The SOVEREIGN® High Vacuum Pack is indicated for use with the SOVEREIGN® phacoemulsification machine. The SOVEREIGN® High Vacuum pack includes a filter protected flow restriction orifice used during cataract surgery to minimize vacuum surges in the aspiration line. The SOVEREIGN® Compact High Vacuum Pack is indicated for use with the SOVEREIGN® Compact phacoemulsification machine. The SOVEREIGN® Compact High Vacuum pack includes a filter protected flow restriction orifice used during cataract surgery to minimize vacuum surges in the aspiration line.

Device Description

The SOVEREIGN® High Vacuum Pack and the SOVEREIGN® Compact High Vacuum Pack are accessory kits indicated for use with the SOVEREIGN® phacoemulsification machine and the SOVEREIGN® Compact phacoemulsification machine, respectively, to perform an irrigation/aspiration (I/A) procedure or a phacoemulsification procedure during cataract surgery. The tubing assembly component of the kit incorporates a flow restriction feature for preventing/neutralizing post occlusion surge following an occlusion break at the distal end of a phaco tip. The materials, basic scientific concepts, physical properties and intended use of the device kits are similar to those of the identified predicate devices.

AI/ML Overview

The provided text describes a 510(k) summary for the SOVEREIGN® High Vacuum Pack and SOVEREIGN® Compact High Vacuum Pack, which are accessory kits for phacoemulsification machines used in cataract surgery. The summary focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with acceptance criteria and performance metrics in the typical sense of a diagnostic medical device.

However, based on the information provided, we can infer some "acceptance criteria" and the nature of the "study" conducted for this type of submission. The primary goal was to prove substantial equivalence to existing legally marketed devices.

Here's an interpretation of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance
Equivalence in Intended Use: Device performs irrigation/aspiration or phacoemulsification during cataract surgery, minimizes vacuum surges.	The SOVEREIGN® High Vacuum Pack and SOVEREIGN® Compact High Vacuum Pack are indicated for use with the respective SOVEREIGN® phacoemulsification machines to perform irrigation/aspiration or phacoemulsification during cataract surgery. They include a filter protected flow restriction orifice to minimize vacuum surges in the aspiration line, similar to predicate devices.
Equivalence in Technological Characteristics: Materials, method of sterilization, mode of operation.	"The technological characteristics of the SOVEREIGN® High Vacuum Pack were compared to those of the predicate devices and were found to be equivalent with respect to the materials, method of sterilization, intended use, and mode of operation."
Equivalence in Performance Characteristics (Nonclinical): Flow resistance and chamber maintenance.	"Bench testing was conducted which verified that the performance characteristics (flow resistance and chamber maintenance) associated with the SOVEREIGN® High Vacuum Pack were equivalent to that of the predicate devices."
Safety and Effectiveness: No new questions of safety or effectiveness.	"AMO® has demonstrated through its evaluation of the SOVEREIGN® High Vacuum Pack that the device is equivalent to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a "sample size" in the context of clinical patient data. The evaluation was primarily bench testing. For bench testing, the sample size would refer to the number of units tested. This information is not provided in the document.
Data Provenance: The data provenance is nonclinical bench testing. The country of origin for the testing is not explicitly stated. It is considered retrospective in the sense that it compares performance to established predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. This was bench testing, not an expert-driven clinical evaluation requiring ground truth establishment in that manner.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Bench tests typically involve direct measurement and comparison to predefined engineering specifications or predicate device performance, not expert adjudication in the clinical sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

MRMC Study: No, an MRMC study was not done. This device is a surgical accessory, not an AI-powered diagnostic tool.
Effect Size of AI Improvement: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This device is a physical accessory used with a phacoemulsification machine, hence inherently "human-in-the-loop" in its application during surgery. No standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the bench testing was derived from established performance characteristics of the predicate devices (e.g., their known flow resistance and chamber maintenance capabilities). This is a form of engineering specification/benchmark comparison, rather than expert consensus, pathology, or outcomes data in a clinical trial.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The device design and verification were based on engineering principles and comparisons to existing predicate designs.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable, as there was no training set in the context of machine learning.

