(175 days)
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Not Found
No
The 510(k) summary describes a standard phacoemulsification handpiece and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for "surgical removal of cataract tissues or other unwanted eye tissue," which is a therapeutic intervention.
No
The device description clearly states its purpose is for "surgical removal of cataract tissues or other unwanted eye tissue" and to "break up (emulsify) and remove unwanted or degenerative tissues". This describes a therapeutic, not a diagnostic, function.
No
The device description explicitly states it is a "phacoemulsification handpiece" and includes hardware components like a "Piezoelectric driver module" and is used with "standard, disposable phaccemulsification needles". This indicates it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Whittingham UltraClean Phaco Handpiece is a surgical tool used during a surgical procedure to physically break up and remove tissue from the eye. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "surgical removal of cataract tissues or other unwanted eye tissue." This is a surgical intervention, not a diagnostic test.
Therefore, based on the provided information, the Whittingham UltraClean Phaco Handpiece is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Whittingham UltraClean Phaco Handpiece is intended for use as a component of a phacemulsification surgical system, in the surgical removal of unwanted or degencrative tissues, such as cataract tissue.
The Whittingham UltraClean Phaco Handpiece is indicated for surgical removal of cataract tissues or other unwanted eye tissue.
Product codes
86 HQC
Device Description
The Whittingham UltraClean Phaco Handpiece is a phacoemulsification handpiece, for use with standard, disposable phaccemulsification needles, a 39 to 55 KHz Piezoelectric driver module, and the associated ophthalmic surgical system control units. A handpiece such as this is used in ophthalmic surgery to break up (emulsify) and remove unwanted or degenerative tissues, such as cataract tissue.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
eye
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Allergan Model 5000 Ophthalmic Surgical System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/1 description: The image shows two long, thin objects, possibly tools or instruments, lying horizontally against a white background. The objects appear to be made of metal or a similar material, and they have a dark color. The top object has a more complex shape with some angular features, while the bottom object is more streamlined and cylindrical.
William F. Whittingham 22 Flores Foothill Ranch, CA 92610
UltraClean Phaco
William F. Whittingham Premarket Notification Whittingham UltraClean Phaco Handpicc
2 5 1997
Part D. 510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of SMDA 1990, and 21 CFR 807.92:
A. Submitter: William F. Whittingham, 22 Flores Rd., Foothill Ranch, California 92610. Contact: (714) 855-0535; (714) 380-1523 (F).
B. Name of Device: Whittingham UltraClean™ Phaco Handpiexe
C. Predicate Device: Allergan Model 5000 Ophthalmic Surgical System
D. Description of the New Device: The Whittingham UltraClean Phaco Handpiece is a phacoemulsification handpiece, for use with standard, disposable phaccemulsification needles, a 39 to 55 KHz Piezoelectric driver module, and the associated ophthalmic surgical system control units. A handpiece such as this is used in ophthalmic surgery to break up (emulsify) and remove unwanted or degenerative tissues, such as cataract tissue.
E. Intended Use: The Whittingham UltraClean Phaco Handpicce is intended for use as a component of a phacemulsification surgical system, in the surgical removal of unwanted or degencrative tissues, such as cataract tissue.
F. Comparison of Technological Features: The Whittingham UltraClean Phaco Handpiece shares the same general technological characteristics as the predicate device. Both the new and predicate devices are components of a surgical phacofragmentation system which includes attachments and controls for irrigation solutions, and aspiration of tissues and fluids. The standard driver unit operates on 110 v of alternating current. Both phaco handpieces are self cooling, autoclavable, and incorporate a piezoelectric motor operating at 39 to 55 KHz to vibrate an attached phaco needle. Both phaco handpicces accept a standard phaco needle.
Design improvements to the new device include changes that allow 1) the new device to be taken apart for cleaning; 2) the outer shell to be rotated so that attached connectors can be rotated out of the surgeon's line of vision; and 3) the irrigation fluid to be delivered without creating cavitation bubbles, and conscruently improving the surgeon's view of the surgical field. These changes are exported to enhance the safety and effectiveness of the device.
Signed,
William F. Whittingham
8/29/97
date
Phone: (714 ) 380-1458
Fax: (714) 380-1523
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Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of what appears to be a caduceus, a symbol often associated with healthcare, featuring a staff entwined with snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 25 1997
Mr. William F. Whittingham 22 Flores Foothill Ranch, CA 92610
Re: K972063
Trade Name: Whittingham UltraClean™ Phaco Handpiece Regulatory Class: II Product Code: 86 HQC Dated: August 29, 1997 Received: September 4, 1997
Dear Mr. Whittingham:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. William F. Whittingham
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
William F. Whittingham Premarket Notification .......... gham UltraClean Phaco Handpiece
Indications for Use __________
| 510(k) Number: | K972063 |
|---|---|
| ---------------- | --------- |
Device Name:
Whittingham UltraClean Phaco Handpiece
Indications for Use:
The Whittingham UltraClean Phaco Handpiece is indicated for surgical removal of cataract tissues or other unwanted eye tissue.
Naisha K. Dick-Nichols
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use سيا (Per 21 CFR 801.109)
or
Over-the-Counter Use
000010