(132 days)
Not Found
No
The summary describes a surgical system with standard functions for vitrectomy and does not mention any AI or ML capabilities.
Yes
The device is a surgical system used to perform vitrectomy procedures, which are treatments for various ophthalmic conditions.
No
The device is a surgical system for ophthalmic procedures, and while it can be used for "Removal of samples of vitreous for diagnostic purposes," its primary function is surgical intervention, not diagnosis. The system performs actions like vitreous cutting, aspiration, illumination, and fluid-air exchange, all of which are surgical functions.
No
The device description explicitly states it is an "AC powered device with an internal Li-Ion battery" and a "multifunction footswitch," indicating it is a hardware system, not software-only.
Based on the provided information, the ProCare Plus™ Vitrectomy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical system for performing ophthalmic procedures (vitrectomy, removal of lens fragments, etc.). While it mentions "Removal of samples of vitreous for diagnostic purposes," the device itself is used for the removal of the sample, not for the in vitro diagnostic testing of that sample.
- Device Description: The description details a surgical system with functions like vitreous cutting, aspiration, illumination, and fluid-air exchange. These are all surgical functions, not diagnostic ones performed on samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples in vitro (e.g., reagents, analyzers, test strips).
In summary, the ProCare Plus™ Vitrectomy System is a surgical device used during ophthalmic procedures, including the collection of samples for potential subsequent diagnostic testing. It does not perform the diagnostic testing itself.
N/A
Intended Use / Indications for Use
The ProCare Plus™ Vitrectomy System is a portable surgical system intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries.
The PROCARE PLUS™ Vitrectomy System is indicated for use in support of the following ophthalmic surgical procedures:
- Removal of vitreous in cases of vitreous clouding, diabetic vitreal hemorrhaging, trauma, including contusions, penetrations, and intraocular foreign bodies; opacity, inflammation, endophthalmitis (bacterial or fungal), uvitis
- Removal of lens fragments after cataract surgery;
- Remove vitreous traction under the retina producing localized or complete retinal detachment;
- Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis;
- Treatment of vitreous loss during cataract surgery;
- Clean vitreous strands from the cataract wound;
- Provide internal illumination for vitreous surgery;
- Provide air pressure for maintaining intraocular pressure for retinal surgery.
Product codes (comma separated list FDA assigned to the subject device)
HQE
Device Description
The ProCare PlusTM Vitrectomy System is a portable surgical system intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries.
The ProCare Plus™ Vitrectomy System is an AC powered device with an internal Li-Ion battery that provides backup power in the event that AC power is interrupted.
The system is primarily run from one multifunction footswitch which gives the surgeon control over all of the surgical functions.
The ProCare Plus Vitrectomy system provides many of the functions required by the ophthalmic surgeon for performing a vitrectomy including vitreous cutting and aspiration, illumination, and fluid-air exchange.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior segment, Posterior segment (vitrectomy) ophthalmic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Ophthalmic surgeon
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)
The ProCare Plus Vitrectorny System has passed all safety tests for demonstrated compliance with the applicable non-clinical tests below:
- IEC 60601-1 Medical equipment/medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical Electrical Equipment - Part 1: General requirements for safety to collateral Standard: Electromagnetic Compatibility requirements and tests.
- EN ISO 15004-2 Ophthalmic instruments - Fundamental requirements and test methods -- Part 2: Light hazard protection
- ISO 11137-1 Sterilization of Health Care Product Requirements for Validation and Routine Control-Radiation Sterilization
- ISO 11137-2 Sterilization of health care products-Radiation-Part 2: Establishing the sterilization dose.
- ISO 11737-1 Sterilization of medical devices-Microbiological methods-Part 1: Determination of a population of microorganisms on products.
- ISO 11737-2 Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
- ISO 11607-1 Packaging for Terminally Sterilized Medical Devices
- IEC 62471 Photobiological Safety of lamps and lamp systems
In-House Testing:
- P1-112411 Main AC Electrical System
- P1-112511 Internal DC Electrical System
- P1-112611 Pneumatic Cutting System
- P1-112711 Pneumatic Air Exchange System
- P1-112811 Vacuum System
- P1-112911 Lightsource
- P1-113011 Battery Performance Testing
- P1-113111 Pneumatic Handpiece Testing
- P1-113211 Ergonomics/Portable System Testing
- P1-113311 Medical Air Gas Cylinders & Regulators
- FP1-113411 Foot Control
- P1-051112 Pneumatic Handpiece HSP Burst Testing
Summary: Updated technology has been extensively tested to recognized standards. The technological characteristics affecting the performance of the system are substantially equivalent to those of the predicate devices previously listed.
