(38 days)
Not Found
No
The description focuses on the mechanical components and function of the device (Nitinol basket, pusher wire, radiopaque markers) and mentions guidance via fluoroscopy. There is no mention of AI, ML, or any software-driven analysis or decision-making.
Yes
The device is intended for the non-surgical removal of emboli and thrombi to restore blood flow, which is a therapeutic intervention.
No
The ReVive™ PV Thrombectomy Device is intended for the non-surgical removal of emboli and thrombi and for temporary use in peripheral vessel/graft occlusion, which are therapeutic interventions, not diagnostic functions. While it uses fluoroscopy for guidance, this is for operational purposes, not for diagnosing a condition.
No
The device description clearly outlines physical components like a Nitinol basket, core pusher wire, platinum markers, and a flexible radiopaque tip, indicating it is a hardware device.
Based on the provided information, the ReVive™ PV Thrombectomy Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The ReVive™ PV Thrombectomy Device is a physical device used within the body to remove thrombi and emboli from blood vessels and grafts.
- The intended use and device description clearly state its function is mechanical removal of blockages within the peripheral vasculature. It does not involve analyzing biological samples.
- The device description focuses on its physical components and how it interacts with the body. There is no mention of reagents, assays, or any processes related to analyzing biological specimens.
Therefore, the ReVive™ PV Thrombectomy Device falls under the category of a medical device used for therapeutic intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ReVive™ PV Thrombectomy Device is indicated for:
- · The non-surgical removal of emboli and thrombi from peripheral blood vessels,
- · The non-surgical removal of thrombi from synthetic grafts,
- · Temporary use in peripheral vessel/graft occlusion,
- Use with aspiration and with the injection or infusion of contrast media and other . fluids
Product codes
QEW, OEW, DXE
Device Description
The ReVive" PV (Peripheral Vasculature) Thrombectomy Device is a sterile, disposable, thrombectomy device that is intended to restore blood flow via non-surgical removal of emboli and thrombi from peripheral blood vessels, non-surgical removal of thrombi from synthetic grafts and also for temporary use in peripheral vessel/graft occlusion. The ReVive " PV Thrombectomy Device is radiopaque so that fluoroscopy can be used to guide insertion and verify position as necessary.
The ReVive™ PV Thrombectomy Device consists of a self-expanding Nitinol basket attached to a core pusher wire. Platinum markers at the proximal and distal ends of the basket facilitate visualization under fluoroscopy. A flexible radiopaque tip is attached to the distal aspect of the basket.
The ReVive™ PV Thrombectomy Device is provided as a sterile device and is intended for single patient use only. It is not intended to be resterilized and/or reused. No accessories are provided with the ReVive™ PV Thrombectomy Device. The system is used in conjunction with the appropriately sized microcatheter, as indicated in the proposed Instructions for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Peripheral blood vessels, synthetic grafts
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:
- Radial Force Test
- Tip Deflection Force
- Rapid Flow Restoration
- Corrosion
- Tensile Testing
- Track Test
- Cyclic Fatigue
- Deploy and Recapture
- Torsion
- Force for Recapture
- Biocompatibility testing in accordance with ISO 10993-1: 2009
- I Cytotoxicity
- I Sensitization
- I Pyrogenicity
- Irritation: Intracutaneous Reactivity
- l Acute Systemic Toxicity
- I Hemocompatibility: hemolysis
- Thrombogenicity
- I Complement Activation
- Partial Thromboplastin Time (PTT)
- Sterilization method validation in accordance with ISO 11137: 2006
- Bioburden measurement
- Identify top three organisms
- I Bioburden recovery study (Extraction efficiency)
- Verification dose experiment
- Bacteriostasis/Fungistasis (B/F)
- 트 Confirmatory dose experiment (if Sterility Test fails)
- LAL Validation I
- Packaging Validation in accordance with ISO 11607-1: 2006 and ISO 11607-2: ● 2006
- Package Integrity Testing
- Dye Leak
- Seal Strength Testing
Key Results: Test results demonstrated that all acceptance criteria were met, and, therefore, the ReVive PV Thrombectomy Device conforms to expected device performance and intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.
