(28 days)
No
The description focuses on mechanical function and magnetic coupling, with no mention of AI, ML, or data processing for decision making.
No.
The device is described as an accessory to a system (PleuraFlow® System with FlowGlide®) that proactively removes clots from a chest tube to prevent occlusion. While it contributes to a therapeutic outcome by maintaining chest tube patency, THE ZIP itself is a mechanical accessory (magnetic shuttle) that couples and moves a clearance wire. It does not directly provide therapy (e.g., drug delivery, energy delivery, diagnostic information for treatment). Its function is to facilitate the operation of another system designed for clot clearance.
No
Explanation: The device description states its purpose is to proactively remove clots and maintain the patency of a chest tube post-surgically, which is a therapeutic and maintenance function, not a diagnostic one.
No
The device description clearly states it is a "non-sterile reusable external, hand-held free-standing magnetic shuttle," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: THE ZIP is an accessory to a chest tube system used during and after surgery to clear obstructions in the chest tube. It is a mechanical device that interacts with the chest tube itself, not with a specimen taken from the body.
- Intended Use: The intended use clearly states its purpose is to "proactively remove clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot." This is a mechanical function related to maintaining the patency of a medical device, not analyzing a biological sample for diagnostic purposes.
Therefore, THE ZIP falls under the category of a surgical accessory or a device used in patient care, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
OTK, GBX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest
Indicated Patient Age Range
adult and pediatric patients including infant, preadolescent and adolescent patients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of THE ZIP was shown to be substantially 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
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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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3
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 |
4
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
5
- . 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.