(211 days)
Not Found
No
The summary describes a traditional phacoemulsification system with standard functions (ultrasonic phacoemulsification, diathermy, irrigation, aspiration, vitrectomy) and a user interface. There is no mention of AI, ML, image processing, or data sets for training or testing, which are typical indicators of AI/ML integration in medical devices.
Yes
The device is used to disrupt and extract cataracts in cataract surgery, which is a direct treatment for a medical condition.
No
The device is described as a surgical system for cataract extraction, not for diagnosing medical conditions. It performs therapeutic functions like phacoemulsification, not diagnostic ones.
No
The device description explicitly states it is an "AC-powered device with a fragmenting needle" and a "modular ophthalmic microsurgical system" with a console, handpiece, and other hardware components. It performs physical actions like ultrasonic phacoemulsification and diathermy.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The description clearly states the device is a "phacofragmentation system" used in "cataract surgery to disrupt a cataract with ultrasound and extract the cataract." This is a surgical procedure performed on the patient's eye, not an examination of a specimen outside the body.
- Intended Use: The intended use is for "cataract surgery," which is a surgical intervention.
- Lack of Specimen Handling: There is no mention of the device being used to analyze or test any biological specimens.
Therefore, the Sovereign Compact Phacoemulsification System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sovereign Compact Phacoemulsification 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.
Product codes (comma separated list FDA assigned to the subject device)
HQC
Device Description
The Sovereign Compact Phacoemulsification System) is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery for the disruption and extraction of a cataractous lens. As with other phacofragmentation systems, The System is identified in 21 CFR 886.4670 as a "phacofragmentation system that 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."
The main performance functions of The System include ultrasonic phacoemulsification, diathermy, irrigation and aspiration, and vitrectomy. Ultrasonic phacoemulsification provides vibration at an ultrasonic frequency when used in conjunction with a compatible AMO ultrasonic handpiece. The System is controlled and powered by The System console, which includes an active color graphic user interface and receptacles for an automated IV pole, footpedal, remote control, and drainage packs.
The materials, basic scientific concepts, physical properties and intended use of The System are identical to those of The Mojave Cataract Extraction System (branded as Sovereign Compact) (K003638) predicate device. The AMO Ophthalmic Surgical System was also listed as a predicate because it shares the same available software modes as The System. Both predicate devices are manufactured by Abbott Medical Optics Inc. (AMO).
The System will be marketed as either a complete unit or an optional software upgrade kit for current Sovereign Compact Systems in the field.
In addition, the enhancements made to The System include an optional feature-activated capability for the use of the AMO Ultrasonic Handpiece 690880 (Handpiece 690880), which is substantially equivalent to the Sovereign Phaco Handpiece cleared under the Sovereign Cataract Extraction System 510(k) (K981116). Handpiece 690880 is intended for use during the phacoemulsification procedure to break up (emulsify) the nucleus of the cataractous lens and remove the remaining nuclear fragments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior Segment (cataract)
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)
The System and Handpiece 690880 have undergone testing and are in compliance with applicable safety standards. The subject device was found to perform equivalently to the predicate device during the following modes of anterior segement ophthalmic surgery: phacoemulsification, irrigation, diathermy and vitrectomy. Therefore, the subject device and the predicate devices have similar safety, effectiveness, and performance profiles.
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
DEC 2 1 2011
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM K111446
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:
Abbott Medical Optics Inc. 1700 E. St. Andrew Place P.O. Box 25162 Santa Ana, CA 92799-5162, USA
Contact Person:
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.H
Date of 510(k) Summary Preparation:
November 28, 2011
Device that is the subject of this notification:
| Trade/Proprietary Name: | The Sovereign Compact Phacoemulsification System |
|---|---|
| Classification Name: | Phacofragmentation System |
| Regulation Number: | 21 CFR 886.4670 |
| Regulation Name: | Phacofragmentation system |
| Regulatory Class: | Class II |
| Product Code: | HQC |
The devices to which substantial equivalence is claimed:
| Table 4-1: Predicate Devices to Which Substantial Equivalence is Claimed | ||||
|---|---|---|---|---|
| Predicate Device Name | Predicate Trade Name | 510(k) Holder | 510(k) Number | Clearance Date |
| Sovereign Compact Phacoemulsification System Predicate Devices | ||||
| Mojave Cataract | ||||
| Extraction System | Sovereign Compact | AMO | K003638 | 02/13/2001 |
| AMO Ophthalmic | ||||
| Surgical System | WhiteStar Signature | AMO | K060366 | 04/07/2006 |
| AMO Ultrasonic Handpiece 690880 Predicate Device | ||||
| Sovereign Phaco | ||||
| Handpiece | Sovereign Handpiece | AMO | K981116 | 05/19/1998 |
ABBOTT MEDICAL OPTICS INC.