July 27, 2020
Codman & Shurtleff, Inc. Amarilys Machado Sr. Manager, Regulatory Affairs 325 Paramount Dr. Raynham, Massachusetts 02767-0350
Re: K132281
Trade/Device Name: ReVive PV (Peripheral Vasculature) Thrombectomy Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW
Dear Amarilys Machado:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 30, 2013. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory. Oconnell@FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. O'connell -S Date: 2020.07.27 08:19:38 -04'00
Gregory O'Connell Assistant Director Plaque Modification Devices Team DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 29, 2019
Codman & Shurtleff, Inc. Amarilys Machado Sr. Manager, Regulatory Affairs 325 Paramount Dr. Raynham, MA 02767
Re: K132281
Trade/Device Name: Revasc Thrombectomy Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: OEW Dated: July 22, 2013 Received: July 23, 2013
Dear Ms. Amarilys Machado:
This letter corrects our substantially equivalent letter of August 30, 2013.
We have reviewed vour 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
2
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
| Gregory
O'Connell | 2019.04.29
12:59:52 -04'00' |
|--------------------------------------------|--------------------------------|
| For | |
| Bram D. Zuckerman, M.D. | |
| Director | |
| Division of Cardiovascular Devices | |
| Office of Device Evaluation | |
| Center for Devices and Radiological Health | |
Enclosure
3
SECTION 4.
INDICATIONS FOR USE STATEMENT
510(k) Number: K132281
Device Name: ReVive™ PV Thrombectomy Device
The ReVive™ PV Thrombectomy Device is indicated for:
- · The non-surgical removal of emboli and thrombi from peripheral blood vessels,
- · The non-surgical removal of thrombi from synthetic grafts,
- · Temporary use in peripheral vessel/graft occlusion,
- Use with aspiration and with the injection or infusion of contrast media and other . fluids
Prescription Use AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bram D. Zuckerman -S 2013.08.30 12:47:01 -04'00'
4
SECTION 5. 510(k) SUMMARY
(As Required By 21 CFR 807.92(a))
A. Company Information
| Company Name: | Codman & Shurtleff, Inc. |
|---|---|
| Address: | 325 Paramount Drive |
| Raynham, MA 02767 | |
| Telephone: | (305) 265-6869 |
| Fax: | (305) 265-6889 |
| Contact Person: | Amarilys Machado |
| Date of Submission: | July 22, 2013 |
| B. Trade/Device Name: | The ReVive™ PV Thrombectomy Device |
| Common Name: | Embolectomy Catheter |
| Classification Name: | Embolectomy Catheter |
| Regulation Number: | 21 CFR 870.5150 |
| Product Code: | DXE |
C. Predicate Device Information:
| Table 1. Prior 510(k) Clearances | |||
|---|---|---|---|
| 510(k) | |||
| Number | Date | ||
| Cleared | Name | Manufacturer | |
| K092623 | |||
| Predicate | 10/30/09 | F.A.S.T. System SED (Self Expanding | |
| Device) and F.A.S.T CXD (Controlled | |||
| Expansion Device) | Genesis Medical | ||
| Interventional Inc.* | |||
| *On 01/18/10, certain assets of Genesis Medical Inc. were acquired by Micrus | |||
| Endovascular Corporation. Effective 09/27/10, Micrus Endovascular Corporation was | |||
| acquired by Johnson & Johnson and now operates as a wholly-owned subsidiary of Codman | |||
| & Shurtleff within the Johnson & Johnson family of companies. |
5
D. Device Description:
The ReVive" PV (Peripheral Vasculature) Thrombectomy Device is a sterile, disposable, thrombectomy device that is intended to restore blood flow via non-surgical removal of emboli and thrombi from peripheral blood vessels, non-surgical removal of thrombi from synthetic grafts and also for temporary use in peripheral vessel/graft occlusion. The ReVive " PV Thrombectomy Device is radiopaque so that fluoroscopy can be used to guide insertion and verify position as necessary.
The ReVive™ PV Thrombectomy Device consists of a self-expanding Nitinol basket attached to a core pusher wire. Platinum markers at the proximal and distal ends of the basket facilitate visualization under fluoroscopy. A flexible radiopaque tip is attached to the distal aspect of the basket.
The ReVive™ PV Thrombectomy Device is provided as a sterile device and is intended for single patient use only. It is not intended to be resterilized and/or reused. No accessories are provided with the ReVive™ PV Thrombectomy Device. The system is used in conjunction with the appropriately sized microcatheter, as indicated in the proposed Instructions for Use.
An overview of the main components comprising the ReVive™ PV Thrombectomy Device is presented in Table 2, followed by illustrative representation in Figure 1.