The ProCare Plus Vitrectorny System will be manufactured in compliance with FDA and ISO quality system requirements. System validation and verification will demonstrate that the functional requirements and system specifications have been met prior to commercial release.
Based upon the design, intended use, indications for use, classification, and safety testing the ProCare Plus Vitrectomy System is substantially equivalent, in whole or part, to the listed predicate devices (K980480, K904909, and K896622).
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.
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
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
MAY 3 0 2012
Image /page/0/Picture/1 description: The image shows a logo with the text "VISIONCARE DEVICES" at the bottom. Above the text, there are three mountain-like shapes with the letters "VCD" in between. At the top of the image, there is a handwritten number "K120170".
1246 Redwood Blvd.
Redding, California 96001 (530) 243-5047
| 5 | 510(K) Summary | |
|---|---|---|
| 5.1 | Date Prepared: | 1/13/2012 |
| 5.2 | 510(K) Submission | |
| Type: | This is a traditional 510(K) | |
| 5.3 | Submitter/Owner: | VisionCare Devices, Inc. |
| FDA #2939964 | ||
| 1246 Redwood Boulevard | ||
| Redding, California 96003 | ||
| +1-530-243-5047 Phone | ||
| +1-530-241-7532 Fax | ||
| 5.4 | Key Contacts: | Kurtis Montegna |
| Regulatory Affairs Manager | ||
| Kurtis@VitCutter.com | ||
| Susan Cook | ||
| General Manger | ||
| Susan@VitCutter.com | ||
| 5.5 | Trade Name | ProCare PlusTM Vitrectomy System |
| 5.6 | Common Name | Vitrectomy System |
| 5.7 | Classification Name: | 886.4150 Vitreous Aspiration and cutting instrument. |
| Product Codes (HQE) | ||
| 5.8 | Predicate Devices | K980480 - Syntec Vitman - HQC (Primary Predicate Device) |
| K904909 - YPR 2001 - HQE (Secondary Predicate Device) | ||
| K896622 - Intrector - HKP (Secondary Predicate Device) | ||
| 5.9 | Device Description | The ProCare PlusTM Vitrectomy System is a portable surgical system intended for use in both |
| 5.10 System Power | The ProCare Plus™ Vitrectomy System is an AC powered | |
| device with an internal Li-Ion battery that provides backup | ||
| power in the event that AC power is interrupted. | ||
| 5.11 System Control | The system is primarily run from one multifunction | |
| footswitch which gives the surgeon control over all of the | ||
| surgical functions. | ||
| 5.12 System Functions | The ProCare Plus Vitrectomy system provides many of | |
| the functions required by the ophthalmic surgeon for | ||
| performing a vitrectomy including vitreous cutting and | ||
| aspiration, illumination, and fluid-air exchange. | ||
| 5.13 Intended Use: | The ProCare Plus™ Vitrectomy System is a portable | |
| surgical system intended for use in both anterior and | ||
| posterior segment (vitrectomy) ophthalmic surgeries. | ||
| 5.14 Indications for Use: | The PROCARE PLUS™ Vitrectomy System is indicated | |
| for use in support of the following ophthalmic surgical | ||
| procedures: | ||
| Removal of vitreous in cases of vitreous clouding, diabetic vitreal | ||
| hemorrhaging, trauma, including contusions, penetrations, and | ||
| intraocular foreign bodies; opacity, inflammation, endophthalmitis | ||
| (bacterial or fungal), uvitis | ||
| Removal of lens fragments after cataract surgery; | ||
| Remove vitreous traction under the retina producing | ||
| localized or complete retinal detachment; | ||
| Removal of samples of vitreous for diagnostic purposes, i.e. | ||
| endophthalmitis; | ||
| Treatment of vitreous loss during cataract surgery; | ||
| Clean vitreous strands from the cataract wound; | ||
| Provide internal illumination for vitreous surgery; | ||
| Provide air pressure for maintaining intraocular pressure for | ||
| retinal surgery. | ||
| Identical to predicate devices |
anterior and posterior segment (vitrectomy) ophthalmic surgeries.
VisionCare Devices, Inc. FDA Device Registration Number 2939964 +1-530-243-5047, Kurtis@Vitcutter.com, Susan@Vitcutter.com
1
Image /page/1/Picture/0 description: The image shows a logo for VisionCare Devices. The logo includes three mountain peaks above the letters V, C, and D. Above the logo is the number K120170.
1246 Redwood Blvd.
Redding, California 96001
(530) 243-5047
.
2
Image /page/2/Picture/0 description: The image shows a logo for VisionCare Devices. The logo features the letters "VCD" in a stylized font, with a mountain range above the letters. Below the letters is the text "VisionCare Devices" in a smaller font.
