(196 days)
Not Found
No
The document describes surgical instruments and their intended uses, focusing on physical modifications and compatibility with existing systems. There is no mention of AI or ML capabilities.
Yes
The device is intended for various procedures such as vitreous aspiration, cutting, retinal photocoagulation, and lens removal, all of which are therapeutic interventions.
No
The device description, intended use, and indications for use all describe instruments used for surgical procedures (vitreous aspiration & cutting, retinal photocoagulation, laser treatments, scleral incision, infusion), not for diagnosing conditions.
No
The device description explicitly states it is a set of five instruments, which are physical hardware components used in surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus.
- Device Description and Intended Use: The description and intended use clearly indicate that these instruments are used directly on the eye during surgical procedures. They are tools for cutting, aspirating, illuminating, and delivering laser energy to tissues within the eye.
- Lack of Specimen Examination: There is no mention of examining specimens derived from the human body. The instruments are used for therapeutic and surgical interventions, not for analyzing biological samples.
Therefore, the 27+ Retina Instrument Set falls under the category of surgical instruments and accessories, not In Vitro Diagnostics.
N/A
Intended Use / 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 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.
27+ Endoilluminator Probe: Endoillumination
27+ Valved Entry System: Scleral incision
27+ Infusion Cannula: Posterior segment infusion
Product codes (comma separated list FDA assigned to the subject device)
HQE, HMX, HQB, MPA, NGY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eye, Retina, Choroid
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 testing noted above has demonstrated that the functional requirements have been met and that the modified devices are equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K093305, K062624, K063583, K101285
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
| Modified
Instrument | 21 CFR | Classification name | Class | Product
Code | Predicate
510(k) | Date
Cleared |
|---------------------------------|----------|-----------------------------------------------|-------|-----------------|---------------------|----------------------|
| 27+ UltraVit®
Probe | 886.4150 | Vitreous aspiration and
cutting instrument | II | HQE | K093305 | 04/02/10 |
| 27+ Flex-Tip
Laser Probe | 886.4390 | Ophthalmic laser | II | HQB | K062624 | 11/05/07 |
| 27+
Endoilluminator
Probe | 876.1500 | Endoscope and
accessories | II | MPA | K063583
K101285 | 05/09/08
11/12/10 |
| 27+ Valved Entry
System | 886.4350 | Manual ophthalmic
surgical instrument | I | NGY | n/a | |
| 27+ Infusion
Cannula | 886.4350 | Manual ophthalmic
surgical instrument | I | HMX | n/a | |
1
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 Date
510(k)
| Cleared | Predicate Device | Predicate Instrument | Modified Instrument |
|---|---|---|---|
| K093305 | |||
| 04/02/10 | Enhanced UltraVit® Probe | 25+ UltraVit® | |
| Probe | 27+ UltraVit® Probe | ||
| K062624 | |||
| 11/05/07 | Next Generation Laser and | ||
| accessories (PurePoint® | |||
| laser) | 25+ Flex-Tip Laser | ||
| Probe | 27+ Flex-Tip Laser | ||
| Probe | |||
| K063583 | |||
| 05/09/08 | |||
| K101285 | |||
| 11/12/10 | Alcon Vision System (and | ||
| accessories) | |||
| CONSTELLATION® Vision | |||
| System (and accessories) | 25+ | ||
| Endoilluminator | |||
| Probe | 27+ Endoilluminator | ||
| Probe | |||
| n/a | n/a | 25Ga Valved | |
| Entry System | 27+ Valved Entry | ||
| System | |||
| n/a | n/a | 25Ga Infusion | |
| Cannula | 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 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. | |
| 27+ Endoilluminator | |
| Probe | Endoillumination |
| 27+ Valved Entry | |
| System | Scleral incision |
| 27+ Infusion Cannula | Posterior segment infusion |
3
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: 2009 | |
| AAMI/ANSI/ISO | Biological Evaluation of Medical Devices -- Part 1: Evaluation and |
| testing within the Risk Management Process | |
| 10993-5: 2009 | |
| AAMI/ANSI/ISO | Biological Evaluation of Medical Devices -- Part 5: Tests for In Vitro |
| Cytotoxicity | |
| 10993-7: 2008 | |
| AAMI/ANSI/ISO | Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide |
| Sterilization Residuals | |
| 10993-10: | |
| 2002/R:2008 | |
| AAMI/ANSI/BE78 | Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation |
| and Delayed-type Hypersensitivity | |
| 10993-10:2009 | |
| EN ISO | Biological Evaluation of Medical Devices - Part 10: Tests for Irritation |
| and Delayed -type Hypersensitivity | |
| 10993-11:2009 | |
| AAMI/ANSI/ISO | Biological Evaluation of Medical Devices -- Part 11: Tests for systemic |
| toxicity | |
| 10993-12:2009 | |
| AAMI/ANSI/ISO | Biological Evaluation of Medical Devices --Part 12: Sample Preparation |
| and 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.
4
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
6
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 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.) |
Bob
(Division Sign-Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110951
7
Page 2/2
| 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) |
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