6
| Table 2. ReVive™ PV Thrombectomy Device Components | |
|---|---|
| Component* | Description |
| Introducer Sheath | The device is packaged such that the basket is constrained within a polymer |
| introducer sheath. The device is designed to be front-loaded via the introducer | |
| sheath into the proximal hub of a 0.027 inch inner diameter microcatheter. | |
| Soft Distal Tip (A) | A short atraumatic guidewire type element extends distal to the distal termination of |
| the basket. The Soft Distal Tip also has a platinum maker affixed for visualization | |
| purposes. | |
| Distal (B)/ Proximal (F) | |
| Radiopaque Marker | As stated above, the Distal Tip serves as the distal radiopaque marker using a |
| platinum coil. The proximal radiopaque marker is also provided via a platinum | |
| coil, covering the tapered portion of the core pusher wire from the proximal | |
| junction of the basket and extending 13cm proximally. | |
| Distal End / Distal | |
| Mesh (C) | The basket terminates distally to the Soft Distal Tip radiopaque marker as a mesh |
| having a higher strut density than the proximal end. | |
| Basket (D) | A permanently affixed self-expanding basket element. The basket is attached near |
| the distal end of the pusher wire. The basket is self-expanding when deployed out of | |
| the microcatheter and reduces into the microcatheter when reconstrained. | |
| Proximal End / | |
| Proximal Mesh (E) | The basket terminates proximally to the core pusher wire as a mesh having a lower |
| strut density than the distal end. | |
| Core Pusher Wire (G) | The proximal portion of the core pusher wire is similar to a standard core pusher |
| wire. The remaining distal portion of the core pusher wire is tapered to a smaller | |
| diameter and is attached to the "Basket". | |
| *The letters following the component name refer to the letters used in Figure 1. |
Image /page/6/Figure/3 description: This image is titled "Figure 1. Basket Design and Distal Tip". The image shows a basket design with labels A through G. The labels correspond to the following items: Soft Distal tip, Distal radiopaque marker, Distal end / Distal mesh, Basket, Proximal end / Proximal mesh, Proximal radiopaque marker, and Core pusher wire.
7
E. Intended Use:
The ReVive™ PV Thrombectomy Device is indicated for:
- · The non-surgical removal of emboli and thrombi from peripheral blood vessels,
- · The non-surgical removal of thrombi from synthetic grafts,
- · Temporary use in peripheral vessel/graft occlusion,
- Use with aspiration and with the injection or infusion of contrast media and other ● fluids
F. Summary of technological characteristics of the proposed device to the predicate device:
The ReVive™ PV Thrombectomy Device, (the basket, core pusher wire, radiopaque markings and introducer sheath), is identical to the predicate F.A.S.T System SED with regard to design, material, function, mechanism of action, clinical utility and manufacturing processes.
Compared to the predicate device, device modifications for the ReVive™ PV Thrombectomy Device include a change of sterilization method and product shelf life, and modifications to product labeling and packaging. Labeling changes are focused on rebranding the product with updated directions for use, including clarification and simplification of the product intended use and directions for use.
Table 3 provides a comparison of the regulatory information and intended use for the predicate and subject devices.
No new technological characteristics are being introduced with the proposed device. A summary table including characteristics of the proposed device compared with those of the predicate device is provided in Table 4.
8
| Characteristic | F.A.S.T. System SED | ReVive PV Thrombectomy Device |
|---|---|---|
| (Predicate Device) | (Subject Device) | |
| 510(k) Number | K092623 | To Be Assigned |
| Clearance Date | 10/30/09 | To Be Assigned |
| Classification Name | Embolectomy Catheter | Embolectomy Catheter |
| Product Code | DXE | DXE |
| FDA Regulation | 870.5150 | 870.5150 |
| Indication | • The non-surgical removal of emboli and thrombi from | |
| blood vessels, | ||
| • The non-surgical removal of thrombi from synthetic grafts, | ||
| • Temporary use in vessel/graft occlusion, | ||
| • Injection, infusion, and/or aspiration of contrast media and | ||
| other fluids into or from a vessel/graft, and | ||
| • Catheter placement over a guidewire | • The non-surgical removal of emboli and thrombi | |
| from peripheral blood vessels, | ||
| • The non-surgical removal of thrombi from synthetic | ||
| grafts, | ||
| • Temporary use in peripheral vessel/graft occlusion, | ||
| • Use with aspiration and with the injection or infusion | ||
| of contrast media and other fluids |
9
