(113 days)
Not Found
No
The summary describes a mechanical surgical tool and irrigation system without any mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is used to remove vitreous matter from the eye and provide irrigation during a surgical procedure, which is a therapeutic intervention.
No
The device is described as a vitrectomy cutter and an irrigation sleeve, used to remove vitreous matter from the eye and provide irrigation during the procedure. This is a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly describes physical components (Vitrectomy Cutter and Irrigation Sleeve) intended for surgical procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is intended for surgical procedures within the eye (removing vitreous matter and providing irrigation). This is an in vivo application, meaning it's used directly on a living organism.
- Device Description: The description further elaborates on the surgical use cases in both the anterior and posterior segments of the eye.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. These devices are for use with the Whitestar Signature™ System.
Product codes (comma separated list FDA assigned to the subject device)
MLZ
Device Description
The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. The vittectomy mode is used to cut and remove vitreous matter from the anterior segment of the eye during secondary intraocular lens implantation following vitreous loss associated with trauma or during primary cataract surgery. It can also be used to provide vitreous cutting in the posterior segment by enabling surgeons to remove vitreous matter for the treatment of various posterior segment conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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): 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.
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
§ 886.4150 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
OCT 0 8 2008
K081861 Vitrectory Cutter/Aspiration Device and Irrigation Sleeve - Request for Information Advanced Medical Optics, Inc.
510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the Medical Device Amendments of 1976, the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92.
| The applicant is: | Advanced Medical Optics, Inc.
1700 E. St. Andrew Place
Santa Ana CA 92705, USA |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Est. Registration number: | 2020664 |
| The contact person is: | Evelyn De La Vega
Regulatory Affairs Specialist
Tel: (714) 247-8487
Fax: (714) 247-8784 |
| Date: | September 18, 2008 |
| Device Trade Name: | AMO™ 20GA Vitrectomy Cutter and
Irrigation Sleeve, AMO™ 20GA
Vitrectomy Cutter, AMO™ 20GA Irrigation
Sleeve. |
| Device Classification Name: | Vitreous Aspiration and Cutting Device, and
Irrigation Sleeve |
| Classification: | Class II, Tier II |
The devices to which substantial equivalence is claimed:
| 510(k) Number | Clearance Date | Device |
|---|---|---|
| K950287 | March 3, 1995 | UnuVit and 4422CE |
| (Midlabs) |
DEVICE DESCRIPTION
The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. The vittectomy mode is used to cut and remove vitreous matter from the anterior segment of the eye during secondary intraocular lens implantation following vitreous loss associated with trauma or during primary cataract surgery. It can also be used to provide vitreous cutting in the posterior segment by enabling surgeons to remove vitreous matter for the treatment of various posterior segment conditions.
1
K081861 Vitrectory Cutter/Aspiration Device and Irrigation Sleeve -- Request for Information Advanced Medical Optics, Inc.
The device has been placed in Class II under section 513 of the Federal Food, Drug, and Cosmetic Act. The device is a Tier II and the appropriate panel is the Ophthalmic devices Its classification maybe found in Part 886 of 21 CFR (Code of Federal Panel. Regulations); it's specifically identified under regulation number 886.4150.
INDICATIONS FOR USE
The Vitrectorny Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure.
SUMMARY
The physical and performance characteristics of the vitrectomy cutter and the irrigation sleeve are substantially equivalent to those of the predicate devices. The products will be manufactured in compliance with both FDA (QSR) and ISO standards and have demonstrated to be safe and effective for the indicated use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 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" arranged around the perimeter. Inside the seal is a stylized symbol that resembles an abstract human figure or a caduceus without the snake.
OCT 0 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Medical Optics, Inc. c/o Evelyn De La Vega 1700 E. St. Andrew Place P.O. Box 25162 Santa Ana, CA 92705
Re: K081681
Trade/Device Name: AMOTM 20GA Vitrectomy Cutter and Irrigation Sleeve NGP0020, AMOTM 20GA Vitrectomy Cutter NGP0020A, AMOTM 20GA Irrigation Sleeve NGP0020B Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration and Cutting instrument Regulatory Class: II Product Code: MLZ Dated: August 25, 2008 Received: August 26, 2008
Dear Evelyn De La Vega:
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 such 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); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours.
Madina B. Eggleston, M.D.
Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
510(k) number (if known): K081681
Device Name: AMO™ 20GA Vitrectomy Cutter and Irrigation Sleeve,AMO™ 20GA Vitrectomy Cutter, AMO™ 20GA Irrigation Sleeve
Indication for Use:
The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. These devices are for use with the Whitestar Signature™ System.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
M. O'Connell
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K081681