(14 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The "Intended Use" states that the device is for "infusion of various diagnostic, embolic and therapeutic agents" and for "guidewire exchange/support; and superselective angiography". While it can deliver therapeutic agents, the device itself is a delivery vehicle, not a therapeutic device.
No
The device is an infusion microcatheter used to deliver diagnostic, embolic, and therapeutic agents, perform guidewire exchange/support, and conduct superselective angiography. While it aids in procedures that involve diagnostic steps (like angiography), the device itself is a tool for substance delivery and access, not a diagnostic instrument that analyzes or interprets data to determine a diagnosis.
No
The device description clearly details a physical catheter with specific dimensions, materials, and features like a radiopaque marker and luer adapter. The performance studies also involve physical testing of the device's mechanical properties and performance in simulated anatomy. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures." This describes a device used within the body for delivering substances or facilitating procedures, not for testing samples outside the body.
- Device Description: The description details a catheter designed for navigating blood vessels and delivering substances. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on the analysis of such samples.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The EmboCath® Plus Infusion Microcatheter does not fit this description.
N/A
Intended Use / Indications for Use
The EmboCath® Plus Infusion Microcatheter is intended for: infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The EmboCath® Plus Infusion Microcatheter, same as its predicate device EmboCath Hydrophilic Catheter (K003105) is sterile, biocompatible, single use, peripheral vascular catheter constructed of a tapered reinforced shaft, inner lubricious lined lumen, hydrophilic outer surface, radiopaque marker and a standard luer adapter at the proximal end.
The device will be provided in the following configurations:
- . Inner Diameter: 0.028 in.
- . Outer Diameters: 3 F proximally to 2.8 F distally
- Lengths: 100 cm and 135 cm as indicated on product label .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular systems, peripheral vasculatures
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)
In-vitro design verification and validation testing demonstrates that the EmboCath® Plus Infusion Microcatheter is equivalent to its predicate device and fulfills design and performance specifications.
The following design verification testing were performed:
- Visual Inspection
- Dimensional Inspection
- Trackability Test (in simulated anatomy)
- Kink Resistance Test
- Patency Test (for embolic patency)
- Coating Lubricity Test
- Aspiration Test
- Stiffness Test
- Tensile Failure Load Test
- Column Test
- Leak/Burst Test (Static Pressure)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
510(k) Summary EmboCath® Plus Infusion Microcatheter BioSphere Medical, Inc.
AUG - 9 2006
1. SUBMITTER/510(K) HOLDER
BioSphere Medical, Inc. 1050 Hingham Street Rockland, MA 02370 USA
Contact Person: Irina Kulinets Sr. Director Regulatory Affairs and Quality Assurance Telephone: 781-681-7900
Fax: 781-681-5093
Date Prepared: July 26, 2006
2. DEVICE NAME
EmboCath® Plus Infusion Microcatheter Proprietary Name: Common/Usual Name: Infusion Catheter Catheter Intravascular Diagnostic (21CFR 870.1200, Classification Name: DQO)
3. PREDICATE DEVICES
- . EmboCath Hydrophilic Catheter (K003105)
4. DEVICE DESCRIPTION
The EmboCath® Plus Infusion Microcatheter, same as its predicate device EmboCath Hydrophilic Catheter (K003105) is sterile, biocompatible, single use, peripheral vascular catheter constructed of a tapered reinforced shaft, inner lubricious lined lumen, hydrophilic outer surface, radiopaque marker and a standard luer adapter at the proximal end.
The device will be provided in the following configurations:
- . Inner Diameter: 0.028 in.
- . Outer Diameters: 3 F proximally to 2.8 F distally
- Lengths: 100 cm and 135 cm as indicated on product label .
1
న. INTENDED USE
The EmboCath® Plus Infusion Microcatheter is intended for: infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
BioSphere Medical, Inc. bases its claim of the substantial equivalence of the EmboCath® Plus Infusion Microcatheter with the cited predicate device based on intended use, indications for use, fundamental technological characteristics, and fundamental operational characteristics. The function of the EmboCath® Plus Infusion Microcatheter is to facilitate the access of distal vasculature over a guidewire and deliver various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems.