| Table 4. Comparison of Subject and Predicate Devices: Device Characteristics | ||||
|---|---|---|---|---|
| Characteristic | F.A.S.T. System SED | ReVive PV Thrombectomy Device | ||
| (Predicate Device) | (Subject Device) | |||
| GENERAL DESIGN | ||||
| Thrombectomy Mechanism | Compressed basket deployment | Same as predicate device | ||
| Microcatheter compatibility | 0.021 inch (0.533 mm) Inner Diameter microcatheters | 0.027 inch (0.686 mm) Inner Diameter microcatheters | ||
| Guidewire compatibility | 0.014 inch systems | Same as predicate device | ||
| Introducer Mechanism | Introducer sheath and core pusher wire | Same as predicate device | ||
| Radiopacity | Proximal and distal end markers | Same as predicate device | ||
| Sterilization method | Ethylene Oxide | eBeam Irradiation | ||
| Shelf Life | 1 year | 3 years | ||
| MATERIALS | ||||
| Distal Tip | Nitinol, platinum | Same as predicate device | ||
| Catheter hub | Nvlon | Same as predicate device | ||
| Core pusher pusher Wire | Nitinol | Same as predicate device | ||
| DIMENSIONS | ||||
| Basket length | 22 mm - 28 mm; full expansion into sheath/microcatheter | |||
| (engaging portion) | Same as predicate device | |||
| Basket Diameter | 0.6 mm (in sheath/microcatheter) | Same as predicate device | ||
| Basket Working Length | 22 mm to 28 mm for 1.5 mm to 5.0mm vessel range. | Same as predicate device | ||
| Expanded Basket Diameter | 4.5 mm | Same as predicate device | ||
| Distal Tip Length | 6 mm | Same as predicate device | ||
| PACKAGING | ||||
| Configuration | 1, 5 or 10 pouched devices and one (1) IFU into one (1) carton | One (1) device and one (1) IFU placed into one (1) carton | ||
| Protective enclosure | Device placed into PETG formed tray | Device placed into a medical grade polyethylene dispenser hoop | ||
| with a thermoplastic clip to hold the wire | ||||
| Sterility barrier | Tyvek/polyethylene film thermo sealed pouch | Polyester Film/LD Polyethylene thermo sealed pouch | ||
| Labels | Inner (pouch) and outer (carton) | Same as predicate device | ||
| Carton | Chipboard box | Reverse tuck end style carton with thumb notch, 24 point | ||
| chinboard |
10
G. Summary of Nonclinical Testing:
No new technological characteristics are being introduced with the proposed ReVive" PV Thrombectomy Device and the design, materials, mechanism of action, performance specifications, and clinical utility of the device are the same as the predicate device (K092623). Codman performed non-clinical testing necessary to demonstrate substantial equivalence to the predicate device. Bench testing was conducted using the same test methods as the predicate device. Resulting data demonstrated that the ReVive" PV Thrombectomy Device performed according to the established performance characteristics of the predicate device.
Bench Testing
In alignment with the Design Risk Assessment, verification and validation testing was identified as appropriate to support device modifications. This testing demonstrated equivalence between the proposed and predicate device, and also that modifications made had no impact to device performance.
The following verification and validation testing was conducted:
- Radial Force Test
- Tip Deflection Force ●
- Rapid Flow Restoration ●
- Corrosion ●
- Tensile Testing
- Track Test
- Cyclic Fatigue
- Deploy and Recapture
- Torsion ●
- Force for Recapture
- Biocompatibility testing in accordance with ISO 10993-1: 2009 ●
- I Cytotoxicity
- I Sensitization
- I Pyrogenicity
- Irritation: Intracutaneous Reactivity
- l Acute Systemic Toxicity
- I Hemocompatibility: hemolysis
11
■
- Thrombogenicity
- I Complement Activation
- Partial Thromboplastin Time (PTT)
- · Sterilization method validation in accordance with ISO 11137: 2006
- Bioburden measurement
- Identify top three organisms
- I Bioburden recovery study (Extraction efficiency)
- Verification dose experiment
- Bacteriostasis/Fungistasis (B/F) ■
- 트 Confirmatory dose experiment (if Sterility Test fails)
- LAL Validation I
- Packaging Validation in accordance with ISO 11607-1: 2006 and ISO 11607-2: ● 2006
- Package Integrity Testing
- Dye Leak
- Seal Strength Testing
Test results demonstrated that all acceptance criteria were met, and, therefore, the ReVive PV Thrombectomy Device conforms to expected device performance and intended use.
H. Summary of Clinical Testing:
No clinical studies were required as appropriate verification and validation of device modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Conclusion:
Based upon the design, materials, function, intended use, and the non-clinical testing performed by Codman & Shurtleff, Inc., it is concluded that the ReVive™ PV Thrombectomy Device is substantially equivalent to the F.A.S.T. System SED, and therefore, does not raise any new questions of safety and effectiveness.