(129 days)
Not Found
No
The description focuses on the mechanical and material properties of a surgical needle and does not mention any computational or algorithmic components.
Yes
The device is used to break up and remove cataractous lens fragments, which directly treats a medical condition (cataract).
No
This device is a surgical tool used to break up and remove a cataractous lens, not to diagnose a condition.
No
The device is a physical medical device (phacoemulsification needles/tips) made of surgical grade titanium, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "break up (emulsify) the nucleus of a cataractous lens and remove the remaining nuclear fragments." This is a surgical procedure performed directly on the patient's eye.
- Device Description: The device is a "fragmenting needle" or "phaco tip" used in conjunction with an ultrasonic handpiece during cataract surgery. It physically interacts with the cataractous lens within the eye.
- Anatomical Site: The anatomical site is the "Eye."
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests on samples.
The device is a surgical instrument used in vivo (within the living body) during an ophthalmic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Laminar Flow Phacoemulsification Needles (Tips) are designed to emulsify and excise cataract tissue in ophthalmic microsurgical procedures.
The Laminar Flow Phacoemulsification Needles (Tips) are used to break up (emulsify) the nucleus of a cataractous lens and remove the remaining nuclear fragments.
Product codes (comma separated list FDA assigned to the subject device)
HOC
Device Description
Phacoemulsification (Phaco) is a technique used during cataract surgery to emulsify and extract a cataractous lens from the eye with an ultrasonic handpiece. The ultrasonic handpiece is connected to and powered by a phacoemulsification system, which is identified in 21 CFR 886.4670 as "an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract."
The fragmentation needle - also referred to as a phaco tip - referenced in the aforementioned definition is the focus of this 510(k) premarket notification. Phaco tips vibrate at an ultrasonic frequency and emulsify a cataract when connected to an ultrasonic phacoemulsification handpiece. The fragmented tissue can then be aspirated and removed through the lumen of the tip. During a surgical procedure, irrigation solution, typically Balanced Salt Solution (BSS), used to irrigate the eye also passes through the hollow opening of the phaco tip.
The subject of this 510(k) premarket notification is for the Phacoemulsification Tips (Phaco Tips) that are additions to the family of Laminar Flow Phacoemulsification Tips, of which there are two proposed designs: a straight tip and a curved tip. Both Phaco Tip models will be marketed as single-use devices, will be compatible with all currently marketed AMO ultrasonic handpieces, and will be made of the same surgical grade titanium as the predicate device; the AMO Profinesse III Needle cleared under the AMO Profinesse III Handpiece 510(k), K951462.
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
Non-clinical animal studies were performed for the Straight and Curved Laminar Flow Phaco Tips. Both studies demonstrate that the tips perform well with various AMO phacoemulsification systems and handpieces and pose no additional risks. The results of the animal studies also indicate that the Phaco Tips are safe and effective.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to demonstrate that the Phaco Tips perform equivalently to the predicate device with respect to safety and effectiveness. Functional validation testing, sterilization, packaging, and biocompatibility assessments all demonstrate that the proposed device, the Phaco Tips, are substantially equivalent in their function and performance to the legally marketed predicate device, the AMO Profinesse III Needle (K951462).
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
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.
0
4. 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 21CFR 807.92.
Applicant:
Contact Person:
Abbott Medical Optics Inc. 1700 E. St. Andrew Place P.O. Box 25162 Santa Ana, CA 92799-5162, USA
Rosanne M. Yetemian, PhD, MSRS Regulatory Affairs Specialist 1700 E. St. Andrew Place Santa Ana, CA 92705 Tel: (714) 247-8282 Fax: (714) 247-8487 Email: rosanne yetemian@amo.abbott.com
R. A.
Date the 510(k) Summary Preparation:
June 30, 2011
Device that is the subject of this notification:
Trade/Proprietary Name: | Laminar Flow Phaco Tip |
---|---|
Classification Name: | Phacoemulsification Needle |
The devices to which substantial equivalence is claimed:
Table 4-1: Predicate Device to Which Substantial Equivalence is Claimed
| Predicate Device
Name | Predicate Trade
Name | 510(k)
Holder | 510(k)
Number | Clearance
Date |
|------------------------------|-------------------------|------------------|------------------|-------------------|
| AMO Profinesse III
Needle | Phaco Tip | AMO | K951462 | 06/15/1995 |
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4.1 Device Description
Phacoemulsification (Phaco) is a technique used during cataract surgery to emulsify and extract a cataractous lens from the eye with an ultrasonic handpiece. The ultrasonic handpiece is connected to and powered by a phacoemulsification system, which is identified in 21 CFR 886.4670 as "an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract."
