(60 days)
Not Found
No
The summary describes a mechanical device (phacoemulsification needles) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used to remove a cataractous crystalline lens, which is a medical treatment, thus qualifying it as a therapeutic device.
No
Explanation: The device is described as an accessory to a phacoemulsification handpiece, intended for the "ultrasonic surgical removal of the cataractous crystalline lens." This describes a therapeutic, not a diagnostic, function.
No
The device description clearly states it is a "cylindrical, metal tip" and a "component of a phaco system," indicating it is a physical hardware accessory, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Function: The Storz MicroFlow Plus, MicroFlow Plus Angled, and Standard Angled Phacoemulsification Needles are surgical tools used directly within the eye to fragment and remove the crystalline lens during cataract surgery. They are not used to analyze specimens taken from the body.
- Intended Use: The intended use clearly states "intended for use in the ultrasonic surgical removal of the cataractous crystalline lens." This is a surgical procedure, not an in vitro diagnostic test.
Therefore, based on the provided information, this device is a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The new Storz MicroFlow Plus, MicroFlow Plus Angled, and Standard Angled Phacoemulsification Needles are accessories to a phacoemulsification handpiece, which is intended for use in the ultrasonic surgical removal of the cataractous crystalline lens.
Product codes
86 HQC
Device Description
A phaco needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Crystalline lens (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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K954340, K952259, K943102, K946176
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.
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Image /page/0/Picture/0 description: The image shows the word "storz" in white letters against a black background. The letters are stylized and bold. There is a circled R symbol in the upper right corner of the image.
JUN 17 1997
Storz Instrument Company Storz MicroFlow Plus, Storz MicroFlow Plus Angled, and Storz Standard Angled Phacoemulsification Needles 510(k) Summary of Safety and Effectiveness
The following information is submitted in accordance with the requirements of 21 CFR § 807.92:
Submitted by:
Mill H. Satter
Michael H. Southworth RAC Group Manager, Regulatory Affairs Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis, MO 63122
Contact Person: Patrick G. Balsmann, 314-225-5051, ext. 5538
Date Prepared: 16 April 1997
Proprietary Name: Storz MicroFlow Plus, Storz MicroFlow Plus Angled, and Storz Standard Angled Phacoemulsification Needles
Common/Usual Name: Phacoemulsification Needles
Classification Name: System, Phacofragmentation, 86(HQC). Phacoemulsification needles are accessories to "Phacofragmentation Systems" which are Class II medical devices in accordance with 21 CFR § 886.4670.
Intended Use: The new Storz MicroFlow Plus, MicroFlow Plus Angled, and Standard Angled Phacoemulsification Needles are accessories to a phacoemulsification handpiece, which is intended for use in the ultrasonic surgical removal of the cataractous crystalline lens.
Device Description: A phaco needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece. 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.
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Predicate Devices: The Storz MicroFlow Plus, Storz MicroFlow Plus Angled, and Storz Standard Angled Phacoemulsification Needles are substantially equivalent to legally marketed predicate devices. The Storz MicroFlow Plus and Storz MicroFlow Plus Angled Phaco Needles are subsatantially equivalent to the existing Storz MicroFlow Phaco Needles (K954340), the Storz MicroSeal Phaco Needles (K952259), and the Surgin High-Performance Phaco Tips (K943102). The Storz Standard Angled Phaco Needles are substnatially equivalent to the existing Storz Standard Phaco Needles (K946176) and the Surgin High-Performance Phaco Tips (K943102). Charts comparing basic characteristics of these new Storz Phaco Needles to those of the predicate devices, demonstrating substantial equivalence, are attached.
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| Device
Characteristic | Storz MicroFlow Plus | Storz MicroFlow Plus,
Angled | Storz MicroFlow | Storz MicroSeal | Surgin High-
Efficiency |
|-----------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------|
| 510(k) | present | present | K954340 | K952259 | K943102 |
| Intended Use | Accessory to phaco
handpiece used in lens
removal. | Accessory to phaco
handpiece used in lens
removal. | Accessory to phaco
handpiece used in lens
removal. | Accessory to phaco
handpiece used in lens
removal. | Accessory to phaco .
handpiece used in lens
removal. |
| Number of
Models | Four | Four | Four | Two | Two |
| Model Variations | Needle tip bevel angle | Needle tip bevel angle | Needle tip bevel angle | Needle tip bevel angle | Degree angled shaft |
| Angled Shaft | No | Yes | No | No | Yes |
| Material(s) | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Titanium
(alloy unknown) |
| Needle I.D.
(inches) | 0.024 | 0.024 | 0.020 | 0.024 | 0.026 |
| Needle O.D.
(inches) | 0.046 | 0.046 | 0.046 | 0.042 | 0.036 |
| Recommended
Surgical Incision
Size (mm) | 2.8 | 2.8 | 2.5 | 2.5 | 2.75 |
| Number of Uses
Recommended | 10 | 10 | 10 | 5 | Unknown |
(
{
Substantial Equivalence Chart Storz MicroFlow Plus and MicroFlow Plus Angled Phaco Needles
ਾ ਨੇ
(
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Substantial Equivalence Chart Storz Standard Angled Phaco Needles
| Device Characteristic | Storz Standard, Angled | Storz Standard | Surgin High-
Efficiency |
|-----------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|
| 510(k) | present | K946176 | K943102 |
| Intended Use | Accessory to phaco
handpiece used in lens
removal. | Accessory to phaco
handpiece used in lens
removal. | Accessory to phaco
handpiece used in lens
removal. |
| Number of Models | Three | Three | Two |
| Model Variations | Needle tip bevel angle | Needle tip bevel angle | Degree angled shaft |
| Angled Shaft | Yes | Yes | Yes |
| Material(s) | Ti-6Al-4V | Ti-6Al-4V | Titanium
(alloy unknown) |
| Recommended
Surgical Incision Size
(mm) | Unspecified
(3.2 mm typical) | Unspecified
(3.2 mm typical) | 2.75 |
| Needle I.D. (inches) | 0.036 | 0.036 | 0.026 |
| Needle O.D. (inches) | 0.042 | 0.042 | 0.036 |
| Number of Uses
Recommended | Unspecified | Unspecified | Unknown |
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 17 1997
Mr. Michael H. Southworth, RAC Group Manager, Regulatory Affairs Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis, MO 63122-6694
Re: K971439
Trade Name: Storz MicroFlow Plus, Storz MicroFlow Plus Angled, and Storz Standard Angled Phacoemulsification Needles Regulatory Class: II Product Code: 86 HQC Dated: April 16, 1997 Received: April 18, 1997
Dear Mr. Southworth:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 unnouncements 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. Michael H. Southworth, RAC
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
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Image /page/6/Picture/0 description: The image shows the word "storz" in white letters on a black background. The letters are stylized and have a unique font. There is a registered trademark symbol to the right of the word.
INDICATIONS FOR USE
| Device Name: | Storz MicroFlow Plus, Storz MicroFlow Plus Angled, and Storz
Standard Angled Phacoemulsification Needles |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | The Storz MicroFlow Plus, MicroFlow Plus Angled, and Standard
Angled Phacoemulsification Needles are accessories to a
phacoemulsification handpiece, intended for use in the ultrasonic
surgical removal of the cataractous crystalline lens. |
Emeath R. Been
(Division Sign-Off)
Division of Ophthalmic Devices 510(k) Number_ K971439
Prescription Denied ✓