(166 days)
MAXReach Laser Probe is indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm to 1100nm. The MAXReach Laser Probe is compatible with the following lasers: Alcon Constellation/Pure Point Lasers, Iridex GL Laser and Ellex Solitaire Laser
MAXReach Laser Probe is a sterile, single use medical device used for delivering laser endophotocoagulation into the posterior segment of the eye. The laser probe is a cable made from one fiberoptic, one laser connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates the surgical site, and protective sheath over the fiber. On one side, the fiberoptic is terminated by a connector that attaches to the laser console. On the other side, it is terminated by Nitinol tubing which penetrates the eye. It can be either 23ga or 25ga. The fiber for laser transmission is made from glass and is restricted for use with the wavelength of 500nm to 1100nm. The total length of the device is 101 inches. The total length of the fiber is 96 inches.
The provided text is a 510(k) summary for the Vortex Surgical MAXReach Laser Probe. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain information related to software-driven device performance, clinical study acceptance criteria, or a study proving device performance against such criteria.
The document primarily focuses on:
- Regulatory information: 510(k) number, regulation details, classification, and general controls.
- Device description: Physical characteristics, materials, and compatibility with laser systems.
- Comparison to a predicate device: Highlighting similarities in indications for use, intended use, wavelength, optical fiber, and other technical characteristics.
- Non-clinical bench testing: This testing involved laser output, laser spot size, laser compatibility, ophthalmic cannula interface, and handle actuation testing. The conclusion states these tests indicate the device operates similarly to the predicate and is safe and effective.
- Risk management: Compliance with ISO 14971.
- Biocompatibility, sterilization, and shelf-life testing.
Therefore, I cannot provide the requested table of acceptance criteria and study details because the provided text does not describe a study proving the device meets acceptance criteria. The document focuses on showing substantial equivalence to a predicate device through engineering and bench testing, not through a clinical performance study with human subjects, which would typically involve the type of acceptance criteria and study design elements you've asked about.
The "study" referenced in the text is "Non-Clinical Bench Testing," which is distinct from a clinical study assessing reader performance.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 23, 2019
Vortex Surgical Inc. Gary Oliveros Consultant 680 Crown Industrial Ct. Suite F Chesterfield, MI 63005
Re: K191846
Trade/Device Name: MAXReach Laser Probe Regulation Number: 21 CFR 886.4690 Regulation Name: Ophthalmic photocoagulator Regulatory Class: Class II Product Code: HQB Dated: November 13, 2019 Received: November 14, 2019
Dear Gary Oliveros:
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 control's provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidanceregulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-devices/medical-devicesafety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-andconsumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Tieuvi Nguyen, Ph.D. Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191846
Device Name Vortex Surgical MAXReach Laser Probe
Indications for Use (Describe)
MAXReach Laser Probe is indicated for use in laser endophotocoagulation procedures in the eye during vitreoretinal surgery at 500nm. The MAXReach Laser Probe is compatible with the following lasers: Alcon Constellation/Pure Point Lasers, Iridex GL Laser and Ellex Solitaire Laser
| 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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Image /page/3/Picture/0 description: The image is a logo for Vortex Surgical. The logo features a large, blue, stylized "V" on the left side. To the right of the "V" is the word "Vortex" in a cursive font, with a swirl design incorporated into the "V". Below "Vortex" is the word "SURGICAL" in a blocky, sans-serif font.
510 (k) Summary Vortex Surgical MaxReach Laser Probe Submitted in accordance with the requirements of 21 CFR 807.92
| Applicant's Name: | Vortex Surgical |
|---|---|
| Address: | 680 Crown Industrial CourtSuite FChesterfield, MO 63005 |
| Contact Person: | Bob NeuDirector, Product Development and QA/RATelephone Number: 314-971-3812Fax: 636-778-4352Email: rneu@vortexsurgical.com |
| Regulatory Contact: | Gary OliverosRegulatory ConsultantTelephone Number - 636 219-5090Email: goliveros1@att.net |
| 510 (k) Number: | K191846 |
| Date Prepared: | December 23, 2019 |
| Device Trade Name: | Vortex Surgical MAXReach Laser Probe |
| Common Name: | Single Use Endo Ocular Laser Probe |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 886.4690 |
| Classification Name: | Photocoagulator and Accessories |
| Product Code: | HQB |
| FDA Panel: | Ophthalmic |
| Predicate Device: | Ophthalmed Directional Laser Probe, K142830 |
| Device Description: |
MAXReach Laser Probe is a sterile, single use medical device used for delivering laser endophotocoagulation into the posterior segment of the eye.
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Image /page/4/Picture/0 description: The image shows the logo for Vortex Surgical. The logo features a large, blue letter V on the left side. To the right of the V is the word "Vortex" in a cursive font, with a swirl design in the center of the "O". Below "Vortex" is the word "SURGICAL" in a bold, sans-serif font.
