(371 days)
Not Found
No
The summary describes a mechanical device for cataract surgery and does not mention any AI or ML components or functions.
Yes.
The device is used to emulsify and excise cataract tissues as part of ophthalmic microsurgical procedures, which directly treats a medical condition.
No
This device is used for emulsifying and excising cataract tissues during ophthalmic microsurgical procedures, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a physical tip used in ophthalmic surgery, connected to a handpiece, and vibrates at an ultrasonic frequency. This indicates a hardware component, not a software-only device.
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 vibrates to break down tissue and aspirate it. This is a mechanical action performed during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to perform surgical procedures directly on the body.
N/A
Intended Use / Indications for Use
Reprocessed Phacoemulsification Tips are intended to emulsify and excise cataract 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eye
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 (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 MAR 1 9 2007 Ascent Healthcare Solutions Submitter: 10232 South 51st Street Phoenix, Arizona 85044 Katie Bray Contact: Requlatory Affairs Engineer (480) 763-5386 (o) (480) 763-6089 (f) kbray@ascenths.com March 9, 2007 Date of preparation: Trade/Proprietary Name: Reprocessed Phacoemulsification Tips Name of device: (Mackool) Classification Name: Needle, Phacoemulsification, Reprocessed Manufacturer 510(k) Title Predicate Device Alcon Laboratories ALCON SERIES 20000 LEGACY K955789 MACKOOL SYSTEM Phacoemulsification Tips are used to emulsify and excise Device description: 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. Reprocessed Phacoemulsification Tips are indicated for use to Indications emulsify and excise cataract tissues in patients requiring eye statement: surgery. The design, materials, and intended use of Reprocessed Technological Phacoemulsification Tips are identical to the predicate devices. characteristics: 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
Ascent Healthcare Solutions Reprocessed Phacoemulsification Tips Traditional 510(k)
1
components prior to packaging and labeling operations.
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.
Conclusion:
Alliance Medical Corporation concludes that the modified devices (Reprocessed Phacoemulsification Tips) are safe, effective, and substantially equivalent to the predicate devices as described herein.
Ascent Healthcare Solutions Reprocessed Phacoemulsification Tips Traditional 510(k)
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its head turned to the left and its wings outstretched. The eagle is composed of three curved lines that create a sense of movement and dynamism. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2007
Ascent Healthcare Solutions c/o Ms. Katie Bray Regulatory Affairs Engineer 10232 South 51st Street Phoenix, AZ 85044
Re: K060648
Trade/Device Name: Ascent Reprocessed Phacoemulsification Tips Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: NKX Dated: March 9, 2007 Received: March 12, 2007
Dear Ms. Bray:
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 - Ms. Katie Bray
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egelman M.D.
Malvina B. Evdelman, 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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Indications For Use Statement 2.
510(k) Number (if known):
Device Name: Reprocessed Phacoemulsification Tips
Indications For Use: Reprocessed Phacoemulsification Tips are indicated for use to emulsify and excise cataract tissues in patients requiring eye surgery.
Prescription Use __ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MRRB Nicholas
Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K060648
CONFIDENTIAL
Alliance Medical Corporation Reprocessed Phacoemulsification Tips Traditional 510(k)