(28 days)
No
The description focuses on mechanical and pneumatic functions, with no mention of AI or ML.
Yes
The device is intended to remove vitreous and dissect tissue in the eye, and perform vitreous aspiration & cutting, membrane cutting & aspiration, and lens removal, which are all therapeutic functions.
No
The device is described as a vitrectomy probe designed for surgical procedures like removing vitreous, dissecting tissue, and supporting aspiration and cutting functions, which are therapeutic rather than diagnostic.
No
The device description clearly states it is a "sterile, single-use pneumatically actuated device" comprised of a "pre-assembled hand piece and tubing," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "remove vitreous and dissect tissue in the eye," "Vitreous aspiration & cutting," "Membrane cutting & aspiration," and "Lens removal." These are all surgical procedures performed on the body, not tests performed on samples taken from the body.
- Device Description: The description details a surgical instrument with cutting and aspiration functions for use during eye surgery. It does not describe a device that analyzes biological samples.
- Anatomical Site: The anatomical site is the "eye," indicating a direct interaction with the body during a procedure.
- Performance Studies: The performance studies focus on mechanical aspects of the device's function (cut quality, aspiration flow, heat generation, metal particulates), not on the accuracy or reliability of diagnostic measurements from biological samples.
IVD devices are designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The HyperVit™ Vitrectomy Probe is a surgical tool used during a procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
HyperVit™ Vitrectomy Probe (23, 25 gauge)
The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended to be used to remove vitreous and dissect tissue in the eye.
HyperVit™ Vitrectomy Probe (27 gauge) The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended for use as follows:
- · Vitreous aspiration & cutting
- Membrane cutting & aspiration
- · Lens removal
- · Dissect tissue in the eye
Product codes (comma separated list FDA assigned to the subject device)
MLZ
Device Description
The HyperVit" Vitrectomy Probe is an accessory to the Constellation® Vision System (K141065, K101285 and K063583). The HyperVit™ Vitrectomy Probe is a sterile, single-use pneumatically actuated device which supports aspiration and guillotine style cutting functions for the purpose of vitreous cutting and aspiration, as well as tissue dissection, in the eye during vitreoretinal or cataract surgery. The HyperVit™ Vitrectomy Probe is comprised of a pre-assembled hand piece and tubing. The tubing assembly interfaces with a Constellation® Vision System console by means of RFID tags at the proximal end of the probe. The HyperVit" Vitrectomy Probe is offered in three different sizes: 23, 25 and 27 gauge.
The HyperVit" Vitrectomy Probe is a modification of the existing UltraVit® Vitrectomy Probes currently used with the Constellation® Vision System. A port opening has been added to the cutter tip to create a second cutting edge. Thus, two cuts are made during a single operating cycle, compared to one cut for the existing UltraVit® Vitrectomy Probes. With an operating actuation speed of 10,000 cycles per minutes, the HyperVit™ Vitrectomy Probe can achieve 20,000 cuts per minute.
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)
Mechanical Testing
- . Cut Quality: Testing was conducted on the vitreous cutting surfaces in order to verify that the forward and return cutting surfaces met the same acceptance criteria for cut quality and cut reliability as the predicate device. Results show that the probe met the acceptance criteria and, therefore, have the same cut quality as the predicate device.
- Aspiration Flow: The aspiration flow characteristics of the HyperVit™ Vitrectomy Probe . at the default vacuum settings were characterized and compared with the predicate device. The flow characteristics of the HyperVit™ Vitrectomy Probe at the default vacuum setting were similar to those of the predicate device as a result of the identical dimensions of the fluid path (e.g., cutter and aspiration tubing). Therefore, the aspiration flow is equivalent to the predicate device.
- Heat Generation: Testing was conducted to measure the temperature increase at the . vitreous cutter tip operated at 150% of HyperVit™ Vitrectomy Probe maximum speed. Testing showed that the maximum temperature increase was 0.8℃ throughout 30 minutes of operation; this is less than the maximum allowed temperature increase at the probe tip of no more than 10°C, based on literature review (Ref: Wu et al., Photochemical damage of the retina. Survey of Ophthalmology, 51(5), 461–481, 2006).
- Metal Particulates: Testing was performed to evaluate whether metal particulates were . generated by the HyperVit™ Vitrectomy Probe during operation. The probe was actuated at the maximum 10.000 cycles per minute in a water container. After running the test continuously for 20 minutes, the filter in the container was microscopy-examined for metal particulate and no particulates were detected, thus meeting the acceptance criteria.
