(253 days)
No
The description focuses on the manual nature of the device, its mechanical functions (irrigation/aspiration), and standard performance/biocompatibility testing. There is no mention of AI, ML, image processing, or data-driven decision making.
No
This device is a surgical instrument used to perform a procedure (irrigation and aspiration) and is not intended to treat or cure a disease or condition itself.
No
The device is described as a "manual ophthalmic surgical instrument with irrigation and aspiration functions" for performing procedures, not for identifying or diagnosing a condition.
No
The device description clearly states it is a manual ophthalmic surgical instrument with irrigation and aspiration functions, and describes physical components like a handpiece, knife, and incision sealing sleeve. It also details bench testing, biocompatibility, sterility, and shelf life studies related to physical device performance and materials. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states it's a "manual ophthalmic surgical instrument with irrigation and aspiration functions." This indicates a device used during a surgical procedure on a patient, not a device used to test samples outside the body to diagnose a condition.
- Device Description: It's described as a "manual ophthalmic knife" used in conjunction with an I/A system. This further reinforces its role as a surgical tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
- Performance Studies: The performance studies focus on the device's mechanical functions (irrigation/aspiration rates), biocompatibility, sterility, and shelf life – all typical for a surgical instrument, not an IVD.
In summary, the TrabEx Pro Handpiece is a surgical instrument used for a procedure, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The TrabEx Pro Handpiece is a manual ophthalmic surgical instrument with irrigation and aspiration functions.
Product codes
MRH
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 provide irrigation and aspiration while the procedure is being performed.
TrabEx PRO has an incision sealing sleeve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Bench Testing: The Trabectome was identified as a reference device for demonstration of acceptable performance for the irrigation/aspiration function-under review.
Biocompatibility: TrabEx Pro is an external communicating device with limited (
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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)861-4002 | |||
| www.microsurgical.com | |||
| Date Prepared | June 7, 2022 | ||
| Contact | Dave Scott | ||
| COO | |||
| (425)861-4002 | |||
| info@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 provide | |||
| irrigation 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 and | ||
| aspiration 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 as | |||
| functions that are not subject to FDA premarket review. For this application, if the product has | |||
| functions that are not subject to FDA premarket review, FDA assessed those functions only to | |||
| the extent that they either could adversely impact the safety and effectiveness of the functions | |||
| subject to FDA premarket review or they are included as a labeled positive impact that was | |||
| considered 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 establishing | |||
| irrigation 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 Irrigation | |||
| and Aspiration | Irrigation Rate Min 3 ml/min at | ||
| 40 cm bottle height (0.59 psi) | Irrigation Rate Min 3 ml/min at | ||
| 40 cm bottle height (0.59 psi) | |||
| Aspiration Rate 4 ml/min at no | |||
| more than 250 mmHg (4.8psi) | Aspiration Rate 4 ml/min at no | ||
| more than 250 mmHg (4.8psi) | |||
| Non-Clinical tests | |||
| performed | Bench Testing | The Trabectome was identified as a reference device for | |
| demonstration of acceptable performance for the | |||
| irrigation/aspiration function-under review | |||
| Biocompatibility | TrabEx Pro is an external communicating device with limited ( |