(91 days)
Not Found
No
The description focuses on the mechanical and ultrasonic action of the phaco tip and does not mention any AI or ML components or functionalities.
Yes
The device directly performs phacofragmentation of the cataractous lens, which is a therapeutic intervention to remove cataracts.
No
The device, a phaco tip, is used for the automated phacoemulsification of a natural crystalline lens, which involves the physical breakdown and removal of the lens. It assists in a surgical procedure, not in diagnosing a condition.
No
The device description explicitly states that the submission is for a "phaco tip," which is a physical component of a phacoemulsification system and undergoes bench testing and process validation for cleaning, sterilization, and packaging. This indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the automated phacoemulsification of a natural crystalline lens." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a mechanical device (phaco tip) used for fragmenting and removing the lens during surgery. It does not describe a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and surgical.
N/A
Intended Use / Indications for Use
The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.
Product codes (comma separated list FDA assigned to the subject device)
NKX, HQC
Device Description
The phaco tip is a component of the phacoemulsification system. The tip is attached to an ultrasonic transducer. When properly stimulated, the transducer lengthens and shortens, causing the tip to oscillate at a specific frequency usually between 27 to 64 kHz. Phacofragmentation of the cataractous lens is accomplished by the action of the phaco tip, a hollow needle located centrally in the device handpiece. When the device is used in the phacofragmentation mode both irrigation and aspiration occur simultaneously. The irrigating solution enters the eye via a collinear axial lumen, which encircles the phaco tip. The fragmentation process is the result of combined mechanical and ultrasonic action induced by the oscillating phaco tip. The cataractous lens and its fragments are disrupted by the phaco tip during the procedure and removed due to the pump suction at the phaco tip orifice. This submission is for the phaco tip only.
The phaco needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
natural crystalline lens
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)
Functional and Safety Testing: Representative samples of phaco tips underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Alcon Limited Reuse Ultrasonic Tip (K981103), Phaco Tip (K914229), Surgin High Efficiency Phaco Tip (K943102)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
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 circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three bars above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SterilMed, Inc. % Dr. Bruce Lester Vice President Research and Development 11400 73td Avenue, North Minneapolis, MN 55369
1 2004 NOV
Re: K012579 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: NKX Dated: October 15, 2001 Received: October 22, 2001
Dear Dr. Lester:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on November 8, 2001. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.
1
Page 2 - Dr. Bruce Lester
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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.
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
David Whipple
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
2
ENCLOSURE
The following OEM models are covered under SVS for Phaco Tips (K012579):
ALCON
ALLERGAN, INC.
Small-Incision™ Phaco Tip 20 Gauge (0.9 mm)
-
54158 5430S 54458 5430H05 5430H20
Fluid-Dynamic™ Phaco Tip 19 Gauge (1.0 mm) -
5115 2115F 2130 5130F 5145 5145F 6130 6130F 6145F
Turbosonics 20000 Legacy
| 20130M | 8065740632 |
|---|---|
| 20130MM | 8065740633 |
| 20130MV | 8065740634 |
| 20130S | 8065740635 |
| 20145 | 8065749847 |
| 20145MM | 8065740848 |
| 20145MV | 8065740849 |
| 20145S | 8065740850 |
| 20130K | 8065740887 |
| 20130KMM | 8065740888 |
| 20130KMV | 8065740889 |
| 20130KS | 8065740890 |
AMO Titan™ Tips
OM342302E OM342302A OM342302B OM342302C
OPTIKON
3
Indications for Use
510(k) Number (if known):
Device Name:
Reprocessed Phaco Tip
