(62 days)
The speX LP Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
The speX LP Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter body with a luer end. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.
Based on the provided text, the acceptance criteria and study information for the speX LP Support Catheter are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use Testing | All specified criteria for safety and performance. | "The speX LP Support Catheter met all specified criteria and did not raise new safety or performance questions." |
| Design Testing | Performance equal to legally marketed predicate devices. | "The design testing performed for the speX LP Support Catheter demonstrated that the performance of the device is equal to the legally marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Simulated Use Testing" and "design testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information about experts, their number, or their qualifications for establishing ground truth. The testing appears to be nonclinical, focusing on device performance rather than clinical diagnostic accuracy.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method, as the testing described is nonclinical.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The device is a support catheter, not an AI or diagnostic tool that would typically involve human readers.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable as the device is a medical catheter, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this device appears to be defined by engineering and performance specifications related to its function as a support catheter, as opposed to a diagnostic ground truth like pathology or outcome data. The stated goal was to meet "specified criteria" and have "performance equal to the legally marketed predicate devices."
8. Sample Size for the Training Set
Not applicable, as this is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is a physical medical device.
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March 18, 2020
Reflow Medical Krystal Santiago Director RA/QA 208 Avenida Fabricante #100 San Clemente, California 92672
Re: K200094
Trade/Device Name: speX LP Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 26, 2020 Received: February 27, 2020
Dear Krystal Santiago:
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 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
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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 (QS) 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,
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Interventional Devices OHT2: Office of Cardiovascular 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)
Device Name speX LP Support Catheter
Indications for Use (Describe)
The speX LP Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
| 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) |
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510(K) SUMMARY
| Contact | ReFlow Medical, Inc.208 Avenida Fabricante#100San Clemente, CA 92672Contact person: Krystal SantiagoPhone: (949) 481-0399 |
|---|---|
| Date Prepared | January 15, 2020 |
| Device | Name of the device: speX LP Support CatheterCommon of usual name: Support CatheterClassification name: Percutaneous CatheterRegulatory Class: 2Product Code: DQY |
| Legally marketed deviceto which your firm isclaiming equivalence | speX Support Catheter (K173662)This predicate has not been subject to a design-related recall |
| Description of the device | The speX LP Support Catheter is a device intended to provide additionalsupport to a steerable guidewire when accessing discrete regions of theperipheral and/or coronary vasculature.The device consists of a support catheter body with a luer end. Thethrough-lumen of the device can serve as a conduit for the delivery ofdiagnostic and therapeutic agents |
| Intended use of thedevice | The speX LP Support Catheter is intended to be used in conjunction withsteerable guidewires to access discreet regions of the peripheralvasculature. It may be used to facilitate placement and exchange ofguidewires and other interventional devices and provide a conduit for thedelivery of saline solutions or diagnostic/therapeutic agents. |
| Summary of the technological characteristics of your device compared to the predicate device | |
| The speX LP Support Catheter is nearly identical to the speX Support Catheter previously cleared(K173662) version of the device. | |
| The subject and predicate devices are based on the following identical technological elements: | |
| ● all delivered to the target site using an over-the-wire percutaneous technique | |
| ● all have a through lumen to allow passage and exchange of guidewires | |
| ● all have a smooth inner lumen to provide reduced friction for guidewire movement | |
| ● all have a polymer catheter shaft with specific geometry to control the torque and pushmovements associated with lesion crossing |
The following technological differences exist between the subject and predicate devices:
- The distal tip of the speX LP support catheter has been modified to replace the one (1) ● radiopaque marker with three (3) lower profile markers.
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A brief discussion of the nonclinical tests submitted
The following performance data were provided in support of the substantial equivalence.
- Simulated Use Testing .
The speX LP Support Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the speX LP Support Catheter was found to have a safety and effectiveness profile that is similar to the predicate device.
Conclusions
The design testing performed for the speX LP Support Catheter demonstrated that the performance of the device is equal to the legally marketed predicate devices.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).