Summary

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Image /page/0/Picture/2 description: The image shows the number K050648 in a handwritten style. Below the number, the text "510(K) SUMMARY" is printed in a bold, serif font. The text is centered below the number.

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Submitter's name, address, telephone number, contact person, and date 1. summary prepared;

a. Applicant:	Advance Medial Optics, Inc. (AMO®)1700 E. St. Andrew PlaceSanta Ana, CA 92799
b. Contact Person:	Pam SchaubDirector, Worldwide Regulatory Affairs, AMO®1700 E. St. Andrew PlaceSanta Ana, CA 92799714-247-8603 (phone)714-247-8677 (fax)
c. Date Summary Prepared:	March 11, 2005

Name of device, including trade name and classification name: 2.

a. Trade/Proprietary Name:	SOVEREIGN® High Vacuum PackSOVEREIGN® Compact High Vacuum Pack
b. Classification Name:	Phacofragmentation System
c. Device Classification:	Class II per 21 CFR 886.4670
d. Product Code:	HQC

1. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

Company:	Advanced Medical Optics (AMO®)
Device:	SOVEREIGN® Phaco Pack
510(k):	K981116
Date Cleared:	May 19, 1998
Company:	Staar Surgical Company
Device:	Staar Surge-free Aspiration Adapter
510(k):	K020734
Date Cleared:	May 16, 2002

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A description of the device that is the subject of the 510(k), including explanation 4. of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

న. Statement of intended use:

The SOVEREIGN® Compact High Vacuum Pack is indicated for use with the SOVEREIGN® Compact phacoemulsification machine. The SOVEREIGN® Compact High Vacuum pack includes a filter protected flow restriction orifice used during cataract surgery to minimize vacuum surges in the aspiration line.

6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.

The technological characteristics of the SOVEREIGN® High Vacuum Pack were compared to those of the predicate devices and were found to be equivalent with respect to the materials, method of sterilization, intended use, and mode of operation.

7. Brief summary of nonclinical tests and results:

Bench testing was conducted which verified that the performance characteristics (flow resistance and chamber maintenance) associated with the SOVEREIGN® High Vacuum Pack were equivalent to that of the predicate devices.

8. Conclusions

AMO® has demonstrated through its evaluation of the SOVEREIGN® High Vacuum Pack that the device is equivalent to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2005 APR 5

Advanced Medical Optics, Inc. % Pam Schaub 1700 East St. Andrew P1. Santa Ana, CA 92705

Re: K050648

Trade/Device Name: Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HOC Dated: March 11, 2005 Received: March 15, 2005

Dear Ms. Schaub:

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 mav 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.

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Page 2 - Pam Schaub

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 Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 2

INDICATIONS FOR USE

K050648 (To Be Assigned By FDA) 510(k) Number: SOVEREIGN® High Vacuum Pack Device Trade Name: SOVEREIGN® Compact High Vacuum Pack The SOVEREIGN® High Vacuum Pack is indicated for use with Indications For Use: SOVEREIGN® phacoemulsification machine. the the The SOVEREIGN® High Vacuum pack includes a filter protected flow restriction orifice used during cataract surgery to minimize vacuum surges in the aspiration line. The SOVEREIGN® Compact High Vacuum Pack is indicated for use with the SOVEREIGN® Compact phacoemulsification The SOVEREIGN® Compact High Vacuum pack machine. includes a filter protected flow restriction orifice used during cataract surgery to minimize vacuum surges in the aspiration line.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clay R. Buttiglieri

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

Page 1 of

510(k) Number.

ADVANCED MEDICAL OPTICS, INC. SOVEREIGN® HIGH VACUUM PACK 510(K)

Regulation Number and Section

§ 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.