(15 days)
Not Found
No
The summary describes a mechanical surgical system with aspiration and illumination, and there is no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is used for ophthalmic surgery, which is a therapeutic intervention for medical conditions.
No
The device is described as an "ophthalmic microsurgical system" intended for "posterior segment (i.e. vitreoretinal) ophthalmic surgery." Its components like a vitrector drive, aspiration, and illumination are for performing surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is a "compact, stand-alone, portable device with a pneumatic vitrector drive, aspiration, and illumination through an imbedded solid state LED light source," indicating it is a hardware device with integrated components.
Based on the provided information, the Synergetics VersaVit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "ophthalmic microsurgical system that is indicated for posterior segment (i.e. vitreoretinal) ophthalmic surgery." This describes a surgical tool used on the patient, not a device used to test samples from the patient (which is the definition of an IVD).
- Device Description: The description details a surgical system with a vitrector drive, aspiration, and illumination. These are all components of a surgical instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing diagnostic tests, or providing diagnostic information based on in vitro analysis.
Therefore, the Synergetics VersaVit is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Synergetics VersaVit is an ophthalmic microsurgical system that is indicated for posterior segment (i.e. vitreoretinal) ophthalmic surgery. The integrated light source is intended to illuminate the eye during vitreoretinal procedures.
Product codes (comma separated list FDA assigned to the subject device)
HQE
Device Description
The VersaVit is a compact, stand-alone, portable device with a pneumatic vitrector drive, aspiration, and illumination through an imbedded solid´state LED light source.
The subject device includes 1) a console for controlling the functions and for powering the device; 2) consumable convenience packs, which include fluid aspiration drainage bags; and 3) a control accessory (foot pedal).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior segment (i.e. vitreoretinal) ophthalmic
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)
The VersaVit has undergone testing and is in compliance with the applicable requirements of safety standards. The subject device was found to perform equivalently to the predicate device in a series of bench tests. Therefore, the subject device and the predicate device have similar safety, effectiveness, and performance profiles.
The conclusions performed by independent laboratories and internal comparative bench testing provide objective evidence to substantiate the Synergetics VersaVit is as safe and effective as the predicate device, the Alcon Accurus.
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.
Alcon Accurus, K911808
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
21675
Image /page/0/Picture/1 description: The image shows the word "Synergetics" in bold, black font. To the left of the word is a right-pointing arrow. To the right of the word is the letters "TM" in a smaller font, indicating a trademark.
JUN 2 1 2012
Section 5
510 (k) Summary
Submitted in accordance with the requirements of 21 CFR 807.92
| Applicant's Name and Address: | Synergetics
3845 Corporate Centre Drive
O'Fallon, MO 63368 |
| ------------------------------- | ------------------------------------------------------------------ |
|---|
Contact Person:
Dan Regan, RA Director (T) 636-794-5013 (F) 636-939-6885
Date Prepared: June 21, 2012
Device Trade Name: VersaVit
Common Name: Vitreous Aspiration and Cutting
Regulation Number: 21 CFR 886.4150
Regulation Name: Vitreous Aspiration and Cutting Instrument
Regulatory Class: Class II
Product Code: HQE
FDA Panel: Ophthalmic
Predicate Device: Alcon Accurus, K911808
Device Description . The VersaVit is a compact, stand-alone, portable device Summary: with a pneumatic vitrector drive, aspiration, and illumination through an imbedded solid´state LED light source.
The Synergetics VersaVit is an ophthalmic microsurgical Indications for Use: system that is indicated for posterior segment (i.e. vitreoretinal) ophthalmic surgery. The integrated light
Page 1 of 4
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Image /page/1/Picture/0 description: The image contains the logo for "Synergetics". The logo consists of a geometric shape resembling a diamond made up of smaller squares on the left, followed by the word "Synergetics" in a bold, sans-serif font. There is a superscript "TM" symbol to the right of the word.
Section 5
510 (k) Summary
Submitted in accordance with the requirements of 21 CFR 807.92
source is intended to illuminate the eve during vitreoretinal procedures.
Technological characteristics:
Summary of The Synergetics VersaVit is equivalent to the predicate device, the Alcon Accurus in terms of its intended use, technological characteristics, energy used, materials, and FDA-recognized standards used for performance testing.
