(132 days)
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.
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.
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.
Here's a breakdown of the acceptance criteria and study information for the ProCare Plus Vitrectomy System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the ProCare Plus Vitrectomy System as being substantially equivalent to predicate devices. The acceptance criteria are primarily defined by meeting recognized standards and demonstrating equivalence in operational and technological characteristics. The "reported device performance" columns below generally reflect how the ProCare Plus compares or meets these established characteristics.
| Acceptance Criteria (Characteristic) | Predicate Device Performance (Benchmark) | ProCare Plus Vitrectomy System Performance (Reported and Proven) |
|---|---|---|
| Intended Use | Anterior/Posterior Ophthalmic Surgery | Anterior/Posterior Ophthalmic Surgery |
| Vitrectomy: | ||
| Type | Guillotine | Guillotine |
| Drive Mechanism | Pneumatic | Pneumatic |
| Maximum Cut Rate | 2000 cuts/minute (Vitman), 1200 cuts/min (YPR 2001, Intrector) | 3000 cuts/minute (Exceeds predicate devices) |
| Irrigation/Aspiration: | ||
| Aspiration Type | Venturi (Vitman, YPR 2001), Syringe (Intrector) | Electrical (On-board vacuum pump) - claimed substantially equivalent |
| Linear Control | Yes | Yes |
| Maximum Vacuum | 400 mmHg (Vitman, YPR 2001) | 400 mmHg |
| Fiber Optic Light Source: | ||
| Dual/Single Output | Dual (Vitman), Single (YPR 2001) | Single |
| Lamp Type | Halogen | HB LED - claimed substantially equivalent, reduces heat & blue light toxicity |
| Air Infusion: | ||
| Maximum Pressure | 95 mmHg | 95 mmHg |
| Multifunction Footswitch | Yes | Yes |
| Power: | ||
| AC Power | Yes | Yes |
| Battery | Yes (Vitman, Intrector), No (YPR 2001) | Yes (Li-Ion, 8 hours backup) - claimed substantially equivalent, more capacity |
| Safety Standards | Compliance with relevant IEC, ISO, EN standards | Passed all safety tests for demonstrated compliance with: IEC 60601-1, IEC 60601-1-2, EN ISO 15004-2, ISO 11137-1, ISO 11137-2, ISO 11737-1, ISO 11737-2, ISO 11607-1, IEC 62471 |
| In-House Performance Testing | N/A (Internal benchmarks) | Passed internal tests: Main AC Electrical System, Internal DC Electrical System, Pneumatic Cutting System, Pneumatic Air Exchange System, Vacuum System, Lightsource, Battery Performance Testing, Pneumatic Handpiece Testing, Ergonomics/Portable System Testing, Medical Air Gas Cylinders & Regulators, Foot Control, Pneumatic Handpiece HSP Burst Testing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of clinical trials or AI/algorithm performance. The evaluation described is primarily a non-clinical comparative study against predicate devices and adherence to recognized standards. Therefore, information regarding sample size, data provenance, ground truth experts, and adjudication methods for a "test set" as typically understood in AI/imaging studies is not applicable to this submission.
The "test set" here refers to the actual physical device prototypes and components that underwent testing against the listed standards and in-house protocols. The provenance of this would be the manufacturing site of VisionCare Devices, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable, as this is a device substantial equivalence submission, not an AI/algorithm performance study requiring expert ground truth for image interpretation or similar. The "ground truth" for the device's performance is established by objective measurements against established engineering and safety standards.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically used in clinical studies or human-in-the-loop AI evaluations involving subjective assessments or disagreements among experts. The evaluation of this device is based on objective, standardized testing.
5. 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. This submission is for a medical device (vitrectomy system) and does not involve AI or human "readers" in the context of image interpretation or diagnosis. It's a hardware system for surgical procedures.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI product.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is based on:
- Established engineering specifications and performance benchmarks derived from predicate devices.
