology" or "outcomes data" in the typical sense for proving the fundamental safety aspects covered in this non-clinical testing.
8. The Sample Size for the Training Set
This is not applicable. There is no AI algorithm being developed or "trained" for this surgical instrument set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI algorithm.
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OCT 1 7 2011
Alcon Research, Ltd. Traditional 510(k) Premarket Notification 27+ Retina Instrument Set
March 31, 2011
PREMARKET NOTIFICATION 510(k) SUMMARY 5.
This 510(k) Summary is provided here and is also included in Attachment B.
The submitter of the 510(k) is:
Martin A. Kaufman Director, Regulatory Affairs Alcon Research, Ltd. 18500 Alton Parkway Irvine, CA 92618 Phone: (949) 753-6250 Fax: (949) 753-6237
Devices Subject to this 510(k):
Trade Name: 27+ Retina Instrument Set Common Name: Vitreoretinal Surgical Accessories Classification Name: See below
| ModifiedInstrument | 21 CFR | Classification name | Class | ProductCode | Predicate510(k) | DateCleared |
|---|---|---|---|---|---|---|
| 27+ UltraVit®Probe | 886.4150 | Vitreous aspiration andcutting instrument | II | HQE | K093305 | 04/02/10 |
| 27+ Flex-TipLaser Probe | 886.4390 | Ophthalmic laser | II | HQB | K062624 | 11/05/07 |
| 27+EndoilluminatorProbe | 876.1500 | Endoscope andaccessories | II | MPA | K063583K101285 | 05/09/0811/12/10 |
| 27+ Valved EntrySystem | 886.4350 | Manual ophthalmicsurgical instrument | I | NGY | n/a | |
| 27+ InfusionCannula | 886.4350 | Manual ophthalmicsurgical instrument | I | HMX | n/a |
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Alcon Research, Ltd. Traditional 510(k) Premarket Notification 27+ Retina Instrument Set
5.1. Predicate Devices:
The legally marketed devices(s) to which we are claiming equivalence to are:
| Predicate Date510(k)Cleared | Predicate Device | Predicate Instrument | Modified Instrument |
|---|---|---|---|
| K09330504/02/10 | Enhanced UltraVit® Probe | 25+ UltraVit®Probe | 27+ UltraVit® Probe |
| K06262411/05/07 | Next Generation Laser andaccessories (PurePoint®laser) | 25+ Flex-Tip LaserProbe | 27+ Flex-Tip LaserProbe |
| K06358305/09/08K10128511/12/10 | Alcon Vision System (andaccessories)CONSTELLATION® VisionSystem (and accessories) | 25+EndoilluminatorProbe | 27+ EndoilluminatorProbe |
| n/a | n/a | 25Ga ValvedEntry System | 27+ Valved EntrySystem |
| n/a | n/a | 25Ga InfusionCannula | 27+ Infusion Cannula |
5.2. Device Description
The five instruments comprising the 27+ Retina Instrument Set are modified versions of approved larger gauge CONSTELLATION accessories but with smaller diameter instrument tips for less invasive surgery. All other features are exactly the same as the respective predicate devices cleared in K093305, K062624, K063583, and K101285.