The subject device includes 1) a console for controlling the functions and for powering the device; 2) consumable convenience packs, which include fluid aspiration drainage bags; and 3) a control accessory (foot pedal).
A comparison matrix is included below.
Summary of Non-
The VersaVit has undergone testing and is clinical tests: in compliance with the applicable requirements of safety standards. The subject device was found to perform equivalently to the predicate device in a series of bench tests. Therefore, the subject device and the predicate device have similar safety, effectiveness, and performance profiles.
Substantial Equivalence Basis:
The conclusions performed by independent laboratories and internal comparative bench testing provide objective evidence to substantiate the Synergetics VersaVit is as safe and effective as the predicate device, the Alcon Accurus.
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Image /page/2/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric shape that looks like a diamond made up of smaller squares and triangles. The letters are black, and the geometric shape is white with black outlines. The trademark symbol is located at the top right of the word.
Section 5
510 (k) Summary.
Submitted in accordance with the requirements of 21 CFR 807.92
| Element | Synergetics VersaVit
(Subject Device) | Alcon Accurus
(Predicate Device
K911808) |
|---------------------------------------------|------------------------------------------|---------------------------------------------------------|
| Intended Use | Posterior Segment
Vitrectomies | Anterior and Posterior
Segment Ophthalmic
Surgery |
| Microprocessor based | Yes | Yes |
| Aspiration Pump Type | Diaphragm | Venturi |
| Operating Pressure | 72.5 - 120 PSI | 70 - 120 PSI |
| Pneumatic Source | Compressed Air
CO2 cartridges | Compressed Air |
| Unit Height x Weight x
Depth | 10" x 13" x 11" | 20" x 19" x 20.5" |
| Unit weight | 25 pounds | 90 pounds |
| Electrical power
specifications | 100-120V
220-240V
50/60 Hz | 100-120V
220-240V
50/60 Hz |
| Consumable Packs
provided sterile | Yes | Yes |
| Consumable Packs
method of sterilization | ETO | ETO |
3
Image /page/3/Picture/0 description: The image shows the logo for "Synergetics™". The logo consists of a geometric shape resembling a diamond made up of smaller squares on the left, followed by the word "Synergetics" in a bold, sans-serif font. The letters are closely spaced, and the "TM" symbol is placed as a superscript to the right of the word.
Section 5
510 (k) Summary
Submitted in accordance with the requirements of 21 CFR 807.92
| Comparison of Technical Characteristics | ||
|---|---|---|
| Element | Synergetics VersaVit | |
| (Subject Device) | Alcon Accurus | |
| (Predicate Device | ||
| K911808) | ||
| Consumable Packs | ||
| Sterility Assurance | ||
| Level | 10-6 | 10-6 |
Quality Management System:
Synergetics is an ISO 13485 compliant company and is required to ensure our quality management system and design control practices fully comply with internal quality system standards and domestic regulations. Pursuant to our design control process, Synergetics has established a risk management process that ensures during the design validation phase, the safety and effectiveness of the device meets applicable input requirements and complies with applicable harmonized standards.
Risk Management:
Risk Management has been implemented and complies with ISO 14971, Medical Devices - Application of Risk Management to Medical Devices and GHTF/SGS/N15R8, Implementation of Risk Management Principles and Activities within a Quality Management System.
4
Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is black and appears to be printed on a white background. The words are evenly spaced and aligned horizontally.
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 1 2012
Synergetics c/o Mr. Ned Devine Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, IL 60062
Re: K121675
Trade Name: Versa Vit Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous aspiration and cutting instrument Regulatory Class: Class II Product Code: HOE Dated: June 5, 2012 Received: June 6, 2012
Dear Mr. Devine:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 -- Mr. Ned Devine
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/CDRHOffices/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
Enclosure
6
Indications for Use
510(k) Number (if known): K121675
Device Name: Synergetics VersaVit
Indications For Use:
The Synergetics VersaVit is an ophthalmic microsurgical system that is indicated for posterior segment (i.e. vitreoretinal) ophthalmic surgery. The integrated light source is intended to illuminate the eye during vitreoretinal procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 K121675
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