(87 days)
Not Found
No
The device description and performance studies focus on the physical components and basic functionality of a sheath introducer kit, with no mention of AI or ML capabilities.
No
A therapeutic device is one that treats a disease or condition. This device is an introducer sheath kit, which facilitates the introduction of cardiovascular catheters but does not directly treat a condition.
No
The device is described as a sheath introducer kit intended to facilitate the percutaneous introduction of cardiovascular catheters into the heart. Its components and functions (e.g., preventing backflow, blood sampling, pressure monitoring, contrast media injection) are all related to introducing and managing access for other medical procedures, not directly diagnosing a condition.
No
The device description clearly outlines multiple physical components including sheath introducers, dilators, introducer catheters, and guide wires. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the percutaneous introduction of cardiovascular catheters into the heart, while preventing backflow of blood." This describes a device used in vivo (within the body) for a procedural purpose (introducing catheters).
- Device Description: The description details components like sheaths, dilators, guide wires, and valves, all designed for physical manipulation and access within the cardiovascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve analyzing biological samples in vitro (outside the body).
The device is clearly a medical device used for a surgical or interventional procedure, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The CryoCor Model 3100 Series Sheath Kits are intended to facilitate the percutaneous introduction of cardiovascular catheters into the heart, while preventing backflow of blood.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Model 3100 Series Sheath Introducer Kit consists of various sheath introducers, each packaged in a kit together with a dilator, introducer catheter and guide wire.
The sheath introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with three-way stopcock is provided for air aspiration, fluid infusion, blood sampling and pressure monitoring. A radioopaque marker at the tip of the sheath will aid during placement while utilizing fluoroscopic guidance. There are side holes at the distal end to allow for injection of contrast media.
The dilator is tapered at the distal tip to allow for use of standard needles for trans-septal procedures, and will accommodate a guide wire or needle no larger than 0.038".
The introducer catheter is gradually tapered distally to allow for gradual dilation of entry into vasculature without producing damage.
The guide wire is 0.038" in diameter, 150 cm in length with a "I"-tip configuration. It is supplied in a hoop dispenser with a "J" straightener attached to the distal end. The proximal end of the hoop dispenser has a luer hub to facilitate flushing of the wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart
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)
Bench testing confirmed that the Model 3100 Series Sheath Kits met all of its design and performance requirements.
Comparison testing found that the Model 3100 Series Sheath Kits performed at least as well as the predicate device.
Biocompatibility testing was performed on the materials which are blood contacting according to ISO 10993-1. All materials were found to be biocompatible.
The Model 3100 Series Sheath Kits are sterilized using a validated E-beam radiation sterilization cycle.
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
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
MAY 2 8 2004
510(k) Summary of Substantial Equivalence
| Date Prepared | March 01, 2004 |
|---|---|
| Submitter | |
| Address | CryoCor, Inc. |
| 9717 Pacific Heights Blvd. | |
| San Diego, Ca 92121 | |
| Contact | Jami Miller |
| Regulatory Affairs Specialist | |
| Phone | 858-909-2231 |
| Fax | |
| E-Mail Address | 858-909-2350 |
| jmiller@cryocor.com | |
| Device Trade Name/ Model Numbers | Model 3100 Series Sheath Kits |
| Model 3110 | |
| Model 3130 | |
| Device Common Name | Catheter Introducer |
| Device Classification Name | Catheter Introducer |
| Classification Regulation | Class II, C.F.R. Section 870.1340 |
| Product Code | DYB |
Device Description
The Model 3100 Series Sheath Introducer Kit consists of various sheath introducers, each packaged in a kit together with a dilator, introducer catheter and guide wire.
The sheath introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with three-way stopcock is provided for air aspiration, fluid infusion, blood sampling and pressure monitoring. A radioopaque marker at the tip of the sheath will aid during placement while utilizing fluoroscopic guidance. There are side holes at the distal end to allow for injection of contrast media.
The dilator is tapered at the distal tip to allow for use of standard needles for trans-septal procedures, and will accommodate a guide wire or needle no larger than 0.038".
The introducer catheter is gradually tapered distally to allow for gradual dilation of entry into vasculature without producing damage.
1
The guide wire is 0.038" in diameter, 150 cm in length with a "I"-tip configuration. It is supplied in a hoop dispenser with a "J" straightener attached to the distal end. The proximal end of the hoop dispenser has a luer hub to facilitate flushing of the wire.
Intended Use
The CryoCor Model 3100 Series Sheath Kits are intended to facilitate the perculaneous introduction of cardiovascular catheters into the heart, while preventing backflow of blood.
Substantially Equivalent Devices
The Model 3100 Series Sheath Kits are substantially equivalent to the Daig Fast-Cath Intra-Cardiac Introducer cleared under K973840 and the Daig Fast-Cath Transseptal Introducer cleared under K964518.
The physical characteristics, the intended use, and the mode of use of the Model 3100 Series Sheath Kits are similar to the predicate device.
Test Summarv
Performance Testing
Bench testing confirmed that the Model 3100 Series Sheath Kits met all of its design and performance requirements.
Pre-Clinical Studies
Comparison testing found that the Model 3100 Series Sheath Kits performed at least as well as the predicate device.
Biocompatibility Information
Biocompatibility testing was performed on the materials which are blood contacting according to ISO 10993-1. All materials were found to be biocompatible.
Sterilization Validation
The Model 3100 Series Sheath Kits are sterilized using a validated E-beam radiation sterilization cycle.
Conclusion
CryoCor, Inc. considers the Model 3100 Series Sheath Kits to be substantially equivalent to their legally marketed predicate device based on the data and information presented within this application.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2004
CryoCor, Inc. c/o Ms. Jami Miller Regulatory Affairs Specialist 9717 Pacific Heights Blvd. San Diego, CA 92121
K040552 Re: Model 3100 Series Sheath Kits Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 1, 2004 Received: March 2, 2004
Dear Ms. Miller:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined 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 I ou may, arorely manns 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 may or dayses to de 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 -- Ms. Jami Miller
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualite of a verse complies with other requirements of the Act that FDA has made a decertifications administered by other Federal agencies. You must or any Federal statutes and regulations damands. but not limited to: registration and listing (21 Comply with an the Fiel 31 cquinements, 110, good manufacturing practice requirements as set CFR Fart 807), adoning (21 OF R Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation oom or provision arketing your device as described in your Section 510(k) This letter will anow you to begin maxicong your antial equivalence of your device to a legally premarket notheation. The PDF intelling sizes cation 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 11 you desire specific acries 101 ) 594-4648. Also, please note the regulation entitled, Connact the Office or Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnational 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,
R. Vachner
Br
Di
Bram D. Zuckerman, M.D. Director Office of Device Evaluation
Division of Cardiovascular Devices Center for Devices and Radiological Health
4
Indications for Use
510(k) Number: K (140557
Device Name: Model 3100 Series Sheath Kits
Indications for Use:
The CryoCor Model 3100 Series Sheath Kits are intended to facilitate the percutaneous introduction of cardiovascular catheters into the heart, while preventing backflow of blood.
Prescription Use
(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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vachner
(Division Sign
(Division Sign-Off) Statution Olgh-Oll)
Division of Cardiovascular Devices
510(k) Number_K040552