The EmboCath® Plus Infusion Microcatheter is a tapered 3.0-2.8F single lumen catheter designed to facilitate the access of distal vasculature over a guidewire. The catheter has a semi-rigid proximal shaft and becomes progressively more flexible toward the distal end. The shaft is reinforced, which provides improved torque transmission. The inner lumen is lined with a lubricious material to facilitate the movement of guidewires or other devices. The outer diameter of the catheter is coated with a hydrophilic surface to enhance the ability to navigate tortuous anatomy. The distal tip of the catheter has a single radiopaque marker to facilitate fluoroscopic visualization. The hub at the proximal end incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter lumen is 0.028 inches and guidewires measuring up to 0.025 inches (0.635 mm) in diameter are recommended.
7. PERFORMANCE TESTING
In-vitro design verification and validation testing demonstrates that the EmboCath® Plus Infusion Microcatheter is equivalent to its predicate device and fulfills design and performance specifications.
The following design verification testing were performed:
- Visual Inspection ਼
- Dimensional Inspection o
2
- Trackability Test (in simulated anatomy) 0
- Kink Resistance Test o
- Patency Test (for embolic patency) ಂ
- Coating Lubricity Test o
- Aspiration Test o
- Stiffness Test 0
- Tensile Failure Load Test 0
- Column Test o
- Leak/Burst Test (Static Pressure) o
8. PRODUCT FEATURE COMPARISON
| Feature | EmboCath® Plus
Infusion Microcatheter
Subject device | EmboCath Hydrophilic Infusion
Catheter (K003105)
Predicate device |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The EmboCath® Plus
Infusion Microcatheter is
intended for: infusion of
various diagnostic,
embolic and therapeutic
agents into the body's
vascular systems
(peripheral) guidewire
exchange/support; and
superselective
angiography of the
peripheral vasculatures. | The EmboCath® Plus Infusion
Microcatheter is intended for: infusion
of various diagnostic, embolic and
therapeutic agents into the body's
vascular systems (neuro, peripheral,
coronary) guidewire exchange/support;
and superselective angiography of the
peripheral and coronary vasculatures. |
| Design: Length | 100 cm and 135 cm | 100 cm and 135 cm |
| Design:
Internal
Diameter | 0.028 in. | 0.028 in. |
| Design Outer
Diameter: | 0.038 in. distal 30 cm
0.039 in. proximal (65 cm
and 70 cm) | 0.038 in. distal 30 cm
0.039 in. proximal (65 cm and 70 cm) |
| Materials | Predominantly Pebax,
Nylon12, Stainless Steel,
Polyvinylpyrrolidone
(PVP), Polyachrylamide | Predominantly Pebax, Nylon12,
Stainless Steel
Polyvinylpyrrolidone (PVP) |
3
9. SUMMARY OF SUBSTANTIAL EQUIVALENCE
Biosphere Medical, Inc determination of substantial equivalence to EmboCath Hydrophilic Catheter (K003105) predicate device is based on the following. The subject catheter is substantially equivalent to EmboCath Hydrophilic Catheter (K003105) with respect to:
- o Size
- Construction O
- Intended use o
- Performance characteristics O
- Biocompatibility 0
- 0 Packaging
- Sterilization method 0
4
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 9 2006
BioSphere Medical, Inc. c/o Ms. Irina Kulinets 1050 Hingham Street Rockland, MA 02370
Re: K062126
EmboCath Plus Infusion System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (Two) Product Code: DQO Dated: July 26, 2006 Received: July 26, 2006
Dear Ms. Kulinets:
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, listing of devices, good manufacturing 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 may be subject to such 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.
5
Page 2 - Ms. Irina Kulinets
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); 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. 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 marketed 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
R.Z. M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): KO6 J 126
escription USA
EmboCath® Plus Infusion Microcatheter Device Name: Indications For Use:
The EmboCath® Plus Infusion Microcatheter is intended for:
infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures.
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------- | ------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division/Sign-Off) | Division of Cardiovascular Devices |
|---|---|
| 510(k) Number | K062126 |
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AND/OR
er-The-Counter Use