(60 days)
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.
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.
The provided document is a 510(k) summary for Storz MicroFlow Plus, Storz MicroFlow Plus Angled, and Storz Standard Angled Phacoemulsification Needles. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that a device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain information about acceptance criteria, a specific study proving the device meets them, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established in the context of a clinical performance study.
Instead, the document focuses on demonstrating substantial equivalence based on device characteristics, intended use, and materials compared to several predicate devices.
Here's a breakdown of why the requested information cannot be fully provided from this document:
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A table of acceptance criteria and the reported device performance: This document does not establish new acceptance criteria. It compares the device's characteristics to those of predicate devices to establish substantial equivalence. The tables provided (on pages 2 and 3) are "Substantial Equivalence Charts" comparing device characteristics, not performance against pre-defined acceptance criteria.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or clinical data is presented for this 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No ground truth established by experts is mentioned as this is not a study assessing diagnostic or clinical performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there is no test set or clinical study.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a phacoemulsification needle, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a surgical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth was established for a performance study.
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The sample size for the training set: Not applicable as there's no machine learning algorithm involved requiring a training set.
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How the ground truth for the training set was established: Not applicable as there's no machine learning algorithm involved requiring a training set.
Summary based on the document:
The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. The "study" referenced in the prompt (if considering the 510(k) process as a form of "study" for regulatory clearance) is a comparison of device characteristics to existing, legally marketed devices.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the Substantial Equivalence Charts):
While not framed as "acceptance criteria" in the traditional sense of a clinical trial, the tables compare characteristics of the new devices to predicates. The "acceptance criteria" in this context are implicitly that the new devices share similar fundamental technological characteristics and intended use with the predicate devices, thereby demonstrating safety and effectiveness.
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Storz MicroFlow Plus, MicroFlow Plus Angled, Standard Angled Needles) |
|---|---|---|
| Intended Use | Accessory to phaco handpiece used in lens removal (K954340, K952259, K943102, K946176) | Accessory to phaco handpiece used in lens removal |
| Materials | Ti-6Al-4V (for Storz MicroFlow, MicroSeal, Standard); Titanium (alloy unknown for Surgin High-Efficiency) | Ti-6Al-4V |
| Needle I.D. | Ranging from 0.020 to 0.026 inches (depending on specific predicate) | MicroFlow Plus/Angled: 0.024 inchesStandard Angled: 0.036 inches |
| Needle O.D. | Ranging from 0.036 to 0.046 inches (depending on specific predicate) | MicroFlow Plus/Angled: 0.046 inchesStandard Angled: 0.042 inches |
| Recommended Surgical Incision Size (mm) | Ranging from 2.5 to 2.8 mm, or unspecified (3.2 mm typical) (depending on specific predicate) | MicroFlow Plus/Angled: 2.8 mmStandard Angled: Unspecified (3.2 mm typical) |
| Number of Uses Recommended | Ranging from 5 to 10, or unknown/unspecified (depending on specific predicate) | MicroFlow Plus/Angled: 10Standard Angled: Unspecified |
| Angled Shaft | Yes or No, depending on specific predicate device and model variant | MicroFlow Plus: NoMicroFlow Plus Angled: YesStandard Angled: Yes |
| Model Variations | Needle tip bevel angle; Degree angled shaft (depending on specific predicate) | Needle tip bevel angle (MicroFlow Plus, MicroFlow Plus Angled, Standard Angled) |
Study to Prove Acceptance Criteria:
The "study" is implicitly the submission of the comparison charts and other descriptive information to the FDA, which then determined substantial equivalence. No separate, formal clinical study or performance study is detailed in this 510(k) summary as proof against quantitative acceptance criteria for the new devices. The FDA's letter (pages 4-5) confirms the determination of substantial equivalence.
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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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| DeviceCharacteristic | 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 phacohandpiece used in lensremoval. | Accessory to phacohandpiece used in lensremoval. | Accessory to phacohandpiece used in lensremoval. | Accessory to phacohandpiece used in lensremoval. | Accessory to phaco .handpiece used in lensremoval. |
| Number ofModels | 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 |
| RecommendedSurgical IncisionSize (mm) | 2.8 | 2.8 | 2.5 | 2.5 | 2.75 |
| Number of Uses Recommended | 10 | 10 | 10 | 5 | Unknown |
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Substantial Equivalence Chart Storz MicroFlow Plus and MicroFlow Plus Angled Phaco Needles
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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 phacohandpiece used in lensremoval. | Accessory to phacohandpiece used in lensremoval. | Accessory to phacohandpiece used in lensremoval. |
| 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) |
| RecommendedSurgical 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 UsesRecommended | Unspecified | Unspecified | Unknown |
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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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INDICATIONS FOR USE
| Device Name: | Storz MicroFlow Plus, Storz MicroFlow Plus Angled, and StorzStandard Angled Phacoemulsification Needles |
|---|---|
| Indications For Use: | The Storz MicroFlow Plus, MicroFlow Plus Angled, and StandardAngled Phacoemulsification Needles are accessories to aphacoemulsification handpiece, intended for use in the ultrasonicsurgical removal of the cataractous crystalline lens. |
Emeath R. Been
(Division Sign-Off)
Division of Ophthalmic Devices 510(k) Number_ K971439
Prescription Denied ✓
§ 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.