(33 days)
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Not Found
No
The summary describes a phaco tip, a physical surgical instrument, and contains no mention of software, algorithms, or AI/ML terms.
Yes
The device is described as assisting in ophthalmic surgery to remove cataract tissue, which is a therapeutic intervention.
No
Explanation: The device is intended for surgical removal of cataract tissue, which is a treatment, not a diagnostic purpose.
No
The device is described as a "Phaco Tip," which is a physical component used in ophthalmic surgery. The description of its intended use in conjunction with an ultrasonic handpiece further confirms it is a hardware device, not software.
Based on the provided information, the Paradigm Phaco Tip is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ophthalmic surgery to remove cataract tissue." This is a surgical procedure performed directly on the patient's body (in vivo).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
The Paradigm Phaco Tip is a surgical instrument used during a surgical procedure, not a device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The Paradigm Phaco Tip is intended to be used in conjunction with an ultrasonic handpiece for ophthalmic surgery to remove cataract tissue.
Product codes
86 HQC
Device Description
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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
ophthalmic
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
.JAN 20 1998
Mr. Richard Dirkson Regulatory/ Quality Affairs Paradigm Medical Industries, Inc. 1772 West 2300 South Salt Lake City, Ut. 84119
Re: K974719/S1 Trade Name: Phacopak Regulatory Class: II Product Code: 86 HQC Dated: December 16, 1997 Received: December 18, 1997
Dear Mr. Dirkson:
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.
1
Page 2 - Mr. Richard Dirkson
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. Raeyl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 2
510(K) Number K974719
..............................................................................................................................................................................
Device Name: Phaco Tip
:
Indications For Use:
: 上
The Paradigm Phaco Tip is intended to be used in conjunction with an ultrasonic handpiece for ophthalmic surgery to remove cataract tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
:
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Division Sign-Off | |
|---|---|
| Division of Ophthalmic Devices | |
| 510(k) Number | K974719 |
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use |
|---|
| (Optional Format 1-2-96) |