The fragmentation needle - also referred to as a phaco tip - referenced in the aforementioned definition is the focus of this 510(k) premarket notification. Phaco tips vibrate at an ultrasonic frequency and emulsify a cataract when connected to an ultrasonic phacoemulsification handpiece. The fragmented tissue can then be aspirated and removed through the lumen of the tip. During a surgical procedure, irrigation solution, typically Balanced Salt Solution (BSS), used to irrigate the eye also passes through the hollow opening of the phaco tip.
The subject of this 510(k) premarket notification is for the Phacoemulsification Tips (Phaco Tips) that are additions to the family of Laminar Flow Phacoemulsification Tips, of which there are two proposed designs: a straight tip and a curved tip. Both Phaco Tip models will be marketed as single-use devices, will be compatible with all currently marketed AMO ultrasonic handpieces, and will be made of the same surgical grade titanium as the predicate device; the AMO Profinesse III Needle cleared under the AMO Profinesse III Handpiece 510(k), K951462.
4.2 Indications for Use
The Laminar Flow Phacoemulsification Needles (Tips) are designed to emulsify and excise cataract tissue in ophthalmic microsurgical procedures.
4.3 Technological Characteristics
The technological characteristics of the Phaco Tips are identical to those of the legally marketed predicate device also manufactured by AMO. The mechanism of action and technological features of the Phaco Tips are the same as the predicate device with respect to materials, intended use, claims, clinical applications, patient population, method of operation, and performance specifications.
· 4.4 Summary of Performance Data
Performance testing was conducted to demonstrate that the Phaco Tips perform equivalently to the predicate device with respect to safety and effectiveness. Functional validation testing, sterilization, packaging, and biocompatibility assessments all demonstrate that the proposed device, the Phaco Tips, are substantially equivalent in their function and performance to the legally marketed predicate device, the AMO Profinesse III Needle (K951462).
4.5 Non-Clinical Tests
Non-clinical animal studies were performed for the Straight and Curved Laminar Flow Phaco Tips. Both studies demonstrate that the tips perform well with various AMO
2
ﺎ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
phacoemulsification systems and handpieces and pose no additional risks. The results of the animal studies also indicate that the Phaco Tips are safe and effective.
4.6 Summary
The information presented in this 510(k) premarket notification demonstrates that the Laminar Flow Phaco Tips are substantially equivalent to the legally marketed predicate device, also manufactured by AMO. The technological characteristics, material, intended use, and manufacturing processes remain unchanged for the Phaco Tips when compared to the predicate. AMO concludes that this device is safe, effective, and substantially equivalent to its predicate device as described herein.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The overall design is simple and monochromatic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 7 2011
Abbott Medical Optics Inc. c/o Ms. Rosanne Yetemian Regulatory Affairs Specialist 1700 E. St. Andrew Place Santa Ana, CA 92705
Re: K111882 Trade/Device Name: Laminar Flow Phaco Tips Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HOC Dated: October 21, 2011 Received: October 24, 2011
Dear Ms. Yetemian:
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
Page 2 - Ms. Rosanne Yetemian
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/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
MR.
DR.
DR.
CO
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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3. Indications For Use Statement
510(k) Number (if known): Unknown at this time
Device Name: Phacoemulsification Needles (Tips)
Indications For Use:
The Laminar Flow Phacoemulsification Needles (Tips) are used to break up (emulsify) the nucleus of a cataractous lens and remove the remaining nuclear fragments.
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
Joe Callaway
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K111882