(206 days)
Not Found
No
The device description and performance studies focus on the mechanical and reprocessing aspects of the phacoemulsification tips, with no mention of AI or ML.
Yes
The device is intended to 'emulsify and excise cataract tissues', which is a direct treatment performed on the patient and addresses a disease state (cataracts).
No
Explanation: The "Intended Use" and "Device Description" sections clearly state that the device is used to "emulsify and excise cataract tissues," which are therapeutic actions, not diagnostic ones. There is no mention of the device being used to identify, detect, or monitor a medical condition.
No
The device description clearly describes a physical tip that connects to a handpiece and vibrates to emulsify tissue, indicating it is a hardware device. The performance studies also focus on physical properties and processes like biocompatibility, reprocessing, and sterilization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "emulsify and excise cataract tissues in ophthalmic microsurgical procedures." This describes a surgical procedure performed directly on the patient's eye.
- Device Description: The description details how the tip physically breaks down and removes tissue during surgery.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings for analysis of biological samples.
The device is a surgical instrument used in vivo (within the living body) during an ophthalmic procedure.
N/A
Intended Use / Indications for Use
Reprocessed Phacoemulsification Tips are intended to emulsify and excisecataract tissues in ophthalmic microsurgical procedures.
Reprocessed Phacoemulsification Tips are indicated for use to emulsify and excise cataract tissues in patients requiring eye surgery.
Product codes
NKX
Device Description
Phacoemulsification Tips are used to emulsify and excisecataract tissue in ophthalmic microsurgical procedures. Whenconnected to the ultrasonic handpiece of a phacoemulsificationsystem and activated, the Phacoemulsification Tip vibrates at anultrasonic frequency that emulsifies cataract tissue. Theextracted tissue is then aspirated away through the hollow tip.Irrigation of the eye with a saline solution compensates for theloss of volume in the eye when the cataract tissue is removed.
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
Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of Reprocessed Phacoemulsification Tips. This included the following tests:
- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation .
- . Function test(s)
- . Packaging Validation
Performance testing demonstrates that Reprocessed Phacoemulsification Tips perform as originally intended.
Key Metrics
Not Found
Predicate Device(s)
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
PART B: 510(k) SUMMARY
| Submitter: | Alliance Medical Corporation
10232 South 51st Street
Phoenix, Arizona 85044 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Elizabeth Renken
Regulatory Affairs Specialist
(480) 763-5394 (o)
(480) 763-5320 (f)
erenken@alliance-medical.com |
| Date of preparation: | February 25, 2005 |
| Name of device: | Trade/Proprietary Name: Reprocessed Phacoemulsification Tips
Classification Name: Phacofragmentation System |
| Predicate Device
K911808 | 510(k) Title
Alcon® Series 20,000® Legacy®
Manufacturer
Alcon® Surgical, Inc. |
| Device description: | Phacoemulsification Tips are used to emulsify and excise
cataract tissue in ophthalmic microsurgical procedures. When
connected to the ultrasonic handpiece of a phacoemulsification
system and activated, the Phacoemulsification Tip vibrates at an
ultrasonic frequency that emulsifies cataract tissue. The
extracted tissue is then aspirated away through the hollow tip.
Irrigation of the eye with a saline solution compensates for the
loss of volume in the eye when the cataract tissue is removed. |
| Intended use: | Reprocessed Phacoemulsification Tips are intended to emulsify
and excise cataract tissues in ophthalmic microsurgical
procedures. |
| Indications
statement: | Reprocessed Phacoemulsification Tips are indicated for use to
emulsify and excise cataract tissues in patients requiring eye
surgery. |
| Technological
characteristics: | The design, materials, and intended use of Reprocessed
Phacoemulsification Tips are identical to the predicate devices.
The mechanism of action of Reprocessed Phacoemulsification
Tips is identical to the predicate devices in that the same
standard mechanical design, materials, and sizes are utilized.
There are no changes to the claims, intended use, clinical
applications, patient population, performance specifications, or
method of operation. In addition, Alliance Medical Corporation's
reprocessing of Phacoemulsification Tips includes removal of
adherent visible soil and decontamination. Each individual
Phacoemulsification Tip is tested for appropriate function of its
components prior to packaging and labeling operations. |
Alliance Medical Corporation Reprocessed Phacoemulsification Tips
1
Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of Reprocessed Phacoemulsification Tips. This included the following tests:
- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation .
- . Function test(s)
- . Packaging Validation
Performance testing demonstrates that Reprocessed Phacoemulsification Tips perform as originally intended.
Alliance Medical Corporation concludes that the modified Conclusion: devices (Reprocessed Phacoemulsification Tips) are safe, effective, and substantially equivalent to the predicate devices as described herein.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes, creating a sense of unity or interconnectedness.
SEP 2 3 2005
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alliance Medical, Inc. c/o Ms. Elizabeth Renken Regulatory Specialist 10232 South 51st Street Phoenix. AZ 85044
Re: K050518
KU50518
Trade/Device Name: Alliance Reprocessed Phacofragmentation Needles
1778 Trade/Device Name: 178 Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: NKX Dated: May 4, 2005 Received: August 29, 2005
Dear Ms. Renken:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(tx) prematic is substantially equivalent (for the indications
referenced above and have determined the device is subscripted in interstate referenced above and nave detellinited the arreted predicate devices marketed in interstate for use stated in the enclosure) to tegally manced te of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment the engagions of the Federal Food. commerce prior to May 28, 1970, the encomence with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance whatest approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act The and Cosmetic Act (Act) that do not require appear of the general controls provisions of the Act. The You may, therefore, market the device, subject to the gents for annual registration, listing of general controls provisions of the receined required.
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 If your device is classified (see adver) mo entirely significal sifecting your device can
may be subject to such additional controls. Existing major regulations affective FD may be subject to such additional controlist Existing insults 898 In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 899 be found in the Code of Federal Regarates.
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 Please be advised that FDA s issualic of a substitution on the requirements of the Act
that FDA has made a determination that your device accepains. You must that HDA has made a delermination inal your areas by other Federal agencies. You must
or any Federal statutes and regulations administered to: registration and listin or any Federal statures and regilances and unities and linited to: registration and listing (21)
comply with all the Act's requirements, including, but not securements as set comply with an the Act S requirements, monanagements practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good if emplicable, the electronic CFR Part 807); labeling (21 CFR 1 at 607); good manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000, 1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Elizabeth Renken
This letter will allow you to begin marketing your device as described in your Section 510(k)
the same of the many of a first of a least of souvelenee of your device to a le This letter will allow you to begin marketing your article as assisteme of your device to a legally
premarket notification. The FDA finding of substantial end this permits v premarket notification. The FDA inding of substanted by 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
rs the same of the same and as a the same of a regulation entitled If you desire specific advice for your device on our acoming the regulation entitled,
contact the Office of Compliance at (301) 827-8910. Also, please note of the Mourmay ob contact the Office of Computation in (301) 027 07 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification the Division of Small "Misbranding by relerence to prematics nontheaton"