{2}------------------------------------------------
5.3. Indications for Use:
The 27+ Retina Instrument Set instruments, along with the CONSTELLATION Vision System or Next Generation Laser System, are intended for the following uses:
| 27+ UltraVit® Probe | Vitreous aspiration & cutting. Membrane cutting & aspiration. Remove a crystalline lens. Dissect tissues in the eye. |
|---|---|
| 27+ Flex-Tip LaserProbe | Retinal photocoagulation, panretinal photocoagulation andintravitreal photocoagulation of vascular and structuralabnormalities 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 AngleGlaucoma (COAG, POAG) and Refractory Glaucoma. Trabeculoplasty for treatment of Chronic/Primary Open AngleGlaucoma (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. |
| 27+ EndoilluminatorProbe | Endoillumination |
| 27+ Valved EntrySystem | Scleral incision |
| 27+ Infusion Cannula | Posterior segment infusion |
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5.4. Brief Summary of Nonclinical test and Results:
Biocompatibility evaluations of materials coming in contact with the patient or patient fluid path have been performed to the following standards:
| Standard # | Title |
|---|---|
| 10993-1: 2009AAMI/ANSI/ISO | Biological Evaluation of Medical Devices -- Part 1: Evaluation andtesting within the Risk Management Process |
| 10993-5: 2009AAMI/ANSI/ISO | Biological Evaluation of Medical Devices -- Part 5: Tests for In VitroCytotoxicity |
| 10993-7: 2008AAMI/ANSI/ISO | Biological Evaluation of Medical Devices - Part 7: Ethylene OxideSterilization Residuals |
| 10993-10:2002/R:2008AAMI/ANSI/BE78 | Biological Evaluation of Medical Devices -- Part 10: Tests for Irritationand Delayed-type Hypersensitivity |
| 10993-10:2009EN ISO | Biological Evaluation of Medical Devices - Part 10: Tests for Irritationand Delayed -type Hypersensitivity |
| 10993-11:2009AAMI/ANSI/ISO | Biological Evaluation of Medical Devices -- Part 11: Tests for systemictoxicity |
| 10993-12:2009AAMI/ANSI/ISO | Biological Evaluation of Medical Devices --Part 12: Sample Preparationand Reference.Materials |
These accessories are provided sterile and are intended for single use only. These products are EO sterilized and the process has been validated to a SAL of 106 per FDA Recognized Consensus Standard EN ISO 11135-1:2007: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed. The 27+ Retina Instrument Set has been developed and will be manufactured in compliance with 21 CFR 820 and ISO 14971:2007. Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the modified devices are equivalent to the predicate devices.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the snakes and a base representing the staff. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alcon Research, Ltd. c/o Mr. Martin Kaufman, RAC Director, Regulatory Affairs 15800 Alton Parkway Irvine, CA 92816
0CT 1 7 2011
Re: K110951
Trade/Device Name: 27+ Retina Instrument Set Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous aspiration and cutting instrument Regulatory Class: II Product Codes: HQE, HMX, HQB, MPA, NGY Dated: October 6, 2011 Received: October 7, 2011
Dear Mr. Kaufman:
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, Dr to 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 contractly und warranties. We remind you, however, that device labeling must be truthful and not midlers]
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 madon a color incant 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
{5}------------------------------------------------
Page 2 - Mr. Martin Kaufman, RAC
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/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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
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
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K110951
Device Name: 27+ Retina Instrument Set
Indications for Use:
The 27+ Retina Instrument Set instruments, along with the Constellation Vision System or Next Generation Laser System, are intended for the following uses:
| 27+ UltraVit Probe | Vitreous aspiration & cutting. Membrane cutting & aspiration. Lens removal. Dissect tissue in the eye. (The 27+ UltraVit Probe is intended to be used with the AlconConstellation Vision System.) |
|---|---|
| 27+ Flex-Tip LaserProbe | Retinal photocoagulation, panretinal photocoagulation andintravitreal photocoagulation of vascular and structuralabnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (includingdiabetic); Choroidal neovascularization secondary to age-relatedmacular degeneration; Retinal tears and detachments; Macular edema; Retinopathy of prematurity; Choroidal neovascularization; Leaking microaneurysms. Iridotomy/Iridectomy for treatment of Chronic/Primary OpenAngle Glaucoma (COAG,POAG) and Refractory Glaucoma. Trabeculoplasty for treatment of Chronic/Primary Open AngleGlaucoma (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. (The 27+ Flex-Tip Probe is intended to be used with 532 nm lasersystems such as the Alcon Constellation Vision System, or theAlcon PurePoint Laser System.) |
Bob
(Division Sign-Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110951
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Page 2/2
| 27+ EndoilluminatorProbe | • Endoillumination(The 27+ Endoilluminator Probe is intended to be used with theAlcon Constellation Vision System) |
|---|---|
| 27+ Valved EntrySystem | • Scleral incision• Canulae for posterior segment instrument access• Venting (of valved cannulae) |
| 27+ Infusion Cannula | • Posterior segment infusion (liquid or gas) |
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)
Rk
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110951
§ 886.4690 Ophthalmic photocoagulator.
(a)
Identification. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.(b)
Classification. Class II.