(110 days)
Fogarty Thru-Lumen Embolectomy Catheter, K892410
No
The summary describes a mechanical catheter system for removing emboli and thrombi, with no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device is indicated for the removal of emboli and thrombi from within vessels, which is a therapeutic intervention aimed at treating a medical condition.
No
This device is described as an embolectomy catheter used for the removal of emboli and thrombi, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical catheter with a balloon system and valve, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description and Intended Use: The description clearly states the device is a catheter designed for use within vessels in the arterial system and synthetic arteriovenous dialysis fistulae. It is used to physically remove emboli and thrombi from inside the body.
This device is an invasive medical device used for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Hotspur EMBO-Plus Embolectomy Catheter is indicated for use within vessels in the arterial system and synthetic arteriovenous dialysis fistulae for the removal of fresh, soft emboli and thrombi.
Product codes
DXE
Device Description
The proposed EMBO-Plus Embolectomy Catheter is designed for the removal of fresh, soft emboli and thrombi from within vessels in the arterial system and synthetic arteriovenous dialysis fistulae. The EMBO-Plus Embolectomy Catheter is an .035" guide-wire compatible, compliant embolectomy balloon system with a proprietary valve system which allows injection of physician specified agents without the need to remove the guidewire. By providing two functions within the catheter the operator is able to remove fresh, soft emboli and thrombi from within the arterial system and synthetic arteriovenous dialysis fistulae without having to lose guidewire position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels in the arterial system and synthetic arteriovenous dialysis fistulae
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing on the proposed EMBO-Plus Embolectomy Catheter has been completed. The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use. The following Biocompatibility tests were completed:
- ISO MEM Elution Assay
- ASTM Hemolysis Assay
- Complement Activation C3a and SC5b-9 Assay
- Partial Thromboplastin Time
- Four Hour Thromboresistance Evaluation
- Materials Mediated Rabbit Pyrogen
- ISO Guinea Pig Maximization Sensitization
- ISO Acute Systemic Injection Test
- ISO Intracutaneous Reactivity Test
- Pyrogen (LAL) Chromogenic
The proposed EMBO-Plus Embolectomy Catheter was tested in-viro and in an in-vivo animal model to confirm the performance characteristics as compared to the Edwards Fogarty Thru-Lumen Embolectomy Catheter predicate device. The following in-vitro performance bench tests were completed for the EMBO-Plus Embolectomy Catheter:
- Balloon Crossing Profile
- Catheter Shaft Diameter
- Guidewire Lumen Diameter
- Catheter Shaft Markings
- Balloon Working Diameter
- Balloon Inflation/Deflation Time
- Balloon Fatigue
- Catheter Body Burst Strength
- Catheter Bond and Tip Pull Strength
- Catheter Torque Strength
- Contrast Media Flow Rate
- Adherent Clot Removal
- Simulated Use/Flexibility/Kink
- Radiopacity
In-vivo testing for the EMBO-Plus Embolectomy Catheter was completed in accordance with 21 CFR Part 58 "Good Laboratory Practices for Nonclinical Laboratory Studies". Synthetic arteriovenous access grafts were surgically placed in ovine specimens and allowed to mature. Following graft maturation, a simulated procedure was performed on test and control comparator groups. Post procedure animals were survived and observed for a predetermined period. Post survival, vessel and organ histology was completed to compare vessel and organ response to the test and control device treatments.
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the EMBO-Plus Embolectomy Catheter met the established specifications necessary for consistent performance during its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Fogarty Thru-Lumen Embolectomy Catheter, K892410
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
Klooryo
CONFIDENTIAL
Hotspur Technologies, Inc. 510(k) Notification: EMBO-Plus Embolectomy Catheter
SECTION 5.0: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| A. Submitter Information | |
|---|---|
| Submitter's Name: | Hotspur Technologies, Inc. |
| Address: | 880 Maude Ave., Suite A |
| Mountain View, CA 94043 | |
| Telephone: | 650-969-3150 |
| Fax: | 408-608-1597 |
| Contact Person: | Eric Ankerud, Executive Vice President Clinical, Regulatory, |
| Quality | |
| Date of Preparation: | July 6, 2010 |
| JUL 12 2010 | |
| B. Subject Device | |
| Trade Name: | EMBO-Plus Embolectomy Catheter |
| Common/Usual Name: | Embolectomy Catheter |
| Classification Name: | Catheter, Embolectomy (21 CFR 870.5150, Product Code DXE) |
| C. Predicate Device Name(s) | |
| Trade Name(s): | Fogarty Thru-Lumen Embolectomy Catheter, K892410 |
D. Device Description:
The proposed EMBO-Plus Embolectomy Catheter is designed for the removal of fresh, soft emboli and thrombi from within vessels in the arterial system and synthetic arteriovenous dialysis fistulae. The EMBO-Plus Embolectomy Catheter is an .035" guide-wire compatible, compliant embolectomy balloon system with a proprietary valve system which allows injection of physician specified agents without the need to remove the guidewire. By providing two functions within the catheter the operator is able to remove fresh, soft emboli and thrombi from within the arterial system and synthetic arteriovenous dialysis fistulae without having to lose guidewire position.