510(k) SUMMARY
1
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM K111446
4.1 DEVICE DESCRIPTION SUMMARY
The Sovereign Compact Phacoemulsification System) is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery for the disruption and extraction of a cataractous lens. As with other phacofragmentation systems, The System is identified in 21 CFR 886.4670 as a "phacofragmentation system that 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."
The main performance functions of The System include ultrasonic phacoemulsification, diathermy, irrigation and aspiration, and vitrectomy. Ultrasonic phacoemulsification provides vibration at an ultrasonic frequency when used in conjunction with a compatible AMO ultrasonic handpiece. The System is controlled and powered by The System console, which includes an active color graphic user interface and receptacles for an automated IV pole, footpedal, remote control, and drainage packs.
The materials, basic scientific concepts, physical properties and intended use of The System are identical to those of The Mojave Cataract Extraction System (branded as Sovereign Compact) (K003638) predicate device. The AMO Ophthalmic Surgical System was also listed as a predicate because it shares the same available software modes as The System. Both predicate devices are manufactured by Abbott Medical Optics Inc. (AMO).
The System will be marketed as either a complete unit or an optional software upgrade kit for current Sovereign Compact Systems in the field.
In addition, the enhancements made to The System include an optional feature-activated capability for the use of the AMO Ultrasonic Handpiece 690880 (Handpiece 690880), which is substantially equivalent to the Sovereign Phaco Handpiece cleared under the Sovereign Cataract Extraction System 510(k) (K981116). Handpiece 690880 is intended for use during the phacoemulsification procedure to break up (emulsify) the nucleus of the cataractous lens and remove the remaining nuclear fragments.
4.2 INDICATIONS FOR USE
The Sovereign Compact Phacoemulsification 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.
4.3 TECHNOLOGICAL CHARACTERISTICS
For anterior segment (cataract) surgical procedures, the system provides the following main diathermy, phacoemulsification, irrigation and aspiration, and vitrectorny. The modes: technological characteristics of the device are substantially equivalent to those cleared under the 510(k)s of the Mojave Cataract Extraction System (K003638) and the AMO Ophthalmic Surgical System (K060366). The technological characteristics of the AMO Ultrasonic Handpiece are substantially equivalent to those of the Sovereign Phaco Handpiece cleared under 510(k) of the Sovereign Cataract Extraction System (K981116).
The System, which is the subject device, is an upgrade to the existing predicate device, the Mojave Cataract Extraction System (branded as Sovereign Compact and cleared on February 13, 2001 under K003638). Since the clearance of this device, The System has been upgraded
2
to include software modes that are also available with the second predicate, the AMO Ophthalmic Surgical System (K060366).
The differences between The System and its two predicate devices include:
- AMO Ultrasonic Handpiece 690880 compatibility 0
- Support for the latest version of the Surgical Media Center (SMC) o
- The ability to view vacuum units in kilopascals (kPa) o
- Support for an IV pole extension o
A comparison summary of The System and the two predicate devices is provided in Table 4-2. All unique features available with The System with respect to both predicates are underlined for clarity.
