(53 days)
No
The summary describes a phacofragmentation system for cataract surgery, focusing on mechanical and fluidic aspects. There is no mention of AI, ML, image processing, or data-driven decision-making within the device's operation.
Yes
Explanation: The device is a phacofragmentation system used in cataract surgery to disrupt and extract cataracts, which directly treats a medical condition.
No
The device is described as a "phacofragmentation system" and "phacoemulsification system" used to disrupt and extract cataracts during surgery. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a "phacofragmentation system" and a "phacoemulsification system" with "accessories, which are connected to the consoles," indicating it is a hardware-based medical device used in surgery.
No, 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, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential donors and recipients, or to monitor therapeutic measures.
- Device Function: The Sovereign™ Cataract Extraction System is a surgical device used directly on the patient's eye to physically break up and remove a cataract. It is an active medical device used in a surgical procedure.
- Lack of Specimen Analysis: The description does not mention the device analyzing any biological specimens (blood, tissue, etc.) outside of the body. Its function is entirely within the surgical field.
Therefore, based on the provided information, the Sovereign™ Cataract Extraction System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of the device is to emulsify and remove cataracts.
The Sovereign™ Cataract Extraction System is a phacofragmentation system for use with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Sovereign™ Cataract Extraction System is designed to provide the surgical capabilities desired by the Anterior Segment/Cataract Surgeon for use in the cataract extraction.
Product codes
86 KYG
Device Description
The Sovereign™ Cataract Extraction System is a phaccemulsification system which is used by ophthalmic surgeons during cataract surgery. Accessories, which are connected to the consoles, aid the surgeon in breaking up and removing the cataract from the patient's eye. The Sovereign™ Cataract Extraction System is a modification of a previous device and is substantially equivalent to the predicate devices listed above.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmic surgeons
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)
Performance testing was conducted on the Sovereign™ Cataract Extraction System. Performance in an in vivo model system was comparable to the predicate with respect to phaccemulsification, irrigation, diathermy, vitrectorny and fluidics. The reusable tubing sets (OPO55) were qualified through cleaning, sterilization and durability studies for up to 20 uses when reprocessed in accordance with the Directions for Use provided.
The results of these tests indicate that Sovereign™ Cataract Extraction System performs equivalent to the predicate devices. The overall function and intended use of the modified device are substantially equivalent to the predicate devices. Therefore, the Sovereign™ Cataract Extraction System is substantially equivalent to the predicate devices in commercial distribution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4360 Ocular surgery irrigation device.
(a)
Identification. An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
0
Premarket Notification [510(k)] Summary 0.
This summary document is being submitted in accordance with section 807.92(c).
The submitter of the 510(k) is:
Marcia S. Yaross, Ph.D. Director, Worldwide Regulatory Affairs and Medical Compliance Allergan, Inc. 2525 Dupont Ave. Irvine, CA 92713-9534 714-246-2362 phone 714 246-2205 fax
Date Summary Prepared: March 26, 1998
Device Subject to this 510(k):
| Trade Name: | Sovereign TM Cataract Extraction System |
|---|---|
| Common Name: | Phacofragmentation or Phacoemulsification System |
| Classification Name: | Phacofragmentation System (886.4670) |
Comparison with Predicate Devices:
The device which is the subject of this 510(k), Sovereign™ Cataract Extraction System, is substantially equivalent to the other AMO® cataract extraction devices which were authorized for marketing via 510(k) K971186 (AMO®Diplomax® System-modified), K946054 (AMO®Diplomax® System), and K924235 (AMO®Prestige® system). The handpiece component of the Sovereign™ system is equivalent to ultrasonic handpieces authorized for marketing under 510(k) K951462 (AMO@ProFicient® Handpiece), and K844373 (AMO®Series III® Handpiece). The manufacturer of the predicate devices is Allergan.
The significant changes to the predicate devices are:
- The name is changed to the Sovereign™ Cataract Extraction System. 1.
- There is structural redesign, both internally and to the user interface. 2.
- There are changes in the system control architecture. 3.
- A new pressure measurement system, similar to that of the AMO®Prestige®, is 4. employed.
-
- There is new host software and redesigned printed circuit boards.
- A new biocompatible material is used in the OPO55 reusable tubing sets. 6.
- A new graphical user interface (LCD display) is introduced. 7.
- The phaco handpiece has been redesigned. 8.
* ALLERGAN*
1
Sovereign TM Cataract Extraction System 510(k) Premarket Notification
Page 36 1481116
Device Description:
The Sovereign™ Cataract Extraction System is a phaccemulsification system which is used by ophthalmic surgeons during cataract surgery. Accessories, which are connected to the consoles, aid the surgeon in breaking up and removing the cataract from the patient's eye. The Sovereign™ Cataract Extraction System is a modification of a previous device and is substantially equivalent to the predicate devices listed above.
Indications for Use:
The intended use of the device is to emulsify and remove cataracts.
Brief summary of nonclinical tests and results:
Performance testing was conducted on the Sovereign™ Cataract Extraction System. Performance in an in vivo model system was comparable to the predicate with respect to phaccemulsification, irrigation, diathermy, vitrectorny and fluidics. The reusable tubing sets (OPO55) were qualified through cleaning, sterilization and durability studies for up to 20 uses when reprocessed in accordance with the Directions for Use provided.
The results of these tests indicate that Sovereign™ Cataract Extraction System performs equivalent to the predicate devices. The overall function and intended use of the modified device are substantially equivalent to the predicate devices. Therefore, the Sovereign™ Cataract Extraction System is substantially equivalent to the predicate devices in commercial distribution.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The eagle is a common symbol of the United States, and its presence on the seal signifies the department's role in protecting the health and well-being of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 19 1998
Marcia S. Yaross, Ph.D. Director, Worldwide Regulatory Affairs and Medical Compliance Allergan, Inc. 2525 Dupont Ave. Irvine, CA 92713-9534
Re: K981116 Trade Name: Sovereign ™ Cataract Extraction System Regulatory Class: I Product Code: 86 KYG Dated: March 26, 1998 Received: March 27, 1998
Dear Ms. Yaross:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
3
Page 2 - Ms. Marcia S. Yaross, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Roirl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K981116 ORIGINAL
Indications for Use
510(k) Number (if known): _Unknown at this time
Device Name: Sovereign™ Cataract Extraction System
Indications for Use:
The Sovereign™ Cataract Extraction System is a phacofragmentation system for use with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Sovereign™ Cataract Extraction System is designed to provide the surgical capabilities desired by the Anterior Segment/Cataract Surgeon for use in the cataract extraction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Denis L. McCarthy
Division Sign-Off Division of Ophthalmic Devices 510(k) Number
ALLERILAN - SERICIEI CON - BENTIAL