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.
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
Image /page/0/Picture/2 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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human profile in triplicate.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 22, 2017
Alcon Research, Ltd. Karen Mudd. Ph.D. Director. Regulatory Affairs 20511 Lake Forest Drive Lake Forest, CA 92630
Re: K170520
Trade/Device Name: Hypervit Vitrectomy Probe, 23 Ga, Hypervit Vitrectomy Probe, 25+, Hypervit Vitrectomy Probe, 27+ Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration and Cutting Instrument Regulatory Class: Class II Product Code: MLZ Dated: February 16, 2017 Received: February 22, 2017
Dear Dr. Mudd:
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.
1
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 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 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,
Denise L. Hampton -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
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Indications for Use
510(k) Number (if known) K170520
Device Name HyperVit™ Vitrectomy Probe
Indications for Use (Describe)
HyperVit™ Vitrectomy Probe (23, 25 gauge)
The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended to be used to remove vitreous and dissect tissue in the eye.
HyperVit™ Vitrectomy Probe (27 gauge) The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended for use as follows:
- · Vitreous aspiration & cutting
- Membrane cutting & aspiration
- · Lens removal
- · Dissect tissue in the eye
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
(510)k SUMMARY
This 510(k) summary document has been prepared in accordance with Section 21 CFR 807.92.
I. Submitter of the 510(k)
| Company: | Alcon Laboratories, Inc. |
|---|---|
| 6201 South Freeway | |
| Fort Worth, TX 76134-2099, USA | |
| Primary Contact Person: | Karen Mudd, Ph.D. |
| Phone: | 949-505-7269 |
| Fax: | 949-505-6237 |
| Email: | karen.mudd@alcon.com |
| Back up Contact Person: | Amy Tezel, Ph.D. |
| Phone: | 817-363-1513 |
| Fax: | 817-551-4630 |
| Email: | amy.tezel@alcon.com |
| Date Prepared: | 16 February 2017 |
II. Devices Subject to this 510(k)
| Trade Names: | HyperVit™ Vitrectomy Probe |
|---|---|
| Common Name: | Vitrectomy Device |
| Classification Name: | Vitreous Aspiration & Cutting Instrument (21 CFR |
| 886.4150) | |
| Product Code: | MLZ |
III. Predicate Devices
4
Device Description IV.
The HyperVit" Vitrectomy Probe is an accessory to the Constellation® Vision System (K141065, K101285 and K063583). The HyperVit™ Vitrectomy Probe is a sterile, single-use pneumatically actuated device which supports aspiration and guillotine style cutting functions for the purpose of vitreous cutting and aspiration, as well as tissue dissection, in the eye during vitreoretinal or cataract surgery. The HyperVit™ Vitrectomy Probe is comprised of a pre-assembled hand piece and tubing. The tubing assembly interfaces with a Constellation® Vision System console by means of RFID tags at the proximal end of the probe. The HyperVit" Vitrectomy Probe is offered in three different sizes: 23, 25 and 27 gauge.
The HyperVit" Vitrectomy Probe is a modification of the existing UltraVit® Vitrectomy Probes currently used with the Constellation® Vision System. A port opening has been added to the cutter tip to create a second cutting edge. Thus, two cuts are made during a single operating cycle, compared to one cut for the existing UltraVit® Vitrectomy Probes. With an operating actuation speed of 10,000 cycles per minutes, the HyperVit™ Vitrectomy Probe can achieve 20,000 cuts per minute.
Indications for Use V.
HyperVit™ Vitrectomy Probe (23, 25 gauge)
The HyperVit" Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended to be used to remove vitreous and dissect tissue in the eye.
HyperVit™ Vitrectomy Probe (27 gauge)
The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended for use as follows:
- Vitreous aspiration & cutting
- Membrane cutting & aspiration
- Lens removal
- Dissect tissue in the eye
Comparison of Technological Characteristics with the Predicate Device VI.
The technological characteristics of the HyperVit™ Vitrectomy Probe are substantially equivalent to those of the predicate device, as shown in the table below.
