(288 days)
Not Found
No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the mechanical and fluidic control aspects of the surgical system.
Yes
The device is used for emulsification, separation, irrigation, and aspiration of cataracts, and other surgical procedures within the eye, which are therapeutic interventions aimed at treating a medical condition (cataracts).
No
The description explicitly states the device is for "emulsification, separation, irrigation, and aspiration of cataracts, residual cortical and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection." These are all surgical or therapeutic functions, not diagnostic ones. The device is used to treat conditions, not to identify or characterize them.
No
The device description clearly outlines a physical ophthalmic surgical instrument with handpieces, a footswitch, and fluidics control, indicating it is a hardware-based system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system used for procedures within the eye (emulsification, aspiration, irrigation, vitrectomy, coagulation, IOL injection). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description details a surgical instrument designed for use in cataract extraction and IOL injection procedures performed directly on the patient's eye.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
The device is a surgical system used for performing procedures, not for diagnosing conditions by testing samples outside the body.
N/A
Intended Use / Indications for Use
The CENTURION® Vision system (Active SentryTM) is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection. The AutoSert IOL Injector Handpiece is intended to deliver qualified ACRYSOF intraocular lenses into the eye following cataract removal.
The AutoSert IOL Injector Handpiece achieves the function of intraocular lenses. The AutoSert IOL Injector Handpiece is indicated for use with the ACRYSOF lenses SN6OWF. SNWAD1. SN6AT3 through SN6AT9. as well as approved ACRYSOF lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
Product codes
HQC
Device Description
Alcon's CENTURION ® Vision System is an ophthalmic surgical instrument designed for use in cataract extraction using the CENTURION® OZil® handpiece, the CENTURION® Active Sentry® handpiece, and the INFINITI® OZil® handpiece.
The CENTURION® Vision System is intended for use in small incision cataract lens extraction and IOL injection surgical procedures. This system allows the surgeon to emulsify and aspirate the lens in the eye, while replacing aspirated fluid and lens material with balanced salt solution. This process maintains a stable (inflated) eye chamber volume. Using system controls, the surgeon regulates the amount of power applied to the handpiece tip, the rate of aspiration, vacuum, and the flow of BSS® irrigating solution. The system includes a footswitch to enable the surgeon to control flow of fluidics, aspiration rate, phaco power, vitrectomy cut rate, IOL injection rate, and coagulation power.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance of the CENTURION® Vision System (Active Sentry®) has been demonstrated through various performance validations, biocompatibility testing and electromagnetic compatibility and electrical safety testing.
Biocompatibility Testing for Active Sentry Handpiece:
- Cytotoxicity ISO Elution Method 1X MEM, Cell Line/Species: L-929 Mouse, Test Media Extract: MEM Extract, Result: PASS
- Cytotoxicity ISO MTT Method, Cell Line/Species: L-929 Mouse, Test Media Extract: MEM Extract, Result: PASS
- Sensitization ISO Maximization Sensitization Study, Cell Line/Species: Guinea Pig, Test Media Extract: Saline & Sesame Oil Extracts, Result: PASS
- Acute Systemic Toxicity ISO Acute Systemic Toxicity Study, Cell Line/Species: Mouse, Test Media Extract: Saline & Sesame Oil Extracts, Result: PASS
- Ocular Irritation ISO (Intraocular Injection) Method, Cell Line/Species: Rabbit, Test Media Extract: Balanced Salt Solution (BSS® Irrigating Solution), Result: PASS
- Material Characterization (Leachables) ISO Method, Cell Line/Species: Not Applicable, Test Media Extract: Isopropanol and Purified Water, Result: PASS
Electromagnetic compatibility and electrical safety testing:
- EN 60601-1: 2013, Medical Electrical Equipment, Part 1 – General requirements for basic safety and essential performance. (Including A1:2013) (Equivalent to IEC 60601-1: 2005+ A1: 2012), Result: PASS
- EN 60601-1-2: 2007, Medical electrical equipment Part 1: General requirements for basic safety and essential performance - 2. Collateral Standard: Electromagnetic compatibility-Requirements and test. (Equivalent to IEC 60601-1-2: 2007), Result: PASS
- EN 60601-2-2: 2009, Medical electrical equipment – Part 2: General requirements for basic safety and essential performance - Particular requirements for the Safety of high frequency surgical equipment. (Equivalent to IEC 60601-2-2: 2009), Result: PASS
- EN 60601-1-8: 2007, Medical Electrical Equipment, Part 1: General requirements for basic safety and essential performance - 6. Collateral standard for alarm systems (Equivalent to IEC 60601-1-8: 2006), Result: PASS
- EN 80601-2-58: 2009, Medical Electrical Equipment, Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery (Equivalent to IEC 80601-2-58:2008), Result: PASS
- IEC 60601-1-6: 2010, Medical Electrical Equipment Part 1-6: General requirements for safety - collateral standard: usability (Including A1:2013), Result: PASS
- IEC 62366: 2007, Medical Devices - Application of usability engineering to medical devices (Including A1:2014), Result: PASS
Key results: The modified CENTURION® Vision System (Active Sentry®) is substantially equivalent to the originally submitted CENTURION® Vision System in that both devices:
- have the same indicated use.
- use the same operating principle,
- incorporate the same basic phaco handpiece, same consumables and accessories cleared in the original submission as a system
- use the same technology including components used.
- are of the same design, incorporate the same materials, have the same shelf life, and are packaged and sterilized using the same materials and processes;
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized human figure with three overlapping profiles, creating a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2017
Alcon Research, Ltd. Mr. Paul Swift, RAC Director, Global Regulatory Affairs Project 6201 South Freeway Dr. Fort Worth, TX 76134-2099
Re: K161794
Trade/Device Name: Centurion Vision System (Active Sentry") Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC Dated: March 6, 2017 Received: March 8, 2017
Dear Mr. Swift:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is 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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Bradley S. Cunningham -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161794
Device Name
CENTURION VISION SYSTEM (Active Sentry™)
Indications for Use (Describe)
The CENTURION® Vision system (Active SentryTM) is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection. The AutoSert IOL Injector Handpiece is intended to deliver qualified ACRYSOF intraocular lenses into the eye following cataract removal.
The AutoSert IOL Injector Handpiece achieves the function of intraocular lenses. The AutoSert IOL Injector Handpiece is indicated for use with the ACRYSOF lenses SN6OWF. SNWAD1. SN6AT3 through SN6AT9. as well as approved ACRYSOF lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
5 510(k) Summary
This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.
Submitter of the 510(k)
| Company: | Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099, USA |
|-------------------------|----------------------------------------------------------------------------------|
| Primary Contact Person: | Paul Swift, RAC
Director, Global Regulatory Affairs |
| Phone: | 817.615.2952 |
| Fax: | 817.551.4630 |
| Email: | Paul.Swift@alcon.com |
| Date Prepared: | December 16, 2016 |
Devices Subject to this 510(k)
| Trade Names: | CENTURION® Vision System (Active Sentry® |
|---|---|
| Regulation Number: | 21 CFR 886.4670 |
| Regulation Name: | Phacofragmentation System |
| Regulatory Class: | Class II |
| Product Code: | HQC |
A. Predicate Device
CENTURION Vision System K121555 December 21, 2012
B. Device Description
Alcon's CENTURION ® Vision System is an ophthalmic surgical instrument designed for use in cataract extraction using the CENTURION® OZil® handpiece, the CENTURION® Active Sentry® handpiece, and the INFINITI® OZil® handpiece.