- Recognized international and national standards (e.g., IEC, ISO, EN) for medical device safety, electromagnetic compatibility, light hazard protection, sterilization, and packaging.
- Internal validation protocols (e.g., P1-112411 to FP1-113411) with their own predefined pass/fail criteria.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that utilizes a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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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) SubmissionType: | This is a traditional 510(K) |
| 5.3 | Submitter/Owner: | VisionCare Devices, Inc.FDA #29399641246 Redwood BoulevardRedding, California 96003+1-530-243-5047 Phone+1-530-241-7532 Fax |
| 5.4 | Key Contacts: | Kurtis MontegnaRegulatory Affairs ManagerKurtis@VitCutter.comSusan CookGeneral MangerSusan@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 powereddevice with an internal Li-Ion battery that provides backuppower in the event that AC power is interrupted. | |
| 5.11 System Control | The system is primarily run from one multifunctionfootswitch which gives the surgeon control over all of thesurgical functions. | |
| 5.12 System Functions | The ProCare Plus Vitrectomy system provides many ofthe functions required by the ophthalmic surgeon forperforming a vitrectomy including vitreous cutting andaspiration, illumination, and fluid-air exchange. | |
| 5.13 Intended Use: | The ProCare Plus™ Vitrectomy System is a portablesurgical system intended for use in both anterior andposterior segment (vitrectomy) ophthalmic surgeries. | |
| 5.14 Indications for Use: | The PROCARE PLUS™ Vitrectomy System is indicatedfor use in support of the following ophthalmic surgicalprocedures: | |
| Removal of vitreous in cases of vitreous clouding, diabetic vitrealhemorrhaging, trauma, including contusions, penetrations, andintraocular foreign bodies; opacity, inflammation, endophthalmitis(bacterial or fungal), uvitis | ||
| Removal of lens fragments after cataract surgery; | ||
| Remove vitreous traction under the retina producinglocalized 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 forretinal 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
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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
.
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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
| CurrentSubmission | Primary Predicate | Secondary Predicates | ||
|---|---|---|---|---|
| ProCare Plus | Vitman | YPR 2001 | Intrector | |
| 510(K) Number | K980480 | K904909 | K896622 | |
| Intended Use | Anterior/PosteriorOphthalmicSurgery | Anterior/PosteriorOphthalmicSurgery | Anterior/PosteriorOphthalmicSurgery | Anterior/PosteriorOphthalmicSurgery |
| 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 LightSource | 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 |
| MultifunctionFootswitch | 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
:
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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 VitrectomySystem difference | Summary |
| Venturi VacuumSyringe Vacuum | On-board vacuum pump | The on-board vacuum pump produces thesame vacuum characteristics andpressures as both the venturi and manualsyringe vacuum systems. The vacuumpump is substantially equivalent to thepredicate device. |
| Halogen Lamps | LED | Halogen lamps have been replaced with aLED lamp that significantly reduces heatand significantly reduces "Blue LightToxicity". LED tested to harmonizedstandards and is substantially equivalent tothe predicate device. |
| Ni-Cd Battery | Li-Ion Battery | The Syntec Vitman contained a Ni-Cdbattery that allows 10 minutes ofoperational backup power. The ProCarePlus™ Vitrectomy System contains a Li-Ionbattery that provides operational power forup to 8 hours. Batteries are rechargeableand substantially equivalent to thepredicate 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
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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: Generalrequirements for basic safety and essential performance |
| IEC 60601-1-2 | Medical Electrical Equipment - Part 1: General requirements for safetyto collateral Standard: Electromagnetic Compatibility requirements andtests. |
| EN ISO 15004-2 | Ophthalmic instruments - Fundamental requirements and testmethods -- Part 2: Light hazard protection |
| ISO 11137-1 | Sterilization of Health Care Product Requirements for Validation andRoutine Control-Radiation Sterilization |
| ISO 11137-2 | Sterilization of health care products-Radiation-Part 2: Establishingthe 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 andmaintenance 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
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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).
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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
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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
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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
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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
§ 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.