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| Characteristic | Predicate Devices
K093305, Enhanced UltraVit Probe
(23 and 25 gauge)
K110951, 27+ UltraVit Probe (27 gauge) | HyperVit Vitrectomy Probe
(23, 25 and 27 gauge) |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 886.4150 | Same |
| Intended use /
Indications for use | K093305, Enhanced UltraVit
Probe (23 and 25 gauge):
The ALCON® Enhanced UltraVit®
Probe is designed for use with the
Constellation® Vision System and is
intended to be used to remove
vitreous and dissect tissue in the eye.
K110951, 27+ UltraVit Probe
(27 gauge):
• Vitreous aspiration & cutting
• Membrane cutting & aspiration
• Remove a crystalline lens
• Dissect tissue in the eye
(The 27 UltraVit Probe is intended to
be used with the Alcon Constellation
Vision System) | 23 and 25 gauge:
The HyperVit™ Vitrectomy
Probe is designed for use with
the Constellation® Vision System
and is intended to be used to
remove vitreous and dissect
tissue in the eye.
27 gauge:
The HyperVit™ Vitrectomy
Probe is designed for use with
the Constellation® Vision System
and is intended for use as
follows:
• Vitreous aspiration & cutting
• Membrane cutting & aspiration
• Lens removal
• Dissect tissue in the eye |
| Power source for cutter
activation | Forward and return pneumatic
pressure pulses | Same |
| Probe needle gauge | 23, 25, 27 | Same |
| Cutting action format | Guillotine | Same |
| Frequency of cutter
activation | Up to 15,000 pulses per minute | Up to 10,000 pulses per minute |
| Cutting port format | Side port, one | Side port, two |
| Cutting rate | Up to 15,000 cuts per minute | Up to 20,000 cuts per minute |
| Aspiration channel | Through the cutter tubing cannula | Same |
| Patient contact material
(direct or through fluid
path) | Stainless steel | Same |
| Overall length of probe
(nominal) | 3.3" | Same |
| Single-use / Reusable | Single use only | Same |
| Shelf-life | Two years | Same |
| Sterile product
packaging | Tyvek pouch | Same |
| Sterility method | EtO-sterilized | Same |
| Gauge identifier | Color coded and molded in the
product | Same |
| Connector | RFID (connectors for pneumatic lines
and luer connectors for aspiration
line) | Same |
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VII. Performance Data
Testing and validations have demonstrated that the functional requirements and specifications have been met. Therefore, the HyperVit" Vitrectomy Probe is as safe and effective as the predicate device. An overview of key performance tests conducted is provided below:
Mechanical Testing
- . Cut Quality: Testing was conducted on the vitreous cutting surfaces in order to verify that the forward and return cutting surfaces met the same acceptance criteria for cut quality and cut reliability as the predicate device. Results show that the probe met the acceptance criteria and, therefore, have the same cut quality as the predicate device.
- Aspiration Flow: The aspiration flow characteristics of the HyperVit™ Vitrectomy Probe . at the default vacuum settings were characterized and compared with the predicate device. The flow characteristics of the HyperVit™ Vitrectomy Probe at the default vacuum setting were similar to those of the predicate device as a result of the identical dimensions of the fluid path (e.g., cutter and aspiration tubing). Therefore, the aspiration flow is equivalent to the predicate device.
- Heat Generation: Testing was conducted to measure the temperature increase at the . vitreous cutter tip operated at 150% of HyperVit™ Vitrectomy Probe maximum speed. Testing showed that the maximum temperature increase was 0.8℃ throughout 30 minutes of operation; this is less than the maximum allowed temperature increase at the probe tip of no more than 10°C, based on literature review (Ref: Wu et al., Photochemical damage of the retina. Survey of Ophthalmology, 51(5), 461–481, 2006).
- Metal Particulates: Testing was performed to evaluate whether metal particulates were . generated by the HyperVit™ Vitrectomy Probe during operation. The probe was actuated at the maximum 10.000 cycles per minute in a water container. After running the test continuously for 20 minutes, the filter in the container was microscopy-examined for metal particulate and no particulates were detected, thus meeting the acceptance criteria.
Safety and Effectiveness Information VIII.
A review of the indications for use and technical characteristics demonstrates that the HyperVit™ Vitrectomy Probe is substantially equivalent to the predicate devices and is safe and effective for use for the stated indications for use.
7
Conclusion IX.
The HyperVit™ Vitrectomy Probe was found to be substantially equivalent to the predicate device.
The HyperVit™ Vitrectomy Probe shares identical indications for use, similar design features and functional features with the predicate device, and thus is substantially equivalent to the predicate device.