The CENTURION® Vision System is intended for use in small incision cataract lens extraction and IOL injection surgical procedures. This system allows the surgeon to emulsify and aspirate
4
the lens in the eye, while replacing aspirated fluid and lens material with balanced salt solution. This process maintains a stable (inflated) eye chamber volume. Using system controls, the surgeon regulates the amount of power applied to the handpiece tip, the rate of aspiration, vacuum, and the flow of BSS® irrigating solution. The system includes a footswitch to enable the surgeon to control flow of fluidics, aspiration rate, phaco power, vitrectomy cut rate, IOL injection rate, and coagulation power.
C. Indications for Use
The CENTURION® Vision system (Active Sentry®) is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection. The AutoSert IOL Injector Handpiece is intended to deliver qualified ACRYSOF intraocular lenses into the eye following cataract removal.
The AutoSert IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert IOL Injector Handpiece is indicated for use with the ACRYSOF lenses SN6OWF, SNWAD1, SN6AT3 through SN6AT9, as well as approved ACRYSOF lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
5
D. Comparison to Technological Characteristics with the Predicate Device
| Characteristic | CENTURION® Vision System | CENTURION® Vision System
(Active Sentry®) |
|----------------------------------------------------|------------------------------------------------|------------------------------------------------|
| 510 (k) # | K121555 | K161794 |
| Intended Use | Anterior Segment Ophthalmic
Surgery | Anterior Segment Ophthalmic
Surgery |
| Hardware (Modular) Design | Yes | Yes |
| Microprocessor based | Yes | Yes |
| Programmable for multiple
surgeons | Yes | Yes |
| User Interface | Footswitch, Touch Screen and
Remote control | Footswitch, Touch Screen and
Remote control |
| Self-Diagnostics | Yes | Yes |
| Real-Time Display | Yes | Yes |
| Software platform | Windows based | Windows based |
| U/S Pulse Mode | Yes | Yes |
| Heads-Up Display | Yes (optional only) | Yes (optional only) |
| Anterior Vitrectomy | Yes | Yes |
| Posterior Vitrectomy | No | No |
| Occlusion Mode | | |
| Longitudinal | Yes | Yes |
| Torsional | Yes | Yes |
| Operating U/S Frequency | | |
| Longitudinal | 44kHz nominal | 44kHz nominal |
| Torsional | 32kHz nominal | 32kHz nominal |
| Support for ALCON®
UltraChopper® Tip | Yes (K091777) | Yes (K091777) |
| Power Watch Mode | Yes | Yes |
| IOL Injection Mode | Yes | Yes |
| Coagulation/Cautery/Diathermy | Yes | Yes |
| Irrigation | | |
| Gravity | Yes | Yes |
| Pressurized | Yes | Yes |
| Maximum Irrigation Pressure
Threshold (in mmHg) | Less than 207 | Less than 207 |
| Aspiration Pump Type | Peristaltic | Peristaltic |
| Vacuum Range (in mmHg) | 0-650(+) | 0-650(+) |
| Console Screen | Active Matrix color LCD | Active Matrix color LCD |
| Multi-function Foot Pedal | | |
| Wired | Yes | Yes |
| Wireless | Yes | Yes |
| Characteristic | CENTURION®
Vision System | CENTURION® Vision System
(Active Sentry®) |
| Remote Control | Yes(if selected) | Yes(if selected) |
| Automatic IV Pole | Yes | Yes |
| Voice Confirmation | Yes | Yes |
| Prime Mode | Yes | Yes |
| Machine Height Width and
Depth | 63" x 23" x 30" max | 63" x 23" x 30" max |
| Machine Weight | 235 lbs max | 235 lbs max |
| Electrical Power Specifications | 100-240 V AC, 50/60 Hz | 100-240 V AC, 50/60 Hz |
| Operating Temperature Range | 10 - 35°C | 10 - 35°C |
| Maximum Humidity
(RH = Relative Humidity) | 95% RH noncondensing | 95% RH noncondensing |
| Disposable Pack - Provided
Sterile | Yes | Yes |
| Disposable Pack - Method of
sterilization | EtO and Gamma | EtO and Gamma |
Table 1 Substantial equivalence comparison
6
E. Performance Data
Performance of the CENTURION® Vision System (Active Sentry®) has been demonstrated through various performance validations, biocompatibility testing and electromagnetic compatibility and electrical safety testing.