(530) 243-5047
| | Current
Submission | Primary Predicate | Secondary Predicates | |
|-------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------------------------|
| | ProCare Plus | Vitman | YPR 2001 | Intrector |
| 510(K) Number | | K980480 | K904909 | K896622 |
| Intended Use | Anterior/Posterior
Ophthalmic
Surgery | Anterior/Posterior
Ophthalmic
Surgery | Anterior/Posterior
Ophthalmic
Surgery | Anterior/Posterior
Ophthalmic
Surgery |
| Computer Based System | No | No | No | No |
| Vitrectomy | | | | |
| Type: | Guillotine | Guillotine | Guillotine | Guillotine |
| Drive Mechanism: | Pneumatic. | Pneumatic | Pneumatic | Pneumatic |
| Maximum Cut Rate: | 3000 cuts/minute | 2000 cuts/minute | 1200 cuts/minute | 1200 cuts/minute |
| Irrigation/Aspiration | Yes | Yes | Yes | Yes |
| Aspiration Type | Electrical | Venturi | Venturi | Syringe |
| Linear Control: | Yes | Yes | Yes | Yes |
| Maximum Vacuum: | 400 mmHg | 400 mmHg | 400 mmHg | Unknown |
| Phacofragmentation | No | Yes | No | No |
| Diathermy | No | No | No | No |
| Fiber Optic Light
Source | Yes | Yes | Yes | No |
| Dual/single output: | Single | Dual | Single | NA |
| Lamp Type: | HB LED | Halogen | Halogen | NA |
| Air Infusion | Yes | Yes | Yes | No |
| Maximum Pressure: | 95 mmHg | 95 mmHg | 95 mmHg | NA |
| Multifunction
Footswitch | Yes | Yes | Yes | No |
| Power | | | | |
| AC Power: | Yes | Yes | Yes | Yes |
| Battery: | Yes | Yes | No | Yes |
Table 1- Predicate Device Comparison Table
. :
・
VisionCare Devices, Inc. FDA Device Registration Number 2939964 +1-530-243-5047, Kurtis@Vitcutter.com, Susan@Vitcutter.com
:
3
Image /page/3/Picture/0 description: The image shows a logo for VisionCare Devices. The logo includes the text "VISIONCARE DEVICES" in a stylized font. Above the text, there is an image of mountains with the letters "VCD" in the foreground and the number "K120170" above the mountains.
1246 Redwood Blvd. Redding, California 96001 (530) 243-5047
| 5.15 Substantial Equivalence Summary - Differences | ||
|---|---|---|
| Predicate Device(s) | ProCare Plus Vitrectomy | |
| System difference | Summary | |
| Venturi Vacuum | ||
| Syringe Vacuum | On-board vacuum pump | The on-board vacuum pump produces the |
| same vacuum characteristics and | ||
| pressures as both the venturi and manual | ||
| syringe vacuum systems. The vacuum | ||
| pump is substantially equivalent to the | ||
| predicate device. | ||
| Halogen Lamps | LED | Halogen lamps have been replaced with a |
| LED lamp that significantly reduces heat | ||
| and significantly reduces "Blue Light | ||
| Toxicity". LED tested to harmonized | ||
| standards and is substantially equivalent to | ||
| the predicate device. | ||
| Ni-Cd Battery | Li-Ion Battery | The Syntec Vitman contained a Ni-Cd |
| battery that allows 10 minutes of | ||
| operational backup power. The ProCare | ||
| Plus™ Vitrectomy System contains a Li-Ion | ||
| battery that provides operational power for | ||
| up to 8 hours. Batteries are rechargeable | ||
| and substantially equivalent to the | ||
| predicate device. |
Operational and technological characteristics form the basis for the determination of substantial equivalence of the ProCare Plus Vitrectomy System with legally marketed predicate devices.
VisionCare Devices, Inc. FDA Device Registration Number 2939964 +1-530-243-5047, Kurtis@Vitcutter.com, Susan@Vitcutter.com
5-4
4
Image /page/4/Picture/0 description: The image shows the text "K120/70" at the top. Below that is a logo with three mountain peaks and the letters "VCD" in a stylized font. Underneath the logo, the words "VISIONCARE DEVICES" are printed in capital letters. The last line of text is illegible.
(530) 243-5047
.
