The Milvella Perfect Capsule is intended to be used after phacoemulsification of the natural crystalline lens by providing a method for sealed capsule polishing and irrigation, for the purpose of removing residual cortex and/or epithelial cells.

The Milvella Perfect Capsule is intended for use after phacoemulsification of the natural crystalline lens for the purpose of removing residual cortex and/or epithelial cells, by providing a method for sealed capsule polishing and irrigation.

Device Description

The Perfect Capsule is a single-use, sterile instrument molded from silicone and designed for use in cataract surgery for the purpose of removing residual cortex and/or epithelial cells after cataract extraction by phacoemulsification. This device provides a method of holding the empty lens capsule and containing irrigation fluid to within the lens capsule after cataract removal, thus reducing the risk of irrigating fluid contacting other ocular structures including the corneal endothelium.

AI/ML Overview

The provided text describes a medical device called the "Milvella Perfect Capsule" and its 510(k) submission for market clearance. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly available in the provided document.

However, I can extract the information directly available and infer what might be considered "acceptance" based on the regulatory context.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or a dedicated performance study with specific metrics. Instead, the "acceptance criteria" are implied by compliance with established standards and demonstrated "substantial equivalence" to predicate devices. The reported "performance" is a general statement of meeting requirements and performing consistently with intended use.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with Sterilization Standards: ANSI/AAMI/ISO 11137-1994, ANSI/AAMI/ISO 10993	"The Milvella Perfect Capsule complies with the following standards... STERILIZATION - ANSI/AAMI/ISO 11137-1994... ANSI/AAMI/ISO 10993; Biological Evaluation of Medical Devices-Part 1." (Implied successful sterilization and biocompatibility)
Compliance with Shelf-Life and Packaging Integrity Standards: ANSI/AAMI/ISO 11607-1997, AAMI TIR Guidance	"The Milvella Perfect Capsule complies with the following standards... SHELF-LIFE AND PACKAGING INTEGRITY - ANSI/AAMI/ISO 11607-1997... AAMI TIR, Guidance for ANSI/AAMI/ISO 11607-1997..." (Implied successful shelf-life and packaging integrity)
Functionality and Safety (General)	"Additionally, performance testing and clinical testing were conducted to establish the functionality and safety of the Perfect Capsule." (No specific metrics or results are provided, only that tests were conducted and it met requirements.) "the Perfect Capsule is safe and effective and performs in a fashion consistent with its intended use as well as the intended use of the predicate device(s)." (General conclusion of meeting requirements)
Substantial Equivalence to Predicate Devices	"Milvella Pty. Ltd. concludes that the Perfect Capsule is substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act." (The core "acceptance" criteria for a 510(k) submission)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "performance testing and clinical testing" but does not provide any details regarding sample size, data provenance, or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of experts to establish ground truth for any test set. The evaluation seems to be based on compliance with technical standards and comparison to predicate devices, rather than a diagnostic performance study requiring expert adjudicated ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no external expert adjudication for a test set is described.

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

Not applicable. This device is an accessory to a phacoemulsification device, designed for capsule polishing and irrigation in cataract surgery. It is a physical instrument, not an AI-powered diagnostic or assistive tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical instrument for surgical use, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The document assesses the device's substantial equivalence based on its technological characteristics and compliance with standards, not on a diagnostic test's performance against a specific ground truth.

8. The sample size for the training set

Not applicable. This device is a physical instrument and does not involve AI or machine learning that would require a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

{0}------------------------------------------------

SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT	Milvella Pty. Ltd.10 Melrose St.Epping, NSW, 2121Australia61(2) 9868 369161(2) 9869 7991Geoff Neilson, C.E.O.
OFFICIALCORRESPONDENT	Judy F. Gordon, D.V.M.ClinReg Consulting Services, Inc.2 DelphinusIrvine, CA 92612U.S.A.Tel: (949) 854-6314FAX (949) 854-9652e-mail: judygordon@earthlink.net
TRADE NAME:	Milvella Perfect Capsule
COMMON NAME:	Accessory to a Phacoemulsification Device
CLASSIFICATIONNAME:	Ophthalmic Cannula

DEVICE DESCRIPTION

INDICATION FOR USE

{1}------------------------------------------------

PREDICATE DEVICES

The Milvella Perfect Capsule is substantially equivalent to the following predicate devices:

Company:	Katena
Device:	Ophthalmic Cannulas
510(k):	Class I, exempt
Company:	Advanced Surgical Products, Inc.
Device:	Prisma Disposable Capsule Polishers
510(k):	K874969, K874974, K874985
Company:	Chiron Vision Corp.
Device:	Site Simcoe Style I/A Handpiece
510(k):	K842458
Company:	Advanced Surgical Products, Inc.
Device:	Prisma Disposable Simcoe I/A Cannula
510(k):	K874973

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The intended use of the Perfect Capsule does not differ from the legally marketed predicate device(s). The technological differences between the Perfect Capsule and the predicate device(s) are related to the method for creating vacuum, and the smaller vacuum channel width. However, these differences do not raise new questions of safety and effectiveness.

SUMMARY OF PERFORMANCE DATA

The Milvella Perfect Capsule complies with the following standards, practices, and quidance's:

STERILIZATION

ANSI/AAMI/ISO 11137-1994, Sterilization of Health Care Products A Requirements for Validation and Routine Control - Radiation Sterilization .
ANSI/AAMI/ISO 10993; Biological Evaluation of Medical Devices-Part 1.

SHELF-LIFE AND PACKAGING INTEGRITY

ANSI/AAMI/ISO 11607-1997, Packaging for Terminally Sterilized Medical Devices.
AAMI TIR, Guidance for ANSI/AAMI/ISO 11607-1997, Packaging for Terminally Sterilized Medical Devices, 1997.

{2}------------------------------------------------

Additionally, performance testing and clinical testing were conducted to establish the functionality and safety of the Perfect Capsule.

Conclusion

Since the Milvella Perfect Capsule meets the requirements of the stated standards and has technological characteristics and intended use similar to the predicate devices, the Perfect Capsule is safe and effective and performs in a fashion consistent with its intended use as well as the intended use of the predicate device(s).

Based on the 510(k) statements (21 CFR 807) and the information provided herein, Milvella Pty. Ltd. concludes that the Perfect Capsule is substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains an image of an eagle with three lines extending from its back. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

Public Health Service

AUG 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Milvella Pty. Ltd. c/o Judy F. Gordon, D.V.M. ClinReg Consulting Services, Inc. 2 Delphinus Irvine, CA 92612

Re: K030957

Trade/Device Name: Milvella Perfect Capsule™ Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC Dated: March 25, 2003 Received: March 27, 2003

Dear Dr. Gordon:

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.

{4}------------------------------------------------

Page 2 - Judy F. Gordon, D.V.M.

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) 594-4613. 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/dsma/dsmamain.html

Sincerely vours.

A halpi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 1 of 1

510(k) Number (if known): K0 30 957

Device Name: Perfect Capsule

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number	K030957
---------------	---------

Prescription Use	✓
------------------	--------------

OR Over-The-Counter Use
(Optional Format 1-2-96)

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.