| Features and
Characteristics | Proposed Device
The Sovereign Compact
Phacoemulsification
System | Predicate Device
Mojave Cataract
Extraction System
(K003638) | Predicate Device
AMO Ophthalmic-
Surgical System
(K060366) |
|---------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------|
| Intended Use | Anterior Segment
Ophthalmic Surgery | Anterior Segment
Ophthalmic Surgery | Anterior and Posterior
(optional) Segment
Ophthalmic Surgery |
| Technological
Characteristics | | | |
| User Interface | Key panel, remote
control, footpedal | Key panel, remote
control, footpedal | Touch screen, remote
control, footpedal |
| Hardware:
-Console | Compact system console
with display screen and
key entry | Compact system console
with display screen and
key entry | Upper-Tier system
console with display
screen and key entry |
| -Footpedal | Wired
(closed or open-toe) | Wired
(closed toe) | Wired or wireless
(open-toe) |
| -Remote control unit | Wired | Wired | Wireless |
| -Console stand | Cart with mayo tray and
articulating arm | Cart with mayo tray and
articulating arm | Cart with mayo tray and
articulating arm |
| -IV Pole | Yes
(with optional extension) | Yes | Yes |
| Software:
-OS for Safety Critical
Functions | Same | Same | Same |
| Available Modes: | Same | No | Same |
| Specifications:
-Aspiration Pump Type | Peristaltic | Peristaltic | Peristaltic and Venturi |
| - Handpiece 690880
compatibility | Yes | No | No |
| -SMC Support | Yes | No | No |
| -Multilingual support | Yes | No | Yes |
| -Vacuum/pressure | mmHg, kPa | mmHg | mmHg |
Table 4-2 Comparison Overview of The System to the Predicate Devices
3
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM K111446
| Features and
Characteristics
Accessories | Proposed Device
The Sovereign Compact
Phacoemulsification
System | Predicate Device
Mojave Cataract
Extraction System
(K003638) | Predicate Device
AMO Ophthalmic
Surgical System
(K060366) |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Disposable Accessories | • Tips and Sleeves
• Fluidics Packs
• Administration Set
• Sterilization Tray
• Phaco Handpieces | • Tips and Sleeves
• Fluidics Packs
• Administration Set
• Sterilization Tray
• Phaco Handpieces | • Tips and Sleeves
• Fluidics Packs
• Administration Set
• Sterilization Tray
• Phaco Handpieces |
| Reusable Accessories | • Fluidics Pack
• Irrigation/Aspiration
Handpiece
• Diathermy Cord with
Bipolar Forceps
• Vitrectomy Handpiece | • Fluidics Pack
• Irrigation/Aspiration
Handpiece
• Diathermy Cord with
Bipolar Forceps
• Vitrectomy Handpiece | • N/A (Disposable Only)
• Irrigation/Aspiration
Handpiece
• Diathermy Cord with
Bipolar Forceps
• Vitrectomy Handpiece |
4.4 SUMMARY OF NON-CLINICAL. TESTS
The System and Handpiece 690880 have undergone testing and are in compliance with applicable safety standards. The subject device was found to perform equivalently to the predicate device during the following modes of anterior segement ophthalmic surgery: phacoemulsification, irrigation, diathermy and vitrectomy. Therefore, the subject device and the predicate devices have similar safety, effectiveness, and performance profiles.
4.5 SUMMARY OF CLINICAL TESTS
No clinical studies were deemed necessary to determine the safety and effectiveness or substantial equivalence of The System and Handpiece 690880 to their predicate devices.
4.5 CONCLUSIONS
The technological characteristics that determine the functionality and performance of The Sovereign Compact Phacoemulsification System and the AMO Ultrasonic Handpiece 690880 are substantially equivalent to those of the predicate devices listed. The Sovereign Compact Phacoemulsification System and the AMO Ultrasonic Handpiece will be manufactured in . compliance with FDA and ISO quality systems requirements. The data presented from the nonclinical tests demonstrate that the device is safe and effective, and performs as safely and effectively as the legally marketed predicate devices. Validation and verification demonstrates that the functional requirements and specifications have been met prior to commercial release.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Abbott Medical Optics, Inc. c/o Rosanne Yetemian, PhD, MSRS Regulatory Affairs Specialist 1700 E. St. Andrew Place Santa Ana, CA 92705
DEC 2 1 2011
Re: K111446
Trade/Device Name: Sovereign Compact Phacoemulsification System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HQC Dated: December 19, 2011 Received: December 20, 2011
Dear Dr. 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.
5
Page 2 - Dr. 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.
Malvina B. Evdelman, 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): K111446
Device Name: The Sovereign Compact Phacoemulsification System
Indications For Use:
The Sovereign Compact Phacoemulsification 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.
Prescription Use X (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)
CLC
(Division Sign-Off) (Division Sign-Off)
Division of Ophthalmic, Neurological as
The Cources of Devices Ear. Division of OF
Nose and Throat Devices
510(k) Number
Sovereign Compact Phacoemulsification System Abbott Medical Optics Inc.