Table 2: Summary of biocompatibility studies for the Active Sentry® Handpiece
| Biocompatibility Testing for
Active Sentry Handpiece | Cell Line/
Species | Test Media Extract | Test
Result |
|--------------------------------------------------------------|-----------------------|------------------------------------------------------|----------------|
| Cytotoxicity
ISO Elution Method 1X MEM | L-929 Mouse | MEM Extract | PASS |
| Cytotoxicity
ISO MTT Method | L-929 Mouse | MEM Extract | PASS |
| Sensitization
ISO Maximization Sensitization
Study | Guinea Pig | Saline & Sesame Oil Extracts | PASS |
| Acute Systemic Toxicity
ISO Acute Systemic Toxicity Study | Mouse | Saline & Sesame Oil Extracts | PASS |
| Ocular Irritation
ISO (Intraocular Injection) Method | Rabbit | Balanced Salt Solution (BSS® Irrigating
Solution) | PASS |
| Material Characterization
(Leachables)
ISO Method | Not Applicable | Isopropanol and Purified Water | PASS |
7
Table 3: CENTURION® Vision System (Active Sentry®) electromagnetic compatibility and electrical safety
| Document
| Number | Revision | Document Name | Result |
|---|---|---|---|
| EN 60601-1 | 2013 | Medical Electrical Equipment, Part 1 – General requirements for basic safety | |
| and essential performance. (Including A1:2013) | |||
| (Equivalent to IEC 60601-1: 2005+ A1: 2012) | PASS | ||
| EN 60601-1- | |||
| 2 | 2007 | Medical electrical equipment Part 1: General requirements for basic safety | |
| and essential performance - 2. Collateral Standard: Electromagnetic | |||
| compatibility-Requirements and test. | |||
| (Equivalent to IEC 60601-1-2: 2007) | PASS | ||
| EN 60601-2- | |||
| 2 | 2009 | Medical electrical equipment – Part 2: General requirements for basic safety | |
| and essential performance - Particular requirements for the Safety of high | |||
| frequency surgical equipment. | |||
| (Equivalent to IEC 60601-2-2: 2009) | PASS | ||
| EN 60601-1- | |||
| 8 | 2007 | Medical Electrical Equipment, Part 1: General requirements for basic safety | |
| and essential performance - 6. Collateral standard for alarm systems | |||
| (Equivalent to IEC 60601-1-8: 2006) | PASS | ||
| EN 80601-2- | |||
| 58 | 2009 | Medical Electrical Equipment, Part 2-58: Particular requirements for the basic | |
| safety and essential performance of lens removal devices and vitrectomy | |||
| devices for ophthalmic surgery (Equivalent to IEC 80601-2-58:2008) | PASS | ||
| IEC 60601-1- | |||
| 6 | 2010 | Medical Electrical Equipment Part 1-6: General requirements for safety - | |
| collateral standard: usability (Including A1:2013) | PASS | ||
| IEC 62366 | 2007 | Medical Devices - Application of usability engineering to medical devices | |
| (Including A1:2014) | PASS |
F. Conclusions
The modified CENTURION® Vision System (Active Sentry®) is substantially equivalent to the originally submitted CENTURION® Vision System in that both devices:
- . have the same indicated use.
- . use the same operating principle,
- . incorporate the same basic phaco handpiece, same consumables and accessories cleared in the original submission as a system
- . use the same technology including components used.
- o are of the same design, incorporate the same materials, have the same shelf life, and are packaged and sterilized using the same materials and processes;
In summary, the changes made to the CENTURION® Vision System (Active Sentry®) described in this submission are substantially equivalent to the predicate device: CENTURION® Vision System.