The laser probe is a cable made from one fiberoptic, one laser connector, one handle for surgeon manipulation, stainless steel tubing extending from the handle which penetrates the surgical site, and protective sheath over the fiber. On one side, the fiberoptic is terminated by a connector that attaches to the laser console. On the other side, it is terminated by Nitinol tubing which penetrates the eye. It can be either 23ga or 25ga. The fiber for laser transmission is made from glass and is restricted for use with the wavelength of 500nm to 1100nm. The total length of the device is 101 inches. The total length of the fiber is 96 inches.
Indications for Use:
MAXReach Laser Probe is indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm to 1100nm. The MAXReach Laser Probe is compatible with the following lasers: Alcon Constellation/Pure Point Lasers, Iridex GL Laser and Ellex Solitaire Laser
| TechnicalCharacteristics | Vortex Surgical MAXReachLaser Probe - K191846 | Ophthalmed Directional LaserProbe - K142830 |
|---|---|---|
| Indications for Use | MAXReach Laser Probe isintended to perform laserendophotocoagulation in theposterior segment of the eye duringvitreoretinal surgery at 500nm to1100nm. The MAXReach LaserProbe is compatible with thefollowing lasers: AlconConstellation/Pure Point Lasers,Iridex GL Laser and Ellex SolitaireLaser. | Ophthalmed Bending Laser Probe isintended to perform laserendophotocoagulation in theposterior segment of the eye duringvitreoretinal surgery at 500nm to1100nm |
| Intended Use | The device is intended to performlaser endophotocoagulation in theposterior segment of the eye duringvitreoretinal surgery. | The device is intended to performlaser endophotocoagulation in theposterior segment of the eye duringvitreoretinal surgery. |
| Wavelength | 500 nm - 1100nm | 500 nm - 1100nm |
| Optical Fiber | Glass Optical Fiber | Glass Optical Fiber |
| Distal End | 304 Stainless Steel with NitinolTubing | 304 Stainless with PEEK |
| Jacketing | PVC to protect the glass fiber | PVC to protect the glass fiber |
| Connector | 905 SMA | 905 SMA |
| Proximal End - Handle | Plastic Handle - Delrin | Plastic Handle |
| Overall Length | 101 inches | 101 inches |
| Cord Length | 96 inches | 96 inches |
| Biocompatibility | CytotoxicitySensitizationIrritationAcute Systemic Toxicity | CytotoxicitySensitizationIrritation |
Comparison of Technical Characteristics:
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Image /page/5/Picture/0 description: The image shows the logo for Vortex Surgical. The logo features a large blue "V" on the left side. To the right of the "V" is the word "Vortex" in a stylized font, with a swirl in the middle of the "o". Below "Vortex" is the word "SURGICAL" in a bold, sans-serif font.
| TechnicalCharacteristics | Vortex Surgical MAXReachLaser Probe - K191846 | Ophthalmed Directional LaserProbe - K142830 |
|---|---|---|
| Pyrogenicity | ||
| Sterilization | Ethylene Oxide in accordance withISO 11135 | Ethylene Oxide in accordance withISO 11135 |
| Sterility Testing | Complies with FDA GuidanceDocument Endotoxin TestingRecommendations for Single-UseIntraocular Ophthalmic Devices | Not known |
| Shelf Life | 3 years | 3 years |
Risk Management:
Risk Management has been implemented for the Vortex Surgical MaxReach Laser Probe and complies with ISO 14971, Medical Devices - Application of Risk Management to Medical Devices. The Vortex Surgical MAXReach Laser Probe is as safe and effective as the predicate device when used as intended.
Summary of Non-Clinical Bench Testing:
Non-Clinical bench testing was performed on both the Vortex Surgical MaxReach Laser Probe and the predicate device. The Non-Clinical Bench Testing included laser output, laser spot size, laser compatibility, ophthalmic cannula interface, and handle actuation testing. The results of the testing indicate the Vortex Surgical MaxReach Laser Probe operates in a similar fashion as the predicate and ensures the Vortex Surgical MaxReach Laser Probe is as safe and effective as the predicate device.
Conclusion:
The Non-Clinical bench testing indicates the device performance for the Vortex Surgical MaxReach Laser Probe is substantially equivalent to the predicate device. Vortex Surgical has demonstrated through, sterility testing, biocompatibility testing, shelf-life testing and non-clinical bench test results that the Vortex Surgical MaxReach Laser Probe is safe and effective as the predicate device and the slight differences between the two raise no new issue of safety or effectiveness.
§ 886.4690 Ophthalmic photocoagulator.
(a)
Identification. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.(b)
Classification. Class II.