(253 days)
The TrabEx Pro Handpiece is a manual ophthalmic surgical instrument with irrigation and aspiration functions.
The MicroSurgical Technology TrabEx Pro is a single use, sterile, manual ophthalmic knife. The device can be connected to an ophthalmic Irrigation/Aspiration (I/A) system to provide irrigation and aspiration while the procedure is being performed. TrabEx PRO has an incision sealing sleeve.
The MicroSurgical Technology TrabEx Pro is a manual ophthalmic knife with irrigation and aspiration functions. The device was compared to the Trabectome (K040584) to demonstrate substantial equivalence, specifically for its irrigation and aspiration performance.
Here's an analysis of the acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate: Trabectome K040584) | Reported Device Performance (TrabEx Pro) |
|---|---|
| Irrigation Rate: Minimum 3 ml/min at 40 cm bottle height (0.59 psi) | Irrigation Rate: Minimum 3 ml/min at 40 cm bottle height (0.59 psi) |
| Aspiration Rate: 4 ml/min at no more than 250 mmHg (4.8 psi) | Aspiration Rate: 4 ml/min at no more than 250 mmHg (4.8 psi) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance testing of the TrabEx Pro (bench testing). It mentions that "The TrabEx Pro and the Trabectome were tested using the same test methods," implying a comparative bench test.
The data provenance is from bench testing conducted by MicroSurgical Technology, Inc. It does not involve human subjects or clinical data, thus there is no information on country of origin or retrospective/prospective nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device's performance (irrigation and aspiration rates) was established through objective physical measurements in a lab setting, not through expert opinions or clinical evaluation. The performance was directly measured against the specified rates of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. Since the "ground truth" was based on objective physical measurements of flow rates, there was no need for adjudication involving human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This device is a surgical instrument whose performance was evaluated based on physical operating parameters (irrigation and aspiration rates) in a bench test, not on an imaging-based diagnosis or interpretation that would typically involve a multi-reader study.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, in essence. The performance evaluation of the TrabEx Pro for irrigation and aspiration was a standalone assessment of the device's physical capabilities in a controlled bench test environment, without human surgical interaction being part of the primary performance measurement for regulatory submission.
7. The Type of Ground Truth Used
The ground truth used for establishing substantial equivalence was based on objective, quantitative physical measurements of irrigation and aspiration rates, mimicking the performance parameters of the legally marketed predicate device (Trabectome).
8. The Sample Size for the Training Set
Not applicable. This device is a manual surgical instrument, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as point 8.
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June 8, 2022
MicroSurgical Technologies Inc Ms. Angela Mallery Principle Product Development Strategist, Regulatory 8415 154th Ave NE Redmond, Washington 98052
Re: K213173
Trade/Device Name: TrabEx Pro Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: MRH Dated: Mav 3, 2022 Received: May 3, 2022
Dear Ms. Angela Mallery:
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. 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related 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/guidance-regulatory-information/postmarketing-safety-reportingcombination-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-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,
Anjana Jain, PhD Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213173
Device Name TrabEx Pro
Indications for Use (Describe)
The TrabEx Pro Handpiece is a manual ophthalmic surgical instrument with irrigation and aspiration functions.
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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| 510(k) SUMMARY | |||
|---|---|---|---|
| Submitted by: | MicroSurgical Technology, Inc.8415 154th Ave NE Redmond, WA 98052(425)861-4002www.microsurgical.com | ||
| Date Prepared | June 7, 2022 | ||
| Contact | Dave ScottCOO(425)861-4002info@microsurgical.com | ||
| Trade/Proprietary Name | TrabEx Pro | ||
| Regulatory Name and Classification | Infusion Pump;21 CFR 880.5725 (Product code: MRH) | ||
| Predicate | K993039 Bausch & Lomb Storz Millennium Viscous Fluid Injector System | ||
| Reference Devices | K040584 Trabectome | ||
| Device Description | The MicroSurgical Technology TrabEx Pro is a single use, sterile, manual ophthalmic knife.The device can be connected to an ophthalmic Irrigation/Aspiration (I/A) system to provideirrigation and aspiration while the procedure is being performed.TrabEx PRO has an incision sealing sleeve. | ||
| Indications for Use | The TrabEx Pro Handpiece is a manual ophthalmic surgical instrument with irrigation andaspiration functions. | ||
| Comparative Technology Characteristics | The subject and predicate device both include an irrigation and aspiration feature.This medical device product has functions subject to FDA premarket review as well asfunctions that are not subject to FDA premarket review. For this application, if the product hasfunctions that are not subject to FDA premarket review, FDA assessed those functions only tothe extent that they either could adversely impact the safety and effectiveness of the functionssubject to FDA premarket review or they are included as a labeled positive impact that wasconsidered in the assessment of the functions subject to FDA premarket review. | ||
| Technological Characteristics | Irrigation/aspiration performance of the TrabEx Pro was compared to the Trabectome(K040584) to demonstrate substantial equivalence of the TrabEx Pro to the Trabectome.The TrabEx Pro and the Trabectome were tested using the same test methods for establishingirrigation and aspiration rates; the rates are identical. | ||
| Irrigation and Aspiration Rates | |||
| Subject device TrabEx Pro | Trabectome K040584 | ||
| Intended Use | Ophthalmic surgical instrument | ||
| K213177 | |||
| Ability for Irrigationand Aspiration | Irrigation Rate Min 3 ml/min at40 cm bottle height (0.59 psi) | Irrigation Rate Min 3 ml/min at40 cm bottle height (0.59 psi) | |
| Aspiration Rate 4 ml/min at nomore than 250 mmHg (4.8psi) | Aspiration Rate 4 ml/min at nomore than 250 mmHg (4.8psi) | ||
| Non-Clinical testsperformed | Bench Testing | The Trabectome was identified as a reference device fordemonstration of acceptable performance for theirrigation/aspiration function-under review | |
| Biocompatibility | TrabEx Pro is an external communicating device with limited (<24hours) contact with tissue. The device components with direct andindirect tissue contact were assessed for biocompatibility per FDABiocompatibility Guidance "Use of International Standard ISO10993-1, 'Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process,'" andincluded the following tests:• Cytotoxicity (test extract method)• Guinea pig maximization• Ocular Irritation• Acute systemic toxicity• Material mediated pyrogenicityThe primary packaging does not contact the device components withdirect tissue contact and was evaluated using chemicalcharacterization assessment." | ||
| Sterility | The TrabEx Pro was adopted into an existing radiation sterilizationprocess. The radiation sterilization dose range provided a SterilityAssurance Level (SAL) of 10-6 in accordance with FDA Guidance,"Submission and Review of Sterility Information in PremarketNotification (510(k)) Submissions for Devices Labeled as Sterile"issued on January 21, 2016. Limulus Amebocyte Lysate (LAL)testing was performed to support the direct and indirect contactingcomponents of the TrabEx Pro are non-pyrogenic. | ||
| Shelf Life | The labeled 2-year shelf life was supported with device performancetesting and package integrity testing as per ISO 11607-1 and -2:2019, "Requirements for materials, sterile barrier systems andpackaging systems." Samples were aged in compliance with ASTMF1980-16, "Standard Guide for Accelerated Aging of Sterile BarrierSystems for Medical Devices." | ||
| Conclusion | Conclusion(s) drawn from the nonclinical tests demonstrate the device is substantiallyequivalent to the identified legally marketed device. |
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§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).