(86 days)
No
The summary explicitly states the device "contains no software or firmware" and is controlled by the host console's amplified signal, indicating a lack of AI/ML components.
Yes
The device is intended for "precision surgical tissue removal" in ophthalmic procedures, indicating it directly performs a therapeutic action.
No
The device is described as an accessory for ophthalmic surgical procedures, specifically for precision tissue removal, and not for identifying or diagnosing a medical condition.
No
The device description explicitly lists multiple hardware components (Power Pack Console, Connector Cables, Tmesis™ multi-function handpiece, Adjunct Footswitch, Ultra Tip™ Pack) and states that it contains no software or firmware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cataract surgery or other ophthalmic surgical procedures where precision surgical tissue removal is required." This describes a surgical device used during a procedure on a patient, not a device used to examine specimens in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description details a surgical accessory that replaces a handpiece on a phaco emulsifier system. It focuses on surgical capabilities like ultrasonic power and tissue removal.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
The device is clearly intended for use in a surgical setting for therapeutic purposes (tissue removal), which is outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Synergist™ Power Pack is intended for use in cataract surgery or other ophthalmic surgical procedures where precision surgical tissue removal is required.
Product codes
Not Found
Device Description
The Synergist™ Power Pack is an accessory device that operates in conjunction with currently marketed Phaco Emulsifier Aspirator Systems used in ophthalmic surgery. The Synergist™ replaces the ultrasonic handpiece of the host console. As such, it is intended for use in cataract surgery or other ophthalmic surgical procedures where precision surgical tissue removal is required. The Synergist™ delivers two distinct surgical capabilities: 1) load compensating ultrasonic handpiece power, and 2) Tmesis™ multifunction handpiece capability.
The Synergist™ Power Pack consists of:
Power Pack Console Connector Cables Tmesis™ multi-function handpiece, Adjunct Footswitch Ultra Tip™ Pack in various configurations
The Synergist™ Power Pack utilizes the programmable features of the Phaco Emulsifier host console but contains no software or firmware. It is controlled by the amplified signal of the host console by measuring the handpiece output of the host console and establishing that exact power level to the connected handpiece. Displayed power levels and energy summations on the host console are precisely maintained by the Synergist™. The Power Pack neither provides or utilizes power from the host console.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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
APR 2 4 1996
SECTION 14: SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
- Submitter's name, address, telephone number, contact person, and date summary 1. prepared;
- Chiron Vision Corporation a. 555 West Arrow highway Claremont, CA 91711
- Judy F. Gordon, D. V. M. Contact Person: b. Vice President, Scientific Affairs
Judy L. Gordon
Date Summary Prepared: January 26, 1996 C.
- Name of device, including trade name and classification name: 2.
- Synergist™ Power Pack Trade/Proprietary Name: a.
- b. Classification Name: Phacofragmentation System
-
- Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
Company: Chiron Intraoptics
Phacotron ™Gold Multifunction Ultrasonic (Tmesis"M) Handpiece Device:
510(k) : K925631
Date Cleared: July 29, 1993
)
1
- A description of the device that is the subject of the 510(k), including explanation of how 4. the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The Synergist™ Power Pack is an accessory device that operates in conjunction with currently marketed Phaco Emulsifier Aspirator Systems used in ophthalmic surgery. The Synergist™ replaces the ultrasonic handpiece of the host console. As such, it is intended for use in cataract surgery or other ophthalmic surgical procedures where precision surgical tissue removal is required. The Synergist™ delivers two distinct surgical capabilities: 1) load compensating ultrasonic handpiece power, and 2) Tmesis™ multifunction handpiece capability.
The Synergist™ Power Pack consists of:
Power Pack Console Connector Cables Tmesis™ multi-function handpiece, Adjunct Footswitch Ultra Tip™ Pack in various configurations
The Synergist™ Power Pack utilizes the programmable features of the Phaco Emulsifier host console but contains no software or firmware. It is controlled by the amplified signal of the host console by measuring the handpiece output of the host console and establishing that exact power level to the connected handpiece. Displayed power levels and energy summations on the host console are precisely maintained by the Synergist™. The Power Pack neither provides or utilizes power from the host console.
ട്. Statement of intended use:
The Synergist™ Power Pack is intended for use in cataract surgery or other ophthalmic surgical procedures where precision surgical tissue removal is required.
065
2
- Statement of how the technological characteristics of the device compare to those of the 6. predicate or legally marketed device.
| Characteristic | Synergist™ Power Pack | Phacotron™ Gold Multifunction Handpiece |
|---|---|---|
| Intended use | Cataract/ophthalmic surgery | Cataract/ophthalmic surgery |
| Operating principle | Equivalent to US handpiece | |
| impedance matched | Equivalent to US handpiece | |
| impedance matched | ||
| Console controlled via | ||
| standard footswitch | Console controlled via | |
| standard footswitch | ||
| External module | Internal module | |
| Independent power supply | Phaco console power supply | |
| Operating frequency-40khz | Operating frequency-40kHz |
The operating principals listed above compare the principles of operation of the system with the module contained within the host console (predicate 510(k) ) and with the module contained in a external housing (subject 510(k)). The characteristics of the multifunction handpiece vs. predicate devices is set forth in the 510(k) for the Phacotron™ Gold Multifunction Handpiece, a copy of which is provided in Section 11.
Materials
Standard materials used in Phaco Emulsifier Aspirator consoles and handpieces
Standard materials used in Phaco Emulsifier Aspirator consoles and handpieces
066