(28 days)
THE ZIP is an accessory to the PleuraFlow® System with FlowGlide®. It is indicated for use during cardiothoracic surgical procedures and chest trauma. Its Active Clearance Technology® proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. The product is indicated for adult and pediatric patients including infant, preadolescent patients under clinical settings.
THE ZIP accessory is a non-sterile reusable external, hand-held free-standing magnetic shuttle that is used to couple and move the Clearance Wire of the PleuraFlow System. It can be used instead of the PleuraFlow System's integral Shuttle when the user determines that increase of magnetic coupling is needed to break up and clear any tube obstructions or clogging to keep the tube patent.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Decoupling Force | Results from performance testing demonstrate suitability for intended use and do not raise new issues of safety and effectiveness when compared to the predicate device (PleuraFlow System with FlowGlide®). The exact numerical criterion and result are not provided in the summary. |
| Magnetic Flux | Results from performance testing demonstrate suitability for intended use and do not raise new issues of safety and effectiveness when compared to the predicate device. The exact numerical criterion and result are not provided in the summary. |
| Functionality | Performance testing confirmed functionality, demonstrating suitability for intended use and no new safety or effectiveness issues compared to the predicate. Specific functional parameters and outcomes are not detailed. |
| Drop | Drop testing confirmed device robustness, demonstrating suitability for intended use and no new safety or effectiveness issues compared to the predicate. Specific drop test parameters (e.g., height, number of drops) and outcomes are not detailed. |
| Indications For Use | THE ZIP's Indications For Use are the same as the predicate (PleuraFlow System with FlowGlide®). This implies that the device is expected to perform equivalently in its intended clinical applications: proactively removing clots, preventing or minimizing chest tube occlusion, and enabling evacuation of blood and fluid during cardiothoracic surgical procedures and chest trauma. This is a qualitative rather than a quantitative performance metric. |
| Technological Characteristics | Technological characteristics of THE ZIP are similar to the predicate. This suggests design and operational principles are comparable, leading to similar performance and safety profiles. This is a qualitative comparison rather than a quantitative performance metric. |
| Risk-Benefit Analysis | The risk-benefit analysis, verification and validation, and biocompatibility of THE ZIP do not raise any additional concerns regarding safety and effectiveness compared to the predicate. This is a qualitative assessment rather than a quantitative performance metric. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document describes bench testing for THE ZIP accessory. Therefore, there are no "test set" or "data provenance" in the clinical sense (e.g., patient data, country of origin, retrospective/prospective). The "sample size" would refer to the number of individual devices or components tested for each specific bench test. However, the document does not specify the exact number of units tested for Decoupling Force, Magnetic Flux, Functionality, or Drop tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This was a bench testing study, not a study involving human interpretation of medical data. Therefore, no experts were used to establish ground truth in this context.
4. Adjudication Method for the Test Set:
Not applicable. As this was a bench testing study, there was no need for adjudication of expert opinions. The performance metrics were directly measured from the device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. THE ZIP is a mechanical accessory to a medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. THE ZIP is a mechanical device, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance was established through direct physical measurement and observation during bench testing against predefined engineering specifications and functional requirements. These requirements were based on the performance of the legally marketed predicate device (PleuraFlow System with FlowGlide®) which served as the benchmark for substantial equivalence.
8. The Sample Size for the Training Set:
Not applicable. This is a mechanical device, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, for the same reason as above; there is no training set for a mechanical device.
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July 26, 2019
ClearFlow, Inc. Dov Gal Vice President, Regulatory Affairs, Quality Assurance and Clinical 1630 S. Sunkist St. Suite E Anaheim, California 92806
Re: K191733
Trade/Device Name: The ZIP Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OTK, GBX Dated: June 26, 2019 Received: June 28, 2019
Dear Dov Gal:
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.
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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 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 medical devices and radiation-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.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K191733
Device Name THE ZIP
Indications for Use (Describe)
THE ZIP is an accessory to the PleuraFlow® System with FlowGlide®. It is indicated for use during cardiothoracic surgical procedures and chest trauma. Its Active Clearance Technology® proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. The product is indicated for adult and pediatric patients including infant, preadolescent patients under clinical settings.
| 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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510k Premarket Notification
Section 5: 510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for THE ZIP 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
| Date of Submission: | June 26, 2019 |
|---|---|
| Applicant: | ClearFlow, Inc. |
| 1630 S. Sunkist St., Suite E | |
| Anaheim CA 92806 | |
| Primary Contact Person: | Dov Gal, DVM |
| ClearFlow, Inc. | |
| 1630 S. Sunkist St., Suite E | |
| Anaheim CA | |
| 92806 | |
| Phone: 714-916-5014 | |
| Fax: 714-916-5019 | |
| Email: dgal@clearflow.com | |
| CEO/President: | Paul Molloy |
| ClearFlow, Inc. | |
| 1630 S. Sunkist St., Suite E | |
| Anaheim CA | |
| 92806 | |
| Phone: 714-905-5271 | |
| Fax: 714-916-5019 | |
| Email: pmolloy@clearflow.com | |
| Device Proprietary Name: | THE ZIP |
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Device Common Name: Introduction/drainage; wound drain catheter system.
Regulatory Class and Name: Class II, Powered Suction Pump
-
Product Codes: OTK and GBX
Predicate Device: Predicate device is the PleuraFlow System with FlowGlide (K163139) by ClearFlow, Inc. -
Device Description: THE ZIP accessory is a non-sterile reusable external, hand-held free-standing magnetic shuttle that is used to couple and move the Clearance Wire of the PleuraFlow System. It can be used instead of the PleuraFlow System's integral Shuttle when the user determines that increase of magnetic coupling is needed to break up and clear any tube obstructions or clogging to keep the tube patent.
-
THE ZIP is an accessory to the PleuraFlow® System with Indication For Use: FlowGlide® is indicated for use during cardiothoracic surgical procedures and chest trauma. Its Active Clearance Technology proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. The product is indicated for adult and pediatric patients including infant, preadolescent and adolescent patients under clinical settings.
-
The performance of THE ZIP was shown to be substantially Performance Data: equivalent to the PleuraFlow System with FlowGlide® (predicate) through bench testing.
Performance of THE ZIP was verified using the following testing summarized in the submission:
- . Decoupling Force
- . Magnetic Flux
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- . Functionality
- . Drop.
Results from performance testing of THE ZIP demonstrate its suitability for the intended use and do not raise new issues of safety and effectiveness when compared to its predicate.
THE ZIP Indications For Use are the same and technological Conclusion: characteristics are similar to the predicate. Risk benefit analysis, verification and validation and biocompatibility of the subject device do not raise any additional concerns regarding safety and effectiveness. Accordingly, THE ZIP is substantially equivalent to its predicate.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.