5.16 Non-Clinical Tests
The ProCare Plus Vitrectorny System has passed all safety tests for demonstrated compliance with the applicable non-clinical tests below:
| Standard/Guideline | Title |
|---|---|
| IEC 60601-1 | Medical equipment/medical electrical equipment - Part 1: General |
| requirements for basic safety and essential performance | |
| IEC 60601-1-2 | Medical Electrical Equipment - Part 1: General requirements for safety |
| to collateral Standard: Electromagnetic Compatibility requirements and | |
| tests. | |
| EN ISO 15004-2 | Ophthalmic instruments - Fundamental requirements and test |
| methods -- Part 2: Light hazard protection | |
| ISO 11137-1 | Sterilization of Health Care Product Requirements for Validation and |
| Routine Control-Radiation Sterilization | |
| ISO 11137-2 | Sterilization of health care products-Radiation-Part 2: Establishing |
| the sterilization dose. | |
| ISO 11737-1 | Sterilization of medical devices-Microbiological methods-Part 1: |
| Determination of a population of microorganisms on products. | |
| ISO 11737-2 | Sterilization of medical devices-Microbiological methods-Part 2: |
| Tests of sterility performed in the definition, validation and | |
| maintenance of a sterilization process. | |
| ISO 11607-1 | Packaging for Terminally Sterilized Medical Devices |
| IEC 62471 | Photobiological Safety of lamps and lamp systems |
VisionCare Devices, Inc. FDA Device Registration Number 2939964 +1-530-243-5047, Kurtis@Vitcutter.com, Susan@Vitcutter.com
5
Image /page/5/Picture/0 description: The image shows the logo for VisionCare Devices. The logo includes the text "VisionCare Devices" in a stylized font. Above the text is an image of three mountain peaks with the letters V, C, and D in front of each peak. Above the logo is the text "R120170" in a cursive font.
1246 Redwood Blvd. Redding, California 96001 (530) 243-5047
| In-House Testing | Title |
|---|---|
| P1-112411 | Main AC Electrical System |
| P1-112511 | Internal DC Electrical System |
| P1-112611 | Pneumatic Cutting System |
| P1-112711 | Pneumatic Air Exchange System |
| P1-112811 | Vacuum System |
| P1-112911 | Lightsource |
| P1-113011 | Battery Performance Testing |
| P1-113111 | Pneumatic Handpiece Testing |
| P1-113211 | Ergonomics/Portable System Testing |
| P1-113311 | Medical Air Gas Cylinders & Regulators |
| FP1-113411 | Foot Control |
| P1-051112 | Pneumatic Handpiece HSP Burst Testing |
5.17 Summary of Non-Clinical Tests
Updated technology has been extensively tested to recognized standards. The technological characteristics affecting the performance of the system are substantially equivalent to those of the predicate devices previously listed.
The ProCare Plus Vitrectorny System will be manufactured in compliance with FDA and ISO quality system requirements. System validation and verification will demonstrate that the functional requirements and system specifications have been met prior to commercial release.
Based upon the design, intended use, indications for use, classification, and safety testing the ProCare Plus Vitrectomy System is substantially equivalent, in whole or part, to the listed predicate devices (K980480, K904909, and K896622).
6
Image /page/6/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 or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire. Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
VisionCare Devices, Inc. c/o Mr. Kurtis Montegna Regulatory Affairs Manager 1246 Redwood Blvd. Redding, CA 96003
MAY 3 0 2012
Re: K120170
Trade/Device Name: ProCare Plus Vitrectomy System Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous aspiration and cutting instrument Regulatory Class: II Product Code: HQE Dated: Not Dated Received: May 18, 2012
Dear Mr. Montegna:
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 todevices 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 (reporting of medical
7
Page 2 - Mr. Kurtis Montegna
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
8
Indications for Use
510(K) Number (if known): K120170
Device Name: ProCare Plus Vitrectomy System
Indications For Use:
The VCD HSP VitCutter and Accessories is a single use (disposable) product intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumaticallydriven vitrectomy module.
Prescription use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ·
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
15120170
510(k) Number
Page 1 of 2
9
Indications for Use
510(K) Number (if known): K120170
Device Name: ProCare Plus Vitrectomy System
Indications For Use:
The PROCARE PLUS™ Vitrectorny System is indicated for use in support of the following ophthalmic surgical procedures:
Removal of vitreous in cases of vitreous clouding, diabetic vitreal hemorrhaging, trauma, including contusions, penetrations, and intraocular foreign bodies; opacity, inflammation, endophthalmitis (bacterial or fungal), uvitis
- Removal of lens fragments after cataract surgery; .
- Remove vitreous traction under the retina producing localized or complete retinal detachment; .
- Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis; t
- � Treatment of vitreous loss during cataract surgery;
- . Clean vitreous strands from the cataract wound;
- Provide internal illumination for vitreous surgery; ●
- Provide air pressure for maintaining intraocular pressure for retinal surgery. �
AND/OR Prescription use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K120170
Page 2 of 2