(27 days)
In selective areas of 2.5 mm diameter peripheral and coronary vessels, the uSyringe Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The uSyringe Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.
The EndoBionics uSyringe is a wire-gulded endovascular catheter that consists of a perpendicular microneedle delivery port, which is sheathed by and contained within a semi-rigid polymer balloon actuator. The device is advanced over a 0.014" guidewire, using a single operator method, into the treatment vessel and hydraulically actuated to move the needle delivery port into the vessel in order to deliver substances to 2.5 min vascular structures.
The acceptance criteria and device performance for the EndoBionics MicroSyringe Infusion Catheter are described by a series of engineering tests. The submission states that "The results of the above tests demonstrated that the device is as safe and effective as the legally marketed predicate devices. All components, subassemblies and/or full devices met the required specifications for the above tests."
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Balloon Minimum Burst Strength | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Balloon Compliance (Distensibility) | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Balloon Inflation/Deflation Performance | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Balloon Fatigue | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Bond Strengths | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Catheter Diameter and Balloon Profile | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Tip Pull Test | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Over-the-Arch Torque Strength Test | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Over-the-Arch Torque Response Test | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Balloon Preparation | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Catheter Body Burst Pressure | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Biocompatibility Testing | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| In-vivo Safety | Not explicitly stated, implied by "met all specifications" | Met required specifications |
| Fluid Delivery Performance | Not explicitly stated, implied by "determine performance" | Performance determined, met required specifications |
| Integrity of Device Components | Not explicitly stated, implied by "determine performance" | Integrity determined, met required specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for any of the tests. The data provenance (country of origin, retrospective/prospective) is also not mentioned. These tests appear to be bench and in-vivo safety studies, which are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The study involves engineering and biocompatibility testing, not clinical human-expert-based ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the tests are engineering performance and safety assessments, not expert-adjudicated clinical studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described in the device or its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical infusion catheter and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the engineering and biocompatibility tests would be the established scientific and engineering principles for material properties, mechanical performance, and biological response, and the pass/fail criteria derived from regulatory standards, internal specifications, and predicate device performance. For the in-vivo safety testing, the ground truth would be determined through observation of biological responses and standard histopathological evaluations.
8. The sample size for the training set
This is not applicable as there is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established
This is not applicable as there is no mention of a training set.
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FEB 1 8 2004
LO40139
510(k) Notification EndoBionics MicroSyringe™ Infusion Catheter February 9, 2004
Appendix E 510(k) Summary of Safety and Effectiveness
| Submitted by | Kirk SewardVice President and Chief Technology OfficerEndoBionics, Inc.3077 Teagarden StreetSan Leandro, CA 94577Telephone: 510 614-4550Facsimile: 510 667-0435 | |
|---|---|---|
| Contact Person | Same as above | |
| Date Summary Prepared | February 9, 2004 | |
| Trade Name | EndoBionics MicroSyringe ( $\mu$ Syringe) Infusion Catheter | |
| Common Name | Continuous Flush Infusion Catheter (per 21 CFR 870.1210) | |
| Performance Standards | Not promulgated for Continuous Flush Infusion Catheters | |
| PROCODE/Classification | KRA/Class II | |
| Panel | Cardiovascular | |
| Predicate Devices | Dispatch Coronary Infusion CatheterManufactured by SCIMED Life Systems, Inc. | K932616 |
| Selective Infusion II CatheterManufactured by ACS/Guidant, Inc. | K914751 | |
| Isolate Infusion Catheter SystemManufactured by Lake Region, Inc. | K913517 |
Device Description
The EndoBionics uSyringe is a wire-gulded endovascular catheter that consists of a perpendicular microneedle delivery port, which is sheathed by and contained within a semi-rigid polymer balloon actuator. The device is advanced over a 0.014" guidewire, using a single operator method, into the treatment vessel and hydraulically actuated to move the needle delivery port into the vessel in order to deliver substances to 2.5 min vascular structures.
Intended Use
In selective areas of 2.5 mm diameter peripheral and coronary vessels, the pSyringe Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The uSyringe Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.
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41,139
510(k) Notification EndoBionics MicroSyringe™ Infusion Catheter February 9, 2004
Technological Characteristics
All materials used in the manyfacture of the uSyringe are suitable for this use and have been used in several previously cleared products.
Testing
The following testing was conducted to ensure the uSyringe met all specifications
- Balloon Minimum Burst Strength .
- Balloon Compliance (Distensibility) .
- Balloon Inflation/Deflation Performance .
- Balloon Fatigue .
- Bond Strengths .
- Catheter Diameter and Balloon Profile .
- ア Tip Pull Test
- Over-the-Arch Torque Strength Test *
- Over-the-Arch Torque Response Test ◆
- Balloon Preparation .
- Catheter Body Burst Pressure 4
- . Biocompatibility Testing
- In-vivo Safety .
、
The results of the above tests demonstrated that the device is as safe and effective as the legally marketed predicate devices. All components, subassemblies and/or full devices met the required specifications for the above tests. Additional tests were performed to determine performance of the uSyringe in fluid delivery and integrity of device components.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 18 2004
EndoBionics, Inc. c/o KEMA Quality B.V. Ms. Patricia L. Murphy 4377 County Line Road Chalfont, PA 18914
K040139 Re:
R0-01-9
Trade/Device Name: EndoBionics MicroSyringe (µSyringe) Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: January 20, 2004 Received: January 22, 2004
Dear Ms. Murphy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boodeermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enersburg to regars) the enactment date of the Medical Device Amendments, or to conninered pror to they 2011-11-11 de nees that hat e ocen that do not require approval of a premarket approval application (PMA). and Cosmetic Fee (i're, market the device, subject to the general controls provisions of the Act. The r ou may, morelore, mainer of the Act include requirements for annual registration, listing of general voltarely pro resuring practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your device is exaseries (controls. Existing major regulations affecting your device can may be subject to basil as a sublimations, 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 r lease to advisou that I Dr resum that your device complies with other requirements of the Act that I Dr Has made a wond regulations administered by other Federal agencies. You must or any I edetar statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Ms. Patricia L. Murphy
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Dwane R. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Notification EndoBionics MicroSyringe™ Infusion Catheter February 9, 2004
Appendix J Indications for Use Form
Indications for Use
510(k) Number (if known): 1940139
Device Name: EndoBionics MicroSyringe (μSyringe) Infusion Catheter
Indications For Use:
In selective areas of 2.5 mm diameter peripheral and coronary vessels, the uSyringe Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The pSyringe Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.
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)
Muna R. Vachinel
(Division Sian-Off) Division of Cardiovascular Devices
510(k) Number K 040 | 39
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§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).