(146 days)
Not Found
No
The summary describes a physical surgical instrument for removing residual cells after cataract surgery and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an instrument used in cataract surgery to remove residual cells and irrigate the lens capsule, which are therapeutic actions to treat a condition or restore function.
No
The device is described as an instrument for surgical procedures (removing residual cortex and/or epithelial cells after phacoemulsification) and not for diagnosing a condition or disease.
No
The device description explicitly states it is a "single-use, sterile instrument molded from silicone," indicating it is a physical hardware device, not software.
Based on the provided information, the Milvella Perfect Capsule is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Milvella Perfect Capsule's Function: The description clearly states the device is a surgical instrument used during cataract surgery to remove residual material from the lens capsule within the eye. It is not used to analyze a sample taken from the body.
- Intended Use: The intended use describes a surgical procedure, not a diagnostic test performed on a specimen.
- Device Description: The description details a surgical tool for manipulating structures within the eye.
Therefore, the Milvella Perfect Capsule falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
HQC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Additionally, performance testing and clinical testing were conducted to establish the functionality and safety of the Perfect Capsule.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K874969, K874974, K874985, K842458, K874973
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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, 2121
Australia
61(2) 9868 3691
61(2) 9869 7991
Geoff Neilson, C.E.O. |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL
CORRESPONDENT | Judy F. Gordon, D.V.M.
ClinReg Consulting Services, Inc.
2 Delphinus
Irvine, CA 92612
U.S.A.
Tel: (949) 854-6314
FAX (949) 854-9652
e-mail: judygordon@earthlink.net |
| TRADE NAME: | Milvella Perfect Capsule |
| COMMON NAME: | Accessory to a Phacoemulsification Device |
| CLASSIFICATION
NAME: | Ophthalmic Cannula |
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.
INDICATION FOR USE
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.
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.
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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
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Page 1 of 1
510(k) Number (if known): K0 30 957
Device Name: Perfect Capsule
Indications for Use:
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.
(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)