Indications For Use:
The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dr. Callaway
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K012579
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
4
NOV 0 8 2001
SECTION 2. SUMMARY AND CERTIFICATION
A. 510(k) Summary
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Patrick Fleischhacker |
| 11400 73rd Avenue North | |
| Minneapolis, MN 55369 | |
| Ph: 763-488-3400 | |
| Fax: 763-488-3350 | |
| Date Prepared: | August 7, 2001 |
| Trade Name: | Reprocessed Phaco Tips |
| Classification Name: | |
| and Number: | Phacofragmentation Needle |
| Class II, 21 CFR 886.4670 | |
| Product Code: | HQC |
| Predicate Device(s): | The reprocessed phaco tip is substantially equivalent to: |
| Alcon Limited Reuse Ultrasonic Tip (K981103), | |
| manufactured by Alcon; Phaco Tip (K914229), | |
| manufactured by Tri-Star Ophthalmic; Surgin High | |
| Efficiency Phaco Tip (K943102), manufactured by Surgin; | |
| and the counterpart devices from the original | |
| manufacturer. | |
| Device Description: | The phaco tip is a component of the phacoemulsification |
| system. The tip is attached to an ultrasonic transducer. | |
| When properly stimulated, the transducer lengthens and | |
| shortens, causing the tip to oscillate at a specific frequency | |
| usually between 27 to 64 kHz. Phacofragmentation of the | |
| cataractous lens is accomplished by the action of the phaco | |
| tip, a hollow needle located centrally in the device | |
| handpiece. When the device is used in the | |
| phacofragmentation mode both irrigation and aspiration | |
| occur simultaneously. The irrigating solution enters the eye | |
| via a collinear axial lumen, which encircles the phaco tip. | |
| The fragmentation process is the result of combined | |
| mechanical and ultrasonic action induced by the oscillating | |
| phaco tip. The cataractous lens and its fragments are | |
| disrupted by the phaco tip during the procedure and | |
| removed due to the pump suction at the phaco tip orifice. | |
| This submission is for the phaco tip only. |
5
Intended Use:
Functional and Safety Testing:
Conclusion:
The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.
Representative samples of phaco tips underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
The reprocessed phaco tips are substantially equivalent to the Alcon Limited Reuse Ultrasonic Tip (K981103), manufactured by Alcon; Phaco Tip (K914229), manufactured by Tri-Star Ophthalmic; Surgin High Efficiency Phaco Tip (K943102), manufactured by Surgin and the counterpart devices from the original manufacturer.
6
| Device
Characteristics | SterilMed's Reprocessed Phaco
Tips | Alcon Limited Reuse
Ultrasonic Tip
(K981103) | Tri-Star Ophthalmic
Phaco Tip (K914229) | Surgin High
Efficiency
(K943102) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|--------------------------------------------|----------------------------------------|
| Device
Description | The phaco needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece. | Same | Same | Same |
| Intended Use | The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens. | Same | Same | Same |
| Principles of
Operation | The needle is the component of a phaco system which, as driven by the ultrasonic handpiece, contacts and fragments the crystalline lens.
Irrigation fluid flows between the external surface of the needle and the internal surface of an irrigation sleeve and into the eye. The emulsified lens material and irrigant are aspirated from the eye through the lumen of the phaco needle. | Same | Same | Same |
| Needle Tip Bevel
Angle | 0°-45° Round
30°-60°Oval
30° or 45° Kelman | 15-45° Round
30° or 45° Oval | 30° or 45° Round
30° or 45° Oval | 15-45° Round
30° or 45° Oval |
| Shaft Shape | Straight or curved | Same | Same | Same |
| Outer Diameter | 19-20 Gage | 19-20 Gage | Unknown | 19-20 Gage |
| Materials | Same* | Titanium alloy tip | Titanium alloy tip | Titanium alloy
tip |
| Sterility | EtO SAL 10⁻⁶ | EtO Sterilization or
Radiation Sterilization | Radiation Sterilization | Unknown |
| Product Code | HOC | Same | Same | Same |
Table 1: Comparison of Subject Devices' and Predicate Devices' Characteristics
*Same materials as Alcon Phaco Tips, Tri-Star Phaco Tips, Surgin Phaco Tips or previously approved devices.