E. Intended Use:
The Hotspur EMBO-Plus Embolectomy Catheter is indicated for use within vessels in the arterial system and synthetic arteriovenous dialysis fistulae for the removal of fresh, soft emboli and thrombi.
F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:
The proposed Hotspur EMBO-Plus Embolectomy Catheter and the predicate Fogarty Thru-Lumen Embolectomy Catheter have the same intended use. Both are indicated for removal of soft emboli and thrombi. The predicate Fogarty Thru-Lumen Embolectomy Catheter is also indicated for infusion of fluids, temporary occlusion of blood vessels and blood sampling.
The proposed Hotspur EMBO-Plus Embolectomy Catheter has similar technological characteristics as the predicate device. The catheter body of the proposed Hotspur EMBO-Plus Embolectomy Catheter is Nylon and the catheter body of the predicate Fogarty Thru-Lumen Embolectomy Catheter is PVC. The balloon of the proposed Hotspur EMBO-Plus Embolectorny Catheter is Polyurethane and the Balloon of the predicate Fogarty Thru-Lumen Embolectorny Catheter is Latex. The usable length of the proposed EMBO-Plus Catheter is 55 cm whereas the usable length of the predicate Fogarty Thru-Lumen embolectomy Catheter is available in 40 or 80 cm lengths. For removal of emboli and thrombi, inflation of the balloon is done with sterile fluid for both the proposed EMBO-Plus Embolectomy Catheter and the predicate Fogarty Thru-Lumen Embolectomy Catheter. The Fogarty Thru-Lumen Embolectomy Catheter
1
may also be inflated with carbon dioxide gas. The maximum inflated balloon diameter for the proposed EMBO-Plus Catheter is 15 mm whereas the predicate Fogary Thru-Lumen Embolectomy Catheter is available in sizes up to 13 mm. The maximum guidewire size for the proposed EMBO-Plus Embolectomy Catheter is .035" which is the same guidewire size as the predicate Fogarty Thru-Lumen Embolectomy Catheter.
G. Performance Data:
Biocompatibility testing on the proposed EMBO-Plus Embolectomy Catheter has been completed. The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use. The following Biocompatibility tests were completed:
- ISO MEM Elution Assay .
- ASTM Hemolysis Assay ●
- . Complement Activation C3a and SC5b-9 Assay
- . Partial Thromboplastin Time
- Four Hour Thromboresistance Evaluation .
- Materials Mediated Rabbit Pyrogen .
- . ISO Guinea Pig Maximization Sensitization
- . ISO Acute Systemic Injection Test
- . ISO Intracutaneous Reactivity Test
- Pyrogen (LAL) Chromogenic .
The proposed EMBO-Plus Embolectomy Catheter was tested in-viro and in an in-vivo animal model to confirm the performance characteristics as compared to the Edwards Fogarty Thru-Lumen Embolectomy Catheter predicate device. The following in-vitro performance bench tests were completed for the EMBO-Plus Embolectomy Catheter:
- . Balloon Crossing Profile
- Catheter Shaft Diameter .
- . Guidewire Lumen Diameter
- Catheter Shaft Markings .
- . Balloon Working Diameter
- Balloon Inflation/Deflation Time .
- . Balloon Fatigue
- Catheter Body Burst Strength
- . Catheter Bond and Tip Pull Strength
- . Catheter Torque Strength
- . Contrast Media Flow Rate
- . Adherent Clot Removal
- Simulated Use/Flexibility/Kink .
- . Radiopacity
In-vivo testing for the EMBO-Plus Embolectomy Catheter was completed in accordance with 21 CFR Part 58 "Good Laboratory Practices for Nonclinical Laboratory Studies". Synthetic arteriovenous access grafts were surgically placed in ovine specimens and allowed to mature. Following graft maturation, a simulated procedure was performed on test and control comparator groups. Post procedure animals were survived and observed for a predetermined period. Post survival, vessel and organ histology was completed to compare vessel and organ response to the test and control device treatments.
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the EMBO-Plus Embolectomy Catheter met the established specifications necessary for consistent performance during its intended use.
H. Conclusions:
The EMBO-Plus Embolectomy Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs. The EMBO-Plus Embolectomy Catheter is substantially equivalent to the legally marketed predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
JUL 1 2 2010
Hotspur Technologies, Inc. c/o Mr. Eric Ankerud Executive Vice President, Clinical Regulatory and Quality 880 Maude Avenue, Suite A Mountain View, CA 94043
Re: K100840
EMBO-Plus Embolectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: July 6, 2010 Received: July 7, 2010
Dear Mr. Ankerud:
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. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. However, we remind you 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.
3
Page 2 – Mr. Eric Ankerud
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
er R. V. V.
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4.0: INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Indication For Use:
EMBO-Plus Embolectomy Catheter The EMBO-Plus Embolectomy Catheter is indicated for use within vessels in the arterial
system and synthetic arteriovenous dialysis fistulae for the removal of fresh, soft emboli and thrombi.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
R. J. A
(Division Sign-Off) (Division Sign-Om)
Division of Cardiovascular Devices
510(k) Number_k100840_